Delivery and retrieval devices and methods for laterally deliverable transcatheter prosthetic valves

Abstract

A delivery system for laterally delivering a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end, the first perimeter being larger than a second perimeter at a distal end of the lumen. A loading device is coupleable to the compression device and defines a lumen having approximately the second perimeter. The distal end of the loading device includes a first door 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 approximately the second perimeter. The proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second door movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of the following provisional patent applications: U.S. Provisional Patent Application No. 63 / 038,807, filed on June 13, 2020, entitled “Retrieval Device and Method for Side-Deliverable Transcatheter Prosthetic Valves”; U.S. Provisional Patent Application No. 63 / 027,345, filed on May 19, 2020, entitled “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, entitled “Wrap Around Anchor Arm and Catheter Delivery System for Side-Delivered Transcatheter Heart Valve Prosthesis”; and U.S. Provisional Patent Application No. 62 / 891,964, filed on August 27, 2019, entitled “Loader System for Side-Delivered Transcatheter HeartValve Prosthesis”. Prosthesis"; the disclosures of each of which are incorporated herein by reference in their entirety. Background Art

[0003] The embodiments described herein relate generally to transcatheter prosthetic valves, and more particularly to delivery and / or retrieval devices and methods for laterally deliverable transcatheter prosthetic valves.

[0004] Artificial heart valves may present challenges to delivery, deployment and / or retrieval within the heart, particularly for delivery by catheter through the patient's vasculature rather than by surgical methods. Delivery of conventional transcatheter artificial valves typically involves compressing the valve in a radial direction and loading the valve into a delivery catheter so that the central annular axis of the valve 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 outward from the central annular axis in a radial direction. However, the expanded size (e.g., diameter) of a conventional valve may be limited by the inner diameter of the delivery catheter. Competing interests in minimizing the size of the delivery catheter pose challenges to increasing the expanded diameter of conventional valves (e.g., attempting to compress too much material and structure into too small a space). In addition, the orientation of conventional valves during deployment may pose additional challenges when attempting to align the valve with the native valve annulus.

[0005] Some transcatheter artificial valves can be configured for lateral and / or orthogonal delivery, which can allow the expanded diameter of the valve delivered laterally to be increased relative to traditional valves. For example, in lateral (orthogonal) delivery, the valve can be in a compressed configuration or a delivery configuration and loaded into a delivery catheter so that the central annular axis of the valve is substantially perpendicular and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. More specifically, the valve can be compressed axially (e.g., along the central annular axis) and laterally (e.g., perpendicular to each of the central annular axis and the longitudinal axis of the valve), and longitudinally (e.g., in a direction parallel to the longitudinal or longitudinal axis of the delivery catheter) uncompressed or stretched. The compressed valve (e.g., the valve in the delivery configuration) can be loaded into a delivery catheter, advanced through the lumen of the delivery catheter, and deployed from the end of the delivery catheter. In addition, the valve delivered laterally is typically in a desired orientation relative to the native valve annulus when deployed from the end of the delivery catheter.

[0006] However, in some implementations, challenges associated with compressing the sideways deliverable valve and / or loading the valve into the delivery system may persist. Furthermore, in some cases, it may be desirable to retrieve or at least partially retrieve the valve from the end of the delivery catheter after deployment.

[0007] Therefore, a need exists for delivery and / or retrieval devices and methods for laterally deliverable transcatheter prosthetic valves. Summary of the Invention

[0008] Embodiments described herein relate to laterally deliverable prosthetic valves and devices and / or methods for delivering and / or retrieving such laterally deliverable prosthetic valves. In some embodiments, a delivery system for laterally delivering a transcatheter prosthetic valve comprises a compression device, a loading device, and a delivery device. The compression device defines a lumen extending through a proximal end and a distal end, wherein the lumen at the proximal end has a perimeter greater than the perimeter of the lumen at the distal end. The loading device defines a lumen extending through its proximal and distal ends. The perimeter of the lumen of the loading device is substantially similar to the perimeter of the lumen of the compression device at the distal end. The proximal end of the loading device is capable of coupling to the compression device, and the distal end of the loading device comprises a first door that is movable between an open state and a closed state, wherein in the closed state, the first door at least partially blocks the lumen of the loading device. The delivery device comprises a handle and a delivery catheter extending distally from the handle. The handle and the delivery catheter together define a lumen extending through the delivery device. The perimeter of the lumen of the delivery device is substantially similar to the perimeter of the lumen of the loading device. The proximal end of the handle is coupleable to the distal end of the loading device and includes a second door movable between an open state and a closed state in which the second door at least partially occludes the lumen of the delivery device. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A and Figure 1B are front view schematic illustrations of a side-delivery transcatheter prosthetic heart valve (also referred to herein as a "prosthetic valve") according to one embodiment, and shown in expanded and compressed configurations, respectively.

[0010] Figure 1C and Figure 1D yes Figure 1A and Figure 1B Schematic top view of an artificial valve, shown in expanded and compressed configurations, respectively.

[0011] Figure 1E yes Figures 1A to 1D Schematic diagram of a prosthetic valve deployed within the annulus of a native heart valve.

[0012] Figure 2A and Figure 2B is a schematic side view of a prosthetic valve in a first configuration and a second configuration, respectively, according to one embodiment.

[0013] Figure 2C and Figure 2D yes Figures 2A to 2BSchematic bottom view and schematic side view of an artificial valve of FIG, and are shown in a second configuration and a third configuration, respectively.

[0014] Figures 3A to 3C are schematic diagrams of an outer frame of a laterally delivered transcatheter prosthetic heart valve according to one embodiment, shown in a delivery configuration, a seating configuration, and a deployed configuration, respectively.

[0015] Figure 4 is a perspective view of a prosthetic valve according to one embodiment.

[0016] Figure 5 yes Figure 4 A top perspective view of the supra-annular region of the outer support frame of a prosthetic valve is shown.

[0017] Figure 6 yes Figure 4 A distal perspective view of the trans-annular region of the outer support frame of a prosthetic valve is shown.

[0018] Figure 7 yes Figure 4 A distal perspective view of the subannular region of the outer support frame of a prosthetic valve is shown.

[0019] Figure 8 yes Figure 4 A top perspective view of the inner frame of a flow control component included in a prosthetic valve is shown.

[0020] Figure 9 is a side perspective view of a leaflet band having an inner flow control component with leaflet pockets sewn into the structural band and shown in a position suitable for coupling to Figure 8 The inner frame has a cylindrical configuration.

[0021] Figure 10 yes Figure 9 Bottom view of the leaflet band in a cylindrical configuration and showing the partial coaptation of the leaflets forming a partially closed fluid seal.

[0022] Figures 11 to 14 is a bottom perspective view of a laterally delivered transcatheter prosthetic heart valve according to one embodiment and illustrating a sequence of actuating one or more portions of the prosthetic valve to reduce the perimeter and / or circumference of the subannular member to facilitate deployment of the valve in the native annulus.

[0023] Figure 15 and Figure 16 Top and bottom perspective views, respectively, of a prosthetic valve removably coupled to at least a portion of a delivery and / or actuation system, according to one embodiment.

[0024] Figures 17 to 20is a bottom perspective view of a prosthetic valve according to one embodiment and illustrating the process of transitioning a proximal anchoring element of the prosthetic valve between a first configuration and a second configuration.

[0025] Figure 21 and Figure 22 are side perspective and bottom views, respectively, of a prosthetic valve according to one embodiment, and showing a supra-annular member having an arcuate configuration.

[0026] Figures 23A to 23C is a schematic diagram of at least a portion of a laterally deliverable prosthetic valve and a delivery system for delivering the prosthetic valve, according to one embodiment.

[0027] Figure 24 is a partially exploded perspective view of a delivery system for laterally delivered prosthetic valves according to one embodiment.

[0028] Figures 25A to 25E yes Figure 24 Various views of a compression device included in a delivery system.

[0029] Figure 26A yes Figures 25A to 25E A side view of a compression device is shown without a coupling member.

[0030] Figure 26B It is along Figure 26A A cross-sectional view of the compression device taken along line 26B-26B in FIG. Figure 26C is corresponding to Figure 26B Side perspective view of a semi-compressed prosthetic valve sized for the lumen of the compression device at the transverse plane shown.

[0031] Figure 26D It is along Figure 26A A cross-sectional view of the compression device taken along line 26D-26D in FIG. Figure 26E is corresponding to Figure 26D Side perspective view of a semi-compressed prosthetic valve sized for the lumen of the compression device at the transverse plane shown.

[0032] Figure 26F It is along Figure 26A A cross-sectional view of the compression device taken along line 26F-26F in FIG. Figure 26G is corresponding to Figure 26F Side perspective view of a semi-compressed prosthetic valve sized for the lumen of the compression device at the transverse plane shown.

[0033] Figure 27 yes Figure 24 A perspective view of a loading device included in a delivery system.

[0034] Figure 28 yes Figure 24 A perspective view of a compression device included in a delivery system.

[0035] Figure 29 yes Figure 24 A perspective view of a control device included in a delivery system.

[0036] Figure 30 yes Figure 29 30 - 30 . FIG. 30 is a cross-sectional view of a multi-lumen control catheter included in a control device of FIG. 30 and taken along line 30 - 30 .

[0037] Figure 31A yes Figure 29 A perspective view of a distal portion of a control device showing a yoke included in the distal portion.

[0038] Figure 31B and Figure 31C yes Figure 29 Perspective views of a distal portion of a controlled delivery device at least partially disposed in a delivery catheter of a delivery system, and shown in a first configuration and a second configuration, respectively.

[0039] Figure 32 yes Figure 29 A perspective view of a distal portion of a control device showing a yoke removably coupled to a pair of tethers.

[0040] Figure 33 yes Figure 29 A side perspective view of a distal portion of a control device showing a yoke and a pair of tethers that removably couple the yoke to a prosthetic valve.

[0041] Figure 34A and Figure 34B yes Figure 29 1 is a side perspective view of a distal portion of a control device showing a yoke, a pair of tethers, a tension member, and a guidewire catheter extending from a multi-lumen control catheter, wherein the multi-lumen control catheter is shown in a first configuration and a second configuration, respectively.

[0042] Figures 35 to 38 yes Figure 24 A cross-sectional view of a portion of a delivery system illustrating the process of compressing a prosthetic valve and loading the prosthetic valve into a delivery device for lateral delivery to a target location within a patient's body.

[0043] Figure 39 yes Figure 38 An enlarged cross-sectional view of a portion of the delivery system identified by area A in FIG, and showing the side-deliverable valve being loaded into the delivery device.

[0044] Figures 40 to 42are various views of a prosthetic valve illustrating manners of attaching at least one of a guidewire and / or a control catheter to one or more portions of the prosthetic valve, each view according to a different embodiment.

[0045] Figure 43 is a partially exploded perspective view of at least a portion of a delivery system for laterally delivered prosthetic valves, according to one embodiment.

[0046] Figure 44 and Figure 45 yes Figure 43 A side perspective view of a loading device included in a delivery system of FIG. 1 and illustrating the compression process associated with inserting a prosthetic valve into the loading device.

[0047] Figure 46 is connected to Figure 43 A side perspective view of a loading device of a delivery system of FIG. 1 , wherein a compressed prosthetic valve is disposed in the loading device.

[0048] Figures 47A to 47E is a cross-sectional view of a portion of a delivery system according to one embodiment, illustrating the process of compressing a prosthetic valve using a compression device of the delivery system for insertion into a loading device of the delivery system.

[0049] Figure 47F and Figure 47G yes Figure 47A A cross-sectional view of a portion of a delivery system of FIG. 1 is shown illustrating the process of using a pushing device of the delivery system to push a compressed prosthetic valve from a loading device into the lumen of a delivery catheter.

[0050] Figures 48A to 48D is a cross-sectional view of a portion of a delivery system according to one embodiment, illustrating the process of compressing a prosthetic valve having a guidewire device and a control device attached to a proximal portion thereof using a compression device of the delivery system for insertion into a loading device of the delivery system.

[0051] Figure 48E yes Figure 48A A side view of a portion of a delivery system showing the compression device laterally separated from the guidewire device and the surrounding control device to allow the compression device to be removed from the loading device.

[0052] Figure 48F yes Figure 48A 0014] A side view of a portion of a delivery system of FIG. 10 is shown illustrating a portion of a loading device disposed within a lumen of a delivery catheter included in the delivery system, the loading device having a compressed prosthetic valve disposed therein.

[0053] Figure 48G yes Figure 48AA side view of a portion of a delivery system illustrating the process of using a pushing device of the delivery system to push a compressed material from a loading device into the lumen of a delivery catheter.

[0054] Figures 49A to 49C A side perspective view and a partial cross-sectional view, respectively, of a compression device and a prosthetic valve of a delivery system according to one embodiment, illustrating the process of pulling the prosthetic valve through the compression device and into a loading device using a pulling device coupled to the proximal side of the prosthetic valve.

[0055] Figures 50A to 50E is a proximal view of a prosthetic valve according to one embodiment, illustrating the process of compressing the prosthetic valve from an expanded or deployed configuration to a compressed or delivery configuration in both the axial and transverse directions.

[0056] Figure 50F is a cross-sectional view of a delivery catheter showing a prosthetic valve disposed within its lumen in a compressed or delivery configuration.

[0057] Figure 51A and 51B is a side view illustration of an artificial valve in a compressed or delivery configuration disposed in a loading (or control) catheter device according to one embodiment, which device can be used to advance the artificial valve in a compressed or delivery configuration through a delivery catheter and into a target location in a patient's body (e.g., a space within a human heart).

[0058] Figures 52A to 52C is a side perspective illustration of a portion of a proximal anchoring element of a prosthetic valve coupled to and decoupled from an actuator or the like, according to one embodiment.

[0059] Figures 53A to 53C is a side view schematic illustration of a prosthetic valve showing a sequence for retracting the valve into a portion of a delivery and / or retraction system, according to one embodiment.

[0060] Figures 54A to 54I is a top perspective view of a valve sequence diagram showing a sequence for retracting a prosthetic valve into a portion of a delivery and / or retraction system, according to one embodiment.

[0061] Figures 55A to 55D is a schematic illustration of a front side view of a delivery catheter having an extendable capture element for capturing and / or surrounding at least a portion of a prosthetic valve to facilitate its compression and retrieval process, according to one embodiment.

[0062] Figure 56A and Figure 56Bis a schematic diagram of a front side view of a delivery catheter according to one embodiment and showing a push / pull 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 to allow the prosthetic valve to be at least partially retrieved into the delivery catheter.

[0063] Figure 57A and Figure 57B is a schematic diagram of a front side view of a delivery catheter according to one embodiment and showing a push / pull member extending from the delivery system and attached to the proximal side of the prosthetic valve and (i) a compression tether and (ii) an extendable capture element for at least partially compressing the proximal side of the prosthetic valve to allow the prosthetic valve to be at least partially retrieved into the delivery catheter.

[0064] Figure 58A and 58B is a schematic diagram of the proximal end of a prosthetic valve showing a compression tether routed through one or more portions of the proximal side of the prosthetic valve for at least partially compressing the proximal side of the prosthetic valve to facilitate the retrieval procedure, according to one embodiment.

[0065] Figures 59A to 59C is a schematic diagram of a front side view of a delivery catheter according to one embodiment and illustrating the process of retrieving a prosthetic valve into the delivery catheter using a push / pull member, at least one compression tether, and an extendable capture element.

[0066] Figure 60A is an exploded side view illustration of at least a portion of a delivery and / or retrieval system including, for example, a capture element, a prosthetic valve, and a delivery catheter, according to one embodiment.

[0067] Figure 60B yes Figure 60A A side view of a portion of a delivery and / or retrieval system of FIG. 1 is shown showing a prosthetic valve in a compressed configuration and each of a capture element disposed in a lumen of a delivery catheter.

[0068] Figure 60C yes Figure 60A A side view of a portion of a delivery and / or retrieval system is shown showing a prosthetic valve distal to a delivery catheter and a capture element deployed from the delivery catheter and at least partially surrounding the prosthetic valve.

[0069] Figures 61A to 61G are various views of at least a portion of a delivery and / or retrieval system according to one embodiment and illustrating a capture element for facilitating compression of a prosthetic valve to allow the prosthetic valve to be retrieved into a lumen of a delivery catheter.

[0070] Figures 62A to 62Bis a top view of at least a portion of a delivery and / or retrieval system according to one embodiment and illustrating the process of extending a capture element around the proximal side of a 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.

[0071] Figure 63A is a perspective view of a portion of a capture element sheath having an expansion feature included in a delivery and retrieval system, according to one embodiment.

[0072] Figures 63B to 63D is a side perspective view of a prosthetic valve and a portion of a delivery and retrieval system showing the process of extending a delivery catheter over an expansion feature of a capture element sheath and around a portion of the prosthetic valve.

[0073] Figure 63E yes Figures 63B to 63D A side perspective view of a prosthetic valve and a portion of a delivery and retrieval system showing a capture element that facilitates the process of compressing and / or retrieving at least a portion of the prosthetic valve into a delivery catheter.

[0074] Figure 64A and Figure 64B Each is a top view of a laser-cut workpiece configured to be formed into at least a portion of a distal end of a control device having, for example, a yoke, according to various embodiments.

[0075] Figure 65 is a flow chart illustrating a method of compressing a prosthetic valve into a delivery configuration for sideways delivery to a patient through a delivery catheter, according to one embodiment.

[0076] Figure 66 is a flow chart illustrating a method of preparing a prosthetic valve for sideways delivery to a patient via a delivery catheter, according to one embodiment.

[0077] Figure 67 is a flow chart illustrating a method of preparing a prosthetic valve for delivery to a patient through the luminal side of a delivery catheter included in a delivery device, according to one embodiment.

[0078] Figure 68 is a flow chart illustrating a method of selectively controlling a laterally deliverable transcatheter prosthetic valve using a control device during at least one of delivery and deployment, according to one embodiment. DETAILED DESCRIPTION

[0079] The disclosed embodiments relate to methods for laterally deliverable transcatheter artificial valves (and / or their components) and for loading, delivering, deploying and / or retrieving artificial valves (and / or their components). In some embodiments, the laterally deliverable artificial heart valve may include an outer frame and a flow control component. The outer frame may have an annular region, a subannular region and a cross-annular region coupled therebetween. The subannular region may form a distal anchoring element and a proximal anchoring element. The flow control component may be mounted to the annular region of the outer frame so that at least a portion of the flow control component is disposed in the cross-annular region. The artificial valve may be in a delivery configuration for laterally delivering the artificial valve to the patient's heart via a delivery catheter of a delivery system. When the artificial valve is released from the delivery catheter, the artificial valve may be allowed to transition to an expanded or released configuration. In some implementations, when the artificial valve is placed in the annulus of the native heart valve, the subannular region of the outer frame may be in a first configuration and may be converted to a second configuration after the artificial valve is placed in the annulus of the native heart valve.

[0080] In some embodiments, the delivery and / or retrieval system can facilitate compression, loading, advancement, delivery, and / or deployment of a prosthetic valve through a delivery catheter of the delivery system and into a desired position relative to the native valve annulus. In some implementations, the delivery and / or retrieval system can include a self-expanding capture element that can extend from the end of the delivery catheter and / or other components of the delivery system to funnel, wrap around, and / or at least partially capture the prosthetic valve during or after deployment, thereby facilitating compression of the valve and at least partial retrieval thereof.

[0081] In some embodiments, a delivery system for laterally delivered transcatheter prosthetic valves may include a compression device, a loading device, and a delivery device. The compression device defines a lumen extending through a proximal end and a distal end. The lumen has a perimeter greater than a perimeter at the distal end. The loading device defines a lumen extending through the proximal end and the distal end of the loading device. The perimeter of the lumen of the loading device is substantially similar to the perimeter of the lumen at the distal end of the compression device. The proximal end of the loading device is removably coupled to the compression device. The distal end of the loading device includes a first door that is movable between an open state and a closed state, in which the first door at least partially blocks the lumen of the loading device. The delivery device includes a handle and a delivery catheter extending distally from the handle. The handle and delivery catheter together define a lumen extending through the delivery device. The lumen of the delivery device has a perimeter substantially similar to the perimeter of the lumen of the loading device. The proximal end of the handle is coupled to the distal end of the loading device and includes a second door that is movable between an open state and a closed state, in which the second door at least partially blocks the lumen of the delivery device.

[0082] In some embodiments, a method for compressing an artificial valve into a delivery configuration for delivery to a patient laterally via a delivery catheter may include compressing the artificial valve along a transverse axis of the artificial valve that is perpendicular to the central axis of the artificial valve, the central axis being in turn parallel to the direction of fluid flow through the artificial valve. After compression, the artificial valve is inserted into the proximal end of a compression device. The compression device defines a lumen extending through a proximal end and a distal end. The periphery of the lumen at the proximal end is greater than the periphery of the lumen at the distal end. The artificial valve is advanced through the lumen of the compression device to compress the artificial valve along the central axis. The artificial valve in 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 periphery that is substantially similar to (i) the periphery of the lumen at the distal end of the compression device and (ii) the periphery of the lumen of the delivery catheter.

[0083] In some implementations, a method for preparing a laterally deliverable prosthetic valve for laterally delivering it to a patient via a delivery catheter may include compressing the prosthetic valve along a transverse axis of the prosthetic valve that is perpendicular to a central axis of the prosthetic valve, the central axis in turn being parallel to a direction of fluid flow through the prosthetic valve. After compression, the prosthetic valve is inserted into a lumen of a compression device. The prosthetic valve is pulled through the lumen of the compression device and into the lumen of a loading device coupled to the compression device by a tether attached to a distal portion of the prosthetic valve. When positioned in the lumen of the loading device, the prosthetic valve is compressed along the central axis so that the prosthetic valve is in a delivery configuration. The tether is removed from the distal portion of the prosthetic valve, and the distal end and distal end of the loading device are coupled to a delivery device comprising a delivery catheter.

[0084] In some implementations, a method for preparing a laterally deliverable prosthetic valve for laterally delivering to a patient through a lumen of a delivery catheter included in a delivery device may include compressing the prosthetic valve along a central axis parallel to a direction of fluid flow through the prosthetic valve and a transverse axis perpendicular to the central axis to transition the prosthetic valve from an expanded configuration to a delivery configuration. While a first gate at a distal end of the loading device is in a closed state to at least partially occlude the lumen of the loading device, advancing the prosthetic valve in the delivery configuration into the lumen of the loading device. While (i) the first gate is in the closed state and (ii) a second gate at a proximal end of a handle of the delivery device is in a closed state to at least partially occlude the lumen of the handle, coupling the distal end of the loading device to the handle. The lumen of the delivery catheter is in fluid communication with the lumen of the handle distal to the second gate. Following coupling, each of the first and second gates is transitioned from the closed state to an open state.

[0085] In some embodiments, an apparatus for selectively engaging a laterally deliverable transcatheter prosthetic valve may include 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 configured to extend 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 a first side of the yoke. A second tether is configured to extend through a second control arm of the control portion and a second lumen of the multi-lumen catheter, and a portion of the second tether is configured to loop through a second side of the yoke. A tension member is configured to extend through a third control arm of the control portion and a third lumen of the multi-lumen catheter, and a portion of the tension member is configured to removably couple to a proximal subannular anchoring element of the prosthetic valve.

[0086] In some embodiments, a control device may include a control catheter having at least a first tether, a second tether, and a tension member extending therethrough, and a yoke coupled to a distal end of the control catheter. In some implementations, a method for selectively controlling a laterally deliverable transcatheter prosthetic valve using a control device during at least one of delivery and deployment may include increasing tension along the first and second tethers to secure the yoke against a surface of the prosthetic valve. While securing the yoke against the surface of the prosthetic valve, the prosthetic valve is advanced through the lumen of a delivery catheter. The prosthetic valve is released from the distal end of the delivery catheter. Following release, tension is increased along the tension member to cause a proximal subannular anchoring element to transition from a first configuration to a second configuration. In response to the force applied by the yoke on the surface of the prosthetic valve, the prosthetic valve is positioned within the annulus of the native valve. After the prosthetic valve is positioned, tension along the tension member is released to allow the proximal subannular anchoring element to transition from the second configuration toward the first configuration. The control device is then decoupled from the prosthetic valve.

[0087] In some embodiments, a delivery and retrieval system for a laterally deliverable prosthetic valve may include 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 delivery through the lumen of the catheter and a deployment configuration when released from the distal end of the catheter. The capture element can be disposed in the lumen of the catheter in a substantially closed configuration and can be converted to an open configuration when advanced beyond the distal end of the catheter. The control device can be at least partially disposed in the lumen of the catheter and can be attached to the prosthetic valve. The control device can be operated to (i) apply a distal guide force to advance the prosthetic valve in the delivery configuration through the lumen of the catheter and (ii) apply a proximal guide force to pull the prosthetic valve in the deployment configuration into the distal end of the catheter. When the control device pulls the prosthetic valve into the distal end of the catheter, the capture element can extend around at least a portion of the prosthetic valve to convert the prosthetic valve from the deployment configuration to the delivery configuration.

[0088] In some embodiments, a retrieval system for a laterally deliverable prosthetic valve may include a control device and a self-expanding capture element. The control device can be removably coupled to the prosthetic valve during delivery and deployment of the prosthetic valve in the annulus of a native heart valve. The self-expanding capture element can extend from a distal end of a delivery catheter to form a funnel or wrap around at least a portion of the prosthetic valve at least partially deployed in the annulus to facilitate compression of the prosthetic valve in response to a force applied by the control device to move the prosthetic valve in a proximal direction toward the delivery catheter.

[0089] In some embodiments, a method for retrieving a laterally deliverable prosthetic heart valve may include extending a self-expanding capture element from a distal end of a catheter disposed in a native atrium of the heart. The capture element is configured to have and / or define a cavity shape when in an extended position. The prosthetic heart valve is pulled into the cavity of the extended capture element to facilitate compression of the prosthetic heart valve. Pulling the prosthetic heart valve into the capture element may be operable to transition the capture element from an extended position to a retracted position or toward a retracted position, in which the prosthetic heart valve is wrapped around the capture element. After wrapping, the prosthetic heart valve (at least partially) wrapped around the capture element is pulled into the catheter using a cable.

[0090] Any of the artificial heart valves described herein can be a relatively low profile laterally deliverable implantable artificial heart valve (also referred to herein as a "prosthetic valve" or simply "valve"). Any of the artificial valves can be a transcatheter artificial valve that is constructed to be delivered into the heart via a delivery catheter. The artificial valve can have at least an annular outer valve frame and an internal flow control component (e.g., a 2-leaflet valve or a 3-leaflet valve, a sleeve and / or the like) mounted within and / or extending through a central lumen or orifice of the valve frame. The flow control component can be constructed to allow blood flow in a first direction through the inflow end of the valve and to block blood flow in a second direction opposite to the first direction through the outflow end of the valve. In addition, the artificial valve can include a single anchoring element or multiple anchoring elements that are constructed to anchor the valve in the annulus of the native valve.

[0091] Any of the artificial valves described herein can be configured to transition between a compressed configuration or delivery configuration for introduction into the body using a delivery catheter and an expanded or deployed configuration for implantation at a desired location in the body. For example, any of the embodiments described herein can be a balloon-expandable artificial valve, a self-expanding artificial valve, and / or the like.

[0092] Any of the prosthetic valves described herein can be compressed into a compressed or delivery configuration along an elongated or orthogonal direction relative to the central axis of the flow control component (e.g., along the longitudinal axis), which can allow large diameter valves (e.g., having a height of about 5 mm to 60 mm and a diameter of about 20 mm to 80 mm) to be delivered and deployed directly from the inferior vena cava into the annulus of the native mitral or tricuspid valve using, for example, a 24 Fr to 36 Fr delivery catheter. The longitudinal axis can be substantially parallel to the elongated cylindrical axis of the delivery catheter, which can allow the prosthetic valve to be deployed without the acute approach angle common in traditional transcatheter delivery.

[0093] 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 orthogonal 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 orthogonal to the direction of blood flow (e.g., transversely) and parallel to the direction of blood flow (e.g., axially). In some embodiments, when in compression or delivery configuration and / or expansion or deployment configuration, the long axis or longitudinal axis is oriented at an intersection angle of 45 degrees to 135 degrees with the first direction.

[0094] Any of the artificial valves described herein may include an outer support frame comprising a group of compressible wire units having an orientation and a unit geometry substantially orthogonal to a central axis to minimize strain in the wire units when the outer support frame is in a delivery configuration (e.g., a compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration).

[0095] Any of the outer support frames described herein may have an upper annular region, a lower annular region, and a cross-annular region coupled therebetween. The upper annular region may form, for example, an upper collar portion of the outer support frame and may include any number of features constructed to engage native tissue, internal flow control components of an artificial valve, and / or a delivery actuator and / or a retrieval mechanism. The lower annular region may form, for example, distal anchoring elements and proximal anchoring elements that are constructed to engage lower annular (ventricular) tissue when the artificial valve is placed in the native annulus. The cross-annular region may be coupled between the upper annular region and the lower annular region. When the outer support frame is in an expanded configuration, the cross-annular region may form a shape such as a funnel, a cylinder, a flat cone, or a circular hyperboloid. In some embodiments, the outer support frame is formed by a wire, a braided wire, or a laser-cut wire frame and is covered with a biocompatible material. The biocompatible material may cover the outer support frame such that the inner surface is covered with pericardial tissue and the outer surface is covered with the woven synthetic polyester material, and / or the inner surface is covered with pericardial tissue and the outer surface is covered with the woven synthetic polyester material.

[0096] Any of the outer support frames described herein can have a side profile of an oblate cone shape having an outer diameter R of 40 mm to 80 mm, an inner diameter r of 20 mm to 60 mm, and a height of 5 mm to 60 mm. In some embodiments, the annular support frame has a side profile of an hourglass shape having a top diameter R1 of 40 mm to 80 mm, a bottom diameter R2 of 50 mm to 70 mm, an inner diameter r of 20 mm to 60 mm, and a height of 5 mm to 60 mm.

[0097] Any of the artificial valves described herein may include one or more anchoring elements extending from, coupled to, and / or otherwise integral with a portion of a valve frame. For example, any of the artificial valves may include a distal anchoring element that may serve as, for example, a right ventricular outflow tract ("RVOT") tab or a left ventricular outflow tract ("LVOT") tab. Any of the valves described herein may also include an anchoring element extending proximally from the valve frame that may be used, for example, to anchor the valve to proximal subannular tissue of the ventricle. The anchoring element may include a wire loop or wire frame extending approximately 10 mm-40 mm away from the tubular frame, an integrated frame segment, and / or a stent and / or may be formed from the above. For example, any of the artificial valves described herein may include a valve frame having a wire or laser-cut subannular region or member that forms a distal anchoring element and a proximal anchoring element.

[0098] Any of the artificial valves described herein may also include (i) a distal upper (supra-annular) anchoring element extending from the distal upper edge of the valve frame, attached to the distal upper edge and / or otherwise integrated with the distal upper edge and (ii) a proximal upper (supra-annular) anchoring element extending from the proximal upper edge of the valve frame, attached to the proximal upper edge and / or otherwise integrated with the proximal upper edge. The distal upper anchoring element and the proximal upper anchoring element may include a wire loop or wire frame extending approximately 2mm-20mm away from the valve frame or may be formed as described above. In some embodiments, the artificial valve described herein may include a wire or laser-cut supra-annular region or member forming the distal upper anchoring element and the proximal upper anchoring element. The distal upper anchoring element and the proximal upper anchoring element are constructed to be positioned in an supra-annular position in contact with and / or adjacent to the supra-annular tissue of the atrium. In some implementations, the artificial valve described herein can be tightened or at least partially compressed after being placed in the native annulus so that the proximal upper anchoring element and the distal upper anchoring element apply force to the supraannular tissue and the proximal lower anchoring element and the distal lower anchoring element apply force to the subannular tissue in opposite directions, thereby securing the artificial valve in the native annulus. Any of the valves described herein may further include an anterior anchoring element or a posterior anchoring element extending from and / or attached to the anterior side or posterior side of the valve frame, respectively.

[0099] Any of the artificial valves described herein may include an internal flow control component having a leaflet frame having 2-4 flexible leaflets mounted thereon. The 2-4 leaflets are constructed to allow blood flow in a first direction through the inflow end of the flow control component and to block blood flow in a second direction opposite to the first direction through the outflow end of the flow control component. The leaflet frame may include two or more diamond-shaped or eye-shaped wire unit panels made of a heat-set shape memory alloy material such as nitinol. The leaflet frame may be constructed to be foldable from a circular or cylindrical configuration to a flat cylindrical configuration along the z-axis (e.g., the longitudinal axis) and to be compressible to a compressed configuration along the vertical y-axis (e.g., the central axis). In some embodiments, the leaflet frame may include a pair of hinge areas, folding areas, connection points, etc., which may allow the leaflet frame to be folded flat along the z-axis before being compressed along the vertical y-axis. The leaflet frame can be, for example, a one-piece structure having two or more living hinges (e.g., stress concentrating risers and / or any suitable structure constructed to allow elastic / non-permanent deformation of the leaflet frame) or a two-piece structure in which the hinge area is formed using a secondary attachment method (e.g., sutures, fabric, molded polymer parts, etc.).

[0100] In some embodiments, the internal flow control component in the expanded configuration forms a shape such as a funnel, a cylinder, an oblate cone, or a circular hyperboloid. In some embodiments, the internal flow control component has a leaflet frame having a side profile of an oblate cone shape having an outer diameter R of 20 mm to 60 mm, an inner diameter r of 10 mm to 50 mm (wherein diameter R is greater than diameter r), and a height of 5 mm to 60 mm. In some embodiments, the leaflet frame is composed of a wire, a braided wire, or a laser-cut wire frame. In some embodiments, the leaflet frame may have one or more longitudinal supports integrated therein or mounted thereon and selected from rigid or semi-rigid columns, rigid or semi-rigid ribs, rigid or semi-rigid rods, rigid or semi-rigid panels, and combinations thereof.

[0101] Any of the artificial valves and / or components thereof may be made of any suitable biocompatible material or combination of materials. For example, the outer valve frame (e.g., of the internal flow control component), the inner valve frame, and / or components thereof may be made of biocompatible metals, metal alloys, polymer-coated metals, and / or the like. Suitable biocompatible metals and / or metal alloys may include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, nickel-titanium alloys (e.g., ) and / or the like. In addition, any of the outer or inner frames described herein may be made of a material such as nickel titanium alloy (e.g., ) superelastic or shape memory alloy. Suitable polymer coatings may include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), styrene isoprene butadiene (SIBS), copolymers, polylactic acid, polyesters, polylactide, D-lactic polylactic acid (DLPLA), polylactic-co-glycolic acid (PLGA), and / or the like. Some such polymer coatings may form suitable carrier matrices for drugs such as, for example, sirolimus, zotarolimus, ugliolimus, novolimus, tacrolimus, paclitaxel, probucol, and / or the like.

[0102] Some biocompatible synthetic materials may include, for example, polyester, polyurethane, polytetrafluoroethylene (PTFE) (e.g., Teflon), and / or the like. Where a thin, durable synthetic material is envisioned (e.g., for a covering), a synthetic polymer material such as expanded PTFE or polyester may alternatively be used. Other suitable materials may optionally include elastomers, thermoplastics, polyurethanes, thermoplastic polycarbonate polyurethanes, polyether polyurethanes, block polyether polyurethanes, silicone polyether polyurethanes, polyether ether ketone (PEEK), silicone-polycarbonate polyurethanes, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefins, polyethylene glycol, polyethersulfone, polysulfone, polyvinyl pyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., polyester), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylon), PTFE, extended PTFE, expanded PTFE, silicone polymers and / or oligomers and / or polylactones and block copolymers using the same.

[0103] Any of the outer valve frame (e.g., of the flow control component), the inner valve frame, and / or portions or components thereof may be partially or completely covered internally or externally with a biocompatible material such as pericardium. The valve frame may also optionally be covered externally with a second biocompatible material such as polyester or ) partially or completely covered. The disclosed embodiments may use tissue, such as biological tissue, which is chemically stable pericardial tissue of an animal, such as a cow (bovine pericardium), a sheep (sheep pericardium), a pig (porcine pericardium), or a horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include those in the product and Of the tissues used in the study, all products are currently used in surgical procedures and are typically sold as harvested from cattle less than 30 months of age.

[0104] Any method for manufacturing an artificial valve described herein may include using metal or metal alloy additive or subtractive manufacturing to produce, for example, a compressible / expandable outer support frame and / or a compressible / expandable inner leaflet frame. Metal or metal alloy additive manufacturing may include, but is not limited to, 3D printing, direct metal laser sintering (powder melting), etc. Metal or metal alloy subtractive manufacturing may include, but is not limited to, photolithography, laser sintering / cutting, CNC machining, electrical discharge machining, etc. In addition, any of the manufacturing processes described herein may include forming and / or shaping (e.g., heat setting) the cut or machined workpiece into any suitable shape, size, and / or configuration. For example, any of the outer support frame and / or inner leaflet frame described herein may be laser cut from one or more workpieces and heat set into a desired shape, size, and / or configuration. In addition, any of the frames described herein may include multiple independent components that are formed into a desired shape and coupled together to form a frame.

[0105] In some embodiments, the manufacturing process may also include mounting 2-4 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.

[0106] Any of the delivery systems described herein can be configured to deliver a laterally deliverable transcatheter prosthetic valve to a target location within a patient's body (eg, to or into the annulus of a native heart valve). Such a delivery system may include one or more of the following components: (i) an expander for expanding at least a portion of an arterial access to the heart (such as the femoral artery, IVC and / or SVC), (ii) a compression device such as a funnel for compressing the prosthetic valve into a delivery configuration, (iii) a loader, capsule, chamber, or the like for receiving the prosthetic valve in a delivery configuration, (iv) a delivery device comprising a handle and a delivery catheter extending from the handle for delivering the prosthetic valve in a delivery configuration to a space within the heart, such as the atrium, (v) a control device, controller, and / or actuator such as a multi-lumen control catheter for engaging and / or actuating one or more portions of the prosthetic valve, and (vi) a guidewire catheter for coupling to the prosthetic valve and for receiving a guidewire to allow the prosthetic valve to be advanced along the guidewire during delivery and / or deployment.

[0107] Any of the delivery systems described herein may include a delivery catheter for side delivery of a side-deliverable artificial valve. The delivery catheter may include an outer shaft having an outer proximal end, an outer distal end, and an outer shaft lumen, wherein the outer distal end is closed with an atraumatic ball mounted thereon. The outer shaft lumen has an inner diameter of 8 mm to 10 mm and is sized to pass a transcatheter artificial valve (e.g., a tricuspid valve and / or a mitral valve) for side delivery.

[0108] Any of the delivery systems described herein may include a delivery catheter, a control catheter and / or other suitable portions comprising one or more components, parts, features and / or the like that are constructed to facilitate at least partial retrieval of the valve from the annulus of the native heart valve. For example, such a delivery system may include, for example, a self-expanding capture element that may be in an extended position to at least partially surround and / or capture a portion of the prosthetic valve. In some implementations, during delivery and / or deployment, the prosthetic valve may be pulled and / or drawn into the self-expanding capture element by means of the control catheter and / or other components attached to the prosthetic valve. Thus, the self-expanding capture element may surround and / or capture at least a portion of the prosthetic valve, which in turn may facilitate transitioning the prosthetic valve from an at least partially expanded configuration to an at least partially compressed configuration, thereby allowing the prosthetic valve to at least partially retract into the delivery catheter used to deliver the prosthetic valve.

[0109] Any method for delivering and deploying an artificial valve in the annulus of a native heart valve may include removably coupling the artificial valve or its outer frame to a portion of a delivery system. The artificial valve is placed in a delivery configuration, loaded into a delivery device including a delivery catheter and advanced through the lumen of the delivery catheter. The artificial valve can then be released from the distal end of the delivery catheter disposed in the atrium of the heart. In some implementations, after releasing the artificial valve, the proximal anchoring element of the subannular member of the artificial valve can be placed in a first configuration, and when the proximal anchoring element is in the first configuration, the artificial valve is placed in the annulus of the native heart valve. After the artificial valve is placed in the annulus, the proximal anchoring element can then be converted from the first configuration to a second configuration. In some implementations, the method for delivering and / or deploying an artificial valve may optionally include retrieving at least a portion of the artificial valve from the annulus to allow at least a portion of the artificial valve to be repositioned and / or relocated.

[0110] Any of the methods described herein for delivering and / or deploying a prosthetic heart valve may include orthogonal delivery of the prosthetic heart valve to the native annulus of a human heart, comprising at least one of: (i) advancing a delivery catheter via the femoral vein through the inferior vena cava (IVC) to the tricuspid valve or pulmonary artery of the heart, (ii) advancing via the jugular vein through the superior vena cava (SVC) to the tricuspid valve or pulmonary artery of the heart, or (iii) advancing via an IVC-femoral or SVC-jugular approach through a transatrial approach (e.g., the fossa ovalis or lower) to the mitral valve of the heart; and (iv) delivering and / or deploying the prosthetic heart valve to the native annulus by releasing the valve from the delivery catheter.

[0111] Any of the methods described herein for delivering a prosthetic valve may include placing the prosthetic valve in a delivery configuration. The delivery configuration may include at least one of: (i) compressing the valve along a central vertical axis to reduce the vertical dimension of the valve from top to bottom to place the valve in the delivery configuration, (ii) flattening the valve into two parallel panels substantially parallel to the long axis to place the valve in the delivery configuration, or (iii) flattening the valve into two parallel panels substantially parallel to the long axis and then compressing the valve along the central vertical axis to reduce the vertical dimension of the valve from top to bottom to place the valve in the delivery configuration.

[0112] Any of the methods described herein for delivering a prosthetic valve may include orthogonal delivery of the prosthetic valve to a desired location within the body, comprising advancing a delivery catheter to the desired location within the body and delivering the prosthetic valve to the desired location within the body by releasing the valve from the delivery catheter. The valve is in a compressed or delivery configuration while in the delivery catheter and transitions to an expanded or released configuration when released from the delivery catheter.

[0113] Any of the methods described herein for delivering a prosthetic valve may include releasing the valve from a delivery catheter by: (i) pulling the valve out of the delivery catheter using a pulling member (e.g., a wire or rod) releasably connected to a sidewall, drum or collar and / or anchoring element (e.g., a distal anchoring element), wherein advancing the pulling member away from the delivery catheter pulls the valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a pushing member (e.g., a wire, rod, catheter, delivery member, yoke, etc.) releasably connected to the sidewall, drum or collar and / or anchoring element (e.g., proximal and / or distal anchoring elements), wherein advancing the pushing member away from the distal end of the delivery catheter pushes the valve out of the delivery catheter. Furthermore, releasing the valve from the delivery catheter allows the valve to transition and / or expand from its delivery configuration to an expanded and / or deployed configuration.

[0114] Any of the methods described herein for delivering and / or deploying a prosthetic valve may include releasing the valve from a delivery catheter while increasing blood flow during deployment of the valve by: (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and blood flow through a flow control component; (ii) completely releasing the valve from the delivery catheter while maintaining attachment to the valve to transition to a state of increased blood flow through the flow control component and reduced blood flow around the valve; (iii) deploying the valve to a final installation or placement position in the native annulus to transition to a state of complete blood flow through the flow control component and little or no blood flow around the valve; and (iv) disconnecting and withdrawing the positioning catheter, pulling or pushing a wire or rod, delivery catheter, actuator and / or other suitable portion of the delivery system.

[0115] In some implementations, prior to disconnection and withdrawal, the method may optionally include transitioning the valve, via an actuator or portion of the delivery system, to a secured or tightened state such that the valve contacts the annular tissue to secure the valve within the native annulus. In some implementations, prior to disconnection and withdrawal, the method may optionally include at least partially retrieving the valve from the annulus and repositioning at least a portion of the valve within the annulus. In some implementations, retrieval may include retrieving and / or retracting at least a portion of the valve into the delivery catheter.

[0116] Any method for delivering and / or deploying an artificial valve described herein may include positioning the valve or a portion thereof in a desired position relative to native tissue. For example, the method may include positioning the distal anchoring tab of the artificial heart valve in the ventricular outflow tract of the left ventricle or the right ventricle. In some embodiments, the method may also include positioning the upper distal anchoring tab in an upper annular position, wherein the upper distal anchoring tab provides an annular downward force in the direction of the ventricle and the distal anchoring tab (e.g., the lower distal anchoring tab) provides an annular downward force in the direction of the atrium. In some implementations, the method may include partially inserting the artificial valve into the annulus so that the distal portion of the artificial valve contacts the native annular tissue, and the proximal portion of the artificial valve is at least partially compressed and disposed in a delivery catheter. In some embodiments, the method may include rotating the artificial heart valve along an axis parallel to the plane of the valve annulus using a steerable catheter, a yoke, a set of tethers, an actuator, and / or any other part of the delivery system (or a combination thereof). In some embodiments, the method can include transitioning one or more anchoring elements into a desired position and / or state to engage native tissue surrounding at least a portion of the annulus. In some implementations, one or more tissue anchors can be attached to the valve and native tissue to secure the valve in a desired position.

[0117] Any of the methods described herein for at least partially retrieving a prosthetic valve may include: (i) extending a self-expanding capture element from a distal end of a delivery catheter positioned in an atrium of the heart, wherein the capture element is configured to have a cavity shape when in an extended position, and (ii) pulling the heart valve into the cavity of the extended capture element to facilitate compressing the heart valve into or toward its delivery (compression) configuration, wherein pulling the heart valve into the capture element causes the capture element to transition from the extended position to a retracted position, wherein the heart valve is surrounded by the capture element in the retracted position, and wherein the heart valve-capture element combination is pulled into a delivery and / or retrieval catheter (e.g., using a cable, a control catheter, an actuator, and / or any other suitable portion of a delivery and retrieval system). In some embodiments, the method may optionally include pre-compressing the heart valve prior to pulling it into the cavity of the capture element and subsequently into the delivery and / or retrieval catheter by: (a) proximal to the subannular anchoring element against the underside seam of the atrial or supraannular ring or member, or (b) constricting the proximal sidewall hip of the prosthetic valve, or (c) both.

[0118] Any of the prosthetic valves (or components, features, and / or aspects thereof), delivery systems, methods of manufacture, methods of delivery, methods of deployment, and / or methods of retrieval described herein may be similar and / or substantially the same as any of those described in the following international patent applications: International Patent Application No. PCT / US2019 / 051087, filed on September 19, 2019 (referred to herein as “'957 PCT”), entitled “Transcatheter Deliverable Prosthetic Heart Valves and Method of Delivery”; International Patent Application No. PCT / US2019 / 067010, filed on December 18, 2019 (referred to herein as “'010 PCT”), entitled “Transcatheter Deliverable Prosthetic Heart Valves and Methods of Delivery”; International Patent Application No. PCT / US2019 / 067010, filed on December 18, 2019 (referred to herein as “'010 PCT”), entitled “Collapsible Inner Flow Control Component for Side-Deliverable Transcatheter Heart Valve and International Patent Application No. PCT / US2020 / 015231, entitled “Cinch Device and Method for Deployment of a Side-Delivered Prosthetic Heart Valve in a Native Annulus,” filed on May 4, 2020 (referred to herein as “the '231 PCT”); International Patent Application No. PCT / US2020 / 031390, entitled “Cinch Device and Method for Deployment of a Side-Delivered Prosthetic Heart Valve in a Native Annulus,” filed on May 4, 2020 (referred to herein as “the '390 PCT”); and / or International Patent Application No. PCT / US2020 / 045108, entitled “Side-Deliverable Transcatheter Prosthetic Valves and Methods for Delivering and Anchoring the Same,” filed on August 6, 2020 (referred to herein as “the '108 PCT”), the disclosures of which are incorporated herein by reference in their entirety.

[0119] Similarly, any of the artificial valves (or components, features and / or aspects thereof), delivery systems, manufacturing methods, delivery methods, deployment methods and / or retrieval methods described herein may be similar and / or substantially identical to any of those described in the following U.S. provisional patent applications: U.S. Provisional Patent Application No. 62 / 889,327 (referred to herein as the “'327” provisional filing); U.S. Provisional Patent Application No. 62 / 891,964 (referred to herein as the “'964 provisional filing”); U.S. Provisional Patent Application No. 63 / 027,345 (referred to herein as the “'345 provisional filing”); and / or U.S. Provisional Patent Application No. 63 / 038,807 (referred to herein as the “'807 provisional filing”); this application claims priority to and the benefit of the U.S. provisional patent applications, and the disclosures of the U.S. provisional patent applications have been incorporated by reference in their entirety above.

[0120] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.

[0121] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art can translate from the plural to the singular and / or from the singular to the plural, as appropriate to the context and / or application. For clarity, various singular / plural permutations may be expressly set forth herein.

[0122] In general, the terms used herein, and particularly in the appended claims (e.g., the bodies of the appended claims), are generally intended to be “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” etc.). Similarly, the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, integers (or fractions thereof), steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers (or fractions thereof), steps, operations, elements, components, and / or groups thereof. As used in this document, the term “including” means “including but not limited to.”

[0123] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It should be understood that any suitable transition word and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, contemplates the possibility of including one of the terms, either one of the terms, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B."

[0124] Unless expressly stated otherwise, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Unless expressly stated otherwise, any listed range should be considered to fully describe and enable the same range to be broken down into at least equal subportions. As will be understood by one skilled in the art, a range includes each individual member.

[0125] The terms "valve prosthesis," "artificial heart valve," and / or "artificial valve" can refer to a combination of a frame and leaflets or flow control structure or components and can encompass both complete replacements for an anatomical site (e.g., a new mechanical valve replacing a native valve) and medical devices that replace and / or assist, repair, or improve an existing anatomical site (e.g., leaving the native valve in place).

[0126] The artificial valve disclosed herein may include a component (e.g., a frame) that can be placed within the native valve annulus and can be used as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve valve. Depending on the embodiment, it may or may not include such a leaflet structure or flow control component. Such components may be referred to herein as "annular support frame," "tubular frame," "wire frame," "valve frame," "flange," "ring," and / or any other similar terms.

[0127] The term "flow control component" may refer in a non-limiting sense to a leaflet structure having 2, 3, or 4 leaflets of flexible biocompatible material, such as treated or untreated pericardium sutured or attached to an annular support frame to act as an artificial heart valve. Such a valve may be a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, which opens to blood flowing from the atria to the ventricles during diastole and closes due to ventricular systolic pressure applied to the outer surface. Repeated opening and closing in sequence may be described as "reciprocating". It is envisaged that the flow control component includes a variety of (bio)artificial artificial heart valves. Bioartificial pericardial valves may include bioartificial aortic valves, bioartificial mitral valves, bioartificial tricuspid valves, and bioartificial pulmonary valves.

[0128] Any of the disclosed valve embodiments can be delivered by a transcatheter method. The term "transcatheter" is used to define the lumen of a catheter that is deployed into a cardiac chamber (or other desired location in the body), the process of controlling a medical device or instrument in the lumen and / or delivering the medical device or instrument in the lumen, and items that have been delivered or controlled by a process such as a procedure. Known transcatheter pathways include a lumen through the femoral artery and / or vein, a lumen through the brachial artery and / or vein, a lumen through the carotid artery, a lumen through the jugular vein, a cardiac pathway through the intercostal (costal) and / or subxiphoid space and / or the like. In addition, a transcatheter cardiac pathway can be through the inferior vena cava (IVC), the superior vena cava (SVC) and / or through the atrium (e.g., the fossa ovalis or lower). Transcatheter can be synonymous with transcavity and is functionally related to the term "percutaneous" because it involves the delivery of a heart valve. As used herein, the term "lumen" can refer to the inside of a cylinder or tube. The term "aperture" can refer to the inner diameter of a lumen.

[0129] The pattern of cardiac pathways may be based at least in part on a "body passageway" used to define blood ducts or vessels within the body, and the specific application of the disclosed prosthetic valve embodiments may determine the body passageway in question. For example, an aortic valve replacement would be implanted in or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement would be implanted at the tricuspid or mitral valve annulus, respectively. Although certain features described herein may be particularly advantageous for a given implantation site, any valve embodiment described herein may be implanted in any body passageway unless the combination of features is structurally impossible or excluded by the claim language.

[0130] As used herein, the term "expandable" can refer to a prosthetic heart valve or component of a prosthetic heart valve that is capable of expanding from a first delivery size or configuration to a second implanted size or configuration. Thus, unless the context clearly indicates otherwise, an expandable structure is not intended to refer to a structure that may undergo slight expansion, for example, due to an increase in temperature or other such incidental causes. Conversely, "non-expandable" should not be interpreted to mean completely rigid or dimensionally stable, as some degree of slight expansion may be observed with, for example, conventional "non-expandable" heart valves.

[0131] The artificial valves disclosed herein and / or their components are generally capable of transitioning between two or more configurations, states, shapes and / or arrangements. For example, the artificial valves described herein may be capable of "compression" and / or "expansion" between any suitable number of configurations. Unless the context clearly indicates otherwise, various terms may be used to describe or refer to these configurations and are not intended to be limiting. For example, the artificial valve may be described as being in a "delivery configuration," which may be any suitable configuration that allows or enables the delivery of the artificial valve. Examples of delivery configurations may include compressed configurations, folded configurations, rolled configurations and / or similar configurations or any suitable combination thereof. Similarly, the artificial valve may be described as being in an "expanded configuration," which may be any suitable configuration that is not explicitly intended for 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 described herein and / or their components or features may have a variety of additional configurations that may be associated with various modes, levels, states and / or parts of actuation, deployment, engagement, etc. Examples of such configurations may include actuation configurations, placement configurations, fastening configurations, engagement configurations, and / or similar configurations, or any suitable combination thereof. Although specific examples are provided above, it should be understood that they are not intended to be an exhaustive list of configurations. Other configurations may be possible. In addition, various terms may be used to describe identical or substantially similar configurations, and therefore, the use of a particular term is not intended to limit and / or exclude other terms, unless these terms and / or configurations are mutually exclusive, or the context clearly indicates otherwise.

[0132] Generally speaking, conventional delivery of a prosthetic valve can be performed with the central cylindrical axis of the valve substantially parallel to the longitudinal axis of the delivery catheter used to deliver the valve. Typically, the valve is compressed in a radial direction relative to the central cylindrical axis and advanced through the lumen of the delivery catheter. The valve is deployed from the end of the delivery catheter and expanded outward in a radial direction from the central cylindrical axis. The delivery orientation of the valve generally means that the valve is fully released from the delivery catheter and reoriented relative to the annulus when located in the atrium of the heart, which can limit the size of the valve in some cases.

[0133] Unless otherwise expressly stated, the artificial valves described herein are constructed to be delivered via lateral or orthogonal delivery techniques. As used herein, the terms "laterally delivered," "lateral delivery," "orthogonal delivery," "orthogonally delivered," and the like may be used interchangeably to describe such a delivery method and / or a valve delivered using such a method. Orthogonal delivery of an artificial valve can result in the central cylindrical axis of the valve being substantially orthogonal to the longitudinal axis of the delivery catheter. In the case of orthogonal delivery, the valve is compressed (or otherwise reduced in size) in a direction substantially parallel to the central cylindrical axis and / or in a transverse direction relative to the central cylindrical axis. Thus, the longitudinal axis (e.g., longitudinal axis) of the orthogonally delivered valve is substantially parallel to the longitudinal axis of the delivery catheter. In other words, compared to the traditional process of compressing and delivering a transcatheter artificial valve, the orthogonally delivered artificial valve is compressed and / or delivered at an angle of approximately 90 degrees. Furthermore, in some cases, the orientation of the orthogonally delivered valve relative to the annulus can allow the distal portion of the valve to be at least partially inserted into the annulus of the native heart valve while the proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints faced by some known conventional delivery techniques. Examples of prosthetic valves configured for orthogonal delivery and processes for delivering such valves are described in detail in the '957 PCT and / or the '010 PCT, incorporated by reference above.

[0134] In mathematics, the term "orthogonal" refers to an intersection angle of 90 degrees between two lines or planes. As used herein, the term "substantially orthogonal" refers to an intersection angle of 90 degrees plus or minus a suitable tolerance. For example, "substantially orthogonal" can refer to an intersection angle within the range of 75 degrees to 105 degrees.

[0135] The embodiments herein and / or various features or advantageous details thereof are more fully explained with reference to the non-limiting embodiments shown in the accompanying drawings and described in detail in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments herein. Like numbers refer to like elements throughout the text.

[0136] The discussion of various embodiments, components and / or features of artificial valves is followed by a discussion of delivery and / or retrieval systems for delivering, deploying and / or at least partially retrieving such artificial valves. The examples and / or embodiments described herein are intended to promote an understanding of the structure, function and / or aspects of the embodiments, the manner in which the embodiments can be practiced, and / or to further enable those skilled in the art to practice the embodiments herein. Similarly, the methods and / or manner of using the embodiments described herein are provided by way of example only and not by way of limitation. Unless the context clearly indicates otherwise, the specific uses described herein do not exclude other uses. For example, any of the artificial valves described herein can be used to replace a native valve of the human heart, including, for example, a mitral valve, a tricuspid valve, an aortic valve and / or a pulmonary valve. Although some artificial valves are described herein in the context of replacing a native mitral valve or a native tricuspid valve, it should be understood that unless otherwise explicitly stated or unless it is clear to those skilled in the art that one or more components and / or features would otherwise make the artificial valve incompatible with such use, such artificial valves can be used to replace any native valve. Therefore, the specific examples, embodiments, methods and / or uses described herein should not be interpreted as limiting the scope of the invention or inventive concept herein. On the contrary, examples and embodiments are provided so that this disclosure will be comprehensive and complete and will fully convey the scope of the inventive concept to those skilled in the art.

[0137] Figures 1A to 1E 1 are various schematic diagrams of a transcatheter prosthetic valve 100 according to one embodiment. The transcatheter prosthetic valve 100 is configured to be deployed in a desired location within the body (e.g., of a human patient) and to allow blood flow in a first direction through an inflow end of the transcatheter prosthetic valve 100 and to block blood flow in a second direction, opposite to the first direction, through an outflow end of the transcatheter prosthetic valve 100. For example, the transcatheter prosthetic valve 100 may be a transcatheter prosthetic heart valve configured to be deployed within the annulus of a native tricuspid valve or a native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0138] The transcatheter prosthetic valve 100 (also referred to herein as a "prosthetic valve" or simply as a "valve") is capable of compression and expansion in at least one direction relative to a long axis 102 of the valve 100 (also referred to herein as a "horizontal axis," "longitudinal axis," or "elongate axis"). The valve 100 is capable of compression and expansion in an expanded configuration (e.g., a "valve") at a desired location for implantation in the body (e.g., a human heart). Figure 1A 、 Figure 1C and Figure 1E ) and a compressed or delivery configuration for introduction into the body using a delivery catheter ( Figure 1B and Figure 1D ) between compression and expansion.

[0139] In some embodiments, the valve 100 (and / or at least a portion thereof) can begin in a generally tubular configuration and can be thermoformed and / or otherwise formed into any desired shape. In some embodiments, the valve 100 can include an upper atrial cuff or flange for atrial sealing, a lower ventricular cuff or flange for ventricular sealing, and a trans-annular segment or region (e.g., a body segment, a tubular segment, a cylindrical segment, etc.) disposed therebetween. The trans-annular region can have an hourglass-shaped cross-section of approximately 60%-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20%-40% of the annular circumference to conform to the septal annular segment. Although the valve 100 is Figures 1A to 1E 1 and 2. Although shown as having a given shape, it should be understood that the size and / or shape of the valve 100 (and / or at least a portion thereof) can be based on the size and / or shape of the anatomy of the native tissue.

[0140] For example, the valve 100 can be central (e.g., radially symmetric about the central y-axis 104), or can be eccentric (e.g., radially asymmetric about the central y-axis 104). In some eccentric embodiments, the valve 100 or its outer frame can have a complex shape determined by the anatomical structure in which the valve 100 is being installed. For example, in some cases, the valve 100 can be deployed in a tricuspid annulus having a circumference in the shape of a rounded ellipse with a substantially vertical septal wall, and the tricuspid annulus is known to enlarge along the anterior-posterior line in a disease state. In some cases, the valve 100 can be deployed in a mitral annulus (e.g., near the anterior leaflet), the mitral annulus having a circumference in the shape of a rounded ellipse with a substantially vertical septal wall, and the mitral annulus is known to enlarge in a disease state. Thus, the valve 100 can have a complex shape that is determined at least in part by the disease state of the native annulus and / or the native valve. For example, in some such embodiments, the valve 100 or its outer frame may have a D-shape (viewed from the top) so that the flat portion can match the anatomy in which the valve 100 will be deployed.

[0141] As shown, the valve 100 generally includes an annular support frame 110 and a flow control component 150. In addition, the valve 100 and / or at least the annular 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 aspects or portions thereof may be similar and / or substantially identical to the valves (and / or corresponding aspects or portions thereof) described in detail in the '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional, '964 Provisional, '345 Provisional, and / or '807 Provisional, which are incorporated by reference above. Therefore, certain aspects, portions, and / or details of the valve 100 may not be described in further detail herein.

[0142] The annular support frame 110 (also referred to herein as a "tubular frame," "valve frame," "wire frame," "external frame," or "frame") may have an supra-annular region 120, a sub-annular region 130, and a trans-annular region 112 disposed and / or coupled therebetween. In some embodiments, the supra-annular region 120, the sub-annular region 130, and the trans-annular region 112 may be separate, independent, and / or modular components that are coupled to collectively form the frame 110. In some implementations, such a modular configuration may allow the frame 110 to adapt to a given size and / or shape of the anatomical structure in which the valve 100 is being installed. For example, one or more of the supra-annular region 120, the sub-annular region 130, and / or the trans-annular region 112 may be designed and / or adapted so that the support frame has any desired height, outer diameter, and / or inner diameter, such as any of those described above. Furthermore, this modular configuration can allow the frame 110 to be bent, flexed, compressed, folded, rolled, and / or otherwise reconfigured without plastically or permanently deforming it. For example, the frame 110 can be compressed into a compressed configuration for delivery and, when released, configured to return to its original shape (uncompressed or expanded configuration).

[0143] The support frame 110 and / or the upper annular region 120, the lower annular region 130 and / or the cross annular region 112 may be formed of or may be any suitable material. In some embodiments, the upper annular region 120, the lower annular region 130 and the cross annular region 112 may be formed of or may be a shape memory or super elastic metal, metal alloy, plastic and / or the like. For example, the upper annular region 120, the lower annular region 130 and the cross annular region 112 may be formed of or may be nitinol or the like. In addition, the upper annular region 120, the lower annular region 130 and the cross annular region 112 may be coupled from a wire frame portion of the support frame 110, which in turn may be covered by a biocompatible material, such as, for example, pericardial tissue (e.g., etc.), polymers (e.g. polyesters, etc.) and / or the like, as described above.

[0144] The supra-annular region 120 of the frame 110 can be and / or can be formed into, for example, a hoop or collar that can be attached or coupled to an upper edge or upper portion of the trans-annular region 112, as described in further detail herein. When the valve 100 is deployed within a human heart, the supra-annular region 120 can be an atrial collar that is shaped to conform to the native deployment position. For example, in tricuspid and / or mitral valve replacement, the supra-annular region 120 collar can have portions that are constructed to conform to the native valve and / or a portion of the atrial floor surrounding the tricuspid and / or mitral valve, respectively. In some implementations, the supra-annular region 120 can be deployed on the atrial floor to direct blood from the atrium into the flow control component 150 of the valve 100 and seal to prevent blood leakage around the frame 110 (paravalvular leakage).

[0145] In some embodiments, the upper ring area 120 can be a wire frame laser cut from any suitable material. In some embodiments, the upper ring area 120 can be formed by shape memory or superelastic materials (such as, for example, nitinol). In some embodiments, the upper ring area 120 can be laser cut from a shape memory metal alloy (such as nitinol) sheet and, for example, heat-set into a desired shape and / or configuration. In some embodiments, forming the upper ring area 120 in this manner can allow the upper ring area 120 to bend, flex, fold, compress and / or otherwise reconfigured without substantially plastic deformation and / or the absence of fatigue that may cause one or more parts thereof to fail or break. In addition, the wire frame of the upper ring area 120 can be covered by any suitable biocompatible material (such as any of those described above).

[0146] like Figure 1A As shown, the supra-annular region 120 includes a distal portion 122 and a proximal portion 124. In some embodiments, the distal portion 122 can be and / or can include a distal supra-annular anchoring element and / or the like that can engage native tissue on the distal side of the annulus when the prosthetic valve 100 is positioned in the annulus. In some embodiments, the proximal portion 124 can be and / or can include a proximal supra-annular anchoring element and / or the like that can engage native tissue on the proximal side of the annulus when the prosthetic valve 100 is positioned in the annulus. In some embodiments, the distal portion 122 and / or the distal supra-annular anchoring element can be sized and / or shaped to correspond to the size and / or shape of the distal portion of the atrial floor of the heart in which the prosthetic valve 100 is positioned. Similarly, the proximal portion 124 and / or the proximal supra-annular anchoring element can be sized and / or shaped to correspond to the size and / or shape of the proximal portion of the atrial floor of the heart.

[0147] Although not in Figures 1A to 1E 10, but the supra-annular region 120 may be shaped and / or formed to include any number of features that are configured to engage native tissue and / or one or more other portions of the valve 100, the actuator 170, and / or the delivery system interface 180. For example, in some embodiments, the supra-annular region 120 may include and / or may be formed to include an outer portion, an inner portion, and one or more splines disposed between the outer portion and the inner portion. In some implementations, the outer portion may be sized and / or shaped to engage native tissue, the inner portion may provide structure for mounting the flow control component 150 to the support frame 110, and the one or more splines may receive, couple to, and / or otherwise engage the actuator 170 and / or the delivery system interface 180, as described in further detail herein with reference to specific embodiments.

[0148] The subannular region 130 of the frame 110 can be and / or can be formed into, for example, a hoop or collar that can be attached or coupled to a lower edge or upper portion of the transannular region 112, as described in further detail herein. When the valve 100 is deployed in a human heart, the subannular region 130 can be a ventricular collar that is shaped to conform to the native deployment position. For example, in tricuspid and / or mitral valve replacement, the subannular region 130 or collar can have portions configured to conform to the native valve and / or a portion of the ventricular apex surrounding the tricuspid and / or mitral valve, respectively. In some embodiments, the subannular region 130, or at least a portion thereof, may engage the top of the ventricle surrounding the native annulus to secure the valve 100 in the native annulus, prevent displacement of the valve 100, clamp or compress the native annulus or adjacent tissue between the supraannular region 120 and the subannular region 130, and / or seal to prevent blood leakage around the frame 110 (paravalvular leakage and / or regurgitation during heart contraction).

[0149] In some embodiments, the subannular region 130 can be a wire frame laser-cut from any suitable material. In some embodiments, the subannular region 130 can be formed from a shape memory or superelastic material (such as, for example, nitinol). In some embodiments, the subannular region 130 can be laser-cut from a shape memory metal alloy (such as nitinol) sheet and, for example, heat-set into a desired shape and / or configuration. In some embodiments, forming the subannular region 130 in this manner can allow the subannular region 130 to bend, flex, fold, compress and / or otherwise reconfigure without substantially plastic deformation and / or the absence of fatigue that may cause one or more parts thereof to fail or break. In addition, the wire frame of the subannular region 130 can be covered by any suitable biocompatible material (such as any of those described above).

[0150] The subannular region 130 can be shaped and / or formed to include any number of features configured to engage native tissue, one or more other portions of the valve 100, and / or the actuator 170. For example, in some embodiments, the subannular region 130 can include and / or be formed to include a distal portion having a distal anchoring element 132 and a proximal portion having a proximal anchoring element 134. In some embodiments, the subannular region 130 can include and / or be formed to include any other suitable anchoring element (not described herein). Figures 1A to 1E ). In some embodiments, the anchoring elements 132 and 134 are integrally and / or monolithically formed with the subannular region 130. The distal anchoring element 132 and the proximal anchoring element 134 of the subannular region 130 can be any suitable shape, size, and / or configuration, such as any of those described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional, '964 Provisional, '345 Provisional, and / or '807 Provisional, and / or any of those described herein with respect to specific embodiments. For example, the anchoring elements 132 and 134 can extend from a portion of the subannular region 130 by approximately 10 mm to 40 mm.

[0151] In some embodiments, distal anchoring element 132 can optionally include a guide wire coupler, which is constructed to selectively engage and / or receive a part for a guide wire or a part for a guide wire assembly. The guide wire coupler is constructed to allow a part for a guide wire to extend through the orifice of the guide wire coupler, thereby allowing valve 100 to advance on or along the guide wire during delivery and deployment. In some embodiments, the guide wire coupler selectively allows the guide wire to advance through it, while blocking or preventing other elements and / or parts (such as pushers etc.).

[0152] The anchoring elements 132 and / or 134 of the subannular region 130 can be configured to engage a desired portion of native tissue to mount the valve 100 and / or support frame 110 to the annulus of the native valve in which it is deployed. For example, in some implementations, the distal anchoring element 132 can be a protrusion or projection extending from the subannular region 130 and extending into the RVOT or LVOT. In such implementations, the distal anchoring element 132 can be shaped and / or biased so that the distal anchoring element 132 applies a force on the subannular tissue that is operable to at least partially secure the distal portion of the valve 100 in the native annulus. In some implementations, the proximal anchoring element 134 can be configured to engage subannular tissue on the proximal side of the native annulus to assist in securing the valve 100 in the annulus.

[0153] In some implementations, at least the proximal anchor element 134 can be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchor element 134 extends a first amount or distance from the subannular region 130, and a second configuration in which the proximal anchor element 134 extends a second amount or distance from the subannular region 130. For example, in some embodiments, the proximal anchor element 134 can have a first configuration in which the proximal anchor element 134 is in a compressed, contracted, retracted, undeployed, folded, and / or constrained state (e.g., positioned proximal to, adjacent to, and / or in contact with the transannular region 112 and / or the supraannular region 120 of the support frame 110), and a second configuration in which the proximal anchor element 134 is in an expanded, extended, deployed, unfolded, and / or unconstrained state (e.g., extending away from the transannular region 112). Furthermore, in some implementations, the proximal anchoring element 134 can transition in response to actuation of the actuator 170 , as described in further detail herein.

[0154] In some implementations, the proximal anchoring element 134 can transition from a first configuration to a second configuration during deployment to selectively engage native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure to help secure the valve 100 in the native annulus. The proximal anchoring element 134 (and / or the distal anchoring element 132) can include any suitable features, surfaces, members, etc. configured to facilitate engagement between the proximal anchoring element 134 (and / or the distal anchoring element 132) and the native tissue. For example, in some embodiments, the proximal anchoring element 134 can include one or more features configured to engage and / or become entangled in native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration, as described in further detail herein with reference to specific embodiments.

[0155] The cross-loop region 112 of the support frame 110 is disposed between the upper loop region 120 and the lower loop region 130. In some embodiments, the cross-loop region 112 can be coupled (e.g., welded, bonded, sewn, adhered, etc.) to each of the upper loop region 120 and the lower loop region 130 to achieve a desired amount of movement and / or flexure therebetween. For example, in some implementations, the cross-loop region 112 and / or portions thereof can be sewn to each of the upper loop region 120 and the lower loop region 130 (and / or portions thereof).

[0156] The cross-annulus region 112 can be shaped and / or formed into a ring, a cylindrical tube, a tapered tube, a D-shaped tube, and / or any other suitable annular shape. In some embodiments, the cross-annulus region 112 can have a side profile that includes a flat cone, an inverted flat cone (narrower at the top and wider at the bottom), a concave cylinder (with walls that bend inward), a convex cylinder (with walls that protrude), an angled hourglass shape, a curved hourglass shape, a ring or cylinder with an open top, an open bottom, or both. In addition, the cross-annulus region 112 can form and / or define an orifice or central channel 114 extending along the central axis 104 (e.g., the y-axis). The central channel 114 (e.g., a central axial lumen or channel) can be sized and configured to receive a flow control component 150 that spans a portion of the diameter of the central channel 114. In some embodiments, the annular spanning region 112 can have a shape and / or size based at least in part on the size, shape, and / or configuration of the native annulus in which the supra-annular region 120 and / or sub-annular region 130 and / or the annular spanning region 112 of the support frame 110 are configured to be deployed. For example, the annular spanning region 112 can have an outer circumferential surface for engaging native annular tissue, which can be tensioned against an inner face of the native annulus to provide structural patency to a weakened native annular ring.

[0157] In some embodiments, the annular region 112 can be a wire frame laser cut from any suitable material. In some embodiments, the annular region 112 can be formed from a shape memory or superelastic material such as, for example, Nitinol. In some embodiments, the annular region 112 can be laser cut from a sheet of a shape memory metal alloy such as Nitinol and, for example, heat set into the desired shape and / or configuration. Although not described herein, Figures 1A to 1E , but in some embodiments, the cross-annular region 112 may include and / or may be formed with two laser cut halves that may be formed into a desired shape and / or configuration and coupled together to form the cross-annular region 112. The cross-annular region 112 may be formed to include a set of compressible wire elements having a shape aligned with the central axis 104 ( Figure 1A ) substantially orthogonal orientation and / or cell geometry to minimize filament cell strain when the cross-loop region 112 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. In some embodiments, forming the cross-loop region 112 in this manner may allow the cross-loop region 112 to respond to changes in the orientation and / or cell geometry along the transverse axis 106 ( Figure 1C ) or folded transversely along the direction of the transverse axis 106 and / or folded along the central axis 104 ( Figure 1D ) or vertically compressed in the direction of the central axis 104 to bend, flex, fold, deform and / or otherwise reconfigured (without substantial plastic deformation and / or excessive fatigue), as further described in detail herein.

[0158] As described above with reference to the upper area 120 of the ring and the lower area 130 of the ring, the silk frame of the cross-annular area 112 can be covered by any suitable biocompatible material (such as any of those described above). In some implementations, the silk frames of the upper area 120 of the ring, the cross-annular area 112 and the lower area 130 of the ring can be flexibly coupled (for example, sutured) to form the silk frame portion of the support frame 110, and the silk frame portion is then covered in a biocompatible material. In other words, the upper area 120 of the ring, the cross-annular area 112 and the lower area 130 of the ring can be covered with a biocompatible material before or after coupling. In the embodiment in which the silk frame is covered after coupling, the biocompatible material can promote and / or support the coupling therebetween.

[0159] Although not in Figures 1A to 1E , but the frame 110 may also have and / or form additional functional elements (e.g., loops, anchors, etc.) for attaching auxiliary components such as biocompatible covers, tissue anchors, releasable deployment and retrieval controls (e.g., actuator 170, delivery system interface 180, and / or other suitable guides, knobs, attachments, rigging, etc.), etc. In some implementations, the frame 110 (or aspects and / or portions thereof) may be structurally and / or functionally similar to the frames (or corresponding aspects and / or portions thereof) described in detail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the '345 Provisional, and / or the '807 Provisional.

[0160] The flow control component 150 can refer, in a non-limiting sense, to a device for controlling the flow of fluid therethrough. In some embodiments, the flow control component 150 can be a leaflet structure having two leaflets, three leaflets, four leaflets, or more leaflets made of a flexible, biocompatible material, such as treated or untreated pericardium. The leaflets can be sutured or attached to a support structure, such as an inner frame, which in turn can be sutured or attached to the outer frame 110. The leaflets can be configured to move between an open and closed or substantially sealed state to allow blood to flow through the flow control component 150 in a first direction through the inflow end of the valve 100 and to block blood flow in a second direction, opposite to the first direction, through the outflow end of the valve 100. For example, the flow control component 150 can be configured such that the valve 100 acts as a heart valve, such as the tricuspid valve, mitral valve, aortic valve, or pulmonary valve, which can open to blood flow from the atria to the ventricles during diastole and can close due to ventricular systolic pressure applied to the outer surface. This repeated opening and closing sequence can be described as "reciprocating."

[0161] The inner frame and / or portions or aspects thereof may be similar in at least form and / or function to the outer frame 110 and / or portions or aspects thereof. For example, the inner frame may be a laser-cut wire frame formed of or being a shape memory material such as nitinol. In addition, the inner frame may be capable of being compressed for delivery and may be configured to return to its original (uncompressed) shape upon release (e.g., after delivery). In some embodiments, the inner frame may include and / or may be formed into any suitable number of compressible, elastically deformable diamond-shaped or eye-shaped wire units and / or the like. The wire units may have an orientation and unit geometry that is substantially orthogonal to the axis of the flow control component 150 to minimize wire unit strain when the inner frame is in a compressed configuration.

[0162] In some embodiments, the flow control component 150 and / or its inner frame is in the expanded configuration of the valve 100 (see, e.g., Figure 1C ) can have a substantially cylindrical or tubular shape and can be configured to be in a compressed configuration when the valve 100 is in a compressed configuration (see, e.g. Figure 1B and Figure 1D ) when elastically deformed. Figures 1A to 1E 106, but in some embodiments, the inner frame of the flow control component 150 may include and / or may be formed into two halves that may be coupled together to allow the inner frame to respond to movement along the transverse axis 106 ( Figure 1C ) or elastically deformed by being laterally compressed or folded in the direction of the transverse axis 106, as further described in detail herein.

[0163] like Figures 1A to 1DAs shown, the flow control component 150 is mounted within the central passage 114 of the frame 110. More specifically, the flow control component 150 is mounted and / or coupled to the supra-annular region 120 (e.g., an interior portion thereof) and is configured to extend into and / or through the central passage 114 formed and / or defined by the trans-annular region 112. In some embodiments, the flow control component 150 can be coupled to the supra-annular region 120 via tissue, a biocompatible mesh, one or more woven or knitted fabrics, one or more superelastic or shape memory alloy structures that are sutured, stitched, and / or otherwise secured to a portion of the supra-annular region 120. In some embodiments, the flow control component 150 can be coupled to the supra-annular region 120 such that a portion of the flow control component 150 is disposed above and / or otherwise extends beyond the supra-annular region 120 (e.g., extending away from the annulus in a direction of the atria). In some embodiments, the portion of the flow control component 150 that extends above and / or beyond the supra-annular region 120 can form a ridge, a protrusion, a wall, a step-up, and / or the like. In some implementations, such an arrangement can promote ingrowth of native tissue over the supra-annular region 120 without blocking the flow control component 150.

[0164] The flow control component 150 can be at least partially disposed in the central channel 114 such that an axis of the flow control component 150 extending through the flow control component 150 in the direction of blood flow is substantially parallel to the central axis 104 of the frame 110. In some embodiments, the support frame 110 can be arranged such that the flow control component 150 is centered within the central channel 114. In other embodiments, the support frame 110 can be arranged such that the flow control component 150 is off-center within the central channel 114. In some embodiments, the central channel 114 can have a diameter and / or circumference that is larger than the diameter and / or circumference of the flow control component 150. Although not described herein, Figures 1A to 1E 1 , but in some embodiments, the valve 100 can include a spacer or the like that can be positioned adjacent to the flow control component 150 within the central channel 114. In other embodiments, the spacer can be a cover or the like that is coupled to a portion of the frame 110 and is configured to cover a portion of the central channel 114. In some cases, the spacer can be used to facilitate coupling of the flow control component 150 to the frame 110.

[0165] In some embodiments, flow control component 150 (or portions and / or aspects thereof) can be similar to any of the flow control components described, for example, in the '231 PCT. Accordingly, flow control component 150 and / or aspects or portions thereof are not described in further detail herein.

[0166] Return Reference Figure 1A, the valve 100 includes and / or is coupled to an actuator 170 and a delivery interface 180. The actuator 170 can be any suitable member, mechanism, and / or device configured to actuate at least a portion of the valve 100. For example, in some embodiments, the actuator 170 and / or a portion of the actuator 170 can be configured to at least temporarily couple to the supra-annular region 120 of the support frame 110 (e.g., the splines and / or other portions thereof) and can be configured to actuate one or more portions of the valve 100. More specifically, the actuator 170 can be configured to actuate at least the proximal anchoring element 134 of the subannular region 120 of the support frame 110 to transition the proximal anchoring element 134 between its first configuration and its second configuration. In some implementations, the actuator 170 can include one or more cables, tethers, linkages, joints, connections, etc., which can apply a force (or remove the applied force) on a portion of the proximal anchor element 134, the force being operable to transition the proximal anchor element 134 between the first configuration and the second configuration. For example, the subannular region 130 of the support frame 110 can be formed with the proximal anchor element 134 biased in an uncompressed and / or expanded configuration, and the actuator 170 can be actuated to apply a force, via one or more cables, tethers, etc., the force being operable to transition the proximal anchor element 134 to a compressed and / or retracted configuration.

[0167] In some embodiments, the actuator 170 can tighten and / or lock when the proximal anchoring element 134 is compressed and / or retracted (e.g., a first configuration) to at least temporarily maintain the proximal anchoring element 134 in the first configuration. As described above, in some embodiments, the proximal anchoring element 134 can be in a first configuration for delivery and deployment before the valve 100 is placed in the native annulus. Once the valve 100 is placed in the native annulus, the user can manipulate a portion of the delivery system to actuate the actuator 170. In this example, actuating the actuator 170 can cause the actuator 170 (e.g., via one or more cables, one or more tethers, etc.) to release and / or remove the force applied to the proximal anchoring element 134, thereby allowing the proximal anchoring element 134 to return to its original or biased configuration (e.g., a second configuration), as described above.

[0168] Figure 1AThe delivery system interface 180 shown may include any number of components having any suitable shape, size and / or configuration. In some implementations, the delivery system interface 180 may be and / or may include, for example, a distal portion of a delivery system that is used to deliver the valve 100 to a desired location in the patient's body (e.g., the annulus of a native heart valve). In some embodiments, the delivery system interface may include a delivery catheter, such as, for example, a 12Fr-34 Fr delivery catheter, having any suitable corresponding internal lumen diameter sufficient to receive the artificial valve 100 in a compressed configuration, for example as described in '957PCT. In addition, the delivery system may include a secondary catheter, which may, for example, be a multi-lumen catheter constructed to engage the valve 100 to advance the valve 100 through the delivery catheter. In some embodiments, each lumen of the multi-lumen secondary catheter may include, for example, a cable, a tether and / or any other suitable component associated with and / or included in the actuator 170. Each cable, tether, and / or component, in turn, may be coupled to a portion of the valve 100 or support frame 110 and configured to actuate a portion thereof, as described in further detail herein with reference to specific embodiments.

[0169] In addition, a lumen (e.g., a central lumen) of the multi-lumen secondary catheter may include and / or may receive a torque cable and a guidewire. The guidewire extends through the secondary catheter and into a desired position relative to native tissue (e.g., the RVOT or LVOT) to provide a path along which the valve 100 travels during delivery and / or deployment, as described in '957 PCT. The torque cable may be any suitable cable or the like that is constructed to be removably coupled to the supra-annular region 120 of the frame 110 (e.g., coupled to the supra-annular region 120 and / or a waypoint formed by the supra-annular region). The torque cable may be a relatively rigid cable that may be constructed to facilitate delivery and / or deployment of the valve 100 and retraction of the valve 100 (if desired). In this way, Figure 1A The delivery system interface 180 shown can be a distal portion of a delivery system that includes any of the above-described components. Thus, the delivery system interface 180 can be used to and / or otherwise facilitate the delivery of the valve 100, the deployment and / or actuation of the valve 100 or a portion thereof (e.g., the proximal anchoring element 134), and / or the retraction of the valve 100. Furthermore, the delivery system interface 180 can be configured to decouple, disengage, and / or otherwise release the valve 100 after the valve 100 is deployed in the native annulus, as described in further detail herein with reference to specific embodiments.

[0170] As described above, the valve 100 can be compressed and expanded between an expanded configuration and a compressed configuration. The valve 100 can have a first height or size along the central axis 104 when in the expanded configuration, and can have a second height or size along the central axis 104 that is less than the first height or size when in the compressed configuration. The valve 100 can also be compressed in other directions. For example, the valve 100 can be compressed along a transverse axis 106 that is perpendicular to both the longitudinal axis 102 and the central axis 104 (see, e.g., FIG. 1 ). Figure 1B and Figure 1C ).

[0171] The valve 100 is compressed during delivery of the valve 100 and is configured to expand upon release from the delivery catheter. More specifically, the valve 100 is configured for orthogonal transcatheter delivery to a desired location in the body (e.g., the annulus of a native valve), wherein the valve 100 is compressed in an orthogonal or transverse direction (e.g., along the central axis 104 and / or the transverse axis 106) relative to the dimensions of the valve 100 in the 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.

[0172] The valve 100 is in the expanded configuration before being loaded into the delivery system and after being released from the delivery catheter and deployed or implanted (or prepared for deployment or implantation) at a desired location in the body. Figure 1A 、 Figure 1B and Figure 1E In the expanded configuration shown, the valve 100 has an extent along any direction orthogonal to or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the transverse axis 106) that is greater than the diameter of the lumen of a delivery catheter used to deliver the valve 100. For example, in some embodiments, the valve 100 can have an expanded height (e.g., along the central axis 104) of 5 mm to 60 mm. In some embodiments, the valve 100 can have an expanded diametrical length (e.g., along the longitudinal axis 102) and an expanded diametrical width (e.g., along the transverse axis 106) of approximately 20 mm to 80 mm or approximately 40 mm to 80 mm.

[0173] When in Figure 1C and Figure 1DIn the compressed configuration shown, the valve 100 has an extent in any direction orthogonal to or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the transverse axis 106) that is less than the diameter of the lumen of the delivery catheter, thereby allowing the valve 100 to be delivered through the lumen. For example, in some embodiments, the valve 100 can have a compressed height (e.g., along the central axis 104) and a compressed width (e.g., along the transverse axis 106) of about 6 mm to 15 mm, about 8 mm to 12 mm, or about 9 mm to 10 mm. The valve 100 can be compressed by compression, rolling, folding, and / or any other suitable means or combination thereof, as described in detail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327 Provisional Document, the '964 Provisional Document, the '345 Provisional Document, and / or the '807 Provisional Document. In some embodiments, it is contemplated that the length of the valve 100 (e.g., along the longitudinal axis 102) is not compressed for delivery. Conversely, in some embodiments, the length of the valve 100 can increase in response to compression of the valve 100 along the central axis 104 and / or the transverse axis 106.

[0174] like Figure 1E As shown, the valve 100 can, for example, be delivered to an atrium of a human heart and positioned within the annulus of a native valve, such as, for example, the pulmonary valve (PV), the mitral valve (MV), the aortic valve (AV), and / or the tricuspid valve (TV). As described above, the valve 100 can be in a compressed configuration and delivered to the annulus via a delivery system, and can be released from the delivery system and allowed to expand to an expanded configuration. For example, the valve 100 can be delivered to an atrium of a human heart and released from a delivery catheter (not shown) via any of the delivery systems, devices, and / or methods described in detail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327 Provisional Paper, the '964 Provisional Paper, the '345 Provisional Paper, and / or the '807 Provisional Paper.

[0175] In some implementations, delivery of the valve 100 can include advancing a guidewire into the atrium of a human heart, through the native valve, and into a desired location within the ventricle (e.g., RVOT or LVOT). After positioning the guidewire, the delivery catheter can be advanced along and / or over the guidewire and (e.g., through the IVC, SVC, and / or trans-septal access) into the atrium. In some embodiments, a guidewire coupler of the valve 100 (e.g., included in or on the distal anchoring element 132) can be coupled to the proximal portion of the guidewire, and the valve 100 can be in a compressed configuration, allowing the valve 100 to be advanced along the guidewire and through the lumen of the delivery catheter and into the atrium.

[0176] Deployment of the valve 100 can include placing the distal anchoring element 132 of the subannular region 130 in the ventricle (RV, LV) below the annulus, with the remainder of the valve 100 in the atria (RA, LA). In some cases, the distal anchoring element 132 can be advanced over and / or along a guidewire to a desired location within the ventricle, such as, for example, the outflow tract of the ventricle. For example, in some implementations, the valve 100 can be delivered to the annulus of the native tricuspid valve (TV), and at least a portion of the distal anchoring element 132 can be positioned in the RVOT. In other implementations, the valve 100 can be delivered to the annulus of the native mitral valve (MV), and at least a portion of the distal anchoring element 132 can be positioned in the LVOT.

[0177] In some implementations, the prosthetic valve 100 can be temporarily maintained in a partially deployed state. For example, the valve 100 can be partially inserted into the annulus and maintained at an angle relative to the annulus to allow blood to flow partially through the native annulus around the valve 100 and partially through the valve 100 from the atrium to the ventricle, which can allow for assessment of valve function.

[0178] The valve 100 can be placed or positioned in the annulus (PVA, MVA, AVA, and / or TVA) of a native valve (PV, MV, AV, and / or TV) such that the subannular region 130 (e.g., a ventricular collar) is disposed in a subannular position, the transannular region 112 of the valve frame 110 extends through the annulus, and the supraannular region 120 (e.g., an atrial collar) remains in a supraannular position. For example, in some embodiments, a delivery system, a delivery system interface 180, an actuator 170, and / or any other suitable component, tool, etc. can be used to push at least the proximal portion of the valve 100 into the annulus. In some implementations, the proximal anchoring element 134 can remain in its first configuration when the valve 100 is positioned in the annulus. For example, as described above, the proximal anchoring element 134 can be in a compressed, contracted and / or retracted configuration, in which the proximal anchoring element 134 is in contact with, adjacent to and / or near the cross-annular region 112 and / or the supra-annular region 120 of the frame 110, which in turn can limit the overall circumference of the sub-annular region 130 of the frame 110, thereby allowing the sub-annular region 130 and the cross-annular region 112 of the frame 110 to be inserted into and / or through the ring.

[0179] Once positioned, the proximal anchoring element 134 can transition from its first configuration to its second configuration, as described in detail in the '010 PCT, the '108 PCT, and / or the '345 Provisional Document. For example, in some implementations, a user can manipulate a portion of the delivery system to actuate the actuator 170. In some implementations, actuating the actuator 170 can release and / or reduce the amount of tension within one or more tethers, cables, connections, and / or portions of the actuator 170, thereby allowing the proximal anchoring element 134 to transition. Thus, when the valve 100 is positioned in the annulus, the proximal anchoring element 134 can be in its second configuration, in which the proximal anchoring element 134 contacts, engages, and / or is otherwise positioned adjacent to subannular tissue. In some embodiments, the proximal anchoring element 134 can be configured to engage and / or capture native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or the like when the proximal anchoring element 134 is positioned in the ventricle. For example, in some embodiments, after the valve 100 is positioned in the annulus, the proximal anchoring element 134 can be transformed from a first (compressed) configuration to a second (extended) configuration such that the proximal anchoring element 134 extends around and / or through one or more portions of the native tissue, chordae tendineae, etc. The proximal anchoring element 134 can then return to the first configuration to capture and / or secure one or more portions of the native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, etc. between the proximal anchoring element 134 and, for example, a trans-annular segment of the outer frame 110. In other embodiments, after the valve 100 is positioned in the native annulus, the proximal anchoring element 134 can remain in the second (extended) configuration. In such implementations, for example, the proximal anchoring element 134 can contact and / or engage subannular tissue on the proximal side of the annulus such that the proximal anchoring element and the proximal portion of the atrial collar apply a compressive force on the proximal portion of the annulus tissue.

[0180] In this manner, the distal anchoring element 132 can be configured to engage native tissue on the distal side of the annulus, and the proximal anchoring element 134 can be configured to engage native tissue on the proximal side of the annulus (e.g., when in the second or expanded configuration), thereby securely seating the valve 100 in the native annulus, as shown. Figure 1E In some implementations, any other or additional portions of the valve may similarly engage native tissue to securely seat the valve 100 in the native annulus and / or to form a seal between the support frame 110 and the tissue forming the native annulus (e.g., the distal portion 122 and / or proximal portion 124 of the supra-annular region 120, the trans-annular region 112, and / or one or more other or additional anchoring elements (not shown). Figures 1A to 1E shown in ).

[0181] Although not in Figures 1A to 1E, but in some implementations, the valve 100 and / or delivery system may include one or more tissue anchors that can be used to anchor one or more portions of the valve 100 to the annular tissue, as described in detail in the '957 PCT. In some embodiments, the tissue anchors can be configured to puncture, penetrate, and / or otherwise secure the anchoring elements 132 and / or 134 and / or the atrial collar to the annular tissue. In other embodiments, the tissue anchors can be, for example, atraumatic anchors that are configured to secure the anchoring elements 132 and / or 134 and / or the atrial collar to the annular tissue without puncturing, penetrating, and / or otherwise causing trauma to the native tissue.

[0182] Figures 2A to 2D is a schematic diagram of an annular support frame 210 according to one embodiment. The annular support frame 210 (also referred to herein as a "tubular frame," "valve frame," "wire frame," "external frame," "support frame," or "frame") may include and / or be coupled to an actuator 270 configured to actuate one or more portions of the support frame 210. In some embodiments, the support frame 210 and / or the actuator 270 may be respectively similar in at least form and / or function to the annular support frame 210 described above with reference to FIG. Figures 1A to 1E The support frame 110 and / or actuator 170 described are substantially similar. Therefore, portions and / or aspects of the support frame 210 and / or actuator 270 are not described in further detail herein.

[0183] As shown, the annular support frame 210 has an upper ring member and / or region 220, a lower ring member and / or region 230, and a cross-ring member and / or region 212 disposed and / or coupled therebetween. Figures 2A to 2DIn the illustrated embodiment, the upper ring member and / or zone 220, the lower ring member and / or zone 230, and the cross-ring member and / or zone 212 are separate, independent, and / or modular components that are coupled to collectively form the frame 210. Each of the upper ring member and / or zone 220, the lower ring member and / or zone 230, and the cross-ring member and / or zone 212 (referred to herein as the upper ring "member," the lower ring "member," and the cross-ring "member") is a wire frame laser-cut from any suitable material, such as a shape memory or superelastic material like Nitinol. In some implementations, each of the upper ring member 220, the lower ring member 230, and the cross-ring member 212 can be laser-cut from a sheet of Nitinol and, for example, heat-set into a desired shape and / or configuration. As described above, forming the upper ring member 220, the lower ring member 230, and the cross-ring member 212 in this manner can provide a desired amount of flexibility and / or resistance to plastic or permanent deformation, which can allow the frame 210 to be folded and / or compressed for delivery. In addition, the wire frame portions of the upper ring member 220, the lower ring member 230, and the cross-ring member 212 can be covered by any suitable biocompatible material, such as any of those described above.

[0184] In some embodiments, the ring member 220 of the frame 210 may be similar in at least form and / or function to the ring member 220 described above with reference to FIG. Figures 1A to 1E 20. The over-the-annular member 220 may be similar to the over-the-annular member 120 described above. For example, the over-the-annular member 220 may be and / or may be formed, for example, a hoop or collar that may be attached or coupled to an upper edge or upper portion of the over-the-annular member 212, as described in further detail herein. In some implementations, the over-the-annular member 220 may be deployed on the floor of the atrium to direct blood from the atrium to a flow control component mounted to the frame 210, as described in detail above. The over-the-annular member 220 may be shaped and / or formed to include any number of features configured to engage native tissue and / or one or more other portions of the frame 210 and / or the actuator 270. For example, in some embodiments, the over-the-annular member 220 may include and / or may be formed to include an outer portion or loop, an inner portion or loop, and one or more splines disposed between the outer portion or loop and the inner portion or loop.

[0185] In some embodiments, the outer portion or loop (referred to herein as the "outer loop") can be shaped and / or sized to engage native tissue. More specifically, the supra-annular member 220 (or its outer loop) can have a distal portion 222 configured to engage distal supra-annular tissue and a proximal portion 224 configured to engage proximal supra-annular tissue. In some embodiments, the distal portion 222 and the proximal portion 224 can have a circular and / or curved shape, wherein the radius of curvature of the proximal portion 224 is greater than the radius of curvature of the distal portion 222. In some implementations, the distal portion 222 can form, for example, a distal supra-annular anchoring element that can engage distal supra-annular tissue to at least partially stabilize and / or secure the frame 210 in the native annulus. Similarly, the proximal portion 224 can form, for example, a proximal supra-annular anchoring element that can engage proximal supra-annular tissue to at least partially stabilize and / or secure the frame 210 in the native annulus.

[0186] The inner portion or loop of the upper ring member 220 (referred to herein as the "inner loop") can be substantially circular and can be coupled to and / or suspended from the outer loop via one or more splines. As described in further detail herein with reference to specific embodiments, the inner loop can be coupled to an inner frame of the flow control component to at least partially mount the flow control component to the support frame 210. In some implementations, suspending the inner loop from the outer loop (via one or more splines) can, for example, at least partially isolate the inner loop from at least a portion of the forces associated with transitioning the frame 210 between its expanded configuration and its compressed configuration, as described in further detail herein. Additionally, mounting the flow control component to the inner loop of the upper ring member 220 similarly at least partially isolates and / or reduces the amount of force transmitted to the flow control component when the frame 210 transitions between its expanded configuration and its compressed configuration.

[0187] The one or more splines of the ring upper member 220 can be of any suitable shape, size and / or configuration. For example, in some embodiments, the ring upper member 220 may include distal splines and proximal splines. As described above, the splines can be constructed to support the inner loop and / or otherwise couple the inner loop to the outer loop. In some embodiments, the ring upper member 220 may include splines (e.g., proximal splines) that are constructed to receive, couple to and / or otherwise engage the actuator 270 and / or delivery system interface. For example, in some embodiments, the proximal splines can form a connection point, an attachment point, a waypoint and / or any other suitable feature that can be temporarily and / or removably coupled to the actuator 270, as described in further detail herein with reference to specific embodiments.

[0188] In some embodiments, the under-ring member 230 of the frame 210 may be similar in at least form and / or function to the above-referenced Figures 1A to 1E13. The subannular region 130 of the frame 210 can be similar to the subannular region 130 described herein. For example, the subannular member 230 of the frame 210 can be and / or can be formed into, for example, a hoop or collar that can be attached or coupled to a lower edge or upper portion of the trans-annular member 212, as described in further detail herein. When the frame 210 is deployed within a human heart, the subannular member 230 can be a ventricular collar that is shaped to conform to the native deployment position. For example, in tricuspid and / or mitral valve replacement, the subannular member 230 or collar can have portions that are configured to conform to the native valve and / or a portion of the ventricular apex surrounding the tricuspid and / or mitral valve, respectively. In some embodiments, the subannular member 230, or at least a portion thereof, may engage the top of the ventricle surrounding the native annulus to secure the frame 210 in the native annulus, prevent displacement of the frame 210, clamp or compress the native annulus or adjacent tissue between the supra-annular member 220 and the subannular member 230, and / or seal to prevent blood leakage around the frame 210 (paravalvular leakage and / or regurgitation during cardiac contraction).

[0189] The sub-annular member 230 can be shaped and / or formed to include any number of features configured to engage native tissue, one or more other portions of the frame 210, and / or the actuator 270. For example, in some embodiments, the sub-annular member 230 can include and / or be formed to include a distal portion having a distal anchoring element 232 and a proximal portion having a proximal anchoring element 234. In some embodiments, the sub-annular member 230 can include and / or be formed to include any other suitable anchoring element (not described herein). Figures 2A to 2D ). In some embodiments, the anchoring elements 232 and 234 are integrally and / or monolithically formed with the subannular member 230. The distal anchoring element 232 and the proximal anchoring element 234 of the subannular member 230 can be any suitable shape, size, and / or configuration, such as any of those described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional, '964 Provisional, '345 Provisional, '807 Provisional, any of those described above with reference to the valve 100, and / or any of those described herein with respect to specific embodiments.

[0190] In some embodiments, distal anchoring element 232 can optionally include a guide wire coupler, and described guide wire coupler is constructed to selectively engage and / or receive a part for guide wire or a part for guide wire assembly.The guide wire coupler is constructed to allow a part for guide wire to extend through the aperture of the guide wire coupler, thereby allowing framework 210 to advance on guide wire or along guide wire during delivery and deployment.In some embodiments, the guide wire coupler selectively allows guide wire to advance through wherein, blocks or stops other elements and / or parts (such as pusher etc.) simultaneously.

[0191] The anchoring elements 232 and / or 234 of the subannular member 230 can be configured to engage a desired portion of native tissue to mount the frame 210 to the annulus of the native valve in which it is deployed. For example, in some implementations, the distal anchoring element 232 can be a protrusion or projection extending from the subannular member 230 and extending into the RVOT or LVOT. In such implementations, the distal anchoring element 232 can be shaped and / or biased so that the distal anchoring element 232 applies a force on the subannular tissue that is operable to at least partially secure the distal portion of the frame 210 in the native annulus. In some implementations, the proximal anchoring element 234 can be configured to engage subannular tissue on the proximal side of the native annulus to assist in securing the frame 210 in the annulus.

[0192] In some implementations, at least the proximal anchoring element 234 can be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 234 extends a first amount or distance from the sub-loop member 230 and a second configuration in which the proximal anchoring element 234 extends a second amount or distance from the sub-loop member 230. As described above, the sub-loop member 230 of the frame 210 can be and / or include, for example, a laser-cut wire frame formed of a shape memory material such as Nitinol that is heat-set into a desired shape. In some embodiments, heat-setting the sub-loop member 230 can include forming one or more torsions in a portion of the laser-cut wire, which can, in turn, allow one or more portions of the sub-loop member 230 to be biased in different directions and / or orientations. For example, generally, the sub-loop member 230 of the frame 210 can be formed to provide a significant amount of flexibility in a direction that allows the sub-loop member 230 to be folded and / or compressed (e.g., relative to the longitudinal axis of the sub-loop member 230). However, in some embodiments, a portion of the sub-annular member 230 may be twisted and / or otherwise oriented to provide a substantial amount of flexibility in a direction that allows the proximal anchoring element 234 to be actuated and / or otherwise transitioned between its first and second configurations (e.g., in a direction orthogonal to the longitudinal axis of the sub-annular member 230 and to the direction of folding and / or compression).

[0193] In some embodiments, the proximal anchoring element 234 can be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state when in a first configuration (e.g., in a position near, adjacent to, and / or in contact with the cross-ring member 212 and / or the upper ring member 220 of the support frame 210), and can be in an expanded, extended, deployed, unfolded, and / or unconstrained state when in a second state (e.g., extending away from the cross-ring member 212). In some embodiments, the proximal anchoring element 234 can be biased and / or heat set in the second configuration. Furthermore, in some implementations, the proximal anchoring element 234 can transition in response to actuation of the actuator 270, as described in further detail herein.

[0194] In some implementations, the proximal anchoring element 234 can transition from a first configuration to a second configuration during deployment to selectively engage native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure to help secure the frame 210 in the native annulus. The proximal anchoring element 234 (and / or the distal anchoring element 232) can include any suitable features, surfaces, members, etc. configured to facilitate engagement between the proximal anchoring element 234 (and / or the distal anchoring element 232) and the native tissue. For example, in some embodiments, the proximal anchoring element 234 can include one or more features configured to engage and / or become entangled in native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration, as described in further detail herein with reference to specific embodiments.

[0195] In some embodiments, the cross-ring members 212 of the frame 210 may be similar in at least form and / or function to the above-referenced Figures 1A to 1E The cross-ring region 112 described above is similar. For example, the cross-ring member 212 is disposed between the upper ring member 220 and the lower ring member 230. In some embodiments, the cross-ring member 212 may be coupled (e.g., welded, bonded, sewn, adhered, etc.) to each of the upper ring member 220 and the lower ring member 230 so as to achieve a desired amount of movement and / or flexure therebetween. For example, in some implementations, the cross-ring member 212 and / or portions thereof may be sewn to each of the upper ring member 220 and the lower ring member 230 (and / or portions thereof). The cross-ring member 212 may be shaped and / or formed into a ring, a cylindrical tube, a tapered tube, a D-shaped tube, and / or any other suitable annular shape, as described above with reference to the cross-ring member 112. In some embodiments, the cross-ring member 212 can have a shape and / or size that is based at least in part on the size, shape, and / or configuration of the upper ring member 220 and / or lower ring member 230 of the support frame 210, a flow control component configured to be coupled to the support frame 210, and / or the native annulus in which the cross-ring member 212 is configured to be deployed. For example, the cross-ring member 212 can have an outer circumferential surface for engaging native annular tissue, which can be tensioned against an inner face of the native annulus to provide structural patency to the weakened native annular ring.

[0196] As described above, the supra-annular member 220, the subannular member 230, and the cross-annular member 212 can be independent and / or modular components that are coupled to collectively form the frame 210. In some embodiments, the supra-annular member 220 is constructed to engage the supra-annular tissue of the native valve and can be shaped and / or biased to form a substantially fluid-tight seal with the bottom of the atrium, thereby limiting and / or substantially preventing leakage around the frame (e.g., paravalvular leakage). Similarly, the supra-annular member 220 is constructed to engage the subannular tissue of the native valve and can be shaped and / or biased to form a substantially fluid-tight seal with the top of the ventricle, thereby limiting and / or substantially preventing leakage around the frame. In addition, in some implementations, the cross-annular member 212 can have a circumference that is slightly oversized relative to the native annular tissue and can, for example, form at least a partial seal between the cross-annular member 212 of the frame 210 and the native tissue forming the wall of the annulus. In such an implementation, forming a seal against the atrial floor, ventricular top, and walls of the annulus can provide redundancy in the event of an incomplete or partial seal formed by one or more of the supra-annular member 220, sub-annular member 230, and / or trans-annular member 212.

[0197] In other implementations, the distal anchoring element 232 and the proximal anchoring element 234 can exert a force on the subannular tissue that can operatively pull the supraannular member 220 of the frame 210 toward the atrial floor, thereby promoting the formation of a seal. In such implementations, for example, the subannular member 230 and / or the transannular member 212 need not form a seal with native tissue or may form a partial seal with native tissue due to the seal formed by the supraannular member 220.

[0198] In some embodiments, the arrangement of the frame 210 can be such that structural support and / or rigidity is provided by the upper ring member 220 and the lower ring member 230, while the cross-ring member 212 does not need to provide substantial support and / or rigidity. In some such embodiments, the cross-ring member 212 can be constructed to couple the upper ring member 220 to the lower ring member 230 and easily (elastically) deform for delivery, rather than providing substantial support and / or rigidity. In addition, although the cross-ring member 212 is described above as being formed by a laser-cut wire frame covered with a biocompatible material, in other embodiments, the cross-ring member 212 can be formed by any suitable flexible material (such as pericardial tissue, fabric, polyester and / or the like). In some such embodiments, forming a flexible material without a laser-cut wire frame can, for example, reduce the size of the frame 210 when in a compressed configuration, thereby allowing the use of a smaller delivery catheter to deliver the valve. In some embodiments, the frame 210 does not need to include a separate cross-ring member 212. For example, in such embodiments, a flow control component may be coupled between the supra-annular member 220 and the sub-annular member 230, thereby allowing for further reduction in the size of the valve in the compressed configuration.

[0199] like Figures 2A to 2D 20. As shown, actuator 270 can be at least temporarily coupled to upper annular member 220 and lower annular member 230. In some embodiments, actuator 270, or a portion thereof, can also be at least temporarily coupled to a portion of cross-annular member 212. Actuator 270 can be any suitable member, mechanism, and / or device configured to actuate at least a portion of frame 210. Furthermore, a portion of actuator 270 can extend through a portion of a delivery system for delivering frame 210 and / or a valve including frame 210. In this manner, a user can manipulate the proximal portion of actuator 270 to actuate actuator 270.

[0200] In some embodiments, the actuator 270 and / or a portion of the actuator 270 can be configured to at least temporarily couple to a spline (e.g., an attachment point, a waypoint, a connector, a threaded coupler, etc.) of the upper ring member 220 and can be configured to actuate one or more portions of the frame 210. The actuator 270 can be configured to actuate at least the proximal anchor element 234 of the lower ring member 220 supporting the frame 210 to transition the proximal anchor element 234 between its first and second configurations (as described above).

[0201] In some implementations, the actuator 270 can include one or more cables, tethers, links, joints, connections, and the like that can apply a force (or remove the applied force) on a portion of the proximal anchoring element 234 that is operable to transition the proximal anchoring element 234 between the first configuration and the second configuration. For example, the actuator 270 can be coupled to a waypoint or the like of the upper ring member 220 and can include one or more tethers, cables, and / or members that extend through the waypoint and / or one or more openings or apertures and couple to the proximal anchoring element 234. In some implementations, the one or more tethers, cables, and / or members can be removably and / or temporarily coupled to the proximal anchoring element 234, as described, for example, in the '010 PCT, the '108 PCT, and / or the '345 Provisional Document.

[0202] As described above, the under-loop member 230 can be formed with a proximal anchoring element 234 that is biased in an uncompressed and / or expanded configuration. In this way, the actuator 270 can be actuated to apply a force through one or more cables, tethers, etc. that is operable to transition the proximal anchoring element 234 into a compressed and / or retracted configuration. More specifically, a user can manipulate the proximal portion of the actuator 270 to actuate the distal portion of the actuator 270 that is coupled to the frame 210. For example, actuating the actuator 270 can cause one or more cables, tethers, and / or members, such as the frame 210, to be pulled in a proximal direction (e.g., away from the frame 210 and / or in a manner that increases tension therein). Figure 2B The coupling of the distal portion of the actuator 270 to the frame 210 can cause the proximal movement of the cable, tether, etc. to pull the proximal anchoring element 234 toward the central axis of the frame 210, as shown in FIG. Figure 2B Thus, the actuator 270 can apply a force on the proximal anchoring element 234 that is operable to place the proximal anchoring element 234 in a compressed, retracted, restricted, and / or actuated configuration, such as Figure 2B shown.

[0203] In some implementations, the actuation actuator 270 may also be operable to pull the proximal anterior portion of the subannular member and / or transannular wall and the proximal posterior portion of the subannular member and / or transannular wall toward or towards the longitudinal axis of the valve 200. For example, Figure 2C Actuation of the actuator 270 (e.g., moving the actuator 270 or the tether in the AA direction) is shown to compress and / or move the proximal anchoring element 234 toward the central portion of the valve frame 210, as indicated by arrows BB, and to compress the posterior and anterior sidewalls, as indicated by arrows CC, toward the central portion of the valve frame 210. Thus, actuating the actuator 270 can reduce the circumference of at least the subannular member 230, thereby allowing a desired portion of the valve frame 210 to be inserted into the annulus of the native valve.

[0204] In some implementations, the actuator 270 can tighten and / or lock when the proximal anchoring element 234 is compressed and / or retracted (e.g., the first configuration) to at least temporarily maintain the proximal anchoring element 234 in the first configuration. As described above, in some implementations, the proximal anchoring element 234 can be in the first configuration for delivery and deployment prior to positioning the frame 210 (or valve) in the native annulus. Once the frame 210 is positioned in the native annulus, the user can manipulate the proximal portion of the actuator 270 to actuate and / or release the actuator 270. In this example, actuation can cause the actuator 270 to release and / or remove (e.g., via one or more cables, one or more tethers, etc.) at least a portion of the force applied to the proximal anchoring element 234, thereby allowing the proximal anchoring element 234 (and / or one or more portions of the anterior wall and / or posterior wall) to return to its biased configuration or second configuration (see, e.g., Figure 2A ), as described above.

[0205] In some implementations, the actuator 270 can be configured to further actuate the frame 210 after the frame 210 (or valve) is positioned in the native annulus. For example, in some implementations, a user can manipulate the proximal portion of the actuator 270 (e.g., in the same manner as just described or in a different manner) to move one or more cables, tethers, and / or members of the actuator 270 in a proximal direction (e.g., away from the frame 210 and / or in a manner that increases tension therein), such as Figure 2D In this example, the proximal anchoring element 234 is in its uncompressed or unactuated state after the frame 210 is placed in the native annulus. The actuator 270 can be coupled to the upper ring member 220, the lower ring member 230 and / or the proximal anchoring element 234 so that actuation of the actuator 270 generates a force that is operable to pull the proximal anchoring element 234 toward the proximal portion 224 of the upper ring member 220, as shown in FIG. Figure 2D For example, the actuator 270 may apply a compressive force or the like that is operable to tighten at least a portion of the frame 210.

[0206] like Figure 2D As shown, in some cases, the proximal anchoring element 234 can bend in the direction of the native annulus (e.g., bend beyond its biased position), which can facilitate engagement between the proximal anchoring element 234 and native tissue and / or chordae tendineae proximal to the native annulus. In some implementations, the force generated by actuation of the actuator 270 can be operable to pull, move, compress, and / or tighten other portions of the lower annular member 230 toward the upper annular member 220, such as Figure 2DFF in . In some such implementations, the amount of tightening can vary across the frame 210. For example, the amount of tightening at or near a proximal portion of the frame 210 can be greater than the amount of tightening at or near a distal portion of the frame 210. In other implementations, the amount of tightening can be substantially consistent across the frame 210. Furthermore, when the frame 210 is positioned in the native annulus, at least a portion of the tissue surrounding the native annulus can be disposed between the upper and lower annular members 220, 230, and thus, tightening of the upper and lower annular members 220, 230 can be operable to compress and / or sandwich the native tissue between the members 220, 230. In this way, tightening can enhance the securement of the frame 210 in the native annulus.

[0207] Although not in Figures 2A to 2D , but in some embodiments, the proximal anchoring elements 234 can be sized and / or shaped to engage native tissue, chordae, trabeculae, annular tissue, leaflet tissue, and / or the like when the frame 210 is tightened against or relative to the native annulus. In some embodiments, the proximal anchoring elements 234 can include one or more protrusions, features, ridges, ribs, knobs, knots, beads, loops, etc., which can engage native tissue and / or can facilitate engagement of native tissue when the frame 210 is tightened against or relative to the native annulus.

[0208] While one or more portions of the frame 210 and / or subannular member 230 are described above as being compressed to move inwardly toward the central axis of the frame 210 in response to actuation of the actuator 270, in other embodiments, the actuator 270 can be removably coupled to one or more portions of the frame 210 and configured to move such portions in any suitable manner. For example, in some implementations, the actuator 270 (e.g., one or more tethers or the like, as described above) can be coupled to the proximal anchoring element 234 such that actuation of the actuator 270 causes the proximal anchoring element 234 to fold or wrap around the cross-annular member 212 of the frame 210 in an anterior direction, a posterior direction, or both, depending on the mode of actuation. As described above, the folding and / or wrapping of the proximal anchoring element 234 around the cross-annular member 212 can reduce the circumference or diameter of at least the subannular member 230, thereby allowing the frame 210 to be inserted and / or at least partially inserted through the annulus of a native heart valve.

[0209] Figures 3A to 3Cis a schematic diagram of an annular support frame 310 according to one embodiment. The annular support frame 310 (also referred to herein as a "tubular frame," "valve frame," "wire frame," "exoframe," "support frame," or "frame") may include and / or be coupled to an actuator 370 configured to actuate one or more portions of the support frame 310. In some embodiments, the support frame 310 and / or actuator 370 may be substantially similar in at least form and / or function to the support frames 110, 210 and / or actuators 170, 270, respectively. Accordingly, portions and / or aspects of the support frame 310 and / or actuator 370 are not described in further detail herein.

[0210] As shown, the annular support frame 310 has an upper ring member and / or region 320, a lower ring member and / or region 330, and a cross-ring member and / or region 312 disposed and / or coupled therebetween. Figures 3A to 3C In the illustrated embodiment, the upper ring member and / or zone 320, the lower ring member and / or zone 330, and the cross-ring member and / or zone 312 are separate, independent, and / or modular components that are coupled to collectively form the frame 310. Each of the upper ring member and / or zone 320, the lower ring member and / or zone 330, and the cross-ring member and / or zone 312 (referred to herein as the upper ring "member," the lower ring "member," and the cross-ring "member") is a wire frame laser-cut from any suitable material, such as a shape memory or superelastic material like Nitinol. In some implementations, each of the upper ring member 320, the lower ring member 330, and the cross-ring member 312 can be laser-cut from a sheet of Nitinol and, for example, heat-set into a desired shape and / or configuration. As described above, forming the upper ring member 320, the lower ring member 330, and the cross-ring member 312 in this manner can provide a desired amount of flexibility and / or resistance to plastic or permanent deformation, which can allow the frame 310 to be folded and / or compressed for delivery. In addition, the wire frame portions of the upper ring member 320, the lower ring member 330, and the cross-ring member 312 can be covered by any suitable biocompatible material, such as any of those described above.

[0211] In some embodiments, the upper ring member 320 of the frame 310 can be similar in at least form and / or function to the upper ring members 120, 220 described above. For example, the upper ring member 320 can be and / or can be formed, for example, as a hoop or collar that can be attached or coupled to an upper edge or upper portion of the cross-ring member 312. The upper ring member 320 can be shaped and / or formed to include any number of features configured to engage native tissue and / or one or more other portions of the frame 310 and / or the actuator 370. For example, the upper ring member 320 (or its outer loop) can have a distal portion 322 configured to engage distal supra-annular tissue and a proximal portion 324 configured to engage proximal supra-annular tissue.

[0212] As described above, the upper ring member 320 may include and / or may be formed with an outer portion or loop, an inner portion or loop, and one or more splines disposed between the outer portion or loop and the inner portion or loop. The outer portion or loop (referred to herein as the "outer loop") may be shaped and / or sized to engage native tissue. In some implementations, the outer loop may form, for example, one or more upper anchoring elements or upper ring anchoring elements that may engage the upper ring tissue to at least partially stabilize and / or secure the frame 310 within the native annulus. The inner portion or loop of the upper ring member 320 (referred to herein as the "inner loop") is coupled to and / or suspended from the outer loop via one or more splines and may be coupled to the inner frame of the flow control component to at least partially mount the flow control component to the support frame 310, as described above with reference to the upper ring member 220. The one or more splines of the upper ring member 320 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the upper ring member 320 may include distal splines and proximal splines. In some embodiments, the ring member 320 may include splines (e.g., proximal splines) that are configured to receive, couple to, and / or otherwise engage the actuator 370 and / or the delivery system interface. Figures 3A to 3C In the illustrated embodiment, the ring member 330 (e.g., its splines) may form waypoints and / or the like that may be temporarily and / or removably coupled to and / or receive the actuator 370 and any other suitable portion of the delivery system, as further described in detail herein with reference to specific embodiments.

[0213] The subannular member 330 of the frame 310 can be similar in at least form and / or function to the subannular region and / or members 130, 230 described above. For example, the subannular member 330 of the frame 310 can be and / or can be formed into, for example, a hoop or collar that can be attached or coupled to a lower edge or upper portion of the trans-annular member 312. When the frame 310 is deployed within a human heart, the subannular member 330 can be a ventricular collar that is shaped to conform to the native deployment position. In some implementations, the subannular member 330, or at least a portion thereof, can engage the ventricular roof surrounding the native annulus to secure the frame 310 in the native annulus, prevent the frame 310 from shifting, and / or seal to prevent blood leakage around the frame 310 (paravalvular leakage and / or regurgitation during systole).

[0214] Figures 3A to 3C The under-loop member 330 included in the frame 310 shown in FIG. 3 may include and / or may be formed with a distal portion having a distal anchoring element 332 and a proximal portion having a proximal anchoring element 334. In some embodiments, the under-loop member 330 may include and / or may be formed with any other suitable anchoring element (not shown). Figures 3A to 3C). Anchoring elements 332 and 334 can be integrally and / or monolithically formed with subannular member 330. The distal anchoring element 332 and the proximal anchoring element 334 of subannular member 330 can be of any suitable shape, size, and / or configuration, such as any of those described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional, '964 Provisional, '345 Provisional, '807 Provisional, any of those described above with reference to valve 100, and / or any of those described herein with respect to specific embodiments. The distal anchoring element 332 can be substantially similar to distal anchoring elements 132, 232 and, therefore, not described in further detail herein.

[0215] The proximal anchoring element 334 can be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 334 extends a first amount, distance, and / or direction from the under-loop member 330, and a second configuration in which the proximal anchoring element 334 extends a second amount, distance, and / or direction from the under-loop member 330. In some embodiments, the proximal anchoring element 334 can be similar in at least form and / or function to the proximal anchoring element 334 described above with reference to FIG. Figures 2A to 2D The proximal anchoring elements 234 described are substantially similar. Therefore, such similarities will not be described in further detail herein.

[0216] In some embodiments, the proximal anchoring element 334 can be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state when in a first configuration (e.g., in a position adjacent to, adjacent to, and / or in contact with the cross-ring member 312 and / or the upper ring member 320 of the support frame 310), and can be in an expanded, extended, deployed, unfolded, and / or unconstrained state when in a second state (e.g., extending away from the cross-ring member 312). In some embodiments, the proximal anchoring element 334 can be biased and / or heat set in the second configuration. Furthermore, in some implementations, the proximal anchoring element 334 can transition in response to actuation of the actuator 370, as described in further detail herein.

[0217] The cross-ring member 312 is disposed between the upper ring member 320 and the lower ring member 330. In some embodiments, the cross-ring member 312 can be coupled (e.g., welded, bonded, sewn, adhered, etc.) to each of the upper ring member 320 and the lower ring member 330 to achieve a desired amount of movement and / or flexure therebetween. In some embodiments, the cross-ring member 312 of the frame 310 can be similar in at least form and / or function to the cross-ring regions 112, 212 described above, and therefore, not described in further detail herein.

[0218] Although the frame 310 is described above as being identical to the frame 310 described above with reference to Figures 2A to 2D The frame 210 described is substantially similar, but the frame 310 may differ from the frame 210 in terms of engagement with the actuator and movement of the proximal anchoring element 334. Figures 3A to 3C As shown, actuator 370 can be at least temporarily engaged with the upper annular member 320 and the lower annular member 330. Actuator 370 can be any suitable member, mechanism, and / or device configured to actuate at least a portion of frame 310. In addition, a portion of actuator 370 can extend through a portion of a delivery system for delivering frame 310 and / or a valve including frame 310. In this manner, a user can manipulate the proximal portion of actuator 370 to actuate actuator 370.

[0219] Figure 3A The actuator 370 is shown engaged with the frame 310 when the frame 310 is in a compressed or delivery configuration. As described above with reference to the valve 100, the frame 310 can be compressed, folded, and / or otherwise placed in a delivery configuration for side delivery via a delivery catheter. Prior to placing the frame 310 in a delivery system, the actuator 370 can be removably coupled to the frame 310 so that the frame 310 (or valve) and the actuator 370 are advanced together through the delivery catheter. In this embodiment, the actuator 370 can be a tether that extends through a waypoint 328 defined by the upper ring member 320, loops through one or more attachment points of the lower ring member 330 (e.g., one or more attachment points on or near the proximal anchor element 334), and then loops back through the waypoint 328. Thus, both ends of the tether are proximal to the frame 310 and can be maintained proximal to the delivery system and / or at the proximal end of the delivery system, thereby allowing an operator to manipulate the actuator 370 (tether) to actuate the proximal anchor element 334. Figure 3A The proximal anchoring element 334 is shown in an extended or unactuated configuration when the frame 310 is in a delivery configuration for lateral delivery through a delivery catheter.

[0220] Figure 3B 34. The actuator 370 is shown being actuated to move the proximal anchoring element 334 from a first position or configuration to a second position or configuration. More specifically, the frame 310 (and / or valve) can be advanced through a delivery catheter and allowed to at least partially expand when the frame 310 is released from the delivery catheter. In some implementations, the frame 310 is at least partially inserted into the annulus while the proximal portion of the frame 310 remains in the delivery catheter. After the frame 310 is fully released from the delivery catheter, the operator can manipulate the proximal portion of the actuator 370 to actuate the distal portion of the actuator 370 coupled to the proximal anchoring element 334.

[0221] For example, actuating actuator 370 may cause one or more tethers to be pulled in a proximal direction (eg, away from frame 310 and / or in a manner that increases tension therein), such as Figure 3B As the actuator 370 passes through the waypoint 328 of the ring member 320 (which is not actuated by the actuator 370 in this embodiment), the proximal movement of the cable, tether, etc. pulls the proximal anchoring element 334 toward the waypoint 328, as shown in FIG. Figure 3B Thus, the actuator 370 can apply a force on the proximal anchoring element 334 that is operable to place the proximal anchoring element 334 in a compressed, retracted, restricted, and / or actuated configuration, such as Figure 3B As described above, placing the proximal anchoring element 334 in the compressed and / or actuated configuration reduces the circumference of at least the subannular member 330, thereby allowing the subannular member 330 to pass through the annulus of the native valve.

[0222] After the frame 310 (or valve) is seated in the annulus, the actuator 370 can be re-actuated and / or otherwise returned to an unactuated state or configuration. Thus, the proximal anchoring element 334 is allowed to return to an extended and / or unactuated configuration. Figures 3A to 3C In the illustrated embodiment, the proximal anchoring elements 334 can be biased such that in the extended and / or unactuated configuration, the proximal anchoring elements 334 engage native subannular tissue to at least partially secure the frame 310 within the annulus. Figure 3C It is shown that once the frame 310 is positioned in the annulus, the operator can manipulate the actuator 370 to remove the actuator 370 from the frame 310. For example, the operator can pull on one end of a tether (e.g., the actuator 370) so that the tether is withdrawn from the attachment point of the subannular member 330 and the waypoint 328 of the supraannular member 320. Thus, the actuator 370 and / or the delivery system of which the actuator 370 is a part can be withdrawn from the patient while the frame 310 remains in the annulus of the native heart valve.

[0223] Provided below is a discussion of certain aspects or embodiments of a laterally deliverable transcatheter prosthetic valve (e.g., an artificial valve). The transcatheter prosthetic valve (or aspects or portions thereof) described below with respect to specific embodiments may be substantially similar in at least form and / or function to valve 100 and / or 200 (or corresponding aspects or portions thereof). Similarly, the valve (or aspects or portions thereof) described below may be similar in at least form and / or function to the valves described in detail in '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional Paper, '964 Provisional Paper, '345 Provisional Paper, and / or '807 Provisional Paper. Therefore, certain aspects and / or portions of the specific embodiments may not be described in further detail herein.

[0224] Figures 4 to 10 A laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 400 (also referred to herein as a "prosthetic valve" or "valve") is shown according to one embodiment. Figure 4 is an illustration of a top perspective view of valve 400. In some implementations, valve 400 can be deployed, for example, in the annulus of a native tricuspid valve and / or a native mitral valve. Valve 400 is configured to allow blood flow in a first direction through an inflow end of valve 400 and to block blood flow in a second direction, opposite to the first direction, through an outflow end of valve 400. For example, prosthetic valve 400 can be a laterally deliverable transcatheter prosthetic heart valve configured to be deployed within the annulus of a native tricuspid valve or a native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0225] The valve 400 is capable of compressing and expanding in at least one direction relative to the x-axis (also referred to herein as the "horizontal axis," "longitudinal axis," "longitudinal axis," or "elongated axis") of the valve 400. The valve 400 is capable of being in an expanded configuration for implantation in a desired location in the body (e.g., a human heart) and in a configuration for implantation using a delivery catheter (not in a human body). Figure 4 In some embodiments, the valve 400 is compressed and expanded between a compressed configuration (shown in FIG. 1 ) for introduction into the body. In some embodiments, the horizontal x-axis of the valve 400 is orthogonal (90 degrees), or substantially orthogonal (75 degrees to 105 degrees), or substantially oblique (45 degrees to 135 degrees) to the central (vertical) y-axis when 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 disposed.

[0226] In some embodiments, the valve 400 has an expanded or deployed height of about 5 mm to 60 mm, about 5 mm to 30 mm, about 5 mm to 20 mm, about 8 mm to 12 mm, or about 8 mm to 10 mm, and an expanded or deployed diameter (e.g., length and / or width) of about 25 mm to 80 mm or about 40 mm to 80 mm. In some embodiments, the valve 400 has a compressed height (y-axis) and width (z-axis) of about 6 mm to 15 mm, about 8 mm to 12 mm, or about 9 mm to 10 mm. In some implementations, it is contemplated that the length (e.g., along the x-axis) of the valve 400 is not compressed or otherwise reduced because it can extend along the length of the central cylindrical axis of the delivery catheter.

[0227] In some embodiments, the valve 400 is central or radially symmetric. In other embodiments, the valve 400 is eccentric (e.g., along or relative to the y-axis), or radially asymmetric. In some eccentric embodiments, the frame 410 can have a D-shaped cross-section, wherein the flat portion or surface is configured to substantially match the annulus of the native mitral valve located at or near the anterior leaflet. Figures 4 to 10 In the example shown, valve 400 is eccentric, wherein one or more components are offset or asymmetric with respect to the y-axis.

[0228] The valve 400 includes an annular outer support frame 410 and a collapsible flow control member 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 of 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. Figure 4 As shown, at least the outer support frame 410 of the valve 400 is covered, wrapped, and / or surrounded by a biocompatible cover 440. The biocompatible cover 440 may be a mesh material, pericardial tissue, a woven synthetic polyester material, and / or any other suitable biocompatible material, such as those described above.

[0229] The outer frame 410 has a cross-ring member 412 and / or a body that limits, forms and / or defines a central (inner) channel around and / or along a vertical or central axis (y-axis). The outer frame 410 has an upper ring member 420 circumferentially attached at the top edge of the cross-ring member 412 and a lower ring member 410 circumferentially attached at the bottom edge of the cross-ring member 412. The upper ring member 420 is shaped to conform to the native deployment position. For example, in tricuspid valve replacement, the upper ring member 420 or atrial collar may have a high back wall portion to conform to the septal region of the native valve and may have distal and proximal portions. The distal portion may be larger than the proximal portion to account for the larger flat space above the (atrial) ventricular outflow tract (VOT) lower ring region. For example, in mitral valve replacement, the upper ring member 420 of the outer frame 410 may be D-shaped or shaped like a hyperbolic paraboloid to mimic the native structure.

[0230] The collapsible (inner) 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 an "inner leaflet frame" or "inner frame") having two (or more) folding regions, hinge regions, coupling regions, elastically deformable regions, etc. A set of 2-4 flexible leaflets 456 are mounted in or on the inner frame 451 (not in FIG. Figure 4 ). In some embodiments, the flow control component 450 has three leaflet 456 tips or pockets mounted within an inner frame 451, as described in further detail herein.

[0231] Like the outer frame 410, the inner flow control component 450 is foldable and compressible. For example, the inner frame 451 is capable of folding from a cylindrical configuration to a flattened cylindrical configuration (or two-layer strip) along the z-axis or in the direction of the z-axis (e.g., capable of folding at folding regions, etc.), wherein the folding regions are located on the distal and proximal sides of the inner frame 451. Like the outer frame 410, the flow control component 450 is also capable of compressing vertically (y-axis) to a shortened or compressed configuration. By folding (compressing) in the direction of the z-axis and compressing vertically on the y-axis, the valve 400 is allowed to maintain a relatively large size along the horizontal (x-axis). In some implementations, the outer frame 410 and the flow control component 450 are reduced along the z-axis until the sidewalls touch or nearly touch. This also allows the outer frame 410 and flow control component 450 to maintain a radius along the horizontal axis (x-axis) to minimize the number of wire units making up the outer frame and inner frame that could be damaged due to the forces applied during the folding and / or compression required for loading into the delivery catheter.

[0232] The flow control component 450 has a diameter and / or circumference that is smaller than the diameter and / or circumference of the central passageway of the outer frame 410. The flow control component 450 is mounted to or within the outer frame 410 such that the central or vertical axis (y-axis) of the inner frame 451 is parallel to the central 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 the y-axis defined by the outer frame 410 ( Figure 4 ) defined by but offset from the y-axis. In some implementations, a spacer element 445 is disposed within and / or across the central channel and can facilitate mounting a portion (e.g., an otherwise unsupported portion) of the flow control component 450 to the outer support frame 410 and / or ingrowth of native tissue over at least a portion of the supra-annular member 420 of the valve 400. In some embodiments, the spacer element 445 can be similar to any of those described in the '231 PCT.

[0233] In certain embodiments, the inner frame 451 may have a diameter of approximately 25 mm to 30 mm, the outer frame 410 (or its trans-annular member 412) may have a diameter of approximately 50 mm to 80 mm, and the supra-annular member 420 (or atrial collar) extends approximately 20 mm to 30 mm beyond the top edge of the trans-annular member 412 to provide a seal on the floor of the atrium to prevent paravalvular leakage (PVL). The flow control component 450 and the outer frame 410 may be capable of folding (e.g., in the direction of the z-axis) and / or compressing (e.g., in the direction of the y-axis) to reduce the size of the entire valve 400 to fit within a 24 Fr to 36 Fr (8 mm to 12 mm inner diameter) delivery catheter (not shown herein). Figure 4 within the inner diameter of ).

[0234] Figure 5 It shows Figure 4 A top perspective view of the supra-annular member 420 of the outer support frame 410 of the valve 400 is shown. Figure 5 A laser-cut wire framework of the upper ring member 420 is shown with a biocompatible material 426 coupled thereto to facilitate mounting the inner flow control component 450 to the outer frame 410. In some embodiments, the upper ring member 420 of the outer frame 410 can be substantially similar in at least form and / or function to the upper ring members 120 and / or 220 described above. Accordingly, portions and / or aspects of the upper ring member 420 may not be described in further detail herein.

[0235] As shown, the annular member 420 includes 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 can be shaped and / or sized to engage native tissue. For example, the distal portion 422 of the annular member 420 (formed at least in part by the outer loop 421) is constructed to engage distal supra-annular tissue, and the proximal portion 424 (formed at least in part by the outer loop 421) is constructed to engage proximal supra-annular tissue. The distal portion 422 and the proximal portion 424 can have a circular and / or curved shape, wherein the radius of curvature of the proximal portion 424 is greater than the radius of curvature of the distal portion 422. The distal portion 422 can form, for example, a distal anchoring loop 423, which can engage distal supra-annular tissue to at least partially stabilize and / or secure the frame 410 in the native annulus. Although not shown in Figure 5 , but similarly, the proximal portion 424 can form a proximal supra-annular anchoring element that can engage proximal supra-annular tissue to at least partially stabilize and / or secure the frame 410 in the native annulus.

[0236] The inner loop 425 of the ring member 420 may be substantially circular and may be coupled to and / or suspended from the outer loop via one or more splines 427. Figure 5 As shown, the inner loop 425 can be coupled to a biocompatible material 426 that can 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, suspending the inner loop 425 from the outer loop 421 can, for example, at least partially isolate the inner loop 425 (and the flow control component 450 coupled to the inner loop 425) from at least a portion of the forces associated with transitioning the frame 410 between the expanded and compressed configurations, as described above with reference to the frame 210.

[0237] The one or more splines 427 of the ring upper member 420 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the ring upper member 420 can include a proximal spline 427 and one or more distal splines 427. The distal splines 427 can couple the distal portion of the inner loop 425 to the distal portion of the outer loop 421. Similarly, the proximal splines 427 can 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 can be configured to receive, couple to, and / or otherwise engage a portion of an actuator and / or delivery system. For example, the proximal splines 427 can include, form, and / or be coupled to a waypoint 428, which can be used to couple to one or more portions of an actuator and / or delivery system, as described above with reference to frames 110 and 210.

[0238] Figure 6 It shows Figure 4 A distal perspective view of the cross-ring member 412 of the outer frame 410 of the valve 400 is shown. In some embodiments, the cross-ring member 420 of the outer frame 410 can be substantially similar in at least form and / or function to the cross-ring region and / or members 112 and / or 212 described above. Therefore, portions and / or aspects of the cross-ring member 412 may not be described in further detail herein.

[0239] The cross-ring member 412 can be shaped and / or formed into a ring, a cylindrical tube, a tapered tube, and / or any other suitable annular shape. In some embodiments, the cross-ring member 412 can have the following side profiles: a concave cylinder (walls bend inward), an angular hourglass shape, a curved gradient hourglass shape, a ring or cylinder with an open top, an open bottom, or both. In addition, the cross-ring member 412 can form and / or define an orifice or central channel 414 extending along the central axis 404 (e.g., the y-axis). The central channel 414 (e.g., a central axial lumen or channel) can be sized and configured to receive a flow control component 450 that spans a portion of the diameter of the central channel 414. In some embodiments, the cross-ring member 412 may have a shape and / or size that is based at least in part on the size, shape and / or configuration of the upper ring member 420 and / or lower ring member 430 of the support frame 410 and / or the native ring in which the cross-ring member 412 is constructed to be deployed, as described above.

[0240] The cross-ring member 412 can be and / or include a wire frame that is laser cut from Nitinol or the like and, for example, heat set into a desired shape and / or configuration. The cross-ring member 412 can be formed to include a set of compressible wire units 413 having an orientation and / or unit geometry that is substantially orthogonal to a central axis extending through the central channel 414 to minimize strain on the wire units when the cross-ring member 412 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. Figure 6 As shown, the cross-ring member 412 includes a first laser-cut half 415 (e.g., an anterior side) and a second laser-cut half 416 (e.g., a posterior side) that can be formed into a desired shape and coupled together to form the cross-ring member 412. The anterior side 415 and the posterior side 416 can be coupled at one or more hinge points 417 along the distal and proximal portions of the cross-ring member 412. More specifically, the anterior side 415 and the posterior side 416 can be coupled along the distal side of the cross-ring member 412 by two suture lines forming two hinges or coupling points 417, and can be coupled along the proximal side of the cross-ring member 412 by one suture line forming a single hinge or coupling point 417.

[0241] In some embodiments, forming the cross-ring member 412 in this manner can allow the cross-ring member 412 to bend, flex, fold, deform, and / or otherwise reconfigure in response to lateral folding along or in the direction of the transverse axis or z-axis and / or vertical compression along or in the direction of the central axis or y-axis (without substantially plastic deformation and / or without excessive fatigue). Furthermore, coupling at the hinge point 417 using a seam line can achieve a desired amount of slippage between the seam line and the front side 415 / back side 416 in response to folding along the transverse axis or z-axis, which in turn can limit and / or substantially prevent adhesion, sticking, and / or failure.

[0242] like Figure 6 As shown, the proximal portion of the cross-ring member 412 includes a single hinge or coupling point 417. In some embodiments, the cross-ring member 412 can define a gap or space 418 below the proximal hinge or coupling point 417, which can provide space to allow the proximal anchoring element of the under-ring member 430 to transition between the first configuration and the second configuration, as described in further detail herein.

[0243] Figure 7 It shows Figure 4A distal perspective view of the subannular member 430 of the outer frame 410 of the valve 400 is shown. In some embodiments, the subannular member 430 of the frame 410 can be similar in at least form and / or function to the subannular region and / or members 130 and / or 230 described above. Therefore, portions and / or aspects of the trans-annular member 412 may not be described in further detail herein.

[0244] As shown, the under-loop member 430 of the frame 410 includes and / or forms a distal portion having a distal anchoring element 432 and a proximal portion having a proximal anchoring element 434. The anchoring elements 432 and 434 are integrally and / or monolithically formed with the under-loop member 430. The distal anchoring element 432 and the proximal anchoring element 434 of the under-loop member 430 can be of any suitable shape, size, and / or configuration, such as any of those described in detail in the '957 PCT, the '010 PCT, the '231 PCT, the '390 PCT, the '108 PCT, the '327 Provisional, the '964 Provisional, the '345 Provisional, the '807 Provisional, any of those described above with reference to the frames 110 and / or 210, and / or any of those described herein with respect to specific embodiments.

[0245] Distal anchoring element 432 is shown to comprise atraumatic end, and it forms the guidewire coupler 433 that is constructed to selectively engage and / or receive a part of a guidewire or a part of a guidewire assembly.Guidewire coupler 433 is for example constructed to allow a part of a guidewire to extend through opening and / or orifice of guidewire coupler 433, thereby allows framework 410 to advance on or along the guidewire during delivery and deployment.In some embodiments, guidewire coupler 433 can selectively allow guidewire to advance through wherein, while blocking or preventing other elements and / or parts (such as pusher etc.).

[0246] The anchoring elements 432 and / or 434 are configured to engage a desired portion of native tissue to mount the frame 410 to the annulus of the native valve in which it is deployed. For example, the distal anchoring element 432 may extend (e.g., approximately 10 mm-40 mm) from the subannular member 430 and extend into the RVOT or LVOT. The distal anchoring element 432 may be shaped and / or biased such that the distal anchoring element 432 applies a force on the subannular tissue that is operable to at least partially secure the distal portion of the frame 410 in the native annulus.

[0247] The proximal anchoring element 434 can be configured to engage subannular tissue on the proximal side of the native annulus to assist in securing the frame 410 within the annulus. More specifically, the proximal anchoring element 434 is configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 434 extends a first amount or distance from the subannular member 430 and a second configuration in which the proximal anchoring element 434 extends a second amount or distance from the subannular member 430. As described above, the subannular member 430 of the frame 410 can be and / or include, for example, a laser-cut wire frame formed of a shape memory material such as Nitinol that is heat-set into a desired shape and wrapped around a biocompatible material (e.g., such as Figure 7 The fabric).

[0248] As described above, the proximal anchoring element 434 can be in a compressed, contracted, retracted, undeployed, folded, and / or constrained state when in a first configuration (e.g., in a position near, adjacent to, and / or in contact with the cross-ring members 412 and / or the upper ring members 420 of the support frame 410), and can be in an expanded, extended, deployed, unfolded, and / or unconstrained state when in a second state (e.g., extending away from the cross-ring members 412). In some embodiments, the proximal anchoring element 434 can be biased and / or heat set in the second configuration. Additionally, in some implementations, the space 418 defined by the cross-ring members 412 of the outer frame 410 is configured to provide sufficient leeway to allow the proximal anchoring element 434 to transition between the first and second configurations.

[0249] Figures 8 to 10 Show Figure 4 The valve 400 shown includes at least a portion of a flow control component 450. For example, Figure 8 is an illustration of a top perspective view of an inner leaflet frame 451. In some embodiments, the inner leaflet frame 451 is formed from two separate wire frame sheets or members coupled at transverse connection points 451 and 453 (e.g., folded areas, elastically deformable regions, coupled edge portions, etc.). The inner leaflet frame 451 is shown in an expanded or cylindrical configuration (e.g., before being folded and / or compressed).

[0250] Although not shown, the inner leaflet frame 451 can be converted from an expanded or cylindrical configuration to an at least partially folded configuration. The inner leaflet frame 451 may have a wire frame sidewall that allows rotation or hinge at least at transverse connection points 451 and 453. The inner leaflet frame 451 can be constructed to be folded and / or compressed for delivery in response to the valve 400. For example, when converted to a fully folded configuration, the wire frame sidewall can be rotated, hinged and / or folded at its transverse connection points 451 and 453. In addition, the inner leaflet frame 451 can be vertically compressed into a compressed configuration. The wire frame sidewall can form a unit (e.g., a diamond unit, etc.) 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 vertically compressed into a pleat or accordion (compression) configuration.

[0251] In some embodiments, the inner leaflet frame 451 of the flow control component 450 can be formed from a linear wire frame or laser cut sheets, which are then further assembled into a cylindrical structure (e.g., as Figure 8 ). The inner leaflet frame 451 can be formed into a cylindrical structure or configuration (or a tapered structure or configuration) in which edge portions of the linear wire frame sheet are connected or coupled at transverse connection points 451 and 453 (e.g., hinge areas, fold areas, etc.). In addition, the inner leaflet frame 451 can be expanded (e.g., driven, formed, bent, etc.) from a linear sheet configuration into a cylindrical structure or configuration.

[0252] Figure 9 and Figure 10 A structural band 455 of pericardial tissue is shown with leaflet pockets 456 sutured into the structural band 455 . Figure 9 and Figure 10 Side perspective and bottom views, respectively, show the structural band 455 and leaflet pockets 456 prior to assembly and / or installation on and / or into the inner frame 451 to form the collapsible (foldable, compressible) flow control component 450. Figure 9 A structural band 455 formed from pericardial tissue is shown with leaflet pockets 456 sutured into the structural band 455, which, after assembly into a cylindrical leaflet configuration, are disposed on the inner surface of the structural band 455. The leaflet pockets 456 can be sutured into the structural band 455 such that the open edges extend outwardly and the sutured edges form a closed top parabolic edge to provide attachment. Figure 10 45 is an illustration of a bottom view of the flow control component 450. The cylindrical structural band 455 and the leaflet component 456 are shown with partial engagement tending to form a closed fluid seal. Although not shown, the cylindrical structural band 455 can be mounted to the inner leaflet frame 451 ( Figure 8) or mounted in the inner leaflet frame to together form a flow control component. The flow control component 450 is further mounted to the outer support frame 410, as described above with reference to Figure 4 Described in detail.

[0253] Figures 11 to 14 is a sequence of diagrams illustrating a bottom view of a prosthetic valve 500, according to one embodiment, removably coupled to an actuator 570 for actuating one or more portions of the valve 500. The valve 500 has a subannular member 530 that may have and / or be formed with a laser-cut or wire loop (and attached to the sidewalls) that is drawn inward to reduce the perimeter or circumference of at least the subannular member 530 to facilitate deployment of the valve 500 within the native annulus. In this embodiment, the actuator 570 may be and / or include a set of tethers, tensile members, sutures, cables, and / or any other suitable connectors that may be attached to one or more attachment points along the subannular member 530 (e.g., a proximal anchoring element of the subannular member 530). The actuator 570 may also include and / or be at least partially disposed within a catheter that is insertable through dynamic waypoints, openings, attachment points, through-holes, etc. formed by the supraannular member of the valve frame. In some embodiments, the actuator 570 can be and / or can include separate tethers for actuating (e.g., folding) the proximal anchoring element, actuating (e.g., folding) the septal sidewall, and / or actuating (e.g., folding) the free wall sidewall.

[0254] Figures 11 to 14A set of tethers of an actuator 570 is shown extending from a catheter that extends through and / or is at least partially disposed below the supra-annular member of the valve frame. For example, the tethers can extend through a relatively small dynamic waypoint catheter and can be actuated outside the patient's body to manipulate the shape of the proximal anchoring element, the subannular member 530, and / or the valve 500 to facilitate proximal placement of the valve 500 into the native annulus. In some implementations, during delivery, the dynamic waypoint catheter can be proximal to the compressed valve 500 in the delivery catheter to avoid stacking the dynamic waypoint catheter on top of the compressed valve 500 within the delivery catheter. Actuators having a single tether or multiple tethers are contemplated within the scope of the present invention (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, seven tethers, eight tethers, nine tethers, ten tethers, or more tethers, each of which can be removably coupled to one or more attachment points on the valve 500). The actuator 570 and / or the tether may be equipped with a disconnect element to allow the actuator 570 and / or the tether to be withdrawn after the valve 500 is deployed and secured in the native annulus. The dynamic waypoint catheter may also be included in and / or housed in a portion of a delivery system (such as, for example, a pusher catheter, a multi-lumen control catheter, and / or the like), whereby the dynamic waypoint catheter can be lowered through a waypoint, through-hole, opening, etc. of the valve 500 to a subannular position, while the pusher catheter, the multi-lumen control catheter, and / or one or more other portions of the delivery system are too large to pass through the waypoint. Thus, the pusher catheter, the control catheter, and / or one or more other portions of the delivery system can be used to control the placement of at least a portion of the valve 500. For example, the pusher catheter, the control catheter, and / or other portions of the delivery system can be used to push down on the surface of the superannular member to place the proximal side of the valve 500 in the native annulus, while the subannular member 530 is in an actuated configuration.

[0255] Figure 11 is a bottom perspective view of the valve 500 and actuator 570 and shows the subannular member 530 in an at least partially extended or unactuated configuration. Figure 12 is a bottom perspective view of the valve 500 and actuator 570 and shows the subannular member 530 partially actuated so as to draw the proximal anchoring element of the subannular member 530 toward a dynamic waypoint catheter and / or internal flow control components of the valve 500, for example. Figure 13 is a bottom perspective view of the valve 500 and actuator 570, and shows the subannular member 530 in a compressed, folded and / or actuated configuration so as to draw the proximal anchoring element and, for example, the proximal portions of the septal and free wall sidewalls of the valve 500 toward the dynamic waypoint catheter and / or the internal flow control components of the valve 500. Figure 14is a side perspective inverted view of the valve 500 and actuator 570 and shows the subannular member 530 in an actuated configuration, with the dynamic waypoint catheter extending below the supraannular member of the valve frame and the tether retracted or pulled toward and / or into the dynamic waypoint catheter. Figure 14 It is shown that a dynamic waypoint catheter can also be used to pull the valve down into the ventricle (e.g., via a retracted tether), thereby avoiding the need to push the compressible valve into the native annulus.

[0256] Although actuator 570 is shown in Figures 11 to 14 While the actuator 570 is described above as including a waypoint catheter extending through the valve 500, in other implementations, the actuator 570 need not include a waypoint catheter. For example, any number of tethers, cables, tension members, sutures, and the like may be routed through one or more lumens of a multi-lumen control catheter and may extend through waypoints, through-holes, openings, and / or the like defined by the valve 500 to be removably coupled to the proximal subannular anchoring element.

[0257] Figure 15 and Figure 16 6. Top and bottom perspective views, respectively, of a laterally deliverable transcatheter prosthetic valve 600 removably coupled to a delivery system 680, according to one embodiment. The valve 600 includes a valve frame 610 and a flow control component 650 mounted therein. The valve frame 610 includes an supra-annular member 620, a subannular member 630, and a trans-annular member 612 coupling the supra-annular member 620 to the subannular member 630. The delivery system 680 and / or at least a portion of the delivery system 680 includes a delivery catheter 682 through which the valve 600 is delivered to an atrium of the heart. The delivery system 680 also includes a connecting member 678 that can be removably coupled to the valve 600. Figure 15 and Figure 16 A connection member 678 is shown having a wishbone or yoke configuration, but other configurations are possible. The connection member 678 can be coupled to and / or included in a distal portion of a multi-lumen steerable catheter that can be used to deliver the valve 600 and / or one or more components of the delivery system 680.

[0258] Figure 15A connecting member 678 (e.g., a yoke) is shown in contact with the supra-annular member 620 of the valve frame 610. In some embodiments, the connecting member 678 can be in contact with and / or removably coupled to the drum or cross-annular member 612 of the frame 610. In other embodiments, the connecting member 678 can be in contact with and / or coupled to any suitable portion of the valve 600. The connecting member 678 can be removably coupled to the valve 600 via sutures, tethers, cables, clamps, couplers, and / or any other removable coupling. For example, Figure 15 Attachment members 638 of valve 600 are shown coupled to and / or extending from the supra-annular member 620. In some embodiments, the attachment members 638 of valve 600 can be tethers, sutures, cables, frame structures, and / or the like that can be coupled to and / or extend from a wire frame portion of the supra-annular member 620, or a drum or biocompatible covering, for example. In such embodiments, the connecting member 678 of the delivery system 680 can be removably coupled to the attachment members 638 of valve 600 (e.g., via sutures, tethers, and / or any other removable coupling).

[0259] Figure 15 and Figure 16 Also shown is a guidewire catheter 684 of the delivery system 680 extending through a waypoint or opening, for example, in the upper loop member 630 and / or its drum, and through the guidewire coupler 633 of the distal anchoring element 632 of the lower loop member 630 . Figure 16 A guidewire catheter 684 is shown extending beneath 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 (e.g., Figure 16 ) and is advanced over a guidewire that is already in a desired position within the heart. Thus, delivery of the valve 600 in a compressed configuration via the delivery catheter 682 includes advancing a guidewire catheter 684 along the guidewire. The guidewire catheter 684 can extend through the guidewire coupler 633 of the distal anchoring element 632 (e.g., the distal end of the guidewire catheter 684 can be about 0.1 cm to about 1.0 cm or more distal to the guidewire coupler).

[0260] The guidewire catheter 684 can be sufficiently rigid to, for example, (at least partially) limit and / or define the range of motion of the valve 600 during delivery. For example, the guidewire catheter 684 can define an axis about which the valve 600 can rotate during delivery, but can substantially limit or hinder 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 better control of the position of the valve 600 during delivery. The guidewire catheter 684 and / or one or more portions of the valve 600 (e.g., the subannular member 630) can also include radiopaque markers that allow enhanced visualization during image-guided delivery. For example, in some cases, a radiopaque marker or wire can be placed relative to the annular plane of the native valve, and the radiopaque marker or wire can define a landmark during image-guided delivery. In such cases, radiopaque markers on the guidewire catheter 684 and / or one or more other portions of the valve 600 (e.g., the subannular member 630) can be used to align, orient, position, index, etc. the valve 600 relative to a landmark that, in turn, corresponds to the annular plane of the native valve. Thus, image-guided delivery can allow a user to visualize the valve 600 during delivery and / or deployment, and can allow a user to visualize when the valve 600 has been positioned in the annulus (e.g., with the radiopaque marker band of the valve 600 below or in a subannular direction relative to the radiopaque landmark).

[0261] Figure 16 Also shown is an actuator 670 (or at least a portion of an actuator 670) included in a portion of a delivery system 680. The actuator 670 can be and / or can include, for example, one or more tethers, sutures, cables, tensile members, ties, etc., removably coupled to one or more attachment points on the valve 600. For example, one or more tethers are shown removably coupled to the proximal anchoring element 634 of the subannular member 630. The actuator 670 (e.g., one or more tethers) can be used to actuate the proximal anchoring element 634 between two or more configurations, positions, states, etc. Figure 16 The proximal anchoring element 634 is shown in an expanded or unactuated configuration. During deployment, an operator can actuate a proximal portion of the actuator 670 (e.g., disposed outside the body) to, for example, pull one or more tethers in a proximal direction, thereby folding or compressing the proximal anchoring element 634 toward the flow control component 650. Actuation of the actuator 670 can also fold, compress, and / or draw the proximal portions of the rear and anterior walls of the cross-ring member 612 inwardly toward the flow control component 650 (e.g., as described above with reference to FIG. Figures 11 to 14After the valve 600 is deployed in the annulus of the native valve, the actuator 670 can be removed or decoupled from the valve 600, the guidewire catheter 684 (and the guidewire extending therethrough) can be retracted through the waypoint or opening in the supra-annular member 620, and the portion of the delivery system 680 can be decoupled from the valve 600 and withdrawn from the patient, thereby leaving the deployed prosthetic valve 600 in place in the annulus of the native heart valve.

[0262] Although valves 500 and / or 600 are described above as actuating and / or transforming corresponding proximal anchoring elements in a particular manner, it should be understood that the proximal anchoring elements of the valves may be actuated, moved, oscillated, rotated, and / or otherwise transformed in any suitable manner. For example, Figures 17 to 20 7 is a bottom perspective view of a prosthetic valve 700 according to one embodiment and illustrates the process of transitioning a proximal anchoring element 734 of the prosthetic valve 700 between a first configuration and a second configuration. The valve 700 is shown to include an outer support frame 710 and a flow control component 750 mounted within a central region of the outer support frame 710. The frame 710 is shown having at least an upper annular member 720 and a lower annular member 730. The upper annular member 720 and the lower annular member 730 can be similar to any of those described above. Therefore, certain aspects and / or features may not be described in further detail herein.

[0263] Figure 17 The lower ring member 730 is shown having and / or forming a distal anchoring element 732 and a proximal anchoring element 734. The upper ring member 720 is shown to include a spline 727 (e.g., extending between an outer loop and an inner loop (not shown) of the upper ring member 720) that defines a waypoint 728 at or near a proximal end portion of the upper ring member 720. The upper ring member 720 is also shown to include a drum 3445 that extends between and / or couples to the inner and outer loops of the upper ring member 720 and covers a space not otherwise occupied by a flow control component 750. The upper ring member 720 (or its inner loop) is shown coupled to a flow control component 750 that is offset distally relative to the valve 700.

[0264] The valve 700 is constructed to engage or be engaged by at least a portion of the delivery system 780. The delivery system 780 may include any suitable components for delivering, retrieving, deploying, moving, manipulating, actuating, 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 the native heart valve. The delivery system 780 may also include one or more steerable catheters, control catheters, multi-lumen catheters, and / or the like, or combinations thereof. In some embodiments, the delivery system 780 may include a multi-lumen control catheter having a distal portion that is constructed to removably engage and / or couple to one or more portions of the valve 700 to facilitate the delivery, deployment, and / or retrieval of the valve 700. Although not described herein, the delivery system 780 may include a multi-lumen control catheter having a distal portion that is constructed to removably engage and / or couple to one or more portions of the valve 700 to facilitate the delivery, deployment, and / or retrieval of the valve 700. Figures 17 to 20 , but the delivery system 780 may also include a guidewire catheter that can be advanced over a guidewire during delivery and / or deployment. In such an implementation, the guidewire catheter can pass through the waypoint 728, under the flow control component 750, and through the guidewire coupler of the distal anchoring element, as described above with reference to Figure 15 and Figure 16 The valve 600 shown in FIG.

[0265] Figure 17Also shown is a delivery system 780 that includes an actuator 770. The actuator 770 can be similar to those described above with reference to, for example, 170, 270, and / or 370. For example, the actuator 770 can be and / or can include a tether that extends through a waypoint 728 of the spline 727 and is threaded through one or more attachment points 736 coupled to and / or formed along the lower ring member 730. The tether is looped through the one or more attachments 736 and extends back in a proximal direction through the waypoint 728. Thus, both ends of the tether can remain outside the body, allowing the user to manipulate the tether (actuator 770). In this embodiment, the tether is shown as being threaded through multiple attachment points 736 at or along the proximal anchoring element 734 of the lower ring member 730, such that actuation of the actuator 770 (e.g., one or more tethers) causes at least the proximal anchoring element 734 to transition and / or move between a first configuration and a second configuration. The tether can be threaded through the attachment point 736 in any suitable manner, which in turn can control and / or determine the manner in which the proximal anchoring element 734 transforms or moves. In addition, the attachment point 736 can be formed of any suitable material that can facilitate the tether to be threaded through or threaded therethrough. For example, the attachment point 736 can be included in and / or integrally formed with the laser-cut wire framework (e.g., like eyelets and / or the like) of the lower ring member 720. In other embodiments, the attachment point 736 can be a suture loop and / or loop formed in or by a biocompatible fabric that is at least partially wrapped around the lower ring member 720. In yet other embodiments, the attachment point 736 can be formed by a biocompatible polymer (such as, for example, polyethylene and / or the like). In some such embodiments, the biocompatible material can be, for example, a self-lubricating polymer composite and / or the like that can facilitate the tether to move through the attachment point 736.

[0266] Figure 17 The proximal anchoring element 734 is shown in a first or unactuated configuration, wherein the tether (actuator 770) is looped through the attachment point 736 in a serpentine manner. Figure 18 and Figure 19 The proximal anchor element 734 is shown as it transitions from a first, unactuated configuration toward a second, actuated configuration in response to actuation of the actuator 770 (e.g., pulling the tether in a proximal direction and / or in a direction that otherwise creates tension along the length of the tether). Figure 20 The proximal anchoring element 734 is shown in a second, actuated configuration.

[0267] exist Figures 17 to 20In the illustrated embodiment, the actuator 770 engages the proximal anchoring element 734 such that one of the attachment points 736 on the anterior side, or free wall side, of the subannular member 730 acts as a pivot point about which the proximal anchoring element 734 at least partially rotates, folds, rolls, etc. In other embodiments, the actuator 770 can engage the proximal anchoring element 734 such that the attachment point 736 on the posterior side, or septal side, of the subannular member 730 acts as a pivot point. In other words, the proximal anchoring element 734 can rotate, fold, roll, pivot, swing, and / or otherwise move toward the anterior side of the valve 700 or the posterior side of the valve 700, depending on how the actuator 770 engages the attachment point 736 of the proximal anchoring element 734.

[0268] Figure 19 and Figure 20 Also shown is a tab 737 included on and / or formed by the proximal anchoring element 734. In some embodiments, the tab 737 can contact native subannular tissue to facilitate securing the proximal side of the valve 700 in the annulus of the native valve. More specifically, the tab 737 can be positioned along and / or adjacent the proximal anchoring element 734 and can rotate, swing, pivot, and / or otherwise move with the proximal anchoring element 734 in response to actuation of the actuator 770. In some embodiments, the tab 737 can be positioned so that as the proximal anchoring element 734 moves (e.g., from a compressed configuration to an expanded configuration after the valve 700 is deployed and / or seated in the annulus), the tab 737 moves or slides behind, for example, the commissures, posterior or septal leaflets, chordae tendineae, trabeculae, and / or any other desired portion of the native tissue. Although in Figure 19 and Figure 20 One tab 737 is shown in the figure, but in other embodiments, the proximal anchoring element 734 may include two or more tabs 737, which may be arranged and / or otherwise act as hooks or the like to hook onto or behind the native tissue to secure the proximal anchoring element 734 to the native subannular tissue.

[0269] Figure 21 and Figure 22 8 is a diagram illustrating various views of a laterally deliverable prosthetic valve 800 according to one embodiment and showing a portion of an annular member 820 having an arcuate configuration. The valve 800 is shown to include an outer support frame 810 and a flow control component 850 mounted within a central region of the outer support frame 810. The frame 810 is shown to have at least an annular member 820, an annular member 830, and an inter-annular member 812 coupled therebetween. The frame 810 and / or aspects thereof may be similar to any of those described above. Therefore, certain aspects and / or features may not be described in further detail herein.

[0270] Valve 800 is shown as having member 830 under the ring, and described member under the ring has and / or forms distal anchoring element 832 and proximal anchoring element 834.Distal anchoring element 832 comprises guide wire coupler 833, and described guide wire coupler can receive guide wire and / or guide wire catheter by the opening, hole, orifice, port etc. limited by guide wire coupler 833.In some implementations, guide wire catheter can extend beyond distal anchoring element 832 and can have and / or can provide enough rigidity to allow valve 800 to advance along the guide wire of the lumen of threaded through guide wire catheter.Proximal anchoring element 834 can be for example removable anchoring element, and it is constructed to (for example, by actuator) move and / or otherwise transform between first configuration and second configuration, to reduce the periphery of member 820 under the ring during delivery and / or deployment.

[0271] The proximal anchoring element 834 can be configured to extend from the first extended configuration ( FIG. 1 ) in any suitable direction based at least in part on the manner in which the proximal anchoring element 834 is coupled to the actuator. Figure 21 ) to the second compressed configuration. For example, the proximal anchoring element 834 can move inwardly toward the inner flow control component 850, upwardly toward the supra-annular member 820 and / or portions thereof, and / or toward the anterior or posterior side of the valve 800. Furthermore, where the trans-annular member 812 of the frame 810 is coupled to the sub-annular member 830, in some implementations, actuation of the actuator can move one or more portions of the trans-annular member 812.

[0272] The loop member 820 is shown as having a laser-cut wire frame that is wrapped or covered in a biocompatible material. The loop member 820 includes 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 can be shaped and / or sized to engage native tissue. For example, the distal portion 822 of the loop member 820 (formed at least in part by the outer loop 821) is configured to engage distal supra-annular tissue, and the proximal portion 824 (formed at least in part by the outer loop 821) is configured to engage proximal supra-annular tissue. The distal portion 822 and the proximal portion 824 can have a circular and / or curved shape, wherein the radius of curvature of the proximal portion 824 is greater than the radius of curvature of the distal portion 822. The distal portion 822 and / or the proximal portion 824 can form, for example, a distal supra-annular anchoring element and / or a proximal supra-annular anchoring element, respectively, each of which can engage supra-annular tissue to at least partially stabilize and / or secure the frame 810 in the native annulus.

[0273] The inner loop 825 of the over-the-ring member 820 can have a rectangular or teardrop shape and can be coupled to and / or suspended from the outer loop 821 via one or more splines 827. The inner loop 825 can be coupled to the flow control component 850 via, for example, 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 distally offset relative to the valve 800. In some implementations, suspending the inner loop 825 from the outer loop 821 can, for example, at least partially isolate the inner loop 825 (and the flow control component 850 coupled thereto) from at least a portion of the forces associated with transitioning the frame 810 between the expanded and compressed configurations (e.g., during delivery and / or deployment).

[0274] The one or more splines 827 of the ring upper member 820 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the ring upper member 820 can include a proximal spline 827 that defines a waypoint 828. The waypoint 828 can be, for example, an opening, a hole, an orifice, a port, a coupler, a sealable / resealable access point, and / or the like that is configured to at least temporarily couple to and / or receive a portion of a delivery system. For example, in some implementations, the portion of the delivery system can include at least an actuator and a guidewire catheter.

[0275] The over-the-ring member 820 is further shown to include a drum 845 that extends between and / or is coupled to the outer loop 821 and the inner loop 825 and covers the space not otherwise occupied by the flow control component 850 . Figure 21 A drum 845 is shown having and / or forming a set of spokes 845A that can be used to increase the stiffness of the drum 845. The spokes 845A can be, for example, sutures that are sewn into the drum 845 to increase the stiffness of the drum 845 and / or otherwise modify the deformation pattern of the drum 845 during, for example, systole, which in turn can enhance the performance of the valve 800 and / or reduce fatigue in or along the drum 845. Although specifically shown in Figure 21 Although the spokes 845A may be arranged in any suitable manner that results in increased drum stiffness, for example, the spokes 845A may be arranged longitudinally, transversely, and / or at an angle relative to the longitudinal or transverse directions. In other embodiments, the spokes 845A may be arranged in a crisscross pattern and / or any other suitable pattern.

[0276] Figure 21Also shown is a drum 845 that includes an attachment member 838 that facilitates temporary attachment to a portion of a delivery system. The attachment member 838 can be, for example, a braided wire, a suture, a tether, a cable, and / or the like. As described above, in some embodiments, the delivery system can include a control catheter or a steerable catheter that can include an integrated yoke or other suitable removable coupler. More particularly, the attachment member 838 can include a set of loops 839 through which a set of tethers can be threaded to removably couple the yoke of the delivery system to the valve 800. The tethers can be threaded through the loops 839 so that each end of the tethers remains external to the patient's body, thereby allowing an operator to manipulate the tethers to control the contact between the yoke and the drum 845.

[0277] While the attachment member 838 is shown coupled to the drum 845 at or near the proximal edge of the drum 845, 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, such as a Figure 21 827, or any suitable location therebetween. Although the attachment member 838 is described above as being coupled to the drum 845, in other embodiments, any portion of the valve 800 can include the attachment member 838. In some embodiments, for example, the supra-annular member 820 can include a laser-cut portion of a wire frame that extends across a portion of the outer annulus 825 (e.g., perpendicular to the splines 827).

[0278] Figure 21 and Figure 22 Also shown is splines 827 of the upper ring member 820 having an arcuate shape and / or configuration, wherein the splines 827 protrude away from the lower ring member 820. For example, in some embodiments, the laser-cut frame of the upper ring member 820 can be formed with splines 827 having an arcuate configuration. In some implementations, the arcuate splines 827 can exert a force on the drum 845 that causes it to bow and increases tension across the region of the drum 845. This increase in tension, in turn, increases the relative stiffness of the drum 845, which can reduce and / or limit the amount of drum deformation, for example, during diastole or systole, thereby enhancing the performance of the valve 800 and / or reducing fatigue in or along the drum 845. In other words, due to the arcuate splines 827, the pressure generated on the atrial side of the drum 845 during atrial contraction (diastole) is insufficient to invert the arcuate configuration of the drum 845 (i.e., no oil canning deflection will occur). The arcuate configuration of drum 845 can also withstand the greater pressures generated on the ventricular side of drum 845 during ventricular contraction (systole) without substantial deflection. In addition, the arcuate shape in splines 827 can position waypoint 828 at a desired angle and / or orientation to facilitate insertion or retrieval of one or more portions of the delivery system through waypoint 828.

[0279] The valves described herein are constructed to be delivered to a desired target location in a patient's body by lateral or orthogonal delivery techniques, methods, and / or systems. The delivery system for lateral delivery of a transcatheter prosthetic valve can be of any shape, size, and / or configuration and can include any suitable features, components, members, mechanisms, assemblies, subsystems, and / or the like. In some implementations, the delivery system can be similar to and / or can include any suitable combination of components of the delivery system described in any one of '957 PCT, '010 PCT, '231 PCT, '390 PCT, '108 PCT, '327 Provisional Document, '964 Provisional Document, '345 Provisional Document, and / or '807 Provisional Document.

[0280] For example, Figures 23A to 23C is a schematic diagram 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 a native heart valve, according to one embodiment. The laterally deliverable prosthetic valve 900 ("valve") can be substantially similar to valves 100, 400, 500, 600, 700, and / or 800, for example. For example, valve 900 can have an outer frame with inner flow control components mounted therein. As described in further detail herein, valve 900 can be capable of compression and expansion in at least one direction relative to a longitudinal axis.

[0281] The delivery system 980 may include any one or more suitable components configured to place the valve 900 in a delivery configuration, load the valve 900 into a portion of the delivery system 980, deliver the valve 900 in a delivery configuration through a portion of the delivery system 980, control and / or facilitate deployment of the valve 900 within the annulus of the native valve, and, in some cases, at least partially retrieve the valve 900 from the annulus to allow adjustment and / or repositioning of the valve 900 or (e.g., in the event of failure or patient distress) removal of the valve 900 from the heart.

[0282] exist Figures 23A to 23C In the illustrated embodiment, delivery system 980 includes at least a control device 970, a compression device 990, a loading device 960, and a delivery device 981. Control device 970 can be and / or can include any number of components that can be at least temporarily coupled to and / or in contact with one or more portions of valve 900 and configured to control and / or facilitate, for example, the delivery, deployment, and / or retrieval of valve 900. For example, in some embodiments, control device 970 can include a control catheter including a connecting member disposed at a distal end of the control catheter. In some embodiments, the connecting member can have a wishbone or yoke configuration, although other configurations are possible.

[0283] The connecting member can be removably coupled to the valve 900. More specifically, the connecting member can be removably coupled to the supra-annular member or region of the valve frame and placed in contact therewith. In some embodiments, the connecting member can be in contact with and / or removably coupled to a drum that extends across the supra-annular member or region of the frame, across the annular member or region, and / or any other suitable portion of the valve 900. The connecting member can be removably coupled to the valve 900 via sutures, tethers, cables, clamps, couplers, and / or any other removable couplings. For example, in some embodiments, the valve 900 can include one or more attachment members, such as tethers, sutures, cables, frame structures, drum structures, and / or the like, to which the connecting member of the control device 970 can be removably coupled (e.g., via sutures, tethers, and / or any other removable couplings).

[0284] The control device 970 may include a control catheter coupled to and / or otherwise including a connecting member at its distal end. In some embodiments, the control catheter may be a steerable multi-lumen catheter. The multiple lumens may be configured to provide one or more pathways through which one or more components may extend to selectively engage the valve 900. For example, Figure 23A As shown, the delivery system 980 may include a guidewire catheter 984 that extends through the lumen of the control catheter and through one or more portions of the valve 900. More particularly, the guidewire catheter 984 may extend through a waypoint or opening in or defined by a supra-annular member or region of the valve 900, may traverse a distance below the internal flow control components of the valve 900, and may extend through a guidewire coupler included in, for example, a distal subannular anchoring element, as described above with reference to FIG. Figure 15 and Figure 16 The valve 600 is shown as described in detail.

[0285] In addition, one or more of the lumens of the multi-lumen control catheter can receive a tether, suture, wire, etc., which is configured to be passed through a portion or side of the connecting member (e.g., yoke), around the attachment point of the valve 900, again passed through a portion or side of the connecting member, and looped back through the same lumen of the control catheter, thereby coupling the connecting member to the valve 900. Moreover, such an arrangement can allow an operator to pull one end of the tether, suture, wire, etc. ("tether") to remove the tether from the control device 970, which in turn can at least partially decouple the connecting member from the valve 900 (e.g., after the valve has been successfully deployed). Similarly, one or more of the lumens of the control catheter can receive an actuator, tension member, tether, cable, wire, etc., which can be routed through the lumen of the control catheter to engage the proximal anchoring element of the valve 900. Thus, a tension member or the like can be actuated (eg, placed under tension) to transition the proximal anchoring element between two or more configurations, as described in detail above with reference to valves 500 , 600 , and / or 700 .

[0286] Figure 23A The compression device 990 is shown removably coupled to the loading device 960, and the valve 900 is shown at least partially disposed within a lumen 995 of the compression device 990. In some implementations, it is desirable to couple the control device 970 to the valve 900 prior to inserting the valve 900 into the compression device 990. Thus, the compression device 990 can be, for example, a multi-component device that is separable to allow the compression device 990 to be decoupled from the loading device 960 and from around at least a portion of the control device after the valve 900 has been advanced therethrough, as described in further detail herein.

[0287] Figure 23AThe lumen 995 of the compression device 990 is shown tapering in at least one direction as it extends from the proximal end of the compression device 990 to the distal end of the compression device 990. In some embodiments, for example, the lumen 995 can taper in one direction, such as an axial direction (e.g., parallel to the direction of fluid flow through the valve) that is orthogonal to the longitudinal direction (e.g., the proximal-distal direction). In such embodiments, the size and / or circumference of the lumen 995 at the proximal end of the compression device 990 can enable an operator or user to compress and / or fold the valve 900 in a transverse direction that is orthogonal 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 can taper in two directions (i.e., an axial direction and a transverse direction). In either 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 can be different than 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 can have a substantially rectangular perimeter, while the lumen 995 at the distal end of the compression device 990 can have a substantially circular perimeter. In other embodiments, the lumen 995 can have substantially the same shape at both the proximal and distal ends, or any suitable combination of shapes at both the proximal and distal ends.

[0288] In some implementations, after initially inserting the valve 900 into the proximal end of the compression device 990, a user or operator can apply a force, for example, on the control device 970, causing the connecting member (e.g., yoke) to push the valve 900 through the compression device 990. In other implementations, the control device 970 can include a pusher and / or the guidewire catheter 984 can include a pusher that can selectively engage a portion of the distal subannular anchoring element 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 can include a pulling device and / or the like (not shown) that can be removably coupled to the distal portion of the loading device 960 and the distal end of the valve 900 (e.g., via a tether or the like) and can be manipulated to pull the valve 900 through the compression device 990. In some implementations, a pulling device can be used to pull the valve 900 and the control device 970 can be used to push and / or pull the valve 900 to collectively advance the valve 900 through the compression device 990 .

[0289] Valve 900 Figure 23A990 is shown as being advanced from the proximal end to the distal end through the lumen 995 of the compression device 990, and the compression device 990 compresses the valve 900 in at least an axial direction as the valve 900 is advanced therethrough. In some cases, the valve 900 can be in a substantially uncompressed or laterally compressed configuration when inserted into the proximal end of the compression device 990, and can be compressed into a compressed or delivery configuration when advanced to and / or through the distal end of the compression device 990. Although not shown, in some cases, the valve 900 can be loaded into the compression device 990 and advanced through the lumen 995 while at least the compression device 990 is disposed in a saline bath or the like, which can facilitate advancement of the valve 900 through the compression device 990 and can maintain substantial sterility of the valve 900.

[0290] Figure 23A The proximal end of loading device 960 is shown removably coupled to the distal end of compression device 990. Loading device 960 may be any suitable shape, size, and / or configuration. Figure 23A The loading device 960 is shown as defining a lumen 963 extending through the loading device 960 and having a door 966 at the distal end of the loading device 960. The door 966 is capable of being opened in a closed state ( Figure 23A and Figure 23B ) and open state ( Figure 23C ) The door 966 in the closed state can selectively block a portion of the lumen 963, as described in further detail herein.

[0291] The distal end of the loading device 960 is also 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 can include a first port disposed proximal to the door 966 and in fluid communication with at least a portion of the lumen 963 proximal to the door 966, and a second port disposed distal to the door 966 and in fluid communication with at least a portion of the lumen 963 distal to the door 966. In some implementations, the port 967 (e.g., via a first portion or first port of the port 967) can be used to provide suction to at least a portion of the lumen 963 and to provide a fluid flow for flushing at least a portion of the lumen 963 (e.g., via a second portion or second port of the port 967). In some instances, port 967 can provide flushing of at least a portion of lumen 963 (e.g., a flow of sterile fluid such as saline, with or without simultaneous aspiration) when door 966 is in a closed state and / or after door 966 is transitioned to an open state.

[0292] The lumen 963 of the loading device 960 has a diameter and / or circumference that is 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 a delivery configuration and advanced from the compression device 990 into the lumen 963 of the loading device 960. Figure 23B The valve 900 is shown disposed in a lumen 963 of a loading device 900 in a delivery configuration. Figure 23B Also shown is the compression device 990 being removed and / or decoupled from the proximal end of the loading device 960 after the valve 900 is advanced into the lumen 963. In some implementations, for example, the compression device 990 can be laterally separated and removed from around the control device 970 and withdrawn from the loading device 960, as described above. FIG. 23A to FIG. 23B , but after the compression device 990 is removed from the loading device 960, a hemostatic valve and / or the like can 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 the like can form a substantially fluid-tight seal at the proximal end of the loading device 960 (e.g., and around the control device 970 and / or its control conduit). Furthermore, in implementations in which a pulling 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 pulling device can be decoupled from the loading device 960, and any tethers, cables, and / or connections attached to the distal end of the valve 900 can be removed therefrom.

[0293] Figure 23B The valve 900 is shown loaded into the loading device 960 with the door 966 in a closed state. In some implementations, the valve 900 can be advanced through the lumen 963 until, for example, the distal anchoring element (or distal-most portion) of the valve 900 contacts and / or is adjacent to the proximal surface of the door 966 in the closed state. Figure 23B Also shown is a guidewire catheter 984 extending distally from the valve 900, through the closed door 966, and beyond the distal end of the loading device 960. In some embodiments, for example, the door 966 can be shaped and / or sized such that a space is defined between an edge of the door 966 and an inner surface of the loading device 960, thereby allowing the guidewire catheter 984 to extend therethrough. In some embodiments, the door 966 can define an opening, hole, notch, recess, and / or the like through which the guidewire catheter 984 can extend.

[0294] Figure 23B and Figure 23CThe distal end of the loading device 960 is shown to 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 can be inserted into and advanced through the patient such that the distal end of the delivery device 981 (delivery catheter) is disposed within a space or volume of the heart. Additionally, the delivery device 981 and / or at least its delivery catheter can be tracked and / or advanced over a guidewire 985 that was previously inserted through the patient and placed in a desired position relative to the annulus of the native heart valve. Figure 23B The proximal end of the guidewire 985 is shown extending 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 the loading device 960 are placed in a fluid (e.g., saline) bath. In such cases, the loading device 960 with the valve 900 in the delivery configuration disposed in the lumen 963, the hemostatic valve or the like coupled to the proximal end, and the door 966 in a closed state can be removed from the bath and used, for example, on an operating table or the like to be coupled to the proximal end of the delivery device 981 that has been inserted into the patient.

[0295] Figure 23B A guidewire 985 extending through the proximal end of the delivery device 981 is shown inserted into a guidewire catheter 984 prior to coupling the distal end of the loading device 960 to the delivery device 981. The delivery device 981 is shown as defining a lumen 983 having a circumference and / or diameter that is substantially similar to the circumference and / or diameter of the lumen 963 of the loading device 960. Figure 23B The proximal end of the delivery device 981 is shown to include a Figure 23B ) and open state ( Figure 23C ) between the door 966 and the delivery device 981. The proximal end of the delivery device 981 is also shown as including at least one port 987. The at least one port 987 is in fluid communication 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 may include: a first port disposed proximal to the door 986 and in fluid communication with at least a portion of the lumen 983 proximal to the door 986; and a second port disposed distal to the door 986 and in fluid communication with at least a portion of the lumen 983 distal to the door 986. In some implementations, the port 987 (e.g., via a first portion or first port of the port 987) can be used to provide suction to at least a portion of the lumen 983 and to provide fluid flow for flushing at least a portion of the lumen 983 (e.g., via a second portion or second port of the port 987), as described above with reference to the loading device 960.

[0296] Figure 23BThe distal end of the loading device 960 is shown coupled to the proximal end of the delivery device 981 with each of the doors 966 and 986 in a closed state. In some implementations, after the loading device 960 is coupled to the delivery device 981, the volume defined by the lumens 963 and 983 and disposed between the closed doors 966 and 986 can be flushed through the ports 967 and 987. For example, in some implementations, the port 987 can provide a flow of saline and / or other sterile fluid into the volume, while the port 967 can provide aspiration into and / or through at least the volume (or vice versa).

[0297] Figure 23C 966 and 986 can be transitioned from a closed state to an open state after coupling the loading device 960 to the delivery device 981 and after flushing the volume defined between the doors 966 and 986. Thus, the lumens 963 and 983 are substantially open or otherwise unobstructed. Thus, a user and / or operator can apply a distal force on a portion of the control device 970 to advance the valve 900 in a delivery configuration from the loading device 960 and into the lumen 983 of the delivery device 981. Furthermore, the distal force can be operable to advance the valve 900 through a delivery catheter (not shown) of the delivery device and release the valve 900 from the distal end of the delivery catheter. Once released (or at least partially released), the control device 970 can control and / or manipulate the valve 900 to position the valve in the annulus of the native heart valve.

[0298] In some cases, it may be desirable to at least partially retrieve the valve 900 from the annulus during deployment (e.g., to adjust the position, orientation, and / or placement of the valve 900 in the annulus). In such cases, the control device 970 may also be used to at least partially retrieve the valve 900 into the distal end of a delivery catheter (included in the delivery device). For example, where a connecting member (e.g., a yoke) is coupled to a portion of the valve 900, a user and / or operator may apply a proximal guide force on the control device 970 that may pull the valve 900 proximally toward the delivery catheter and / or pull the valve 900 proximally into the delivery catheter. Additionally, the delivery system 980 may include any suitable capture element, feature, component, mechanism, etc. that is configured to facilitate compression of the valve 900 as the valve 900 is pulled in a proximal direction toward the delivery catheter and / or into the delivery catheter. In some cases, after partially retrieving valve 900, control device 970 may be manipulated to reposition valve 900 within the annulus in a desired orientation and / or configuration.

[0299] Figures 24 to 39Various portions of a delivery and / or retrieval system 1080 for delivering, deploying, and / or at least partially retrieving a prosthetic valve 1000 are shown, according to one embodiment. The delivery and / or retrieval system 1080 ("delivery system") can be of any suitable shape, size, and / or configuration and can include any suitable components or combinations of components. In some embodiments, for example, the delivery system 1080 and / or at least portions or aspects thereof can be similar to those described above with reference to Figures 23A to 23C The delivery system 1080 is similar and / or substantially identical to the delivery system 980 described herein. Therefore, portions and / or aspects of the delivery system 1080 may not be described in further detail herein. Moreover, the delivery system 1080 can be used to deliver, deploy, and / or at least partially retrieve any suitable valve, such as, for example, any of the valves 100, 400, 500, 600, 700, 800, and / or 900. For example, the valve 1000 can have an outer frame having an inner flow control component mounted therein. The valve 1000 can be capable of compression and expansion in an axial direction and a transverse direction relative to the longitudinal axis of the valve 1000, as described in further detail herein.

[0300] The delivery system 1080 may include any one or more suitable components configured to place the valve 1000 in a delivery configuration, load the valve 1000 into a portion of the delivery system 1080, deliver the valve 1000 in a delivery configuration through a portion of the delivery system 1080, control and / or facilitate deployment of the valve 1000 within the annulus of the native valve, and in some cases, at least partially retrieve the valve 1000 from the annulus to allow adjustment and / or repositioning of the valve 1000 or (e.g., in the event of failure or patient distress) remove the valve 1000 from the heart.

[0301] Figure 24 1 is a partially exploded perspective view of a delivery system 1080. As shown, the delivery system 1080 includes 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 pulling device 1098. The dilator 1058 can be any suitable dilator configured to dilate at least a portion of a passageway within the body to allow, for example, a delivery catheter and / or other relatively large-gauge catheter to be advanced through the passageway. In this embodiment, the dilator 1058 can be configured to dilate a passageway through, for example, the femoral vein and IVC to allow the delivery catheter 1082 of the delivery device 1081 to be advanced into the patient's heart.

[0302] The pulling device 1098 can be any suitable device that is configured to be removably coupled to the valve 1000 to facilitate advancing (e.g., pulling) the valve 1000 through one or more portions of the delivery system 1080. For example, in some embodiments, the pulling device 1098 can include a tether (e.g., a suture, a tension member, a cable, a wire, etc.) that can be coupled at a first end to a distal end of the valve 1000. An opposite end of the tether can be coupled to the pulling device 1098, which can be and / or can include a spool mechanism or the like around which at least a portion of the tether can be wound or wrapped. As described in further detail herein, the winding and / or wrapping of the tether can be operable to pull the valve 1000 through one or more portions of the delivery system 1080.

[0303] Figures 25A to 25E and Figures 26A to 26G Various views and / or aspects of a compression device 1090 are shown. 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 can have a funnel-like shape and define a lumen 1095 extending through the proximal and distal ends of the compression device. Figures 25A to 25C A coupler 1092 is shown that can be removably disposed around at least a portion of the first member 1091 and the second member 1092 to couple the members 1091 and 1092 together. Figure 25A The funnel-like shape of the compression device 1090 is shown to allow the coupler 1092 to slide over a portion of the first member 1091 and the second member 1092 and advance into a position in which the outer surface of the compression device 1090 formed by the first member 1091 and the second member 1092 forms a friction fit with the inner surface of the coupler 1092, thereby forming the compression device 1090. Figure 25B The coupler 1092 is shown to be removable from the first member 1091 and the second member 1092 in, for example, a distal direction.

[0304] Figure 25C The first member 1091 and the second member 1092 are shown as being capable of laterally separating. That is, the first member 1091 and the second member 1092 are capable of separating about a plane that extends in a longitudinal direction (e.g., a proximal-distal direction) and an axial direction and is orthogonal to the transverse axis and / or direction. The first member 1091 and the second member 1092 are shown as having a substantially mirror-image arrangement. Furthermore, the inner surface of the first member 1091 and the inner surface of the second member 1092 collectively define a lumen 1095.

[0305] Figure 25D1090 and is a proximal view of the compression device 1090 and illustrates a lumen 1095 extending through the proximal end of the compression device 1090. The lumen 1095 has a substantially rectangular shape at the proximal end. Specifically, the lumen 1095 and / or the perimeter of the lumen 1095 has an axial dimension that substantially corresponds to the axial height of the valve 1000 configured to be inserted therein. In some embodiments, the axial dimension can be slightly greater than the axial height of the valve 1000, thereby allowing the valve 1000 to be substantially uncompressed in the axial direction when inserted into the proximal end of the compression device 1090. In other embodiments, the axial dimension can be slightly less than the axial height of the valve 1000, such that inserting the valve 1000 into the proximal end of the compression device 1090 includes at least slightly compressing the valve 1000 in the axial direction.

[0306] The lumen 1095 and / or the perimeter of the lumen 1095 at the proximal end have a transverse dimension that substantially corresponds to the transverse width of the valve 1000 configured to be inserted therein. More specifically, the transverse dimension substantially corresponds to the width of the valve 1000 in a transversely compressed configuration. As described in detail above, the valve 1000 can be compressed and / or folded in a transverse direction. In this embodiment, the transverse dimension of the lumen 1095 at the proximal end allows the valve 1000 to be manually compressed and / or folded prior to insertion into the proximal end of the compression device 1090.

[0307] Figure 25E 1090 is a distal view of the compression device 1090 and illustrates a lumen 1095 extending through the distal end of the compression device 1090. The lumen 1095 has a substantially circular shape at the distal end. Specifically, the lumen 1095 and / or the perimeter of the lumen 1095 have a size and / or diameter that substantially corresponds to the perimeter and / or axial-lateral extent of the valve 1000 in the delivery configuration. In some embodiments, the transverse 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) can be substantially the same as the transverse 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 in the axial direction. In other embodiments, the diameter of the lumen 1095 at the distal end can be smaller than the axial and transverse dimensions of the lumen 1095 at the proximal end. The reduced size and / or circumference of the lumen 1095 of the compression device 1090 is configured to transition the valve 1000 to the compressed or delivery configuration as the valve 1000 is advanced therethrough.

[0308] Figure 26Ais a side view of the compression device 1090 and shows three planes 26B-26B, 26D-26D, and 26F-26F along the length of the compression device 1090, corresponding to cross-sectional views of the size and / or shape of the lumen 1095 at the locations of the shown planes. For example, Figure 26B It is along Figure 26A FIG. 10B is a cross-sectional view of the compression device 1090 taken along plane 26B-26B in FIG. The lumen 1095 of the compression device 1090 is shown as being substantially rectangular having corners that are larger than corresponding corners of the lumen 1095 at the proximal end of the compression device 1090 (see, e.g., FIG. 10B ). Figure 25D ) is more circular. Lumen 1095 is also shown as having a perimeter having an axial dimension (e.g., a maximum axial dimension) and a transverse dimension (e.g., a maximum transverse dimension) that are substantially similar to the perimeter of lumen 1095 at the proximal end. Figure 26C Shown corresponding to Figure 26B The valve 1000 is shown in a partially compressed configuration around the perimeter of the lumen 1095. For example, the valve 1000 can be compressed laterally with little to no axial compression.

[0309] Figure 26D It is along Figure 26A FIG. 10B is a cross-sectional view of the compression device 1090 taken along plane 26D-26D in FIG. The lumen 1095 of the compression device 1090 is shown as being substantially elliptical or oval in shape with corners that are wider than the lumen 1095 at Figure 26B The corresponding corners at the illustrated location are more rounded.The lumen 1095 is also shown as having a perimeter having a transverse dimension (eg, a maximum transverse dimension) that is substantially similar to the transverse dimension of the perimeter of the lumen 1095 at the proximal end. Figure 26D The perimeter of the lumen 1095 is shown to have an axial dimension (e.g., a maximum axial dimension) that is smaller than the perimeter of the lumen 1095 at Figure 26B Axial dimension of the perimeter at the position shown. Figure 26E Shown corresponding to Figure 26D The valve 1000 is shown in a partially compressed configuration around the perimeter of the lumen 1095. For example, the valve 1000 can be compressed in a transverse direction and partially compressed in an axial dimension.

[0310] Figure 26F It is along Figure 26A FIG. 10B is a cross-sectional view of the compression device 1090 taken along plane 26F-26F in FIG. 10C. The lumen 1095 of the compression device 1090 is shown as being substantially circular having a perimeter and / or diameter that is substantially the same as the perimeter and / or diameter of the lumen 1095 at the distal end of the compression device 1090 (see, e.g., FIG. 10C ). Figure 25E ) are basically similar. Figure 26GShown corresponding to Figure 26G The valve 1000 is shown substantially in a compressed and / or delivery configuration about the periphery of the lumen 1095. Thus, the compression device 1090 is configured to compress the valve 1000 into the delivery configuration as the valve 1000 is advanced therethrough. As described in further detail herein, the control device 1070 and / or the pulling device 1098 can be used to push, pull, and / or otherwise advance the valve 1000 through the compression device 1090.

[0311] Figure 27 1080. The loading device 1060 includes a perspective view of a loading device 1060 included in a delivery system 1080. The loading device 1060 has a distal end and a proximal end and defines a lumen 1063 extending through the loading device 1060. The lumen 1063 has a substantially circular perimeter having a diameter that is 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 removably coupled to the distal end of the compression device 1090, and the distal end of the loading device is configured to be removably coupled to each of the pulling device 1098 and the delivery device 1081 (e.g., one at a time), as described in further detail herein. Figure 27 The proximal end of the loading device 1060 is also shown and includes a door 1066 that is movable between an open state and a closed state to at least partially occlude the lumen 1063 of the loading device 1060, as described in further detail herein. The proximal end of the loading device 1060 is also shown as including a set of ports 1067 to which sterile flexible tubing is coupled, which can be used to flush and / or aspirate at least a portion of the lumen 1063, as described in further detail herein.

[0312] Figure 28 1 is a perspective view of a delivery device 1081 included in a delivery system 1080. The delivery device 1081 includes a handle 1088 and a delivery catheter 1082 extending from a distal end of the handle 1081. The handle 1088 and the delivery catheter 1082 together define a lumen 1083 extending through the delivery device 1081. The lumen 1083 has a substantially circular perimeter having a diameter that is similar 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 removably coupled to the distal end of the loading device 1060, as described in further detail herein. Figure 28The proximal end of the handle 1088 is also shown, which includes a door 1086 that is movable between an open state and a closed state to at least partially occlude the lumen 1083 of the delivery device 1081, as described in further detail herein. The proximal end of the handle 1088 is also shown as including a set of ports 1087 to which sterile flexible tubing is coupled, which can be used to flush and / or aspirate at least a portion of the lumen 1083, as described in further detail herein. The proximal end of the handle 1088 is also shown as including a coupler having an indexing feature 1089 that is configured to align the delivery handle 1088 when coupled to the loading device 1060. The indexing feature 1089 is shown as a slot that can receive a corresponding indexing feature (e.g., a protrusion) included in the distal end of the loading device 1060. In this manner, the delivery device 1081 and the loading device 1060 can be in a predetermined and / or desired orientation when coupled.

[0313] Figures 29 to 34B Various portions of a control device 1070 included in a delivery system 1080 are shown. The control device 1070 can be and / or can include any number of components that can be at least temporarily coupled to and / or in contact with one or more portions of the valve 1000 and 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 can include a control catheter 1071 having a connecting member 1078 disposed at a distal end of the control catheter 1071 and a control portion 1072 at a proximal end of the control catheter 1071.

[0314] The control portion 1072 can be any suitable shape, size, and / or configuration and can provide a means for a user and / or operator to engage one or more portions of the control device 1072. The control portion 1072 is shown having a number of control arms 1077, each of which can receive a portion of the control device 1070 (such as, for example, one or more tethers, tension members, cables, wires, sutures, etc.) and provide a means of controlling that portion.

[0315] The control catheter 1071 can be a steerable multi-lumen catheter. For example, Figure 30 It is along Figure 29FIG3 is a cross-sectional view of a control catheter 1071 taken along line 30-30 in FIG3 . The control catheter 1071 is shown as including a set of tether or tension member lumens 1073 and a guidewire catheter lumen 1074. Each tether or tension member lumen 1073 communicates with a different and / or corresponding control arm 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 a sidewall portion of the control catheter 1071 between an outer surface and an inner surface defining the guidewire catheter lumen 1074. The tether or tension member lumens 1073 provide one or more pathways through which one or more tethers, tension members, cables, wires, sutures, etc. can extend to selectively engage portions 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 can extend to allow the distal end of the guidewire catheter 1084 to engage and / or extend through one or more portions of the valve 1000, as further described in detail herein.

[0316] Figures 31A to 31C is a perspective view of the distal end of the control device 1070 and shows the connecting member 1078 transitioning between an expanded configuration and a compressed configuration. The connecting member 1078 can be formed of any suitable material, such as a shape memory alloy like Nitinol. Figure 31A Shown with reference to the above example 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 the first portion, side, and / or arm. Figure 31A Connecting member 1078 is shown in a deployed configuration. Figure 31B The connecting member 1078 is shown beginning to transition from an expanded configuration to a compressed configuration in response to the delivery catheter 1082 being positioned at or near the distal end of the control device 1070 . Figure 31C The connecting member 1078 is shown in a compressed configuration when the connecting member 1078 is at least partially disposed within the lumen of the delivery catheter 1082. The diameter of the lumen of the delivery catheter 1082 is smaller than the width of the connecting member 1078 in the expanded configuration, and therefore, the delivery catheter 1082 is shown squeezing the connecting member 1078 into the compressed configuration when the connecting member 1078 is at least partially disposed within the delivery catheter 1082. The connecting member 1078 in the compressed configuration allows the control catheter 1071 to be advanced through the delivery catheter 1082, and the connecting member 1078 can automatically transition from the compressed configuration to the expanded configuration when released from and / or otherwise moved to a distal position relative to the delivery catheter 1082.

[0317] Figure 32 is a perspective view of the distal end of the control device 1070 and shows a connecting member 1078 and a set of tethers 1075 extending from corresponding tether and / or tension member lumens 1073 of the control catheter 1071. The tethers 1075 are shown extending from the control catheter 1071, looping through a set of openings 1079 along or defined by each side or arm of the connecting member 1078 (yoke), and extending back into corresponding tether and / or tension member lumens 1073. The tethers 1075 can be used to removably connect the connecting member 1078 to the valve 1000.

[0318] Figure 33 is a side perspective view of the distal end of control device 1070 showing connection member 1078 removably coupled to valve 1000. Valve 1000 is shown having an outer frame 1010 having flow control components 1050 mounted therein, as described above with reference to valves 400, 500, 600, 700, and / or 1000. Frame 1010 has a supra-annular region 1020 and a sub-annular region 1030 with a trans-annular region coupled therebetween.

[0319] The supra-annular region 1020 is shown as having a laser cut frame that is wrapped or covered in a biocompatible material. The supra-annular region 1020 includes a proximal spline 1027 that extends between the outer loop and the inner loop of the supra-annular region 1020, as described above with reference to the valve 800. The flow control component 1050 is shown as being mounted to the inner loop of the supra-annular region 1020. The spline 1027 is shown as having an arcuate configuration and defines a waypoint 1028. The waypoint 1028 can be, for example, an opening, a hole, an orifice, a port, a coupler, a sealable / resealable access point, and / or the like that is constructed to at least temporarily couple to and / or receive a portion of the delivery system 1080.

[0320] The supra-annular region 1020 is further shown to include a drum 1045 that extends between and / or couples to the outer and inner loops and covers the space not otherwise occupied by the flow control component 1050. The drum 1045 may have and / or form a set of spokes that can be used to increase the stiffness of the drum 1045, as described above with reference to valve 800. The arcuate splines 1027 can apply a force on the drum 1045 that causes it to bow and increase tension across the region of the drum 1045. The increased tension in the drum 1045 and the increased stiffness of the drum 1045 due to the spokes can, in turn, reduce and / or limit the amount of drum deformation, for example, during diastole or systole, thereby enhancing the performance of the valve 1000 and / or reducing fatigue in or along the drum 1045, as described above in detail with reference to valve 800. The upper ring region 1020 and / or drum 1045 are also shown with an attachment member 1038 that may extend along or across a portion of the drum 1045. The attachment member 1038 facilitates temporary and / or removable attachment to a portion of the control device 1070. The attachment member 1038 may be, for example, a braided wire, a suture, a tether, a cable, and / or the like that may include and / or form a set of loops 1039 or the like that enable selective engagement of the attachment member 1038.

[0321] Figure 33 The distal end of a control device 1078 is shown removably connected to the valve 1000. Specifically, the connecting member 1078 (yoke) is shown in contact with the drum 1045. A tether 1075 is shown extending from the control catheter 1071 and looped through or around each side or arm of the connecting member 1078 and the corresponding loop 1039 of the attachment member 1038. The looped arrangement of the tether 1075 through and / or around the connecting member 1078 and the attachment member 1038 of the valve 1000 causes each of the proximal and distal ends of the tether 1075 to extend through a single control arm 1077 of the control portion 1072 and to extend outside (e.g., proximal to) the single control arm. Thus, a proximal guide force can be applied to each of the proximal and distal ends of the one or more tethers 1075 to increase tension along the tethers 1075, which pulls the connecting member 1038 toward the drum 1045, thereby securing the connecting member 1078 to the valve. Conversely, a proximal guide force applied to only one of the proximal or distal ends of the one or more tethers 1075 can disengage the one or more tethers 1075 from the connecting member 1078 and can withdraw the one or more tethers 1075 from the control device 1070, which in turn can allow the connecting member 1078 to be decoupled from or removed from the valve 1000.

[0322] Figure 33Also shown is a tension member 1076 extending from the control catheter 1071 (e.g., through one of the tether or tension member lumens 1073) and through the waypoint 1028. The tension member 1076 can be, for example, an actuator or the like that can selectively engage the proximal anchoring element 1034 formed by the subannular region 1030 of the valve 1000. The tension member 1076 can be routed through one of the control arms 1077 of the control portion 1072, through one of the lumens 1073 corresponding to the control arm 1077, around and / or through one or more portions of the proximal anchoring element 1034, and back through the corresponding lumen 1073. Thus, the tension member 1076 can be actuated (or placed under tension) and / or released in a manner similar to that described above with reference to the tether 1075. Furthermore, increasing the amount of tension along the tension member 1076 can operate to transition the proximal anchoring element 1034 between the first configuration and the second configuration, as described in detail above with reference to valves 600 and / or 700 .

[0323] Figure 33 Also shown is a guidewire catheter 1084 extending from the control catheter 1071 (e.g., through the guidewire catheter lumen 1074) and extending through the waypoint 1028. The valve 1000 is shown having a subannular member 1030 having and / or forming a distal anchoring element 1032 having a guidewire coupler 1033 that can receive the guidewire catheter 1084 through an opening, hole, orifice, port, etc. defined by the guidewire coupler 1033. Thus, the guidewire catheter 1084 is shown extending from the control catheter 1071 (at a supra-annular position relative to the valve 1000), through the waypoint 1028 of the valve 1000, beneath the flow control component 1050, and through the distal subannular anchoring element 1032. In addition, the guidewire catheter 1084 is shown as extending beyond the distal anchoring element 1032 and may have and / or provide sufficient stiffness to allow the valve 1000 to be advanced along the guidewire 1085 over which the guidewire catheter 1084 is disposed. The arrangement of the control device 1072 just described allows the control device 1072 (including the connecting member 1078, tether 1075, tension member 1076, and guidewire catheter 1084) to be decoupled from the valve 1000 and withdrawn through the delivery catheter 1082 after the valve 1000 is successfully deployed.

[0324] Figure 34A and Figure 34B The distal end of the control device 1070 is shown in a first configuration and a second configuration, respectively.As described above, the distal end of the control device 1070 is removably coupled to the valve 1000. Figure 34A The distal end of the control catheter 1071 is shown having a substantially straight or undeformed shape when in a first configuration. Figure 34BThe distal end of the control catheter 1071 is shown in a second configuration in which the distal end is bent, flexed, turned, curved, deflected, deformed, etc. For example, as described above, the tether 1075 can be looped through the attachment member 1038 to removably couple the connecting member 1078 to the supra-annular region 1020 of the valve 1000, while the tension member 1076 can be looped around and / or through one or more portions of the proximal subannular anchoring element 1034. In some cases, the tension along the tension member 1076 can be increased to transition the proximal anchoring element 1034 between the first and second configurations. In some cases, the tension along the tether 1075 and the tension along the tension member 1076 can be at least partially opposing forces applied to a relatively small portion of the valve 1000, while the range of motion of the valve 1000 is somewhat limited (e.g., due to the guidewire catheter 1084, as described above). Thus, tension along the tension member 1076 exceeding a threshold amount of tension can be operable to cause the distal end of the control catheter 1071 to bend, flex, turn, bend, deflect, and / or otherwise deform. In other words, in some cases, increasing the tension along the tension member 1076 can allow for a desired deflection of the control catheter 1071. In some cases, for example, the control catheter 1071 can be deflected and / or bent in a supra-annular direction relative to the valve 1000 such that a distally directed force along the control catheter 1071 causes the connecting member 1078 to exert a force on the valve 1000 that is at least partially in a subannular direction, thereby facilitating deployment and / or placement of the valve 1000 within the native annulus.

[0325] Figures 35 to 39 1 is a cross-sectional view of a delivery system 1080 illustrating the process of placing the valve 1000 in a delivery configuration and loading the valve 1000 into a delivery device 1081 for lateral delivery into the heart. Prior to loading the valve 1000 (or during at least a portion of a concurrent process), a user, operator, surgeon, etc., may manipulate the delivery device 1081 to advance a guidewire 1085 along a pathway through the patient and into a desired location 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 pathway through the patient's body. A delivery catheter 1082 may then be advanced through the pathway to place the distal end of the delivery catheter 1082 within a volume of the heart (e.g., an atrium). Furthermore, the delivery device 1081 is arranged such that the proximal end of the guidewire 1085 extends from the proximal end of the handle 1088 of the delivery device 1081, as described in further detail herein.

[0326] Figure 351060 and the distal end of the loading device 1060 are shown removably coupled to the compression device 1090 and removably coupled to the pulling device 1098. More specifically, a tether 1099 of the pulling device 1098 can extend through the lumen 1063 of the loading device 1060 and the lumen 1095 of the compression device and can be removably coupled to the distal end of the valve 1000 (e.g., looped around or through one or more portions of the distal end of the valve 1000). The end of the tether 1099 is shown as being disposed around and / or at least partially wrapped around a spool or the like of the pulling device 1098. In this embodiment, rotation of a portion of the spool or pulling device 1098 increases tension along the tether 1099, which is operable to pull the valve 1000 through the compression device 1090 and / or the loading device 1060. Furthermore, during loading of the valve 1000 into the loading device 1060, the door 1066 is in a closed state, and therefore, the tether 1099 can be configured to extend through the space defined between the door 1066 and the inner surface of the loading device 1060 (as described above).

[0327] Figure 35 The distal end of the valve 1000 is shown removably coupled to a tether 1099 of a pulling device 1098 and the proximal end of the valve 1000 is shown removably coupled to a control device 1070. A guidewire catheter 1084 is shown extending through the valve 1000 and distal to the subannular anchoring element. Figure 35 Also shown is the valve 1000 partially inserted into the lumen 1095 of the compression device 1090. As described above, prior to inserting the valve 1000 into the compression device 1090, the valve 1000 can be at least partially compressed in the posterior direction. Thus, the valve 1000 is shown as being compressed laterally but not yet compressed axially (substantially). As described above, but in some cases, the valve 1000 can be loaded into the compression device 1090 and advanced through the lumen 1095 while at least the compression device 1090 is positioned in a saline bath or the like, which can facilitate advancement of the valve 1000 through the compression device 1090 and can maintain the substantial sterility of the valve 1000.

[0328] Figure 36The valve 1000 is shown at least partially advanced through the compression device 1090 and into the lumen 1063 of the loading device 1060. For example, after initially inserting the valve 1000 into the proximal end of the compression device 1090, the user or operator can, for example, manipulate the pulling device 1098 to further wind and / or spool the tether 1099. In some implementations, the user and / or operator can also apply a force on the control device 1070 so that the connecting member (not shown) pushes the valve 1000 through the compression device 1090. The valve 1000 is shown advanced 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 in at least an axial direction as the valve 1000 is advanced therethrough. In some cases, the valve 1000 can be in a substantially uncompressed or laterally compressed configuration when inserted into the proximal end of the compression device 1090 and can be compressed into a compressed or delivery configuration ( Figure 36 ).

[0329] Figures 35 to 37 The valve 1000 is shown loaded into the loading device 1060 with the door 1066 in a closed state. Figure 37 The valve 1000 is shown advanced through the lumen 1063 until, for example, the distal anchoring element (or distal-most portion) of the valve 1000 contacts and / or is adjacent to the proximal surface of the door 1066 in a closed state. A guidewire conduit 1084 extends distally from the valve 1000, through the closed door 1066, and beyond the distal end of the loading device 1060. In some embodiments, for example, the door 1066 can have a shape and / or size that defines a space between an edge of the door 1066 and an inner surface of the loading device 1060, thereby allowing the guidewire conduit 1084 and the tether 1099 of the pulling device 1098 to extend therethrough. In some embodiments, the door 1066 can define an opening, hole, notch, recess, and / or the like through which the guidewire conduit 1084 and the tether 1099 can extend.

[0330] After the valve 1000 is advanced into the loading device 1060, the compression device 1090 can be removed from the proximal end of the loading device 1060. As described above, when the coupler 1093 is removed, the first member 1091 and the second member 1092 of the compression device 1090 can be laterally separated. Thus, the coupler 1093 can be removed and the first member 1091 and the second member 1092 can be separated to decouple the compression device 1090 from the proximal end of the loading device 1060 without, for example, disconnecting, removing, and / or substantially altering the control device 1070 relative to the valve 1000. After the compression device 1090 is removed from the loading device 1060, the hemostatic valve 1068 and / or the like can be advanced over a portion of the control device 1070 and coupled to the proximal end of the loading device 1060 (see, e.g., Figure 38 ). The hemostatic valve 1068 can form a substantially fluid-tight seal at the proximal end of the loading device 1060 (e.g., and around the control device 1070 and / or its control catheter). In addition, the pulling device 1098 can also be decoupled from and / or removed from the distal end of the loading device 1060, and the tether 1098 can be decoupled from the valve 1000 and withdrawn from the loading device 1060.

[0331] With the hemostatic valve 1068 coupled to the proximal end of the loading device 1060 and the distal end of the loading device 1060 decoupled from the loading device 1060, the loading device 1060 is ready to be coupled to the delivery device 1081. Thus, with the valve 1000 loaded into the loading device 1060 in a fluid (e.g., saline) bath, the loading device 1060, with the valve 1000 in the delivery configuration disposed in the lumen 1063, the hemostatic valve 1068 coupled to the proximal end, and the door 1066 in a closed state, can be removed from the bath and used, for example, on a surgical table or the like to be coupled to the proximal end of the delivery device 1081 that has been inserted into a patient.

[0332] Figure 38 The distal end of the loading device 1060 is shown coupled to the proximal end of the delivery device 1081. Figure 391080 is an enlarged view of a portion of the delivery system 1080 and illustrates the indexing feature 1089 of the handle 1088 engaging the indexing feature 1069 included in the distal portion of the loading device 1069. The indexing features 1089 and 1069 are illustrated as having a keyway arrangement, although other indexing patterns are possible. The indexing features 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 can be delivered to the delivery device 1000 in a predetermined and / or desired orientation (e.g., based on the perimeter of the lumen 1095 at the proximal end of the compression member 1090, such as by inserting the valve 1000 into the lumen 1095 of the compression device 1090).

[0333] As described above, delivery catheter 1082 is previously inserted into the patient and the proximal end of guidewire 1085 extends from the proximal end of handle 1088 of delivery device 1081. Thus, before coupling the distal end of loading device 1060 to the proximal end of handle 1088, the proximal end of guidewire 1085 is inserted into over-the-wire catheter 1084. As described above, loading device 1060 is coupled to the proximal end of handle 1088, while valve 1000 is proximal to door 1066 of loading device 1060 and each of doors 1066 of loading device 1060 and 1086 of delivery device 1081 are in a closed state. In some implementations, after coupling loading device 1060 to delivery device 1081 and before transitioning doors 1066 and 1086 to an open state, the volume defined by lumens 1063 and 1083 and disposed between doors 1066 and 1086 can be flushed through ports 1067 and 1087. For example, in some implementations, one or more ports 1087 can provide saline and / or other sterile fluid flow into the volume, while one or more ports 1067 can provide suction to and / or through at least the volume (or vice versa).

[0334] Figure 38 and Figure 398. It is shown that after coupling the loading device 1060 to the handle 1088 of the delivery device 1081 and after flushing the volume defined between the doors 1066 and 1086, the doors 1066 and 1086 can be transitioned from a closed state to an open state. As a result, the lumens 1063 and 1083 are substantially open or otherwise unobstructed. Thus, a user and / or operator can apply a distal force, for example on the control portion 1072 of the control device 1070, to advance the valve 1000 in a delivery configuration from the loading device 1060 and into the lumen 1083 of the delivery device 1081 and through the delivery catheter 1082. The valve 1000 can then be at least partially released from the distal delivery catheter 1082 and once released (or at least partially released), the control device 1070 can control and / or manipulate the valve 1000 to position the valve in the annulus of the native heart valve (e.g., as described above with reference to Figures 29 to 34B described above).

[0335] In some cases, it may be desirable to at least partially retrieve the valve 1000 from the annulus during deployment (e.g., to adjust the position, orientation, and / or placement of the valve 1000 in the annulus). In such cases, the control device 1070 can also be used to at least partially retrieve the valve 1000 into the distal end of the delivery catheter 1082. For example, with the connecting member 1078 (yoke) removably coupled to the valve 1000, a user and / or operator can apply a proximal guide force on the control device 1070 that can pull the valve 1000 proximally toward and / or into the delivery catheter 1082. Furthermore, the delivery system 1080 can include any suitable capture elements, features, components, mechanisms, etc. (such as those described herein with reference to specific embodiments) that are configured to facilitate compression of the valve 1000 as the valve 1000 is pulled in a proximal direction toward and / or into the delivery catheter 1082. In some instances, after partially retrieving the valve 1000, the control device 1070 can be manipulated to reposition the valve 1000 in the annulus in a desired orientation and / or configuration.

[0336] Figure 40 is an illustration of a top perspective view of valve 1100 with guidewire 1185 threaded through waypoint 1128 and positioning and / or control catheter 1171 attached on the proximal side of valve 1100. Delivery catheter 1182 is shown with guidewire 1185 and positioning and / or control catheter 1171 disposed within the lumen of delivery catheter 1182.

[0337] Figure 41is an illustration of a side perspective view of valve 1200 with guidewire 1285 threaded through waypoint 1228 and positioning and / or control catheter 1271 attached on the proximal side of valve 1200. Delivery catheter 1282 is shown with guidewire 1285 and positioning and / or control catheter 1271 disposed within the lumen of delivery catheter 1282.

[0338] Figure 42 13 is an illustration of a perspective view from below of the valve 1300 coupled to a positioning and / or control catheter 1371. A catheter guide and / or support member can provide additional connection and support for the positioning and / or control catheter 1371 during attachment to the valve 1300. A mounting member 1335 is shown for attaching the positioning and / or control catheter 1371 to the valve 1300. In some embodiments, the positioning and / or control catheter 1371 has a threaded portion that engages a mating threaded component on the valve 1300, whereby the positioning and / or control catheter 1371 can be rotated to engage / disengage the valve 1300. Distal and proximal anchoring channels can be included and / or formed by an outer portion of the sidewall 1312 of the valve 1300 and provide subannular access for deploying tissue anchors (not shown), for example, from the collar portion 1320 through the channel to the subannular space. A distal anchoring element 1332 and a guidewire coupler or anchor head 1333 are shown extending distally from the lower or subannular region 1320 of the valve 1300 .

[0339] Figure 43 is an illustration of a side perspective view of components of delivery system 1480. Loading device 1460 and loading compression cylinder 1462 are shown in one component. Delivery device 1481 and threaded mounting member 1435 are shown in a second component. Guidewire 1485 and positioning and / or control catheter 1471 are shown threaded through a receptacle at the proximal end of delivery catheter 1482. Positioning and / or control catheter 1471 may be equipped with a Luer lock and / or the like to provide a port 1487 for flushing liquid through the lumen of positioning and / or control catheter 1471 and / or delivery catheter 1482.

[0340] Figure 44 is an illustration of a side perspective view of the valve 1400 beginning the compression process associated with loading the valve 1400 into the loading device 1460. The distal anchoring element 1432 is shown introducing the valve 1400 into the loading compression cylinder 1462. The annulus or supra-annular region 1420 of the valve 1400 is shown with lateral portions beginning to fold downwardly and / or inwardly to lie flat against the sidewalls of the valve 1400.

[0341] Figure 45is an illustration of a side perspective view of the valve 1400 partially inserted into the loading compression cylinder 1462. As the valve 1400 is inserted into the loading device 1460, the valve 1400 is further compressed. Figure 45 The valve 1400 is shown almost completely loaded into the loading compression cylinder 1462. A guidewire 1485 and a positioning and / or control catheter 1471 are shown attached to the valve 1400 while it is compressed.

[0342] Figure 46 is an illustration of a side perspective view of a loading device 1460 connected to a delivery device 1481. The valve 1400 is shown fully compressed into a compressed or delivery configuration within a loading compression cylinder 1462. The connection of the loading device 1460 to the delivery device 1481 allows the valve 1400 to be advanced from the loading device 1460 and through a delivery catheter 1482 for deployment in a patient.

[0343] Figure 47A is an illustration of a side view of a compression device 1590 with a loading device 1560 (eg, a compression or receiver catheter) at the distal end and a tether 1599 attached to the valve 1500 being delivered laterally, according to one embodiment. Figure 47A Valve 1500 is shown having a distal tether loop 1511 adjacent to a distal anchoring element 1532. Compression device 1590 defines a lumen, volume, space, and / or the like having and / or forming a rectangular cavity 1595A (e.g., at the proximal end) that opens into a transition cavity 1595B that opens into a circular cavity 1595C (e.g., at the distal end and adjacent to loading device 1560).

[0344] Figure 47B 15 is an illustration of a side view of the valve 1500 being pulled from right to left by the tether 1599 into the rectangular cavity 1595A of the compression device 1590, toward the transition cavity 1595B. The loading device 1560 is connected to the compression device 1590 at the distal end (e.g., adjacent to the circular cavity 1595C). This connection can be a threaded connection, a tension / form-fit connection, or other type of connection, such as a bead and channel connection or a clamp-type connection. Figure 47C 1590 , the distal anchoring element 1532 is shown introducing the valve 1500 into the lumen of the loading device 1560 .

[0345] Figure 47Dis an illustration of a side view of valve 1500 being pulled by tether 1599 from right to left out of compression device 1590 and into the lumen of loading device 1560 coupled to compression device 1590 at the distal end (e.g., adjacent circular cavity 1595C). Figure 47E is an illustration of a side view of valve 1500 fully disposed within loading device 1560 and in a compressed and / or delivery configuration. Loading device 1560 is shown decoupled from and / or otherwise removed from compression device 1590.

[0346] Figure 47F 15 is an illustration of a side view of a pushing device 1519 engaging the valve 1500 in a compressed configuration within a loading device 1560. Furthermore, the loading device 1560 is shown connected to a delivery catheter 1582. The pushing device 1519 may include a screw mechanism or the like that can be used to advance a push rod 1519A to push the compressed valve 1500. The push rod 1519A is shown having a distal end 1519B that engages a sidewall of the valve 1500 to advance the valve 1500 in the delivery configuration from the loading device 1560 and / or into the delivery catheter 1582. Once the valve 1500 in the delivery configuration is positioned within the delivery catheter 1582, the distal anchoring element 1532 can be directed toward the distal open end of the delivery catheter 1582 through which the valve 1500 has just been advanced. Figure 47G is an illustration of a side view of valve 1500 in a delivery configuration, positioned within the lumen of a delivery catheter 1582 by a pusher device 1519. Valve 1500 is shown successfully loaded into delivery catheter 1582, and loading device 1560 can be detached from valve 1500 and withdrawn from delivery catheter 1582. Thus, valve 1500 is ready for delivery into the native annulus through the side of delivery catheter 1582.

[0347] Figure 48A is an illustration of a side view of a compression device 1690 with a loading device 1660 positioned at the distal end of the compression device 1690 and with a tether 1699 attached to the distal end of a side-deliverable valve 1600 having a guidewire 1685 and a torque and / or positioning cable 1647 attached to the proximal end of the valve 1600. Figure 48A Valve 1600 is shown having a distal tether loop 1611 adjacent to a distal anchoring element 1632. Compression device 1690 defines a lumen, volume, space, and / or the like having and / or forming a rectangular cavity 1695A (e.g., at the proximal end) that opens into a transition cavity 1695B that opens into a circular cavity 1695C (e.g., at the distal end and adjacent to loading device 1660).

[0348] Figure 48A An embodiment of a compression device 1690 having a two-part or inherently multi-part configuration is shown. For example, the compression device 1690 can include two substantially mirror-image portions that can be laterally separated or disassembled and removed without disconnecting wires, cables, tethers, catheters, etc. from the valve 1600. The valve 1600 includes a waypoint 1628 for extending a guidewire 1685 through the supra-annular region 1620 (e.g., a collar, drum, etc.) and through the distal subannular anchoring element 1632. The torque and / or positioning cable 1647 is attached to the valve 1600 using a threaded receiver 1635 that can be remotely disconnected by axially rotating the torque and / or positioning cable 1647.

[0349] Figure 48B is an illustration of a side view of valve 1600 (and guidewire 1685 and torque and / or positioning catheter 1647 attached thereto) being pulled from right to left by tether 1699 into rectangular cavity 1695A and toward transition cavity 1695B of compression device 1690. Loading device 1660 is shown connected to the distal end of compression device 1690. This connection can be a threaded connection, a tension / form fit connection, or other type of connection, such as a bead and channel connection or a clamp-type connection. Figure 48C 16 is an illustration of a side view of valve 1600, guidewire 1685, and cable 1647 as they are further pulled from right to left through transition lumen 1695B and into circular lumen 1695C of compression device 1690. Distal anchoring element 1632 is shown introducing valve 1600 into the lumen of loading device 1660.

[0350] Figure 48D is an illustration of a side view of the valve 1600 , guidewire 1685 , and cable 1647 being pulled from right to left by a tether 1699 out of a constriction device 1690 and into a loading device 1660 coupled to the constriction device 1690 at a distal end. Figure 48E is an illustration of a side view of valve 1600 fully disposed within loading device 1660 in a compressed and / or delivery configuration and having guidewire 1685 and cable 1647 coupled thereto. Compression device 1690 is shown laterally separated into first and second portions 1691, 1692, thereby allowing compression device 1690 to be removed from loading device 1660 while maintaining connection of valve 1600 to pre-attached guidewire 1685 and cable 1647.

[0351] Figure 48Fis an illustration of a side view of the valve 1600 in a delivery configuration with the guidewire 1685 and cable 1647 attached, disposed within the loading device 1660 and the loading device 1660 connected, coupled, and / or inserted into the delivery catheter 1682. Figure 48G FIG1 is an illustration of a side view of a pushing device 1619 for pushing a compressed valve 1600 from a loading device 1660 to a delivery catheter 1682 after engaging the valve 1600 within the loading device 1660, according to the present invention. The pushing device 1619 may include a screw mechanism 1619B that can be used to advance the push rod 1619 to push the compressed valve 1600. The push rod 1619 is shown having a distal end 1619A that engages a sidewall of the valve 1600 to advance the valve 1600 in a delivery configuration from the loading device 1660 and / or to the delivery catheter 1682. The valve 1600 is advanced from the loading device 1660 (where the valve 1600 is positioned with the distal anchoring element 1632 facing in a direction opposite to that used during initial delivery of the anchor to the atrioventricular valve) to the delivery catheter 1682 to correct the orientation of the valve 1600 and the distal anchoring element 1632. Once the valve 1600 in the delivery configuration is positioned within the delivery catheter 1682, the distal anchoring element 1632 can be directed toward the distal open end of the delivery catheter 1682 through which the valve 1600 has just been advanced. Figure 48G The valve 1600 is shown successfully loaded into the delivery catheter 1682, and the loading device 1660 is shown detached from the valve 1600 and withdrawn from the delivery catheter 1682. Thus, the valve 1600 is ready for delivery laterally through the delivery catheter 1682 into the native annulus.

[0352] Figure 49A is an illustration of a perspective view of compression device 1790 receiving valve 1700 , proximal side first, with valve tether ring 1711 attached to tether 1799 . Figure 49A A coupler 1793 is shown holding the two halves of compres...

Claims

1. A delivery system for lateral delivery of a transcatheter prosthetic valve, the delivery system comprising: a compression device defining a lumen extending through the proximal and distal ends, the lumen having a circumference at the proximal end that is greater than a circumference at the distal end; a loading device defining a lumen extending through a proximal end and a distal end of the loading device, the lumen of the loading device having a perimeter similar to the perimeter of the lumen of the compression device at the distal end, the proximal end of the loading device being removably coupleable to the compression device, the distal end of the loading device including a first door movable between an open state and a closed state, the first door at least partially occluding the lumen of the loading device in the closed state of the first door; as well as A delivery device having a handle and a delivery catheter extending distally from the handle, the handle and the delivery catheter together defining a lumen extending through the delivery device, the lumen of the delivery device having a periphery similar to the periphery of the lumen of the loading device, the proximal end of the handle being coupleable to the distal end of the loading device and comprising a second door movable between an open state and a closed state, wherein the second door at least partially occludes the lumen of the delivery device in the closed state.

2. The delivery system of claim 1 , wherein the lumen of the compression device tapers in an axial direction as the lumen of the compression device extends longitudinally from a proximal end to a distal end of the compression device.

3. The delivery system of claim 2, wherein the size of the lumen of the compression device at the proximal end along the axial direction is equal to or greater than the height of the artificial valve in the expanded configuration along the axial direction.

4. A delivery system as described in claim 3, wherein the size of the lumen of the compression device at the proximal end along a transverse direction perpendicular to the axial direction is equal to the width of the artificial valve in the delivery configuration along the transverse direction.

5. The delivery system of claim 4, wherein the size of the lumen of the compression device at the distal end along the axial direction is equal to the height of the artificial valve in the delivery configuration along the axial direction.

6. The delivery system of claim 1, wherein a periphery of the lumen of the compression device at the proximal end has a rectangular shape, and a periphery of the lumen of the compression device at the distal end has a circular shape.

7. The delivery system of claim 6, wherein the perimeter of the lumen of the compression device at the proximal end has a transverse width that is equal to the diameter of the lumen of the compression device at the distal end.

8. The delivery system of claim 7, wherein the perimeter of the lumen of the compression device at the proximal end has an axial height that is greater than the diameter of the lumen of the compression device at the distal end.

9. A delivery system as described in claim 1, wherein the compression device includes a first member, a second member and a coupling member, and the coupling member can be removably arranged around the first member and the second member to temporarily couple the first member and the second member, and when the coupling member is removed, the first member and the second member can be laterally separated.

10. The delivery system of claim 9, wherein the first member of the compression device has a first inner surface and the second member of the compression device has a second inner surface that is a mirror image of the first inner surface, the first inner surface and the second inner surface together defining a lumen of the compression device.

11. The delivery system of claim 1 , wherein the compression device is configured to deliver the prosthetic valve in a delivery configuration to a lumen of the loading device when the proximal end of the loading device is removably coupled to the compression device.

12. A delivery system as described in claim 11, wherein the loading device includes a first port distal to the first door and a second port proximal to the first door, and the first port and the second port allow for selective flushing of at least a portion of the lumen of the loading device when the artificial valve in the delivery configuration is positioned in the lumen of the loading device.

13. The delivery system of claim 12, further comprising: A hemostatic valve removably coupled to the proximal end of the loading device when the prosthetic valve in the delivery configuration is in the lumen of the loading device and the compression device is decoupled from the proximal end of the loading device, the hemostatic valve sealing the lumen of the loading device at the proximal end of the loading device during the selective flushing.

14. The delivery system of claim 1 , wherein the distal end of the loading device comprises a first indexing feature and the proximal end of the handle defines a second indexing feature, the first indexing feature and the second indexing feature interconnected to position the loading device in a predetermined orientation relative to the delivery device when the distal end of the loading device is coupled to the proximal end of the handle.

15. The delivery system of claim 14, wherein one of the first indexing feature and the second indexing feature is a protrusion and the other of the first indexing feature and the second indexing feature is a slot.

16. A delivery system as described in claim 1, wherein the delivery device includes a first port distal to the second door and a second port proximal to the second door, the first port and the second port allowing for selective flushing of at least a portion of the lumen of the loading device when the artificial valve in the delivery configuration is positioned in a volume defined between the first door and the second door by the lumen of the loading device and the lumen of the delivery device.

17. A delivery system as described in claim 16, wherein the first door can be set to a closed state when the lumen of the loading device receives the artificial valve in the delivery configuration, and the first door is constructed to be transformed into an open state after the distal end of the loading device is coupled to the proximal end of the handle.

18. The delivery system of claim 17, wherein the second door is configurable in a closed state before the distal end of the loading device is coupled to the proximal end of the handle.

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