Proximal tab for lateral delivery of transcatheter heart valve and method of delivery

Abstract

The invention relates to a proximal tab for lateral delivery of a transcatheter heart valve and a method of delivery. A prosthetic heart valve includes a valve frame defining a bore extending along a central axis and a flow control member mounted within the bore. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow delivery of the prosthetic heart valve to the patient's heart via the delivery catheter and is configured to transition to an expanded configuration when released from the delivery catheter. The prosthetic heart valve is configured to be seated in the native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements are configured to be inserted through the native annulus prior to placement of the prosthetic heart valve. The proximal anchoring element is ready to deploy beneath the annulus or optionally configured to transition from the first configuration to the second configuration after the prosthetic valve is disposed.

Description

[0001] This application is a divisional application of invention patent application 201980090378.6, filed on December 18, 2019, entitled “Proximal patch and delivery method for lateral delivery of transcatheter heart valve”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Provisional Application Serial No. 62 / 782,350, filed on December 20, 2018, entitled “Proximal Tab for Side-Delivered Transcatheter Heart Valve Prosthesis,” and U.S. Provisional Application Serial No. 16 / 445,418, filed on June 27, 2019, entitled “Proximal Tab for Side-Delivered Transcatheter Heart Valve Prosthesis,” the disclosures of each of which are incorporated herein by reference in their entirety. Technical Field

[0004] Described herein are embodiments relating to prosthetic heart valves, and apparatus and methods for delivering and deploying such valves. Background Art

[0005] Prosthetic heart valves present challenges to intracardiac delivery and deployment, particularly delivery through a catheter through the patient's vascular system rather than through a surgical approach. The delivery of a conventional transcatheter prosthetic valve generally includes radially compressing the valve and loading the valve into a delivery catheter so that the central annular axis of the valve is parallel to the longitudinal axis of the delivery catheter. The valve is deployed from the end of the delivery catheter and expanded radially outward from the central annular axis. However, the expanded size (e.g., diameter) of a conventional valve is limited by the inner diameter of the delivery catheter. The conflict of interest in minimizing the size of the delivery catheter presents a challenge to increasing the expanded diameter of a conventional valve (e.g., attempting to compress too much material and structure into too small a space).

[0006]

[0006] Therefore, a need exists for a prosthetic valve having one or more anchoring features while maintaining a relatively small compressed size that allows for transcatheter delivery of the valve. Summary of the invention

[0007] Embodiments described herein generally relate to transcatheter prosthetic valves and methods for delivering transcatheter prosthetic valves. In some embodiments, the prosthetic heart valve includes a valve frame defining a hole extending along a central axis and a flow control component mounted in the hole. The flow control component is configured to allow blood to flow from the inflow end of the flow control component to the outflow end in a first direction roughly parallel to the central axis, and to prevent blood from flowing in a second direction opposite to the first direction. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the prosthetic heart valve to be delivered to the patient's heart through a delivery catheter. The valve frame is configured to change from a compressed configuration to an expanded configuration when the prosthetic heart valve is released from the delivery catheter. The prosthetic heart valve is configured to be placed in the annulus of the native valve of the heart when in an expanded configuration. The distal anchoring element and the proximal anchoring element of the valve frame are configured to be inserted through the annulus of the native valve before the prosthetic heart valve is placed in the annulus of the native valve. The proximal anchoring element is configured to transition from the first configuration to the second configuration after the prosthetic valve is positioned in the annulus of the native valve.

[0008] The embodiments described herein generally relate to transcatheter prosthetic valves configured for lateral / orthogonal delivery, which may have an expanded diameter that is increased relative to conventional valves. For example, in lateral delivery, the valve is compressed and loaded into a delivery catheter so that the central annular axis of the valve is substantially orthogonal to the longitudinal axis of the delivery catheter, which can allow the valve to be compressed laterally and extended longitudinally (e.g., in a direction parallel to the longitudinal axis of the delivery catheter). For conventional and / or orthogonally delivered transcatheter prosthetic valves, it is also desirable to provide one or more ways to anchor the valve in the native annulus without significantly increasing the compressed size of the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figures 1A to 1C is an illustration of a schematic diagram of a transcatheter prosthetic valve, according to an embodiment.

[0010] Figures 2 to 6 are illustrations of side perspective views of transcatheter prosthetic valves having distal and proximal anchoring elements, each according to an embodiment.

[0011] Fig. 7A and Figure 7B is an illustration of a perspective view of a transcatheter prosthetic valve having distal and proximal anchoring elements according to an embodiment, shown in an anchored configuration prior to release and in an extended configuration after release, respectively.

[0012] Figure 8 is an illustration of a cutaway side view of the human heart anatomy.

[0013] Fig.9A and Fig. 9BAn illustration of an anterior perspective view and an illustration of a septal perspective view, respectively, of a transcatheter prosthetic valve positioned with a native tricuspid valve annulus of a human heart, according to an embodiment.

[0014] Fig. 10A and Fig. 10B is an illustration of a proximal side view of a transcatheter prosthetic valve showing its proximal anchoring elements and an illustration of a distal side view of the valve showing its distal anchoring elements, according to an embodiment.

[0015] Fig.11A and Fig. 11B An illustration of a top front view and an illustration of a top septal view, respectively, of a transcatheter prosthetic valve with a dual anchoring element mechanism according to an embodiment.

[0016] Fig.12 is an illustration of a side perspective view of a transcatheter prosthetic valve according to an embodiment shown with a guidewire coupled to a portion of a distal anchoring element for delivery of the valve.

[0017] FIG. 13A to FIG. 13D , FIG. 14A to FIG. 14D , FIG. 15A to FIG. 15D and FIG. 16A to FIG. 16E Processes for deploying a transcatheter prosthetic valve within a native valve annulus of a human heart, each according to a different embodiment, are shown.

[0018] FIG. 17A to FIG. 17E A process for deploying a transcatheter prosthetic valve in a native mitral valve annulus of a human heart is shown according to an embodiment.

[0019] Fig.18A is an illustration of an anterior perspective view of a transcatheter prosthetic valve in a native mitral valve annulus of a human heart, according to an embodiment.

[0020] Fig.18B It is placed in the native mitral valve annulus (shown in solid line) Fig.18A Illustration of a side view of a transcatheter prosthetic valve (shown in dotted lines).

[0021] Fig.19A and Fig.19B Illustration of a perspective view of a proximal anchoring element in a first configuration and a second configuration, respectively, according to an embodiment.

[0022] Fig. 20A and Fig. 20B Illustration of a perspective view of a proximal anchoring element in a first configuration and a second configuration, respectively, according to an embodiment.

[0023] Fig.21A is an illustration of a top view of a transcatheter prosthetic valve in the native tricuspid valve annulus of a human heart, according to an embodiment.

[0024] Fig. 21B It is placed in the native tricuspid valve annulus (shown in solid line) Fig.21A Illustration of a top view of a transcatheter prosthetic valve (shown in dotted lines).

[0025] Fig. 22 is an illustration of a side perspective view of a transcatheter prosthetic valve having multiple subannular anchoring elements, according to an embodiment.

[0026] Fig.23A and Fig. 23B are illustrations of side perspective views of a transcatheter prosthetic valve with a proximal anchoring element coupled to and decoupled from a tensile member, respectively, according to an embodiment.

[0027] Fig.24 and Fig.25 are illustrations of side perspective views of a portion of a proximal anchoring element of a transcatheter prosthetic valve coupled to a tensile member, each according to various embodiments.

[0028] Fig.26 and Fig. 27 are illustrations of side perspective views of a portion of a proximal anchoring element and a tensile member of a transcatheter prosthetic valve, each according to various embodiments.

[0029] Fig.28A and Fig.28B are illustrations of side perspective views of a portion of a proximal anchoring element of a transcatheter prosthetic valve coupled to a tensile member according to an embodiment shown with the tensile member in a first configuration and a second configuration, respectively.

[0030] FIG. 29A to FIG. 29D is an illustration of a side perspective view of a portion of a proximal anchoring element of a transcatheter prosthetic valve coupled to and decoupled from a tensile member, according to an embodiment.

[0031] Fig.30 is an illustration of a side perspective view of a portion of a proximal anchoring element of a transcatheter prosthetic valve coupled to a tensile member, according to an embodiment.

[0032] FIG. 31A to FIG. 31C is an illustration of a side perspective view of a portion of a proximal anchoring element of a transcatheter prosthetic valve coupled to and decoupled from a tensile member, according to an embodiment.

[0033] Fig.32 is a flow chart illustrating a method of delivering a transcatheter prosthetic valve, according to an embodiment.

[0034] Fig.33is a flow chart illustrating a method of delivering a transcatheter prosthetic valve, according to an embodiment. DETAILED DESCRIPTION

[0035] The disclosed embodiments relate to transcatheter prosthetic heart valves and / or components thereof, and methods for manufacturing, loading, delivering and / or deploying the transcatheter prosthetic heart valves and / or components thereof. The transcatheter prosthetic heart valve may have a valve frame and a flow control component mounted in a central cavity or hole of the valve frame. The flow control component may be configured to allow blood to flow through the inflow end of the valve in a first direction, and to prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction. The valve may be compressed and expanded along a long axis substantially parallel to the longitudinal cylindrical axis of a delivery catheter. The valve may be configured to switch between a compressed configuration for introduction into the body using a delivery catheter and an expanded configuration for implantation at a desired position in the body.

[0036] In some embodiments, the embodiments described herein relate to a dual-tab prosthetic heart valve, which is a low-profile, laterally delivered implantable prosthetic heart valve. The prosthetic heart valve can have at least an annular or ring-shaped valve frame, an internal flow control component (e.g., a 2-leaflet or 3-leaflet cannula, etc.) mounted in the valve frame, a distal anchoring element (e.g., a subannular distal anchoring tab, etc.) configured to extend into the right ventricular outflow tract (RVOT), and a proximal anchoring element (e.g., a subannular proximal anchoring tab) configured to extend into the proximal subannular space, preferably between the anterior and posterior leaflets of the heart.

[0037] Any prosthetic heart valve described herein can be configured to transition between an expanded configuration and a compressed configuration. For example, any embodiment described herein can be a balloon-expandable prosthetic heart valve, a self-expanding prosthetic heart valve, and the like.

[0038] Any of the prosthetic heart valves described herein can be compressed into a compressed configuration in a longitudinal or orthogonal direction relative to the central axis of the flow control component, which can allow a large diameter valve (e.g., having a height of approximately 5-60 mm and a diameter of approximately 20-80 mm) to be delivered and deployed directly from the inferior vena cava into the annulus of a native mitral valve or tricuspid valve using, for example, a 24-36Fr delivery catheter, without the need for delivery and deployment from the delivery catheter at an acute approach angle.

[0039] When in the compressed configuration, any of the prosthetic heart valves described herein can have a central axis that is coaxial or at least substantially parallel to the direction of blood flow through the valve. In some embodiments, the compressed configuration of the valve is orthogonal to the direction of blood flow. In some embodiments, when in the compressed configuration and / or expanded configuration, the long axis is oriented at an angle of 45 to 135 degrees to the first direction.

[0040] Any of the prosthetic heart valves described herein may include an anchoring element extending from a distal side of a tubular frame, which may, for example, be used as a right ventricular outflow tract ("RVOT") tab or a left ventricular outflow tract ("LVOT"). The anchoring element may include and / or may be formed from a wire ring or wire frame, an integral frame portion, and / or a stent extending approximately 10-40 mm away from the tubular frame.

[0041] Any of the prosthetic heart valves described herein may include (i) an upper anchoring element attached to an upper edge of a distal side of a tubular frame, which may include or may consist of a wire ring or wire frame extending approximately 2-20 mm away from the tubular frame; and (ii) a lower anchoring element (e.g., for use as an RVOT patch) extending from the distal side of the tubular frame, which may include and / or may consist of a wire ring or wire frame extending approximately 10-40 mm away from the tubular frame.

[0042] Any prosthetic heart valve described herein may include a distal lower anchoring element configured to be positioned in the RVOT of the right ventricle and a proximal lower anchoring element configured to be positioned in a subannular position in contact with and / or adjacent to the subannular tissue of the right ventricle. The catheter prosthetic heart valve may also include a distal upper anchoring element configured to be positioned in a supraannular position in contact with and / or adjacent to the supraannular tissue of the right atrium. The distal upper anchoring element may provide a downward force above the annulus in the direction of the right ventricle, and the distal and proximal lower anchoring elements may provide an upward force below the annulus in the direction of the right atrium.

[0043] Any prosthetic heart valve described herein and / or any components, features, and / or aspects thereof may be similar and / or substantially identical to the prosthetic heart valve (or components, features, and / or aspects thereof) described in International Patent Application No. PCT / US2019 / 051957, filed on September 19, 2019, entitled “Transcatheter Deliverable Prosthetic Heart Valves and Method of Delivery” (referred to herein as “'957 PCT”), the disclosure of which is incorporated herein by reference in its entirety.

[0044] Any of the methods for delivering a prosthetic heart valve described herein may include lateral / orthogonal delivery of the prosthetic heart valve to a desired location in the body, the lateral / orthogonal delivery comprising (i) advancing a delivery catheter to the desired location in the body, and (ii) delivering the prosthetic heart valve to the desired location in the body by releasing the valve from the delivery catheter. When in the delivery catheter, the valve is in a compressed configuration, and when released from the delivery catheter, the valve transitions to an expanded configuration.

[0045] Any method for delivering a prosthetic heart valve described herein may include attaching a pulling wire (e.g., a rigid, elongated pull rod / push rod or guide wire) to a sidewall or anchoring element (e.g., a distal anchoring element) of a transcatheter prosthetic valve and pulling the valve into and / or through a delivery catheter.

[0046] Any method for delivering a prosthetic heart valve described herein may include releasing the valve from a delivery catheter by: (i) pulling the valve out of the delivery catheter using a pull wire or rod releasably connected to a side wall or anchoring element, wherein advancing the pull wire away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a push wire or rod releasably connected to a side wall or anchoring element, wherein pushing the push wire or rod from the delivery catheter pushes the compressed valve out of the delivery catheter.

[0047] Any method for delivering a prosthetic heart valve described herein may include releasing the valve from a delivery catheter while increasing blood flow during valve deployment by: (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and 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 in which blood flow through the flow control component is increased and blood flow around the valve is reduced; (iii) deploying the valve into a final installation position in the native valve annulus to transition to a state in which blood flow is completely through the flow control component and there is minimal or no blood flow around the valve; and (iv) disconnecting and withdrawing the positioning catheter, pull wire or pull rod or push wire or push rod, and / or delivery catheter.

[0048] Any method for delivering a prosthetic heart valve described herein may include orthogonal delivery of the prosthetic heart valve to the native annulus of a human heart, wherein the orthogonal delivery includes 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 vein or SVC-jugular vein approach through a transatrial approach (e.g., the fossa ovalis or lower) to the mitral valve of the heart; and (iv) delivering the prosthetic heart valve to the native annulus by releasing the valve from the delivery catheter.

[0049] Any method for delivering a prosthetic heart valve and / or any portion thereof described herein may be similar and / or substantially the same as one or more methods for delivering a prosthetic heart valve (or one or more portions thereof) described in the '957 PCT.

[0050] In some embodiments, the prosthetic heart valve includes a valve frame defining a hole extending along a central axis and a flow control component installed in the hole. The flow control component is configured to allow blood to flow from the inflow end of the flow control component to the outflow end in a first direction roughly parallel to the central axis, and to prevent blood from flowing in a second direction opposite to the first direction. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the prosthetic heart valve to be delivered to the patient's heart through a delivery catheter. The valve frame is configured to change from a compressed configuration to an expanded configuration when the prosthetic heart valve is released from the delivery catheter. The prosthetic heart valve is configured to be placed in the annulus of the native valve of the heart when in an expanded configuration. The distal anchoring element and the proximal anchoring element of the valve frame are configured to be inserted through the annulus of the native valve before the prosthetic heart valve is placed in the annulus of the native valve. The proximal anchoring element is configured to transition from the first configuration to the second configuration after the prosthetic valve is positioned in the annulus of the native valve.

[0051] In some embodiments, the prosthetic heart valve includes a valve frame having a trans-annular portion and an atrial collar attached around the top edge of the trans-annular portion, a distal anchoring element coupled to the trans-annular portion, a proximal anchoring element coupled to the trans-annular portion, and a flow control component mounted in the valve frame. The flow control component is configured to allow blood to flow through the inflow end of the prosthetic heart valve in a first direction and to prevent blood from flowing through the outflow end of the prosthetic heart valve in a second direction opposite to the first direction. The prosthetic heart valve has a compressed configuration for introduction into the patient's heart through a delivery catheter and an expanded configuration when the prosthetic heart valve is released from the delivery catheter in the atrium of the heart. The prosthetic heart valve is configured to be placed in the annulus of the heart's native valve when in the expanded configuration. The distal anchoring element is configured to be disposed in the ventricular outflow tract when the prosthetic heart valve is positioned in the annulus of the native valve, and the proximal anchoring element is configured to transition from a first configuration to a second configuration after the prosthetic heart valve is positioned in the annulus of the native valve.

[0052] In some embodiments, a method for delivering a prosthetic heart valve to the annulus of a native valve between the atrium and ventricle of a patient's heart includes arranging the distal end of a delivery catheter adjacent to the annulus of the native valve, wherein the delivery catheter is provided with a prosthetic heart valve in its lumen. The prosthetic heart valve comprises a valve frame having a distal anchoring element and a proximal anchoring element, and a flow control component mounted in the valve frame. The prosthetic heart valve is in a compressed configuration in the lumen of the delivery catheter. The prosthetic heart valve is released from the lumen of the delivery catheter. The prosthetic heart valve is configured to change from a compressed configuration to an expanded configuration in response to being released. A portion of the distal anchoring element is placed on the ventricular side of the annulus of the native valve. When the proximal anchoring element is in a first configuration, the prosthetic heart valve is placed in the annulus, and after the prosthetic heart valve is placed in the annulus, the proximal anchoring element changes from the first configuration to a second configuration.

[0053] In some embodiments, the present invention includes a laterally delivered transcatheter prosthetic heart valve having a distal anchoring patch and a proximal anchoring patch, which has: (i) a self-expanding annular support frame, the annular support frame having a central channel and a peripheral wall, the peripheral wall surrounding a central vertical axis in an expanded configuration, the annular support frame having a distal side and a proximal side; (ii) a flow control component mounted within the annular support frame and configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite to the first direction; (iii) a distal anchoring patch mounted within the annular support frame; shaped support frame at the distal side; (iv) a proximal anchoring patch mounted on the proximal side of the annular support frame; wherein the valve can be compressed to a compressed configuration for introduction into the body using a delivery catheter so as to be implanted at a desired position in the body, the compressed configuration is oriented along a horizontal axis at an angle of 45 to 135 degrees to the central vertical axis, and can be expanded to an expanded configuration with a horizontal axis at an angle of 45 to 135 degrees to the central vertical axis; wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter; wherein the height of the valve is approximately 5-60 mm and the diameter is approximately 25-80 mm.

[0054] In some embodiments, the proximal tab is fixed to or integral with the external support frame. In other embodiments, the proximal tab is movable from a first stowed position, i.e., held against the peripheral wall when the valve is positioned in the native annulus, and to a second deployed position extending away from the peripheral wall to provide a subannular anchor.

[0055] In some embodiments, the valve has a lower distal tab and a lower proximal tab. In other embodiments, the valve has a lower distal tab, a lower proximal tab, and an upper distal anchoring tab attached to the distal upper edge of the annular support frame, the upper distal anchoring tab can be composed of a wire ring, a wire frame, a laser cut frame, an integral frame portion, or a stent, and can extend about 2-20 mm away from the annular support frame.

[0056] In some embodiments, the annular support frame is composed of compressible filament units, and the filament units are selected from the group consisting of: braided filament units, laser cut filament units, lithographically produced filament units, 3D printed filament units, filament units formed by single strands of wavy, zigzag or spirally intermittently connected filaments, and combinations thereof.

[0057] In some embodiments, the present invention provides a method for laterally delivering an implantable prosthetic heart valve to a desired location in a body, the method comprising the following steps: advancing a delivery catheter to the desired location in the body, and delivering the expandable prosthetic heart valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises an annular support frame having a flow control component mounted within the annular support frame and configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite to the first direction; a valve mounted within the annular support frame; a distal anchoring patch on the distal side of the frame; and a proximal anchoring patch mounted on the proximal side of the annular support frame, wherein the valve can be compressed to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired position in the body, wherein the valve can be compressed to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired position in the body, the height of the compressed configuration is 8-12mm, the width is 8-12mm, the length is 25-80mm, and wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, the height of the expanded configuration is approximately 5-60mm, and the diameter is approximately 25-80mm.

[0058] In some embodiments, the compressed configuration has a long axis oriented at an angle of 45 to 135 degrees to the first direction, and can be expanded to an expanded configuration having a long axis oriented at an angle of 45 to 135 degrees to the first direction, wherein the long axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter.

[0059] In some embodiments, the method includes the step of releasing the valve from the delivery catheter, the step being selected from the following steps: (i) using a rigid, slender push rod / guide wire releasably connected to the distal side of the valve to pull the valve out of the delivery catheter, wherein pushing the push rod out of the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) using a rigid, slender push rod releasably connected to the proximal side of the valve to push the valve out of the delivery catheter, wherein pushing the push rod out of the delivery catheter pushes the compressed valve out of the delivery catheter.

[0060] In some embodiments, the method includes the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

[0061] In some embodiments, the method includes the additional step of positioning a distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.

[0062] In some embodiments, the method includes the additional steps of positioning a distal anchoring patch of a heart valve prosthesis in the right ventricular outflow tract of the right ventricle, and positioning an upper distal anchoring patch in a supra-annular position, the upper distal anchoring patch providing a downward force above the annulus in a ventricular direction, and the distal anchoring patch providing an upward force below the annulus in an atrial direction.

[0063] In some embodiments, the method includes the additional step of rotating the heart valve prosthesis along an axis parallel to the plane of the valve annulus using a steerable catheter.

[0064] In some embodiments, the present invention provides a method for laterally delivering an implantable prosthetic heart valve within the body, the method comprising the following steps: (i) advancing the distal end of a guidewire to a distal location, wherein the distal location is the pulmonary artery or the left ventricle of the heart, wherein the guidewire begins outside the patient's body using femoral venous access or brachiocephalic venous access and extends through the inferior vena cava or the superior vena cava to the right atrium, and from the right atrium to the pulmonary artery through the tricuspid valve, or from the right atrium through the atrial septum in a transeptal access, through the mitral valve and into the left ventricle; (ii) advancing a delivery catheter over the guidewire to a target location, wherein the target location is the right atrium of the tricuspid valve or the left atrium of the mitral valve; (iii) advancing and delivering an orthogonally compressed self-expanding prosthetic heart valve to the target location within the body, wherein the compressed configuration of the valve has a long axis that is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, and wherein the expanded configuration of the valve has a height of about 5-60 mm and a diameter of about 25-60 mm. 80mm, wherein the valve comprises an annular support frame having a flow control component, the flow control component being mounted in the annular support frame and being configured to allow blood to flow through the inflow end of the valve in a first direction and to prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction; a distal anchoring patch mounted on the distal side of the annular support frame, the distal anchoring patch having a length of 10-40mm and a width of 2-10mm, wherein a guide wire is screwed through the distal anchoring patch a threaded hole on or in the distal anchoring patch; at least one proximal anchoring patch mounted on the proximal side of the annular support frame, the proximal anchoring patch having a length of 2-25 mm and a width of 2-10 mm; and a valve advancement tool comprising an elongated sheath, wherein a guide wire is located in an inner cavity of the sheath, wherein an outer diameter of the sheath is larger than an inner diameter of the threaded hole on the distal anchoring patch, wherein when the sheath is advanced on the guide wire in a distal direction and the distal end of the sheath contacts the proximal surface of the threaded hole, the distal pulling force imparted by the sheath to the distal anchoring patch will (iv) partially releasing the valve from the delivery catheter by advancing the sheath over the guidewire to position the distal anchoring tab at a desired anchoring region at a target location, wherein the desired anchoring region is selected from the right ventricular outflow tract (RVOT) of the right ventricle and a subannular region below the A1-P1 anterolateral commissure of the mitral valve, wherein positioning the distal anchoring tab maintains the valve at a raised angle of at least 30 degrees relative to a local annular plane relative to a horizontal axis of the valve and the delivery catheter, wherein partially releasing the valve allows blood to flow partially around the prosthetic valve and through the native leaflets, and partially through the flow control components of the prosthetic valve to provide a gradual transition of blood flow from flow through the native leaflets to flow completely through the prosthetic valve;(v) completing the release of the entire valve from the delivery catheter by advancing the sheath over the guidewire, positioning the valve in the native annulus by applying a downward force in the ventricular direction; and (vi) positioning the at least one proximal anchoring tab in a second desired anchoring region.

[0065] In some embodiments, the method includes the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

[0066] In some embodiments, the present invention provides a method for delivering a prosthetic heart valve to the annulus of a native valve between a ventricle and an atrium of a heart, the method comprising the following steps: (i) placing a distal portion of a delivery catheter having an inner lumen and a longitudinal axis in the atrium of the heart, wherein the distal end of the delivery catheter is directed toward the annulus of the native valve, the distal portion of the delivery catheter having a prosthetic heart valve in a compressed configuration disposed in its inner lumen, wherein the compressed configuration of the prosthetic heart valve has a long axis that is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, and wherein The height of the expanded configuration of the prosthetic heart valve is about 5-60 mm, up to about 25-80 mm, wherein the prosthetic heart valve includes an annular support frame with a flow control component, the flow control component is mounted in the annular support frame and is configured to allow blood to flow through the inflow end of the valve in a first direction and prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction, wherein the annular support frame is self-expanding or balloon-expandable; a distal anchoring patch mounted on the distal side of the annular support frame, the distal The length of the distal anchoring patch is 10-40 mm, the distal anchoring patch extends laterally from the annular support frame and is configured to be arranged on the ventricular side of the annulus of the native valve when the annular support frame is arranged in the annulus; at least one proximal anchoring patch installed on the proximal side of the annular support frame, the length of the proximal anchoring patch is 2-25 mm, the at least one proximal anchoring patch extends laterally from the annular support frame and is configured to be arranged on the ventricular side of the annulus of the native valve when the annular support frame is arranged in the annulus; (ii) The delivery catheter partially releases the prosthetic heart valve and positions the distal anchoring patch in the distal subannular anchoring area, wherein the distal subannular anchoring area is the right ventricular outflow tract (RVOT) of the right ventricle or the subannular area below the A1-P1 anterolateral commissure of the mitral valve; (iii) completes the release of the entire prosthetic heart valve from the delivery catheter lumen and places the prosthetic heart valve in the native valve annulus by applying a downward force in the ventricular direction; and (iv) places the proximal anchoring patch in the proximal subannular anchoring area.

[0067] In some embodiments, the method includes wherein positioning the distal anchoring patch maintains the prosthetic heart valve at a convex angle of at least 30 degrees to a local annular plane relative to a horizontal axis of the valve, and wherein partially releasing the prosthetic heart valve allows blood to flow partially around the prosthetic heart valve and through the native leaflets, and partially through a flow control component of the prosthetic valve to provide a gradual transition of blood flow from flowing through the native leaflets to flowing completely through the prosthetic valve.

[0068] In some embodiments, the method includes wherein positioning the proximal anchoring tab includes releasing the proximal anchoring tab from a compressed, pre-release configuration to an expanded, post-release configuration, wherein the proximal anchoring tab extends into a proximal subannular anchoring region.

[0069] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the full scope of the claims. As used herein, the singular forms "a", "an", and "the" are also intended to include plural forms unless the context clearly indicates otherwise. Regarding the use of substantially any plural and / or singular terms herein, those skilled in the art can translate the plural into the singular and / or translate the singular into the plural according to the context and / or application. For clarity, various singular / plural arrangements may be explicitly set forth herein.

[0070] In general, terms used herein, especially in the appended claims (e.g., the bodies of the appended claims), are generally considered 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, when used in this specification, the terms "comprises" and / or "comprising" specify the presence of stated features, integers (or portions thereof), steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers (or portions thereof), steps, operations, elements, components, and / or groups thereof. As used in this document, the term "comprising" means "including but not limited to."

[0071] As used herein, the term "and / or" or the phrase "selected from" or the phrase "selected from the group consisting of..." or the phrase "selected from one or more of..." includes any and all combinations of one or more of the associated listed items. It should be understood that almost any disjunctive word and / or phrase that presents two or more alternatives, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, any, or both / all of the items. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B", and the phrase "selected from A, B, and C" will be understood to include the possibility of "A", "B", "C", "A and B", "B and C", "A and C", and "A and B and C".

[0072] 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 ranges should be considered to fully describe the same range and to allow the same range to be broken down into at least equal sub-portions. As will be understood by those skilled in the art, a range includes each individual member.

[0073] Unless defined otherwise, 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 this disclosure by virtue of prior invention.

[0074] The terms "valve prosthesis," "prosthetic heart valve," and / or "prosthetic valve" can refer to a combination of a frame and leaflets or flow control structures or components, and can encompass both complete replacement of an anatomical part (e.g., a new mechanical valve replaces a native valve), as well as medical devices that replace and / or assist, repair, or improve an existing anatomical part (e.g., a native valve is left in place).

[0075] The disclosed valve includes a component (e.g., a frame) that can be placed in the autologous valve annulus and can be used as a leaflet structure, a flow control component, or a mounting element for a flexible reciprocating sleeve or sleeve valve. Depending on the embodiment, it may or may not include such a leaflet structure or a 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.

[0076] The term "flow control member" may refer in a non-limiting sense to a leaflet structure of a flexible biocompatible material (such as a treated or untreated pericardium sutured or connected to an annular support frame) having 2 leaflets, 3 leaflets, or 4 leaflets that functions as a prosthetic 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 flow from the atrium to the ventricle during diastole and closes when ventricular systolic pressure is applied to the outer surface. The repeated opening and closing in sequence may be described as "reciprocating". Flow control components are contemplated to include a variety of (bio)prosthetic heart valves, including ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards bioprosthesis series, St. Jude prosthetic valves), as well as homograft valves and autograft valves. Bioprosthetic pericardial valves may include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0077] Any disclosed valve embodiment can be delivered via a transcatheter approach. The term "transcatheter" is used to define the process of entering, controlling and / or delivering a medical device or apparatus deployed in a catheter lumen in a heart chamber (or other desired location in the body), as well as items that have been delivered or controlled by such a process. Known transcatheter pathways include cardiac pathways through the femoral artery and / or femoral vein, through the lumen of the brachial artery and / or brachial vein, through the lumen of the carotid artery, through the lumen of the jugular vein, through the intercostal (rib) space and / or the subxiphoid space, etc. Transcatheter can be synonymous with transcavitary, 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 "bore" can refer to the inner diameter of a lumen.

[0078] The pattern of cardiac access can be based at least in part on a "body passage," which can be used to define a blood conduit or vessel within the body, the specific application of the disclosed prosthetic valve embodiments determining the body passage in question. For example, an aortic valve replacement would be implanted within or adjacent to the aortic valve annulus. Similarly, a tricuspid or mitral valve replacement would be implanted at the tricuspid or mitral valve annulus. Certain features are particularly advantageous for one or the other implantation site. However, unless the combination is structurally impossible or is excluded by the claim language, any valve embodiment described herein may be implanted in any body passage.

[0079] As used herein, the term "expandable" may refer to a heart valve component that is capable of expanding from a first delivery diameter to a second implant diameter. Thus, an expandable structure does not mean a structure that may expand slightly due to temperature increase or other accidental reasons. Conversely, "non-expandable" should not be interpreted as meaning completely rigid or dimensionally stable, as, for example, a certain degree of slight expansion of conventional "non-expandable" heart valves can be observed.

[0080] Any disclosed valve embodiment can be delivered by conventional transcatheter delivery techniques or by orthogonal delivery techniques. For example, conventional delivery of a prosthetic valve can be such that the central annular axis of the valve is substantially parallel to the longitudinal axis of the delivery catheter. Typically, the valve is compressed in a radial direction relative to the central cylindrical axis and is advanced through the lumen of the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the central annular axis.

[0081] The lateral or orthogonal delivery of the prosthetic valve can make the central annular axis of the valve substantially orthogonal to the longitudinal axis of the delivery catheter. Through 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. In this way, the longitudinal axis of the valve delivered orthogonally is substantially parallel to the longitudinal axis of the delivery catheter. In other words, compared with the traditional process of compressing and delivering a transcatheter prosthetic valve, the prosthetic valve delivered orthogonally is compressed and / or delivered at an angle of approximately 90 degrees. In addition, the prosthetic valve configured to be delivered orthogonally and the process of delivering such a valve are described in detail in the '957 PCT incorporated by reference above. As used herein, the terms "lateral delivery", "lateral delivery", "orthogonal delivery", "orthogonal delivery", etc. are interchangeably used for such a delivery method and / or a valve delivered using such a method.

[0082] In mathematics, the term "orthogonal" refers to an intersection angle of 90 degrees between two lines or two planes. As used herein, the term "substantially orthogonal" refers to an intersection angle of 90 degrees plus or minus an appropriate tolerance. For example, "substantially orthogonal" may refer to an intersection angle ranging from 75 degrees to 105 degrees.

[0083] In some embodiments, parts can be made of one or more synthetic materials such as polyurethane or polytetrafluoroethylene (PTFE). When thin, durable synthetic materials (e.g., for covering) are envisioned, synthetic polymer materials such as expanded PTFE or polyester can be optionally used. Other suitable materials can optionally include thermoplastic polycarbonate urethane, polyether urethane, multi-block polyether urethane, silicone polyether urethane, polyether ether ketone (PEEK), silicone-polycarbonate urethane, polypropylene, polyethylene, low density polyethylene, high density polyethylene and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include elastomers, polyolefins, polyethylene glycol, polyethersulfone, polysulfone, polyvinyl pyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylons), PTFE, elongated PTFE, expanded PTFE, polyurethanes, siloxane polymers and / or oligomers, and / or polylactones, and block copolymers thereof.

[0084] In some embodiments, the valve frame and / or its components can be made of biocompatible metals, metal alloys, metals coated with polymers, etc. Suitable biocompatible metals and / or metal alloys can include stainless steel (e.g., 316 L stainless steel), cobalt-chromium (Co-Cr) alloys, nitinol (e.g., Nitinol®), etc. Suitable polymer coatings can include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), trans-styrene isoprene butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactic polylactic acid (DLPLA), etc.

[0085] Any valve frame and / or its parts or components may be partially or completely covered internally or externally with a biocompatible material such as pericardium. The valve frame may also optionally be partially or completely covered externally with a second biocompatible material such as polyester or Dacron®. The disclosed embodiments may use tissue, such as biological tissue that is chemically stable pericardial tissue of an animal such as cattle (bovine pericardium), sheep (sheep pericardium), pigs (porcine pericardium), or horses (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissue include tissue used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all currently used in surgical procedures and marketed as products generally obtained from cattle less than 30 months of age.

[0086] The embodiments herein and their various features and advantageous details will be explained more fully with reference to the non-limiting embodiments shown in the accompanying drawings and described in detail in the following description. The description of known components and processing techniques is omitted to avoid unnecessarily blurring the embodiments herein. The embodiments used herein are only for the convenience of understanding the manner in which the embodiments herein can be implemented, and further enable those skilled in the art to implement the embodiments herein. Therefore, the embodiments should not be interpreted as limiting the scope of the embodiments herein. On the contrary, these embodiments are provided to make the disclosure comprehensive and complete, and to fully convey the scope of the inventive concept to those skilled in the art. Throughout the text, the same numerals represent the same elements.

[0087] Figures 1A to 1C 1 is an illustration of various schematic diagrams of a transcatheter prosthetic valve 102 according to an embodiment. The transcatheter prosthetic valve 102 is configured to be deployed at a desired location within a body (e.g., a human patient's body) and to allow blood to flow through an inflow end of the transcatheter prosthetic valve 102 in a first direction and to prevent blood from flowing through an outflow end of the transcatheter prosthetic valve 102 in a second direction opposite to the first direction. For example, the transcatheter prosthetic valve 102 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 operation of the native valve.

[0088] Transcatheter prosthetic valve 102 (also referred to herein as a "prosthetic valve" or simply a "valve") is compressible and expandable in at least one direction relative to a long axis 111 (also referred to herein as a "horizontal axis," "longitudinal axis," or "longitudinal axis") of valve 102. Valve 102 is configured in an expanded configuration (eg, a "valve") for implantation at a desired location within the body (e.g., a human heart). Figure 1A and Figure 1C ) and a compressed configuration for introduction into the body using a delivery catheter 172 ( Figure 1B ) is compressible and expandable.

[0089] In some embodiments, the valve 102 can be centered, or radially symmetrical. In other embodiments, the valve 102 can be eccentric, or radially (y-axis) asymmetrical. In some embodiments, the valve 102 (or its outer frame) can have a D-shape (viewed from the top) so that the flat portion can match the anatomical structure in which the valve 102 will be deployed. For example, in some cases, the valve 102 can be deployed in the tricuspid annulus and can have a complex shape determined by the anatomical structure in which the valve 102 will be installed. In the tricuspid annulus, the circumference of the tricuspid valve can be a circular ellipse, knowing that the septal wall is substantially vertical, and knowing that the tricuspid valve enlarges along the anterior-posterior line in a diseased state. In other cases, the valve 102 can be deployed in the mitral annulus (e.g., near the anterior leaflet) and can have a complex shape determined by the anatomical structure in which the valve 102 will be installed. For example, in the mitral valve annulus, the circumference of the mitral valve may be a rounded ellipse, the septal wall is known to be substantially vertical, and the mitral valve is known to dilate in disease states.

[0090] As shown, valve 102 generally includes an annular support frame 110 and a flow control component 150. In addition, valve 102 and / or at least annular support frame 110 of valve 102 includes one or more anchoring elements. Figures 1A to 1C In the illustrated embodiment, the annular support frame 110 includes at least a distal anchoring element 132 and a proximal anchoring element 134. In some embodiments, the distal anchoring element 132 and the proximal anchoring element 134 can be lower anchoring elements, and the valve 102 and / or the annular support frame 110 can include a distal upper anchoring element and a proximal upper anchoring element (not shown). In some embodiments, the valve 102 and / or aspects or portions thereof can be similar and / or substantially the same as the valve (and / or corresponding aspects or portions thereof) described in detail in the '957 PCT, which is incorporated herein by reference above. Therefore, certain aspects, portions, and / or details of the valve 102 may not be described in further detail herein.

[0091] The annular support frame 110 (also referred to herein as a "tubular frame," "valve frame," "wire frame," or "frame") may have or may define a hole 114 extending along a central axis 113. The hole 114 (e.g., a central axial lumen) may be sized and configured to receive a flow control component 150 over a diameter of the hole 114. The frame 110 may have an outer peripheral surface for engaging native valve annulus tissue, which may be tensioned against an inner aspect of the native valve annulus to provide structural patency to a weakened native valve annulus.

[0092] The frame 110 includes a cuff or ring 120 and a tubular or trans-annular portion 112. The cuff or ring 120 (referred to herein as a "ring") can be attached to the upper edge of the frame 110 and / or can form the upper edge of the frame 110. When the valve 102 is deployed in the human heart, the ring 120 can be an atrial ring. The ring 120 can be shaped to conform to the native deployment position. For example, in a mitral valve replacement, the ring 120 will be configured with varying portions to conform to the native valve. In one embodiment, the ring 120 will have distal and proximal upper ring portions. The distal ring portion can be larger than the proximal upper ring portion to take into account the annular geometry, the supra-annular geometry, and / or the sub-annular geometry.

[0093] The frame 110 may optionally have a separate atrial collar attached to the upper (atrial) edge of the frame 110 for deployment on the atrial floor, for directing blood from the atria into the flow control member 150 and for sealing blood leakage (paravalvular leakage) around the frame 110. The frame 110 may also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame 110 for deployment in the ventricle just below the native annulus, for preventing regurgitant leakage during systole, for preventing dislodgment of the valve 102 during systole, for clamping or compressing the native annulus or adjacent tissues against the atrial collar or collar 120, and / or for optional attachment to and support of the flow control member 150. Some embodiments may have both an atrial collar and a ventricular collar, while other embodiments include a single atrial collar, a single ventricular collar, or no additional collar structure.

[0094] The frame 110 may be an annular, or cylindrical or conical tube, but may also have the following side profiles: flat cone, inverted flat cone (narrower at the top and wider at the bottom), concave cylindrical (walls curved inward), convex cylindrical (walls bulging outward), angular hourglass, curved graduated hourglass, an annular or cylindrical shape with a flared top, a flared bottom, or both. Taking into account the thickness of the frame 110 (e.g., the wire material forming the frame 110), the frame 110 may have a height in the range of about 5 mm to 60 mm, may have an outer diameter dimension R in the range of about 20 mm to 80 mm, and may have an inner diameter dimension in the range of about 21 mm to 79 mm.

[0095] The frame 110 can be compressed for delivery, and when released, it is configured to return to its original (uncompressed) shape. The frame 110 can be compressed for transcatheter delivery, and can be expanded using a transcatheter expansion balloon. In other embodiments, the frame 110 may include a shape memory element and / or may be formed by a shape memory element, thereby allowing the frame 110 to self-expand. In some cases, suitable shape memory materials may include durable and biocompatible metals and / or plastics. For example, the frame 110 may be made of superelastic metal wires such as nitinol wires or other materials that function similarly. The frame 110 may be configured as a braid, wire or laser cut wire frame. The frame 110 may also have and / or form additional functional elements (e.g., rings, anchors, etc.) for attaching accessory components, such as biocompatible covers, tissue anchors, releasable deployment and retrieval control guides, knobs, accessories, rigging, etc. In some embodiments, the framework 110 (or aspects and / or portions thereof) can be structurally and / or functionally similar to the framework (or corresponding aspects and / or portions thereof) described in detail in the '957 PCT.

[0096] As described above, the frame 110 and / or the valve 102 may include at least a distal anchoring element 132 and a proximal anchoring element 134. The distal and proximal anchoring elements 132 and 134 may be, for example, lower anchoring elements (e.g., coupled to and / or included in the lower portion of the frame 110). In some embodiments, the frame 110 and / or the valve 102 may also optionally include one or more of a distal upper anchoring element and a proximal upper anchoring element. The anchoring elements of the valve 102 may be configured to engage a desired portion of the annular tissue to mount the frame 110 to the annulus of the native valve in which the valve 102 is deployed, as described in further detail herein. The anchoring elements of the valve 102 and / or the frame 110 may be of any suitable shape, size, and / or configuration, such as any of those described in detail in the '957 PCT. In addition, at least certain aspects, features, and / or configurations of the distal and proximal anchoring elements 132 and 134 will be described below with reference to specific embodiments.

[0097] like Figure 1A and Figure 1BAs shown, the distal anchoring element 132 may include a guidewire loop 145, which is configured to selectively engage and / or receive a portion of a guidewire 185 or a portion of a guidewire assembly, and / or may have any suitable configuration as described below for a specific embodiment. For example, in some embodiments, a portion of the guidewire 185 may extend through a hole (not shown) of the guidewire loop 145, thereby allowing the valve 102 to be advanced on or along the guidewire 185. The guidewire loop 145 can be any suitable element that selectively allows the guidewire 185 to be advanced therethrough while blocking or preventing other elements and / or components, such as a pusher, etc. In certain embodiments, the distal lower anchoring element 132 may form a guidewire loop 145 and / or may include a feature that forms a guidewire loop 145. In other embodiments, the guidewire loop 145 can be attached to any suitable portion of the framework 110, the proximal anchoring element 134, and / or any other anchoring element and / or feature of the framework 110 (eg, a distal or proximal upper anchoring element).

[0098] The proximal anchoring element 134 can be any suitable shape, size and / or configuration, such as any shape, size and / or configuration described herein for a specific embodiment. The proximal anchoring element 134 can be, for example, a proximal lower anchoring element, and can be configured to engage the subannular tissue of the ventricle to help fasten the valve 102 in the annulus. In some embodiments, the proximal anchoring element 134 can be configured to transition between a first configuration in which the proximal anchoring element 134 remains in a compressed, unexpanded and / or constrained state and a second configuration in which the proximal anchoring element 134 is expanded, extended, expanded and / or unconstrained. More specifically, the proximal anchoring element 134 can be maintained in a first position in contact with, adjacent to and / or otherwise close to the cross-annular portion 112 of the valve frame 110 when in the first configuration, and when in the second configuration, can be released to a second position extending away from the cross-annular portion 112 of the frame 110. In other words, the second position of the proximal anchoring element 134 can be further away from the trans-annular portion 112 than the first position of the proximal anchoring element 134.

[0099] In some embodiments, the valve 102 and / or the frame 110 may include features, components, mechanisms, etc. configured to at least temporarily retain the proximal anchoring element 134 in the first configuration. Figure 1A and Figure 1BAs shown, the valve 102 and / or the frame 110 may include a tensile member 135 configured to selectively engage the proximal anchoring element 134 to temporarily keep the proximal anchoring element 134 in a first configuration. The tensile member 135 can be any suitable shape, size and / or configuration. For example, the tensile member 135 can be an anchor, a ring, a tab, a latch, a hook, a tether, an elastic band, a threaded coupler, a ball and cup mechanism and / or any other suitable removable attachment. The tensile member 135 can be removably coupled to a portion of the proximal anchoring element 134 and can apply a force (e.g., a tensile force or pressure) that is operable in keeping the proximal anchoring element 134 in a first configuration. The tensile member 135 can be reconfigurable, thereby allowing the tensile member 135 to be decoupled from the proximal anchoring element 134, which in turn can allow the proximal anchoring element 134 to transition from its first configuration to its second configuration, as further described in detail herein with reference to specific embodiments.

[0100] The valve 102 can be delivered to a desired location within the body by a procedure that generally includes advancing the delivery catheter 172 over a guidewire 185 to place the distal end of the delivery catheter 172 at or near the desired location. Thus, the guidewire 185 can be disposed within the lumen 174 of the delivery catheter 172. The valve 102 can be disposed within the lumen 174 of the delivery catheter 172 (e.g., in a compressed configuration) such that the guidewire collar 145 engages with and / or receives a portion of the guidewire 185, thereby allowing the valve 102 to be advanced through the delivery catheter 172 over and / or along the guidewire 185.

[0101] The flow control component 150 may refer to a device for controlling the flow of fluid therethrough in a non-limiting sense. In some embodiments, the flow control component 150 may be a leaflet structure having 2-leaflets, 3-leaflets, 4-leaflets or more leaflets, which is made of a flexible biocompatible material (such as treated or untreated pericardium). The leaflets may be sutured or connected to a support structure and / or may be sutured or connected to the frame 110. The flow control component 150 may be mounted within the frame 110 and configured to allow blood to flow through the inflow end of the valve in a first direction and to prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction. For example, the flow control component 150 may be configured so that the valve 102 is used, for example, as a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve or a pulmonary valve, which may be open to blood flow from the atrium to the ventricle during diastole and may be closed by ventricular systolic pressure applied to the outer surface. The repeated opening and closing in sequence may be described as "reciprocating".

[0102] The flow control component 150 is contemplated to include a variety of (bio)prosthetic valves, including ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards bioprosthetic series, St. Jude prosthetic valves), as well as homologous and autologous transplant valves. Bioprosthetic pericardial valves may include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves. In some embodiments, a suitable commercially available valve (flow control component 150) may be received or accepted by the frame 110 and / or otherwise mounted in the frame 110. Commercially available valves (flow control components 150) may include, for example, Edwards Lifesciences' Sapien, Sapien 3, or Sapien XT, Edwards Lifesciences' Inspiris Resilia aortic valve, Abbott's Masters HP 15 mm valve, Boston Scientific's Lotus Edge valve, Livanova / Sorin's Crown PRT leaflet structure, valves from Sorin's Carbomedics valve family, or other one or more flow control components, or a flexible reciprocating sleeve or sleeve-valve. In some embodiments, the flow control component 150 may be similar to or substantially the same as any flow control component described in detail in the '957 PCT.

[0103] The valve 102 is compressible and expandable between an expanded configuration and a compressed configuration. The valve 102 is compressed during delivery of the valve 102 and is configured to expand once released from the delivery catheter 172. When the valve 102 is deployed or implanted (or ready to be deployed or implanted) at a desired location in the body, the valve 102 is in the expanded configuration. When in Figure 1A and Figure 1B In the expanded configuration shown, the valve 102 has an extent in any direction along or transverse to the central axis 113 that is greater than the diameter of the lumen 174 of the delivery catheter 172 used to deliver the valve 102. In other words, the valve 102 has an extent in any direction perpendicular to the longitudinal axis 111 of the valve 102 that is greater than the diameter of the lumen 174 of the delivery catheter 172.

[0104] In some embodiments, the valve 102 may have an expanded height (y-axis) of 5-60 mm. In some embodiments, the valve 102 may have an expanded diameter length and width of about 20-80 mm, more particularly 40-80 mm. In certain embodiments, the valve 102 may have a length and / or width including, for example, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm and / or any size or fraction of a size therebetween.

[0105] When the valve 102 is delivered to a desired location in the body through the delivery catheter 172, it is in a compressed configuration. When the valve 102 is in a compressed configuration, it may have a size that allows the valve 102 to be set in the lumen 174 of the delivery catheter 172. In some embodiments, the valve 102 is configured to be delivered orthogonally to a desired location in the body (e.g., the annulus of a native valve) via a catheter, wherein the valve 102 is compressed in a transverse direction relative to the size of the valve 102 in an expanded configuration (e.g., along the central axis 113) and may be elongated in a longitudinal direction (e.g., along the longitudinal axis 111). In other embodiments, the valve 102 is configured to be delivered to a desired location in the body in a conventional transcatheter delivery manner, wherein the central axis 113 is coaxial with the longitudinal axis 111. The aspects, features, and / or processes of conventional transcatheter delivery are not described in further detail herein.

[0106] During delivery, the longitudinal axis 111 of the valve 102 is substantially parallel to the longitudinal axis 175 of the delivery catheter 172. In orthogonal delivery, the longitudinal axis 111 is oriented at an angle of 45 to 135 degrees (e.g., perpendicular or about 90 degrees) relative to the central axis 113. In some embodiments, when in the expanded configuration, the horizontal x-axis (e.g., longitudinal axis 111) of the valve 102 is orthogonal or substantially orthogonal (e.g., 75-105 degrees), or substantially inclined (45-135 degrees) to the central vertical y-axis (e.g., central axis 113). In some embodiments, the horizontal x-axis (e.g., longitudinal axis 111) of the valve 102 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis 175 of the delivery catheter 172.

[0107] As used herein, the terms "angle of intersection" and / or "orthogonal angle" can refer to (i) the relationship between the longitudinal cylindrical axis (e.g., longitudinal axis 175) of the delivery catheter 174 and the long axis 111 of the compressed valve 102, wherein the long axis 111 is perpendicular to the central axis 113 of the conventional valve; and (ii) the relationship between the long axis 111 of the compressed or expanded valve 102 and the axis defined by blood flowing through the prosthetic valve 102, wherein the blood is flowing (e.g., from one part of the body or heart chamber to another downstream part of the body or heart chamber, such as from the atrium to the ventricle through the native valve annulus).

[0108] The valve 102 may have a first height or size along the central axis 113 when in the expanded configuration, and may have a second height or size less than the first height or size along the central axis 113 when in the compressed configuration. When the valve 102 is in the compressed configuration, its second height or size is less than the diameter of the lumen 174 of the delivery catheter 175, thereby allowing the valve 102 to be delivered therethrough. The valve 102 may also be compressed in other directions. For example, the valve 102 may be compressed along a transverse axis (not shown) perpendicular to both the longitudinal axis 111 and the central axis 113. When the valve 102 is in the expanded configuration, it has a degree greater than the diameter of the lumen 174 of the delivery catheter 172 in any direction along or parallel to the transverse axis. In other words, the valve 102 may have a first width or size along the transverse axis when in the expanded configuration, and may have a second width or size less than the first width or size along the transverse axis when in the compressed configuration, as described in detail in '957 PCT.

[0109] The valve 102 can be compressed (as described above) and delivered in a lateral or orthogonal manner such that the longitudinal axis 111 is substantially parallel to the delivery axis (e.g., the longitudinal axis 175 of the delivery catheter 172). The shape of the expanded valve 102 can be in the shape of a large diameter shortened cylinder with an extended collar (e.g., the collar 120). In some embodiments, the valve 120 can be compressed wherein the central axis 113 of the valve 102 is approximately perpendicular (orthogonal) to the longitudinal axis 175 of the delivery catheter 172. In some embodiments, the valve 102 can be compressed vertically (e.g., along the central axis 113) and / or can be compressed laterally (e.g., along a transverse axis, not shown). In some embodiments, the valve 102 can have a compressed height (y-axis) and / or width (z-axis) of about 6-15 mm, about 8-12 mm, or more specifically 9-10 mm. In some embodiments, the length (x-axis) of the valve 102 does not need to be compressed because it can extend along the length of the lumen 174 of the delivery catheter 172. In some embodiments, the length (x-axis) of the valve 102 increases in response to compression of the height (y-axis) and / or width (z-axis). The valve 102 can be compressed by compression, rolling, folding, and / or any other suitable manner or combination thereof, as described in detail in the '957 PCT.

[0110] In some embodiments, the delivery system may include one or more features or components configured to deliver the valve 102 to a desired location within the body (e.g., the annulus of a native valve) by conventional delivery techniques or by orthogonal delivery techniques. For example, a delivery system 170 adapted for at least orthogonal delivery, such as Figure 1B As shown. The delivery system 170 includes a delivery catheter 172, a secondary catheter 180, and a guidewire 185. The delivery system 170 can be configured to deliver the compressed valve 102 and / or a portion of the valve 102 (e.g., the compressed frame 110 or the compressed flow control component 150) orthogonally to a desired location within the body, for example, the annulus of a native tricuspid valve and / or the annulus of a native mitral valve of a human heart. For example, the delivery catheter 172 can be 12-34 Fr, with any suitable corresponding lumen diameter and / or a lumen diameter sufficient to receive the prosthetic valve 102 in a compressed configuration. In some embodiments, the delivery system 170 and / or aspects or portions thereof can be similar and / or substantially the same as those described in detail in the '957 PCT.

[0111] The guidewire 185 extends or is screwed through the secondary catheter 180, the guidewire collar 145 of the distal anchoring element 132 or the guidewire collar 145 connected to the distal anchoring element 132, and the delivery catheter 172. The guidewire 185 can be, for example, a sheathed guidewire that is at least partially covered by the secondary catheter 180. The guidewire 185 is configured to be advanced through the anatomical structure of the body and placed in a desired position relative to the native tissue (e.g., a native valve). In some cases, the guidewire 185 can be advanced to provide a guidewire path (e.g., for the delivery catheter 172, the valve 102, the secondary catheter 180, etc.) to the outflow tract of the ventricle (e.g., RVOT or LVOT, depending on the native valve). The guidewire 185 extends through the guidewire collar 145 of the valve 102 to provide a guidewire path along which the valve 102 is advanced (eg, through the delivery catheter 172 and / or at least a portion of an atrium or ventricle of the heart).

[0112] like Figure 1B As shown, at least a portion of the secondary catheter 180 can be disposed in the lumen 174 of the delivery catheter 172. The secondary catheter 180 can be disposed on and / or advanced along the guidewire 185. The secondary catheter 180 can be a sheath, a tube, a ring rod or a wire, etc. In some embodiments, the secondary catheter 180 is a hypotube sheath disposed around a portion of the guidewire 185 (e.g., the secondary catheter 180 and the guidewire 185 are formed together with a sheath guidewire or a sheath guidewire assembly). The secondary catheter 180 can have a relatively small size, thereby allowing the secondary catheter 180 to be advanced through the delivery catheter 172 and / or to be at least partially disposed in or otherwise engaged with the guidewire collar 145. The secondary catheter 180 has an inner lumen having an inner diameter greater than the guidewire 185, thereby allowing the guidewire 185 to pass therethrough.

[0113] Pusher 181 is also disposed within secondary catheter 180 and is configured to push a portion of valve 102 to advance valve 102 through delivery catheter 172 and / or out of delivery catheter 172. In some embodiments, pusher 181 is configured to apply a thrust to a portion of guidewire collar 145 and / or distal anchoring element 132. For example, guidewire collar 145 can allow guidewire 185 to be advanced through guidewire collar 145, and can block and / or substantially prevent pusher 181 from being advanced beyond guidewire collar 145 (or at least a portion thereof). Guidewire collar 145 can be and / or can include a feature defining a hole or lumen that is large enough to allow guidewire 185 to pass through, but not large enough to allow other components (e.g., pusher 181) to be advanced through it. Thus, the secondary catheter 180 and / or the pusher 181 can stop against the guidewire ring 145 due to the larger circumference of the secondary catheter 180 and / or the pusher 181 relative to the hole or lumen of the guidewire ring 145. This arrangement allows the secondary catheter 180 and / or the pusher 181 to push the guidewire ring 145, thereby pushing the distal anchoring element 132 attached thereto. When the guidewire ring 145 is attached to the distal anchoring element 132, pushing the guidewire ring 145 can be operated to pull the valve 102 through and / or out of the delivery catheter 172.

[0114] Although pusher 181 is shown disposed in secondary catheter 180, in some embodiments, secondary catheter 180 may be used as pusher 181. In such embodiments, delivery system 170 need not include a separate pusher 181. In addition, although pusher 181 is described above as engaging, for example, distal anchoring element 132, in other embodiments, pusher 181 may be configured to engage any suitable portion of valve 102, such as proximal anchoring element 134, etc. Although not shown in FIG. Figures 1A to 1C However, the guidewire ring 145, secondary catheter 180 and / or pusher 181 may include a release mechanism or feature configured to release the guidewire 185, secondary catheter 180 and / or pusher 181 from the guidewire ring 145, for example after the valve 102 is deployed.

[0115] like Figure 1CAs shown, the valve 102 can be delivered to, for example, an atrium of a human heart and positioned within the annulus of a native valve, such as a pulmonary valve (PV), a mitral valve (MV), an aortic valve (AV), and / or a tricuspid valve (TV). As described above, the valve 102 can be in a compressed configuration and delivered to the annulus through a delivery system 170 - either by conventional delivery techniques or by orthogonal delivery techniques - and can be released from the delivery system 170 and allowed to expand to an expanded configuration. For example, the valve 102 can be delivered to the atrium of a human heart and released from a delivery catheter 172 by any of the delivery systems, devices, and / or methods described in detail in the '957 PCT.

[0116] Deployment of the valve 102 may include placing a distal anchoring element 132 (e.g., a distal lower anchoring element 132) in the ventricle (RV, LV) below the annulus, with the remainder of the valve 102 located in the atrium (RA, LA). In some cases, the distal anchoring element 132 may be positioned in the outflow tract of the ventricle (e.g., the distal anchoring element 132 may be advanced over and / or along the guidewire 185). For example, in some embodiments, the valve 102 may be delivered to the annulus of a native tricuspid valve (TV), and at least a portion of the distal anchoring element 132 may be positioned in the right ventricular outflow tract (RVOT). In other embodiments, the valve 102 may be delivered to the annulus of a native mitral valve (MV), and at least a portion of the distal anchoring element 132 may be positioned in the left ventricular outflow tract (LVOT). In some cases, the distal anchoring element 134 can engage subannular tissue to at least partially secure the distal portion of the valve 102 to native annular tissue while maintaining the remainder of the valve 102 in a supraannular position within the atrial side of the annulus.

[0117] In some embodiments, the prosthetic valve 102 can be temporarily maintained in a partially expanded state. For example, the valve 102 can be partially inserted into the annulus and maintained at a certain angle relative to the annulus to allow blood to partially pass through the native valve annulus surrounding the valve 102 and partially pass through the valve 102 from the atrium to the ventricle, which can allow evaluation of valve function.

[0118] The valve 102 can be placed or positioned in the annulus (PVA, MVA, AVA and / or TVA) of the native valve (PV, MV, AV and / or TV) such that the trans-annular portion 112 of the valve frame 110 extends through the annulus and into the ventricle, while the annulus remains in position above the annulus in the atrium. For example, in some embodiments, the secondary catheter 180 and / or the pusher 181 can be used to push at least the proximal portion of the valve 102 into the annulus. In some embodiments, the proximal anchoring element 134 can be maintained in its first configuration when the valve 102 is positioned in the annulus. For example, as described above, the proximal anchoring element 134, when in the first configuration, can be in contact with, adjacent to and / or close to the trans-annular portion 112 of the frame 110, which in turn can limit the entire circumference of the lower portion of the frame 110, thereby allowing the trans-annular portion 112 of the frame 110 to be inserted through the annulus.

[0119] Once positioned, the proximal anchoring element 134 can be transformed from its first configuration to its second configuration. For example, in some embodiments, a tensile force can be applied on, along, and / or through the tensile member 135, which can be operable to maintain the proximal anchoring element 134 in its first configuration. The tensile member 135 can be manipulated to decouple from the proximal anchoring element 135, thereby allowing the proximal anchoring element 134 to transform into its second configuration. In some embodiments, the secondary catheter 180, the pusher 181, and / or any suitable member or feature of the delivery system 170 can be configured to decouple the tensile member 135 from the proximal anchoring element 134. In some embodiments, a portion of the tensile member 135 can be actuated to decouple from the proximal anchoring element 134. Thus, once the valve 102 is positioned in the annulus, the proximal anchoring element 134 can be placed in its second configuration in which the proximal anchoring element 134 contacts, engages, and / or is otherwise positioned adjacent to the tissue beneath the valve. Additionally, in some embodiments, the distal anchoring element 132, the proximal anchoring element 134, and the collar 120 (or any other upper anchoring element) can exert a compressive force on the annular tissue separating the atria from the ventricles, thereby placing the valve 102 in a fully expanded state. Although not described in detail in the art, the proximal anchoring element 134 can be positioned in a second configuration in which the proximal anchoring element 134 contacts, engages, and / or is otherwise positioned adjacent to the tissue beneath the valve. Figures 1A to 1C 102, but in some embodiments, the valve 102 and / or the delivery system 170 may include one or more tissue anchors that can be used to anchor one or more portions of the valve 102 to the annular tissue, as described in detail in the '957 PCT.

[0120] The following provides a discussion of certain aspects or embodiments of transcatheter prosthetic valves (e.g., prosthetic heart valves). The transcatheter prosthetic valves (or aspects or portions thereof) described below with respect to specific embodiments may be at least similar in form and / or function to those described above with reference to the embodiments of the present invention. Figures 1A to 1CThe valve 102 and / or corresponding aspects or portions of the valve 102 described are substantially similar. Similarly, the valve (or aspects or portions thereof) described below may be similar in form and / or function to the valve described in detail in the '957 PCT. Therefore, certain aspects and / or portions of a particular embodiment will not be described in further detail herein.

[0121] Figure 2 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 202 according to an embodiment. The valve 202 and / or aspects or portions thereof may be similar to those of FIGS. Figure 1C The valve 102 shown is substantially similar. The valve 202 has a wire frame 210 including a distal anchoring element 232 and a proximal anchoring element 234. Figure 2 In the illustrated embodiment, each of the distal anchoring element 232 and the proximal anchoring element 234 is formed from or derived from a loop of superelastic wire (eg, formed from a nitinol wire or the like).

[0122] Figure 3 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 302, in accordance with an embodiment. Valve 302 has a laser cut frame 310 with a laser cut distal anchoring element 332 and a laser cut proximal anchoring element 334.

[0123] Figure 4 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 402, in accordance with an embodiment. Valve 402 has a laser cut frame 410 with a laser cut distal anchoring element 432 and a superelastic wire ring proximal anchoring element 434.

[0124] Figure 5 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 502, in accordance with an embodiment. Valve 502 has a laser cut frame 510 with a superelastic wire ring distal anchoring element 532 and a laser cut proximal anchoring element 534.

[0125] Figure 6 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 602, according to an embodiment. Valve 602 has a laser cut frame 610 with a superelastic wire ring distal anchoring element 632 and a superelastic wire ring proximal anchoring element 634.

[0126] Fig. 7A and Figure 7B A side perspective view of a laterally delivered transcatheter prosthetic heart valve 702 is shown, in accordance with an embodiment. Valve 702 has a laser cut frame 710 with a superelastic wire ring distal anchoring element 732 and a superelastic wire ring proximal anchoring element 734. Fig. 7AThe valve 702 shown has a frame 710 and a flow control component 750. The frame 710 has a trans-annular portion 712 and an atrial collar 720 disposed around and / or coupled to a top edge of the trans-annular portion 712. The flow control component 750 is disposed within a hole 714 of the frame 710. The flow control component 750 can have any number of prosthetic leaflets 753 (e.g., two, three, four, or more) mounted within the flow control component 750. The leaflets 753 can define a passage for unidirectional blood flow from the inflow side of the valve 702 to the outflow side of the valve 702.

[0127] Fig. 7A The frame 710 and / or the tensile member 735 of the valve 702 are shown in a first or initial state, in which the tensile member 735 engages the proximal anchoring element 734 to maintain the proximal anchoring element 734 in its first configuration (e.g., pre-release configuration). The proximal anchoring element 734 can be in its first configuration before and during deployment of the valve 702 and / or placement of the valve 702 in the annulus. Figure 7B 735 is shown in a second state in which the tensile member 735 is decoupled from the proximal anchoring element 734. The proximal anchoring element 734 is allowed to transition from its first configuration to its second configuration, as shown in FIG. Figure 7B As shown by the arrow in . After the valve 702 is positioned in the annulus, the proximal anchoring element 734 can be transformed into a second configuration.

[0128] Figure 8 is an illustration of a side view of the human cardiac anatomy with insets showing the geometric relationships between the inferior vena cava (IVC), superior vena cava (SVC), right atrium (RA), left atrium (LA), right ventricle (RV), left ventricle (LV), and pulmonary artery (PA). The tricuspid tricuspid valve - having anterior, posterior, and septal cusps - is shown between the RA and RV. The bicuspid mitral valve is shown between the LA and LV.

[0129] Fig.9A and Fig. 9B Anterior and posterior perspective views, respectively, of a laterally delivered valve 802 positioned with a native tricuspid valve annulus are shown. The annulus 820 of the valve 802 is positioned above the tricuspid valve annulus and leaflets in the atrium, the transannular portion 812 of the valve 802 extends into and through the annulus to provide correct hemodynamic flow from the flow control component 850, the distal anchoring element 832 is at least partially disposed in the right ventricular outflow tract (e.g., the pulmonary artery (PA)), and the proximal anchoring element 134 is in a released configuration engaging tissue beneath the annulus.

[0130] Fig. 10A and Fig. 10BShown is a side perspective view of a laterally delivered transcatheter prosthetic heart valve 902, in accordance with an embodiment. Fig. 10A is a proximal side perspective view of the valve 902 and illustrates the proximal anchoring element 934 extending away from the wire frame 910 . Fig. 10B is a distal side perspective view of the valve 902 and illustrates the distal anchoring element 932 extending away from the wire frame 910 .

[0131] Fig.11A and Fig. 11B A top front view and a top septal view are shown, respectively, of a laterally delivered transcatheter prosthetic heart valve 1002, according to an embodiment. Valve 1002 can have a wire frame including a wire ring distal anchoring element 1032 and a wire ring proximal anchoring element 1034 attached around the circumference of the frame below a collar 1020 of valve 1002.

[0132] Fig.12 1 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 1102 according to an embodiment. The valve 1102 has a distal anchoring element 1132 and a proximal anchoring element 1134. The distal anchoring element 1132 has a guidewire collar 1145 coupled thereto. The guidewire collar 1145 can be a threaded tip element or the like that can receive a portion of a guidewire 1185. The valve 1102 can be delivered to the native valve annulus through a delivery catheter 1172. More specifically, the guidewire 1185 can be advanced into the human heart and through the annulus of the native valve. The delivery catheter 1172 can be advanced over the guidewire 1172 to place the distal end of the delivery catheter 1172 on the atrial side of the valve annulus. The guidewire collar 1145 can be screwed on or otherwise positioned above the guidewire 1145. The pusher 1110 may be screwed onto or otherwise positioned over the guidewire 1145 at the proximal end of the guidewire collar 1145. The guidewire collar 1145 may allow the guidewire 1180 to pass therethrough, but may prevent the pusher 1180 from passing through the guidewire collar 1145, thereby providing a mechanism for pushing the distal anchoring element 1132. The valve 1102 may be advanced through the delivery catheter 1172, wherein the guidewire collar 1145 may be located distal to the remainder of the valve 1102. Thus, pushing the guidewire collar 1145 (or the distal anchoring element 1132) will pull the valve 1102 through and out of the delivery catheter 1172 from the distal side to avoid damaging compressive thrusts that may otherwise be involved in the process of delivering the valve.

[0133] FIG. 13A to FIG. 13D A septal side view of a laterally delivered transcatheter prosthetic heart valve 1202 is shown, illustrating a process for delivering valve 1202 in accordance with an embodiment. Fig.13AThe valve 1202 is shown in a compressed configuration and disposed within a delivery catheter 1272. In some cases, the process may include extending at least the distal end of the delivery catheter 1272 into an atrium of a human heart via the inferior vena cava (IVC). A pusher 1280 or other member may be used to advance the compressed valve 1202 through the delivery catheter 1272 toward the distal end. Fig. 13B The valve 1202 is shown partially ejected from a delivery catheter 1272. The distal anchoring element 1232 extends through the annulus and into the ventricular outflow tract, such as the pulmonary artery (PA). Fig. 13C The valve 1202 is shown in an uncompressed or expanded configuration ejected from a delivery catheter 1272. In some embodiments, a pusher 1280 can be used to apply force to the proximal side of the valve 1202 to seat the valve 1202 in the native annulus. When the valve 1202 is seated in the annulus, the proximal anchoring element 1234 of the valve 1202 can be in a first, compressed and / or pre-release state. Fig.13D The valve 1202 is shown positioned in the annulus and the proximal anchoring element 1234 is in a second, uncompressed and / or released state. For example, after the valve 1202 is positioned in the annulus, a tensile member (not shown) can be manipulated to allow the proximal anchoring element 1234 to transition to its second state.

[0134] FIG. 14A to FIG. 14D An anterior view of a laterally delivered transcatheter prosthetic heart valve 1302 is shown illustrating a process of delivering valve 1302 according to an embodiment. Valve 1302 can have a wire frame including a wire ring distal anchoring element 1332 and a wire ring proximal anchoring element 1334. Fig.14A A portion of a delivery catheter 1372 is shown extending through the IVC with the valve 1302 disposed within its lumen in a compressed configuration. A pusher 1380 or other member may be used to advance the compressed valve 1302 through the delivery catheter 1372. Fig. 14B The valve 1302 is shown partially ejected from a delivery catheter 1372 and the distal anchoring element 1332 extending through the annulus and into the ventricular outflow tract (such as the PA). Fig. 14C The expanded valve 1302 is shown ejected from a delivery catheter 1372 and positioned within the annulus of a native valve, with the proximal anchoring element 1334 of the valve 1302 in a first, compressed and / or pre-release state. Fig.14D The valve 1302 is shown positioned within the annulus and the proximal anchoring element 1334 is shown in a second, uncompressed and / or released state.

[0135] FIG. 15A to FIG. 15DA septal side view of a laterally delivered transcatheter prosthetic heart valve 1402 is shown illustrating a process of delivering valve 1402, according to an embodiment. Valve 1402 has a laser cut frame having a laser cut distal anchoring element 1432 and a laser cut proximal anchoring element 1434. Fig.15A A portion of a delivery catheter 1472 is shown extending through the IVC with the valve 1402 disposed within its lumen in a compressed configuration. A pusher 1480 or other member may be used to advance the compressed valve 1402 through the delivery catheter 1472. Fig. 15B The valve 1402 is shown partially ejected from a delivery catheter 1472 and the distal anchoring element 1432 extending through the annulus and into the ventricular outflow tract (such as the PA). Fig. 15C The expanded valve 1402 is shown ejected from a delivery catheter 1472 and positioned within the annulus of a native valve, with the proximal anchoring element 1434 of the valve 1402 in a first, compressed and / or pre-release state. Fig.15D The valve 1402 disposed in the annulus and the proximal anchoring element 1434 in a second, uncompressed and / or released state are shown. For example, the proximal anchoring element 1434 can be unhinged, expanded, uncompressed and / or otherwise reconfigured into a second configuration.

[0136] FIG. 16A to FIG. 16E A septal side view of a laterally delivered transcatheter prosthetic heart valve 1502 is shown, illustrating a process for delivering valve 1502 in accordance with an embodiment. Fig.16A A guidewire 1585 is shown being advanced through the IVC, the native annulus, and into the ventricular outflow tract (such as the PA). Fig. 16B The delivery catheter 1572 is shown being advanced over the guidewire 1585 and through the IVC. Additionally, the distal anchoring element 1532 of the valve 1502 can receive and / or allow the guidewire 1585 to extend through a portion thereof. The pusher 1580 can be used to push the distal anchoring element 1532 to advance the distal anchoring element 1532 along the guidewire 1585 and through the delivery catheter 1572. Fig. 16C The valve 1302 is shown ejected and partially expanded from the delivery catheter 1372. The distal anchoring element 1332 extends through the annulus and into the PA. Fig.16D The at least partially expanded valve 1502 is shown temporarily held at an angle relative to the native annulus to allow blood to flow through the native annulus surrounding the valve 1502 and through a flow control component (not shown) of the valve 1502 . Fig.16EThe valve 1502 is shown positioned in the annulus. The proximal anchoring element 1534 can be in a first, compressed and / or pre-released state when the valve 1502 is positioned in the annulus, and can be allowed to transition to a second, uncompressed and / or post-released state after the valve 1502 is positioned.

[0137] FIG. 17A to FIG. 17E A side view of a laterally delivered transcatheter prosthetic heart valve 1602 is shown illustrating the process of delivering valve 1602 to the annulus of a native mitral valve, according to an embodiment. Fig.17A A delivery catheter 1672 is shown with a compressed valve 1602 disposed therein. The distal anchoring element 1632 of the valve 1602 is screwed on and / or otherwise disposed on a guidewire 1685, which can extend through, for example, the femoral vein and IVC, from the right atrium to the left atrium, across the septum, through the annulus of the mitral valve, and into the left ventricle. A pusher 1680 or other valve advancement tool can be used to advance the compressed valve 1602 through the delivery catheter 1672. Fig. 17B The delivery catheter 1672 is shown extending from the femoral / IVC access across the septum into the left atrium, with the pusher 1680 ejecting the valve 1602 out of the delivery catheter 1672 such that the distal anchoring element 1632 extends through the annulus and into or near the anterolateral mitral commissure anchoring region beneath the annulus. Fig. 17C The valve 1602 is shown in an expanded configuration and positioned in the annulus of a mitral valve. The proximal anchoring element 1634 is in a released state, allowing the proximal anchoring element 1634 to engage the subannular commissure anchoring region. Fig.17D A top view of valve 1602 is shown positioned relative to the native mitral valve annulus and illustrates how distal anchoring element 132 and proximal anchoring element 134 provide anchoring in the A1-P1 and A3-P3 commissure anchoring regions. Fig.17E is a top view of the native mitral valve annulus shown in solid lines and the valve 1602 disposed therein shown in dotted lines.

[0138] Fig.18A and Fig.18B An anterior view of a laterally delivered transcatheter prosthetic heart valve 1702 positioned in a native mitral valve annulus is shown, in accordance with an embodiment. Fig.18A It is shown how the distal anchoring element 1732 and the proximal anchoring element 1734 provide anchoring in the A1-P1 and A3-P3 commissure anchoring regions (shown in phantom). Fig.18B is a side view of the native mitral valve annulus shown in solid lines and the valve 1702 disposed therein shown in dotted lines.

[0139] Fig.19A and Fig.19Bis an illustration of a proximal anchoring element 1834 included in a transcatheter prosthetic heart valve according to an embodiment and shown in a first configuration and a second configuration, respectively. The proximal anchoring element 1834 can include, for example, a mechanical hinge or similar mechanism that allows at least an end of the proximal anchoring element 1834 to rotate relative to the remainder of the proximal anchoring element 1834. Although not shown, in some embodiments, the ends of the proximal anchoring element 1834 can be engaged by a tensile member and / or the like that is configured to maintain the proximal anchoring element 1834 in the first configuration prior to positioning the valve in the annulus.

[0140] Fig. 20A and Fig. 20B is an illustration of a proximal anchoring element 1934 included in a transcatheter prosthetic heart valve according to an embodiment and shown in a first configuration and a second configuration, respectively. The proximal anchoring element 1934 may include, for example, a folding and / or release region or mechanism formed of a shape memory or superelastic material, such as nitinol. The proximal anchoring element 1934 may be in a folded state when in the first configuration and in an unfolded or expanded state when in the second configuration. Although not shown, in some embodiments, the ends of the proximal anchoring element 1934 may be engaged by a tensile member and / or the like that is configured to maintain the proximal anchoring element 1934 in the first configuration prior to positioning the valve in the annulus.

[0141] Fig.21A and Fig. 21B Shown is a top view of a laterally delivered transcatheter prosthetic heart valve 2002 positioned in the annulus of a native tricuspid valve, in accordance with an embodiment. Fig.21A It is shown how the distal anchoring element 2032 and the proximal anchoring element 2034 provide anchoring in the RVOT and the proximal anchoring region (adjacent to the IVC), respectively. Fig. 21B is a top view of the native valve annulus shown in solid lines and the valve 1702 disposed therein shown in dotted lines.

[0142] Fig.24 21 is an illustration of a side perspective view of a laterally delivered transcatheter prosthetic heart valve 2102 according to an embodiment. The valve 2102 can include a wire or laser cut frame having any suitable number of subannular anchoring elements. For example, in this embodiment, the valve 2102 includes three subannular anchoring elements, such as a distal anchoring element 2132, a proximal anchoring element 2134, and an intermediate anchoring element 2137.

[0143] Any valve described herein may include a proximal anchoring element that can be transformed from a first state or configuration to a second state or configuration after the valve is inserted or placed in the annulus of the autologous valve. For example, the proximal anchoring element can be configured to transform between a compressed, unexpanded, constrained and / or pre-release state (e.g., a first configuration) and an expanded, extended, expanded, unconstrained and / or post-release state. When in the first configuration, the proximal anchoring element can contact, be adjacent to and / or otherwise be close to the main body or cross-valve ring portion of the valve. When in the second configuration, the proximal anchoring element (or at least its end) can extend away from the main body or cross-valve ring portion of the valve. That is, compared to the end of the proximal anchoring element in the first configuration, at least the end of the proximal anchoring element in the second configuration can be farther away from the main body or cross-valve ring portion of the valve. Such an arrangement can result in the size, circumference and / or girth of at least a portion of the body or trans-annular portion of the valve being smaller when the proximal anchoring element is in the first configuration than when the proximal anchoring element is in the second configuration, which in turn can allow the body or trans-annular portion of the valve (or a portion thereof) to be inserted through the annulus. Once the valve is positioned and the proximal anchoring element is transformed into its second configuration, the larger size, circumference and / or girth of the body or trans-annular portion can be used to secure and / or anchor the valve in the annulus.

[0144] In some embodiments, the valve may include features, members, mechanisms, etc. configured to at least temporarily retain the proximal anchoring element in its first configuration. For example, the valve may include a tensile member that can selectively engage the proximal anchoring element to temporarily retain the proximal anchoring element in the first configuration. In some embodiments, the tensile member can be removably coupled to a portion of the proximal anchoring element and can apply a force (e.g., a tensile force or pressure) that is operable to retain the proximal anchoring element in the first configuration. The tensile member can be reconfigurable, allowing the tensile member to be decoupled from the proximal anchoring element, which in turn can allow the proximal anchoring element to transition from its first configuration to its second configuration, as described in further detail herein with reference to specific embodiments.

[0145] Provided below is a discussion of certain aspects, embodiments, and / or methods of removably coupling a tensile member to a proximal anchoring element of a transcatheter prosthetic valve. The proximal anchoring element (or aspects or portions thereof) described below for a particular embodiment may be substantially similar to any proximal anchoring element described herein in at least form and / or function. Similarly, the tensile member (or aspects or portions thereof) described below may be similar to any tensile member described herein in at least form and / or function. Therefore, certain aspects and / or portions of a particular embodiment are not described in further detail herein.

[0146] Fig.23A and Fig. 23B A side perspective view of a laterally delivered transcatheter prosthetic heart valve 2202 and a tensile member 2235 is shown according to an embodiment. The valve 2202 has a frame 2210 having a distal anchoring element 2232 and a proximal anchoring element 2234 (e.g., a wire ring anchoring element and / or any other suitable type of anchoring element). The tensile member 2235 can be and / or can include any suitable coupler, attachment device, etc. configured to be at least temporarily coupled to the proximal anchoring element 2234. In some embodiments, the tensile member 2235 can be a tether that can be advanced through the delivery catheter when the valve is advanced through the delivery catheter. In some embodiments, the tensile member 2235 can be and / or can include a pusher that can be used to advance the valve through the delivery catheter.

[0147] Fig.23A A tensile member 2235 is shown coupled to a proximal anchoring element 2234. Although not shown, the proximal anchoring element 2234 and / or the tensile member 2235 may include one or more features that allow the tensile member 2235 to be temporarily coupled to the proximal anchoring element 2234. The tensile member 2235 is at least partially disposed within the valve 2202. An end of the tensile member 2235 is shown extending through a waypoint 2221 defined by a portion of the valve 2202 (e.g., a portion of the frame 2210). The waypoint 2221 may be, for example, an opening, a hole, a slit, an incision, a self-healing port, etc. This arrangement may result in the end of the tensile member 2235 forming a substantially U-shaped bend, wherein the distal surface of the tensile member 2235 is oriented and / or faces in a proximal direction. Thus, applying a tensile force along the tensile member 2235 may act to pull the proximal anchoring element 2234 toward the body or transannular portion of the valve 2202. In other words, the user can pull on the proximal portion (eg, the end disposed outside the body) of the tensile member 2235 to place the tensile member 2235 in tension, thereby pulling the proximal anchoring element 2234 toward the body of the valve 2202 - ie, its first configuration.

[0148] Fig. 23BThe tensile member 2235 is shown decoupled from the proximal anchoring element 2234 and withdrawn through the waypoint 2201 and the valve 2202. Although not shown, the tensile member 2235, the proximal anchoring element 2234, and / or any suitable member or element of the delivery system may include a release mechanism that enables the proximal anchoring element 2234 to be released from the tensile member 2235. Once decoupled, the tensile member 2235 can be retracted from the valve 2202. The decoupling allows the proximal anchoring element 2234 to transition from its first configuration to its second configuration. In some embodiments, the tensile member 2235 can remain coupled to the proximal anchoring element 2234 while the valve 2202 is placed in the annulus of the native valve, and can be released or decoupled after the valve 2202 is placed or positioned. As described above, the proximal anchoring element 2234 is configured to engage subannular tissue, such as bridging the septal-posterior and / or anterior-septal commissures of the posterior and anterior leaflets of the native valve.

[0149] Fig.24 is an illustration of a side perspective view of a portion of a proximal anchoring element 2334 and a tensile member 2335 included in a transcatheter prosthetic heart valve, according to an embodiment. Proximal anchoring element 2334 includes an attachment point 2336 (e.g., an eyelet, hole, loop, hook, hole, etc.) to which tensile member 2335 is removably coupled. Tensile member 2335 is shown as, for example, a continuous tether, cable, suture, wire, etc. A portion of tensile member 2335 is screwed through a delivery system, a portion of the valve (e.g., a path point thereof), in a circular motion around or through the attachment point 2336 of proximal anchoring element 2334, and screwed back through the delivery system. Pulling on both ends of tensile member 2335 places tensile member 2335 in tension, which in turn maintains proximal anchoring element 2334 in its first configuration. After the valve has been deployed, one end of the tensile member 2335 is pulled to remove the tensile member 2335 from the attachment point 2336 of the proximal anchoring element 2334.

[0150] Fig.252435 is an illustration of a side perspective view of a portion of a proximal anchoring element 2434 and a tensile member 2435 included in a transcatheter prosthetic heart valve according to an embodiment. The proximal anchoring element 2434 includes an attachment point 2436 (e.g., a threaded eyelet, opening, or coupler) to which the tensile member 2435 is removably coupled. For example, the tensile member 2435 is shown as a continuous cable with a threaded distal portion. The tensile member 2435 can extend through a portion of the delivery system and the valve (e.g., a path point thereof), and can form a threaded coupling with the attachment point 2436 of the proximal anchoring element 2434. Pulling one end of the tensile member 2435 places the tensile member 2435 in tension, which in turn keeps the proximal anchoring element 2434 in its first configuration. After the valve has been deployed, the tensile member 2435 is twisted to unscrew the threaded distal portion from the attachment point 2436 and remove the tensile member 2435 from the delivery system.

[0151] Fig.26 2535 and a side perspective view of a portion of a proximal anchoring element 2534 and a tensile member 2535 included in a transcatheter prosthetic heart valve according to an embodiment. The proximal anchoring element 2534 includes an attachment point 2536, such as an eyelet or a ring, coupled to a lead 2537 of the tensile member 2535. The lead 2537 can be configured to remain coupled to the valve after deployment. In some embodiments, a first end of the lead 2537 can be coupled to the attachment point 2536, and a second end of the lead 2537 opposite the first end can extend through a portion of the valve (e.g., a path point and any other suitable portion). Such an arrangement can result in the second end of the lead 2537 being disposed, for example, outside and / or above the annulus of the valve, so that it can be more easily accessed than the attachment point 2536 of the proximal anchoring element 2334.

[0152] For example, the tensile member 2535 is shown as a continuous tether, cable, suture, wire, etc., which can be screwed through the delivery system, looped around or through the second end of the lead 2537, and screwed back through the delivery system. Pulling on both ends of the tensile member 2535 places the tensile member 2535 in tension, which in turn places the lead 2537 in tension. Thus, the lead 2537 maintains the proximal anchoring element 2534 in its first configuration. After the valve has been deployed, one end of the tensile member 2535 is pulled to remove the tensile member 2535 from the second end of the lead 2536. The tensile member 2535 is removed from the delivery system while the lead 2537 remains coupled to the proximal anchoring element 2534.

[0153] Fig. 272635 and a side perspective view of a portion of a proximal anchoring element 2634 and a tensile member 2635 included in a transcatheter prosthetic heart valve, according to an embodiment. Proximal anchoring element 2634 includes an attachment point 2636 coupled to a lead 2637 of tensile member 2635. A first end of lead 2637 can be coupled to attachment point 2636, and a second end of lead 2637 opposite the first end can extend through a portion of the valve (e.g., a waypoint and any other suitable portion). For example, tensile member 2635 is shown as a continuous cable having a threaded distal portion that can form a removable threaded coupling with a second end of lead 2637. Pulling one end of tensile member 2635 places tensile member 2635 in a tensioned state, which in turn places lead 2637 in a tensioned state. Thus, lead 2637 maintains proximal anchoring element 2634 in its first configuration. After the valve has been deployed, the tensile member 2635 is twisted to screw the threaded distal portion out of the second end of the lead 2637 and the tensile member 2635 is removed from the delivery system while the lead 2637 remains coupled to the proximal anchoring element 2634.

[0154] Fig.28A and Fig.28B A side perspective view of a portion of a proximal anchoring element 2734 and a tensile member 2735 included in a transcatheter prosthetic heart valve according to an embodiment is shown. The proximal anchoring element 2734 includes an attachment point 2736 that is removably coupled to an end 2738 of the tensile member 2735. The tensile member 2735 is shown as, for example, a continuous tether, cable, suture, wire, etc. having a coupling feature 2739 (e.g., a ball, knob, protrusion, etc.) included in and / or formed at the distal end. The tensile member 2735 includes a receiving member 2740 (e.g., a cup, etc.) configured to removably receive an end (e.g., coupling feature 2739) of the tensile member 2735. For example, the coupling feature 2739 can be disposed or snapped into a recessed feature of the receiving member 2740, which can be coaxial with the outer sleeve member. The outer sleeve member can slide (e.g., in a distal direction) to cover the coupling feature 2739 and form a friction fit that retains the coupling feature 279 in the recessed feature of the receiving member 2740 while being covered by the sleeve member.

[0155] Fig.28AThe end 2738 of the tensile member 2735 is shown being threaded through a portion of the valve (e.g., a waypoint thereof), moved in a circular motion around or through the attachment point 2736 of the proximal anchoring element 2734, and threaded back through a portion of the valve (e.g., back through the waypoint) to allow the coupling feature 2739 at the end of the tensile member 2735 to couple to the receiving member 2740. Pulling on the proximal end of the tensile member 2735 places the tensile member 2735 in tension, which in turn maintains the proximal anchoring element 2734 in its first configuration. Fig.28B The sleeve member is shown in a position that allows the coupling feature 2739 at the end of the tensile member 2735 to be removed from the receiving member 2740. After the valve has been deployed and the coupling feature 2739 is released from the receiving member 2740, the tensile member 2735 is pulled to remove the tensile member 2735 from the attachment point 2736 of the proximal anchoring element 2734 and the delivery system.

[0156] FIG. 29A to FIG. 29D A side perspective view of a portion of a proximal anchoring element 2834 and one or more portions of a tensile member 2835 included in a transcatheter prosthetic heart valve according to an embodiment is shown. Proximal anchoring element 2834 includes an attachment point 2836 coupled to a lead 2841 of tensile member 2835. Each end of lead 2841 includes a coupling feature 2842 (e.g., a ball, etc.) and is configured to at least temporarily couple to a receiving member 2843 of tensile member 2835.

[0157] Fig.29A A lead 2841 is shown being threaded through a portion of the valve (e.g., a waypoint thereof), moved in a circular motion around or through an attachment point 2836 of a proximal anchoring element 2834, and threaded back through a portion of the valve (e.g., back through the waypoint) such that each end of the lead 2841 is outside of the valve. Fig.29B and Fig.29C A coupling feature 2842 is shown disposed at each end of the lead 2841, which is coupled to a receiving member 2843 of the tensioning member 2835. For example, the receiving member 2843 can define two recessed features and two sleeve members. Each coupling feature 2842 can be disposed in a corresponding recessed feature, and each sleeve member can be transformed to cover each coupling feature 2842, thereby coupling the lead 2841 to the tensioning member 2835. Pulling one end of the tensioning member 2835 places the tensioning member 2835 in a tensioned state, which in turn places the lead 2841 in a tensioned state. Thus, the lead 2841 maintains the proximal anchoring element 2834 in its first configuration.

[0158] Fig.29DOne of the sleeve members (e.g., the proximal sleeve member) of the receiving member 2843 is shown transitioning to a position that allows the corresponding coupling feature 2842 to be removed from the corresponding recessed feature of the receiving member 2843. After the valve has been deployed and the coupling feature 2842 is released from the receiving member 2843, the tensile member 2835 is pulled to remove the tensile member 2835. In addition, one of the coupling features 2842 can remain coupled to the receiving member 2843, allowing the lead 2841 to be removed from the attachment point 2836 of the proximal anchoring element 2834, thereby allowing the tensile member 2835 and the lead 2841 to be removed from the delivery system.

[0159] Fig.30 2 is an illustration of a side perspective view of a portion of a proximal anchoring element 2934 and a tensile member 2935 included in a transcatheter prosthetic heart valve, according to an embodiment. Proximal anchoring element 2934 includes an attachment point 2936 coupled to a lead 2941 of tensile member 2935. Each end of lead 2941 includes a coupling feature 2942 (e.g., a loop, etc.) and is configured to at least temporarily couple to tensile member 2835. One end of lead 2941 is threaded through a portion of the valve (e.g., a waypoint thereof), looped around or through attachment point 2936 of proximal anchoring element 2934, and threaded back through a portion of the valve (e.g., back through the waypoint) such that coupling features 2944 at each end of lead 2941 are external to the valve.

[0160] For example, the tensile member 2935 is shown as a continuous suture or the like that can be screwed through the coupling feature 2944 at each end of the lead 2941, thereby coupling the tensile member 2935 to the lead 2941. Pulling the ends of the tensile member 2935 places the tensile member 2935 in a tensioned state, which in turn places the lead 2941 in a tensioned state. Thus, the lead 2941 holds the proximal anchoring element 2934 in its first configuration. After the valve has been deployed, a portion of the tensile member 2935 can be severed, thereby allowing at least the tensile member 2935 to be removed from the delivery system. In some embodiments, severing of the tensile member 2935 can include cutting the tensile member 2935 and / or otherwise breaking a portion of the tensile member 2935 at a breakpoint 2946. For example, the breakpoint 2946 can include and / or can form a frangible portion of the tensile member 2935, a magnetic coupler, a threaded coupler, a ball-cup coupler, and / or any other suitable coupler. Furthermore, severing of tensile member 2935 can result in one end of lead 2941 remaining coupled to tensile member 2935 , which in turn can allow lead 2941 to be removed within tensile member 2935 .

[0161] FIG. 31A to FIG. 31CA side perspective view of a laterally delivered transcatheter prosthetic heart valve 3002 and a tensile member 3035 is shown according to an embodiment. Valve 3002 has a frame 3010 with a collar 3020, a distal anchoring element 3032, and a proximal anchoring element 3034 (e.g., a wire ring anchoring element and / or any other suitable type of anchoring element). Frame 3010 defines a waypoint 3021. Collar 3020 includes and / or forms a coupler 3022. Although waypoint 3021 is shown along the body of frame 3010, in other embodiments, collar 3020 and / or any other suitable portion of valve 3002 can form and / or define waypoint 3021. Similarly, although coupler 3022 is shown along collar 3020, in other embodiments, the body of frame 3010 and / or any other suitable portion of valve 3020 can include coupler 3022.

[0162] The tensile member 3035 includes a lead 3041 configured to be coupled to and / or screwed through an attachment point 3036 of the proximal anchoring element 3034. The lead 3041 includes a first end having and / or forming a first coupling feature 3044 and a second end having and / or forming a second coupling feature 3044. The coupling feature can be any suitable configuration. For example, in this embodiment, the first coupling feature 3044 is and / or forms a ring, an eyelet, an opening, etc., and the second coupling feature 3042 is and / or forms a ball, a protrusion, a knob, a knot, etc. The tensile member 3035 can be and / or can include any suitable cable, tether, wire, catheter, pipe, etc. In some embodiments, the tensile member 3035 can be used as, for example, a pusher, etc., which is configured to push and / or otherwise advance the valve 3002 through the delivery system.

[0163] In this embodiment, the tensile member 3035 includes a first cable 3047 having an end forming a threaded coupler configured to engage and / or couple to a coupler 3022 formed by a collar (e.g., a nut, etc.). The tensile member 3035 includes a second cable 3048 having an end forming a receiving member configured to receive and / or removably couple to a second end of the lead 3041. For example, the receiving member of the second cable 3048 and the coupling feature 3042 formed by the second end of the lead 3041 can be a ball-cup coupling mechanism as described above for the tensile members 2735 and 2835. In addition, the tensile member 3035 can include and / or can form an outer sheath or conduit configured to at least partially house the first cable 3047 and the second cable 3048.

[0164] Fig.31ATensile member 3035 is shown prior to coupling to valve 3002 and / or lead 3041. Lead 3041 is shown being threaded through a portion of valve 3002 and waypoint 3021, in a circular motion around or through attachment point 3036 of proximal anchoring element 3034, and threaded back through waypoint 3021 and a portion of valve 3002 such that first and second ends 3044, 3042 are each exterior of valve 3002 and / or above or proximal to annulus 3020.

[0165] Fig.31B An end of a first cable 3047 of a tensile member 3035 is shown coupled to a coupler 3022 of a collar 3020, for example, by a threaded coupling. A first coupling feature 3044 of a lead 3041 is coupled to the first cable 3047 (e.g., the first coupling feature 3044 can be a ring disposed on or around the first cable 3047). In some embodiments, the tensile member 3035 can be used as a proximal pusher due to the coupling of the first cable 3047 to the coupler 3022 formed by the collar 3020. For example, a substantially fixed portion of the first cable 3047 can extend from the tensile member 3035 (e.g., an outer sheath) such that a distal force or push applied to the tensile member 3035 via the first cable 3047 pushes the valve 3002. With the first coupling feature 3044 coupled to the first cable 3047, the first end of the lead 3041 remains in a relatively fixed position relative to the valve 3002. The second cable 3048 of the tensile member 3035 is shown coupled to the second coupling feature 3042 of the lead 3041 (e.g., via a ball-cup coupling mechanism, etc.). Thus, while the tensile member 3035 and / or the first cable 3047 may be used to push the valve 3002, a tensile or pulling force may be applied to the second cable 3048, which may pull the second end of the lead 3041 in the proximal direction, thereby placing the lead in tension. Thus, the lead 3041 may maintain the proximal anchoring element 3034 in its first configuration during deployment.

[0166] Fig.31C 3041. The first cable 3047 is shown decoupled from the coupler 3022 of the collar 3020 and the first coupling feature 3044 at the first end of the lead 3041. The second coupling feature 3042 at the second end of the lead 3041 can remain coupled to the second cable 3048. After the valve has been deployed, the tensile member 3035 is pulled to remove the tensile member 3035 and the lead 3041 from the valve 3002 and the delivery system. As the tensile member 3035 is removed, the proximal anchoring element 3034 is allowed to transform into its second configuration.

[0167] Fig.32is a flow chart showing a method for delivering a transcatheter prosthetic valve according to an embodiment. In some cases, the delivery method may include the following steps: (i) advancing a guidewire through a femoral vein or brachiocephalic vein, an inferior vena cava (IVC), or a superior vena cava (SVC), and into a pulmonary artery or a left ventricle; (ii) advancing a delivery catheter over the guidewire to the right atrium proximal to a native tricuspid valve or to the left atrium proximal to a native mitral valve; (iii) advancing and delivering an orthogonally compressed prosthetic heart valve to the right atrium or the left atrium, wherein the delivery includes partially releasing the valve from the delivery catheter, positioning a distal anchoring element of the valve in the anterolateral aspect of the pulmonary artery (e.g., the right ventricular outflow tract (RVOT)) or the mitral valve. in a subannular region below the commissures and maintaining the valve at a convex angle of approximately 30 degrees relative to a local horizontal annular plane of the native valve to allow blood to flow around and through the prosthetic valve, thereby allowing a gradual transition of blood flow from flowing through the native leaflets to flowing completely through the prosthetic valve; (iv) completely releasing the valve from the delivery catheter and positioning the valve in the native valve annulus by applying a downward force in the ventricular direction (e.g., on the proximal side of the prosthetic valve); and (v) transforming at least one proximal anchoring element into a second configuration in which the proximal anchoring element engages the proximal anchoring region below the annulus.

[0168] Fig.33 is a flow chart illustrating a method 10 for delivering a transcatheter prosthetic valve according to an embodiment. Method 10 includes, at 11, positioning a distal portion of a delivery catheter having a prosthetic valve in a compressed configuration disposed in its lumen adjacent to the annulus of a native valve of the heart. The prosthetic valve can be any valve disclosed herein. For example, the valve can be a valve having (i) a frame having at least a distal anchoring element and a proximal anchoring element, and (ii) a flow control component mounted within the frame, the flow control component being configured to allow blood to flow through an inflow end of the valve in a single direction and to prevent blood from flowing through an outflow end of the valve in an opposite direction. The valve can be delivered by a conventional delivery process or an orthogonal delivery process. For example, the valve can be delivered by any process and / or method described in detail herein and / or in the '957 PCT.

[0169] At 12, the valve is released from the lumen of the delivery catheter so that the valve is transformed from a compressed configuration to an expanded configuration. As described in detail above for specific embodiments, releasing the valve from the delivery catheter allows the prosthetic valve to expand from a compressed configuration within the delivery catheter to an expanded configuration outside the delivery catheter and suitable for deployment into the annulus of the native valve.

[0170] At 13, a portion of the distal anchoring element is placed on the ventricular side of the annulus of the native valve. In some embodiments, the distal anchoring element can be a distal subannular anchoring element, which can be placed on the ventricular side of the annulus, while the remainder of the valve remains on the atrial side of the annulus. In some embodiments, the distal anchoring element can be placed within the ventricular outflow tract. For example, when the native valve is a native tricuspid valve, the distal anchoring element can be placed within the right ventricular outflow tract (e.g., the pulmonary artery). In some cases, the distal anchoring element can engage subannular tissue to at least partially secure the distal portion of the valve to the annular tissue, while the remainder of the valve remains in a supraannular position within the atrial side of the heart.

[0171] In some embodiments, method 10 can optionally include holding the prosthetic valve at an angle relative to the annulus of the native valve. The angle can be, for example, an oblique angle relative to the annulus. In some cases, holding the valve at an angle relative to the annulus can allow blood to partially pass through the annulus of the native valve and around the prosthetic valve, and partially pass through the prosthetic valve from the atrium to the ventricle, which can allow the function of the prosthetic valve to be evaluated.

[0172] At 14, when the proximal anchoring element is in the first configuration, the prosthetic valve is positioned in the annulus of the native valve. The proximal anchoring element may have a first configuration and a second configuration. As described in detail above for specific embodiments, the proximal anchoring element may be maintained in a compressed, restrained, tethered and / or otherwise released state when in the first configuration (e.g., by stretching the member, etc.). When the proximal anchoring element is in the first configuration, the lower portion of the valve (e.g., the portion below the annulus) may have a size that allows the valve to extend through the annulus of the native valve.

[0173] At 15, after the prosthetic valve is positioned in the annulus, the proximal anchoring element is transformed from its first configuration to its second configuration. As described in detail above for specific embodiments, the proximal anchoring element can extend away from the body or trans-annular portion of the valve. The proximal anchoring element can engage the subannular tissue on the proximal side of the annulus, thereby at least partially securing the proximal side of the prosthetic valve to the proximal annular tissue. In some embodiments, the atrial ring of the valve, etc., and the distal and proximal anchoring elements can exert opposing forces on the annular tissue that can secure the prosthetic valve to the annulus of the native valve. In some embodiments, the valve may include one or more additional anchors, etc., which can provide additional fastening, as described in the '957 PCT.

[0174] It will be apparent to those skilled in the art that many modifications and variations may be made without departing from its spirit and scope. In addition to the methods and devices listed herein, functionally equivalent methods and devices within the scope of the present disclosure will be apparent to those skilled in the art from the foregoing description. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is limited only by the terms of the appended claims and the full range of equivalents to which such claims are entitled. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions, or biological systems, which methods, reagents, compounds, compositions, or biological systems may of course vary. It should also be understood that the terms used herein are merely to describe specific embodiments and are not intended to be limiting.

[0175] Although various embodiments have been described above, it should be understood that they are presented as examples only, and are not intended to be limiting. When the above method indicates that certain events occur in a certain order, the order of certain events can be modified. In addition, when possible, certain events can be performed simultaneously in a parallel process, or can be performed in sequence as described above.

[0176] When the schematic diagrams and / or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of the components may be modified. Although embodiments have been specifically shown and described, it should be understood that various changes may be made in form and detail. Except for mutually exclusive combinations, any part of the apparatus and / or method described herein may be combined in any combination. Embodiments described herein may include various combinations and / or sub-combinations of the functions, components and / or features of the different embodiments described.

Claims

1. A prosthetic heart valve, include: a valve frame having a central axis and defining a hole extending along the central axis, the valve frame comprising a distal anchoring element and a proximal anchoring element; and a flow control member mounted in the hole and configured to allow blood to flow from an inflow end to an outflow end of the flow control member in a first direction substantially parallel to the central axis and to prevent blood from flowing in a second direction opposite to the first direction, the valve frame having a compressed configuration to allow the prosthetic heart valve to be delivered to a patient's heart via a delivery catheter, the valve frame being configured to transition from the compressed configuration to an expanded configuration when the prosthetic heart valve is released from the delivery catheter, The prosthetic heart valve is configured to be positioned in the annulus of the native valve of the heart when in the expanded configuration, the distal anchoring element and the proximal anchoring element are configured to be inserted through the annulus of the native valve before the prosthetic heart valve is positioned in the annulus of the native valve, and the proximal anchoring element is configured to transform from a first configuration to a second configuration after the prosthetic heart valve is positioned in the annulus of the native valve.

Images