Devices and methods for delivery of prosthetic heart valves using supraannulus supports

Abstract

A delivery system includes a delivery sheath in which a control device and at least one supraannular support are movable through a lumen of the delivery sheath. The control device includes a connection member coupled to a distal end of the control catheter. The connecting member is configured to be removably coupled to the prosthetic valve at a proximal location along a supraannulus portion of the prosthetic valve. The control device is operable to advance the prosthetic valve through the delivery sheath in a compressed configuration and to at least partially deploy the prosthetic valve into a native valve annulus in an expanded configuration. One or more supraannulus supports are removably coupleable at one or more locations along a supraannulus portion of the prosthetic valve and are configured to stabilize or actuate at least a portion of the prosthetic valve relative to an annulus plane of a native heart valve during deployment.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefits of the following U.S. provisional patent applications: U.S. Provisional Patent Application No. 63 / 510,699, entitled “Devices and Methods for Delivering a Prosthetic Heart Valve using Supra-Annular Support,” filed on June 28, 2023; U.S. Provisional Patent Application No. 63 / 505,966, entitled “Devices and Methods for Delivering a Prosthetic Heart Valve using Supra-Annular Support,” filed on June 2, 2023; and U.S. Provisional Patent Application No. 63 / 379,569, entitled “Devices and Methods for Delivering a Prosthetic Heart Valve using aSupra-Annular Support,” filed on October 14, 2022, the entire disclosure of each of the above applications being incorporated herein by reference in its entirety. Technical Field

[0003] Embodiments described herein relate generally to transcatheter prosthetic heart valves, and more particularly to devices, systems and / or methods for delivering laterally deliverable transcatheter prosthetic heart valves using one or more supra-annular supports and / or actuators (e.g., one or more tethers). Background Art

[0004] Prosthetic heart valves can bring challenges to delivery, deployment and / or retrieval within the heart, especially for delivery by catheter through the patient's vascular system rather than by surgical methods. The delivery of traditional transcatheter prosthetic valves generally includes compressing the valve in a radial direction and loading the valve into a delivery catheter so that the center valve ring axis of the valve is parallel to the longitudinal or longitudinal axis of the delivery catheter. In other words, the traditional prosthetic valve is loaded into the delivery catheter so that the radial range of the valve is aligned with and / or fitted within the radial range of the lumen extending through the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the center valve ring axis. However, the patient's vascular system imposes restrictions on the diameter of the delivery catheter, which in turn limits the radial range of the lumen extending through the delivery catheter, and thereby limits the expansion size (e.g., diameter) of the prosthetic valve delivered using traditional radial compression delivery methods. The competing interests of minimizing the size of the delivery catheter bring challenges to increasing the expansion diameter of the radial compression valve (e.g., trying to compress too much material and structure into too small a space). Furthermore, the orientation of conventional valves during deployment can present additional challenges when attempting to align the valve with the native valve annulus.

[0005] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, which can allow for an increased expanded diameter relative to conventionally delivered valves. For example, for lateral delivery, the valve can be placed in a compressed configuration or a delivery configuration and loaded into a delivery catheter so that the center annulus axis of the valve is substantially perpendicular to and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. More specifically, the valve can be compressed axially (e.g., along the center annulus axis) and laterally (e.g., perpendicular to each of the center annulus axis and the longitudinal axis of the valve) and longitudinally (e.g., in a direction parallel to the longitudinal or longitudinal axis of the delivery catheter) uncompressed or stretched. The compressed valve (e.g., a valve in a delivery configuration) can be loaded into the lumen of a delivery catheter in a lateral or orthogonal orientation, wherein the center annulus axis of the valve is substantially perpendicular to and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. Once loaded, the compressed valve can be advanced through the lumen of the delivery catheter and deployed from the end of the delivery catheter (e.g., into a chamber of the heart such as the atrium). In addition, in some cases, the lateral or orthogonal orientation of the deployed sideways delivered valve relative to the delivery catheter generally results in the valve being deployed in a desired orientation relative to the native valve annulus.

[0006] Although lateral delivery can allow for the delivery of larger valves and can simplify the process of aligning or orienting the valve relative to the native annulus relative to traditional delivery, there are challenges in placing a laterally deliverable prosthetic valve in the native annulus. For example, a traditional radially compressed valve can be maintained in an at least partially compressed state when a portion of the prosthetic valve is inserted through the annulus. Once in the desired position, the prosthetic valve can be allowed to transition to a radially uncompressed state, thereby placing the traditional delivered valve in the native annulus. On the other hand, in some tricuspid valve replacements, placing a laterally deliverable prosthetic valve can include inserting a distal portion of the valve into the annulus so that the distal wall of the valve contacts the distal wall of the annulus, the distal subannular portion, lobes, or anchors are located below the annulus and are disposed within or near the ventricular outflow tract (RVOT), and the supraannular portion of the valve (e.g., an atrial cuff or the like) is located above the annulus. Once positioned, the valve can be pivoted relative to the plane of the annulus to insert the proximal portion of the valve into / through the native annulus to position the valve. However, in some cases, it may be desirable to increase the stability of such a laterally deliverable valve as the valve is being deployed (pivoted) into the annulus. It may also be desirable to reduce the likelihood that a supra-annular portion of the valve (e.g., a portion of an atrial cuff or the like) falls into the annulus and / or to reduce the amount of contact or adjust the manner in which the distal portion of the valve contacts at least a portion of the tissue that defines or surrounds the annulus.

[0007]

[0006] Therefore, a need exists for devices, systems, and / or methods for delivering a laterally deliverable transcatheter prosthetic heart valve using one or more supra-annular supports and / or actuators (eg, one or more tethers). Summary of the invention

[0008] Embodiments described herein relate to transcatheter prosthetic heart valves that can be delivered laterally and devices, systems and / or methods for delivering the prosthetic valves using one or more supra-annular supports and / or actuators. In some embodiments, a delivery system includes a delivery sheath, wherein each of a control device and at least one supra-annular support can move through the lumen of the delivery sheath. The control device includes a control catheter and a connecting member, and the connecting member is connected to the distal end of the control catheter. The connecting member is configured to be removably connected to the prosthetic valve at a proximal position along the supra-annular portion of the prosthetic valve. The control device is operable to advance the prosthetic valve through the delivery sheath in a compressed configuration and to deploy the prosthetic valve at least partially into the annulus of the native valve in an expanded configuration. One or more supra-annular supports can be removably connected to the prosthetic valve at one or more positions along its supra-annular portion and are configured to stabilize or actuate at least a portion of the prosthetic valve relative to the annular plane of the native heart valve during deployment. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figures 1 to 6 is a schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0010] Figure 7 and Figure 8 3 are elevated side and bottom perspective views, respectively, of a prosthetic valve according to an embodiment.

[0011] Fig. 9 yes Figure 7 An elevated side perspective view of the supra-annular region of an outer support frame of a prosthetic valve is shown.

[0012] Fig.10 yes Figure 7 A distal perspective view of the trans-annular region of the outer support frame of a prosthetic valve is shown.

[0013] Fig.11 yes Figure 7 A distal perspective view of the subannular region of an outer support frame of a prosthetic valve is shown.

[0014] Fig.12 is Figure 7 A top perspective view of an internal frame of a flow control component included in a prosthetic valve is shown.

[0015] Fig.13 is a side perspective view of a leaflet band of an inner flow control component having leaflet pockets sewn into a structural band and shown in a position suitable for coupling to Fig.12 The inner frame is in a cylindrical configuration.

[0016] Fig.14 is in a cylindrical configuration Fig.13 A bottom view of a leaflet band is shown, and showing the partial docking of the leaflets to form a partially closed fluid seal.

[0017] Fig.15 and Fig.16 yes Figure 7 An elevated side perspective view of a prosthetic valve removably coupled to a distal end portion of a control device included in a delivery system.

[0018] Fig.17 is a schematic diagram of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0019] Fig.18 is a schematic diagram of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0020] Fig.19 and Fig. 20 is a side view fluoroscopic image showing the delivery system engaged with a prosthetic valve during deployment, shown in a state prior to seating the valve in the annulus ( Fig.19 ) and in a state during and / or after the valve is at least partially positioned in the annulus ( Fig. 20 ).

[0021] Fig.21 is a top perspective view of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0022] Fig. 22 is a top perspective view of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0023] Fig.23 is a top perspective view of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) for delivering and deploying the prosthetic valve into the annulus of a native heart valve, according to an embodiment.

[0024] Fig.24 and Fig.25 is a side view of a prosthetic valve and delivery system (or portions thereof) showing a distal portion or supra-annular region of the valve in a first state and a second state, respectively.

[0025] Fig.26 is a flow chart illustrating a method of delivering and deploying a laterally deliverable transcatheter prosthetic valve into the annulus of a native valve, according to an embodiment. DETAILED DESCRIPTION

[0026] The disclosed embodiments relate to laterally deliverable transcatheter prosthetic heart valves and / or components thereof and devices, systems and / or methods for delivering and deploying the prosthetic valves into the annulus of a native valve using one or more supra-annular supports. In some embodiments, a delivery system includes a delivery sheath, wherein each of a control device and at least one supra-annular support can move through the lumen of the delivery sheath. The control device includes a control catheter and a connecting member, which is connected to the distal end of the control catheter. The connecting member is configured to be removably connected to the prosthetic valve at a proximal position along the supra-annular portion of the prosthetic valve. The control device is operable to advance the prosthetic valve through the delivery sheath in a compressed configuration and to deploy the prosthetic valve at least partially into the annulus of the native valve in an expanded configuration. One or more supra-annular supports can be removably connected to the prosthetic valve at one or more positions along its supra-annular portion and are configured to stabilize or actuate at least a portion of the prosthetic valve relative to the annular plane of the native heart valve during deployment.

[0027] In some embodiments, a delivery system includes a delivery sheath, wherein each of a control device and an supra-annular support member is movable through a lumen of the delivery sheath. The control device includes a connecting member that is coupled to a distal end of a control catheter and is configured to be removably coupled to a proximal supra-annular portion of a prosthetic valve. The control device is operable to advance the prosthetic valve through the delivery sheath in a compressed configuration and to deploy the prosthetic valve into a native valve annulus in an expanded configuration. The supra-annular support member is removably coupled to a distal supra-annular portion of the prosthetic valve and is configured to transition from a first state to a second state when the prosthetic valve is in an expanded configuration. The supra-annular support member in the second state forms a substantially fixed length connection between the delivery sheath and the distal supra-annular portion of the prosthetic valve.

[0028] In some embodiments, a method for delivering and / or deploying a laterally deliverable prosthetic valve into the annulus of a native valve of a heart includes removably connecting a control device and an annular support to the annular portion of the prosthetic valve. In some embodiments, the control device can be removably connected to the proximal annular portion of the prosthetic valve, while the annular support is removably connected to the distal annular portion of the prosthetic valve. The control device and the prosthetic valve in a compressed configuration advance through the lumen of a delivery catheter to place the distal end portion of the control device and the prosthetic valve in a chamber of the heart. The prosthetic valve is configured to be converted to an expanded configuration when in a chamber of the heart. In the case where the prosthetic valve is in a chamber of the heart, the annular support is converted from a first state to a second state. In some embodiments, converting the annular support from a first state to a second state can allow the annular support to form a substantially rigid connection between the distal end of the delivery sheath and the distal annular sub-portion of the prosthetic valve. In some embodiments, transitioning the supra-annular support from a first state to a second state can actuate the supra-annular portion of the prosthetic valve (e.g., can cause at least a portion of the supra-annular portion of the prosthetic valve to move, bend, flex, and / or otherwise reconfigure). While the supra-annular support is in the second state, the prosthetic valve is positioned in the native annulus. After placement, each of the control device and the supra-annular support is disengaged from the prosthetic valve. In some embodiments, disengaging the supra-annular support can, for example, include withdrawing the guidewire catheter into the delivery sheath to release the distal end portion of the supra-annular support.

[0029] Any prosthetic valve described herein can be a relatively low-profile transcatheter prosthetic heart valve. The prosthetic heart valve herein can have a valve frame and a flow control component mounted in a central lumen, orifice and / or channel of the valve frame, wherein the central lumen, orifice and / or channel extend along the central axis of the valve or valve frame, and the central axis is coaxial or at least substantially parallel to the direction of blood flow through the valve. The valve frame can provide structural support for the prosthetic valve and / or at least the flow control component mounted thereon. The valve frame can also provide one or more components or elements for anchoring or otherwise fixing the prosthetic valve in the annulus of the native valve. The flow control component (e.g., a 2-leaflet or 3-leaflet sleeve, valve and / or the like) can be configured to allow blood to flow through the inflow end of the valve and the outflow end of the valve in a first direction, and to prevent blood from flowing in a second direction opposite to the first direction.

[0030] Unless otherwise expressly set forth, any delivery and / or deployment system and / or method described herein may be used and / or implemented for a conventionally deliverable valve or an orthogonally / laterally deliverable valve. For example, the valve described herein may be configured to transition between a compression or delivery configuration for introduction into the body via a delivery catheter and an expansion or deployment / deployed configuration for implantation at a desired position in the body (e.g., via balloon inflation or via one or more self-expanding structures). The delivery catheter may be, for example, a 24-36 French (Fr) delivery catheter that advances through the patient's vascular system into a chamber of the heart. In general, a conventionally delivered / conventionally deliverable valve is configured to be compressed, for example, in a radial direction relative to a central axis or in a blood flow direction through the valve, and is inserted into and / or advanced through a delivery catheter so that the central axis of the compressed valve is parallel to the longitudinal or longitudinal axis of the delivery catheter for delivering the valve. The valve is deployed from the end of the delivery catheter and expands outwardly in a radial direction from the central cylindrical axis. Delivery orientation of the valve generally means that the valve is completely released from the delivery catheter while in the atrium of the heart and reoriented relative to the annulus, which in some cases can limit the size of the valve. Thus, in some embodiments, conventional delivery can be used for relatively small diameter valves, such as prosthetic pulmonary and / or aortic valves.

[0031] Orthogonally or laterally delivered / orthogonally or laterally deliverable valves are configured to be compressed in at least one of a lateral direction (orthogonal to the direction of blood flow through the valve) or an axial direction (parallel to or aligned with the direction of blood flow). In some embodiments, any valve can be compressed in two directions, i.e., a lateral direction and an axial direction, without compressing the valve in a direction along the longitudinal or longitudinal axis of the valve (orthogonal to the direction of blood flow through the valve). In the case of orthogonal or lateral delivery, the compressed valve can be inserted and / or advanced through a delivery catheter so that the central axis of the compressed valve is substantially orthogonal to or perpendicular to the longitudinal or longitudinal axis of the delivery catheter. In other words, in orthogonal or lateral delivery, the longitudinal or longitudinal axis of the valve can be substantially parallel to the longitudinal or longitudinal axis of the delivery catheter through which the valve is delivered. Therefore, compared to the conventional process of compressing and delivering a transcatheter prosthetic valve, the orthogonally delivered and / or laterally delivered prosthetic valve is compressed and / or delivered laterally (e.g., at an angle of approximately 90 degrees).

[0032] In some embodiments, the orientation of an orthogonally delivered valve relative to the annulus can allow a distal portion of the valve to be at least partially inserted into the annulus of a native heart valve while a proximal portion of the valve is at least partially retained in a delivery catheter, thereby avoiding at least some of the size limitations faced by some known conventional delivery techniques. For example, a relatively large laterally deliverable prosthetic valve can have a height of about 5 millimeters (mm) to 60 millimeters (mm) and a diameter of about 20 mm to 80 mm in an expanded configuration, and can have a height of about 5 mm to 12 mm, a width of about 8 mm to 12 mm (e.g., in a lateral direction), and a length of about 25 mm to 80 mm (e.g., in a longitudinal or lengthwise direction) in a compressed configuration. In addition, orthogonal or lateral delivery can allow the valve to be deployed from the inferior vena cava (IVC) into the annulus of a native mitral or tricuspid valve without positioning the delivery catheter at an acute angle relative to the native valve, which is otherwise common in conventional transcatheter delivery.

[0033] Although valves configured for orthogonal delivery can allow for the deployment of relatively large valves, conventionally delivered valves are configured to be radially compressed during delivery, and in some cases such radial compression can aid in the process of placing some conventionally delivered prosthetic valves in the annulus of a native heart valve. For example, such a valve can be at least partially radially compressed to allow a portion of the prosthetic valve to fall into the annulus. Once the valve is in the desired position, the valve can be transformed and / or allowed to transition to a radially expanded (or radially uncompressed) state, thereby placing the prosthetic valve in the annulus of the native heart valve. On the other hand, the process of deploying and / or placing certain orthogonally delivered prosthetic valves can include inserting a distal portion of the prosthetic valve through the annulus and then pivoting one or more remaining portions of the valve into the desired position. In some cases, such differences in the process of positioning the valve in the annulus may give rise to a need for additional features and / or methods that may increase the stability of the orthogonally delivered valve during deployment (positioning) into the native annulus, such as any of those described herein.

[0034] Any prosthetic heart valve described herein may include an external support frame including and / or forming a supra-annular region, a sub-annular region, and a trans-annular region connected therebetween. The supra-annular region may form, for example, an upper collar portion of the external support frame, and may include any number of features configured to engage with autologous tissue, internal flow control components of the prosthetic valve, and / or delivery, actuator, and / or retrieval mechanisms. The sub-annular region may form, for example, one or more anchoring elements configured to engage sub-annular (ventricular) tissue when the prosthetic valve is positioned in the autologous annulus. The trans-annular region may be connected between the supra-annular region and the sub-annular region. When the external support frame is in an expanded configuration, the trans-annular region may form, for example, a funnel, a cylinder, a flat cone, or a circular hyperboloid.

[0035] In some embodiments, the external support frame comprises and / or is at least partially formed of a wire, braided wire, or laser-cut wire frame and is at least partially covered with a biocompatible material. For example, the external support frame and / or at least its cross-annular region may include and / or form a set of compressible wire monomers, such as braided wire monomers, laser-cut wire monomers, photolithographically generated wire monomers, 3D-printed wire monomers, wire monomers formed by intermittently connected single strands of wavy, zigzag, or spiral-shaped wires, and / or combinations thereof. In some embodiments, the compressible wire monomers may have an orientation and a monomer geometry that is substantially orthogonal to the central axis so as to reduce or substantially minimize wire monomer strain when the external support frame is in a delivery configuration (e.g., a compressed, coiled, and / or folded configuration).

[0036] Any of the prosthetic heart valves described herein (and / or their external frames) can include a single anchoring element or multiple anchoring elements (e.g., a subannular anchoring element, an supraannular anchoring element, and / or a combination thereof) configured to anchor the valve in the annulus of a native valve. For example, in some embodiments, the prosthetic valve and / or external frame can include one or more of the following: a distal subannular anchoring element configured to engage with ventricular tissue distal to the annulus (e.g., can extend into the right ventricular outflow tract (RVOT)); a proximal subannular anchoring element configured to engage with ventricular tissue proximal to the annulus (e.g., between the septal leaflets and the posterior leaflets of the heart); a septal anchoring element configured to engage with at least one of the native septal wall or the native septal leaflets when the prosthetic heart valve is positioned in the annulus (e.g., to pin at least the native septal leaflets away from the docking leaflets of the prosthetic valve); and / or any other suitable anchoring element. In some embodiments, one or more of the subannular anchoring elements can stabilize the valve against intraannular coiling and / or torsional forces, etc., that may affect the desired position or positioning of the prosthetic valve within the annulus (e.g., tilting, angulation, twisting, coiling, etc.).

[0037] Any prosthetic valve and / or its external frame may also, for example, include distal and / or proximal upper anchoring elements configured to be positioned in a supra-annular position in contact with and / or adjacent to supra-annular tissue of the right atrium. In some embodiments, one or more upper anchoring elements may be configured to exert a force on supra-annular tissue, and one or more lower anchoring elements may be configured to exert a force in an opposite direction on sub-annular tissue, thereby securing the prosthetic valve in the native annulus. In some embodiments, one or more anchoring elements may include and / or may be formed from a wire ring or wire frame extending from the frame (e.g., about 10 mm to 40 mm away from the periphery of at least a corresponding portion of the frame), an integrated frame segment and / or a stent.

[0038] Any of the prosthetic valves described herein may include an internal flow control component having a leaflet frame on which 2 to 4 flexible leaflets are mounted. The 2 to 4 leaflets are configured to allow blood to flow through the inflow end of the valve and the outflow end of the valve in a first direction, and to block blood flow in a second direction opposite to the first direction. The leaflet frame may include any number of panels or walls of a diamond or eye-shaped wire monomer made of a heat-set shape memory alloy material such as nickel-titanium alloy (e.g., Nitinol®). The leaflet frame may be configured to be foldable from a circular or cylindrical configuration to a flat cylindrical configuration along the z-axis (e.g., the longitudinal axis), and compressible to a compressed configuration along the vertical y-axis (e.g., the central axis). In some embodiments, the leaflet frame may include a pair of hinge regions, folding regions, connection points, etc., which may allow the leaflet frame to be folded flat along the z-axis before the leaflet frame is compressed along the vertical y-axis. For example, the leaflet frame can be a one-piece structure with two or more living hinges (e.g., one or more stress concentrating risers and / or any suitable structure configured to allow elastic / non-permanent deformation of the leaflet frame), or can be a two-piece structure that uses a secondary attachment method (e.g., sutures, fabrics, molded polymer components, etc.) to form the hinge area. In some embodiments, the internal flow control component in the expanded configuration forms a shape such as a funnel, a cylinder, a flat cone, or a circular hyperboloid. In some embodiments, the internal flow control component has a leaflet frame having a side profile in the shape of a flat cone, the side profile having an outer diameter R of about 20 mm to 60 mm, an inner diameter r of about 10 mm to 50 mm (wherein the diameter R is greater than the diameter r), and a height of about 5 mm to 60 mm. In some embodiments, the leaflet frame is composed of a wire, a braided wire, or a laser cut wire frame.

[0039] Any prosthetic valve and / or its components can be made of any suitable biocompatible material or combination of biocompatible materials. For example, the outer valve frame, the inner valve frame (e.g., of the inner flow control component), and / or its components can be made of biocompatible metals, metal alloys, polymer-coated metals, and / or the like. Suitable biocompatible metals and / or metal alloys can include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, nickel-titanium alloys (e.g., Nitinol®), and / or the like. In addition, any outer frame or inner frame described herein can be formed of a superelastic or shape memory alloy, such as a nickel-titanium alloy (e.g., Nitinol®). Synthetic biocompatible materials can, for example, include polyesters, polyurethanes, elastomers, thermoplastics, thermoplastic polycarbonate polyurethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketones (PEEK), silicone-polycarbonate polyurethanes, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefins, polyethylene glycols, polyether sulfones, polysulfones, 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) copolymers (PDLA), silicone polyesters, polyamides (nylons), polytetrafluoroethylene (PTFE) (e.g., Teflon), elongated PTFE, expanded PTFE, siloxane polymers and / or oligomers, polylactones and / or the like or block copolymers thereof.

[0040] Any prosthetic valve and / or its components may include and / or may be formed with one or more biocompatible coatings and / or the like. Suitable polymer coatings may, for example, include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), solute styrene isoprene butadiene (SIBS) copolymers, polylactic acid, polyester, polylactide, D-lactic acid polylactic acid (DLPLA), polylactic acid-co-glycolic acid (PLGA), and / or the like. Some such polymer coatings may form a suitable carrier matrix for drugs, such as Sirolimus, Zotarolimus, Biolimus, Novolimus, Tacrolimus, Paclitaxel, Probucol, and / or the like.

[0041] Any external valve frame, internal flow control frame and / or parts or components thereof may be partially or completely covered internally or externally with an autologous or synthetic biocompatible and / or biological material (e.g., pericardium or the like). For example, where a thin, durable synthetic material (e.g., for a covering) is contemplated, a synthetic polymer material such as expanded PTFE, PET, or polyester (or any other material described herein) may optionally be used. Suitable biological materials or tissues for use as coverings or the like may, for example, include chemically stable pericardial tissue of an animal, such as a cow (bovine pericardium), a sheep (sheep pericardium), a pig (porcine pericardium), or a horse (equine pericardium). For example, suitable tissues include, but are not limited to, tissues used in the products Duraguard®, Peri-Guard®, and Vascu Guard®, products currently used in surgical procedures, products sold on the market that are typically harvested from cows under 30 months of age, and / or the like. In some embodiments, the valve can be configured such that the inner surface of the outer valve frame (e.g., a wire frame monomer) is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material (or vice versa), or both the inner and outer surfaces are covered with pericardial tissue or a woven synthetic polyester material.

[0042] Any method for delivering and / or deploying a prosthetic heart valve described herein may include delivering the prosthetic heart valve to the native annulus of a human heart, including advancing a delivery catheter to at least one of the following: (i) via the femoral vein through the inferior vena cava (IVC) or via the jugular vein through the superior vena cava (SVC) to the tricuspid valve or pulmonary artery of the heart, or (ii) via a transatrial approach (e.g., fossa ovalis or inferior), via the IVC femoral artery or SVC jugular approach to the mitral valve or aortic valve of the heart. One or more prosthetic valves are removably connected to a portion of a delivery system, placed in a compressed or delivery configuration, loaded into a delivery device and / or delivery catheter, and advanced through the lumen of the delivery catheter. Then, one or more prosthetic valves can be released from the distal end of the delivery catheter, which is placed in the atrium of the heart using the IVC femoral artery or SVC jugular approach. When released from the delivery catheter, one or more prosthetic valves are allowed to transition to an expanded or released configuration.

[0043] Any method for delivering and / or deploying a prosthetic valve described herein may include positioning the valve or a portion thereof in a desired position relative to autologous tissue. For example, a method may include inserting a distal subannular anchoring element of a prosthetic valve through the annulus of a native tricuspid valve and into, for example, the right ventricular outflow tract (RVOT) of the right ventricle. In some embodiments, the method may include partially inserting the prosthetic valve into the annulus (e.g., of a native tricuspid valve) so that its distal portion contacts the autologous annular tissue while the proximal portion of the prosthetic valve is at least partially compressed and placed in a delivery catheter. In some embodiments, the method may include rotating the prosthetic heart valve along an axis parallel to the plane of the valve annulus using a steerable control catheter, a yoke, a set of tethers, an actuator, and / or any other portion of a delivery / deployment system (or a combination thereof). In some embodiments, the method may include transforming one or more anchoring elements into a desired position and / or state to engage autologous tissue surrounding at least a portion of the annulus. In some embodiments, one or more tissue anchors can be attached to the valve and native tissue to secure the valve in a desired position.

[0044] Any delivery and / or deployment system described herein may include an outer catheter (e.g., a delivery catheter), a control catheter, and / or other suitable one or more parts, which may include one or more components, parts, features, and / or the like, which are configured to facilitate delivery and / or deployment of the valve into the annulus of the native heart valve. For example, in some embodiments, the delivery and / or deployment system may include any number of supports or the like, which may be at least temporarily coupled to the prosthetic valve, such as to support, stabilize, actuate, and / or control one or more parts of the prosthetic valve during deployment. Some such supports or the like may be and / or may include tethers, sutures, tensile or tension members, rods, cables, wires, catheters, hypotubes, connectors, couplers, and the like. In such embodiments, the supports may engage one or more parts of the prosthetic valve to support, stabilize, actuate, and / or control the prosthetic valve (e.g., during deployment), and then once the prosthetic valve is positioned in the annulus of the native valve in a desired manner, orientation, and the like, the supports may be detached and / or removed from the prosthetic valve. For example, certain embodiments described herein may include one or more supports configured to removably couple to a supra-annular portion of a prosthetic valve so as to at least partially support, stabilize, actuate, control, etc. the prosthetic valve and / or at least one or more portions thereof.

[0045] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the full scope of the claims. Unless otherwise defined, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0046] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. With respect to the use of substantially any plural and / or singular terms herein, one skilled in the art can translate from the plural to the singular and / or from the singular to the plural as required by the context and / or application. For clarity, various singular / plural arrangements may be expressly set forth herein.

[0047] In general, the terms used herein, and particularly in the appended claims (e.g., the subject matter of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be understood as "having at least", etc.). Similarly, when used in this specification, the terms "comprises" and / or "comprising" specify the presence of the recited features, integers (or fractions thereof), steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers or portions thereof, steps, operations, elements, components, and / or groups thereof. As used in this document, the term "including" means "including but not limited to".

[0048] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It should be understood that any suitable separator and / or phrase presenting two or more alternative terms, whether in the specification, claims or drawings, contemplates the possibility of including one of the terms, any term, or both / all terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B".

[0049] Unless otherwise expressly stated, all ranges disclosed herein also include any and all possible subranges and combinations of subranges thereof. Unless otherwise expressly stated, any listed range should be considered to fully describe and be able to decompose the same range into at least equal sub-portions. As will be understood by those skilled in the art, a range includes each individual member.

[0050] The terms "prosthetic heart valve" and / or "prosthetic valve" may refer to a combination of a frame and leaflets or flow control structure or component, and may 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). As used herein, the term "valve" may be used to refer to either a "prosthetic valve" or a "native valve" and will be understood in the specific context in which the term is used.

[0051] The prosthetic valves disclosed herein may include a component (e.g., a "frame") that can be positioned within the annulus of a native valve and can be used as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve valve. Depending on the embodiment, such a component may or may not include such a leaflet structure or flow control component. Such components may be referred to herein as a "valve annulus support frame," "wire frame," "valve frame," "flange," "ring," "cuff," and / or any other similar term.

[0052] The term "flow control assembly" can refer in a non-limiting sense to a leaflet structure with 2, 3, or 4 leaflets of a flexible biocompatible material, for example, a processed or unprocessed pericardium that can be sutured, joined and / or mounted on a valve ring support frame to act as a prosthetic heart valve. Such a valve can be a heart valve, for example, a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, which is open to blood flowing during diastole from the atrium to the ventricle, and is closed by systolic ventricular pressure applied to the outer surface. The opening and closing repeated in sequence can be described as "reciprocating". The flow control component is expected to include a wide variety of (bio)prosthetic artificial heart valves and / or components. For example, such (bio)prostheses may include ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilted disc valves (e.g., BjorkShiley), stented pericardial valves (bovine, porcine, ovine) (Edwards' biovalve series, St. Jude prosthetic valves), as well as homograft and autograft valves. Bioprosthetic pericardial valves may include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0053] The term "anchoring element" or "tab" or "arm" refers to a structural element that extends from a portion of a valve or valve frame to provide an anchoring or stabilizing function to the valve (e.g., extending away from the valve sidewall, body, or collar). When used in conjunction with the terms "distal," "proximal," "septum," and / or "anterior," it is understood that the anchoring or stabilizing element so described is attached to and / or integral with the valve (or valve frame) at a distal, proximal, septum, and / or anterior location, respectively. A distal location on the valve refers to the portion of the valve farthest from the physician, which portion of the valve exits the delivery catheter first, and may be placed at or near the distal subannular native tissue (e.g., the ventricular outflow tract). A proximal location on the valve refers to the portion of the valve closest to the physician, which portion of the valve exits the delivery catheter last, and may be placed at or near the proximal subannular native tissue (e.g., tissue closest to the inferior vena cava). A septal position on the valve refers to a portion of the valve at a point between a proximal position and a distal position, and the portion of the valve can be placed at or near native tissue (e.g., septal leaflets or septal wall) beneath the septal annulus. An anterior position on the valve refers to a portion of the valve at a point between a proximal position and a distal position, and the portion of the valve can be placed at or near anterior tissue opposite to the septal tissue. When used in conjunction with the terms "inferior" or "subannular," it should be understood that the anchoring or stabilizing element so described is attached to and / or integral with the valve sidewalls, body, and / or frame at or along the inferior or subannular region of the valve. In contrast, when used in conjunction with the terms "upper" or "supra-annular," it will be understood that the anchoring or stabilizing element so described is attached to and / or integral with the valve or frame at or along a supra-annular region, ring, or atrial cuff of the valve.

[0054] Any disclosed valve embodiment can be delivered via a transcatheter approach. The term "transcatheter" is used to define the process of approaching, controlling and / or delivering a medical device or instrument within the lumen of a catheter deployed into a cardiac chamber (or other desired location in the body), and to define items that have been delivered or controlled by such a process. Known transcatheter approaches include approaching the heart via the lumen of the femoral artery and / or vein and IVC, via the lumen of the brachial artery and / or vein, via the lumen of the carotid artery, via the lumen of the jugular vein and SVC, via the intercostal (costal) and / or subxiphoid space and / or the like. In addition, transcatheter approaches to the heart can also include accessing the left atrium and / or ventricle via an atrial (e.g., fossa ovalis or lower) approach. Transcatheter can be synonymous with transcavitary, and is functionally related to the term "percutaneous" when it comes to the delivery of a heart valve.

[0055] As used herein, the terms "orthogonal delivery," "orthogonally delivered," "lateral delivery," "laterally deliverable," "laterally deliverable," and / or the like may be used interchangeably to describe such a delivery method and / or a valve delivered using such a method. The term "orthogonal" refers to an angle of 90 degrees between two lines or two planes (e.g., perpendicular). As used herein, the term "substantially orthogonal" refers to an angle of 90 degrees plus or minus an appropriate tolerance. For example, "substantially orthogonal" may refer to an angle within the range of 75 to 105 degrees. Orthogonal and / or lateral delivery of a prosthetic valve may be such that a central axis of the valve is substantially orthogonal to the lengthwise or longitudinal axis of the delivery catheter (e.g., the valve is oriented laterally relative to a conventional radial compression valve).

[0056] The mode of approach to the heart can be based at least in part on a "body passage" used to define blood conduits or vessels within the body, and the specific application of the disclosed prosthetic valve embodiments can determine the body passage in question. For example, an aortic valve replacement would be implanted within or near the aortic valve annulus. Similarly, a tricuspid or mitral valve replacement would be implanted at the tricuspid annulus or mitral annulus, respectively. Although certain features described herein may be particularly advantageous for a given implantation site, any valve embodiment described herein may be implanted in any body passage unless a combination of features is structurally impossible or excluded by the claim language.

[0057] As used herein, the terms "expandable" and / or "compressible" can refer to a prosthetic heart valve or component of a prosthetic heart valve that is capable of expanding and / or compressing from a first size or configuration to a second size or configuration. For example, a prosthetic valve can be "compressible" to a delivery size or configuration and / or "expandable" to an implantation or deployment size or configuration. Thus, unless the context clearly indicates otherwise, an "expandable" / "compressible" structure is not intended to refer to a structure that may undergo slight expansion / compression, for example, due to temperature changes or other such incidental causes. Conversely, "non-expandable" / "non-compressible" should not be interpreted to mean completely rigid or dimensionally stable, as, for example, some slight expansion / compression may be observed with conventional "non-expandable" / "non-compressible" heart valves.

[0058] The prosthetic valves and / or components thereof disclosed herein are generally capable of transitioning between two or more configurations, states, shapes, and / or arrangements. For example, the prosthetic valves described herein may be compressible and / or expandable between any suitable number of configurations. Various terms may be used to describe or refer to these configurations, and are not intended to be restrictive, unless the context clearly indicates otherwise. For example, a prosthetic valve may be described as being placed in a "delivery configuration," which may be any suitable configuration that allows or enables the delivery of a prosthetic valve. Examples of delivery configurations may include a compressed configuration, a folded configuration, a coiled configuration, and / or a similar configuration, or any suitable combination thereof. Similarly, a prosthetic valve may be described as being placed in an "expanded configuration," which may be any suitable configuration that is not explicitly intended for the delivery of a prosthetic valve. Examples of expanded configurations may include a release configuration, a relaxed configuration, a deployment configuration, a non-delivery configuration, and / or a similar configuration, or any suitable combination thereof. Some prosthetic valves described herein and / or their components or features can have many additional configurations, which can be associated with various modes, levels, states and / or parts of actuation, deployment, engagement, etc. Examples of such configurations can include an actuation configuration, a placement configuration, a safety configuration, an engagement configuration and / or a similar configuration or any suitable combination thereof. Although specific examples are provided above, it should be understood that they are not intended to be an exhaustive list of configurations. Other configurations will also be possible. In addition, various terms can be used to describe the same or substantially similar configurations, and thus unless these terms and / or configurations are mutually exclusive or the context clearly stipulates otherwise, the use of specific terms is not intended to limit and / or exclude other terms.

[0059] The examples and / or embodiments described herein are intended to facilitate understanding of the structure, function and / or aspects of the embodiments, the manner in which the embodiments can be practiced and / or to further enable those skilled in the art to practice the embodiments herein. Similarly, the methods and / or approaches for using the embodiments described herein are provided only as examples and not limitations. Unless the context clearly indicates otherwise, the specific uses described herein do not exclude other uses. For example, any prosthetic valve described herein can be used to replace a native valve of a human heart, including a mitral valve, a tricuspid valve, an aortic valve and / or a pulmonary valve. Although some prosthetic valves are described herein in the context of replacing a native mitral valve or a native tricuspid valve, it should be understood that such prosthetic valves can be used to replace any native valve unless otherwise clearly indicated, or unless a person skilled in the art will clearly recognize that one or more components and / or features will otherwise make the prosthetic valve incompatible with such use. The specific examples, embodiments, methods and / or uses described herein should not be interpreted as limiting the scope of the inventive concept herein. Rather, examples and embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art.

[0060] The embodiments herein and / or their various features or 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. Descriptions of well-known components and processing techniques are omitted so as not to obscure the embodiments herein. Similar reference numerals refer to similar elements throughout the text. Discussion of various embodiments, components and / or features of one or more prosthetic valves (e.g., laterally deliverable transcatheter prosthetic heart valves) is followed by a discussion of delivery / deployment systems and methods of using such systems to deliver and / or deploy prosthetic valves into the annulus of a native heart valve.

[0061] Figures 1 to 6 1 is a schematic diagram of a laterally deliverable transcatheter prosthetic heart valve 100 (also referred to herein as a "prosthetic valve" or simply a "valve") according to an embodiment. As further described in detail herein, the valve 100 generally includes a valve ring support frame 110 and a flow control component 150 mounted within the valve ring support frame 110. In addition, Figures 1 to 6At least a portion of a delivery / deployment system 180 is shown, which can at least temporarily couple and / or otherwise engage the valve 100 and / or portions thereof to facilitate delivery and / or deployment of the valve 100 into a desired location in the body. For example, the delivery / deployment system 180 can be used to deliver and deploy the prosthetic valve 100 in the annulus of a native valve of a human heart (e.g., the tricuspid valve, mitral valve, aortic valve, and / or pulmonary valve of a human heart), and once the prosthetic valve 100 is deployed, the prosthetic valve 100 is configured to allow blood to flow from the inflow end of the prosthetic valve 100 to the outflow end of the prosthetic valve 100 in a first direction (e.g., through or via the flow control component 150), and to block blood flow in a second direction opposite to the first direction. Thus, the prosthetic valve 100 can be configured to supplement and / or replace the function of a native valve. In some embodiments, the valve 100 and / or the delivery / deployment system 180 can be similar to and / or substantially the same as one or more valves and / or one or more delivery / deployment systems described in WIPO Patent Publication No. WO 2021 / 040996, filed on August 6, 2020, entitled “Side-Deliverable Transcatheter Prosthetic Valves and Methods for Delivering and Anchoring the Same” (referred to herein as “'996 PCT”) and WIPO Patent Publication No. WO 2021 / 035032, filed on August 20, 2020, entitled “Delivery and Retrieval Devices and Methods for Side-Deliverable Transcatheter Prosthetic Valves” (referred to herein as “'032 PCT”), the entire disclosure of each of which is incorporated herein by reference in its entirety and is attached herein as Appendix A and Appendix B, respectively.

[0062] Prosthetic valve 100 is in an expanded configuration (eg, a human heart) for implantation at a desired location in the body. Figure 1 and Figure 2 ) and a compressed or delivery configuration for introduction into the body via, for example, a delivery catheter 182 of a delivery / deployment system 180 ( Figure 3 and Figure 4). The prosthetic valve 100 can be compressible and expandable in at least one direction relative to a longitudinal axis 102 (also referred to herein as a "horizontal axis," "long axis," or "longitudinal axis") of the valve 100. For example, the valve 100 can be compressible / expandable along a central axis 104, when in an expanded configuration ( Figure 1 ) The valve 100 has a first height or dimension along the central axis 104 and when in the compressed configuration ( Figure 3 ) The valve 100 has a second height or dimension along the central axis 104 that is smaller than the first height or dimension. In some embodiments, the prosthetic valve 100 can be compressible and expandable in at least two directions relative to the longitudinal axis 102 of the valve 100. For example, the valve 100 can be compressible / expandable along the central axis 104 (as just described) and can be compressible / expandable along a lateral axis 106 that is perpendicular to the longitudinal axis 102 and the central axis 104 (see, for example, Figure 1 and Figure 2 In such an embodiment, the valve 100 may be in an expanded configuration ( Figure 1 and Figure 2 ) has a first height and a first width, and the valve 100 can be in a compressed configuration ( Figure 3 and Figure 4 ) has a second height and a second width that are smaller than the first height and the first width, respectively.

[0063] When in Figure 1 , Figure 2 and Figure 6 When in the expanded configuration shown, the extent of the valve 100 in any direction orthogonal or lateral to the longitudinal axis 102 (e.g., along the central axis 104 and / or the lateral axis 106) is greater than the diameter of the lumen of the delivery catheter 182 used to deliver the valve 100. For example, in some embodiments, the valve 100 can have an expanded height (e.g., along the central axis 104) of 5 mm to 60 mm. In some embodiments, the valve 100 can have an expanded length (e.g., along the longitudinal axis 102) and width (e.g., along the lateral axis 106) of about 20 mm to 80 mm or about 40 mm to 80 mm. ... Figure 3 and Figure 4When in the compressed configuration shown, the extent of the valve 100 in any direction orthogonal or lateral to the longitudinal axis 102 (e.g., along the central axis 104 and / or the lateral axis 106) is less than the diameter of the lumen of the delivery catheter 182, thereby allowing the valve 100 to be delivered therethrough. For example, in some embodiments, the valve 100 can have a compressed height (e.g., along the central axis 104) and a compressed width (e.g., along the lateral axis 106) of about 5 mm to 15 mm, about 8 mm to 12 mm, or about 9 mm to 10 mm. The valve 100 can be compressed by compression, coiling, folding, and / or any other suitable manner or combination thereof. In some embodiments, the length of the valve 100 (e.g., along the longitudinal axis 102) is not compressed at or during delivery. Conversely, in some embodiments, the length of the valve 100 can increase in response to compression of the valve 100 along the central axis 104 and / or the lateral axis 106.

[0064] In some embodiments, the valve 100 (and / or at least a portion thereof) can be thermoformed and / or otherwise formed into any desired shape, e.g., a generally tubular shape, a generally hourglass shape, and / or the like. In some embodiments, the valve 100 can include an supra-annular segment or region (e.g., an supra-atrial cuff or flange for atrial sealing), a sub-annular segment or region (e.g., a sub-ventricular cuff or flange for ventricular sealing), and a trans-annular segment or region disposed therebetween (e.g., a main body segment, a tubular segment, a cylindrical segment, etc.). The trans-annular region can have an hourglass-shaped cross-section that occupies approximately 60% to 80% of the circumference to conform to the native annulus along the posterior annular segment and the anterior annular segment, while remaining substantially vertically flat along 20% ​​to 40% of the annular circumference to conform to the septal annulus segment.

[0065] Although the valve 100 Figures 1 to 6100 is shown as having a given shape (general shape), but it should be understood that the size and / or shape of the valve 100 (and / or at least a portion thereof) can be based on the size and / or shape of the anatomical structure of the native tissue. For example, the valve 100 can be central (e.g., radially symmetric relative to the central axis 104 (y-axis)) or eccentric (e.g., radially asymmetric relative to the central axis 104). In some eccentric embodiments, the valve 100 or its outer frame can have a complex shape determined by the anatomical structure in which the valve 100 is installed. For example, in some cases, the valve 100 can be deployed in the annulus of a native tricuspid valve, wherein the valve 100 has a circumference of a rounded elliptical shape with a substantially vertical septal wall that is known to be enlarged along the anterior-posterior line in a diseased state. In some cases, valve 100 can be deployed in the annulus of a native mitral valve (eg, near the anterior leaflet), wherein annulus 100 has a circumference with a rounded elliptical shape with a substantially vertical septal wall that is known to enlarge in disease states.

[0066] Thus, the valve 100 can have a complex shape that is at least partially determined by the native annulus of the native valve and / or the disease state. For example, the valve 100 or its outer frame can have a D-shape (viewed from the top) so that the flat or substantially flat portion can match the anatomical structure (e.g., a substantially vertical septal wall) in which the valve 100 will be deployed. In some embodiments, the valve 100 or its outer frame can have a circumference of a rounded elliptical shape, e.g., a hyperbolic paraboloid, to account for the location of the native septum, anterior leaflet and / or posterior leaflet and / or native septal wall; avoid native electrical bundles, e.g., the atrioventricular (AV) node and / or AV node-related structures such as the Triangle of Koch, AV bundles, etc.; avoid interference with coronary blood flow, e.g., the coronary sinus; accommodate changes in the septal wall that is known to be substantially vertical but expands along the anterior-posterior axis toward the free wall in a disease state; and / or the like.

[0067] As shown, the valve 100 generally includes a valve ring support frame 110 and a flow control component 150 mounted within the valve ring support frame 110. In addition, the valve 100 and / or at least the valve ring support frame 110 of the valve 100 can include a delivery / deployment system 180, can be connected to a delivery / deployment system 180, and / or can otherwise engage the delivery / deployment system 180. The valve ring support frame 110 (also referred to herein as a "valve frame", "wire frame", "external frame", "support frame", "frame", etc.) can have an upper valve ring region 120, a lower valve ring region 130, and a trans-valve ring region 112 disposed therebetween and / or coupled therebetween. In some embodiments, the frame 110 can be constructed integrally and / or unitarily. In some embodiments, one or more of the upper valve ring region 120, the lower valve ring region 130, and / or the trans-valve ring region 112 can be separate, independent, and / or modular components that are connected to form the frame 110 together. For example, in some embodiments, supra-annular region 120 may be an atrial collar, cuff, portion, and / or the like coupled to the top, upper portion, and / or upper annular edge of trans-annular region 112, and sub-annular region 130 may be a ventricular collar, cuff, portion, and / or the like coupled to the bottom, lower portion, and / or lower annular edge of trans-annular region 112. Alternatively, sub-annular region 130 may be and / or may be formed by the bottom, lower, and / or lower annular portion or segment of trans-annular region 112.

[0068] In some embodiments, a modular and / or at least partially modular configuration can allow the frame 110 to be adapted to a given size and / or shape of the anatomical structure to which the valve 100 is mounted. For example, one or more of the supra-annular region 120, the sub-annular region 130, and / or the trans-annular region 112 can be designed and / or adapted so that the support frame 110 has any desired height, outer diameter, and / or inner diameter, for example, any of those described above. In addition, such a modular configuration can allow the frame 110 to be bent, flexed, compressed, folded, rolled, and / or otherwise reconfigured without causing plastic or permanent deformation thereof. For example, the frame 110 can be compressed to a compressed or delivery configuration for delivery, and when released, the frame 110 is configured to return to its original shape (uncompressed, expanded, or released configuration) with substantially no plastic or permanent deformation.

[0069] The support frame 110 and / or the supra-annular region 120, the sub-annular region 130, and / or the trans-annular region 112 can be formed from or by any suitable material. In some embodiments, the frame 110 and / or one or more portions or regions thereof can be formed from or by a shape memory or superelastic metal, metal alloy, plastic, and / or the like. For example, the frame 110 (e.g., one or more of the supra-annular region 120, the sub-annular region 130, and the trans-annular region 112) can be formed from or by nitinol or the like. In some embodiments, the frame 110 (and / or any region thereof) can be laser cut from a nitinol sheet or tube. In other embodiments, the frame 110 (and / or any region thereof) can be formed from or by a nitinol wire that is bent, kinked, formed, and / or manipulated into a desired shape. In still other embodiments, the frame 110 (and / or any region thereof) can be formed from or by a desired material using any suitable additive or subtractive manufacturing process (e.g., those described above). In addition, the frame 110 and / or one or more of the supra-annular region 120, the sub-annular region 130, and the trans-annular region 112 can be formed by or from a metal or other structural frame material, which is in turn covered by a biocompatible material, such as pericardial tissue (e.g., Dura-Guard®, Peri-Gard®, Vascu Guard®, etc.), a polymer (e.g., polyester, Dacron®, etc.), and / or the like, as described above.

[0070] The supra-annular region 120 of the frame 110 may be and / or may form, for example, a cuff or a collar that may be attached to or coupled to an upper edge or upper portion of the trans-annular region 112. When the valve 100 is deployed in a human heart, the supra-annular region 120 may be an atrial collar that is shaped to conform to a native deployment location. For example, in tricuspid and / or mitral valve replacement, the supra-annular region 120 (e.g., an atrial collar) may have various portions that are configured to conform to a native valve and / or a portion of the atrial floor around the tricuspid and / or mitral valves, respectively. In some embodiments, the supra-annular region 120 may be deployed on the atrial floor to direct blood from the atrium into the flow control component 150 of the valve 100 and seal to prevent blood leakage (paravalvular leakage) around the frame 110 (e.g., through the annulus, but outside the flow control component 150).

[0071] In some embodiments, the supra-annular region 120 can be and / or can include a wire frame laser cut from any suitable material. In some embodiments, the supra-annular region 120 can be formed from a tube or sheet of a shape memory or superelastic material (e.g., nitinol) and, for example, heat-set into a desired shape and / or configuration. In some embodiments, forming the supra-annular region 120 in this manner can allow the supra-annular region 120 to bend, flex, fold, compress, and / or otherwise reconfigure without substantially plastic deformation and / or fatigue that would cause one or more portions thereof to fail or break. In addition, the wire frame of the supra-annular region 120 can be covered by any suitable biocompatible material, such as, for example, any of those described above.

[0072] The supra-annular region 120 includes a distal portion and a proximal portion. In some embodiments, the distal portion may be and / or may include a distal supra-annular anchoring element and / or the like, which may engage supra-annular autologous tissue on the distal side of the annulus when the prosthetic valve 100 is placed in the annulus. In some embodiments, the proximal portion may be and / or may include a proximal supra-annular anchoring element and / or the like, which may engage supra-annular autologous tissue on the proximal side of the annulus when the prosthetic valve 100 is placed in the annulus. In some embodiments, the size and / or shape of the distal portion and / or the distal supra-annular anchoring element may be set to correspond to the size and / or shape of the distal portion of the atrial floor of the heart in which the prosthetic valve 100 is disposed. Similarly, the size and / or shape of the proximal portion and / or the proximal supra-annular anchoring element may be set to correspond to the size and / or shape of the proximal portion of the atrial floor of the heart. In some embodiments, the distal portion (or distal supra-annular anchoring element) and / or the proximal portion (or proximal supra-annular anchoring element) can be actuated to transition between two or more configurations and / or states (e.g., during deployment or the like), as further described in detail herein.

[0073] Despite Figures 1 to 6100, the supra-annular region 120 may be shaped and / or formed to include any number of features configured to engage autologous tissue and / or one or more other portions of the valve 100, the delivery / deployment system 180, and / or the like. For example, in some embodiments, the supra-annular region 120 may include and / or may form an outer portion and an inner portion suspended from and / or coupled to the outer portion. In some embodiments, the outer portion may be sized and / or shaped to engage autologous tissue, the inner portion may provide a structure for mounting the flow control component 150 to the support frame 110, and one or more covers, drums, spacers, struts, splines, and / or structures may be disposed therebetween. In some embodiments, a portion of the supra-annular region 120 may be at least temporarily coupled to a portion of the delivery / deployment system 180, at least a portion of an actuator, at least a portion of a guidewire (or guidewire catheter), and / or the like and / or may at least temporarily receive these portions (as described in further detail herein).

[0074] The cross-annular region 112 of the support frame 110 is coupled to the supra-annular region 120 and extends from the supra-annular region 120 and at least partially through the annulus of the native valve when the prosthetic valve 100 is placed therein. In some embodiments, the cross-annular region 112 can be coupled to the supra-annular region 120 so as to allow a desired amount of movement and / or flexure therebetween (e.g., welding, bonding, suturing, bonding, and / or the like). For example, in some embodiments, the cross-annular region 112 and / or portions thereof can be sewn and / or sutured to the supra-annular region 120 (and / or portions thereof).

[0075] The trans-annular region 112 can be shaped and / or formed into a ring, a cylindrical tube, a conical tube, a D-shaped tube, and / or any other suitable annular shape. In some embodiments, the trans-annular region 112 can have a flat cone, an inverted flat cone (narrower at the top and wider at the bottom), a concave cylinder (walls curved inward), a convex cylinder (walls bulging outward), an angular hourglass, a curved and / or graduated hourglass, and / or a side profile of a ring or cylinder with a flared top, a flared bottom, or both. In some embodiments, the shape and / or size of the trans-annular region 112 can be based at least in part on the size, shape, and / or configuration of the supra-annular region 120 (and / or the sub-annular region 130) and / or the native annulus in which the trans-annular region 112 is configured to be deployed. For example, the cross-annular region 112 can have a circumferential outer surface for engaging native annular tissue, which can be tensioned against the inner aspect of the native annulus to provide structural patency to the weakened native annular ring. In addition, the cross-annular region 112 can form and / or define an orifice or central channel 114 extending along the central axis 104 (e.g., the y-axis). The size and configuration of the central channel 114 (e.g., the central axis to the lumen or channel) can be set to receive the flow control component 150 across at least a portion of the diameter of the central channel 114.

[0076] In some embodiments, the inter-annular region 112 can be and / or include a wire frame laser cut from any suitable material. For example, the inter-annular region 112 can be formed from a tube or sheet of a shape memory or superelastic material (e.g., nitinol) and, for example, heat set into a desired shape and / or configuration. Although in Figures 1 to 6 104 ( FIG. 105 ), but in some embodiments, the inter-annular region 112 may include and / or may be formed from two laser cut halves that may be formed into a desired shape and / or configuration and coupled together to form the inter-annular region 112. The inter-annular region 112 may be formed to include a set of compressible wire monomers having a shape aligned with the central axis 104 ( Figure 1 ) substantially orthogonal orientation and / or cell geometry to limit and / or substantially minimize linear cell strain when the transannular region 112 is in a vertically compressed configuration, a coiled and compressed configuration, or a folded and compressed configuration. In some embodiments, forming the transannular region 112 in this manner may allow the transannular region 112 to respond to changes in the orientation and / or cell geometry along the lateral axis 106 ( Figure 4 ) or lateral folding in the direction of said lateral axis and / or along the central axis 104 ( Figure 3 ) or vertical compression in the direction of the central axis to bend, flex, fold, deform and / or otherwise reconfigure (substantially without plastic deformation and / or undue fatigue), as further described in detail herein.

[0077] As described above with reference to the supra-annular region 120, the wire frame of the trans-annular region 112 can be covered by any suitable biocompatible material, for example, any of those described above. In some embodiments, at least the supra-annular region 120 and the wire frame of the trans-annular region 112 can be flexibly connected (e.g., sewn or sutured) and then covered together or individually in a biocompatible material. In other words, before or after the connection, at least the supra-annular region 120 and the trans-annular region 112 can be covered with a biocompatible material. In embodiments where the wire frame is covered after the connection, the biocompatible material can promote and / or support the connection between them.

[0078] The subannular region 130 of the frame 110 may be and / or may form a cuff or ring, for example, along the end of the transannular region 112 opposite the supraannular region 120. For example, when the valve 100 is deployed in a human heart, the subannular region 130 may be and / or may form a ventricular ring that is shaped to conform to a native deployment location. For example, in a tricuspid and / or mitral valve replacement, the subannular region 130 or ring may have various portions that are configured to conform to a native valve and / or a portion of the ventricular apex around the tricuspid and / or mitral valve, respectively. In some embodiments, the subannular region 130 or at least a portion thereof can be engaged to the ventricular apex around the native annulus to secure the valve 100 in the native annulus, stabilize the valve 100 in the annulus, prevent displacement of the valve 100, clamp or compress the native annulus or adjacent tissue between the supraannular region 120 and the subannular region 130 (or the lower portion of the transannular region 112), and / or seal to prevent blood leakage around the frame 110 (paravalvular leakage and / or regurgitation during systole).

[0079] In some embodiments, the subannular region 130 is a lower portion or subannular part of the transannular region 112 (e.g., the transannular region 112 and the subannular region 130 are integrally and / or unitarily formed). In other words, the lower portion or subannular region of the transannular region 112 can form and / or include the subannular region 130. In other embodiments, the subannular region 130 is a separate and / or independent component that can be attached or coupled to a lower edge or lower portion of the transannular region 112, as described above with reference to the supraannular region 120. In such embodiments, for example, the subannular region 130 can be and / or can include a wire frame that is laser cut from any suitable material (e.g., a shape memory or superelastic material, such as Nitinol), heat set into a desired shape and / or configuration, covered by any suitable biocompatible material, and attached to a lower edge of the transannular region 112, as described above with reference to the supraannular region 120. In some embodiments, forming the subannular region 130 in this manner can allow the subannular region 130 to bend, flex, fold, compress, and / or otherwise reconfigure substantially without plastic deformation and / or without excessive or undesirable fatigue that could cause one or more portions thereof to fail or fracture.

[0080] The subannular region 130 of the frame 110 can be shaped and / or formed to include any number of features configured to engage autologous tissue, one or more other portions of the valve 100, one or more portions of the delivery / deployment system 180, one or more actuators (not shown), and / or the like. For example, Figure 1 As shown, the subannular region 130 may include and / or may form a distal portion having a distal anchoring element 132 and a proximal portion having a proximal anchoring element 134. In some embodiments, each of the distal anchoring element 132 and the proximal anchoring element 134 is integrally and / or monolithically formed with the subannular region 130 and / or the lower portion of the transannular region 112 or the subannular region.

[0081] In some embodiments, the distal anchoring element 132 can optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire catheter. The guidewire coupler 133 is configured to allow a portion of the guidewire or guidewire catheter to extend through the orifice of the guidewire coupler 133, thereby allowing the valve 100 to advance over or along the guidewire and / or guidewire catheter during delivery and deployment.

[0082] The distal anchoring element 132 is configured to engage with a desired portion of the native tissue on the distal side of the native valve annulus to facilitate placement, installation and / or deployment of the valve 100 in the annulus of the native valve. For example, in some embodiments, the distal anchoring element 132 can be a protrusion or projection extending from the frame 110 (e.g., the lower portion of the subannular region 130 and / or the transannular region 112) and entering a distal subannular position relative to the annulus (e.g., the right ventricular outflow tract (RVOT) for tricuspid valve replacement and / or the like). In such an embodiment, the distal anchoring element 132 can be shaped and / or biased so that the distal anchoring element 132 exerts a force on the subannular tissue that is operable to at least partially fix, stabilize and / or anchor the distal end portion of the valve 100 in the native valve annulus. In some embodiments, the distal anchoring element 132 can extend approximately 10 mm to 40 mm from the distal portion of the subannular region 130 (or the lower portion of the transannular region 112).

[0083] The proximal anchoring element 134 is configured to engage with the subannular tissue on the proximal side of the native valve annulus to facilitate the deployment, placement, installation and / or fixation of the valve 100 in the valve annulus. In some embodiments, the proximal anchoring element 134 can be an anchoring element with a substantially fixed configuration. In such embodiments, the proximal anchoring element 134 can be flexible and / or movable through a relatively limited range of motion, but otherwise has a single fixed configuration. In some such embodiments, the proximal anchoring element 134 can extend approximately 10 mm to 40 mm from the proximal portion of the subannular region 130 (or the lower portion of the transannular region 112).

[0084] In other embodiments, the proximal anchoring element 134 can be configured to transition, move, and / or otherwise reconfigure between two or more configurations. For example, the proximal anchoring element 134 can transition between a first configuration in which the proximal anchoring element 134 extends a first amount or distance from the subannular region 130, and a second configuration in which the proximal anchoring element 134 extends a second amount or distance from the subannular region 130 that is different from the first amount or distance. In some embodiments, the proximal anchoring element 134 can have a first configuration in which the proximal anchoring element 134 is in a compressed, retracted, retracted, undeployed, folded, and / or constrained state (e.g., in a position close to, adjacent to, and / or in contact with the transannular region 112 and / or supraannular region 120 of the frame 110), and a second configuration in which the proximal anchoring element 134 is in an expanded, extended, deployed, expanded, and / or unconstrained state (e.g., extending away from the transannular region 112). In some embodiments, the proximal anchoring element 134 in an expanded or deployed configuration (e.g., a second configuration) can extend from the trans-annular region 112 by about 10 mm to 40 mm, and the proximal anchoring element 134 in a compressed or undeployed configuration (e.g., a first configuration) can be in contact with the trans-annular region 112, or can extend less than about 10 mm from the trans-annular region 112. In some embodiments, at least a portion of the trans-annular region 112 can be reconfigured based at least in part on the state and / or configuration of the proximal anchoring element 134. For example, placing the proximal anchoring element 134 in a compressed state or configuration can also at least partially compress or reconfigure at least the proximal portion of the trans-annular region 112. Furthermore, in some embodiments, the proximal anchoring element 134 can transition from the first configuration to the second configuration in response to actuation of an actuator, a tensile member, a portion of the delivery / deployment system 180, and / or the like, as described in further detail herein.

[0085] In some embodiments, the proximal anchoring element 134 can transition from a first configuration to a second configuration during deployment to selectively engage autologous tissue, chordae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure to help secure the valve 100 in the native annulus. The proximal anchoring element 134 (and / or the distal anchoring element 132) can include any suitable features, surfaces, members, etc. configured to facilitate engagement between the proximal anchoring element 134 (and / or the distal anchoring element 132) and the autologous tissue. For example, in some embodiments, the proximal anchoring element 134 can include one or more features configured to engage autologous tissue, chordae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure and / or become entangled in autologous tissue, chordae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration.

[0086] Despite Figures 1 to 6 1 , but the subannular region 130 may include and / or form any number of additional anchoring elements, such as septal anchoring elements and / or the like. For example, the subannular region 130 may include a post-septal (PS) tab or anchoring element that may engage post-septal tissue to help stabilize the valve in the annulus of the native valve. In some embodiments, a septal subannular anchoring element may be included and configured to engage subannular septal tissue, septal leaflet tissue, and / or any other suitable tissue at, near, and / or along the septum of the heart. In some embodiments, when the valve 100 is at least partially inserted into the annulus, the septum anchoring elements can extend downwardly along the septum wall to pin the native septum leaflets away from, for example, the docking leaflets of the prosthetic valve 100, and / or stabilize the valve against any intra-annular winding forces and / or any intra-annular torsional forces (e.g., tilting, angulation, twisting, winding, etc.) that may affect the desired position or positioning of the prosthetic valve within the annulus.

[0087] In some embodiments, an anchoring element included in or extending from the subannular region 130 can be configured with a predetermined atrial or ventricular bias, which in some embodiments can be designed, selected, and / or tuned to allow the subannular anchoring element to engage native ventricular tissue with a desired amount of force. For example, in some embodiments, the distal subannular anchoring element 132 can have a slight atrial bias, meaning that the distal anchoring element 132 is set or extends at a certain angle in the supraannular direction (e.g., toward the annulus). In other embodiments, the distal subannular anchoring element 132 can have a slight ventricular bias, meaning that the distal anchoring element 132 is set or extends at a certain angle in the subannular direction (e.g., away from the annulus). In other embodiments, the distal subannular anchoring element 132 can have a neutral bias, meaning that the distal anchoring element 132 is not set at an angle and / or otherwise extends in a substantially straight or neutral manner. Similarly, any other subannular anchoring elements may have an atrial, ventricular, or neutral bias, which may be designed, selected, and / or tuned to allow one or more anchoring elements to engage native ventricular tissue with a desired amount of force.

[0088] Despite Figures 1 to 6 Not shown, the frame 110 may also have and / or form additional functional elements (e.g., loops, anchors, attachment points, etc.) for attaching accessory components, such as, for example, a biocompatible covering, a tissue anchor, a releasable deployment / retrieval control (e.g., an actuator, a tensile member, a torque cable, a hypotube, a portion of the delivery / deployment system 180, a support member or tether and / or other suitable guides, knobs, accessories, rigging, etc.), and the like.

[0089] The flow control component 150 can refer to a device for controlling the flow of fluid flowing therethrough in a non-limiting sense. In some embodiments, the flow control component 150 can be a leaflet structure having two, three, four or more leaflets, the leaflet structure being made, for example, of a flexible biocompatible material such as treated or untreated pericardium. The leaflets can be sutured or attached to a support structure, for example, an internal frame, which in turn can be sutured or attached to the valve frame 110 (i.e., an external frame). The leaflets can be configured to move between an open state and a closed state or a substantially sealed state to allow blood to flow through the flow control component 150 in a first direction, through the inflow end of the valve 100, and to block blood from flowing through the outflow end of the valve 100 in a second direction opposite to the first direction. For example, the flow control component 150 can be configured such that the valve 100 serves as a heart valve, for example, a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, which can be open to blood flowing during diastole from the atria to the ventricles and can be closed due to systolic ventricular pressure applied to the outer surface.

[0090] The inner frame and / or its parts or aspects may be similar to the valve frame 110 (i.e., the outer frame) and / or its parts or aspects at least in form and / or function. For example, the inner frame may be a laser cut frame formed from or by a shape memory material such as nitinol. In addition, the inner frame may be compressible for delivery and configured to return to its original (uncompressed) shape when released (e.g., after delivery). In some embodiments, the inner frame may include a plurality of parts or components coupled together to form the inner frame together. This arrangement may allow the inner frame to transition between a compressed state and an uncompressed state without excessive or undesirable plastic deformation, fatigue, and / or the like. In some embodiments, the inner frame may include and / or may be formed with any suitable number of compressible, elastically deformable diamond or eye-shaped wire monomers and / or the like. The wire monomer may have an orientation and a monomer geometry substantially orthogonal to the axis of the flow control component 150 so as to limit or substantially minimize wire monomer strain when the inner frame is in a compressed configuration.

[0091] In some embodiments, when the valve 100 is in the expanded configuration (e.g., see Figure 2 ), the flow control component 150 and / or its internal frame can have a substantially cylindrical or tubular shape and when the valve 100 is placed in a compressed configuration (e.g., see Figure 3 and Figure 4 ), the flow control component 150 and / or its internal frame can be configured to deform elastically. Figures 1 to 6106 ( FIG. 10A ), but in some embodiments, the internal frame of the flow control component 150 may include and / or may be formed of two halves that may be coupled together to allow the internal frame to respond to movement along the lateral axis 106 ( Figure 3 ) or in the lateral axis 106 ( Figure 3 ) direction and elastically deformed by lateral compression or folding, as further described in detail herein.

[0092] like Figures 1 to 6 As shown, the flow control component 150 is mounted within the central passage 114 of the frame 110. More specifically, the flow control component 150 is mounted and / or coupled to the supra-annular region 120 (e.g., an interior portion thereof) and is configured to extend into and / or through the central passage 114 formed and / or defined by the trans-annular region 112. In some embodiments, the flow control component 150 can be coupled to the supra-annular region 120 via tissue, a biocompatible mesh, one or more woven or knitted fabrics, one or more superelastic or shape memory alloy structures that are sewn, sutured, and / or otherwise secured to a portion of the supra-annular region 120. In some embodiments, the flow control component 150 can be coupled to the supra-annular region 120 such that a portion of the flow control component 150 is disposed above the supra-annular region 120 and / or otherwise extends beyond the supra-annular region 120 (e.g., extending away from the annulus in the direction of the atria). In some embodiments, the portion of the flow control component 150 that extends above and / or beyond the supra-annular region 120 can form a ridge, flange, wall, step, and / or the like. In some embodiments, such an arrangement can promote in-growth of autologous tissue above the supra-annular region 120 without obstructing the flow control component 150.

[0093] The flow control component 150 can be at least partially disposed in the central channel 114 such that an axis of the flow control component 150 extending in the direction of blood flow through the flow control component 150 is substantially parallel to the central axis 104 of the frame 110. In some embodiments, the support frame 110 can be arranged so that the flow control component 150 is centered within the central channel 114. In other embodiments, the support frame 110 can be arranged so that the flow control component 150 is eccentric within the central channel 114. In some embodiments, the diameter and / or circumference of the central channel 114 can be greater than the diameter and / or circumference of the flow control component 150. Although in Figures 1 to 6100, but in some embodiments, the valve 100 can include a spacer or the like that can be disposed within the central channel 114 adjacent to the flow control component 150. In other embodiments, the spacer can be a cover or the like that is coupled to a portion of the frame 110 and is configured to cover a portion of the central channel 114. In some cases, the spacer can be used to facilitate coupling of the flow control component 150 to the frame 110.

[0094] Figure 5 A delivery / deployment system 180 for deploying valve 100 is shown, and Figure 6 The valve 100 is shown positioned in the annulus of a native heart valve after delivery and deployment. As described above, the prosthetic valve 100 can be a replacement prosthetic valve for any native valve of the human heart (pulmonary valve, mitral valve, aortic valve and / or tricuspid valve (PV, MV, AV, TV)). More specifically, the valve 100 is configured for transcatheter, orthogonal / lateral delivery to a desired location in the body via a delivery catheter 182. During delivery via the delivery catheter 182, the valve 100 is compressed in an orthogonal and / or lateral direction relative to the size of the valve 100 in the expanded configuration (e.g., as described above, along the central axis 104 and / or the lateral axis 106), and the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter 182. In some embodiments, the apparatus and methods for delivering valve 100 to a desired location in the body (e.g., via delivery / deployment system 180) may be similar and / or substantially the same as one or more of the delivery systems described in the '032 PCT, which is incorporated herein by reference above. Therefore, the apparatus and methods for delivering valve 100 to, for example, a desired location in the body are not described in further detail herein. Figure 5 and Figure 6 Portions and / or aspects of devices and / or procedures for the annulus of a native heart valve are shown.

[0095] like Figure 5 and Figure 6 As shown, the delivery / deployment system 180 can be used to deliver the valve 100 to, for example, an atrium of a human heart ( Figure 6120). For example, in some embodiments, the valve 100 (e.g., the supra-annular member / region 120) can be removably coupled to a control device 170 included in a delivery / deployment system 180, which can be used to advance the valve 100 in a compressed state through the lumen of a delivery catheter 182 into the atria (RA, LA) of the heart, as described in detail in the delivery / deployment system in reference to the '032 PCT. For example, a distal end portion of the control device 170 can include and / or can be coupled to a connecting member 178, which can be removably coupled to and contact a portion of the valve 100 (e.g., the supra-annular region 120), while a proximal end portion of the control device 170 is proximal and lateral to the delivery catheter 182. This arrangement can allow a distal force applied to or at the proximal end portion of the control device 170 to advance the valve 100 along or over a guidewire and / or guidewire catheter (e.g., disposed within and / or extending through the guidewire connector 133) through the delivery catheter 182 into the annulus of the native heart valve.

[0096] Once in the atrium and released from the delivery catheter 182, the valve 100 can be transitioned to an expanded configuration for deployment into the annulus of a native valve, such as the pulmonary valve, mitral valve, aortic valve, and / or tricuspid valve. In some embodiments, at least a portion of the control device 170 or the like can extend through one or more lumens of the delivery catheter 182 to a position distal to the delivery catheter 182 and within the atrium, thereby allowing a user (e.g., a physician, surgeon, technician, etc.) to manipulate the distal end of the control device 170 and thereby manipulate one or more portions of the valve 100 for deployment into the annulus. For example, a connecting member 178 can be included and / or disposed at the distal end of the control device 170 and can be advanced through the delivery catheter 182 into the atrium of the heart (e.g., distal to the delivery catheter 182). Although in Figures 1 to 6 178, but the connecting member 178 can be any suitable shape, size and / or configuration. For example, the connecting member 178 can be a yoke or the like that is removably coupled to the supra-annular region 120 of the valve frame 110, as described in detail in the '996 PCT and / or the '032 PCT. The arrangement of the connecting member 178 can allow a user to at least partially control the position, orientation, angle, etc. of the valve 100 while manipulating the control device 170 to deploy the valve 100 in the annulus.

[0097] As described above, in some cases, it may be desirable to include one or more components, members, features, etc. in the delivery / deployment system 180 that may at least temporarily couple to or otherwise engage (e.g., in conjunction with the connection member 178) one or more portions of the valve 100 to provide additional control and / or stability of the valve 100 during deployment. The support may extend through the delivery catheter 182 directly (e.g., through a lumen of the delivery catheter) or indirectly (e.g., via a lumen of a multi-lumen control catheter or any other suitable catheter or sheath extending through the delivery catheter 182). The distal end of the support may be removably coupleable to a portion of the valve 100 and / or valve frame 110 while the proximal end of the support may be maintained proximal to the delivery catheter 182, thereby allowing a user to manipulate the support to at least partially control, support, and / or stabilize one or more portions of the valve 100 during deployment.

[0098] Figure 5 An example of such a support is shown in the form of at least one supra-annular support 179. The supra-annular support 179 (also referred to herein as a "support") can be any suitable feature, component, member, device, mechanism, and / or the like that is configured to support at least the valve frame 110 and / or the supra-annular region 120 of the valve 100 during deployment into the annulus. In some embodiments, the support 179 can be one or more tethers, sutures, tensile members, rods, cables, tubes, catheters, and / or the like that extend directly or indirectly through the delivery catheter 182 such that a proximal end portion (not shown) of the support 179 is maintained proximal to the delivery catheter 182 and a distal end portion of the support 179 is removably coupled to the supra-annular region 120 of the valve frame 110. In some embodiments, the arrangement of the supports 179 (e.g., one or more tethers, sutures, tensile members, rods, cables, tubes, catheters, and / or the like) is such that the supports 179 can be placed under tension and / or otherwise allowed to be in a supported configuration and / or state after the valve 100 is released from the delivery catheter 182 and allowed to expand to an expanded / deployed configuration, thereby providing additional control, support, and / or stabilization of the valve 100 during deployment. In some embodiments, the arrangement of the supports 179 is such that the supports 179 can have a desired or predetermined hardness, stiffness, durometer hardness, etc., thereby allowing the supports 179 to transmit distal forces to the supra-annular region 120 of the valve frame 110 (e.g., enabling the supports 179 to push the valve 100, for example, toward or into the annulus).

[0099] The delivery / deployment system 180 can include any number of supports 1779 configured to be removably coupled to any number of attachment points at any suitable location along the supra-annular region 120 of the valve frame 110. For example, in some embodiments, the delivery / deployment system 180 can include a single support 179 that is removably coupled to an attachment point at or near the distal end of the supra-annular region 120 of the valve frame 110. In some embodiments, the supra-annular region 120 of the valve frame 110 can include two or more attachment points at or near its opposite lateral extents, with at least one support 179 coupled to each attachment point (e.g., at least two supports 179 extend from the distal end of the delivery catheter 182 in a Y-shaped configuration). In such embodiments, the attachment point can be located distal to the point of contact between the supra-annular region 120 of the valve frame 110 and the connecting member 178. In some embodiments, the delivery / deployment system 180 can include any number of supports 179 that can be coupled to attachment points at any suitable location or locations along the supra-annular region 120 of the valve frame 110 to provide a desired degree of control, support, and / or stability of the valve 100 during deployment, as further described in detail herein.

[0100] In some embodiments, the support 179 can be one or more reconfigurable members that can be transformed from a first state / configuration (e.g., during delivery via the delivery catheter 182) to a second state / configuration (e.g., during deployment into the annulus). For example, when in the first state, the support 179 can be relatively flexible, and when in the second state, the support 179 can be relatively rigid or solid, thereby forming a substantially rigid or fixed connection between the supra-annular region 120 of the valve frame 110 and the distal end portion of the delivery / deployment system 180, which can support, stabilize and / or at least partially control the valve 100 during deployment. For example, the support 179 can be one or more tethers that are relatively flexible when in the first state during delivery and can be placed under tension to transform to the second state in which the tethers form a relatively rigid, solid and / or fixed connection between the supra-annular region 120 of the valve frame 110 and the distal end portion of the delivery / deployment system 180. In some embodiments, the substantially rigid, strong and / or fixed connection between the supra-annular region 120 of the valve frame 110 and the distal end portion of the delivery / deployment system 180 can be based on a substantially fixed length portion of the support 179 disposed therebetween. In some embodiments, the support 179 can be configured to transform and / or actuate one or more portions of the supra-annular region 120 of the valve frame 110 to facilitate deployment, as described in further detail herein.

[0101] In some embodiments, the support 179 can extend through the lumen of the delivery catheter 182 (or through the lumen of the delivery sheath of the delivery catheter 182) while being located outside of or otherwise not directly attached to the control device 170. In some embodiments, this arrangement can allow the support 179 to anchor and / or couple the supra-annular region 120 of the valve frame 110 to the delivery / deployment system 180 while allowing the control device 170 to be moved, transformed, and / or otherwise reconfigured to control and deploy the valve 100 into the annulus. In some embodiments, the support 179 in the second or supported state / configuration can stabilize at least a portion of the valve 100, which in turn can provide greater control of the valve 100 when moving and / or positioning the valve via the control device 170.

[0102] The supra-annular region 120 of the valve frame 110 may include and / or may form one or more attachment points or the like to which the distal end of the support 179 may be removably connected. In some such embodiments, the attachment point may be a suture or the like around which or through which the support 179 may be wrapped, looped, and / or otherwise removably attached. In some embodiments, the attachment point may be, for example, an opening or hole (e.g., in a drum of the supra-annular region 120 of the valve frame 110 and / or valve 100), through which a portion of the support 179 may extend (e.g., allowing the support 179 to engage a portion of the valve 100 other than the supra-annular region 120 of the valve frame 110). In some embodiments, the supraannular region 120 of the valve frame 110 may include one or more attachment points, e.g., one or more sutures, and may provide and / or define an opening or aperture to allow a first portion of the support member 179 to be engaged or removably connected to the attachment point while a second portion of the support member 179 extends through the opening or aperture (e.g., allowing the support member 179 to engage portions of the valve 100 other than the supraannular region 120 of the valve frame 110).

[0103] For example, the attachment point can be a suture attached to the distal end or portion of the supra-annular region 120 of the valve frame, and an opening or hole can be formed at or along the distal region of the drum (e.g., proximal to the attachment point) to allow the distal portion of the support 179 to extend therethrough. In such an embodiment, the distal end of the support 179 can include and / or can form a ring, hoop, annulus, etc., which can be disposed over a guidewire catheter, a guidewire, and / or a sub-annular region of the valve 100. In some embodiments, once the valve 100 is placed in the annulus, such an arrangement can facilitate the retrieval and / or withdrawal of the support 179. For example, the provision of a ring or annulus around the guidewire catheter at the distal end of the support 179 can allow the withdrawal of the guidewire catheter after the valve 100 is placed to release the distal end of the support 179, thereby allowing the support 179 to be withdrawn into the deployment system 180. In some embodiments, the distal portion of the support member 179 can extend from the supra-annular region 120 (or component) to the sub-annular region 130 (or component) along the distal wall of the trans-annular region 112 on the outside of the valve 100, or to a guidewire or guidewire catheter extending therefrom, which can allow the distal portion of the support member 179 to be clamped or captured between the wall of the valve 100 and the autologous tissue forming a portion of the annulus, which in turn can secure or promote fixation of the support member 179 to the distal portion of the valve 100.

[0104] like Figure 5 and Figure 6 As shown, deployment and / or placement of the valve 100 may include placing the distal anchoring element 132 of the subannular region 130 below the annulus in a ventricle of the heart ( Figure 61, 2, and 3. In some embodiments, the valve 100 is positioned in the right or left ventricle - (RV, LV) as shown, while the rest of the valve 100 is located in the atrium (RA, LA). In some cases, the distal anchoring element 132 can be advanced over and / or along a guidewire or guidewire catheter (not shown) to a desired location within the ventricle, such as the outflow tract of the ventricle. For example, in some embodiments, the valve 100 can be delivered to the annulus of a native tricuspid valve, and at least a portion of the distal anchoring element 132 can be positioned in the right ventricular outflow tract (RVOT). In other embodiments, the valve 100 can be delivered to the annulus of a native mitral valve, and at least a portion of the distal anchoring element 132 can be positioned in a subannular position distal to the annulus and / or in any other suitable location where the distal anchoring element 132 can engage with native tissue, leaflets, chordae tendineae, etc. When the distal anchoring element 132 is positioned in a ventricle (e.g., in the right ventricular outflow tract (RVOT)), a distal portion or surface of the valve 100 can be placed in contact with and / or adjacent to a distal surface of the annular tissue. With the distal portion of the valve 100 in a desired position within the annulus, the control device 170 can be manipulated to pivot the proximal portion of the valve 100 into the annulus, thereby positioning the prosthetic valve 100. For example, the control device 170 can be and / or can include a steerable control catheter that can be manipulated (steered) to exert a force on the proximal portion of the valve 100 in a direction toward the annulus, thereby pivoting the valve 100 or at least the proximal portion of the valve 100 toward and / or into the annulus.

[0105] As described above, the embodiments described herein can be configured to support, stabilize, and / or at least partially control valve 100 while valve 100 is being positioned in the annulus. For example, Figure 5One or more supports 179 are shown to be coupled to the supra-annular region 120 of the valve frame 110 and can be placed under tension and / or otherwise allowed to be in a support configuration to at least partially support, stabilize, and / or control the valve 100 during deployment. For example, in some embodiments, the connecting member 178 can be configured to be removably coupled to a proximal portion of the supra-annular region 120 of the valve frame 110, and the one or more supports 179 can be configured to be removably coupled to a distal portion of the supra-annular region 120 of the valve frame 110. In some such embodiments, the distal portion of the supra-annular region 120 of the valve frame 110 can include one or more attachment points to which one or more supports 179 can be removably coupled. In some embodiments, a distal portion of a drum or other surface of the valve 100 can form and / or define an opening or hole through which a distal portion of the support 179 can extend. The distal end of the support 179 may include and / or may be formed into a ring, hoop, annulus, etc., which may be disposed over, around, or near a guidewire catheter (or guidewire) and / or a subannular region of the valve 100 to releasably secure and / or anchor the distal portion of the support 179. In some embodiments, the distal portion of the support 179 may extend along the distal wall of the valve frame 110 from the supraannular region 120 to the subannular region 130 (or guidewire or guidewire catheter), and the contact between the surface of the valve 100 and the surface of the annular tissue may clamp, squeeze, hold, constrain, and / or otherwise substantially secure the distal portion of the support 179 to the distal portion of the valve 100.

[0106] With the distal portion of the support 179 fixed relative to the distal portion of the valve 100 (in any suitable manner, such as those described above), the support 179 can be transformed to a second or supported state / configuration. The support 179 can, in turn, provide support for at least the distal portion of the valve 100, which support can, for example, resist, limit and / or otherwise prevent the valve frame 110 and / or the distal supra-annular portion of the valve 100 from falling into the annulus. In some embodiments, removably coupling the support 179 to an attachment point at or along a distal portion of the supra-annular region 120 of the valve frame 110 (e.g., a distal portion of the outer ring of the supra-annular region 120, also referred to herein as the "atrial distal cuff or portion" of the valve 100) can allow the support 179 to actuate, manipulate, reconfigure and / or otherwise transform at least the atrial distal portion of the valve 100. For example, as Figure 5As shown, during the initial stages of deployment, the distal subannular anchoring element 132 can be positioned in the ventricle and the distal wall of the valve 100 (or at least a portion thereof) can be in contact with the distal surface of the annulus, while the proximal subannular anchoring element 134 is in the atrium. As such, the valve 100 is angled relative to the annular plane of the annulus. In some embodiments, the atrial distal cuff or portion can be sized and / or shaped to contact the atrial floor, and the angle of the valve 100 can cause the atrial distal cuff to push the distal portion of the valve 100 away from the annulus, thereby resisting the process of pivoting and / or positioning the valve 100. In some such embodiments, removably coupling the support 179 to an attachment point at or along the atrial distal cuff can allow the support 179 to actuate at least a portion of the atrial distal cuff to facilitate the process of positioning the valve 100. For example, as Figure 5 As shown by the arrows in , a proximal force can be applied on or along the support member 179, which in turn can pull, actuate, or otherwise act on the atrial distal cuff to move, bend, flex, and / or translate the atrial distal cuff in a proximal direction away from the atrial floor or atrial tissue that defines or surrounds the valve annulus. Thus, translating or actuating the atrial distal cuff in this manner can reduce contact between the atrial distal cuff and atrial tissue that can otherwise resist pivoting motion associated with placing the valve 100 in the valve annulus.

[0107] although Figure 5 179, each of which is coupled to an attachment point at or near the lateral extent of the supra-annular region 120 and distal to the connecting member 178. In such an embodiment, the supports 179 can stabilize the valve 100, for example, against undesired rotation or swiveling about a guidewire or guidewire catheter (or its axis) relative to the plane of the annulus. In some embodiments, the supra-annular region 120 can be coupled to any suitable number of supports 179 in any suitable one or more positions (or combination of positions) such that the supports 179 can support, stabilize, actuate and / or control the valve 100 when the valve 100 is disposed in the annulus.

[0108] In some embodiments, the prosthetic valve 100 can be temporarily maintained in a partially deployed state. For example, the valve 100 can be partially inserted into the annulus and held at an angle relative to the annulus to allow blood to flow from the atrium to the ventricle partially through the native valve annulus around the valve 100 and partially through the valve 100, which can allow for evaluation of valve function. In some cases, the support 179 can support the valve 100 when the valve 100 is in a partially deployed state.

[0109] In some embodiments, the support 179 and / or a substantially rigid or fixed-length connection between the distal supra-annular portion of the valve 100 and a portion of the delivery / deployment system 180 provided by the support 179 (e.g., outside of or substantially independent of the control device 170) can generate a reaction / opposing force in response to a force applied by the control device 70 to pivot or seat at least a proximal portion of the valve 100 in the annulus. In some cases, such an arrangement can reduce relative motion of at least a portion of the control device 170 that does not contribute to the deployment of the valve 100, thereby facilitating the deployment process.

[0110] As described above, in some embodiments, during this stage of deployment, the proximal subannular anchoring element 134 can be maintained in its first configuration, which in turn allows the proximal portion of the valve 100 to "fall into" the annulus. For example, the proximal anchoring element 134 can be in a compressed, retracted, and / or retracted configuration in which the proximal anchoring element 134 is in contact with, adjacent to, and / or close to the transannular region 112 and / or supraannular region 120 of the frame 110. In turn, such a configuration can constrain the entire circumference of the subannular region 130 of the frame 110, thereby allowing the subannular region 130 and the transannular region 112 of the frame 110 to be inserted into and / or through the annulus.

[0111] Figure 6 The valve 100 (PV, MV, AV, TV) is shown placed and / or positioned in the annulus (PVA, MVA, AVA, TVA) of a native valve such that the subannular region 130 (e.g., ventricular collar) is disposed in a subannular position, the transannular region 112 of the valve frame 110 extends through the annulus, and the supraannular region 120 (e.g., atrial collar) is maintained in a supraannular position. In some embodiments, the control device 170 of the delivery / deployment system 180 can be configured to actuate one or more portions of the valve 100, such as the proximal anchoring element 134, between a first configuration and a second configuration of the valve 100. For example, the control device 170 can include one or more cables, tethers, links, joints, connections, tensile members, etc., which can exert a force on a portion of the proximal anchoring element 134 (or can eliminate the applied force), the force being operable to transition the proximal anchoring element 134 between the first configuration and the second configuration. In some embodiments, the subannular region 130 of the support frame 110 can be formed with a proximal anchoring element 134 that is biased in an uncompressed and / or expanded configuration.

[0112] Thus, the control device 170 can be actuated to apply a force via one or more cables, tethers, etc. to transform the proximal anchoring element 134 to a compressed and / or retracted configuration, and can be actuated and / or otherwise manipulated to release or reduce the force to transform the proximal anchoring element 134 from a compressed and / or retracted configuration to an expanded or uncompressed configuration or allow the proximal anchoring element 134 to transform from a compressed and / or retracted configuration to an expanded or uncompressed configuration. For example, once the valve 100 is positioned in the native annulus (PVA, MVA, AVA, TVA), the user can manipulate a portion of the delivery / deployment system 180 to actuate the control device 170, thereby causing the control device 170 to release and / or remove the force applied to the proximal anchoring element 134 (e.g., via one or more cables, one or more tethers, etc.). In turn, the proximal anchoring element 134 can return to its original or biased configuration (e.g., a second configuration).

[0113] As described above, the supra-annular region 120 (e.g., the atrial cuff) of the valve frame 110 can be configured to engage native atrial tissue, the distal anchoring element 132 can be configured to engage native ventricular tissue on the distal side of the annulus, and the proximal anchoring element 134 can be configured to engage native ventricular tissue on the proximal side of the annulus (e.g., when in the second or expanded configuration), thereby securely securing the valve 100 in the native annulus, as described above. Figure 6 In some embodiments, any other or additional portion of the valve 100 can similarly engage native tissue to securely position the valve 100 in the native annulus and / or form a seal between the support frame 110 and the tissue forming the native annulus (e.g., the anterior anchoring element can engage subannular tissue on the anterior side of the annulus, or the supraannular region 120 can include any number of supraannular anchoring elements for engaging supraannular tissue ( Figures 1 to 6 100). With the valve 100 secured in the annulus, the delivery / deployment system 180 (including the control device 170, the support 179, the guidewire and / or the guidewire catheter, and / or any other portion or component of the delivery / deployment system 180) can be detached from the valve 100 and withdrawn / removed from the patient, leaving the prosthetic valve 100 in the proper position. As described above, in some embodiments, the arrangement of the support 179 can allow the distal end to be wrapped or looped around the guidewire and / or the guidewire catheter. In such embodiments, withdrawing the guidewire and the guidewire catheter into the delivery / deployment system 180 (e.g., proximal to the valve 100) can release the distal end of the support 179, thereby allowing the support 179 to be withdrawn from the valve 100 and / or withdrawn into or through the delivery / deployment system 180. In other embodiments, the distal end of the support 179 can be detached from the attachment point in any suitable manner.

[0114] Provided below is a discussion of certain aspects or embodiments of laterally deliverable transcatheter prosthetic valves (e.g., prosthetic valves) and / or delivery systems and methods for delivering such prosthetic valves. The prosthetic valves (or aspects or portions thereof) described below with respect to specific embodiments may be substantially similar to valve 100 (or corresponding aspects or portions thereof) in at least form and / or function. Similarly, the delivery / deployment systems and / or methods (or aspects or portions thereof) described below with respect to specific embodiments may be substantially similar to deployment system 180 or processes using deployment system 180 (or various aspects, portions, and / or processes thereof) in at least form, function, and / or process. Therefore, certain aspects and / or portions of specific embodiments may not be described in further detail herein.

[0115] Figures 7 to 16 A laterally deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 200 (also referred to herein as a "prosthetic valve" or "valve") is shown in accordance with an embodiment. Figure 7 is an illustration of a top perspective view of valve 200. In some embodiments, valve 200 can be deployed in the annulus of, for example, a native tricuspid valve and / or a native mitral valve. Valve 200 is configured to allow blood to flow through an inflow end of valve 200 in a first direction, and to block blood from flowing through an outflow end of valve 200 in a second direction opposite to the first direction. For example, prosthetic valve 200 can be a laterally deliverable transcatheter prosthetic heart valve configured to be deployed in the annulus of a native tricuspid valve or a native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0116] The valve 200 is compressible and expandable in at least one direction relative to the x-axis (also referred to herein as the "horizontal axis," "longitudinal axis," "major axis," and / or "longitudinal axis") of the valve 200. The valve 200 is compressible and expandable between an expanded configuration for implantation at a desired location within the body (e.g., a human heart) and a compressed configuration for delivery using a delivery catheter ( Figure 7 In some embodiments, when in the expanded and / or compressed configuration, the horizontal x-axis of the valve 200 is orthogonal (90 degrees) or substantially orthogonal (75 degrees to 105 degrees) or substantially inclined (45 degrees to 135 degrees) to the central (vertical) y-axis. In addition, the horizontal x-axis of the valve 200 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which the valve 200 is disposed.

[0117] In some embodiments, the valve 200 has an expanded or deployed height of about 5 mm to 60 mm, about 5 mm to 30 mm, about 5 mm to 20 mm, about 8 mm to 12 mm, or about 8 mm to 10 mm and an expanded or deployed diameter (e.g., length and / or width) of about 25 mm to 80 mm, or about 40 mm to 80 mm. In some embodiments, the valve 200 has a compressed height (y-axis) and width (z-axis) of about 6 mm to 15 mm, about 8 mm to 12 mm, or about 9 mm to 10 mm. In some embodiments, the length of the valve 200 (e.g., along the x-axis) is not compressed or otherwise reduced because the length of the valve 200 can extend along the length of the central cylindrical axis of the delivery catheter (e.g., the longitudinal axis or elongated axis).

[0118] In some embodiments, valve 200 can be centered or eccentric (e.g., radially symmetric or radially asymmetric along or relative to the y-axis, respectively). In some eccentric embodiments, frame 210 can have a D-shaped cross-section, wherein the flat portion or surface is configured to substantially mate with the native mitral annulus at or near the anterior leaflet. Figures 7 to 16 In the example shown, valve 200 is eccentric, wherein one or more components are offset or asymmetric relative to the y-axis.

[0119] Figure 7 and Figure 8 A valve 200 is shown, which includes an annular outer support frame 210 and a collapsible flow control component 250 mounted within the annular outer support frame 210. The annular outer support frame 210 (also referred to herein as the "external frame") is made of a shape memory material such as nickel titanium alloy (Nitinol) and is therefore a self-expanding structure from a compressed configuration to an expanded configuration. The outer frame 210 has a trans-annular member 212 and / or a body that defines, forms and / or defines a central (inner) channel around and / or along a vertical or central axis (y-axis). The outer frame 210 has an upper annular member 220 circumferentially attached at the top edge of the trans-annular member 212 and a lower annular member 230 circumferentially attached at the bottom edge of the trans-annular member 212. As shown in FIG. Figure 7 and Figure 8 As shown, at least the outer support frame 210 of the valve 200 is covered, wrapped and / or surrounded by a biocompatible covering 240. The biocompatible covering 240 may be a mesh material, pericardial tissue, a woven synthetic polyester material, and / or any other suitable biocompatible material, such as those described above.

[0120] The biocompatible covering 240 disposed on or along the supra-annular component 220 can form a drum 245 that extends between and / or is coupled to the outer and inner rings of the supra-annular component 220. As such, the drum 245 can cover space that is otherwise not occupied by the flow control component 250. The drum 245 can have and / or can form a set of spokes 245A that can be used to increase the stiffness of the drum 245. The drum 245 is also shown as having an attachment member 238 that can extend along or across a portion of the drum 245 (or supra-annular component 220). As described in further detail herein, the attachment member 238 can facilitate temporary and / or removable attachment to a portion of a delivery / deployment system, such as a control device, an actuator, etc.

[0121] The shape of the supra-annular component 220 is set to conform to the native deployment position. For example, in tricuspid valve replacement, the supra-annular component 220 or atrial collar can have a higher posterior wall portion to conform to the septal region of the native valve, and can have a distal portion and a proximal portion. The distal portion can be larger than the proximal portion to account for the larger flat space above the sub-annular region of the ventricular outflow tract (VOT) (atrium). For example, in mitral valve replacement, the supra-annular component 220 of the external frame 210 can be D-shaped or similar to a hyperbolic parabola to simulate the native structure. For example, in some embodiments, the supra-annular component 220 of the external frame 210 can be substantially similar to the supra-annular region 120 (or component) described above in at least form and / or function. Therefore, parts and / or aspects of the supra-annular component 220 may not be described in further detail herein.

[0122] Fig. 9 A laser cut wireframe portion (not covered) of the supra-annular component 220 is shown. As shown, the supra-annular component 220 includes a distal portion 222, a proximal portion 224, an outer ring 221, an inner ring 225, and at least one spline 227. In some embodiments, the shape and / or size of the outer ring 221 can be set to engage autologous tissue. For example, the distal portion 222 of the supra-annular component 220 (at least partially formed by the outer ring 221) is configured to engage distal supra-annular tissue, and the proximal portion 224 (at least partially formed by the outer ring 221) is configured to engage proximal supra-annular tissue. The distal portion 222 and the proximal portion 224 can have a circular and / or curved shape, wherein the radius of curvature of the proximal portion 224 is greater than the radius of curvature of the distal portion 222. The distal portion 222 can form, for example, a distal anchoring ring 223 that can engage distal supra-annular tissue to at least partially stabilize and / or secure the frame 210 in the native annulus. Fig. 9Not shown, but the proximal portion 224 can similarly form a proximal superior anchoring element that can engage proximal supra-annular tissue to at least partially stabilize and / or secure the frame 210 in the native annulus.

[0123] The inner ring 225 of the valve ring component 220 can be substantially circular, elliptical, teardrop-shaped, and / or any other suitable shape. The inner ring 225 can be connected to the outer ring and / or suspended from the outer ring by one or more splines 227. Figure 7 As shown, the inner ring 225 can be coupled to a biocompatible material 226, which can be used to couple the inner frame 251 of the flow control component 250 to the inner ring 225 of the outer support frame 210. In some embodiments, suspending the inner ring 225 from the outer ring 221 can, for example, at least partially isolate the inner ring 225 (and the flow control component 250 coupled to the inner ring 225) from at least a portion of the forces associated with transitioning the frame 210 between the expanded configuration and the compressed configuration, as described above with reference to the frame 210.

[0124] The one or more splines 227 of the annular component 220 can be any suitable shape, size and / or configuration. For example, in some embodiments, the annular component 220 can include a proximal spline 227 and one or more distal splines. The distal spline can connect the distal portion of the inner ring 225 to the distal portion of the outer ring 221. Similarly, the proximal spline 227 can connect the proximal portion of the inner ring 225 to the proximal portion of the outer ring 221. In some embodiments, the proximal spline 227 can be configured to receive, connect to and / or otherwise engage a portion of an actuator, a control device and / or a delivery system. For example, the proximal spline 227 includes, forms and / or can be connected to a path point 228, which can be used to connect and / or receive one or more portions of a control device and / or a delivery system, as described above with reference to the frame 110.

[0125] like Figures 7 to 9 As shown, in this embodiment, the supra-annular component 220 has an arcuate configuration, wherein the splines 227 protrude away from the rest of the supra-annular component 220. For example, the laser cut frame of the supra-annular component 220 can be formed with the splines 227 having an arcuate configuration ( Fig. 9). In some embodiments, the arcuate splines 227 can exert a force on the drum 245 that causes the drum 245 to bend and increase tension across the region of the drum 245. The increase in tension increases the relative stiffness of the drum 245, either alone or in combination with the spokes 245A, which can reduce and / or limit the amount of deformation of the drum during, for example, diastole or systole, thereby enhancing the performance of the valve 200 and / or reducing fatigue in or along the drum 245. In other words, due to the arcuate splines 227, the pressure generated on the atrial side of the drum 245 during atrial contraction (diastole) is not sufficient to reverse the arcuate configuration of the drum 245 (e.g., no oil canning deflection will occur). The arcuate configuration of the drum 245 can also withstand the larger pressures generated on the ventricular side of the drum 245 during ventricular contraction (systole) without substantial deflection. Additionally, the bows in the spokes 227 can position the waypoint 228 at a desired angle and / or orientation to facilitate insertion or retrieval of one or more portions of the delivery system through the waypoint 228 .

[0126] Fig.10 2 is a distal perspective view showing a trans-annular member 212 of the outer frame 210 of the valve 200. In some embodiments, the trans-annular member 212 of the outer frame 210 can be substantially similar to the trans-annular region 112 (or member) described above in at least form and / or function. Therefore, portions and / or aspects of the trans-annular member 212 may not be described in further detail herein.

[0127] The cross-annular member 212 can be shaped and / or formed into a ring, a cylindrical tube, a conical tube, and / or any other suitable annular shape. In some embodiments, the cross-annular member 212 can have a side profile of a concave cylinder (walls curved inward), an angular hourglass, a curved graduated hourglass, an annular or cylindrical body with a flared top, a flared bottom, or both, and / or the like. In addition, the cross-annular member 212 can form and / or define an orifice or central channel 214 extending along the central axis 204 (e.g., the y-axis). The size and configuration of the central channel 214 (e.g., the central axis to the lumen or channel) can be set to receive the flow control component 250 across a portion of the diameter of the central channel 214. In some embodiments, the shape and / or size of the trans-annular member 212 can be based at least in part on the size, shape and / or configuration of the supra-annular member 220 and / or sub-annular member 230 of the external support frame 210 and / or based on the size, shape and / or configuration of the autologous annulus in which the trans-annular member 212 is configured to be deployed, as described above.

[0128] The inter-annular member 212 can be and / or can include a wire frame laser cut from nitinol or the like and, for example, heat set into a desired shape and / or configuration. The inter-annular member 212 can be formed to include a set of compressible wire monomers 213 having an orientation and / or monomer geometry that is substantially orthogonal to a central axis extending through the central channel 214 so as to minimize wire monomer strain when the inter-annular member 212 is in a vertically compressed configuration, a rolled and compressed configuration, or a folded and compressed configuration. Fig.10 As shown, the trans-annular member 212 includes a front side 215 (e.g., a first laser cut half) and a back side 216 (e.g., a second laser cut half), which can be formed into a desired shape and connected together to form the trans-annular member 212. The front side 215 and the back side 216 can be connected at one or more hinge points 217 along the distal and proximal portions of the trans-annular member 212. More specifically, the front side 215 and the back side 216 can be connected along the distal side of the trans-annular member 212 via two sutures forming two hinges or connection points 217, and can be connected along the proximal side of the trans-annular member 212 via one suture forming a single hinge or connection point 217.

[0129] In some embodiments, forming the cross-valve ring member 212 in this manner can allow the cross-valve ring member 212 to bend, flex, fold, deform, and / or otherwise reconfigure (substantially without plastic deformation and / or excessive fatigue) in response to lateral folding along or in the direction of the lateral axis or z-axis and / or vertical compression along or in the direction of the central axis or y-axis. In addition, the connection at the hinge point 217 using sutures can allow a desired amount of slippage between the sutures and the front side 215 / back side 216, which in turn can limit and / or substantially prevent binding, adhesion, and / or failure that occurs in response to folding along the lateral axis or z-axis.

[0130] like Fig.10 As shown, the proximal portion of the trans-annular member 212 includes a single hinge or connection point 217. In some embodiments, the trans-annular member 212 can define a gap or space 218 below the proximal hinge or connection point 217, which can provide space to allow the proximal anchoring element of the sub-annular member 230 to transition between the first configuration and the second configuration, as further described in detail herein.

[0131] Fig.11 2 is a perspective view of the distal side of the subannular component 230 of the outer frame 210 of the valve 200. In some embodiments, the subannular component 230 of the frame 210 can be similar to the subannular region 130 (or component) described above in at least form and / or function. Therefore, parts and / or aspects of the subannular component 230 may not be described in further detail herein.

[0132] As shown, the subannular member 230 of the frame 210 includes and / or forms a distal portion having a distal anchoring element 232 and a proximal portion having a proximal anchoring element 234. The anchoring elements 232 and 234 are integrally and / or monolithically formed with the subannular member 230. The distal anchoring element 232 and the proximal anchoring element 234 of the subannular member 230 can be any suitable shape, size and / or configuration. The distal anchoring element 232 is shown as including an atraumatic end that forms a guidewire connector 233 that is configured to selectively engage and / or receive a portion of a guidewire catheter 284 (in which a guidewire 285 is disposed) through an opening, hole, orifice, port, etc. defined by the guidewire connector 223 (e.g., see Fig.15 and Fig.16 ). With the guidewire catheter 284 extending through the guidewire coupler 233, the valve 200 is allowed to be advanced over or along a placed guidewire 285 disposed in the guidewire catheter 284. In some embodiments, the guidewire catheter 284 can extend under the valve 200 and beyond the distal anchoring element 232 and can provide a desired stiffness during delivery and / or deployment.

[0133] The anchoring elements 232 and / or 234 are configured to engage a desired portion of the autologous tissue to mount the frame 210 to the annulus of the native valve in which it is deployed. For example, the distal anchoring element 232 can extend (e.g., about 10 mm to 40 mm) from the subannular member 230 and extend into the right ventricular outflow tract (RVOT) or other ventricular location. The distal anchoring element 232 can be shaped and / or biased so that the distal anchor 232 exerts a force on the subannular tissue that is operable to at least partially fix the distal end portion of the frame 210 in the native valve annulus.

[0134] The proximal anchoring element 234 can be configured to engage with subannular tissue on the proximal side of the native annulus to assist in fixation of the frame 210 in the annulus. As described above, the subannular member 230 of the frame 210 can be and / or can include, for example, a laser-cut wire frame formed of a shape memory material (e.g., nitinol) that is heat-set into a desired shape and wrapped in a biocompatible material (e.g., fabric and / or the like). The proximal anchoring element 234 is configured to transition, move, and / or otherwise reconfigure between a first configuration and a second configuration, in which the proximal anchoring element 234 extends a first amount or distance from the subannular member 230 and in which the proximal anchoring element 234 extends a second amount or distance from the subannular member 230. In other words, the proximal anchoring element 234 can be, for example, a movable anchoring element that is configured to move and / or otherwise transition (e.g., via an actuator) between a first configuration and a second configuration to reduce the circumference of the subannular member 230 during delivery and / or deployment.

[0135] As described above, when in the first configuration, the proximal anchoring element 234 can be in a compressed, contracted, retracted, undeployed, folded and / or constrained state (e.g., in a position close to, adjacent to and / or in contact with the trans-annular member 212 and / or the supra-annular member 220 of the external support frame 210), and when in the second state, the proximal anchoring element 234 can be in an expanded, extended, deployed, unfolded and / or unconstrained state (e.g., extending away from the trans-annular member 212). In some embodiments, the proximal anchoring element 234 can be biased and / or heat set in the second configuration. In addition, in some embodiments, the space 218 defined by the trans-annular member 212 of the external frame 210 is configured to provide sufficient space to allow the proximal anchoring element 234 to transition between the first configuration and the second configuration.

[0136] The proximal anchoring element 234 can be configured to move from a first extended configuration to a second compressed configuration in any suitable direction based at least in part on how the proximal anchoring element 234 is coupled to an actuator and / or the like. For example, the proximal anchoring element 234 can move inwardly toward the inner flow control component 250, upwardly toward the supra-annular member 220 and / or portions thereof, and / or toward the anterior or posterior side of the valve 200. In addition, where the trans-annular member 212 of the frame 210 is coupled to the sub-annular member 230, actuation of an actuator, control device, etc. can, in some cases, cause one or more portions of the trans-annular member 212 to move, as described in further detail herein.

[0137] The collapsible (inner) flow control component 250 is mounted within the outer frame 210. The flow control component 250 has a foldable and compressible inner wire frame 35 (also referred to as an "inner leaflet frame" or "inner frame") having two (or more) folding regions, hinge regions, connection regions, elastically deformable regions, etc. A set of 2 to 4 flexible leaflet components 256 are mounted in or on the inner frame 251 ( Figure 7 ). In some embodiments, flow control component 250 has three leaflet components 256 (eg, cusps, pockets, or simply leaflets) mounted within inner frame 251, as described in further detail herein.

[0138] The inner flow control component 250 is foldable and compressible like the outer frame 210. For example, the inner frame 251 is foldable from a cylindrical configuration along the z-axis or in the direction of the z-axis to a flat cylindrical configuration (or a double-layer band) (for example, foldable at a folding area or the like), wherein the folding area is located on the distal and proximal sides of the inner frame 251. The flow control component 250 is also vertically (y-axis) compressible to a shortened or compressed configuration like the outer frame 210. By folding (compressing) in the direction of the z-axis and compressing vertically on the y-axis, the valve 200 is allowed to maintain a relatively large size along the horizontal (x-axis). In some embodiments, the outer frame 210 and the flow control component 250 are reduced along the z-axis until the side walls touch or nearly touch. This also allows the outer frame 210 and flow control component 250 to maintain a radius along the horizontal axis (x-axis) to limit or substantially minimize the number of wire monomers that could be damaged by forces applied during folding and / or compression when the valve 200 is loaded into a delivery catheter.

[0139] The diameter and / or circumference of the flow control component 250 is smaller than the diameter and / or circumference of the central passage of the outer frame 210. The flow control component 250 is mounted to or within the outer frame 210 such that the central axis or vertical axis (y-axis) of the inner frame 251 is parallel to the central axis or vertical axis (y-axis) of the outer frame 210. In some embodiments, the y-axis defined by the inner frame 251 is parallel to the y-axis defined by the outer frame 210, but is offset from the y-axis ( Figure 7 In some embodiments, a drum 245 (or other spacer element) is disposed within and / or across the central passage and can facilitate mounting of a portion (e.g., an otherwise unsupported portion) of the flow control component 250 to the outer support frame 210 and / or facilitate ingrowth of autologous tissue over at least a portion of the supra-annular component 220 of the valve 200.

[0140] In certain embodiments, the inner frame 251 can have a diameter of about 25 mm to 30 mm, the outer frame 210 (or its trans-annular member 212) can have a diameter of about 50 mm to 80 mm, and the supra-annular member 220 (or atrial collar) extends about 20 mm to 30 mm beyond the top edge of the trans-annular member 212 to provide a seal on the atrial floor to prevent paravalvular leakage (PVL). The flow control component 250 and the outer frame 210 can be foldable (e.g., in the z-axis direction) and / or compressible (e.g., in the y-axis direction) to reduce the size of the valve 200 so that the valve 20 fits within a 24 Fr to 36 Fr (8 mm to 12 mm inner diameter) delivery catheter ( Figure 7 within the inner diameter of (not shown).

[0141] Figure 12 to Figure 14 At least a portion of a flow control component 250 included in valve 200 is shown. For example, Fig.12 is an illustration of a top perspective view of inner leaflet frame 251. In some embodiments, inner leaflet frame 251 is formed of two separate wire frame sheets or members connected at lateral connection points 252 and 253 (e.g., folded areas, elastically deformable areas, connected edge portions, etc.). Inner leaflet frame 251 is shown in an expanded or cylindrical configuration (e.g., before being folded and / or compressed).

[0142] Although not shown, the inner leaflet frame 251 can be transformed from an expanded or cylindrical configuration to an at least partially folded configuration. The inner leaflet frame 251 can have wire frame sidewalls that allow for rotation or articulation at least at lateral connection points 252 and 253. The inner leaflet frame 251 can be configured to fold in response to the valve 200 being folded and / or compressed for delivery. For example, when transitioning to a fully folded configuration, the wire frame sidewalls can rotate, articulate, and / or fold at their lateral connection points 252 and 253. In addition, the inner leaflet frame 251 can be vertically compressed into a compressed configuration. The wire frame sidewalls can form monomers (e.g., diamond-shaped monomers or the like) that can be oriented in a compression direction to allow for elastic compression of the inner frame 251. In some embodiments, the inner frame 251 can be vertically compressed into a pleated or accordion (compressed) configuration.

[0143] In some embodiments, the inner leaflet frame 251 of the flow control component 250 can be formed from a linear wire frame or laser cut sheets (e.g., as shown) before being further assembled into a cylindrical configuration. Fig.12). The inner leaflet frame 251 can be formed into a cylindrical structure or configuration (or a conical structure or configuration) in which edge portions of the linear wire frame sheet are connected or coupled at lateral connection points 252 and 253 (e.g., hinge areas, fold areas, etc.). In addition, the inner leaflet frame 251 can be expanded (e.g., driven, formed, bent, etc.) from a linear sheet configuration to a cylindrical structure or configuration.

[0144] Fig.13 and Fig.14 A structural band 255 of pericardial tissue is shown with leaflet components 256 sutured into the structural band 255 . Fig.13 and Fig.14 Side perspective and bottom views, respectively, show the structural band 255 and leaflet component 256 (e.g., bag) prior to assembly and / or installation on and / or within the internal frame 251 to form the collapsible (foldable, compressible) flow control component 250. Fig.13 A structural band 255 formed of pericardial tissue is shown with leaflet components 256 sutured into the structural band 255. After assembly into the cylindrical leaflet configuration shown, the leaflet components 256 are disposed on the inner surface of the structural band 255. The leaflet components 256 may be sutured into the structural band 255 such that the open edges extend outwardly and the sutured edges form a closed top parabolic edge that provides attachment. Fig.14 250. The cylindrical structural band 255 and the leaflet member 256 are shown as having a partial abutment to form a closed fluid seal. Although not shown, the cylindrical structural band 255 can be mounted to the inner leaflet frame 251 ( Fig.12 ) on or within to jointly form a flow control component 250, which is in turn mounted to the inner ring 225 of the valve ring component 220 of the outer support frame 210, as described above with reference to Figure 7 and Figure 8 Described in detail.

[0145] Fig.15 and Fig.162 is a perspective side view showing a prosthetic valve 200 removably coupled to a control device 270 for advancing, controlling and / or retracting the valve and / or actuating one or more portions of the valve 200, e.g., at least the subannular member 230 of the valve frame 210, via a delivery catheter, as described herein. The control device 270 and / or at least a portion thereof includes a control catheter 271 having a connection member 278 coupled to and / or disposed at a distal end. The control catheter 271 can be, for example, a multi-lumen steerable catheter having one or more components of the control device 270 extending therethrough, as described in detail in the '032 PCT, incorporated herein by reference above. The connection member 278 is removably coupleable to the supraannular member 220 of the valve frame 210 and thereby couples the valve 200 to the control catheter 271. As described in further detail herein, the control catheter 271 can be manipulated to, for example, advance the prosthetic valve 200 through a delivery catheter (not shown), control or steer the prosthetic valve 200 during deployment, retrieve and / or withdraw the prosthetic valve 200 into a delivery catheter (e.g., after at least partial deployment), and / or the like.

[0146] Fig.15 A connecting member 278 having a wishbone, yoke, or Y-shaped configuration is shown, but other configurations are possible. Thus, the connecting member 278 can have a first portion, side, and / or arm and a second portion, size, and / or arm opposite the first portion, side, and / or arm. The connecting member 278 can be configured to transition between an expanded configuration and a compressed configuration, such as to allow the control catheter 271 (and the connecting member 278 disposed at its distal end) to advance through a delivery catheter. The connecting member 278 can be formed of any suitable material, such as a shape memory alloy (e.g., nitinol) or the like.

[0147] In some embodiments, the connecting member 278 can contact and / or removably couple with the drum 245 of the supra-annular member 220 and / or the frame 210 or any other suitable portion of the valve 200. The connecting member 278 can be removably coupled to the valve 200 via sutures, tethers, cables, clips, couplers, and / or any other removable coupling. For example, in some embodiments, the control device 270 can include a set of tethers 275 extending from one or more lumens defined by the control catheter 271. The tethers 275 are shown extending from the control catheter 271, looping through a set of openings defined along or by each side or arm of the connecting member 278 (yoke), looping around one or more attachment members 238 of the valve 200, and extending back into the corresponding lumens of the control catheter 271. One or more attachment members 238 can be formed by, coupled to, and / or extend from the supra-annular component 220 (e.g., drum 245). In some embodiments, the attachment members 238 of the valve 200 can be tethers, sutures, cables, frame structures, and / or the like, which can be coupled to and / or extend from a wire frame portion of the supra-annular component 220 or, for example, the drum 245 (or other biocompatible covering). In addition, the attachment members 238 can form a pair of rings 239 or the like around which the tethers 275 of the control device 270 can be routed or looped.

[0148] The looped arrangement of the tethers 275 through and / or around the connection members 278 and attachment members 238 of the valve 200 causes each of the proximal and distal ends of the tethers 275 to extend through and beyond (e.g., proximal to) the single control arm 277 of the control portion 272. Thus, a proximal force may be applied to each of the proximal and distal ends of the one or more tethers 275 to increase tension along the tethers 275, which pulls the connection members 238 toward the drum 245, thereby securing the connection members 278 to the valve. Conversely, a proximal force applied to only one of the proximal or distal ends of the one or more tethers 275 may disengage the one or more tethers 275 from the connection members 278, and may withdraw the one or more tethers 275 from the control device 270, which in turn may allow the connection members 278 to be detached or removed from the valve 200.

[0149] Fig.15Also shown is a guidewire catheter 284 of the delivery system, which extends through, for example, a waypoint 228 or opening in the supra-annular member 220 and / or its drum 245, and extends through the guidewire coupler 233 of the distal anchoring element 232. The guidewire catheter 284 can extend below the flow control component 250 of the valve 200. Prior to delivery and / or as part of delivery, the guidewire catheter 284 can be advanced and / or inserted through the valve 200 and advanced over the guidewire 285 that has been placed in the desired position within the heart. Thus, delivering the valve 200 in a compressed configuration through the delivery catheter includes advancing the guidewire catheter 284 along the guidewire 285. The guidewire catheter 284 can extend through and beyond the guidewire coupler 233 of the distal anchoring element 232 (e.g., the distal end of the guidewire catheter 284 can be about 0.1 cm to about 1.0 cm or more distal to the guidewire coupler 233).

[0150] The guidewire catheter 284 can be sufficiently rigid to, for example, (at least partially) limit and / or define the range of motion of the valve 200 during delivery. For example, the guidewire catheter 284 can define an axis about which the valve 200 can rotate during delivery, but can substantially limit or resist movement of the valve 200 in other directions. In some embodiments, the arrangement of the connecting member 278 (e.g., yoke) and the guidewire catheter 284 can allow for better control of the position of the valve 200 during delivery. The guidewire catheter 284 and / or one or more portions of the valve 200 (e.g., subannular member 230) can also include radiopaque markers, thereby allowing for enhanced visualization during image-guided delivery. For example, in some cases, the radiopaque marker or line can be placed relative to the plane of the annulus of the native valve and can define a landmark during image-guided delivery. In this case, radiopaque markers on the guidewire catheter 284 and / or one or more other portions of the valve 200 (e.g., the subannular member 230) can be used to align, orient, position, index, etc. the valve 200 relative to a marker that in turn corresponds to the annular plane of the native valve. Thus, image-guided delivery can allow the user to visualize the valve 200 during delivery and / or deployment, and can allow the user to visualize when the valve 200 has been positioned in the annulus (e.g., a radiopaque marker band of the valve 200 is inferior or in a subannular direction relative to the radiopaque marker).

[0151] Fig.15Also shown is at least one tether 276 (e.g., a tether, suture, cable, tensile member, and / or the like) extending from the control catheter 271 (e.g., through one or more lumens thereof) and through the waypoint 228. The control device 270 can include a single tether or multiple tethers (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, a seven system, eight tethers, nine tethers, ten tethers, or more tethers, each of which can be removably coupled to one or more attachment points on the valve 200). The one or more tethers 276 can be configured to actuate and / or transform one or more portions of the valve 200, e.g., the subannular member 230 and / or at least the proximal anchoring element 234 thereof. In some embodiments, one or more tethers 276 can extend through the waypoint 228, can be looped around and / or through the attachment points along the subannular member 230 or at least the proximal anchoring element, and can then be routed back through the waypoint 228 and the control catheter 271 so that both ends of each tether 276 are outside the patient's body, thereby allowing manipulation of the one or more tethers 276 to actuate the valve 200 and / or transform the shape of the proximal anchoring element 234, the subannular member 230, and / or other portions of the valve 200 to facilitate placement of at least the proximal side of the valve 200 into the native annulus. In other words, increasing the amount of tension along the one or more tethers 276 can be operable to transform at least the subannular member 230 (or a portion thereof) between a first configuration and a second configuration. Thus, the one or more tethers 276 can be actuated (or placed under tension) and / or released in a manner similar to that described above with reference to the one or more tethers 275.

[0152] Fig.16 The valve 200 and control device 270 are shown during deployment into the native annulus of the heart. As described above, the control device 270 can advance the valve 200 into the atrium of the heart through the delivery catheter 282. In some embodiments, the delivery catheter 282 can be maintained in a substantially fixed position relative to the atrium or relative to the IVC through which it extends, while the distal end of the control device 270 and the valve 200 are advanced toward the valve along the guidewire catheter 284 in a distal direction relative to the delivery catheter 282 (e.g., away from the delivery catheter 282). As a result, the length of a portion of the control catheter 271 distal to the delivery catheter 282 is increased. Because the valve 200 is no longer constrained by the delivery catheter 282, releasing the valve 200 into the atrium allows the valve 200 to transition from a compressed configuration to an expanded configuration.

[0153] The control device 270 can be manipulated or steered to place the valve 200 in an expanded configuration at a desired deployment angle, wherein the distal anchoring element 232 is positioned below the annulus and close to, adjacent to, and / or at least partially in, for example, the ventricular outflow tract (e.g., RVOT). At the deployment angle, at least the proximal portion of the supra-annular member 220 of the valve frame 210 and the sub-annular member 230 of the valve frame 210 remain in the atrium. In some embodiments, the distal surface of the trans-annular member 212 of the valve frame 210 can be placed in contact with autologous tissue forming the distal surface or wall of the annulus. In some cases, the valve 200 can be temporarily maintained in this partially deployed position (e.g., at the deployment angle), allowing the user to verify the positioning of the valve 200 relative to the angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or allowing blood to flow through the annulus to begin the transition from flowing completely through the native valve to flowing through the flow control component 250. In some cases, this may also allow the user to verify that the flow control component 250 is functioning in the desired manner before fully seating the valve 200 in the annulus.

[0154] Once the position and / or function of the valve 200 is verified, the control device 270 can be manipulated and / or steered to pivot the valve 200 relative to the annulus so that the proximal portion of the valve 200 is inserted and / or dropped into the annulus. In some embodiments, for example, the proximal anchoring element 234 can be in a compressed configuration and / or can be transformed into a compressed configuration so that the circumference and / or extent of the subannular member 230 of the valve frame 210 is less than the circumference or extent of the annulus. In some embodiments, the control device 270 and / or control catheter 271 can be manipulated and / or steered so that a distal force applied by a user on the control device 270 causes the connecting member 278 to push the proximal portion of the valve 200 in the direction of the annulus. In some embodiments, the pivoting valve 200 may include "steering the control catheter 271" so that the distal portion of the control catheter 271 bends relative to the distal end of the delivery catheter 282, allowing the connecting member 278 to position the proximal portion of the valve 200 in the annulus. Once positioned, the control device 270 and / or at least one tether 276 can be actuated to transform the proximal anchoring element 234 to an expanded configuration, as described above with reference to Fig.15 The delivery / deployment system 280 may then be detached from the valve 200 and withdrawn / removed from the patient, leaving the prosthetic valve 200 in the annulus.

[0155] In some cases, it may be desirable to Fig.16 The invention provides additional support to one or more portions of a prosthetic valve and / or control device during the deployment process described. For example, Fig.17300 is a schematic diagram of a prosthetic valve 300 coupled to a delivery / deployment system 380, according to an embodiment, and is shown during the process of deploying the valve 300 in the annulus of a native heart valve. The valve 300 and the delivery / deployment system 380 can be similar to and / or substantially the same as the valve 200 and the delivery / deployment system 280, respectively. Therefore, the valve 300 (or at least aspects thereof) and the delivery / deployment system 380 (or at least aspects thereof) are not described in further detail herein.

[0156] As described above, the control device 370 may include a control catheter 371 having a connecting member 378 disposed at a distal end thereof. The connecting member 378 is removably coupled to the supra-annular region 320 of the valve 300 (or its valve frame 310). The coupling, engagement, and / or contact of the connecting member 378 and the supra-annular region 320 enables the control device 370 to advance the valve 300 along a guidewire catheter 384 (and / or a guidewire disposed in the guidewire catheter 384) through a delivery catheter 382 into an atrium of the heart. In some embodiments, the control device 370 and the valve 300 may be disposed within a lumen of a delivery sheath 383, which in turn is disposed within a lumen of a delivery catheter 382. In such embodiments, at least a portion of the delivery sheath 383, at least a portion of the control device 370, and the valve 300 may be advanced through the delivery catheter 382 into an atrium of the heart, such as Fig.17 As shown. In some embodiments, the delivery catheter 382 and optionally the delivery sheath 383 can be maintained in a substantially fixed position relative to the atrium or relative to the IVC through which the delivery catheter 382 extends, while the distal end of the control device 370 and the valve 300 are advanced toward the annulus along the guidewire catheter 384 in a distal direction relative to the delivery catheter 382 (e.g., away from the delivery catheter 382). As a result, the length of a portion of the control catheter 371 distal to the delivery catheter 382 and / or the delivery sheath 383 is increased. Because the valve 300 is no longer constrained by the delivery catheter 382 and / or the delivery sheath 383, releasing the valve 300 into the atrium allows the valve 300 to transition from a compressed configuration to an expanded configuration.

[0157] The control device 370 can be manipulated or steered to place the valve 300 at a desired deployment angle (in an expanded configuration) wherein the distal anchoring element 332 is positioned below the annulus and near, adjacent to, and / or at least partially in, for example, a ventricular outflow tract (e.g., right ventricular outflow tract (RVOT)). At the deployment angle, at least a proximal portion of the supra-annular region 320 of the valve frame 310 and the sub-annular region 330 of the valve frame 310 remain in the atrium. In some embodiments, the distal surface of the trans-annular member 312 of the valve frame 310 can be placed in contact with autologous tissue forming a distal surface or wall of the annulus. In some cases, the valve 300 can be temporarily maintained in this partially deployed position (e.g., at the deployment angle), allowing a user to verify the positioning of the valve 300 relative to the angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or allowing blood to flow through the annulus to begin a transition from flowing completely through the native valve to flowing through the flow control component 350. In some cases, this may also allow the user to verify that the flow control component 350 is functioning in the desired manner before fully seating the valve 300 in the annulus.

[0158] As described above with reference to valve 200, a guidewire catheter 384 extending beneath a portion of valve 300, through the portion of valve 300 and extending from distal anchoring element 332 can provide support for at least a portion of valve 300 during deployment. For example, guidewire catheter 384 can define an axis about which valve 300 can rotate while movement of valve 300 in other directions can be at least partially constrained. In addition to the support provided by guidewire catheter 384, Fig.17 The illustrated delivery / deployment system 380 also includes a supra-annular support 379 configured to support at least a portion of the valve 300. In some embodiments, the supra-annular support 379 (also referred to herein as a "support") can extend through the lumen of the delivery sheath 383. The proximal end of the support 379 is proximal to and / or outside of the proximal end of the delivery catheter 382, ​​thereby allowing a user to manipulate the support 379. The distal end of the support 379 is removably connectable to the supra-annular portion of the valve 300 and / or valve frame 310. In addition, the support 379 can extend through the lumen of the delivery sheath 383 while being outside of or otherwise not directly attached to the control device 370. In some embodiments, this arrangement can allow the support member 379 to form a supporting connection between the supra-annular portion of the valve 300 and the delivery sheath 383, while simultaneously allowing the control device 370 to move, transform and / or otherwise reconfigure to control the valve 300 and deploy the controlled valve 300 into the annulus.

[0159] Fig.17A support 379 is shown removably coupled to an attachment point 346 located at or along a distal portion of the supra-annular region 320 of the valve frame 310. The support 379 can be any suitable feature, component, member, device, mechanism, and / or the like configured to support at least a portion of the valve 300 during deployment into the annulus. In some embodiments, the support 379 can be one or more tethers, sutures, tensile members, rods, cables, tubes, catheters, and / or the like, or a combination thereof. In some embodiments, the support 379 can be one or more reconfigurable members configured to transition from a first state / configuration (e.g., during delivery by a delivery catheter 382) to a second state / configuration (e.g., during deployment into the annulus). For example, when in the first state, the support member 379 can be relatively flexible, and when in the second state, the support member 379 can be relatively rigid, thereby forming a substantially rigid connection between the attachment point 346 and the distal end portion of the delivery sheath 383.

[0160] In some embodiments, the support member 379 is configured to transition to the second / support configuration in response to being placed under tension after the valve 300 is released from the delivery catheter 382 and allowed to expand to the expanded / deployed configuration. In embodiments where the support member 379 is or includes one or more tethers, the tethers may be similar to or substantially the same as those described above with reference to Fig.15 The tethers 275 and / or 276 described herein. Thus, a proximal force can be applied to the proximal end portion of the support 379 (one or more tethers), which can increase the tension along at least a portion of the support 379, thereby transforming the support 379 to its second configuration. In some embodiments, the support 379 in the second or supported state or configuration can stabilize at least a portion of the valve 300, which, in combination with the support provided by the guidewire catheter 384, can provide enhanced control of the valve 300 when the valve 300 is moved and / or positioned into the annulus 300 via the control device 370. In addition, in some embodiments, the support 379 in the second configuration can provide support for at least the distal supra-annular portion of the valve 300, which can, for example, resist, limit and / or otherwise prevent the distal supra-annular portion of the valve 300 (and / or the distal portion of the supra-annular region 320 of the valve frame 310) from falling into the annulus.

[0161] With the distal portion of the valve 300 in a desired position within the annulus (and optionally, after verifying the position and / or function of the valve as described above), the control device 370 can be manipulated and / or steered to pivot the valve 300 so that the proximal portion of the valve 300 is inserted and / or dropped into the annulus. For example, the proximal anchoring element 334 can be in a compressed configuration and / or can be transitioned to a compressed configuration so that the circumference and / or extent of the subannular region 330 of the valve frame 310 is less than the circumference or extent of the annulus. In some embodiments, the control device 370 and / or control catheter 371 can be manipulated and / or steered so that a distal force applied by a user on the control device 370 causes the connecting member 378 at the end of the control catheter 371 to push the proximal portion of the valve 300 in the direction of the annulus. In some embodiments, the pivoting valve 300 can include "steering the control catheter 371" so that the distal portion of the control catheter 371 is bent relative to the distal end of the delivery catheter 382 and / or delivery sheath 383, allowing the control device 370 to position the proximal portion of the valve 300 in the annulus.

[0162] In some embodiments, the support 379 and / or a substantially rigid and / or supporting connection between the attachment point 346 located at or along the distal supra-annular portion of the valve 300 and the distal end of the delivery sheath 383 (through which the support 379 extends) (e.g., outside of or substantially independent of the control device 370) can cause a reaction force / opposing force in response to a force applied by the control catheter 371 and / or bending of the control catheter 371 that is operable to pivot or seat at least a proximal portion of the valve 300 in the annulus. In some cases, such an arrangement can reduce relative motion of at least a portion of the control device 370 that does not contribute to the deployment of the valve 300, thereby facilitating the deployment process. For example, while the distal end portion of the control catheter 371 is advanced distally and movable relative to the delivery catheter 382, ​​the distal end portion of the delivery sheath 383 can be in a substantially fixed position relative to the delivery catheter 382.

[0163] With the support 379 extending outside of the control catheter 371 through the lumen of the delivery sheath 383, the support 379 in the second configuration can form a substantially rigid or substantially fixed length connection between the attachment point 346 and the delivery sheath 383. The substantially rigid or substantially fixed length connection, in turn, limits and / or substantially prevents a distal supra-annular portion of the valve 300 from falling into the annulus, while also at least partially directing and / or controlling the bending and / or movement of the distal end portion of the control catheter 371 so as to facilitate placement of the proximal portion of the valve 300 in the annulus. In some instances, the substantially rigid or substantially fixed length connection can also limit and / or substantially prevent a portion of the control catheter 371 from pushing away from the annulus, which would otherwise cause the anatomical structure of the heart (e.g., the inferior vena cava (IVC)) to support the control catheter 371. In some cases, placement of the distal anchoring element 332, for example in the right ventricular outflow tract (RVOT), and coupling of the support 379 to the attachment point 346 work together to anchor, restrain, secure and / or otherwise control at least a distal portion of the valve 300, thereby allowing the proximal portion of the valve 300 to pivot into the annulus.

[0164] Once the valve 300 is positioned in the annulus, the control device 370 and / or at least one actuator, tether, tensile member, etc. can be actuated to transform the proximal anchoring element 334 into an expanded configuration (or otherwise allow the proximal anchoring element 334 to transform), as described above with reference to Fig.15 200 is depicted. In some embodiments, fully positioning the valve 300 as just described is sufficient to secure the valve 300 in the annulus. In other embodiments, one or more portions of the valve 300 can be tightened or actuated to, for example, engage autologous tissue forming the annulus and / or clamp autologous tissue, thereby securing the valve 300. With the valve 300 secured in the annulus, the delivery / deployment system 380 can be detached from the valve 300 and retrieved / removed from the patient, leaving the prosthetic valve 300 in the annulus.

[0165] In some embodiments, the support 379 can be removably coupled to the valve 300 at the attachment point 346, so as to allow the support 379 to be detached from the valve and retracted with at least one of the guidewire catheter 384, the control device 370, and / or the delivery sheath 383. For example, the support 379 can be and / or include a tether that passes through or "loops" around the attachment point 346, so that each of the proximal and distal ends of the tether (support 379) is disposed proximal to the delivery catheter 382 and outside the body, as described above with reference to the tethers 275 and / or 276. In some embodiments, the support 379 can be and / or include a tether, wherein the distal end portion of the support 379 is removably coupled to the attachment point 346, while the proximal end of the support 379 is disposed outside the body (e.g., the tether and / or support 379 is not "looped" around the attachment point as described above with reference to the tethers 275 and / or 276). In some such embodiments, the distal end portion of the support 379 can be wrapped around the connection point 346 or any other portion of the valve 300, thereby allowing the support 379 to be unwound or otherwise detached from the valve 300 without having to pull one side of the support 379 through the delivery / deployment system 380 as would be the case when the support 379 is "looped." In some embodiments, the attachment point 346 can be a breakaway suture and / or any other suitable temporary attachment that allows the distal end portion of the support 379 to be detached and / or detached. In some embodiments, this arrangement can allow the distal end of the support 379 (e.g., a tether or any other form of supra-annular support) to be detached from the valve 300 and retracted into the delivery sheath 383 without pulling the support 379 all the way out of the delivery sheath 383. In this way, the support 379 can be retracted and / or removed from the patient while the delivery catheter 382 and / or delivery sheath 383 are retracted and / or removed.

[0166] Although the support member 379 is described above as transitioning from a first configuration to a second configuration to form, for example, a substantially rigid or substantially fixed length connection between the delivery sheath 383 and the attachment point 346 on the valve 300, in other embodiments, the support member 379, or at least a portion thereof, can be formed from a material that can provide a desired amount of stiffness without transitioning between one or more states or configurations. For example, in some embodiments, the support member 379, or at least a portion thereof, can be formed from a metal (e.g., stainless steel or the like) or a relatively stiff polymer. In some embodiments, the support member 379 can include a tether that is at least partially disposed in a catheter having a desired durometer hardness or the like (e.g., similar to the above reference to a tether). Figures 7 to 16200 is depicted). In some embodiments, positioning the catheter around a portion of the tether can provide sufficient rigidity to allow a user to apply, for example, a distal force on the supra-annular region 320 of the valve 300 and / or valve frame 310. For example, where the support is coupled to the distal supra-annular portion of the valve 300, the distal force can be used to push at least the distal supra-annular portion of the valve 300 and / or valve frame 310 into a desired position relative to the annulus (or to help advance the valve 300 through the delivery sheath 383 and / or delivery catheter 382).

[0167] Fig.18 4 is a schematic diagram of a prosthetic valve 400 coupled to a delivery / deployment system 480, according to another embodiment, and is shown during the process of deploying the valve 400 in the annulus of a native heart valve. The valve 400 and the delivery / deployment system 480 can be similar to and / or substantially the same as the valve 300 and the delivery / deployment system 380, respectively. Therefore, the valve 400 (or at least aspects thereof) and the delivery / deployment system 480 (or at least aspects thereof) are not described in further detail herein.

[0168] As described above, the control device 470 can include a control catheter 471 having a connection member 478 disposed at a distal end thereof. The connection member 478 is removably coupled to the supra-annular region 420 of the valve 400 (or its valve frame 410). The coupling, engagement, and / or contact of the connection member 478 and the supra-annular region 420 enables the control device 470 to advance the valve 400 along the guidewire catheter 484 (and / or a guidewire disposed in the guidewire catheter 484) through the delivery catheter 482 into the atrium of the heart. The delivery catheter 482 and optionally the delivery sheath 483 can be maintained in a substantially fixed position relative to the atrium or relative to the inferior vena cava (IVC) through which the delivery catheter 482 extends, while the distal end of the control device 470 and the valve 400 are advanced toward the annulus along the guidewire catheter 484 in a distal direction relative to the delivery catheter 482 (e.g., away from the delivery catheter 482). Thus, the length of a portion of control catheter 471 distal to delivery sheath 483 is increased. Because valve 400 is no longer constrained by delivery catheter 482 and / or delivery sheath 483, releasing valve 400 into the atrium allows valve 400 to transition from a compressed configuration to an expanded configuration.

[0169] The control device 470 can be manipulated or steered to place the valve 400 in an expanded configuration at a desired deployment angle, wherein the distal anchoring element 432 is positioned below the annulus and near, adjacent to, and / or at least partially in, for example, a ventricular outflow tract (e.g., a right ventricular outflow tract (RVOT)). At the deployment angle, at least a proximal portion of the supra-annular region 420 of the valve frame 410 and the sub-annular region 430 of the valve frame 410 remain in the atrium. In some embodiments, the distal surface of the trans-annular member 412 of the valve frame 410 can be placed in contact with autologous tissue forming a distal surface or wall of the annulus. In some cases, the valve 400 can be temporarily maintained in this partially deployed position (e.g., at the deployment angle), allowing a user to verify the positioning of the valve 400 relative to the angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or allowing blood to flow through the annulus to begin the transition from flowing completely through the native valve to flowing through the flow control component 450. In some cases, this may also allow the user to verify that the flow control component 450 is functioning in the desired manner before fully seating the valve 400 in the annulus.

[0170] As described above with reference to delivery / deployment system 380, Fig.18 The delivery / deployment system 480 shown includes a support 479 configured to provide support for one or more portions of the valve 400 during deployment. The support 479 can extend outside the control device 470 through the lumen of the delivery sheath 483. The proximal end of the support 479 is proximal to and / or outside the delivery catheter 482, thereby allowing a user to manipulate the support 479. The distal end of the support 479 is removably connectable to and / or otherwise configured to selectively engage a distal portion of the valve 400 and / or valve frame 410.

[0171] The support member 479 can be the same as that mentioned above. Fig.17 The support member 479 may be similar and / or substantially identical to the support member 379 described above. For example, the support member 479 may be and / or may include one or more tethers, sutures, cables, rods, tensile members, tubes, catheters, and / or the like, or combinations thereof. In some embodiments, the support member 479 may be configured to transition to a support configuration in response to being placed under tension, as described in detail above with reference to the support member 379. However, while the support member 379 is described above as being removably coupled to the attachment point 346 at or along a distal portion of the supra-annular region 320 of the valve frame 310, Fig.18 The distal portion of the illustrated support 479 may be engaged and / or may be at least temporarily secured to a distal portion of the valve 400 via one or more other features, components, members, fasteners, coupling mechanisms, etc.

[0172] For example, Fig.18 The distal portion of the support member extending through the attachment or anchor point 446 is shown, which in this embodiment is a hole, opening, orifice, slit, waypoint, through hole and / or the like. The distal portion of the support member 479 extends outside the valve frame 410 along the outer surface or wall. The distal end of the support member 479 is shown to include and / or form a ring, hoop, annulus, etc. disposed above the guide wire catheter 484 (at least during deployment). In other words, the ring at the distal end of the support member 479 receives and / or otherwise allows the guide wire catheter 484 to extend therethrough. In some embodiments, routing the distal portion of the support member 479 along the distal wall of the valve 400 from the supra-annular member or region 420 of the valve frame 410 to the sub-annular member or region 430 of the valve frame 410 can cause the distal portion of the support member 479 to be clamped or captured between the wall of the valve 400 and autologous tissue forming a portion of the annulus, which in turn can anchor and / or secure the support member 479 to the distal portion of the valve 400 (e.g., in a manner similar to the manner in which the support member 379 is removably connected to the attachment point 346).

[0173] For example, Fig.18 A distal anchoring element 432 is shown in a subannular region 430 below the annulus, at, near, or at least partially within the ventricular outflow tract (e.g., the right ventricular outflow tract (RVOT)), while the remainder of the valve 400 is in the atrium. Positioning the distal anchoring element 432 in the ventricle (e.g., in the right ventricular outflow tract (RVOT)) can place a distal portion or surface of the valve 400 in contact with and / or adjacent to a distal surface of autologous tissue forming the annulus. Thus, contact between the surface of the valve 400 and the surface of the annular tissue can clamp, squeeze, retain, restrain, anchor, and / or otherwise substantially secure a distal portion of the support 479 to the distal portion of the valve 400, thereby allowing the support 479 to be in and / or transition to a second or supported state / configuration (e.g., by placing the support under tension, as described in detail above).

[0174] In some embodiments, the support member 479 can be formed of a material that can provide a desired stiffness and / or can define a substantially fixed length without transitioning (e.g., without being placed under tension). In some embodiments, the support member 479 can include a tether that is disposed in a tube, catheter, tube, etc. along a portion proximal to the attachment and / or penetration point 446 (e.g., similar to the guidewire and guidewire catheter arrangement described above with reference to the valve 200). In such embodiments, the tube, catheter, tube, etc. can provide a desired stiffness and / or can define a substantially fixed length between the delivery sheath 483 and the attachment and / or penetration point 446, while the distal portion of the tether can extend through the attachment and / or penetration point 446 to allow the ring and / or loop 479B to be disposed around the guidewire catheter 484. In addition, at least the distal portion of the tether can be relatively flexible, allowing the tether to bend, flex, and / or reconfigure based on the shape of the outer wall of the valve 400 and / or autologous tissue forming a portion of the annulus (e.g., when clamped, squeezed, constrained, compressed, etc.).

[0175] With the portion of the support 479 distal to the attachment point 446 (e.g., hole, waypoint, through hole, etc.) being fixed or anchored, the portion of the support between the attachment point 446 and the delivery sheath 483 can function in substantially the same manner as described above with reference to the support 379. Thus, the support 479 can provide support for at least a distal portion of the valve 400 that can resist, limit, and / or otherwise prevent the valve frame 410 and / or distal supra-annular portions of the valve 400 from falling into the annulus; can at least partially direct and / or control the bending and / or movement of a distal end portion of the control device 470 in a manner that facilitates placement of a proximal portion of the valve 400 in the annulus; can limit and / or substantially prevent a portion of the control device 470 from being pushed away from the annulus; and can provide a reaction point, pivot point, fulcrum, etc., which can facilitate pivoting or "falling" of the proximal portion of the valve 400 into the annulus, as described above with reference to the support 379.

[0176] Once the valve 400 is secured in the annulus, the delivery / deployment system 480 (including the control device 470, the support 479, the guidewire catheter 484, and / or any other portion or component of the delivery / deployment system 480) can be detached from the valve 400 and withdrawn / removed from the patient, leaving the prosthetic valve 400 in place. In some embodiments, with the ring or annulus 479B at the distal end of the support 479 disposed around the guidewire catheter 484, withdrawing the guidewire catheter 484 from the distal anchoring element 432 into the delivery / deployment system 480 (e.g., proximal to the valve 400) releases the distal end of the support 479. Thus, the support 479 can be withdrawn in a proximal direction such that the distal end of the support 479 is pulled through the attachment point 446 (e.g., an opening, hole, waypoint, through hole, etc.). In some cases, the distal end of the support 479 can be withdrawn or retracted into the lumen of the delivery sheath 483 before the delivery / deployment system 480 is removed from the patient's body. In other cases, the support 479 is not retracted into the delivery sheath 483 (e.g., the support can be pulled behind the rest of the delivery / deployment system 480 as it is withdrawn from the patient's body).

[0177] Fig.19 and Fig. 20 is a side view fluoroscopic image showing delivery / deployment system 580 engaged with prosthetic valve 500 during deployment, in accordance with an embodiment. Fig.19 The valve 500 is shown in a state prior to full insertion and / or seating of the valve 500 in the annulus of a native heart valve. Fig. 20 The valve 500 is shown in a state during and / or after the valve 500 is inserted and at least partially positioned in the annulus. The delivery / deployment system 580 includes a support 579 (e.g., a distal support, an supra-annular support, and / or the like) that can pass through the distal supra-annular portion of the valve 500 and be looped or removably coupled to a guidewire catheter 584, as described in detail above with reference to the valve 400. In other embodiments, the support 579 can be configured to be removably coupled to an attachment point or the like at or along the distal supra-annular portion of the valve 500, as described in detail above with reference to the valve 300.

[0178] In some embodiments, support member 579 can be formed of a radiopaque material, or can include a portion formed of a radiopaque material, allowing visualization of support member 579 (or at least a portion thereof) under fluoroscopy or other image-guided procedures, such as Fig.19 and Fig. 20as shown. In some embodiments, the support member 579 can be and / or can include a tether at least partially disposed in a tube or catheter. The tube or catheter can, in turn, be formed of a radiopaque material and / or of any other material that allows visualization during an image-guided procedure such as fluoroscopy. As described above, at least a portion of the support member 579 between the delivery sheath or catheter of the delivery / deployment system 580 and the attachment and / or penetration point on the valve 500 can be in and / or can be placed in a substantially rigid and / or substantially fixed length state or configuration during deployment, which can reduce the likelihood that the distal supra-annular portion of the valve 500 will fall into the annulus during deployment; can reduce and / or limit undesirable movement of the valve relative to the delivery / deployment system 580; and / or can reduce and / or limit undesirable movement of at least a portion of the delivery / deployment system 580 when the proximal portion of the valve 500 is pushed into or pivoted into the annulus. Thus, the support member 579 can be similar to and / or substantially the same as those described above with reference to, respectively. Fig.17 and Fig.18 Support members 379 and / or 479 are described in detail.

[0179] Although supports 379, 479, and 579 are shown as being coupled to and / or otherwise supporting the distal supra-annular region of valves 300, 400, and 500, respectively, it should be understood that such embodiments are presented by way of example only and not limitation. Any of the valves and / or delivery / deployment systems described herein can be used with supports that are at least temporarily coupled to any suitable portion of the valve and / or at any suitable location along the supra-annular region of the valve. In addition, the valves and / or delivery / deployment systems described herein can be used with any suitable number of supports having any suitable configuration (or combination of different configurations).

[0180] For example, Fig.21 6 is a schematic diagram of a prosthetic valve 600 coupled to a delivery / deployment system 680 that includes a plurality of supra-annular supports. Valve 600 and delivery / deployment system 680 may be similar to and / or substantially the same as valve 300, 400, and / or 500 and delivery / deployment system 380, 480, and / or 580, respectively. Therefore, valve 600 (or at least aspects thereof) and delivery / deployment system 680 (or at least aspects thereof) are not described in further detail herein.

[0181] As described above, the control device 670 can advance the valve 600 along the guidewire catheter 684 (and / or guidewire) through the delivery catheter 682 and / or delivery sheath (not shown) into the atrium of the heart. The delivery catheter 682 and optionally the delivery sheath can be maintained in a substantially fixed position relative to the atrium or relative to the inferior vena cava (IVC) through which the delivery catheter 682 extends, while the distal end of the control device 670 and the valve 600 are advanced toward the annulus along the guidewire catheter 684 in a distal direction relative to the delivery catheter 682 (e.g., away from the delivery catheter 682). Because the valve 600 is no longer constrained by the delivery catheter 682 and / or delivery sheath, releasing the valve 600 into the atrium allows the valve 600 to transition from a compressed configuration to an expanded configuration. The control device 670 can then be manipulated or turned to place and / or deploy the valve 600 into the annulus of the native heart valve, as described in detail above.

[0182] Fig.21 The illustrated embodiment includes a plurality of supports 679 coupled to the supra-annular region 620 of the valve 600 (or its valve frame 610). As described above, the supports 679 are configured to provide support for one or more portions of the valve 600 during deployment. The supports 679 may be similar to and / or substantially the same as the supports 379, 479, and / or 579 described above. For example, each of the supports 679 may be and / or may include one or more tethers, sutures, cables, rods, tensile members, tubes, catheters, and / or the like, or a combination thereof. As described above, the supports 679 may be configured to transition to a support configuration in response to being placed under tension, or may be formed of a material that can provide a desired stiffness and / or can define a substantially fixed length without transitioning (e.g., without being placed under tension).

[0183] The supports 679 are configured to extend outside the control device 670 through the lumen of the delivery catheter 682 and / or delivery sheath (not shown). The proximal end of each support 679 is proximal and / or outside the delivery catheter 682, thereby allowing a user to manipulate each support 679. The distal end of each support 679 is removably connectable to and / or otherwise configured to selectively engage an attachment point 646 along the supra-annular region 620 of the valve frame 610. The supports 679 can be removably connected to the supra-annular region 620 in any suitable manner. In some embodiments, one or more of the supports 679 can be a tether that loops around the attachment point 646 in a manner similar to the tethers 275 and 276 described above (e.g., double-sided support such that both ends of the support are proximal to the delivery catheter 682). In some embodiments, the distal end of one or more supports 649 can be wrapped around the corresponding attachment point without "looping". In some embodiments, one or more attachment points 646 can be openings through which a portion of a corresponding support 679 can extend, as described above with reference to support 479. In some embodiments, support 679 can be removably coupled to the supra-annular region 620 of valve frame 610 using any combination of attachment methods. For example, an attachment point 646 at or near the distal end of the supra-annular region 620 can be an opening that allows a portion of a corresponding support 679 to extend through it. In some embodiments, the end of support 679 can have a ring that allows it to be placed around or around a guidewire catheter 684, as described above with reference to support 479. In this example, other attachment points 646 can be sutures that are configured to be temporarily coupled to corresponding supports 679.

[0184] Fig.21 The illustrated example includes a distal supra-annular support 679 and two additional supports 679. The distal supra-annular support 679 is coupled to and / or otherwise engaged with an attachment point at or near the distal end of the supra-annular region 620 (referred to as a "distal attachment point"), which may be similar to or substantially the same as support 379 or 479, and thus is not described in further detail. The additional supports 679 are shown extending from a delivery catheter 682 (or delivery sheath) to attachment points at locations along the supra-annular region 620 that are located at or near the relative lateral extent of the supra-annular region 620. In other words, the attachment point 646 is located at or near the lateral edge or perimeter of the supra-annular region 620 (referred to as a "lateral attachment point"). In addition, the attachment point 646 is laterally external and distal to the connecting member 678 of the control device 670. More specifically, the lateral attachment point 646 is shown to be laterally outward of the flow control component 650 and in the center of the flow control component 650 (at Fig.21 In other embodiments, the lateral attachment point 646 can be located anywhere along a segment of the supra-annular region 620 between the flow control component 650 and the lateral edge or perimeter.

[0185] As described above, the support 679 is configured to support and / or stabilize the valve 600 during deployment. In some embodiments, the support coupled to and / or otherwise engaged with the distal attachment point 646 can be configured to support at least a distal portion of the valve 300 and can constrain, limit and / or substantially prevent the distal supra-annular portion of the valve 300 from falling into the annulus, as described above with reference to the supports 379, 479 and 579. The support 679 coupled to and / or otherwise engaged with the lateral attachment point 646 can similarly provide support and / or stability for at least a portion of the valve 300. For example, the support 679 removably coupled to the lateral attachment point 646 can support and / or stabilize the valve 600 against and / or relative to lateral movement or orientation, axial alignment with the centerline of the annular plane, rotation about an axis at least partially defined by the guidewire catheter 684, and / or the like. In some embodiments, the attachment point 646 on the lateral exterior of the connecting member 678 causes the support member 679 to engage the supra-annular region 620 at a wider point, which in turn can allow for enhanced sensitivity to the rotational position, orientation and / or angle of the regulating valve 600 relative to the axis defined by the guidewire catheter 684 and / or the annular plane.

[0186] Although Fig.21679, but it should be understood that this embodiment is provided by way of example only and not limitation. For example, the valve 600 and delivery / deployment system 680 can be configured for use with more than three supports 679 or less than three supports 679. In some embodiments, for example, the valve 600 and delivery / deployment system 680 can be used with supports that are removably coupled to the lateral connection points 646 without requiring the supports 679 to be removably coupled to the distal attachment points 646. In some embodiments, the location of the lateral attachment points 646 can be modified to be distal to the centerline of the flow control component 650, which can allow the supports 679 coupled thereto to provide the lateral support / stability described above, as well as constrain, limit and / or substantially prevent the distal supra-annular portion of the valve 600 from falling into the annulus. In other words, the lateral attachment points 646 can be disposed in suitable locations along the supra-annular region 620, which allow the supports 679 to support the valve 600 in a manner otherwise provided by the supports 679, which are removably coupled to the distal attachment points. In other embodiments, the valve 600 can include attachment points at any other suitable locations along the supra-annular region 620 and / or along any other portion of the valve 600.

[0187] Fig. 22 is a schematic diagram of a prosthetic valve 700 coupled to a delivery / deployment system 780 including an supra-annular support 779, according to an embodiment. Valve 700 (or at least aspects thereof) and delivery / deployment system 780 (or at least aspects thereof) can be similar to and / or substantially the same as valves 300, 400, 500, and / or 600 and delivery / deployment systems 380, 480, 580, and / or 680, respectively. Therefore, valve 700 (or at least aspects thereof) and delivery / deployment system 780 (or at least aspects thereof) are not described in further detail herein.

[0188] As described above, the control device 770 can advance the valve 700 along the guidewire catheter 784 (and / or guidewire) through the delivery catheter 782 and / or delivery sheath (not shown) into the atrium of the heart. The delivery catheter 782 and optionally the delivery sheath can be maintained in a substantially fixed position relative to the atrium or relative to the inferior vena cava (IVC) through which the delivery catheter 782 extends, while the distal end of the control device 770 and the valve 700 are advanced toward the annulus along the guidewire catheter 784 in a distal direction relative to the delivery catheter 782 (e.g., away from the delivery catheter 782). Because the valve 700 is no longer constrained by the delivery catheter 782 and / or delivery sheath, releasing the valve 700 into the atrium allows the valve 700 to transition from a compressed configuration to an expanded configuration. The control device 770 can then be manipulated or turned to place and / or deploy the valve 700 into the annulus of the native heart valve, as described in detail above.

[0189] Fig. 22 The illustrated embodiment includes a support 779 coupled to the supra-annular region 720 of the valve 700 (or its valve frame 710). As described above, the support 779 is configured to provide support for one or more portions of the valve 700 during deployment and / or is configured to facilitate deployment and / or placement of the valve 700 in the annulus, as described in further detail herein. The support 779 can be similar to or substantially the same as the supports 179, 379, 479, 579, and / or 679 described above. For example, the support 779 can be and / or can include one or more tethers, sutures, cables, rods, tensile members, tubes, catheters, hypotubes, and / or the like, or combinations thereof.

[0190] The support 779 is configured to extend outside of the control device 770 through the lumen of the delivery catheter 782 and / or delivery sheath (not shown). The proximal end of the support 779 is located proximal and / or outside of the delivery catheter 782, thereby allowing a user to manipulate the support 779. The distal end of the support 779 is removably connectable to and / or otherwise configured to selectively engage the supra-annular region 720 of the valve frame 710. More specifically, the support 779 is connected to the attachment point 746 in a position along the supra-annular region 720 of the valve frame 710, which is located at or near the free wall side of the valve 700. For example, the prosthetic valve 700 can be a prosthetic tricuspid valve and can be configured for lateral delivery into the right atrium through the inferior vena cava (IVC). When valve 700 is released into the atrium, a first side of valve 700 is in contact with and / or adjacent to the septal wall of the heart (e.g., the "septal side" of prosthetic valve 700), and a second side of valve 700 is opposite the first side and the septum of the heart (e.g., the "free wall side" of prosthetic valve 700). Fig. 22 In the illustrated embodiment, the septal side of the valve 700 includes a post-septal (PS) tab or anchoring element 737 that can engage septal tissue to at least partially stabilize the valve 700. In addition, the supra-annular region 720 of the valve frame 710 includes an attachment point 746, which is located, for example, between the flow control component 750 and the lateral edge of the supra-annular region 720 on the free wall side of the prosthetic valve 700. The support member 779 is in turn removably coupled to the attachment point 746 and is configured to support, stabilize and / or at least partially control the free wall side of the prosthetic valve 700.

[0191] Although the attachment point 746 is shown as being at a particular location along the free wall side of the prosthetic valve 700, it will be appreciated that the attachment point 746 can be at any suitable location along the supra-annular region 720. For example, the attachment point 746 can be located at a location along the free wall side of the supra-annular region 720 that is proximal or distal to the centerline of the flow control component 750. In some embodiments, the proximal-distal positioning of the attachment point 746 can be based at least in part on the anatomy of the heart in which the valve 700 is being deployed. In some embodiments, it may be desirable to include the attachment point 746 at a location laterally outward of the connecting member 778, such as Fig. 22 shown.

[0192] exist Fig. 22 In the illustrated embodiment, the support member 779 is configured to be and / or include a support member formed of a material that can provide a desired stiffness and / or can define a substantially fixed length without being placed under tension (e.g., as described above with reference to support members 379, 479, 579, and / or 679). More specifically, the support member 779 or at least a portion thereof can be formed of a metal (e.g., stainless steel or the like) or a relatively hard polymer. In some embodiments, the support member 779 can be and / or include a support member conduit having a desired durometer hardness. In some embodiments, the support member 779 can be a cable, a hypotube, and / or any other suitable support member. In some embodiments, the distal end portion of the support member 779 (e.g., a conduit, a cable, a hypotube, etc.) can include a tether that facilitates removably connecting the support member 779 to the attachment point 746. In some embodiments, the distal end portion of the support 779 can be removably coupled to the attachment point 746 in any suitable manner (eg, via a threaded coupling, a ball and socket coupling, and / or any other removable coupling).

[0193] In some embodiments, a support 779 formed as and / or otherwise comprising a catheter, cable, hypotube, and / or other relatively rigid or semi-rigid member may provide sufficient stiffness and / or hardness to allow a user to apply, for example, a distal force on a proximal end portion of the support, which in turn is at least partially transmitted along the support 779 such that the distal end portion of the support 779 applies at least a portion of the distal force of the supra-annular region 320 of the valve frame 310. In some embodiments, it may be advantageous to include such a support 779 that is removably coupled to the supra-annular region 720 at or near the free wall side of the prosthetic valve 700 to facilitate placement of the valve 700 into the annulus. More specifically, in some cases, the anatomy of the heart may present challenges to placing the valve 700 into the annulus using only contact between the connecting member 778 (yoke) and the supra-annular region 720 of the valve frame 710. For example, the location of the outlet of the inferior vena cava (IVC) relative to the annulus may constrain or limit the degree of control that would otherwise be associated with deploying the valve 700 using the control device 770. In some cases, the anatomy of the heart may present challenges for positioning the free wall side of the valve 700 into the annulus. Fig. 22 The described support member 779 can allow a user to apply a distal force on the supra-annular region 720 of the valve frame 710 at a position along the free wall side of the valve 700, and the distal force can push the free wall side of the prosthetic valve 700 in a direction toward the annulus, thereby facilitating deployment and / or placement of the valve 700 in the annulus.

[0194] Figure 23 to Figure 25 800 is a prosthetic valve 800 coupled to a delivery / deployment system 880 having a distal supra-annular support 879 according to another embodiment. Valve 800 can be similar to and / or substantially the same as any valve described herein (e.g., valves 100, 200, 300, 400, 500, 600, and / or 700). Similarly, delivery / deployment system 880 can be similar to and / or substantially the same as any delivery / deployment system described herein (e.g., delivery / deployment systems 180, 380, 480, 580, 680, and / or 780). Therefore, valve 800 (or at least aspects thereof) and delivery / deployment system 880 (or at least aspects thereof) are not described in further detail herein.

[0195] As described above, the control device 870 can include a connection member 878 disposed at the distal end of the control catheter. The connection member 878 is removably coupled to the supra-annular region 820 of the valve 800 (or its valve frame 810). The coupling, engagement, and / or contact of the connection member 878 and the supra-annular region 820 enables the control device 870 to advance the valve 800 along the guidewire catheter 884 (and / or guidewire) through a delivery catheter and / or a delivery sheath (not shown) into the atrium of the heart. The delivery catheter and optionally the delivery sheath can be maintained in a substantially fixed position relative to the atrium or relative to the inferior vena cava (IVC) through which the delivery catheter extends, while the distal end of the control device 870 and the valve 800 are advanced toward the annulus along the guidewire catheter 884 in a distal direction relative to the delivery catheter (e.g., away from the delivery catheter). Because valve 800 is no longer constrained by the delivery catheter and / or delivery sheath, releasing valve 800 into the atrium allows valve 800 to transition from a compressed configuration to an expanded configuration. Control device 870 can then be manipulated or steered to position and / or deploy valve 800 into the annulus of a native heart valve, as described in detail above.

[0196] The control device 870 can be manipulated or steered to place the valve 800 (in the expanded configuration) at a desired deployment angle, wherein the distal anchoring element 832 is positioned below the annulus and near, adjacent to, and / or at least partially in, for example, a ventricular outflow tract (e.g., the right ventricular outflow tract (RVOT)). At the deployment angle, the supra-annular region 820 of the valve frame 810 and at least a proximal portion of the sub-annular region 830 of the valve frame 810 remain in the atrium. In some embodiments, the distal surface of the trans-annular region of the valve frame 810 can be placed in contact with autologous tissue forming a distal surface or wall of the annulus. As described above with reference to valve 200, a guidewire catheter 884 extending below a portion of the valve 800, through the portion of the valve 800, and extending from the distal anchoring element 832 can provide support for at least a portion of the valve 800 during deployment.

[0197] Figure 23 to Figure 25 The illustrated embodiment also includes a distal supra-annular support 879 that is removably / releasably coupled to the distal supra-annular region 820 of the valve 800 (or its valve frame 810). As described above, the support 879 can be configured to support and / or actuate one or more portions of the valve 800 during deployment. The support 879 can be similar to and / or substantially the same as the supports 179, 379, 479, 579, and / or 679 described above. More specifically, Figure 23 to Figure 25The support 879 shown is a tether that is removably / releasably coupled to a distal portion of the supra-annular region 820 of the valve 800 or its valve frame 810 (also referred to herein as the "atrial distal cuff"). As described above, in some embodiments, the support 879 can be configured to transition to a support configuration in response to being placed under tension to provide a desired amount of rigidity and / or support to the atrial distal cuff. In addition, the support 879 can include radiopaque markings that allow visualization of the support during image-guided procedures such as fluoroscopy.

[0198] The supports 879 are configured to extend outside of the control device 870 through the lumen of a delivery catheter and / or delivery sheath (not shown). The proximal end of each support 879 is proximal and / or outside of the delivery catheter, thereby allowing a user to manipulate the support 879. The distal ends of the supports 879 are removably connectable to and / or otherwise configured to selectively engage attachment points 846 at or along the atrial distal cuff. More specifically, the attachment points 846 can be attached to an outer wire loop (e.g., similar to or substantially the same as that used to attach to the atrial distal cuff) of the supra-annular region 820 of the valve frame 810. Fig. 9 The outer ring 221 of the annular component 220 (or region) is shown. Figure 23 to Figure 25 In the illustrated embodiment, the attachment point 846 is a suture through which at least a portion of the support member 879 is looped or wrapped. In addition, the supra-annular region 820 of the valve frame 810 defines an opening or hole through which a portion of the support member 879 can extend, as described above with reference to the support member 479. For example, the opening and / or hole is proximal to the attachment point 846 (e.g., along the drum of the supra-annular region 820), allowing a distal portion of the support member 879 to extend therethrough. Although not shown, the end of the support member 879 forms a loop, allowing it to be disposed around or around the guidewire catheter 884 to secure and / or anchor the distal end of the support member 879, as described above with reference to the support member 479.

[0199] Figure 23 to Figure 25 The illustrated support 879 is configured to actuate and / or transition at least a portion of the distal atrial cuff between two or more configurations and / or states, as described in further detail herein. Fig.24800 and delivery / deployment system 880, showing the atrial distal cuff in a first or unactuated state (for purposes of illustration, support member 879 is shown as being under tension, but not under sufficient tension to actuate the atrial distal cuff). As described above with reference to valve 100, the atrial distal cuff can be sized and shaped to substantially correspond to the atrial floor distal to the annulus. However, because the process of placing a laterally deliverable valve includes inserting the distal subannular portion of valve 800 into the ventricle and then pivoting the proximal end portion of valve 800 into the annulus, the shape and size of the atrial distal cuff can, in some circumstances, push the distal portion of valve 800 away from the distal annular wall, thereby resisting the process of deploying valve 800 into the annulus.

[0200] Therefore, if Fig.25 As shown, support member 879 can be transitioned from a first state to a second state and / or can otherwise be placed under sufficient tension to move the distal atrial cuff from a first or unactuated state ( Fig.24 ) transitions to the second or actuated state ( Fig.25 ). In other words, a proximal force may be applied to the support member 879 to actuate the distal atrial cuff. Fig.25 , the support 879 can be configured to apply a force on or at the attachment point that is operable to actuate at least a portion of the atrial distal cuff to facilitate the process of placing the valve 800 by pulling the atrial distal cuff, actuating the atrial distal cuff, and / or otherwise acting on the atrial distal cuff to move, bend, flex, and / or transform the atrial distal cuff in a proximal direction away from the atrial floor or atrial tissue that defines or surrounds the valve annulus. Thus, transforming or actuating the atrial distal cuff in this manner can reduce contact between the atrial distal cuff and atrial tissue that would otherwise resist pivoting motion associated with placing the valve 800 in the valve annulus, as described above with reference to the valve 100 and the support 179.

[0201] Fig.26 is a flow chart illustrating a method 10 for delivering and deploying a laterally deliverable transcatheter prosthetic valve into the annulus of a native valve, according to an embodiment. The laterally deliverable transcatheter prosthetic valve may be similar to and / or substantially the same as any prosthetic valve described herein. For example, the prosthetic valve may include an external support frame and an (internal) flow control component, the (internal) flow control component being mounted in and / or to the external support frame. The external support frame may include, for example, an supra-annular member or region, a sub-annular member or region, and a trans-annular member or region coupled therebetween. The flow control component is mounted to the external support frame, which extends through a portion of the trans-annular member or region, as described above with reference to valves 100 and / or 200.

[0202] Method 10 includes removably coupling a control device to a proximal supra-annular portion of a prosthetic valve at 11. For example, in some embodiments, the supra-annular member may include a proximal attachment member or the like that may be used to temporarily couple the delivery / deployment system to the valve, as described above with reference to Figures 7 to 16 The valve 200 shown in the figure is described. For example, the delivery / deployment system may include a control device or the like, which may include a control catheter and a connecting member coupled to the distal end of the control catheter. The connecting member may be removably connectable to the attachment member of the valve via one or more tethers and / or the like, as described above with reference to valve 200.

[0203] At 12, the supra-annular support of the delivery / deployment system is removably coupled to the supra-annular portion of the prosthetic valve. The supra-annular support may be of any suitable shape, size, and / or configuration. For example, the supra-annular support may be similar to or substantially identical to any of the supra-annular supports 179, 379, 479, 579, 679, 779, and / or 879 described in detail above. For example, in some embodiments, the supra-annular support ("support") may be one or more tethers, tensile members, rods, cables, connectors, and the like configured to be removably coupled to an attachment point or the like at or along the supra-annular portion of the valve (e.g., the supra-annular region of the valve frame). For example, the support may be and / or may include a tether that is removably coupled to and / or otherwise engaged to an attachment point at the distal supra-annular portion of the valve, as described above with reference to supports 379, 479, 579, and / or 879. In some embodiments, the support member can be and / or can include a pair of supports (e.g., tethers) located distally and laterally outwardly of the connecting member of the control device, as described above with reference to Fig.21 The "lateral" support 679 shown is described. For example, the support can be removably connected to a portion of the supra-annular portion of the valve at or near the flow control component. In some embodiments, the support can be and / or can include a support conduit that is removably connected to and / or otherwise engages an attachment point that is located distally and laterally external to the connecting member of the control device, as described above with reference to support 779. In such an embodiment, the location of the attachment point along the supra-annular portion of the prosthetic valve can be at or near the free wall side of the prosthetic valve (e.g., the side of the valve that is opposite or not in contact with the septal wall of the heart). In some embodiments, multiple supra-annular supports having any combination of arrangements, configurations, etc. can be used and the multiple supra-annular supports are connected to the supra-annular region of the valve frame in one or more locations, and the multiple supra-annular supports can support and / or stabilize the valve during deployment into the native valve annulus.

[0204] At 13, the control device and the prosthetic valve are advanced through the lumen of the delivery catheter in the compressed configuration to place the distal end portion of the control device and the prosthetic valve into a chamber of the heart. As described above with reference to valves 100 and / or 200, the prosthetic valve can be placed in a delivery configuration and loaded into the lumen of a delivery catheter and / or delivery sheath. In some cases, placing the valve in a delivery configuration can include, for example, folding the valve in a lateral direction or along a lateral axis, and compressing the valve in an axial or blood flow direction or along the central axis of the valve. In some cases, the control device (or its connecting member) is removably connected to the proximal annular portion of the valve before being advanced through the lumen of the delivery catheter. Therefore, the control device can be used to advance the prosthetic valve in a compression and / or delivery configuration through the lumen of the delivery catheter into a chamber of the heart. In some cases, the chamber of the heart can be an atrium of the heart. Furthermore, the prosthetic valve may be allowed to transition from a compressed configuration to an expanded configuration when the valve is released from a delivery catheter and / or delivery sheath and placed in the atrium.

[0205] At 14, the supra-annular support is transitioned from a first state to a second state. For example, after the prosthetic valve is released from the delivery catheter and / or delivery sheath and allowed to expand to an expanded and / or deployed configuration, a user can manipulate the supra-annular support to transition the support from the first state to the second state. In some embodiments, the support can be one or more tethers that can transition from the first state to the second state in response to a proximal force applied by a user to a proximal end portion of the support. In this way, the proximal force can place at least a portion of the support under tension, thereby forming a substantially rigid or substantially fixed-length connection between a distal end of the delivery sheath (from which the support extends) and an attachment portion at or along a distal supra-annular portion of the valve. In some embodiments, the support can be one or more tethers that can transition from a first state to a second state in response to a distal force, which in turn can actuate, reconfigure, and / or otherwise transition one or more portions of a supra-annular region of a valve or valve frame (e.g., a distal atrial cuff). For example, the support can be configured to actuate the distal atrial cuff to cause the distal atrial cuff to move, bend, flex, and / or otherwise transition in a proximal direction (e.g., away from atrial tissue defining and / or surrounding the annulus).

[0206] At 15, the prosthetic valve is positioned in the native annulus while the supra-annular support is in the second state. The support in the second or supported state or configuration can stabilize at least a portion of the valve, which can provide enhanced control of the valve when the valve is moved and / or positioned into the annulus via a control device. In addition, during deployment, the support can be in a substantially rigid and / or substantially fixed length configuration, which can reduce the likelihood that the distal supra-annular portion of the valve will fall into the annulus during deployment, can reduce and / or limit undesirable movement of the valve relative to the delivery / deployment system, can reduce or limit undesirable lateral or rotational movement of the valve relative to the annular plane of the native valve, and / or can reduce or limit undesirable movement of at least a portion of the delivery / deployment system when the proximal portion of the valve is pushed into or pivoted into the annulus, as described in detail above with reference to supports 179, 379, 479, 579, 679, 779 and / or 879.

[0207] At 16, after the valve is positioned, each of the control device and the supra-annular support is disconnected from the prosthetic valve. For example, in some embodiments, the control device can be removably connected to the proximal portion of the valve via one or more tethers that "loop" through or around a portion of the valve so that each of the proximal and distal ends of the tethers are and / or are disposed outside the body. In this way, changes in the force applied to each end of the tether can be operable to actuate a portion of the tether, the control device, and / or the valve, and a proximal force applied to one of the proximal or distal ends can be operable to disconnect the tether from the valve and withdraw the tether into and / or through the control device. In some embodiments, the supra-annular support can be removably connected to an attachment point or the like at or along the distal supra-annular portion of the valve in a substantially similar manner (e.g., an optional configuration of support 379).

[0208] In other embodiments, the proximal end portion of the support can be proximal to the delivery catheter and / or sheath and disposed outside the body (allowing the user to manipulate the support), while the distal end portion of the support is removably coupled to and / or otherwise removably engages a distal supra-annular portion of the valve, a guidewire, a guidewire catheter, and / or the like. For example, the supra-annular portion of the valve can define or form an opening, hole, path point, through hole, etc., which is configured to allow the distal portion of the support to extend therethrough. In such embodiments, the distal end of the support can include a ring or annulus that can be disposed on or around the guidewire catheter (or other components, features, etc. outside the valve) to fix or anchor the distal end of the support, as described in detail above with reference to supports 479 and / or 879. In this way, retracting the guidewire catheter (or other components, features, etc.) from the distal anchoring element and / or valve typically releases the distal end of the support and allows the support to be retracted through the attachment point (e.g., opening, etc.) into the delivery sheath. Thus, the delivery / deployment system can be detached from the valve and removed from the patient, as described in detail above with reference to delivery / deployment systems 180 , 280 , 380 , 480 , 580 , 680 , 780 , and / or 880 .

[0209] Although various embodiments have been described above, it should be understood that they have been presented by way of example only and not by way of limitation. Similarly, it should be understood that the specific terms used herein are for the purpose of describing specific embodiments and / or their features or components and are not intended to be limiting. Unless otherwise expressly stated, various modifications, changes and / or variations in form and / or detail may be made without departing from the scope of the present disclosure and / or without changing its functions and / or advantages. In addition to the embodiments, implementations and / or methods listed herein, functionally equivalent embodiments, implementations and / or methods will be apparent to those skilled in the art from the above description and are intended to fall within the scope of the present disclosure.

[0210] Where the above schematics, embodiments and / or implementations indicate certain components arranged in certain orientations or positions, the arrangement of the components may be modified. Although various embodiments have been described as having specific combinations of features and / or components, other embodiments may also have any combination of features and / or components from any embodiment described herein, except for mutually exclusive combinations. The embodiments described herein may include various combinations and / or sub-combinations of the functions, components and / or features of the different embodiments described.

[0211] In the case where the above method indicates that certain events occur in a specific order, the ordering of certain events can be modified. In addition, when possible, certain events can be performed simultaneously in a parallel process, and are performed sequentially as described above. Although the method has been described as having a specific step and / or combination of steps, other methods can also have a combination of any steps from any method described herein, except for mutually exclusive combinations and / or unless the context clearly states otherwise.

Claims

1. A delivery system for delivering and deploying a laterally deliverable prosthetic heart valve, the delivery system comprising: delivery sheath; a control device movable through the lumen of the delivery sheath, the control device comprising a control catheter and a connecting member coupled to a distal end of the control catheter, the connecting member configured to be removably coupled to the prosthetic valve at a proximal position along a supra-annular portion of the prosthetic valve, the control device operable to advance the prosthetic valve through the lumen of the delivery sheath into a chamber of the heart in a compressed configuration and to deploy the prosthetic valve from the chamber of the heart into the annulus of the native valve in an expanded configuration; and At least one supra-annular support member is movable through the lumen of the delivery sheath, the at least one supra-annular support member is configured to be removably connected to the prosthetic valve at one or more locations along the supra-annular portion of the prosthetic valve, and the at least one supra-annular support member is configured to stabilize or actuate at least a portion of the prosthetic valve relative to the annular plane of the native heart valve during deployment.

2. The delivery system according to claim 1, wherein The connecting member forms a yoke configured to contact a supra-annular portion of the prosthetic valve.

3. The delivery system according to claim 2, wherein: The yoke has a first arm and a second arm arranged in a Y shape, and the at least one supra-annular support member includes a support member, which is configured to be removably connected to an attachment point along the supra-annular portion of the prosthetic valve at a position distal and laterally external to the first arm of the yoke or one of the second arms of the yoke.

4. The delivery system according to claim 3, wherein The at least one supra-annular support is at least one of a catheter, a cable or a hypotube having sufficient rigidity to transmit a distal force applied to a proximal end portion thereof to the supra-annular portion of the prosthetic valve, wherein the distal force is operable to push a portion of the prosthetic valve toward the annulus.

5. The delivery system according to claim 1, wherein The at least one supraannular support includes at least one tether removably connectable to an attachment point along a distal supraannular portion of the prosthetic valve.

6. The delivery system according to claim 5, wherein The at least one tether is configured to transition from a first configuration to a second configuration in response to a proximal force exerted on a proximal end portion thereof.

7. The delivery system according to claim 6, wherein In the second configuration the at least one tether forms a substantially fixed length connection between a distal end portion of the delivery sheath and a distal supra-annular portion of the prosthetic valve.

8. The delivery system according to claim 1, wherein The prosthetic valve has a valve frame and a flow control component installed in the valve frame, and The at least one supraannular support includes at least one tether removably connectable to an attachment point along a distal portion of the supraannular region of the valve frame.

9. The delivery system according to claim 8, wherein The at least one tether can be removably coupled to the attachment point such that a proximal force applied to a proximal end portion of the at least one tether actuates a distal portion of the supra-annular region of the valve frame.

10. The delivery system according to claim 9, wherein The step of the at least one tether actuating the distal portion of the supraannular region of the valve frame includes moving the distal portion of the supraannular region of the valve frame in a proximal direction away from autologous tissue defining or surrounding at least the distal portion of the annulus.

11. A delivery system for delivering and deploying a laterally deliverable prosthetic heart valve, the delivery system comprising: delivery sheath; a control device movable through the lumen of the delivery sheath, the control device comprising a control catheter and a connecting member coupled to a distal end of the control catheter, the connecting member configured to removably couple to a proximal supra-annular portion of the prosthetic valve, the control device operable to advance the prosthetic valve through the lumen of the delivery sheath into a chamber of the heart in a compressed configuration and to deploy the prosthetic valve from the chamber of the heart into the annulus of the native valve in an expanded configuration; and An supra-annular support member, which can move through the lumen of the delivery sheath, the supra-annular support member is configured to be removably connected to the distal supra-annular portion of the prosthetic valve, and the supra-annular support member is configured to transition from a first state to a second state when the prosthetic valve is in the expanded configuration, in which second state the supra-annular support member forms a connection portion of a substantially fixed length between the delivery sheath and the distal supra-annular portion of the prosthetic valve.

12. The delivery system of claim 11, further comprising: A delivery catheter comprising a distal end configured to be advanced through the patient's vascular system into a chamber of the heart, and a proximal end disposed outside the patient's body, the delivery sheath being movable through the lumen of the delivery catheter.

13. The delivery system according to claim 11, wherein The control device is configured to be removably coupled to a proximal supra-annular portion of the prosthetic valve via a set of tethers.

14. The delivery system according to claim 11, wherein The supra-annular support is at least one tether.

15. The delivery system according to claim 14, wherein The at least one tether extends through the lumen of the delivery sheath and outside of the control device.

16. The delivery system of claim 11, wherein: The distal end portion of the supra-annular support can be removably coupled to an attachment point at or along a distal supra-annular portion of the prosthetic valve.

17. The delivery system of claim 16, wherein: The attachment point is at least one suture.

18. The delivery system of claim 16, wherein: The prosthetic valve has a valve frame and a flow control component installed in the valve frame, and The attachment point is at least one suture that is attached to a distal portion of the supra-annular region of the valve frame.

19. The delivery system of claim 18, wherein: The supra-annular support is configured to be removably coupled to the attachment point such that a distal end portion of the supra-annular support extends through an opening at or along a distal supra-annular portion of the prosthetic valve.

20. The delivery system of claim 19, wherein: The distal end of the supra-annular support forms a ring configured to be disposed around an over-the-wire catheter that is removably coupled to a sub-annular region of the valve frame.

21. The delivery system of claim 20, wherein: deploying the prosthetic valve from a chamber of the heart into the native valve annulus in the expanded configuration such that a distal wall of the prosthetic valve is placed in contact with native tissue forming at least a portion of the annulus, and The distal portion of the supra-annular support is configured to be fixed relative to the attachment point in response to contact between a distal wall of the valve and autologous tissue forming at least a portion of the annulus.

22. A method of delivering and deploying a laterally deliverable prosthetic valve into a native valve annulus of a heart, the method comprising: removably coupling a control device to a supra-annular component of the prosthetic valve; removably coupling a supraannular support to a supraannular component of the prosthetic valve; advancing the control device and the prosthetic valve in the compressed configuration through a lumen of a delivery catheter to place a distal end portion of the control device and the prosthetic valve into a chamber of the heart, the prosthetic valve being in an expanded configuration when in the chamber of the heart; Transforming the supra-annular support from a first state to a second state; while the supra-annular support is in the second state, positioning the prosthetic valve in the native valve annulus; as well as After the positioning, each of the control device and the supra-annular support is disengaged from a supra-annular component of the prosthetic valve.

23. The method according to claim 22, wherein: The supra-annular support comprises at least a support conduit.

24. The method according to claim 23, wherein: The step of transitioning the supra-annular support from the first state to the second state comprises applying a distal force on a proximal end portion of the support conduit, and The step of positioning the prosthetic valve in the native valve annulus while the supra-annular support is in the second state includes transmitting at least a portion of the distal force to the supra-annular component of the prosthetic valve via the support catheter, thereby pushing at least a portion of the prosthetic valve into the native valve annulus.

25. The method according to claim 22, wherein: The supraannular support is at least one tether, and the step of removably coupling the supraannular support to the supraannular component of the prosthetic valve includes removably coupling the at least one tether to an attachment point along the supraannular component of the prosthetic valve.

26. The method according to claim 25, wherein: The proximal end of the at least one tether is proximal to the delivery catheter, the method further comprising: A proximal force is applied on a proximal end of the at least one tether to increase tension along the at least one tether, the increased tension along the at least one tether being operable to transition the at least one tether from the first state to the second state.

27. The method according to claim 26, wherein: When the at least one tether is in the second state, the at least one tether forms a substantially rigid connection between the distal end of the delivery catheter and the attachment point.

28. The method according to claim 26, wherein: The attachment point is attached to a distal portion of the supra-annular component, the method further comprising: The distal portion of the supra-annular component is actuated in response to a proximal force applied to the proximal end of the at least one tether, and the actuation step is operable to cause the distal portion of the supra-annular component to move in a proximal direction away from autologous tissue that defines or surrounds at least the distal portion of the autologous valve annulus.

29. The method according to claim 25, wherein: The at least one tether is removably connected to the attachment point so that the distal end of the at least one tether extends through an opening along the distal portion of the prosthetic valve to allow a loop at the distal end of the at least one tether to be set around a guidewire catheter that is removably connected to the subannular member of the prosthetic valve.

30. The method according to claim 29, wherein: After positioning the prosthetic valve in the native valve annulus, the method further comprises: moving the guidewire catheter in a proximal direction such that a distal end of the guidewire catheter is at least partially disposed within the delivery catheter and disengaged from a subannular component of the prosthetic valve; and In response to the guidewire catheter moving in the proximal direction, a loop at the distal end of the at least one tether is released from the guidewire catheter.

Images