Devices and methods for delivering prosthetic heart valves using supranuclear support

Abstract

The delivery system includes a delivery sheath, with a control device and at least one supranuclear support movable through a lumen of the delivery sheath. The control device includes a connecting member coupled to a distal end of a control catheter. The connecting member is configured to detachably couple to the prosthetic valve at a proximal location along the supranuclear plane of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath and at least partially deploy the prosthetic valve in an expanded configuration into the annulus of the native heart valve. The supranuclear support is detachably coupleable at one or more locations along the supranuclear plane of the prosthetic valve and 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.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 510,699, entitled "Devices and Methods for Delivering a Prosthetic Heart Valve using Supra-Annular Support," filed 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 June 2, 2023; and U.S. Provisional Patent Application No. 63 / 379,569, entitled "Devices and Methods for Delivering a Prosthetic Heart Valve using a Supra-Annular Support," filed October 14, 2022, the disclosures of each of which are incorporated herein by reference in their entirety.

[0002] background

[0002] 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 supranuclear supports and / or actuators such as one or more tethers. [Background technology]

[0003]

[0003] Prosthetic heart valves can present challenges for delivery, deployment, and / or retrieval within the heart, particularly for delivery by catheter through a patient's vasculature rather than a surgical approach. Conventional transcatheter prosthetic valve delivery generally involves radially compressing the valve and loading it into a delivery catheter so that the central annular axis of the valve is parallel to the longitudinal or longitudinal axis of the delivery catheter. In other words, conventional prosthetic valves are loaded into a delivery catheter so that the radial extent of the valve is aligned with and / or within the radial extent of a lumen extending through the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the central annular axis. However, the patient's vasculature imposes limitations on the diameter of the delivery catheter, which in turn imposes limitations on the radial extent of the lumen extending through the delivery catheter and, therefore, the expanded size (e.g., diameter) of a prosthetic valve delivered using conventional radial compression delivery methods. The competing interest of minimizing delivery catheter size presents problems in increasing the expanded diameter of a radially compressed valve (e.g., trying to compress too much material and structure into too little space). Additionally, the orientation of conventional valves during deployment can create additional problems when attempting to align the valve with the native valve annulus.

[0004] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, allowing for an increased expanded diameter compared to conventionally delivered valves. When using lateral delivery, for example, the valve can be placed in a compressed or delivery configuration and loaded into a delivery catheter such that the central annular axis of the valve is substantially perpendicular and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. More specifically, the valve can be compressed axially (e.g., along the central annular axis) and laterally (e.g., perpendicular to each of the central annular axis and the longitudinal axis of the valve) and can be decompressed or elongated longitudinally (e.g., parallel to the longitudinal or longitudinal axis of the delivery catheter). The compressed valve (e.g., a valve in a delivery configuration) can be loaded into the lumen of the delivery catheter in a lateral or orthogonal orientation, with the central annular axis of the valve being substantially perpendicular 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 (e.g., into a heart chamber such as the atrium) from the end of the delivery catheter. Additionally, in some cases, the lateral or perpendicular orientation of the deployed side-delivery valve relative to the delivery catheter generally results in the valve being deployed in a desired orientation relative to the native valve annulus.

[0005] While lateral delivery may allow for the delivery of larger valves and may simplify the process of aligning or orienting the valve relative to the native annulus compared to conventional delivery, problems exist with seating a laterally deliverable prosthetic valve into the native annulus. For example, a conventional radially compressed valve can be maintained in an at least partially compressed state while a portion of the prosthetic valve is inserted through the annulus. Once in the desired position, the prosthetic valve can be transitioned to a radially uncompressed state, thereby seating the conventionally delivered valve into the native annulus. On the other hand, in some tricuspid valve replacements, seating a laterally deliverable prosthetic valve can involve inserting the distal portion of the valve so that its distal wall contacts the distal wall of the annulus, a subannular portion, tabs, or anchors are below the annulus, and the supranuclear portion of the valve, such as an atrial cuff, is located at or near the annulus. Once positioned, the valve can be pivoted out of the plane of the annulus to insert the proximal portion of the valve into / through the native annulus, thereby seating the valve. However, in some cases, it may be desirable to increase the stability of such a laterally deliverable valve while it is deployed (pivoted) into the annulus. It may also be desirable to reduce the likelihood that the supranuclear portion of the valve (e.g., a portion of the atrial cuff, etc.) will intrude into the annulus and / or to reduce or adjust the amount and type of contact between the distal portion of the valve and at least a portion of the tissue defining or surrounding the annulus. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] Therefore, there is a need for a device, system, and / or method for delivering a transcatheter prosthetic heart valve that can be delivered laterally using one or more supranuclear supports and / or actuators such as one or more tethers. [Means for solving the problem]

[0007] overview

[0007] Embodiments described herein relate to devices, systems, and / or methods for delivering a laterally deliverable transcatheter prosthetic heart valve and one or more supranulnar supports and / or actuators to deliver the prosthetic valve. In some embodiments, the delivery system includes a delivery sheath, and the control device and at least one supranulnar support are each movable through a lumen of the delivery sheath. The control device includes a control catheter and a connecting member coupled to a distal end of the control catheter. The connecting member is configured to releasably couple to the prosthetic valve at a proximal location along the supranulnar plane of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath to at least partially deploy the prosthetic valve in an expanded configuration into the annulus of the native heart valve. The supranulnar supports are releasably coupleable to the prosthetic valve at one or more locations along the supranulnar plane and are configured to stabilize or actuate at least a portion of the prosthetic valve relative to the plane of the native heart valve annulus during deployment. [Brief explanation of the drawings]

[0008] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 2]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 3]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 4]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 5]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 6]

[0008] A schematic diagram of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 7]

[0009] FIG. 1 is an elevated side perspective view of a prosthetic valve according to one embodiment. [Figure 8]

[0009] FIG. 1 is a bottom perspective view of an artificial valve according to one embodiment. [Figure 9]

[0010] FIG. 8 is an elevated side perspective view of the supranulular region of the outer support frame of the prosthetic valve shown in FIG. 7. [Figure 10]

[0011] FIG. 8 is a distal perspective view of the transannular region of the outer support frame of the prosthetic valve shown in FIG. 7. [Figure 11]

[0012] FIG. 8 is a distal perspective view of the subannular region of the outer support frame of the prosthetic valve shown in FIG. 7. [Figure 12]

[0013] FIG. 8 is a top perspective view of the inner frame of the flow control component included in the prosthetic valve shown in FIG. 7. [Figure 13]

[0014] 13 is a side perspective view of the leaflet band of the inner flow control component with the leaflet pockets sewn to the structural band and shown in a cylindrical configuration suitable for coupling to the inner frame of FIG. 12. FIG. [Figure 14]

[0015] 14 is a bottom view of the leaflet band of FIG. 13 in a cylindrical configuration and showing partial coaptation of the leaflets to form a partially closed fluid seal. FIG. [Figure 15]

[0016] FIG. 8 is an elevated side perspective view of the prosthetic valve of FIG. 7 removably coupled to a distal end portion of a control device included in a delivery system. [Figure 16]

[0016] FIG. 8 is an elevated side perspective view of the prosthetic valve of FIG. 7 removably coupled to a distal end portion of a control device included in a delivery system. [Figure 17]

[0017] FIG. 1 is a schematic diagram of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 18]

[0018] FIG. 1 is a schematic diagram of a laterally deliverable transcatheter prosthetic valve coupled to a delivery system (or portion thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 19]

[0019] FIG. 1 is a side view perspective view showing a delivery system engaging a prosthetic valve during deployment, shown prior to seating the valve in the annulus. [Figure 20]

[0019] A side view perspective view showing a delivery system engaging a prosthetic valve during deployment, shown while and / or after the valve is at least partially seated in the annulus. [Figure 21]

[0020] FIG. 1 is a top perspective view of a side-deliverable transcatheter prosthetic valve coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 22]

[0021] FIG. 1 is a top perspective view of a side-deliverable transcatheter prosthetic valve coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 23]

[0022] FIG. 1 is a perspective view of a side-deliverable transcatheter prosthetic valve coupled to a delivery system (or part thereof) used to deliver and deploy the prosthetic valve into the annulus of a native heart valve, according to one embodiment. [Figure 24]

[0023] FIG. 1 is a side view of a prosthetic valve and delivery system (or portion thereof) showing the distal or supranuclear region of the valve in a first state. [Figure 25]

[0023] FIG. 1 is a side view of a prosthetic valve and delivery system (or portion thereof) showing the distal or supranuclear region of the valve in a second state. [Figure 26]

[0024] 1 is a flowchart illustrating a method for delivering and deploying a side-deliverable transcatheter prosthetic valve to the annulus of a native valve, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] Detailed Description

[0025] Disclosed embodiments relate to devices, systems, and / or methods for delivering and deploying a prosthetic valve into a native valve annulus using a laterally deliverable transcatheter prosthetic heart valve and / or components thereof and one or more supranullar supports. In some embodiments, the delivery system includes a delivery sheath, and the control device and at least one supranullar support are each movable through a lumen of the delivery sheath. The control device includes a control catheter and a connecting member coupled to a distal end of the control catheter. The connecting member is configured to detachably couple to the prosthetic valve at a proximal location along the supranullar plane of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath to at least partially deploy the prosthetic valve in an expanded configuration into the native valve annulus. The supranullar supports are detachably coupleable to the prosthetic valve at one or more locations along the supranullar plane and are configured to stabilize or actuate at least a portion of the prosthetic valve relative to the plane of the native heart valve annulus during deployment.

[0010]

[0026] In some embodiments, the delivery system includes a delivery sheath, and the control device and the supranulnar support are each movable through a lumen of the delivery sheath. The control device is coupled to a distal end of the control catheter and includes a connecting member configured to detachably couple to a proximal supranulnar portion of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath and deploy the prosthetic valve in an expanded configuration at the annulus of the native valve. The supranulnar support is detachably coupleable to the distal supranulnar portion of the prosthetic valve and configured to transition from a first state to a second state when the prosthetic valve is in the expanded configuration. The supranulnar support in the second state forms a substantially constant length connection between the delivery sheath and the distal supranulnar portion of the prosthetic valve.

[0011]

[0027] In some embodiments, a method for delivering and / or deploying a laterally deliverable prosthetic valve to an annulus of a native heart valve includes removably coupling a control device and a supranulnar support to a supranulnar portion of the prosthetic valve. In some implementations, the control device can be removably coupled to a proximal supranulnar portion of the prosthetic valve, while the supranulnar support is removably coupled to a distal supranulnar portion of the prosthetic valve. The control device and the prosthetic valve in a compressed configuration are advanced through a lumen of a delivery catheter to position the distal end portion of the control device and the prosthetic valve within a heart chamber. The prosthetic valve is configured to transition to an expanded configuration when within the heart chamber. While the prosthetic valve is within the heart chamber, the supranulnar support transitions from a first state to a second state. In some implementations, transitioning the supranulnar support from the first state to the second state can cause the supranulnar support to form a substantially rigid connection between the distal end of the delivery sheath and the distal subannular portion of the prosthetic valve. In some embodiments, transitioning the supranulnar support from the first state to the second state can actuate the supranulnar portion of the prosthetic valve (e.g., move, curve, bend, and / or otherwise reconfigure at least a portion of the supranulnar portion of the prosthetic valve). The prosthetic valve is sealed within the native annulus while the supranulnar support is in the second state. Each of the control device and the supranulnar support is decoupled from the prosthetic valve after sealing. In some embodiments, decoupling the supranulnar support can include, for example, retracting the guidewire catheter into the delivery sheath to release a distal end portion of the supranulnar support.

[0012]

[0028] Any of the prosthetic valves described herein can be relatively low-profile transcatheter prosthetic heart valves. The prosthetic heart valves herein can include a valve frame and a flow control component mounted within a central lumen, aperture, and / or channel of the valve frame that extends along a central axis of the valve or valve frame that is coaxial with 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 on the prosthetic valve. The valve frame can also provide one or more components or elements for anchoring or otherwise securing the prosthetic valve to the annulus of the native valve. The flow control component (e.g., a two-leaflet or three-leaflet sleeve, valve, etc.) can be configured to allow blood to flow in a first direction through the inflow end of the valve and out the outflow end of the valve, and to block blood flow in a second direction opposite the first direction.

[0013]

[0029] Any of the delivery and / or deployment systems and / or methods described herein can be used and / or implemented with conventionally deliverable valves or orthogonal / laterally deliverable valves, unless otherwise specified. For example, the valves described herein can be configured to transition between a compressed or delivery configuration for introduction into the body via a delivery catheter and an expanded or deployment / deployment configuration for implantation at a desired location within the body (e.g., via balloon inflation or via one or more self-expanding structures). The delivery catheter can be, for example, a 24-36 French (Fr) delivery catheter that is advanced through the patient's vasculature into a heart chamber. Generally, conventionally delivered / deliverable valves are configured, for example, to be radially compressed relative to a central axis or direction of blood flow through the valve and advanced through the delivery catheter such that the central axis of the compressed valve is parallel to the longitudinal or longitudinal axis of the delivery catheter used to deliver the valve. The valve is deployed from the end of the delivery catheter and expands radially outward from the central cylindrical axis. Valve delivery orientation generally means that the valve is fully released from the delivery catheter and reoriented relative to the annulus while in the atrium, 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.

[0014]

[0030] Orthogonal or lateral delivery / deliverable valves are configured to be compressed in at least one of a transverse direction (perpendicular to the direction of blood flow through the valve) or an axial direction (parallel or aligned with the direction of blood flow). In some embodiments, any of the valves can be compressed in two directions—laterally and axially—without compressing the valve in a direction along the longitudinal direction or longitudinal axis of the valve (perpendicular to the direction of blood flow through the valve). With orthogonal or lateral delivery, the compressed valve can be inserted and / or advanced through a delivery catheter such that the central axis of the compressed valve is substantially orthogonal or perpendicular to the longitudinal or longitudinal axis of the delivery catheter. Stated differently, with 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. Thus, orthogonally and / or lateral-delivered prosthetic valves are compressed and / or delivered laterally (e.g., at approximately a 90-degree angle) compared to conventional processes for compressing and delivering transcatheter prosthetic valves.

[0015]

[0031] In some embodiments, the orientation of the orthogonal delivery valve relative to the valve annulus allows the distal portion of the valve to be at least partially inserted into the annulus of a native heart valve while the proximal portion of the valve remains at least partially in the delivery catheter, thereby avoiding at least some of the size constraints encountered with some known conventional delivery techniques. For example, a relatively large side-deliverable prosthetic valve can have a height of about 5-60 millimeters (mm) and a diameter of about 20-80 mm in an expanded configuration, and a height of about 5-12 mm, a width (e.g., in the transverse direction) of about 8-12 mm, and a length (e.g., in the longitudinal or vertical direction) of about 25-80 mm in a compressed configuration. Furthermore, orthogonal or lateral delivery allows the valve to be deployed into the annulus of a native mitral or tricuspid valve from the inferior vena cava (IVC) without having to position the delivery catheter at an acute angle relative to the native valve, as is common with conventional transcatheter delivery.

[0016]

[0032] While valves configured for orthogonal delivery can deploy 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 seating some conventionally delivered prosthetic valves into the annulus of a native heart valve. For example, such valves can be at least partially radially compressed to allow a portion of the prosthetic valve to drop into the annulus. Once the valve is in the desired position, the valve can transition and / or be allowed to transition to a radially expanded (or radially uncompressed) state, thereby seating the prosthetic valve into the annulus of a native heart valve. On the other hand, the process of deploying and / or seating certain orthogonally delivered prosthetic valves can include inserting a distal portion of the prosthetic valve through the annulus and then pivoting the remaining portion of the valve to the desired position. In some cases, this difference in the process of seating the valve into the annulus may make additional features and / or methods desirable that increase the stability of an orthogonally delivered valve during deployment (seating) into the native annulus, such as any described herein.

[0017]

[0033] Any of the prosthetic heart valves described herein can include an outer support frame that includes and / or forms a supranullar region, a subannular region, and a transannular region coupled therebetween. The supranullar region can, for example, form the upper collar of the outer support frame and can include any number of features configured to engage native tissue, the inner flow control components of the prosthetic valve, and / or a delivery, actuator, and / or retrieval mechanism. The subannular region can, for example, form one or more anchoring elements configured to engage subannular (ventricular) tissue when the prosthetic valve is seated on the native annulus. The transannular region can be coupled between the supranullar region and the subannular region. The transannular region can form a shape such as a funnel, a cylinder, a flat cone, or a circular hyperboloid when the outer support frame is in an expanded configuration.

[0018]

[0034] In some embodiments, the outer support frame includes and / or is at least partially formed from a wire, braided wire, or laser-cut wire frame and is at least partially covered with a biocompatible material. For example, the outer support frame and / or at least the transannular region thereof can include and / or form a set of compressible wire cells, such as braided wire cells, laser-cut wire cells, photolithographically generated wire cells, 3D-printed wire cells, wire cells formed from intermittently connecting single-stranded wires in a wavy, zigzag, or helical pattern, and / or combinations thereof. In some implementations, the compressible wire cells can have substantially orthogonal orientations of central axes and cell geometries, thereby reducing or substantially minimizing the wire cell strands when the outer support frame is in a delivery configuration (e.g., a compressed, rolled, and / or folded configuration).

[0019]

[0035] Any of the prosthetic valves (and / or their outer frames) described herein can include a single anchoring element or multiple anchoring elements (e.g., subannular anchoring elements, supranuclear anchoring elements, and / or combinations thereof) configured to anchor the valve to the annulus of the native valve. For example, in some embodiments, the prosthetic valve and / or outer frame can include one or more of: a distal subannular anchoring element configured to engage ventricular tissue distal to the annulus (e.g., which may extend into the right ventricular outflow tract (RVOT)); a proximal subannular anchoring element configured to couple with right ventricular tissue near the annulus (e.g., between the septal and posterior leaflets of the heart); a septal anchoring element configured to engage the native septum or at least one of the native septal leaflets when the prosthetic heart valve is seated in the annulus (e.g., to pin at least the native septal leaflets away from the coapted 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 rolling and / or twisting forces within the annulus, which can affect (e.g., tilt, angle, twist, roll) the desired position or positioning of the prosthetic valve within the annulus.

[0020]

[0036] Either the prosthetic valve and / or its outer frame can also include distal and / or proximal upper anchoring elements configured to be positioned in a supranulvular position, e.g., in contact with and / or adjacent to supranulvular tissue of the right atrium. In some embodiments, the upper anchoring elements can be configured to exert a force on the supranulvular tissue and the lower anchoring elements can be configured to exert a force in the opposite direction on the subannular tissue, thereby securing the prosthetic valve to the native annulus. In some embodiments, the anchoring elements can include and / or be formed from wire loops or wire frames, integral frame sections, and / or stents extending from the frame (e.g., about 10-40 mm away from the circumference of at least the corresponding portion of the frame).

[0021]

[0037] Any of the prosthetic valves described herein can include an inner flow control component having a leaflet frame with two to four flexible leaflets. The two to four leaflets are configured to allow blood to flow in a first direction through the inflow end of the valve and out the outflow end of the valve, while blocking blood flow in a second direction opposite the first direction. The leaflet frame can include any number of diamond- or eye-shaped panels or walls made from a heat-set shape memory alloy material, such as a nickel-titanium alloy (e.g., Nitinol®). The leaflet frame can be configured to be foldable along a z-axis (e.g., longitudinal axis) from a round or cylindrical configuration to a flat cylindrical configuration and compressible along a vertical y-axis (e.g., central axis). In some embodiments, the leaflet frame can include a pair of hinge areas, folding areas, connection points, etc., that allow the leaflet frame to fold and flatten along the z-axis before being compressed along the vertical y-axis. The leaflet frame may be a one-piece structure with, for example, two or more living hinges (e.g., stress concentrator risers and / or any suitable structure configured to allow elastic / non-permanent deformation of the leaflet frame) or a two-piece structure in which the hinge areas are formed using a secondary attachment method (e.g., sutures, fabric, molded polymer components, etc.). In some embodiments, the inner 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 inner flow control component has a leaflet frame with a flat cone-shaped side profile having an outer diameter R of about 20-60 mm, an inner diameter r of about 10-50 mm (wherein diameter R is greater than diameter r), and a height of about 5-60 mm. In some embodiments, the leaflet frame is constructed of wire, braided wire, or a laser-cut wire frame.

[0022]

[0038] The prosthetic valve and / or any of its components can be fabricated from any suitable biocompatible material or combination of biocompatible materials. For example, the outer valve frame, inner valve frame (e.g., of the inner flow control component), and / or any of its components can be fabricated from a biocompatible metal, alloy, polymer-coated metal, etc. Suitable biocompatible metals and / or alloys can include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloy, nickel-titanium alloy (e.g., Nitinol®), etc. Furthermore, any of the outer frame or inner frame described herein can be formed from a superelastic or shape-memory alloy, such as nickel-titanium alloy (Nitinol®). Synthetic biocompatible materials can include, for example, polyesters, polyurethanes, elastomers, thermoplastics, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketone (PEEK), silicone polycarbonate urethanes, polypropylene, polyethylene, low density polyethylene (LDPE), high density polyethylene (HDPE), ultra high density polyethylene (UHDPE), polyolefins, polyethylene glycols, polyethersulfones, polysulfones, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron®), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (Nylon), polytetrafluoroethylene (PTFE) (e.g., Teflon), expanded PTFE, expanded PTFE, siloxane polymers and / or oligomers, polylactones, and the like, or block copolymers using these.

[0023]

[0039] Any of the prosthetic valves and / or their components can include and / or be formed with one or more biocompatible coatings. Suitable polymer coatings can include, for example, polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), trans-styrene-isoprene-butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactic acid polylactic acid (DLPLA), polylactic-co-glycolic acid (PLGA), etc. Some such polymer coatings can form suitable carrier matrices for drugs such as sirolimus, zotarolimus, biolimus, novolimus, tacrolimus, paclitaxel, probucol, etc.

[0024]

[0040] The outer valve frame, the inner flow control frame, and / or any of their portions or components can be partially or completely covered internally or externally with natural or synthetic biocompatible and / or biomaterials, such as pericardium. For example, if a thin, durable synthetic material is contemplated (e.g., for the covering), synthetic polymeric materials such as expanded PTFE, PET, or polyester (or any of the other materials described herein) can optionally be used. Suitable biomaterials for use as coverings or the like can include, for example, chemically stabilized pericardial tissue from animals such as bovine (bovine pericardium), ovine (ovine pericardium), porcine (porcine pericardium), or equine (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 generally sold as recovered from cattle under 30 months of age, etc. In some embodiments, the valve can be configured such that the inner surface of the outer valve frame (e.g., wire frame cell) is covered with pericardial tissue and the outer surface is covered with a synthetic polyester fabric (or vice versa), or both the inner and outer surfaces are covered with pericardial tissue or a synthetic polyester fabric.

[0025]

[0041] Any of the methods for delivering and / or deploying a prosthetic heart valve described herein can include delivering a prosthetic heart valve to a native annulus of a human heart, which can involve advancing a delivery catheter through 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 an IVC-femoral approach or an SVC-jugular approach through a transatrial approach (e.g., the fossa ovalis or lower) to the mitral valve or aortic valve of the heart. The prosthetic valve is detachably coupled to a portion of the 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. The prosthetic valve can then be released from the distal end of the delivery catheter, which has been placed in the atrium using the IVC-femoral approach or the SVC-jugular approach. Once released from the delivery catheter, the prosthetic valve can transition to an expanded or released configuration.

[0026]

[0042] Any of the methods for delivering and / or deploying a prosthetic valve described herein can include positioning the valve or a portion thereof at a desired position relative to native tissue. For example, the method can include inserting a distal subannular anchoring element of the prosthetic valve through the annulus of a native tricuspid valve, e.g., into the right ventricle (RVOT). In some embodiments, the method can include partially inserting the prosthetic valve into the annulus (e.g., of a native tricuspid valve) so that a distal portion of the prosthetic valve contacts the native annular tissue while a proximal portion of the prosthetic valve is at least partially compressed and positioned within the delivery catheter. In some embodiments, the method can include rotating the prosthetic heart valve along an axis parallel to the plane of the annulus using a steerable control catheter, a yoke, a set of tethers, an actuator, and / or any other part of the delivery / deployment system (or a combination thereof). In some embodiments, the method can include transitioning one or more anchoring elements to a desired position and / or state to engage with the native tissue surrounding at least a portion of the annulus. In some embodiments, one or more tissue anchors can be attached to the valve and the native tissue to secure the valve in the desired position.

[0027]

[0043] Any of the delivery and / or deployment systems described herein can include an outer catheter (e.g., a delivery catheter), a control catheter, and / or other suitable portions that can include one or more members, components, features, etc. configured to aid in the delivery and / or deployment of a valve to an annulus of a native heart valve. For example, in some embodiments, a delivery and / or deployment system can include any number of supports, etc. that at least temporarily couple to a prosthetic valve to support, stabilize, actuate, and / or control one or more portions of the prosthetic valve, e.g., during deployment. Some such supports, etc. can be and / or include tethers, sutures, tensioning or tensioning members, rods, cables, wires, catheters, hypotubes, connectors, couplers, etc. In such embodiments, the supports can engage one or more portions of the prosthetic valve to support, stabilize, actuate, and / or control the prosthetic valve (e.g., during deployment) and then decouple and / or detach from the prosthetic valve once it is seated in the annulus of the native valve in a desired manner, orientation, etc. For example, certain embodiments described herein may include one or more supports configured to removably couple to the supranuclear portion of the prosthetic valve to at least partially support, stabilize, actuate, control, etc. the prosthetic valve and / or at least one or more portions thereof.

[0028]

[0044] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the claims. Unless otherwise defined, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0029]

[0045] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. With respect to the use of virtually any plural and / or singular terminology herein, one of ordinary skill in the art can convert the plural to the singular and / or from the singular to the plural as appropriate to the situation and / or application. Various singular / plural permutations may not be specified herein for clarity.

[0030]

[0046] In general, terms used herein, and particularly in the appended claims (e.g., the body of the appended claims), are generally intended as "open" terms (e.g., the term "comprises" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," etc.). Similarly, when used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, integers (or portions thereof), steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers (or portions thereof), steps, operations, elements, components, and / or groups thereof. When used in this document, the term "comprises" means "including but not limited to."

[0031]

[0047] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Virtually any disjunctive word and / or phrase indicating two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both / all of the terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0032]

[0048] Unless otherwise expressly stated, every range disclosed herein encompasses any and all possible subranges and combinations of subranges. Any recited range should be recognized as fully descriptive or allowing for the range to be broken down into at least equal subranges, unless otherwise expressly stated. As will be understood by one of ordinary skill in the art, a range includes each individual member.

[0033]

[0049] The terms "prosthetic heart valve" and / or "artificial valve" can refer to the combination of a frame and leaflets or flow-control structures or components, and can encompass both the complete replacement of an anatomical part (e.g., replacing a native valve with a new mechanical valve) and medical devices that replace and / or supplement, repair, or improve an existing anatomical part (e.g., leaving the native valve in place). As used herein, the term "valve" can be used to refer to either a "prosthetic valve" or a "native valve," and will be understood within the particular context in which the term is used.

[0034]

[0050] The prosthetic valves disclosed herein may include members (e.g., "frames") that can be seated within the native valve annulus and used as leaflet structures, flow control components, or anchoring elements for a flexible reciprocating sleeve or sleeve valve. Such members may or may not include such leaflet structures or flow control components, depending on the embodiment. Such members may be referred to herein as "annulus support frames," "wire frames," "valve frames," "flanges," "collars," "cuffs," and / or any other similar terms.

[0035]

[0051] The term "flow control component" can refer, without limitation, to a valve structure having two, three, or four leaflets of a flexible biocompatible material, such as treated or untreated pericardium, that can be sewn, bonded, and / or attached to an annulus support frame to function as a prosthetic heart valve. Such a valve can be a heart valve, such as a tricuspid, mitral, aortic, or pulmonary valve, that opens to blood flowing from the atrium to the ventricle during diastole and closes due to ventricular pressure applied to its exterior during systole. The repeated sequential opening and closing can be described as "reciprocating." The flow control component is intended to include a wide variety of (bio)prosthetic heart valves and / or components. For example, such (bio)prostheses can include ball valves (e.g., Starr-Edward), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), testated pericardial prosthetic heart valves (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valves), as well as homograft and autograft valves. Bioprosthetic pericardial valves include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0036]

[0052] The term "anchor element" or "tab" or "arm" refers to a structural element that extends from a portion of the valve or valve frame (e.g., extends away from the valve's sidewall, body, or collar) and provides an anchoring or stabilizing function to the valve. When used in combination with the terms distal, proximal, septal, and / or anterior, it is understood that the anchoring or stabilizing element so described is attached to and / or integrated into the valve (or valve frame) at the distal, proximal, septal, and / or anterior locations, respectively. The distal location of the valve refers to the portion of the valve farthest from the practitioner, where the delivery catheter exits first and may be positioned at or near distal subannular self-tissue, such as the ventricular outflow tract. The proximal location of the valve refers to the portion of the valve closest to the practitioner, where the delivery catheter exits last and may be positioned at or near proximal subannular self-tissue, such as tissue closest to the inferior vena cava. The septal location of the valve refers to the portion of the valve at a point between the proximal and distal locations and where it may be positioned at or near septal subannular self-tissue, such as the septal leaflet or septal wall. An anterior location on a valve refers to a portion of the valve at a point between a proximal location and a distal location and that can be located on or near the anterior tissue as opposed to the septal tissue. When used in conjunction with the terms "inferior" or "subannular," it is understood that the anchoring or stabilizing element so described is attached to and / or integrated with the valve sidewall, body, and / or frame at or along the inferior or subannular region of the valve. Conversely, when used in conjunction with the terms "superior" or "supraannular," it is understood that the anchoring or stabilizing element so described is attached to and / or integrated with the valve or frame at or along the supranuclear region, collar, or atrial cuff of the valve.

[0037]

[0053] Any of the disclosed valve embodiments can be delivered via a transcatheter approach. The term “transcatheter” is used to define the process of accessing, controlling, and / or delivering a medical device or instrument within the lumen of a catheter deployed in a cardiac chamber (or other desired location within the body) and the item delivered or controlled by such a process. Transcatheter access is known to include cardiac access via the lumen of the femoral artery and / or vein or 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 (rib) and / or subxiphoid space, etc. Additionally, transcatheter cardiac access can also include a transatrial (e.g., fossa ovalis or lower) approach to the left atrium and / or left ventricle. Transcatheter can be synonymous with translumenal and is functionally related to the term “percutaneous” as it relates to the delivery of heart valves.

[0038]

[0054] As used herein, terms such as "orthogonal delivery," "orthogonally delivered," "lateral delivery," and "laterally delivered" can be used interchangeably to describe such delivery methods and / or valves delivered using such methods. The term "orthogonal" refers to an intersection angle between two lines or planes that is 90 degrees (e.g., perpendicular). As used herein, the term "substantially orthogonal" refers to an intersection angle of 90 degrees plus or minus a suitable tolerance. For example, "substantially orthogonal" can refer to an intersection angle in the range of 75 to 105 degrees. Orthogonal and / or lateral delivery of a prosthetic valve can be such that the central axis of the valve is substantially orthogonal to the longitudinal or longitudinal axis of the delivery catheter (e.g., the valve is oriented laterally relative to a conventional radial compression valve).

[0039]

[0055] Cardiac access modes can be based, at least in part, on the "body channel" used to define blood conduits or vessels within the body, and the particular application of the disclosed embodiments of the prosthetic valve can dictate the body channel in question. For example, an aortic valve replacement is implanted at or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement is implanted at the tricuspid or mitral annulus, respectively. While certain features described herein may be particularly advantageous for a given implantation site, any of the valve embodiments described herein can be implanted in any body channel unless a combination of features is structurally impossible or excluded by claim recitation.

[0040]

[0056] As used herein, the terms "expandable" and / or "compressible" may refer to a prosthetic heart valve or a component of a prosthetic heart valve that can be expanded and / or compressed from a first size or configuration to a second size or configuration. For example, a prosthetic valve may 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, from temperature changes or other such incidental causes. Conversely, "non-expandable" / "non-compressible" should not be interpreted as implying complete rigidity or dimensional stability, since, for example, some slight expansion / compression of a conventional "non-expandable" / "non-compressible" heart valve may be observed.

[0041]

[0057] The prosthetic valves disclosed herein and / or their components generally are capable of transitioning between two or more configurations, states, shapes, and / or positions. For example, the prosthetic valves described herein can be compressible and / or expandable between any suitable number of configurations. Various terms can be used to describe or refer to these configurations and are not intended to be limiting unless the context clearly dictates otherwise. For example, the prosthetic valve can be described as being in a "delivery configuration," which can be any suitable configuration that allows or enables delivery of the prosthetic valve. Examples of delivery configurations can include a compressed configuration, a folded configuration, a rolled configuration, and / or similar configurations, or any suitable combination thereof. Similarly, the prosthetic valve can be described as being in an "expanded configuration," which can be any suitable configuration that is not expressly intended for delivery of the prosthetic valve. Examples of expanded configurations can include a released configuration, a relaxed configuration, a deployed configuration, a non-delivery configuration, and / or similar configurations, or any suitable combination thereof. Some prosthetic valves and / or their components or features described herein may have several additional configurations that may be associated with various modes, levels, states, and / or portions of activation, deployment, engagement, etc. Examples of such configurations may include an activated configuration, a seated configuration, a fixed configuration, an engaged configuration, and / or the like, or any suitable combination thereof. While specific examples are provided above, it should be understood that this is not intended to be an exhaustive list of configurations. Other configurations may be possible. Furthermore, various terms may be used to describe the same or substantially similar configurations, and thus, the use of a particular term is not intended to be limiting and / or excluding other terms unless the terms and / or configurations are mutually exclusive or otherwise dictated by context.

[0042]

[0058] The examples and / or embodiments described herein are intended to facilitate understanding of the structure, function, and / or aspects of the embodiments, how the embodiments may be implemented, and / or to further enable those skilled in the art to practice the embodiments herein. Similarly, the methods and / or manners of using the embodiments described herein are provided merely as examples and not as limitations. Specific use examples described herein are not provided to the exclusion of other use examples, unless the context clearly dictates otherwise. For example, any of the prosthetic valves described herein can be used to replace native valves in the human heart, including, for example, the mitral valve, tricuspid valve, aortic valve, and / or pulmonary valve. While some prosthetic valves are described herein in the context of replacing a native mitral valve or native tricuspid valve, it should be understood that such prosthetic valves can be used to replace any native valve unless otherwise specified or unless one or more components and / or features clearly recognize by one skilled in the art that make the prosthetic valve incompatible for such use examples. The specific examples, embodiments, methods, and / or use examples described herein should not be construed as limiting the scope of the inventive concepts 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.

[0043]

[0059]

[0013] The embodiments herein and / or various features or advantageous details thereof will be more fully described with reference to the non-limiting embodiments shown in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted herein so as not to obscure the embodiments. Like numbers refer to like elements throughout. A discussion of various embodiments, components, and / or features of 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 to the annulus of a native heart valve.

[0044]

[0060] 1-6 illustrate various schematic illustrations of a laterally deliverable transcatheter prosthetic heart valve 100 (sometimes referred to herein as a "prosthetic valve" or simply a "valve"), according to one embodiment. As described in further detail herein, the valve 100 generally includes an annular support frame 110 and a flow control component 150 mounted within the annular support frame 110. Additionally, FIGS. 1-6 illustrate at least a portion of a delivery / deployment system 180 that can be coupled to and / or otherwise engaged with the valve 100 and / or portions thereof, to aid in the delivery and / or deployment of the valve 100 to a desired location in the body. For example, delivery / deployment system 180 can be used to deliver and deploy prosthetic valve 100 to the annulus of a native valve of a human heart (e.g., a tricuspid, mitral, and / or pulmonary valve of a human heart), where, upon deployment, prosthetic valve 100 is configured to allow blood to flow in a first direction (e.g., through or via flow control component 150) from the inflow end of prosthetic valve 100 to the outflow end of prosthetic valve 100 and block blood flow in a second direction opposite the first direction. Thus, prosthetic valve 100 can be configured to supplement and / or replace the function of the native valve. In some embodiments, the valve 100 and / or delivery / deployment system 180 may be similar and / or substantially the same as the valves and / or delivery / deployment systems described in WIPO Patent Publication No. WO 2021 / 040996, filed August 6, 2020, entitled “Side-Deliverable Transcatheter Prosthetic Valves and Methods for Delivering and Anchoring the Same” (herein referred to as “'996PCT”), and WIPO Patent Publication No. WO 2021 / 035032, filed August 20, 2020, entitled “Delivery and Retrieval Devices and Methods for Side-Deliverable Transcatheter Prosthetic Valves” (herein referred to as “'032PCT”), the disclosures of each of which are incorporated by reference in their entirety and attached hereto as Exhibits A and B, respectively.

[0045]

[0061] The prosthetic valve 100 is compressible and expandable between an expanded configuration ( FIGS. 1 and 2 ) for implantation at a desired location in the body (e.g., a human heart) and a compressed or delivery configuration ( FIGS. 3 and 4 ) for introduction into the body, for example, via a delivery catheter 182 of a delivery / deployment system 180. The prosthetic valve 100 can be compressible and expandable in at least one direction relative to the longitudinal axis 102 of the valve 100 (also referred to herein as the “horizontal axis,” “long axis,” or “longitudinal axis”). For example, the valve 100 can be compressible / expandable along a central axis 104, and can have a first height or size along the central axis 104 when in the expanded configuration ( FIG. 1 ) and a second height or size along the central axis 104 that is smaller than the first height or size when in the compressed configuration ( FIG. 3 ). 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, valve 100 can be compressible / expandable along a central axis 104 (just mentioned) and compressible / expandable along a transverse axis 106 (see, e.g., FIGS. 1 and 2) that is perpendicular to both longitudinal axis 102 and central axis 104. In such embodiments, valve 100 can have a first height and a first width when in the expanded configuration (FIGS. 1 and 2) and a second height and a second width—less than the first height and first width, respectively—when in the compressed configuration (FIGS. 3 and 4).

[0046]

[0062] When in the expanded configuration shown in FIGS. 1, 2, and 6, the valve 100 has an extent in any direction perpendicular or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the lateral axis 106) that 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 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 to 80 mm or about 40 to 80 mm. When in the compressed configuration shown in FIGS. 3 and 4, the valve 100 has an extent in any direction perpendicular or transverse to the longitudinal axis 102 (e.g., along the central axis 104 and / or the lateral axis 106) that is less than the diameter of the lumen of the delivery catheter 182, allowing the valve 100 to be delivered through the lumen of the delivery catheter 182. For example, in some embodiments, valve 100 can have a compressed height (e.g., along central axis 104) and compressed width (e.g., along lateral axis 106) of about 5-15 mm, about 8-12 mm, or about 9-10 mm. Valve 100 can be compressed by compressing, rolling, folding, and / or any other suitable manner, or combinations thereof. In some embodiments, the length of valve 100 (e.g., along longitudinal axis 102) is not compressed for or during delivery. Rather, in some embodiments, the length of valve 100 can increase in response to compression of the valve along central axis 104 and / or lateral axis 106.

[0047]

[0063] In some embodiments, valve 100 (and / or at least a portion thereof) can be thermoformed and / or otherwise shaped into any desired shape, such as, for example, a generally tubular shape, a generally hourglass shape, etc. In some embodiments, valve 100 can include a supranullar section or region (e.g., an upper atrial cuff or flange for an atrial seal), a subannular section or region (e.g., a lower ventricular cuff or flange for a ventricular seal), and a transannular section or region (e.g., a body section, a tubular section, a cylindrical section, etc.) disposed therebetween. The transannular region can have an hourglass cross-section along approximately 60-80% of its circumference to conform to the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20-40% of the annular circumference to conform to the septal annular segment.

[0048]

[0064] While the valve 100 is shown in FIGS. 1-6 as having a given shape (overall shape), it should be understood that the size and / or shape of the valve 100 (and / or at least a portion thereof) can depend on the size and / or shape of the native anatomical structure. For example, the valve 100 can be centric (e.g., radially symmetric about the central axis 104 (y-axis)) or eccentric (e.g., radially asymmetric about 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 into which the valve 100 is to be placed. For example, in some cases, the valve 100 can be deployed in the annulus of a native tricuspid valve, which has a rounded circumference with a substantially vertical septal wall and is known to hypertrophy along the anterior-posterior line in diseased states. In some cases, the valve 100 can be deployed in the annulus (e.g., near the anterior leaflet) of a native mitral valve, which has a rounded circumference with a substantially vertical septal wall and is known to hypertrophy in diseased states.

[0049]

[0065] Thus, valve 100 can have a complex shape determined, at least in part, by the native valve annulus and / or the disease state of the native valve. By way of example, valve 100 or its outer frame can have a D-shape (as viewed from the top) so that a flat or substantially flat portion can conform to the anatomical structure (e.g., a substantially vertical septal wall) into which valve 100 will be deployed. In some embodiments, valve 100 or its outer frame can have a circumference with a rounded shape, such as a hyperbolic paraboloid, to account for the location of the native septal cusp, anterior cusp, and / or posterior cusp, and / or the native septal wall; avoid native electrical bundles, such as the atrioventricular (AV) node and / or AV node-related structures, such as Koch's triangle and AV bundle; avoid interference with coronary blood flow, such as the coronary sinus; conform to variations in the septal wall, which is substantially vertical but known to thicken toward the free wall along the anterior-posterior axis in diseased states; etc.

[0050]

[0066] As shown, the valve 100 generally includes an annular support frame 110 and a flow control component 150 mounted within the annular support frame 110. Additionally, the valve 100 and at least the annular support frame 110 of the valve 100 can include, be coupled to, and / or otherwise engaged with a delivery / deployment system 180. The annular support frame 110 (also referred to herein as a "valve frame," "wire frame," "outer frame," "support frame," "frame," etc.) can have a supranuclear region 120, a subannular region 130, and a transannular region 112 disposed therebetween and / or coupled thereto. In some embodiments, the frame 110 can be monolithically and / or integrally constructed. In some embodiments, one or more of the supranuclear region 120, the subannular region 130, and / or the transannular region 112 can be separate, independent, and / or modular components coupled together to collectively form the frame 110. For example, in some embodiments, the supranuclear region 120 can be an atrial collar, cuff, portion, etc. coupled to the top, upper, and / or upper annular margin of the transannular region 112, and the subannular region 130 can be a ventricular collar, cuff, portion, etc. coupled to the bottom, lower, and / or lower annular margin of the transannular region 112. Alternatively, the subannular region 130 can be and / or be formed by the bottom, lower, and / or lower annular portions or sections of the transannular region 112.

[0051]

[0067] In some embodiments, the modular and / or at least partially modular construction allows the frame 110 to conform to a given size and / or shape of the anatomical structure in which the valve 100 is to be installed. For example, one or more of the supranuclear region 120, the subannular region 130, and / or the transannular region 112 can be designed and / or adapted so that the support frame 110 has any desired height, outer diameter, and / or inner diameter, such as any of those described above. Furthermore, such modular construction allows the frame 110 to bend, curve, compress, fold, roll, and / or otherwise reconfigure without plastic or permanent deformation. For example, the frame 110 can be compressed into a compressed or delivery configuration for delivery and, upon release, is configured to return to its original shape (uncompressed, expanded, or released configuration) substantially without plastic or permanent deformation.

[0052]

[0068] The support frame 110 and / or the supranullar region 120, the subannular region 130, and / or the transannular region 112 can be formed from or with any suitable material. In some embodiments, the frame 110 and / or one or more portions or regions thereof can be formed from or with a shape memory or superelastic metal, alloy, plastic, or the like. For example, the frame 110 (e.g., one or more of the supranullar region 120, the subannular region 130, and the transannular region 112) can be formed from or with 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 with Nitinol wire that can be bent, twisted, formed, and / or manipulated into a desired shape. In still other embodiments, frame 110 (and / or any region thereof) can be formed of or from any desired material using any suitable additive or subtractive manufacturing process, such as those described above. Additionally, frame 110 and / or one or more of supranullar region 120, subannular region 130, and transannular region 112 can be formed of or from a metal or other structural frame material that is covered with a biocompatible material, such as pericardial tissue (e.g., Dura-Guard®, Peri-Guard®, Vascu-Guard®, etc.), a polymer (e.g., polyester, Dacron®, etc.), etc., as described above.

[0053]

[0069] The supranullar region 120 of the frame 110 may be and / or form, for example, a cuff or collar that can be attached or coupled to the upper edge or top of the transannular region 112. When the valve 100 is deployed in a human heart, the supranullar region 120 can be an atrial collar shaped to fit the native deployment location. In tricuspid and / or mitral valve replacements, for example, the supranullar region 120 (e.g., an atrial collar) can have various portions configured to fit the native valve and / or portions of the atrial floor surrounding the tricuspid and / or mitral valves, respectively. In some embodiments, the supranullar region 120 can be deployed at the atrial floor to direct blood from the atrium toward the flow control component 150 of the valve 100 and seal to prevent blood leakage (paravalvular regurgitation) around the frame 110 (e.g., through the annulus but outside the flow control component 150).

[0054]

[0070] In some embodiments, the supranulular region 120 may be and / or include a wire frame laser-cut from any suitable material. In some embodiments, the supranulular region 120 may be formed from a tube or sheet of a shape-memory or superelastic material, such as Nitinol, and may be heat-set into a desired shape and / or configuration, for example. In some embodiments, forming the supranulular region 120 in this manner allows the supranulular region 120 to bend, curve, fold, compress, and / or otherwise reconfigure without substantial plastic deformation and / or fatigue that could lead to failure or fracture of one or more portions thereof. Additionally, the wire frame of the supranulular region 120 may be covered with any suitable biocompatible material, such as any of those described above.

[0055]

[0071] The supranulvular region 120 includes a distal portion and a proximal portion. In some embodiments, the distal portion can be and / or include a distal supranulvular anchoring element or the like that can engage with supranulvular native tissue distal to the annulus when the prosthetic valve 100 is seated in the annulus. In some embodiments, the proximal portion can be and / or include a proximal supranulvular anchoring element or the like that can engage with supranulvular native tissue proximal to the annulus when the prosthetic valve 100 is seated in the annulus. In some embodiments, the distal portion and / or the distal supranulvular anchoring element can be sized and / or shaped to correspond to the size and / or shape of the distal portion of the atrial floor of the heart in which the prosthetic valve 100 will be placed. Similarly, the proximal portion and / or the proximal supranulvular anchoring element can be sized and / or shaped to correspond to the size and / or shape of the proximal portion of the atrial floor of the heart. In some embodiments, the distal portion (or distal supranulular anchoring element) and / or the proximal portion (or proximal supranulular anchoring element) can be actuated to transition between two or more configurations and / or states (e.g., during deployment, etc.), as described in further detail herein.

[0056]

[0072] 1-6 , the supranulnar region 120 can be shaped and / or formed to include any number of features configured to engage with native tissue and / or one or more other portions of the valve 100, the delivery / deployment system 180, etc. For example, in some embodiments, the supranulnar region 120 can include and / or be formed from an outer portion and an inner portion suspended from and / or coupled to the outer portion. In some implementations, the outer portion can be sized and / or shaped to engage with native tissue, and the inner portion can provide structure for mounting the flow control component 150 to the support frame 110, with one or more coverings, drums, spacers, struts, splines, and / or structures disposed therebetween. In some implementations, a portion of the supranulnar region 120 can at least temporarily couple to and / or at least temporarily receive the delivery / deployment system 180, at least a portion of an actuator, at least a portion of a guidewire (or guidewire catheter), etc. (as described in more detail herein).

[0057]

[0073] The transannular region 112 of the support frame 110 is coupled to the supranuclear region 120 and extends from the supranuclear region 120 at least partially through the annulus of the native valve when the prosthetic valve 100 is sealed therein. In some embodiments, the transannular region 112 can be coupled (e.g., welded, cemented, sewn, constrained, etc.) to the supranuclear region 120 so as to allow a desired amount of movement and / or bending therebetween. For example, in some implementations, the transannular region 112 and / or portions thereof can be sewn and / or sutured to the supranuclear region 120 (and / or portions thereof).

[0058]

[0074] The transannular region 112 can be and / or can be 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 transannular region 112 can have a flat cone shape, an inverted flat cone shape (narrow at the top and wider at the bottom), a concave cylinder (with inward-curving walls), a convex cylinder (with bulging walls), an angular hourglass shape, a curved and / or progressive hourglass shape, and / or a ring or cylindrical side profile with a top flare, a bottom flare, or both. In some embodiments, the transannular region 112 can have a shape and / or size based at least in part on the size, shape, and / or configuration of the supranuclear region 120 (and / or subannular region 130) and / or the native annulus into which it(s) is / are configured to be deployed. For example, the transannular region 112 can have an outer circumferential surface for engaging the native annular tissue, which can be tensioned against the inner surface of the native annulus to provide structural patency to the weakened native annulus. Additionally, the transannular region 112 can form and / or define an aperture or central channel 114 extending along the central axis 104 (e.g., the y-axis). The central channel 114 (e.g., a central axial lumen or channel) can be sized and configured to receive the flow control component 150 across at least a portion of the diameter of the central channel 114.

[0059]

[0075] In some embodiments, the transannular region 112 may be and / or include a wire frame laser-cut from any suitable material. For example, the transannular region 112 may be formed from a tube or sheet of a shape-memory or superelastic material, such as Nitinol, and may be heat-set, for example, into a desired shape and / or configuration. While not shown in FIGS. 1-6 , in some embodiments, the transannular region 112 may include and / or be formed of two laser-cut halves that can be formed into a desired shape and / or configuration and joined together to form the transannular region 112. The transannular region 112 may be formed to include a set of compressible wire cells having an orientation and / or cell geometry substantially perpendicular to the central axis 104 ( FIG. 1 ), thereby limiting and / or substantially minimizing strain on the wire cells when the transannular region 112 is in a vertically compressed, rolled, or folded compressed configuration. In some embodiments, forming the transannular region 112 in this manner enables the transannular region 112 to bend, curve, fold, deform, and / or otherwise reconfigure (without substantial plastic deformation and / or undue fatigue) in response to lateral folding along or in the direction of the lateral axis 106 (FIG. 4) and / or vertical compression along or in the direction of the central axis 104 (FIG. 3), as described in further detail herein.

[0060]

[0076] As discussed above with reference to the supranullar region 120, the wire frame of the transannular region 112 can be covered with any suitable biocompatible material, such as any of those described above. In some embodiments, at least the wire frames of the supranullar region 120 and the transannular region 112 can be flexibly joined (e.g., sewn or sutured) and then collectively or separately covered with a biocompatible material. Stated differently, at least the supranullar region 120 and the transannular region 112 can be covered with a biocompatible material before or after joining. In embodiments in which the wire frames are covered after joining, the biocompatible material can facilitate and / or support the bond therebetween.

[0061]

[0077] The subannular region 130 of the frame 110 can form, for example, a cuff or collar along the end of the transannular region 112 opposite the supranuclear region 120. For example, the subannular region 130 can be and / or form a ventricular collar shaped to fit into a self-deployed position once the valve 100 is deployed in a human heart. In tricuspid and / or mitral valve replacements, for example, the subannular region 130 or collar can have various portions each configured to fit into portions of the ventricular roof surrounding the native valve and / or the tricuspid and / or mitral valve. In some embodiments, the subannular region 130, or at least a portion thereof, can engage with the ventricular roof surrounding the native annulus to secure the valve 100 to the native annulus, stabilize the valve 100 within the annulus, prevent dislodgement of the valve 100, sandwich or compress the native annulus or adjacent tissue between the supranuclear region 120 and the subannular region 130 (or the lower portion of the transannular region 112), and / or seal to prevent blood leakage (paravalvular regurgitation and / or regurgitation during systole) around the frame 110.

[0062]

[0078] In some embodiments, the subannular region 130 is a subannular or inferior portion of the transannular region 112 (e.g., the transannular region 112 and the subannular region 130 are monolithically and / or integrally formed). Stated differently, the subannular or inferior portion of the transannular region 112 can form and / or encompass 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 the inferior edge or inferior portion of the transannular region 112, as described above with reference to the supranuclear region 120. In such embodiments, for example, the subannular region 130 can be and / or include a wire frame that is laser cut from any suitable material, such as a shape memory or superelastic material like Nitinol, heat set to a desired shape and / or configuration, covered with any suitable biocompatible material, and attached to the inferior edge of the transannular region 112, as described above with reference to the supranuclear region 120. In some embodiments, forming the subannular region 130 in this manner allows the subannular region 130 to bend, curve, fold, compress, and / or otherwise reconfigure substantially without plastic deformation and / or without excessive or undesirable fatigue that may lead to failure or fracture of one or more portions of the subannular region 130.

[0063]

[0079] The subannular region 130 of the frame 110 can be shaped and / or formed to include any number of features configured to engage with 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), etc. For example, as shown in FIG. 1 , the subannular region 130 can include and / or form a distal portion having distal anchoring elements 132 and a proximal portion having proximal anchoring elements 134. In some embodiments, each of the distal anchoring elements 132 and the proximal anchoring elements 134 is integrally and / or monolithically formed with the subannular region 130 and / or the lower or subannular portion of the transannular region 112.

[0064]

[0080] In some embodiments, distal anchoring element 132 may optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of a guidewire or guidewire catheter. Guidewire coupler 133 is configured to allow a portion of the guidewire or guidewire catheter to extend through an aperture in guidewire coupler 133, thereby allowing valve 100 to be advanced over or along the guidewire and / or guidewire catheter during delivery and deployment.

[0065]

[0081] The distal anchoring element 132 is configured to engage a desired portion of the native tissue distal to the native valve annulus to facilitate seating, anchoring, and / or deployment of the valve 100 within the native valve annulus. For example, in some embodiments, the distal anchoring element 132 can be a protrusion or projection extending from the frame 110 relative to the annulus (e.g., the subannular region 130 and / or the lower portion of the transannular region 112) to a distal subannular location (e.g., the RVOT in a tricuspid valve replacement). In some embodiments, the distal anchoring element 132 can be shaped and / or biased such that the distal anchoring element 132 exerts a force on the subannular tissue operable to at least partially secure, stabilize, and / or anchor the distal end portion of the valve 100 within the native valve annulus. In some embodiments, the distal anchoring element 132 can extend approximately 10-40 mm from the distal portion of the subannular region 130 (or the lower portion of the transannular region 112).

[0066]

[0082] The proximal anchoring element 134 is configured to engage subannular tissue proximal to the native annulus to facilitate deployment, seating, anchoring, and / or fixation of the valve 100 in the annulus. In some embodiments, the proximal anchoring element 134 can be an anchoring element having 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 10-40 mm from the subannular region 130 (or below the transannular region 112).

[0067]

[0083] In other embodiments, the proximal anchoring element 134 can be configured to transition, shift, 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 compressed, contracted, retracted, undeployed, folded, and / or constrained (e.g., near, adjacent, and / or contacting the transannular region 112 and / or supranuclear region 120 of the frame 110) and a second configuration in which the proximal anchoring element 134 is expanded, expanded, deployed, unfolded, and / or unconstrained (e.g., extending away from the transannular region 112). In some embodiments, the proximal anchoring element 134 in the expanded or deployed configuration (e.g., the second configuration) can extend approximately 10-40 mm from the transannular region 112, and in the compressed or undeployed configuration (e.g., the first configuration), can contact or extend less than approximately 10 mm from the transannular region 112. In some embodiments, at least a portion of the transannular region 112 can be reconfigured, at least in part, based 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 in part, compress or reconfigure at least a proximal portion of the transannular 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 tensioning member, a portion of the delivery / deployment system 180, etc., as described in further detail herein.

[0068]

[0084] In some embodiments, the proximal anchoring element 134 can transition from a first configuration to a second configuration during deployment to selectively engage with autologous tissue, tendons, 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 and / or intertwine with autologous tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration.

[0069]

[0085] 1-6, the subannular region 130 may include and / or form any number of additional anchoring elements, such as, for example, a septal anchoring element. For example, the subannular region 130 may include a posterior septal (PS) tab or anchoring element that engages posterior septal tissue to help stabilize the valve in the native valve annulus. In some embodiments, a septal subannular anchoring element may be included, which may be configured to engage subannular septal tissue, septal leaflet tissue, and / or any other suitable tissue 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 septal anchoring element can extend under the septal wall to pin the native septal leaflets, for example, away from the coapted leaflets of the prosthetic valve 100, and / or stabilize the valve against any rolling and / or twisting forces within the annulus that may affect (e.g., tilt, angle, twist, roll) the desired position or positioning of the prosthetic valve within the annulus.

[0070]

[0086] In some embodiments, the tether elements included in or extending from the subannular region 130 can be configured with a predetermined atrial or ventricular bias, which in some implementations can be designed, selected, and / or adjusted to enable the subannular tether elements to engage native ventricular tissue with a desired amount of force. For example, in some embodiments, the distal subannular tether elements 132 can have a slight atrial bias, meaning that the distal tether elements 132 are disposed or extend at an angle in a supranulvular direction (e.g., toward the annulus). In other embodiments, the distal subannular tether elements 132 can have a slight ventricular bias, meaning that the distal tether elements 132 are disposed or extend at an angle in a subannular direction (e.g., away from the annulus). In yet other embodiments, the distal subannular tether elements 132 can have a neutral bias, meaning that the distal tether elements 132 are not disposed at an angle and / or extend substantially straight or neutrally. Similarly, any other subannular anchoring element may have an atrial, ventricular, or neutral bias that can be designed, selected, and / or adjusted to allow the anchoring element to engage native ventricular tissue with a desired amount of force.

[0071]

[0087] Although not shown in Figures 1-6, the frame 110 may have and / or form additional functional elements (e.g., loops, anchors, attachment points, etc.) for attaching accessory components such as a biocompatible cover, tissue anchors, releasable deployment / retrieval control mechanisms (e.g., actuators, tensioning members, torque cables, hypotubes, portions of the delivery / deployment system 180, support members or tethers, and / or other suitable guides, knobs, attachments, rigging, etc.).

[0072]

[0088] Flow control component 150 may refer, without limitation, to a device that controls the flow of fluid therethrough. In some embodiments, flow control component 150 may be a leaf set structure having two, three, four, or more leaf sets made of a flexible biocompatible material, such as treated or untreated pericardium. The leaf sets may be sewn or bonded to a support structure, such as an inner frame, which may be sewn or bonded to the valve frame 110 (i.e., the outer frame). The leaf sets may be configured to transition between open and closed or substantially sealed states to allow blood to flow through flow control component 150 in a first direction, through the inflow end of valve 100, and block blood flow in a second direction opposite the first direction, through the outflow end of valve 100. For example, the flow control component 150 can be configured so that the valve 100 functions as a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, that opens during diastole to allow blood to flow from the atrium to the ventricle and closes when ventricular systolic pressure is applied to the exterior.

[0073]

[0089] The inner frame and / or portions or aspects thereof can be similar in at least form and / or function to the valve frame 110 (i.e., the outer frame) and / or portions or aspects thereof. For example, the inner frame can be a laser-cut frame formed from or of a shape-memory material, such as Nitinol. Furthermore, the inner frame can be configured to be compressible for delivery and return to its original (uncompressed) shape upon release (e.g., after delivery). In some embodiments, the inner frame can include multiple portions or parts joined together to collectively form the inner frame. Such an arrangement allows the inner frame to transition between compressed and uncompressed states without excessive or undesirable plastic deformation, fatigue, or the like. In some embodiments, the inner frame can include and / or be formed with any suitable number of compressible, elastically deformable, diamond-shaped, eye-shaped, or the like wire cells. The wire cells have an orientation and cell geometry substantially perpendicular to the axis of the flow control component 150 to limit or substantially minimize strain on the wire cells when the inner frame is in the compressed configuration.

[0074]

[0090] In some embodiments, the flow control component 150 and / or its inner frame can have a substantially cylindrical or tubular shape when the valve 100 is in an expanded configuration (see, e.g., FIG. 2 ) and can be configured to elastically deform when the valve 100 is in a compressed configuration (see, e.g., FIGS. 3 and 4 ). Although not shown in FIGS. 1-6 , in some embodiments, the inner frame of the flow control component 150 can include and / or be formed of two halves coupled together to elastically deform the inner frame in response to lateral compression or folding along or in the direction of the lateral axis 106 ( FIG. 3 ), as described in further detail herein.

[0075]

[0091] 1-6 , the flow control component 150 is mounted within the central channel 114 of the frame 110. More specifically, the flow control component 150 is mounted and / or coupled to the supranulvular region 120 (e.g., an inner portion thereof) and configured to extend within and / or through the central channel 114 formed and / or defined by the transannular region 112. In some embodiments, the flow control component 150 can be coupled to the supranulvular region 120 via tissue, a biocompatible mesh, one or more woven or knitted fabrics, one or more superelastic or shape memory alloy structures, sewn, sutured, and / or otherwise secured to a portion of the supranulvular region 120. In some embodiments, the flow control component 150 can be coupled to the supranulvular region 120 such that a portion of the flow control component 150 is disposed above and / or otherwise extends beyond the supranulvular region 120 (e.g., extends away from the annulus in the direction of the atrium). In some embodiments, the portion of the flow control component 150 that extends above and / or beyond the supranuclear region 120 can form a ridge, ledge, wall, step-up, etc. In some implementations, such an arrangement can promote the ingrowth of autologous tissue through and beyond the supranuclear region 120 without occluding the flow control component 150.

[0076]

[0092] The flow control component 150 can be disposed at least partially 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 positioned such that the flow control component 150 is centered within the central channel 114. In other embodiments, the support frame 110 can be positioned such that the flow control component 150 is off-center within the central channel 114. In some embodiments, the central channel 114 can have a diameter and / or circumference that is larger than the diameter and / or circumference of the flow control component 150. Although not shown in FIGS. 1-6 , 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 configured to cover a portion of the central channel 114. In some cases, a spacer can be used to facilitate coupling of the flow control component 150 to the frame 110.

[0077]

[0093] FIG. 5 shows a delivery / deployment system 180 being used to deploy the valve 100, and FIG. 6 shows the valve 100 seated 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 of the native valves of a human heart—pulmonary, mitral, aortic, and / or tricuspid (PV, MV, AV, TV) valves. More specifically, the valve 100 is configured for transcatheter orthogonal / lateral delivery to a desired location within the body through a delivery catheter 182. During delivery through the delivery catheter 182, the valve 100 is compressed orthogonally and / or laterally (e.g., along the central axis 104 and / or lateral axis 106, as described above) relative to the valve 100 in its expanded configuration, such that the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter 182. In some embodiments, devices and methods for / delivering valve 100 to a desired location within the body (e.g., via delivery / deployment system 180) can be similar and / or substantially the same as the delivery systems described in the '032 PCT incorporated by reference above. Accordingly, portions and / or aspects of the devices and / or procedures used to deliver valve 100 to the annulus of a native heart valve, for example, as shown in Figures 5 and 6, will not be described in further detail herein.

[0078]

[0094] As shown in FIGS. 5 and 6 , a delivery / deployment system 180 can be used to deliver the valve 100, for example, to the atria (right or left atria, shown as (RA, LA) in FIG. 6 ) of a human heart. In some embodiments, for example, the valve 100 (e.g., the supranuclear member / region 120) can be removably coupled to a control device 170 included in the delivery / deployment system 180, which can be used to advance the valve 100 in a compressed state through a lumen of a delivery catheter 182 and into the atria (RA, LA), as described in detail with reference to the delivery / deployment system in the '032 PCT. For example, a distal end portion of the control device 170 can include and / or couple to a connecting member 178 that removably couples to and contacts a portion of the valve 100 (e.g., the supranuclear region 120) while a proximal end portion of the control device 170 is adjacent and external to the delivery catheter 182. With such an arrangement, when a distal force is exerted on or at the proximal end portion of the control device 170, the valve 100 can be advanced along or via a guidewire and / or guidewire catheter (e.g., disposed within and / or extending through the guidewire coupler 133), through the delivery catheter 182, and into the annulus of the native heart valve.

[0079]

[0095] Once within the atrium and released from the delivery catheter 182, the valve 100 transitions to an expanded configuration and is deployed at the annulus of a native valve, such as, for example, the pulmonary, mitral, aortic, and / or tricuspid valve. In some embodiments, at least a portion of the control device 170 can extend through one or more lumens of the delivery catheter 182 to a location within the atrium remote from the delivery catheter 182, thereby allowing a user (e.g., a physician, surgeon, technician, etc.) to manipulate the distal end of the control device 170, and thus one or more portions of the valve 100, for deployment at the valve annulus. For example, a connecting member 178 can be included in and / or disposed at the distal end of the control device 170 and advanced through the delivery catheter 182 into the atrium (e.g., distal from the delivery catheter 182). Although not shown in FIGS. 1-6 , the connecting member 178 can be of any suitable shape, size, and / or configuration. For example, connecting member 178 can be a yoke or the like that is removably coupled to supranulvular region 120 of valve frame 110, as described in detail in the '996 PCT and / or the '032 PCT. The location of connecting member 178 allows a user to at least partially control the position, orientation, angle, etc. of valve 100 while control device 170 is manipulated to deploy valve 100 in the valve annulus.

[0080]

[0096] As mentioned above, in some cases, it may be desirable to include one or more components, members, features, etc. in delivery / deployment system 180 that can at least temporarily couple to or otherwise engage one or more portions of valve 100 (e.g., in conjunction with connecting member 178) to provide additional control and / or stability of valve 100 during deployment. The support can extend through 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 delivery catheter 182). A distal end of the support can be removably coupleable to a portion of valve 100 and / or valve frame 110, while a proximal end of the support can be manipulated near 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 valve 100 during deployment.

[0081]

[0097] 5 shows an example of such a support in the form of at least one supranullar support 179. The supranullar support 179 (also referred to herein as a "support") can be any suitable feature, component, member, device, mechanism, etc. configured to support at least the supranullar region 120 of the valve 100 and / or the valve frame 110 during deployment into the valve annulus. In some embodiments, the support 179 can be one or more tethers, sutures, tension members, rods, cables, tubes, catheters, etc. that extend directly or indirectly through the delivery catheter 182 such that a proximal end portion (not shown) of the support 179 is manipulated adjacent the delivery catheter 182 and a distal end portion of the support 179 is removably coupled to the supranullar region 120 of the valve frame 110. In some embodiments, the support 179 (e.g., one or more tethers, sutures, tensioning members, rods, cables, tubes, catheters, etc.) are positioned such that they can be tensioned and / or otherwise allowed to assume a support configuration 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 support 179 is positioned such that the support 179 can have a desired or predetermined stiffness, rigidity, durometer, etc., and can transmit a distal force to the supranullar region 120 of the valve frame 110 (e.g., allowing the support 179 to push the valve 100, for example, toward or into the annulus).

[0082]

[0098] The delivery / deployment system 180 can include any number of supports 1779 configured to removably couple to any number of attachment points at any suitable location along the supranullar region 120 of the valve frame 110. For example, in some embodiments, the delivery / deployment system 180 can include a single support 179 that removably couples to an attachment point at or near the distal end of the supranullar region 120 of the valve frame 110. In some embodiments, the supranullar region 120 of the valve frame 110 can include two or more attachment points at or near its opposite lateral extent, with at least one support 179 coupled to each attachment point (e.g., at least two supports 179 extending in a Y-shaped configuration from the distal end of the delivery catheter 182). In such embodiments, the attachment points can be distant from the contact points between the supranullar 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 along the supranuclear region 120 of the valve frame 110 that provides a desired degree of control, support, and / or stability of the valve 100 during deployment, as described in further detail herein.

[0083]

[0099] In some embodiments, the support 179 can be one or more reconfigurable members that can transition from a first state / configuration (e.g., during delivery through the delivery catheter 182) to a second state / configuration (e.g., during deployment at the valve annulus). For example, the support 179 can be relatively flexible when in the first state and relatively rigid or taught when in the second state, thereby forming a substantially rigid or fixed connection between the supranuclear region 120 of the valve frame 110 and the distal end portion of the delivery / deployment system 180 that 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 that can be placed under tension into a second state in which the tethers form a relatively rigid, taught, and / or fixed connection between the supranuclear region 120 of the valve frame 110 and the distal end portion of the delivery / deployment system 180. In some embodiments, the substantially rigid, taught, and / or fixed connection between the supranuclear 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 transition and / or actuate one or more portions of the supranuclear region 120 of the valve frame 110 to facilitate deployment, as described in further detail herein.

[0084]

[0100] In some embodiments, the support 179, while external to or not otherwise directly attached to the control device 170, can extend through the lumen of the delivery catheter 182 (or the lumen of a delivery sheath extending through the delivery catheter 182). In some embodiments, such an arrangement allows 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 move, shift, and / or otherwise reconfigure the valve 100 to control and deploy it at the valve annulus. In some embodiments, the second or supporting support 179 can stabilize at least a portion of the valve 100 and can provide greater control of the valve 100 when moving and / or positioning it via the control device 170.

[0085]

[0101] The supranulular region 120 of the valve frame 110 can include and / or form one or more attachment points, etc., to which the distal end of the support 179 can be removably coupled. In some such embodiments, the attachment points can be sutures, etc., around or through which the support 179 can be wrapped, looped, and / or otherwise removably attached. In some embodiments, the attachment points can be, for example, openings or holes (e.g., in the drum of the valve 100 and / or the supranulular region 120 of the valve frame 110) through which a portion of the support 179 can extend (e.g., allowing the support 179 to engage with a portion of the valve 100 other than the supranulular region 120 of the valve frame 110). In some embodiments, the supranulvular region 120 of the valve frame 110 may include one or more attachment points, such as one or more sutures, and may provide and / or define openings or holes, thereby allowing a first portion of the support 179 to engage or be removably coupled to the attachment points, while a second portion of the support 179 extends through the opening or hole (e.g., allowing the support 179 to engage with a portion of the valve 100 other than the supranulvular region 120 of the valve frame 110).

[0086]

[0102] For example, the attachment points can be sutures attached to the distal end or portion of the supra-annular region 120 of the valve frame, and openings or holes can be formed in or along the distal region of the drum (e.g., near the attachment points) to allow the distal portion of the support 179 to extend therethrough. In such embodiments, the distal end of the support 179 can include and / or form a loop, hoop, ring, etc., that can be disposed over the guidewire catheter, guidewire, and / or sub-annular portion of the valve 100. In some implementations, such an arrangement can facilitate retrieval and / or retraction of the support 179 once the valve 100 is seated in the valve annulus. For example, disposing a loop or ring on the distal end of the support 179 around the guidewire catheter can be such that retracting the guidewire catheter after seating of the valve 100 releases the distal end of the support 179, thereby allowing the support 179 to be retracted into the deployment system 180. In some embodiments, the distal portion of the support 179 can extend outside the valve 100 along the distal wall of the transannular region 112 from the supranuclear region 120 (or member) to the subannular region 130 (or member) or to a guidewire or guidewire catheter extending therefrom, thereby enabling the distal portion of the support 179 to be sandwiched or captured between the wall of the valve 100 and the native tissue forming part of the annulus, thereby enabling or facilitating fixation of the support 179 to the distal portion of the valve 100.

[0087]

[0103] As shown in FIGS. 5 and 6 , deployment and / or seating of the valve 100 can include positioning the distal anchoring element 132 of the subannular region 130 beneath the annulus in a ventricle (right ventricle or left ventricle—(RV, LV) as shown in FIG. 6 ) while the remainder of the valve 100 is within 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, such as within the ventricular outflow tract. For example, in some embodiments, the valve 100 can be delivered to the annulus of a native tricuspid valve, with at least a portion of the distal anchoring element 132 positioned in the RVOT. In other embodiments, the valve 100 can be delivered to the annulus of a native mitral valve, with at least a portion of the distal anchoring element 132 positioned in a subannular position distal to the annulus and / or any other suitable location where the distal anchoring element 132 can engage with native tissue, leaflets, tendons, etc. When the distal anchoring element 132 is positioned in a cardiac ventricle (e.g., the RVOT), the distal portion or distal surface of the valve 100 can be positioned in contact with and / or adjacent to the distal surface of the valve annulus 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 seating the prosthetic valve 100. For example, the control device 170 can be and / or 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 within the annulus.

[0088]

[0104] As mentioned above, the embodiments described herein can be configured to support, stabilize, and / or at least partially control the valve 100 while it is seated in the valve annulus. For example, FIG. 5 illustrates that one or more supports 179 can be coupled to the supranulular region 120 of the valve frame 110 and can be tensioned and / or otherwise allowed to assume a supportive configuration during deployment to at least partially support, stabilize, and / or control the valve 100. For example, in some embodiments, the connecting member 178 can be configured to removably couple to a proximal portion of the supranulular region 120 of the valve frame 110, and the one or more supports 179 can be configured to removably couple to a distal portion of the supranulular region 120 of the valve frame 110. In some such embodiments, the distal portion of the supranulular region 120 of the valve frame 110 includes one or more attachment points to which the one or more supports 179 can be removably coupled. In some embodiments, the distal portion of the drum or other surface of the valve 100 can form and / or define an opening or hole through which the distal portion of the support 179 can extend. The distal end of the support 179 can include and / or form a loop, hoop, ring, etc. that can be disposed over, beside, or around a guidewire catheter (or guidewire) and / or the 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 can extend along the distal wall of the valve frame 110 from the supranuclear region 120 to the subannular region 130 (or guidewire or guidewire catheter), and contact between the surface of the valve 100 and the surface of the annular tissue can pinch, clamp, hold, restrain, and / or otherwise substantially secure the distal portion of the support 179 to the distal portion of the valve 100.

[0089]

[0105] With the distal portion of the support 179 secured to the distal portion of the valve 100 (in any suitable manner, such as described above), the support 179 can be transitioned to a second or supportive state / configuration. The support 179 can then provide support to at least the distal portion of the valve 100 that can, for example, resist, limit, and / or otherwise prevent the distal supra-annular portion of the valve 100 and / or valve frame 110 from falling into the valve annulus. In some embodiments, the support 179 can be removably coupled to an attachment point at or along the distal portion of the supranuclear region 120 of the valve frame 110 (e.g., the distal portion of the outer loop of the supranuclear region 120, also referred to herein as the “distal atrial cuff or portion” of the valve 100), thereby enabling the support 179 to actuate, manipulate, reconfigure, and / or otherwise transition at least the distal atrial portion of the valve 100. For example, as shown in FIG. 5 , during the initial stages of deployment, the distal subannular tethering element 132 can be positioned within the ventricle, and the distal wall of the valve 100 (or at least a portion thereof) can contact the distal surface of the valve annulus while the proximal subannular tethering element 134 is within the atrium. Thus, the valve 100 is positioned at an angle relative to the annular plane of the valve annulus. In some embodiments, the size and / or shape of the atrial distal cuff or portion can be such that it contacts the atrial floor, and the angle of the valve 100 can be such that the atrial distal cuff pushes the distal portion of the valve 100 away from the annulus, thereby resisting the process of pivoting and / or seating the valve 100. In some such embodiments, a support 179 detachably coupled to an attachment point at or along the atrial distal cuff allows the support 179 to actuate at least a portion of the atrial distal cuff to facilitate the seating process of the valve 100. For example, as shown by the arrows in FIG. 5 , a proximal force can be exerted on or along the support 179, thereby pulling, actuating, or otherwise acting on the atrial distal cuff to move, bend, curve, and / or transition the atrial distal cuff proximally away from the atrial floor or atrial tissue defining or surrounding the annulus.Thus, transitioning or actuating the atrial distal cuff in this manner can reduce contact between the atrial distal cuff and atrial tissue that may resist the pivotal motion associated with seating the valve 100 on the annulus.

[0090]

[0106] 5, in some embodiments, the support can include at least two supports 179, each coupled to an attachment point at or near the lateral extent of the supranullar region 120 and distal to the connecting member 178. In such embodiments, the supports 179 can stabilize the valve 100, for example, preventing undesired rotation or spinning about the guidewire or guidewire catheter (or its axis) and relative to the plane of the annulus. In some embodiments, the supranullar region 120 can be coupled to any suitable number of supports 179 at any suitable location (or combination of locations) that allows the supports 179 to support, stabilize, actuate, and / or control the valve 100 as it seats in the annulus.

[0091]

[0107] 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, allowing blood to flow from the atrium to the ventricle, partially through the native valve annulus surrounding the valve 100 and partially through the valve 100, thereby enabling assessment of valve function. In some cases, a support 179 can support the valve 100 while it is in the partially deployed state.

[0092]

[0108] In some embodiments, support 179 and / or the substantially rigid or fixed length connection provided by support 179 between a distal convenient portion of valve 100 and a portion of delivery / deployment system 180 (e.g., external to or substantially independent of control device 170) can provide a counter / resistance force in response to a force exerted by control device 170 to pivot or seat at least a proximal portion of valve 100 in the valve annulus. In some cases, such an arrangement can reduce relative movement of at least a portion of control device 170 that does not contribute to deployment of valve 100, thereby facilitating the deployment process.

[0093]

[0109] As described above, in some embodiments, the proximal subannular anchoring element 134 can be maintained in a first configuration during this deployment phase, thereby allowing the proximal portion of the valve 100 to be "dropped" into the valve annulus. For example, the proximal anchoring element 134 can be in a compressed, constrained, and / or retracted configuration in which the proximal anchoring element 134 contacts, abuts, and / or is near the transannular region 112 and / or supranuclear region 120 of the frame 110. This configuration can then limit the circumference of the subannular region 130 of the frame 110, thereby allowing the subannular region 130 and transannular region 112 of the frame 110 to be inserted into and / or through the valve annulus.

[0094]

[0110] 6 shows the valve 100 (PV, MV, AV, TV) positioned and / or seated in a native valve annulus (PVA, MVA, AVA, TVA) such that the subannular region 130 (e.g., a ventricular collar) is positioned in a subannular position, the transannular region 112 of the valve frame 110 extends through the annulus, and the supranuclear region 120 (e.g., an atrial collar) remains in a supranuclear 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 its first and second configurations. For example, the control device 170 can include one or more cables, tethers, linkages, joints, connections, tension members, etc., that can exert a force on (or remove an exerted force from) a portion of the proximal anchoring element 134 operable to transition the proximal anchoring element 134 between the first and second configurations. In some embodiments, the subannular region 130 of the support frame 110 can be formed with proximal anchoring elements 134 that are biased in an uncompressed and / or expanded configuration.

[0095]

[0111] Thus, control device 170 can be actuated to exert a force via one or more cables, tethers, etc., to transition proximal tether elements 134 to a compressed and / or retracted configuration, and can be actuated and / or otherwise manipulated to release or reduce the force, causing—or allowing—proximal tether elements 134 to transition from the compressed and / or retracted configuration to an expanded or uncompressed configuration. For example, once valve 100 is seated in a native annulus (PVA, MVA, AVA, TVA), a user can manipulate a portion of delivery / deployment system 180 to actuate control device 170, thereby causing control device 170 to release and / or remove (e.g., via cables, tethers, etc.) the force exerted on proximal tether elements 134. Proximal tether elements 134 can then return to their original or biased configuration (e.g., the second configuration).

[0096]

[0112] As described above, the supranulnar region 120 (e.g., the atrial cuff) of the valve frame 110 can be configured to engage native atrial tissue, the distal anchoring elements 132 can be configured to engage native ventricular tissue distal to the annulus, and the proximal anchoring elements 134 can be configured to engage native ventricular tissue proximal to the annulus (e.g., when in the second or expanded configuration), thereby securely seating the valve 100 in the native annulus, as shown in FIG. 6. In some embodiments, any other or additional portions of the valve 100 can similarly engage native tissue to securely seat 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., an anterior anchoring element can engage subannular tissue anterior to the annulus, or the supranulnar region 120 can include any number of supranulnar anchoring elements (not shown in FIGS. 1-6) for engaging supranulnar tissue). With valve 100 conveniently secured, delivery / deployment system 180 (including control device 170, support 179, guidewire and / or guidewire catheter, and / or any other portions or components of delivery / deployment system 180) can be decoupled from valve 100 and retracted / removed from the patient, leaving prosthetic valve 100 in place. As described above, in some embodiments, support 179 can be positioned such that its distal end is wrapped or looped around the guidewire and / or guidewire catheter. In such embodiments, retracting the guidewire and guidewire catheter into delivery / deployment system 180 (e.g., proximal to valve 100) can release the distal end of support 179, thereby allowing support 179 to be retracted and / or withdrawn from valve 100 into or through delivery / deployment system 180. In other embodiments, the distal end of support 179 can be decoupled from the attachment point in any suitable manner.

[0097]

[0113] 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 such prosthetic valves. The prosthetic valves (or aspects or portions thereof) described below with respect to certain embodiments can be substantially similar to valve 100 (or corresponding aspects or portions thereof), at least in terms of form and / or function. Similarly, the delivery / deployment systems and / or methods (or aspects or portions thereof) described below with respect to certain embodiments can be substantially similar to deployment system 180 or processes using deployment system 180 (or aspects, portions, and / or processes thereof), at least in terms of form, function, and / or process. Accordingly, certain aspects and / or portions of certain embodiments may not be described in further detail herein.

[0098]

[0114] 7-16 illustrate a side-deliverable (orthogonally deliverable) transcatheter prosthetic heart valve 200 (also referred to herein as a "prosthetic valve" or "valve") according to one embodiment. FIG. 7 is a diagram of a perspective view of the valve 200. In some embodiments, the valve 200 can be deployed, for example, in the annulus of a native tricuspid valve and / or a mitral valve. The valve 200 can be configured to allow blood to flow in a first direction through the inflow end of the valve 200 and block blood flow in a second direction opposite the first direction through the outflow end of the valve 200. For example, the prosthetic valve 200 can be a side-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.

[0099]

[0115] Valve 200 is compressible and expandable in at least one direction relative to the x-axis (also referred to herein as the “horizontal axis,” “vertical axis,” “long axis,” and / or “lengthwise axis”) of valve 200. 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 introduction into the body using a delivery catheter (not shown in FIG. 7 ). In some embodiments, the horizontal x-axis of valve 200 is orthogonal (90 degrees), substantially orthogonal (75-105 degrees), or substantially oblique (45-135 degrees) to the central (vertical) y-axis when in the expanded and / or compressed configuration. Furthermore, the horizontal x-axis of valve 200 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which valve 200 is disposed.

[0100]

[0116] In some embodiments, valve 200 has an expanded or deployed height of about 5-60 mm, about 5-30 mm, about 5-20 mm, about 8-12 mm, or about 8-10 mm, and an expanded or deployed diameter (e.g., length and / or width) of about 25-80 mm or about 40-80 mm. In some embodiments, valve 200 has a compressed height (y-axis) and width (z-axis) of about 6-15 mm, about 8-12 mm, or about 9-10 mm. In some implementations, the length (e.g., along the x-axis) of valve 200 is not compressed or otherwise reduced, as it can expand along the length of the central cylindrical axis of the delivery catheter (e.g., the longitudinal or longitudinal axis).

[0101]

[0117] In certain embodiments, valve 200 can be centric or eccentric (e.g., radially symmetric or radially asymmetric along or about the y-axis, respectively). In some eccentric embodiments, frame 210 can have a D-shaped cross-section, with a flat portion or surface configured to substantially match the annulus of the native mitral valve at or near the anterior leaflet. In the example shown in FIGS. 7-16, valve 200 is eccentric, with one or more components being offset or asymmetric relative to the y-axis.

[0102]

[0118] 7 and 8 show a valve 200 including an annular lateral support frame 210 and a foldable flow control component 250 mounted within the annular lateral support frame 210. The annular lateral support frame 210 (also referred to herein as the "outer frame") is made from a shape-memory material, such as a nickel-titanium alloy (Nitinol), and is therefore self-expanding from a compressed configuration to an expanded configuration. The outer frame 210 has a transannular member 212 and / or a transannular body that circumscribes, forms, and / or defines a central (internal) channel around and / or along a vertical or central axis (y-axis). The outer frame 210 has a supra-annular member 220 circumferentially attached at the top edge of the transannular member 212 and a subannular member 230 circumferentially attached at the bottom edge of the transannular member 212. 7 and 8, 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 can be a mesh material, pericardial tissue, a synthetic polyester woven material, and / or any other suitable biocompatible material such as those described above.

[0103]

[0119] The biocompatible covering 240 disposed on or along the supranulular member 220 can form a drum 245 extending between and / or coupled to the outer and inner loops of the supranulular member 220. Thus, the drum 245 can cover space not occupied by the flow control component 250. The drum 245 can have and / or form a set of spokes 245A that can be used to increase the stiffness of the drum 245. The drum 245 is further shown with an attachment member 238 that can extend along or across a portion of the drum 245 (or supranulular member 220). As described in further detail herein, the attachment member 238 can facilitate temporary and / or detachable attachment to a portion of a delivery / deployment system, such as, for example, a control device, an actuator, or the like.

[0104]

[0120] The supranullar member 220 is shaped to accommodate a self-deployed position. In a tricuspid valve replacement, for example, the supranullar member 220 or atrial collar can have a high posterior wall to accommodate the septal area of ​​the native valve and can have a distal and proximal portion. The distal portion can be larger than the proximal portion to allow for a larger flat space (atrium) above the ventricular outflow tract (VOT) subannular area. In a mitral replacement, for example, the supranullar member 220 of the outer frame 210 can be shaped like a D-shape or a hyperbolic paraboloid to mimic the native structure. In some embodiments, the supranullar member 220 of the outer frame 210 can be substantially similar, at least in form and / or function, to the supranullar region 120 (or members) described above. Accordingly, portions and / or aspects of the supranullar member 220 need not be described in further detail herein.

[0105]

[0121] 9 shows the laser-cut wireframe portion (without the cover) of the supranullar member 220. As shown, the supranullar member 220 includes a distal portion 222, a proximal portion 224, an outer loop 221, an inner loop 225, and at least one spline 227. In some embodiments, the outer loop 221 can be shaped and / or sized to engage with natural tissue. For example, the distal portion 222 of the supranullar member 220 (formed at least partially in the outer loop 221) is configured to engage distal supranullar tissue, and the proximal portion 224 (formed at least partially in the outer loop 221) is configured to engage proximal supranullar tissue. The distal portion 222 and the proximal portion 224 can have rounded and / or curved shapes, with the radius of curvature of the proximal portion 224 being greater than the radius of curvature of the distal portion 222. The distal portion 222 can, for example, engage distal supranulus tissue to form a distal anchoring loop 223 that at least partially stabilizes and / or anchors the frame 210 to the native annulus. Although not shown in FIG. 9 , the proximal portion 224 can similarly engage proximal supranulus tissue to form a proximal upper anchoring element that can at least partially stabilize and / or anchor the frame 210 to the native annulus.

[0106]

[0122] The inner loop 225 of the supranullar member 220 can be substantially circular, oval, teardrop-shaped, and / or any other suitable shape. The inner loop 225 can be coupled to and / or suspended from the outer loop by one or more splines 227. As shown in FIG. 7 , the inner loop 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 loop 225 of the outer support frame 210. In some embodiments, suspending the inner loop 225 from the outer loop 221 can, for example, at least partially isolate the inner loop 225 (and the flow control component 250 coupled to the inner loop 225) from at least some of the forces associated with transitioning the frame 210 between the expanded and compressed configurations, as described above with reference to the frame 210.

[0107]

[0123] The one or more splines 227 of the supranullar member 220 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the supranullar member 220 can include a proximal spline 227 and one or more distal splines. The distal spline can couple a distal portion of the inner loop 225 to a distal portion of the outer loop 221. Similarly, the proximal spline 227 can couple a proximal portion of the inner loop 225 to a proximal portion of the outer loop 221. In some embodiments, the proximal spline 227 can be configured to receive, couple, and / or otherwise engage an actuator, a control device, and / or a portion of a delivery system. For example, the proximal spline 227 can include, form, and / or couple with waypoints 228 that can be used to couple and / or receive one or more portions of a control device and / or delivery system, e.g., the proximal spline 227 can be described above with reference to the frame 110.

[0108]

[0124] As shown in Figures 7-9, in this embodiment, the supra-annular member 220 has an arcuate configuration in which the splines 227 protrude away from other portions of the supra-annular member 220. For example, the laser-cut frame of the supra-annular member 220 can be formed with the splines 227 having an arcuate configuration (Figure 9). In some embodiments, the arcuate splines 227 can exert a force on the drum 245 that bends the drum 245 and increases tension across an area of ​​the drum 245. The increased tension, alone or in combination with the spokes 245A, can increase the relative stiffness of the drum 245, thereby reducing and / or limiting 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 at or along the drum 245. In other words, the pressure generated on the atrial side of drum 245 during atrial contraction (diastole) is not sufficient to reverse the bowed configuration of drum 245 (e.g., does not cause an oil can-like deflection) due to bowed splines 227. The bowed configuration of drum 245 can also withstand the greater pressure generated on the ventricular side of drum 245 during ventricular contraction (systole) without substantial deflection. Furthermore, the curvature of splines 227 can be such that waypoints 228 are positioned at a desired angle and / or orientation to facilitate insertion or retraction of one or more portions of a delivery system therethrough.

[0109]

[0125] 10 is a distal perspective view showing the transannular member 212 of the outer frame 210 of the valve 200. In some embodiments, the transannular member 212 of the outer frame 210 can be substantially similar, at least in form and / or function, to the transannular region 112 (or member) described above. Accordingly, portions and / or aspects of the transannular member 212 need not be described in further detail here.

[0110]

[0126] The transannular member 212 can have and / or form a ring, a cylindrical tube, a conical tube, and / or any other suitable tubular shape. In some embodiments, the transannular member 212 can have a side profile such as a concave cylinder (with inward-curving walls); an angular hourglass shape; a curved progressive hourglass shape; a ring or cylinder with a top flare, a bottom flare, or both. Additionally, the transannular member 212 can form and / or define an aperture or central channel 214 extending along the central axis 204 (e.g., the y-axis). The central channel 214 (e.g., a central axial lumen or channel) can be sized and configured to receive the flow control component 250 across a portion of the diameter of the central channel 214. In some embodiments, the transannular member 212 can have a shape and / or size 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 outer support frame 210 and / or the native annulus into which it is configured to be deployed, as described above.

[0111]

[0127] The transannular member 212 can be and / or include a wire frame laser-cut from Nitinol or the like and heat-set to a desired shape and / or configuration. The transannular member 212 can be formed to include a set of compressible wire cells 213 with an orientation and / or cell geometry substantially perpendicular to a central axis extending through the central channel 214, thereby minimizing distortion of the wire cells when the transannular member 212 is in a vertically compressed, rolled, or folded compressed configuration. As shown in FIG. 10 , the transannular member 212 is formed to a desired shape and includes an anterior side 215 (e.g., a first laser-cut half) and a posterior side 216 (e.g., a second laser-cut half) that are formed together to form the transannular member 212. The anterior side 215 and the posterior side 216 can be joined at one or more hinge points 217 along the distal and proximal portions of the transannular member 212. More specifically, the anterior side 215 and posterior side 216 can be joined along the distal side of the transannular member 212 via two sutures forming two hinges or attachment points 217, and can be joined along the proximal side of the transannular member 212 via one suture forming a single hinge or attachment point 217.

[0112]

[0128] In some embodiments, forming the transannular member 212 in this manner allows the transannular member 212 to bend, curve, fold, deform, and / or otherwise reconfigure (without substantial plastic deformation and / or undue fatigue) in response to lateral folding along or in the direction of the lateral or z-axis and / or vertical compression along or in the direction of the central or y-axis. Additionally, the use of sutures to connect at the hinge points 217 allows a desired amount of slippage between the sutures and the anterior / posterior sides 215 / 216, thereby limiting and / or substantially avoiding bending, adhesion, and / or failure in response to folding along the lateral or z-axis.

[0113]

[0129] 10 , the proximal portion of the transannular member 212 includes a single hinge or attachment point 217. In some embodiments, the transannular member 212 can define a gap or space 218 below the proximal hinge or attachment point 217 that can provide space to allow the proximal anchoring element of the subannular member 230 to transition between a first configuration and a second configuration, as described in further detail herein.

[0114]

[0130] 11 is a distal perspective view showing the subannular member 230 of the outer frame 210 of the valve 200. In some embodiments, the frame 210 subannular member 230 can be similar, at least in form and / or function, to the subannular region 130 (or members) described above. Accordingly, portions and / or aspects of the subannular member 230 need not be described in further detail here.

[0115]

[0131] 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 of any suitable shape, size, and / or configuration. The distal anchoring element 232 is shown including an atraumatic end forming a guidewire coupler 233 configured to selectively engage and / or receive a portion of a guidewire catheter 284 (having a guidewire 285 disposed therein) through an opening, hole, aperture, port, etc. defined by the guidewire coupler 233 (see, e.g., FIGS. 15 and 16 ). With guidewire catheter 284 extending through guidewire coupler 233, valve 200 can be advanced over or along a deployed guidewire 285 disposed on guidewire catheter 284. In some embodiments, guidewire catheter 284 can extend below valve 200 and beyond distal anchoring element 232 to provide a desired degree of stiffness during delivery and / or deployment.

[0116]

[0132] The anchoring elements 232 and / or 234 are configured to engage a desired portion of the native tissue to anchor 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., approximately 10-40 mm) from the subannular member 230 to the RVOT or other ventricular location. The distal anchoring element 232 can have a shape and / or bias such that the distal anchoring element 232 exerts a force on the subannular tissue operable to at least partially secure the distal end portion of the frame 210 to the native annulus.

[0117]

[0133] The proximal anchoring element 234 can be configured to engage subannular tissue proximal to the native annulus to aid in securing the frame 210 to the annulus. As described above, the subannular member 230 of the frame 210 can be and / or include a laser-cut wire frame formed of a shape-memory material, such as Nitinol, that is heat-set into a desired shape and encased in a biocompatible material (e.g., fabric, etc.). The proximal anchoring element 234 is configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchoring element 234 extends a first amount or distance from the subannular member 230, and a second configuration 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 a movable anchoring element configured to move and / or otherwise transition (e.g., by an actuator) between a first configuration and a second configuration to reduce the circumference of the subannular member 230 during delivery and / or deployment.

[0118]

[0134] As described above, the proximal anchoring element 234 can be compressed, contracted, retracted, undeployed, folded, and / or constrained when in a first configuration (e.g., near, adjacent, and / or in contact with the transannular region 212 and / or supranullar region 220 of the outer support frame 210) and can be expanded, enlarged, deployed, unfolded, and / or unconstrained when in a second configuration (e.g., extending away from the transannular region 212). In some embodiments, the proximal anchoring element 234 can be biased and / or heat-set in the second configuration. Furthermore, in some implementations, the space 218 defined by the transannular member 212 of the outer frame 210 is configured to provide sufficient room for the proximal anchoring element 234 to transition between the first and second configurations.

[0119]

[0135] The proximal anchoring element 234 is configured to move in any suitable direction from a first expanded configuration to a second compressed configuration based, at least in part, on how the proximal anchoring element 234 is coupled to an actuator or the like. For example, the proximal anchoring element 234 can move inwardly toward the inner flow control component 250, upwardly toward the supranuclear member 220 and / or a portion thereof, and / or toward the anterior or posterior side of the valve 200. Furthermore, with the transannular member 212 of the frame 210 coupled to the subannular member 230, actuation of an actuator, control device, or the like can, as the case may be, move one or more portions of the transannular member 212, as described in more detail herein.

[0120]

[0136] A foldable (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 wire frame" or "inner frame") having two (or more) folding areas, hinge areas, bonding areas, elastically deformable areas, etc. A set of two to four flexible leaflet components 256 is mounted within or on the inner frame 251 (not shown in FIG. 7 ). In some embodiments, the flow control component 250 has three leaflet components 256 (e.g., cusps, pockets, or simply leaflets) mounted within the inner frame 251, as described in further detail herein.

[0121]

[0137] The inner flow control component 250, like the outer frame 210, is foldable and compressible. For example, the inner frame 251 can be folded (e.g., folded at folding areas, etc.) along or in the direction of the z-axis from a cylindrical configuration to a flat cylindrical configuration (or a two-layer band), with the folding areas located distal to and distal from the inner frame 251. The flow control component 250, like the outer frame 210, can also be compressed vertically (y-axis) to a shortened or compressed configuration. By folding (compressing) along the z-axis and compressing vertically in the y-axis, the valve 200 can maintain a relatively large dimension along the horizontal (x-axis). In some embodiments, the outer frame 210 and the flow control component 250 are contracted along the z-axis until their sidewalls 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), limiting or substantially minimizing the number of wire cells that may be damaged by forces applied during folding and / or compression when loading the valve 200 into a delivery catheter.

[0122]

[0138] The flow control component 250 has a diameter and / or perimeter that is smaller than the diameter and / or perimeter of the central channel of the outer frame 210. The flow control component 250 is mounted to or within the outer frame 210 such that the central or vertical axis (y-axis) of the inner frame 251 is parallel to the central 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 but offset from the y-axis defined by the outer frame 210 ( FIG. 7 ). In some implementations, a drum 245 (or other spacer element) can be disposed within and / or across the central channel to 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 to facilitate autologous tissue ingrowth across at least a portion of the supra-annular member 220 of the valve 200.

[0123]

[0139] In certain embodiments, the inner frame 251 can have a diameter of approximately 25-30 mm, the outer frame 210 (or its transannular member 212) can have a diameter of approximately 50-80 mm, and the supranuclear member 220 (or atrial collar) extends approximately 20-30 mm beyond the superior edge of the transannular member 212 to provide a seal on the atrial floor to prevent paravalvular regurgitation (PVL). The flow control component 250 and outer frame 210 can be foldable (e.g., in the z-axis) and / or compressible (e.g., in the y-axis), thereby reducing the size of the valve 200 to fit within a 24-36 Fr (8-12 mm inner diameter) delivery catheter (not shown in FIG. 7).

[0124]

[0140] 12-14 illustrate at least a portion of a flow control component 250 included in valve 200. For example, FIG. 12 is a diagram 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 that are joined at lateral connection points 252 and 253 (e.g., folding areas, elastic deformation regions, joined edged portions, etc.). Inner leaflet frame 251 is shown in an expanded or cylindrical configuration (e.g., before being folded and / or compressed).

[0125]

[0141] Although not shown, the inner leaflet frame 251 can transition from an expanded or cylindrical configuration to at least a partially collapsed configuration. The inner leaflet frame 251 can have wire frame sidewalls that allow for rotation or hinging at least at the lateral connection points 252 and 253. The inner leaflet frame 251 can be configured to collapse in response to the valve 200 being folded and / or compressed for delivery. For example, upon transitioning to a fully collapsed configuration, the wire frame sidewalls can rotate, hinge, and / or collapse at the lateral connection points 252 and 253. Additionally, the inner leaflet frame 251 can be vertically compressed into a compressed configuration. The wire frame sidewalls can be oriented in a compressive direction to form cells (e.g., diamond-shaped cells, etc.) that allow 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.

[0126]

[0142] 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 sheet before being further assembled into a cylindrical structure (e.g., as shown in FIG. 12 ). The inner leaflet frame 251 can be formed into a cylindrical structure or configuration (or a conical structure or configuration) where the edges of the linear wire frame sheet are connected or joined at lateral connection points 252 and 253 (e.g., hinge areas, folding areas, etc.). Additionally, the inner leaflet frame 251 can be expanded (e.g., actuated, formed, bent, etc.) from the linear sheet configuration into a cylindrical structure or configuration.

[0127]

[0143] 13 and 14 show a structural band 255 of pericardial tissue with leaflet components 256 sewn thereto. FIGS. 13 and 14 are side perspective and bottom views, respectively, of the structural band 255 and leaflet components 256 (e.g., pockets) prior to assembly and / or mounting to inner frame 251 to form collapsible (foldable, compressible) flow control component 250. FIG. 13 shows a structural band 255 formed of pericardial tissue with leaflet components 256 sewn thereto. After assembly into the cylindrical leaflet configuration shown, leaflet components 256 are disposed on the inner surface of structural band 255. Leaflet components 256 can be sewn to structural band 255 with open edges extending outward and sutured edges forming a closed parabolic edge that provides attachment. Figure 14 is an illustration of a bottom view of flow control component 250. Cylindrical structural band 255 and leaflet component 256 are shown partially joined to form a closed fluid seal. Although not shown, cylindrical structural band 255 can be mounted to or within inner leaflet frame 251 (Figure 12) to collectively form flow control component 250, which is mounted to inner loop 225 of supranuclear member 220 of outer support frame 210, as described in detail above with reference to Figures 7 and 8.

[0128]

[0144] 15 and 16 are elevated perspective side views illustrating a prosthetic valve 200 removably coupled to a control device 270 used to advance, control, and / or retract the valve through a delivery catheter and / or to actuate one or more portions of the valve 200, such as at least the subannular member 230 of the valve frame 210, as described herein. The control device 270 and / or at least a portion thereof includes a control catheter 271 having a connecting member 278 coupled to and / or disposed at its distal end. The control catheter 271 can be, for example, a multi-lumen steerable catheter through which one or more components of the control device 270 extend, as described in detail in the '032 PCT incorporated by reference above. The connecting member 278 is removably coupleable to the supranuclear member 220 of the valve frame 210, connecting the valve 200 to the control catheter 271. As described in further detail herein, the control catheter 271 can be operated, for example, to advance the prosthetic valve 200 through a delivery catheter (not shown), to control or steer the prosthetic valve 200 during deployment, to retract and / or withdraw the prosthetic valve 200 into the delivery catheter (e.g., after at least partial deployment), etc.

[0129]

[0145] 15 shows connecting member 278 having a wishbone, yoke, or Y-shaped configuration, other configurations are possible. Thus, connecting member 278 can have a first portion, side, and / or arm and a second portion, size, and / or arm opposing the first portion, side, and / or arm. Connecting member 278 can be configured to transition between an expanded configuration and a compressed configuration, for example, to allow advancement of control catheter 271 (and connecting member 278 disposed at its distal end) through a delivery catheter. Connecting member 278 can be formed from any suitable material, such as a shape-memory alloy such as Nitinol.

[0130]

[0146] In some embodiments, the connecting member 278 can contact and / or be removably coupled to the drum 245 and / or frame 210 of the supranullar member 220 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 removably coupled connection. 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 along or through a set of openings defined by each side or arm of the connecting member 278 (yoke), looping around one or more attachment members 238 of the valve 200, and re-extending into the corresponding lumen of the control catheter 271. The attachment members 238 can be formed by, coupled to, and / or extend from the supranullar member 220 (e.g., drum 245). In some embodiments, the attachment members 238 of the valve 200 can be tethers, sutures, cables, frameworks, etc. that can be coupled to and / or extend from a wire frame portion of the supranullar member 220, such as the drum 245 (or other biocompatible covering). Additionally, the attachment members 238 can form a pair of loops 239, etc., around which the tether 275 of the control device 270 can be routed or looped.

[0131]

[0147] The looping arrangement of tether 275 through and / or around connecting member 278 and attachment member 238 of valve 200 is such that the proximal and distal ends of tether 275 each extend outwardly (e.g., proximally) through a single control arm 277 of control unit 272. Accordingly, a proximal force can be applied to each of the proximal and distal ends of tether 275 to increase tension along tether 275, thereby pulling connecting member 238 toward drum 245 and thereby securing connecting member 278 to the valve. Conversely, a proximal force applied to only one of the proximal or distal ends of tether 275 can disengage tether 275 from connecting member 278 and retract tether 275 from control device 270, thereby allowing connecting member 278 to be decoupled or removed from valve 200.

[0132]

[0148] 15 further illustrates a guidewire catheter 284 of the delivery system, for example, extending through waypoints 228 or openings in the supranuclear member 220 and / or its drum 245, and extending through the guidewire coupler 233 of the distal anchoring element 232. The guidewire catheter 284 can extend beneath the flow control component 250 of the valve 200. Prior to and / or as part of delivery, the guidewire catheter 284 can be advanced and / or inserted through the valve 200 and advanced over a guidewire 285 already positioned at a desired location within the heart. Thus, delivering the valve 200 in its compressed configuration through a 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 from the guidewire coupler 233).

[0133]

[0149] The guidewire catheter 284 can be sufficiently rigid to limit and / or define (at least partially) the range of movement of the valve 200 during delivery, for example. For example, the guidewire catheter 284 can define an axis about which the valve 200 can rotate during delivery, while movement of the valve 200 in other directions can be substantially limited or opposed. In some embodiments, the position of the connecting member 278 (e.g., a yoke) and the guidewire catheter 284 can further control the position of the valve 200 during delivery. The guidewire catheter 284 and / or one or more portions of the valve 200 (e.g., the subannular member 230) can also include radiopaque markers that allow for enhanced visualization during image-guided delivery. For example, in some cases, radiopaque markers or wires can be placed relative to the annular plane of the native valve to define landmarks during image-guided delivery. In such cases, radiopaque markers on the guidewire catheter 284 and / or 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 the landmark, which corresponds to the annular plane of the native valve. Thus, image-guided delivery allows the user to visualize the valve 200 during delivery and / or deployment, and the user can visualize when the valve 200 is seated in the annulus (e.g., the radiopaque marker band on the valve 200 is inferior or in the subannular direction relative to the radiopaque landmark).

[0134]

[0150] 15 further illustrates at least one tether 276 (e.g., a tether, suture, cable, tension member, etc.) extending from the control catheter 271 (e.g., through one or more lumens thereof) through the waypoint 228. The control device 270 may include a single tether or may include multiple tethers (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, seven tethers, eight tethers, nine tethers, ten tethers, or more tethers, each tether capable of being removably coupled to one or more attachment points of the valve 200). The tether 276 may be configured to actuate and / or transition one or more portions of the valve 200, such as, for example, the subannular member 230 and / or at least the proximal anchoring element 234 thereof. In some embodiments, the tethers 276 can extend through waypoints 228, loop around and / or through attachment points along the subannular member 230 or at least the proximal anchoring elements, and then be routed back through waypoints 228 and control catheter 271 so that both ends of each tether 276 are external to the patient, thereby manipulating the tethers 276 to actuate the valve 200 and / or transition the shape of the proximal anchoring elements 234, the subannular member 230, and / or other portions of the valve 200 to facilitate at least proximal seating of the valve 200 in the native annulus. In other words, increasing the amount of tension along the tethers 276 can be operable to transition at least the subannular member 230 (or portions thereof) between a first configuration and a second configuration. Thus, the tethers 276 can be actuated (or tensioned) and / or released in a manner similar to that described above with reference to tethers 275.

[0135]

[0151] 16 illustrates the valve 200 and control device 270 during deployment into a native valve of the heart. As described above, the control device 270 can advance the valve 200 through a delivery catheter 282 and into the atrium. In some embodiments, the delivery catheter 282 can remain in a substantially fixed position relative to the atrium or the IVC through which it extends, while the distal end of the control device 270 and the valve 200 are advanced distally relative to the delivery catheter 282 (e.g., away from the delivery catheter 282) toward the valve annulus along a guidewire catheter 284. Thus, the length of the portion of the control catheter 271 away from the delivery catheter 282 increases. 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 the compressed configuration to the expanded configuration.

[0136]

[0152] The control device 270 can be manipulated or steered to position the valve 200 in the expanded configuration at a desired deployment angle where the distal anchoring elements 232 are positioned below the valve annulus and near, adjacent to, and / or at least partially within, for example, the ventricular outflow tract (e.g., RVOT). At the deployment angle, the supra-annular member 220 of the valve frame 210 and at least a proximal portion of the subannular member 230 of the valve frame 210 remain within the atrium. In some embodiments, the distal surface of the transannular member 212 of the valve frame 210 can be positioned in contact with the native tissue forming the distal surface or wall of the valve annulus. In some cases, the valve 200 can be temporarily maintained in this partially deployed position (e.g., deployment angle) to allow a user to confirm the positioning of the valve 200 relative to that angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or to allow blood to pass through the annulus to initiate a transition from flow entirely through the native valve to flow through the flow control component 250. In some cases, this also allows the user to verify that the flow control component 250 is functioning as desired before fully seating the valve 200 in the annulus.

[0137]

[0153] Once the position and / or function of the valve 200 has been confirmed, the control device 270 can be manipulated and / or steered to pivot the valve 200 relative to the annulus so that a distal 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 and / or transition to a compressed configuration such 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 such that a distal force applied to the control device 270 by the user causes the connecting member 278 to push the proximal portion of the valve 200 toward the annulus. In some embodiments, pivoting the valve 200 can include "steering" the control catheter 271 such that a distal portion of the control catheter 271 bends relative to the distal end of the delivery catheter 282 and the connecting members 278 seat a proximal portion of the valve 200 in the valve annulus. Once seated, the control device 270 and / or at least one tether 276 can be actuated to transition the proximal anchoring element 234 to the expanded configuration, as described above with reference to FIG. 15 . The delivery / deployment system 280 can then be decoupled from the valve 200 and retracted / removed from the patient, leaving the prosthetic valve 200 in place in the valve annulus.

[0138]

[0154] In some cases, it may be desirable to provide additional support to one or more portions of the prosthetic valve and / or control device during the deployment process described above with reference to Figure 16. For example, Figure 17 is a schematic illustration of prosthetic valve 300 coupled to delivery / deployment system 380 according to one embodiment and shown during the process of deploying valve 300 into the annulus of a native heart valve. Valve 300 and delivery / deployment system 380 can be similar and / or substantially the same as valve 200 and delivery / deployment system 280, respectively. Accordingly, valve 300 (or at least aspects thereof) and delivery / deployment system 380 (or at least aspects thereof) will not be described in further detail herein.

[0139]

[0155] As described above, the control device 370 can include a control catheter 371 having a connecting member 378 disposed at its distal end. The connecting member 378 is detachably coupled to the supranuclear region 320 of the valve 300 (or its valve frame 310). The coupling, engagement, and / or contact of the connecting member 378 and the supranuclear region 320 enables the control device 370 to advance the valve 300 over a guidewire catheter 384 (and / or a guidewire disposed in the guidewire catheter 384) and through a delivery catheter 382 into the atrium. In some embodiments, the control device 370 and the valve 300 can be disposed within a lumen of a delivery sheath 383, which in turn is disposed within a lumen of the 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 can be advanced into the atrium through the delivery catheter 382, ​​as shown in FIG. 17 . In some embodiments, while the distal end of control device 370 and valve 300 are advanced along guidewire catheter 384 in a direction distal to (e.g., away from) delivery catheter 382 toward the valve annulus, delivery catheter 382 and optionally delivery sheath 383 can remain in a substantially fixed position relative to the atrium or the IVC through which delivery catheter 382 extends. Thus, the length of the portion of control catheter 371 away from delivery catheter 382 and / or delivery sheath 383 increases. Because valve 300 is no longer constrained by delivery catheter 382 and / or delivery sheath 383, releasing valve 300 into the atrium allows valve 300 to transition from the compressed configuration to the expanded configuration.

[0140]

[0156] The control device 370 can be manipulated or steered to position the valve 300 (in the expanded configuration) at a desired deployment angle where the distal anchoring elements 332 are positioned below the valve annulus and near, adjacent to, and / or at least partially within, for example, the ventricular outflow tract (e.g., RVOT). At the deployment angle, the supranuclear region 320 of the valve frame 310 and at least a proximal portion of the subannular region 330 of the valve frame 310 remain within the atrium. In some embodiments, the distal surface of the transannular member 312 of the valve frame 310 can be positioned in contact with the native tissue forming the distal surface or wall of the valve annulus. In some cases, the valve 300 can be temporarily maintained in this partially deployed position (e.g., at the deployment angle) to allow a user to confirm the positioning of the valve 300 relative to that angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or to allow blood to pass through the annulus to initiate a transition from flow entirely through the native valve to flow through the flow control component 350. In some cases, this also allows the user to verify that the flow control component 350 is functioning as desired before fully seating the valve 300 in the annulus.

[0141]

[0157] As described above with reference to valve 200, a guidewire catheter 384 extending through and under a portion of valve 300 and exiting from distal anchoring element 332 can provide support to 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, delivery / deployment system 380 shown in FIG. 17 also includes a supranuclear support 379 configured to support at least a portion of valve 300. In some embodiments, supranuclear support 379 (also referred to herein as a “support”) can extend through a lumen of delivery sheath 383. The proximal end of support 379 is near and / or external to the proximal end of delivery catheter 382, ​​allowing a user to manipulate support 379. The distal end of the support 379 is removably coupleable to the supranuclear portion of the valve 300 and / or valve frame 310. Additionally, the support 379 can extend through a lumen of the delivery sheath 383 while being external to or not directly attached to the control device 370. In some embodiments, such an arrangement allows the support 379 to form a supportive connection between the supranuclear portion of the valve 300 and the delivery sheath 383 while allowing the control device 370 to be moved, shifted, and / or otherwise reconfigured to control and deploy the valve 300 at the annulus.

[0142]

[0158] 17 shows supports 379 removably coupled to attachment points 346 at or along the distal portion of the supranulvular region 320 of the valve frame 310. The supports 379 can be any suitable feature, component, member, device, mechanism, etc. configured to support at least a portion of the valve 300 during deployment into the valve annulus. In some embodiments, the supports 379 can be one or more tethers, sutures, tension members, rods, cables, tubes, catheters, etc. In some embodiments, the supports 379 can be one or more reconfigurable members configured to transition from a first state / configuration (e.g., during delivery through the delivery catheter 382) to a second state / configuration (e.g., during deployment into the valve annulus). For example, the supports 379 can be relatively flexible when in the first state and relatively rigid when in the second state, thereby forming a substantially rigid connection between the attachment points 346 and the distal end portion of the delivery sheath 383.

[0143]

[0159] In some embodiments, support 379 is configured to transition to the second / supporting configuration in response to the application of tension after valve 300 is released from delivery catheter 382 and allowed to expand to the expanded / deployed configuration. In embodiments in which support 379 is or includes one or more tethers, the tethers can be similar to or substantially the same as tethers 275 and / or 276 described above with reference to FIG. 15 . Accordingly, increased tension can be applied along at least a portion of support 379, thereby applying a proximal force to a proximal end portion of support 379 (one or more tethers) that transitions support 379 to its second configuration. In some implementations, support 379 in the second or supporting state or configuration can stabilize at least a portion of valve 300, which, in combination with support provided by guidewire catheter 384, can provide increased control of valve 300 when moving and / or positioning valve 300 in the annulus via control device 370. Additionally, in some embodiments, the second configuration support 379 can provide support to at least the distal supranuclear region of the valve 300, for example, which can resist, restrict, and / or otherwise prevent the distal supranuclear region of the valve 300 (and / or the distal portion of the supranuclear region 320 of the valve frame 310) from falling into the annulus.

[0144]

[0160] With the distal portion of the valve 300 in a desired position within the annulus (and optionally after verifying the valve's position and / or function 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 and / or transition to a compressed configuration such 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 such that when a user applies a distal force to the control device 370, the connecting member 378 at the end of the control catheter 371 pushes the proximal portion of the valve 300 toward the annulus. In some embodiments, pivoting the valve 300 can include "steering" the control catheter 371 so that the distal end of the control catheter 371 bends relative to the distal portion of the delivery catheter 382 and / or delivery sheath 383, allowing the control device 370 to seat the proximal portion of the valve 300 against the valve annulus.

[0145]

[0161] In some embodiments, a substantially rigid and / or supportive connection between the support 379 and / or attachment points 346 at or along the distal supranuclear region of the valve 300 and the distal end of the delivery sheath 383 (e.g., external to or substantially independent of the control device 370) from which the support 379 extends can generate a counter / reverse force operable to pivot or seat at least a proximal portion of the valve 300 against the annulus in response to forces applied by the control catheter 371 and / or bending of the control catheter 371. 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 deployment of the valve 300, thereby facilitating the deployment process. For example, the distal end portion of the control catheter 371 can be advanced and moved distally relative to the delivery catheter 382, ​​while the distal end portion of the delivery sheath 383 can be in a substantially fixed position relative to the delivery catheter 382.

[0146]

[0162] With the support 379 extending through the lumen of the delivery sheath 383 outside of the control catheter 371, 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 can then limit and / or substantially prevent the distal supranuclear portion of the valve 300 from falling into the annulus, while also at least partially directing and / or controlling bending and / or movement of the distal end portion of the control catheter 371 to facilitate seating of the proximal portion of the valve 300 in the annulus. In some cases, the substantially rigid or substantially fixed-length connection can limit and / or substantially prevent a portion of the control catheter 371 from pushing away from the annulus, which could otherwise result in the cardiac anatomy (e.g., the IVC) supporting the control catheter 371. In some cases, the placement of the distal anchoring element 332, for example, in the RVOT and the coupling of the support 379 to the attachment point 346 collectively act to anchor, restrain, fixate, and / or otherwise control at least a distal portion of the valve 300, allowing a proximal portion of the valve 300 to pivot relative to the annulus.

[0147]

[0163] Once the valve 300 is seated in the valve annulus, the control device 370 and / or at least one actuator, tether, tensioning member, etc. can be actuated to transition (or otherwise enable) the proximal anchoring elements 334 to the expanded configuration, as described above with reference to the valve 200 shown in FIG. 15 . In some embodiments, fully seating the valve 300 as just described is sufficient to secure the valve 300 to the valve annulus. In other embodiments, one or more portions of the valve 300 can be tightened or actuated, for example, to engage and / or pinch the native tissue forming the valve annulus, thereby securing the valve 300. With the valve 300 secured in the valve annulus, the delivery / deployment system 380 can be decoupled from the valve 300 and retracted / removed from the patient, leaving the prosthetic valve 300 in place in the valve annulus.

[0148]

[0164] In some embodiments, support 379 can be removably coupled to valve 300 at attachment point 346 such that support 379 can be decoupled from the valve and retracted using at least one of guidewire catheter 384, control device 370, and / or delivery sheath 383. For example, support 379 can be and / or include a tether that "loops" through or around attachment point 346 such that the proximal and distal ends of the tether (support 379) are each positioned near delivery catheter 382 and external to the body, as described above with reference to tethers 275 and / or 276. In some embodiments, support 379 is removably coupled at a distal end portion of support 379 to attachment point 346, while a proximal end of support 379 is disposed external to the body (e.g., tether and / or support 379 is and / or may include a tether that is not "looped" at attachment point as described above with reference to tethers 275 and / or 276). In some such embodiments, the distal end portion of support 379 may be wrapped around attachment point 346 or any other portion of valve 300, thereby allowing support 379 to be unwound or otherwise detached from valve 300 without having to pull one side of support 379 through delivery / deployment system 380, as may be the case when support 379 is "looped." In some embodiments, attachment point 346 may include a breakaway suture that allows the distal end portion of support 379 to be separated and / or detached. The support 379 can be a tether (e.g., a suture) and / or any other suitable temporary attachment. In some embodiments, the arrangement can be such that the distal end of the support 379 (e.g., a tether or any other form of supra-annular support) can be decoupled 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 manner, the support 379 can be retracted and / or removed from the patient as the delivery catheter 382 and / or delivery sheath 383 are retracted and / or removed.

[0149]

[0165] While the support 379 is described above as transitioning from a first configuration to a second configuration, e.g., forming a substantially rigid or substantially fixed-length connection between the delivery sheath 383 and the attachment point 346 of the valve 300, in other embodiments, the support 379, or at least a portion thereof, can be formed from a material that can provide a desired amount of rigidity without transitioning between one or more states or configurations. For example, in some embodiments, the support 379, or at least a portion thereof, can be formed from a metal (e.g., stainless steel, etc.) or a relatively stiff polymer. In some embodiments, the support 379 can include a tether that is at least partially disposed within a catheter having a desired durometer, etc. (e.g., similar to the guidewire and guidewire-catheter arrangement described above with reference to the valve 200 shown in FIGS. 7-16 ). In some implementations, disposing a catheter around a portion of the tether can provide sufficient rigidity to allow a user to, for example, apply a distal force to the supranulvular region 320 of the valve 300 and / or valve frame 310. For example, with the support coupled to the distal upper annulus of the valve 300, a distal force can be used to push at least the distal upper annulus of the valve 300 and / or valve frame 310 into a desired position relative to the annulus (or to assist in advancing the valve 300 through the delivery sheath 383 and / or delivery catheter 382).

[0150]

[0166] 18 is a schematic illustration of a prosthetic valve 400 coupled to a delivery / deployment system 480 according to another embodiment, shown during the process of deploying the valve 400 into the annulus of a native heart valve. The valve 400 and the delivery / deployment system 480 can be similar and / or substantially the same as the valve 300 and the delivery / deployment system 380, respectively. Accordingly, the valve 400 (or at least aspects thereof) and the delivery / deployment system 480 (or at least aspects thereof) will not be described in further detail herein.

[0151]

[0167] As described above, the control device 470 can include a control catheter 471 having a connecting member 478 disposed at its distal end. The connecting member 478 is detachably coupled to the supranulvular region 420 of the valve 400 (or its valve frame 410). The coupling, engagement, and / or contact of the connecting member 478 and the supranulvular region 420 enables the control device 470 to advance the valve 400 along a guidewire catheter 484 (and / or a guidewire disposed in the guidewire catheter 484), through a delivery catheter 482, and into the atrium. The delivery catheter 482 and optionally the delivery sheath 483 can remain in a substantially fixed position relative to the atrium or the IVC through which the delivery catheter 482 extends, while the distal end of the control device 470 and the valve 400 are advanced distally relative to (e.g., away from) the delivery catheter 482 and along the guidewire catheter 484 toward the valve annulus. Thus, the length of the portion of control catheter 471 away from delivery sheath 483 increases. 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 the compressed configuration to the expanded configuration.

[0152]

[0168] The control device 470 can be manipulated or steered to position the valve 400 in the expanded configuration at a desired deployment angle where the distal anchoring elements 432 are positioned below the valve annulus and near, adjacent to, and / or at least partially within, for example, the ventricular outflow tract (e.g., RVOT). At the deployment angle, the supranuclear region 420 of the valve frame 410 and at least a proximal portion of the subannular region 430 of the valve frame 410 remain within the atrium. In some embodiments, the distal surface of the transannular member 412 of the valve frame 410 can be positioned in contact with the native tissue forming the distal surface or wall of the valve annulus. In some cases, the valve 400 can be temporarily maintained in this partially deployed position (e.g., deployment angle) to allow a user to confirm the positioning of the valve 400 relative to that angle (e.g., by visualizing radiopaque markers under fluoroscopy) and / or to allow blood to pass through the annulus to initiate a transition from flow entirely through the native valve to flow through the flow control component 450. In some cases, this also allows the user to verify that the flow control component 450 is functioning as desired before fully seating the valve 400 in the annulus.

[0153]

[0169] 18 includes a support 479 configured to provide support to one or more portions of the valve 400 during deployment. The support 479 can extend through a lumen in the delivery sheath 483 and exterior to the control device 470. A proximal end of the support 479 is proximal to and / or exterior to the delivery catheter 482, thereby allowing a user to manipulate the support 479. A distal end of the support 479 is removably coupleable and / or otherwise configured to selectively engage the distal portion of the valve 400 and / or valve frame 410.

[0154]

[0170] The support 479 can be similar to and / or substantially the same as the support 379 described above with reference to FIG. 17 . For example, the support 479 can be and / or include one or more tethers, sutures, cables, rods, tension members, tubes, catheters, etc., or combinations thereof. In some embodiments, the support 479 can be configured to transition to a support configuration in response to the application of a tensioning force. However, although the support 379 is described above as being removably coupled to attachment points 346 distal to or along the supranuclear region 320 of the valve frame 310, the distal portion of the support 479 shown in FIG. 18 can be at least temporarily engaged and / or secured to the distal portion of the valve 400 via one or more other features, components, members, fastenings, coupling members, etc.

[0155]

[0171] 18 shows the distal portion of the support extending through attachment or anchoring point 446, which in this embodiment is a hole, opening, aperture, slit, waypoint, pass-through, etc. The distal portion of support 479 extends exterior to valve frame 410 along the outer surface or wall. The distal end of support 479 is shown including a loop, hoop, ring, etc. that is disposed over (at least during deployment) a guidewire catheter 484. Stated another way, the loop at the distal end of support 479 receives and / or otherwise allows guidewire catheter 484 to extend therethrough. In some embodiments, routing the distal portion of the support 479 along the distal wall of the valve 400 from the supranulvular member or region 420 of the valve frame 410 to the subannular member or region 430 of the valve frame 410 can sandwich or capture the distal portion of the support 479 between the wall of the valve 400 and the native tissue forming part of the annulus, and can anchor and / or secure the support 479 to the distal portion of the valve 400 (e.g., similar to support 379 removably coupled to attachment point 346).

[0156]

[0172] 18 shows the distal anchoring element 432 in a subannular region 430, which is located below the valve annulus at, near, or at least partially within the ventricular outflow tract (e.g., RVOT) while the remainder of the valve 400 is within the atrium. Positioning the distal anchoring element 432 in the ventricle (e.g., RVOT) can be such that a distal portion or distal surface of the valve 400 is positioned against and / or adjacent to a distal surface of the native tissue forming the valve annulus. Thus, contact between the surface of the valve 400 and the annular tissue can pinch, pinch, hold, restrain, anchor, and / or otherwise substantially secure the distal portion of the support 479 to the distal portion of the valve 400, such that the support 479 can be in and / or transition to a second or supporting state / configuration (e.g., by tensioning the support as described in detail above).

[0157]

[0173] In some embodiments, support 479 can be formed from a material that can provide a desired stiffness and / or define a substantially fixed length without transitioning (e.g., without tension). In some embodiments, support 479 can include a tether that is disposed within a tube, catheter, conduit, etc. along a portion proximal to attachment and / or pass-through point 446 (e.g., similar to the guidewire and guidewire catheter arrangements described above with reference to valve 200). In such embodiments, the tube, catheter, conduit, etc. can provide a desired stiffness and / or define a substantially fixed length between delivery sheath 483 and attachment and / or pass-through point 446, while a distal portion of the tether can extend through attachment and / or pass-through point 446, thereby allowing loop and / or ring 479B to be disposed around guidewire catheter 484. Additionally, at least the distal portion of the tether can be relatively flexible, allowing the tether to bend, curve, and / or reconfigure (e.g., when pinched, pinched, constrained, compressed, etc.) based on the shape of the natural tissue forming part of the outer wall and / or annulus of the valve 400.

[0158]

[0174] While the portion of the support 479 away from the attachment point 446 (e.g., hole, waypoint, pass-through, etc.) is fixed or anchored, the portion of the support between the attachment point 446 and the delivery sheath 483 can function substantially similarly 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 distal annular upper portion of the valve 400 and / or valve frame 410 from dropping into the annulus, as described above with reference to the support 379; can at least partially direct and / or control flexion and / or movement of the distal end portion of the control device 470 to facilitate seating of the proximal portion of the valve 400 into the annulus; can limit and / or substantially prevent portions of the control device 470 from pushing away from the annulus; and can provide reaction points, pivot points, fulcrums, etc. that can facilitate pivoting or "dropping" of the proximal portion of the valve 400 into the annulus, as described above with reference to the support 379.

[0159]

[0175] Once the valve 400 is secured to the valve annulus, the delivery / deployment system 480 (including the control device 470, the support 479, the guidewire catheter 484, and / or any other portions or components of the delivery / deployment system 480) can be decoupled from the valve 400 and retracted / removed from the patient, leaving the prosthetic valve 400 in place. In some embodiments, with the loop or ring 479B at the distal end of the support 479 disposed around the guidewire catheter 484, the distal end of the support 479 is released by retracting the guidewire catheter 484 from the distal anchoring element 432 into the delivery / deployment system 480 (e.g., near the valve 400). Thus, the support 479 can be retracted proximally such that the distal end of the support 479 is pulled through the attachment point 446 (e.g., an opening, hole, waypoint, pass-through, etc.). In some cases, the distal end of the support 479 can be retracted or retracted into the lumen of the delivery sheath 483 before removing the delivery / deployment system 480 from the patient's body, and in other cases, the support 479 does not retract into the delivery sheath 483 (e.g., the support can be pulled behind the rest of the delivery / deployment system 480 as it is retracted from the patient's body).

[0160]

[0176] 19 and 20 are side fluoroscopic views showing a delivery / deployment system 580 engaging a prosthetic valve 500 during deployment, according to one embodiment. FIG. 19 shows the valve 500 prior to full insertion and / or seating of the valve 500 into the annulus of a native heart valve. FIG. 20 shows the valve 500 during and / or after insertion and at least partial seating of the valve 500 into the annulus. The delivery / deployment system 580 includes a support 579 (e.g., a distal support, a supranuclear support, etc.) that passes through the distal supranuclear region of the valve 500 and can be looped or removably coupled to a guidewire catheter 584, as described in detail above with reference to valve 400. In other embodiments, the support 579 can be configured to removably couple to an attachment point, such as at or along the distal supranuclear region of the valve 500, as described in detail above with reference to valve 300.

[0161]

[0177] In some embodiments, the support 579 may be formed of or may include portions formed of a radiopaque material, as shown in Figures 19 and 20, allowing the support 579 (or at least portions thereof) to be visualized under fluoroscopy or other image-guided procedures. In some embodiments, the support 579 may be and / or include a tether disposed at least in part on a tube or catheter. The tube or catheter may be formed of a radiopaque material and / or any other material that allows for visualization during an image-guided procedure, such as fluoroscopy. As described above, at least a portion of the support 579 between the delivery sheath or catheter of the delivery / deployment system 580 and the attachment and / or pass-through point of the valve 500 is and / or can be in a substantially rigid and / or substantially fixed length state or configuration during deployment that 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 undesired movement of the valve relative to the delivery / deployment system 580; and / or can reduce and / or limit undesired movement of at least a portion of the delivery / deployment system 580 as the proximal portion of the valve 500 is pushed or pivoted into the annulus. Thus, the support 579 can be similar to and / or substantially the same as the supports 379 and / or 479 described in detail above with reference to FIGS. 17 and 18, respectively.

[0162]

[0178] While supports 379, 479, and 579 are shown coupled to and / or otherwise supporting the distal supranuclear regions of valves 300, 400, and 500, respectively, it should be understood that such embodiments are presented by way of example only and not by way of limitation. Any valve and / or delivery / deployment system 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 supranuclear region of the valve. Furthermore, the valve and / or delivery / deployment system described herein can be used with any suitable number of supports having any suitable configuration (or combination of different configurations).

[0163]

[0179] 21 is a schematic illustration of a prosthetic valve 600 coupled to a delivery / deployment system 680 that includes multiple supranuclear supports. Valve 600 and delivery / deployment system 680 can be similar and / or substantially the same as valves 300, 400, and / or 500 and delivery / deployment systems 380, 480, and / or 580, respectively. Accordingly, valve 600 (or at least aspects thereof) and delivery / deployment system 680 (or at least aspects thereof) will not be described in further detail herein.

[0164]

[0180] As described above, the control device 670 can advance the valve 600 along the guidewire catheter 684 (and / or guidewire) and through the delivery catheter 682 and / or delivery sheath (not shown) into the atrium. The delivery catheter 682 and, optionally, the delivery sheath can remain in a substantially fixed position relative to the atrium or the IVC through which the delivery catheter 682 extends, while the distal end of the control device 670 and the valve 600 are advanced distally relative to the delivery catheter 682 (e.g., away from the delivery catheter 682) along the guidewire catheter 684 toward the valve annulus. 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 the compressed configuration to the expanded configuration. As described in detail above, the control device 670 can then be manipulated or steered to seat and / or deploy the valve 600 into the annulus of the native heart valve.

[0165]

[0181] The embodiment shown in FIG. 21 includes multiple supports 679 coupled to the supranulvular region 620 of the valve 600 (or its valve frame 610). As described above, the supports 679 are configured to provide support to one or more portions of the valve 600 during deployment. The supports 679 can 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 can be and / or include one or more tethers, sutures, cables, rods, tension members, tubes, catheters, etc., or combinations thereof. As described above, the supports 679 can be configured to transition to a support configuration in response to being tensioned, or can be formed from a material that can provide a desired stiffness and / or define a substantially fixed length without transitioning (e.g., without being tensioned).

[0166]

[0182] The supports 679 are configured to extend through a lumen of the delivery catheter 682 and / or a delivery sheath (not shown) to the exterior of the control device 670. The proximal end of each support 679 is proximal to and / or external to the delivery catheter 682, thereby allowing a user to manipulate each support 679. The distal end of each support 679 is configured to be removably couplable to and / or otherwise selectively engage with an attachment point 646 along the supranuclear region 620 of the valve frame 610. The supports 679 can be removably coupled to the supranuclear 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 (e.g., with both ends of the support folded back so that they are proximal to the delivery catheter 682), similar to tethers 275 and 276 described above. In some embodiments, the distal end of one or more of the supports 649 can wrap around the corresponding attachment point without being "looped." In some embodiments, one or more of the attachment points 646 can be an opening through which a portion of the corresponding support 679 can extend, as described above with reference to the support 479. In some embodiments, the support 679 can be removably coupled to the supranulvular region 620 of the valve frame 610 using any combination of attachment methods. For example, the attachment points 646 at or near the distal end of the supranulvular region 620 can be an opening through which a portion of the corresponding support 679 can extend. In some implementations, the ends of the supports 679 can have loops that allow the supports 679 to be disposed around or around the guidewire catheter 684, as described above with reference to the support 479. In this example, the other attachment points 646 can be sutures configured to be temporarily coupled to the corresponding supports 679.

[0167]

[0183] 21 includes a distal supranulular support 679 and two additional supports 679. The distal supranulular support 679 couples and / or otherwise engages with an attachment point at or near the distal end of the supranulular region 620 (referred to as the "distal attachment point"), can be similar to or substantially the same as supports 379 or 479, and therefore will not be described in further detail. The additional supports 679 are shown extending from the delivery catheter 682 (or delivery sheath) to attachment points at locations along the supranulular region 620 at or near opposing lateral extents of the supranulular region 620. In other words, the attachment points 646 are at or near the lateral edges or peripheries of the supranulular region 620 (referred to as the "lateral attachment points"). Additionally, the attachment points 646 are laterally outward of and spaced apart from the connecting member 678 of the control device 670. More specifically, the lateral attachment points 646 are shown as being laterally outer and near the center (represented by dashed lines in FIG. 21 ) of the flow control component 650. In other embodiments, the lateral attachment points 646 can be anywhere along the section of the supranulular region 620 between the flow control component 650 and the lateral edge or periphery.

[0168]

[0184] As described above, supports 679 are configured to support and / or stabilize valve 600 during deployment. In some embodiments, supports coupled to and / or otherwise engaged with distal attachment points 646 can be configured to support at least a distal portion of valve 300, as described above with reference to supports 379, 479, and 579, and can constrain, limit, and / or substantially prevent the distal supraannular portion of valve 300 from dropping into the annulus. Supports 679 coupled to and / or otherwise engaged with lateral attachment points 646 can similarly provide support and / or stabilization to at least a portion of valve 300. For example, supports 679 detachably coupled to lateral attachment points 646 can support and / or stabilize valve 600 from and / or with respect to lateral movement or orientation, axial alignment with the centerline of the annulus plane, rotation about an axis defined at least in part by guidewire catheter 684, etc. In some embodiments, the attachment point 646 is laterally lateral from the connecting member 678, allowing the support 679 to engage the supranulvular region 620 at a wider point, thereby increasing sensitivity to adjustments in the rotational position, orientation, and / or angle of the valve 600 relative to the axis and / or annular plane defined by the guidewire catheter 684.

[0169]

[0185] 21 is shown including three supports 679, it should be understood that this embodiment is provided by way of example only and not by way of limitation. For example, the valve 600 and delivery / deployment system 680 may be configured to be used with more than three supports 679 or fewer than three supports 679. In some embodiments, for example, the valve 600 and delivery / deployment system 680 may be used with supports 679 that are not removably coupled to the distal attachment point 646, but are instead removably coupled to the lateral attachment point 646. In some embodiments, the location of the lateral attachment point 646 may be altered away from the centerline of the flow control component 650, thereby allowing the supports 679 coupled thereto to provide the lateral support / stability described above, as well as to constrain, limit, and / or substantially prevent the distal supra-annular portion of the valve 600 from dropping into the annulus. In other words, the lateral attachment points 646 can be disposed along the supranuclear region 620 at locations where the support 679 can support the valve 600, as provided by the support 679 removably coupled to the distal attachment points. In other embodiments, the valve 600 can include attachment points at any other suitable locations along the supranuclear region 620 and / or along any other portion of the valve 600.

[0170]

[0186] 22 is a schematic illustration of a prosthetic valve 700 coupled to a delivery / deployment system 780 including a supranuclear support 779, according to one embodiment. Valve 700 (or at least aspects thereof) and delivery / deployment system 780 (or at least aspects thereof) can be similar and / or substantially the same as valves 300, 400, 500, and / or 600 and delivery / deployment systems 380, 480, 580, and / or 680, respectively. Accordingly, valve 700 (or at least aspects thereof) and delivery / deployment system 780 (or at least aspects thereof) will not be described in further detail herein.

[0171]

[0187] As described above, the control device 770 can advance the valve 700 along the guidewire catheter 784 (and / or guidewire) and through the delivery catheter 782 and / or delivery sheath (not shown) into the atrium. The delivery catheter 782 and, optionally, the delivery sheath can remain in a substantially fixed position relative to the atrium or the IVC through which the delivery catheter 782 extends, while the distal end of the control device 770 and the valve 700 are advanced distally (e.g., away from) the delivery catheter 782 along the guidewire catheter 784 toward the valve annulus. 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 the compressed configuration to the expanded configuration. The control device 770 can then be manipulated or steered to seat and / or deploy the valve 700 in the annulus of the native heart valve, as described in detail above.

[0172]

[0188] 22 includes a support 779 coupled to the supranulvular region 720 of the valve 700 (or its valve frame 710). As described above, the support 779 is configured to provide support to one or more portions of the valve 700 during deployment and / or to facilitate deployment and / or seating of the valve 700 in the valve annulus, as described in further detail herein. The support 779 can be similar to and / 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 include one or more tethers, sutures, cables, rods, tension members, tubes, catheters, hypotubes, etc., or combinations thereof.

[0173]

[0189] The support 779 is configured to extend through a lumen of the delivery catheter 782 and / or a delivery sheath (not shown) and outside of the control device 770. A proximal end of the support 779 is near and / or external to the delivery catheter 782, thereby allowing a user to manipulate the support 779. A distal end of the support 779 is configured to be removably coupleable and / or otherwise selectively engage with the supranuclear region 720 of the valve frame 710. More specifically, the support 779 is coupled to an attachment point 746 at a location along the supranuclear region 720 of the valve frame 710 on 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 through the IVC to the right atrium. When the valve 700 is released into the atrium, a first side of the valve 700 contacts and / or is adjacent to the septal wall of the heart (e.g., the "septal side" of the prosthetic valve 700), and a second side of the valve 700 is opposite the first side and the septum of the heart (e.g., the "free wall side" of the prosthetic valve 700). In the embodiment shown in FIG. 22 , the septal side of the valve 700 includes posterior septal (PS) tabs or anchoring elements 737 that can engage septal tissue to at least partially stabilize the valve 700. Additionally, the supranulvular region 720 of the valve frame 710 includes attachment points 746, for example, between the flow control component 750 and a lateral edge of the supranulvular region 720 on the free wall side of the prosthetic valve 700. A support 779 is then removably coupled to the attachment points 746 and configured to support, stabilize, and / or at least partially control the free wall side of the prosthetic valve 700.

[0174]

[0190] Although the attachment points 746 are shown at particular locations along the free wall side of the prosthetic valve 700, it should be understood that the attachment points 746 may be at any suitable location along the supranulvular region 720. For example, the attachment points 746 can be at locations along the free wall side of the supranulvular region 720 closer to or farther from the centerline of the flow control component 750. In some embodiments, the proximal-distal positioning of the attachment points 746 can be based, at least in part, on the anatomy of the heart in which the valve 700 is deployed. In some embodiments, it may be desirable to include the attachment points 746 at a location that is laterally lateral to the connecting members 778, as shown in FIG. 22 .

[0175]

[0191] In the embodiment shown in FIG. 22 , support 779 is and / or is configured to include a support formed from a material capable of providing a desired stiffness and / or defining a substantially fixed length without tension (e.g., as described above with reference to supports 379, 479, 579, and / or 679). More specifically, support 779, or at least a portion thereof, can be formed from a metal (e.g., stainless steel, etc.) or a relatively stiff polymer. In some embodiments, support 779 can be and / or include a support catheter having a desired durometer. In some embodiments, support 779 can be a cable, a hypotube, and / or any other suitable support. In some implementations, a distal end portion of support 779 (e.g., catheter, cable, hypotube, etc.) can include a tether that facilitates detachable coupling of support 779 to 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 (e.g., via a threaded connection, a ball joint, and / or any other removably coupled).

[0176]

[0192] In some embodiments, the support 779, formed as and / or otherwise comprised of a catheter, cable, hypotube, and / or other relatively rigid or semi-rigid member, can provide sufficient rigidity and / or stiffness to allow a user to, for example, apply a distal force to a proximal end portion of the support, and the force is transmitted at least partially along the support 779 such that the distal end portion of the support 779 applies at least a portion of the distal force on the supranulvular region 720 of the valve frame 310. In some embodiments, it may be advantageous to include a support 779 that detachably couples to the supranulvular region 720 at or near the free wall of the prosthetic valve 700 to facilitate seating of the valve 700 in the valve annulus. More specifically, in some cases, the anatomy of the heart may preclude the challenge of seating the valve 700 in the annulus using only contact between the connecting member 778 (yoke) and the supranulvular region 720 of the valve frame 710. For example, the location of the IVC outlet relative to the valve annulus may constrain or limit the degree of control that may be associated with deploying the valve 700 using only the control device 770. In some cases, the anatomy of the heart may interfere with the challenges associated with seating the free wall side of the valve 700 against the annulus. Accordingly, the inclusion of the support 779 described above with reference to FIG. 22 may allow a user to apply a distal force against the supranulvular region 720 of the valve frame 710 at a location along the free wall side of the valve 700, thereby urging the free wall side of the prosthetic valve 700 toward the annulus, thereby facilitating deployment and / or seating of the valve 700 into the annulus.

[0177]

[0193] 23-25 ​​show various views of a prosthetic valve 800 coupled to a delivery / deployment system 880 having a distal supranulus support 879, according to another embodiment. Valve 800 can be similar to and / or substantially the same as any of the valves 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 of the delivery / deployment systems described herein (e.g., delivery / deployment systems 180, 380, 480, 580, 680, and / or 780). Accordingly, valve 800 (or at least aspects thereof) and delivery / deployment system 880 (or at least aspects thereof) will not be described in further detail herein.

[0178]

[0194] As described above, the control device 870 may include a connecting member 878 disposed at the distal end of a control catheter. The connecting member 878 is detachably coupled to the supranulvular region 820 of the valve 800 (or its valve frame 810). The coupling, engagement, and / or contact of the connecting member 878 and the supranulvular region 820 enables the control device 870 to advance the valve 800 along a guidewire catheter 884 (and / or guidewire), through a delivery catheter and / or delivery sheath (not shown), and into the atrium. The delivery catheter and optionally the delivery sheath may remain in a substantially fixed position relative to the atrium or the IVC through which the delivery catheter extends, while the distal end of the control device 870 and the valve 800 are advanced distally relative to (e.g., away from) the delivery catheter along the guidewire catheter 884 toward the valve annulus. Releasing the valve 800 into the atrium allows the valve 800 to transition from the compressed configuration to the expanded configuration because the valve 800 is no longer constrained by the delivery catheter and / or delivery sheath. The control device 870 can then be manipulated or steered to seat and / or deploy the valve 800 in the annulus of the native heart valve, as described in detail above.

[0179]

[0195] The control device 870 can be manipulated or steered to deploy the valve 800 (in the expanded configuration) at a desired deployment angle in which the distal anchoring elements 832 are positioned below the valve annulus and, for example, near, adjacent, and / or at least partially within the ventricular outflow tract (e.g., RVOT). At the deployment angle, the supranuclear region 820 of the valve frame 810 and at least a proximal portion of the subannular region 830 of the valve frame 810 remain within the atrium. In some embodiments, the distal surface of the transannular region of the valve frame 810 can be positioned in contact with the native tissue forming the distal surface or wall of the valve annulus. As described above with reference to the valve 200, a guidewire catheter 884 extending through and below a portion of the valve 800 and out from the distal anchoring elements 832 can provide support to at least a portion of the valve 800 during deployment.

[0180]

[0196] The embodiment shown in FIGS. 23-25 ​​also includes a distal supranullar support 879 that is detachably / releasably coupled to the distal supranullar 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 supports 179, 379, 479, 579, and / or 679 described above. More specifically, the support 879 shown in FIGS. 23-25 ​​is a tether that is detachably / releasably coupled to a distal portion of the supranullar 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 supportive configuration in response to application of tension to provide a desired amount of stiffness and / or support to the atrial distal cuff. Additionally, the support 879 may include radiopaque markers to allow the support to be visualized during image-guided procedures such as fluoroscopy.

[0181]

[0197] The supports 879 are configured to extend through the lumen of the delivery catheter and / or delivery sheath (not shown) and out of the control device 870. The proximal end of each support 879 is near and / or external to the delivery catheter, thereby allowing a user to manipulate the support 879. The distal end of the support 879 is configured to be removably couplable and / or otherwise selectively engageable with an attachment point 846 at or along the distal atrial cuff. More specifically, the attachment point 846 can be attached to an outer wire loop of the supranuclear region 820 of the valve frame 810 (e.g., similar to or substantially the same as the outer loop 221 of the supranuclear member 220 (or region) shown in FIG. 9 ). In the embodiment shown in FIGS. 23-25 ​​, the attachment point 846 is a suture through which at least a portion of the support 879 is looped or wrapped. Additionally, the supranulvular region 820 of the valve frame 810 may define openings or holes through which portions of the support 879 may extend, as described above with reference to the support 479. For example, the openings and / or holes may be near the attachment points 846 (e.g., along the drum of the supranulvular region 820) to allow a distal portion of the support 879 to extend therethrough. Although not shown, as described above with reference to the support 479, the ends of the support 879 may form loops that may be placed around or around the guidewire catheter 884 to secure and / or anchor the distal end of the support 879.

[0182]

[0198] 23-25 ​​is configured to actuate and / or transition at least a portion of the atrial distal cuff between two or more configurations and / or states, as described in further detail herein. For example, FIG. 24 is a side view of valve 800 and delivery / deployment system 880 showing the atrial distal cuff in a first or unactuated state (support 879 is shown in tension for illustrative purposes, but is 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 valve annulus. However, because the process of seating a laterally deliverable valve involves inserting the distal subannular portion of the valve 800 into the ventricle and then pivoting the proximal end portion of the valve 800 into the annulus, the shape and size of the distal atrial cuff may, in some cases, push the distal portion of the valve 800 away from the distal annular wall, thereby resisting the process of deploying the valve 800 into the annulus.

[0183]

[0199] 25, the support 879 can transition from a first state to a second state and / or otherwise exert a tension sufficient to transition the atrial distal cuff from a first or unactuated state (FIG. 24) to a second or actuated state (FIG. 25). In other words, a proximal force can be exerted on the support 879 to actuate the atrial distal cuff. For example, as shown by the arrows in FIG. 25, the support 879 can be configured to exert a force on or to the attachment point operable to actuate at least a portion of the atrial distal cuff to tension, actuate, and / or otherwise affect the atrial distal cuff to move, bend, curve, and / or transition the atrial distal cuff in a proximal direction away from the atrial floor or atrial tissue defining or surrounding the annulus, thereby facilitating the process of seating the valve 800. Thus, as described above with reference to valve 100 and support 179, such transition or actuation of the atrial distal cuff can reduce contact between the atrial distal cuff and atrial tissue that may resist pivotal movement associated with seating of valve 800 into the valve annulus.

[0184]

[0200] 26 is a flowchart illustrating a method 10 for delivering and deploying a side-deliverable transcatheter prosthetic valve to a native valve annulus, according to one embodiment. The side-deliverable transcatheter prosthetic valve can be similar to and / or substantially the same as any of the prosthetic valves described herein. For example, the prosthetic valve can include an outer support frame and (internal) flow control components mounted within and / or to the outer support frame. The outer support frame can include, for example, a supra-annular member or region, a sub-annular member or region, and a transannular member or region coupled therebetween. The flow control components are mounted to the outer support frame so as to extend through a portion of the transannular member or region, as described above with reference to valves 100 and / or 200.

[0185]

[0201] Method 10 includes, at 11, removably coupling a control device to a proximal supranuclear portion of a prosthetic valve. For example, in some embodiments, the supranuclear portion can include a proximal attachment member or the like that can be used to temporarily couple a delivery / deployment system to the valve, as described above with reference to valve 200 shown in FIGS. 7-16 . For example, the delivery / deployment system can include a control device or the like that can include a control catheter and a connecting member coupled to a distal end of the control catheter. The connecting member can be removably coupleable to the valve's attachment member via one or more tethers or the like, as described above with reference to valve 200.

[0186]

[0202] In 12, the supranullar supports of the delivery / deployment system are removably coupled to the supranullar region of the prosthetic valve. The supranullar supports can be of any suitable shape, size, and / or configuration. For example, the supranullar supports can be similar to or substantially the same as any of the supranullar supports 179, 379, 479, 579, 679, 779, and / or 879 described in detail above. In some embodiments, for example, the supranullar supports ("supports") can be one or more tethers, tension members, rods, cables, connectors, etc. configured to removably couple to attachment points, etc. at or along the supranullar region of the valve (e.g., the supranullar region of the valve frame). For example, the supports can be and / or include tethers that removably couple to and / or otherwise engage attachment points at the distal supranullar region of the valve, as described above with reference to supports 379, 479, 579, and / or 879. In some embodiments, the supports can be and / or include a pair of supports (e.g., tethers) distal and laterally lateral to the control device's connecting member, as described above with reference to the "lateral" supports 679 shown in FIG. 21 . For example, the supports can be removably coupled to a portion of the supranulnar region of the valve at or near the flow control component. In some embodiments, the supports can be and / or include a support catheter removably coupled and / or otherwise engaged to attachment points distal and laterally lateral to the control device's connecting member, as described above with reference to supports 779. In such embodiments, the location of the attachment points along the supranulnar region of the prosthetic valve can be on or near the free wall side of the prosthetic valve (e.g., the side of the valve opposite or not contacting the septal wall of the heart). In some embodiments, multiple supranulnar supports having any combination of arrangements, configurations, etc. can be used and can be coupled to the supranulnar region of the valve frame at one or more locations that can support and / or stabilize the valve during deployment into the native annulus.

[0187]

[0203] In 13, the control device and the prosthetic valve in the compressed configuration are advanced through the lumen of a delivery catheter to position the distal end portion of the control device and the prosthetic valve within a heart chamber. 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 the delivery catheter and / or delivery sheath. In some cases, placing the valve in the delivery configuration can include, for example, folding the valve laterally or along its transverse axis and compressing the valve in the axial or blood flow direction or along the central axis of the valve. In some cases, the control device (or its connecting member) is detachably coupled to a proximal supranuclear portion of the valve before advancing through the lumen of the delivery catheter. Thus, the control device can be used to advance the prosthetic valve in the compressed and / or delivery configuration through the lumen of the delivery catheter and into a heart chamber. In some cases, the heart chamber can be the atrium. Furthermore, the prosthetic valve can be enabled to transition from the compressed configuration to the expanded configuration once the valve is released from the delivery catheter and / or delivery sheath and positioned within the atrium.

[0188]

[0204] At 14, the supranullar support transitions 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 supranullar 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 user applying a proximal force to a proximal end portion of the support. In this manner, the proximal force can tension at least a portion of the support, thereby forming a substantially rigid or substantially fixed-length connection between the distal end of the delivery sheath (from which the support extends) and an attachment at or along the distal supranullar region of the valve. 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 that can actuate, reconfigure, and / or otherwise transition one or more portions of the supranullar region of the valve or valve frame (e.g., the distal atrial cuff). For example, the support can be configured to actuate the atrial distal cuff to move, bend, curve, and / or otherwise transition the atrial distal cuff in a proximal direction (e.g., away from the atrial tissue defining and / or surrounding the valve annulus).

[0189]

[0205] At 15, while the supranullar support is in the second state, the prosthetic valve is seated in the native annulus. The support in the second or support state or configuration can stabilize at least a portion of the valve, thereby providing increased control of the valve when moving and / or positioning the valve in the annulus via a control device. Additionally, as described in detail above with reference to supports 179, 379, 479, 579, 679, 779, and / or 879, the support can be substantially rigid and / or have a substantially fixed length configuration during deployment, which can reduce the likelihood that the distal supranullar portion of the valve will fall into the annulus during deployment, reduce and / or limit undesired movement of the valve relative to the delivery / deployment system, reduce and / or limit undesired lateral or rotational movement of the valve relative to the plane of the native valve annulus, and / or reduce and / or limit undesired movement of at least a portion of the delivery / deployment system when the proximal portion of the valve is being pushed or pivoted into the annulus.

[0190]

[0206] At 16, after being seated on the valve, each of the control device and supranullar supports is decoupled from the prosthetic valve. For example, in some embodiments, the control device can be removably coupled to a proximal portion of the valve via one or more tethers that are "looped" through or around a portion of the valve such that each of the distal and proximal ends of the tethers is disposed outside the body. In this manner, varying the force applied to each end of the tether can be operable to actuate the tether, the control device, and / or a portion of the valve, while a proximal force applied to one of the proximal or distal ends can be operable to decouple the tether from the valve and withdraw the tether into and / or through the control device. In some embodiments, the supranullar supports can be removably coupled to attachment points at or along the distal supranululus of the valve in a substantially similar manner (e.g., optional configuration of support 379), or the like.

[0191]

[0207] In other embodiments, a proximal end portion of the support may be located near the delivery catheter and / or sheath and external to the body (allowing a user to manipulate the support), while a distal end portion of the support removably couples and / or otherwise removably engages with a distal supranuclear portion of the valve, guidewire, guidewire catheter, or the like. For example, the supranuclear portion of the valve may define or form an opening, hole, waypoint, pass-through, or the like configured to allow a distal portion of the support to extend therethrough. In such embodiments, as described in detail above with reference to supports 479 and / or 879, the distal end of the support may include a loop or ring that may be disposed on or around a guidewire catheter (or other component, feature, etc. external to the valve) to secure or anchor the distal end of the support. In this manner, retracting the guidewire catheter (or other component, feature, etc.) from the distal anchoring element and / or the valve generally releases the distal end of the support, allowing it to be retracted through the attachment point (e.g., opening, etc.) and into the delivery sheath. The delivery / deployment system can then be decoupled 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.

[0192]

[0208] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Likewise, it should be understood that specific terminology used herein is for the purpose of describing particular embodiments and / or features or combinations thereof, and is not intended to be limiting. Various modifications, changes, and / or variations in form and / or details may be made without departing from the scope of the present disclosure and / or without altering its function and / or advantages, unless otherwise expressly stated. Functionally equivalent embodiments, implementations, and / or methods, in addition to those listed herein, will be apparent to those skilled in the art from the foregoing description and are intended to be within the scope of the present disclosure.

[0193]

[0209] While the above-described schematics, embodiments, and / or implementations show particular components arranged in particular orientations or positions, the arrangement of the components can be changed. Although various embodiments have been described as having particular combinations of features and / or components, other embodiments are possible that have any combination of features and / or components from any of the embodiments described herein, except mutually exclusive combinations. The embodiments described herein can include various combinations and / or subcombinations of the features, components, and / or features of the different embodiments described.

[0194]

[0210] Although the methods described above depict certain events occurring in a particular order, the order of certain events can be changed. Additionally, certain events can be performed simultaneously in parallel processes where possible, as well as sequentially as described above. Although methods have been described as having particular steps and / or combinations of steps, other methods are possible that include any combination of steps from any method described herein, except for mutually exclusive combinations and / or unless otherwise specified by context.

Claims

1. 1. A delivery system for delivering and deploying a laterally deliverable heart valve prosthesis, comprising: a delivery sheath; a control device movable through a lumen of the delivery sheath, the control device including a control catheter and a connecting member coupled to a distal end of the control catheter, the connecting member configured to be detachably coupled to the prosthetic valve at a proximal location along a supracervical portion of the prosthetic valve annulus, the control device operable to advance the prosthetic valve in a compressed configuration through the lumen of the delivery sheath into a heart chamber and to deploy the prosthetic valve in an expanded configuration from the heart chamber into a native valve annulus; at least one supranuclear support movable through the lumen of the delivery sheath, the at least one supranuclear support configured to removably couple to the prosthetic valve at one or more locations along the supranuclear portion of the prosthetic valve, the at least one supranuclear support 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; A delivery system comprising:

2. 10. The delivery system of claim 1, wherein the connecting member forms a yoke configured to contact the supranuclear portion of the heart valve prosthesis.

3. 3. The delivery system of claim 2, wherein the yoke has first and second arms arranged in a Y-shape, and the at least one supralnular support comprises a support configured to removably couple to an attachment point along the supralnular portion of the prosthetic valve at a location distal and laterally outward from one of the first arm of the yoke or the second arm of the yoke.

4. 4. The delivery system of claim 3, wherein the at least one supranullar support is at least one of a catheter, a cable, or a hypotube having sufficient stiffness to transmit a distal force exerted on a proximal end portion to the supranullar portion of the prosthetic valve, operable to push a portion of the prosthetic valve toward the annulus.

5. 10. The delivery system of claim 1, wherein the at least one supranuclear support comprises at least one tether removably coupleable to an attachment point along a distal supranuclear portion of the prosthetic valve.

6. 6. The delivery system of 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 being exerted on the proximal end portion.

7. 7. The delivery system of claim 6, wherein the at least one tether in the second configuration forms a substantially constant length connection between a distal end portion of the delivery sheath and the distal supranuclear portion of the prosthetic valve.

8. the prosthetic valve includes a valve frame and a flow control component mounted to the valve frame; 10. The delivery system of claim 1, wherein the at least one supranullar support comprises at least one tether removably coupleable to an attachment point along a distal portion of the supranullar region of the valve frame.

9. 9. The delivery system of claim 8, wherein the at least one tether is removably couplable to the attachment point such that a proximal force exerted on a proximal end portion of the at least one tether actuates the distal portion of the supranulular region of the valve frame.

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

11. 1. A delivery system for delivering and deploying a laterally deliverable heart valve prosthesis, comprising: a delivery sheath; a control device movable through a lumen of the delivery sheath, the control device including a control catheter and a connecting member coupled to a distal end of the control catheter, the connecting member configured to be detachably coupled to a proximal supraspinulum of the prosthetic valve, the control device operable to advance the prosthetic valve in a compressed configuration through the lumen of the delivery sheath into a heart chamber and to deploy the prosthetic valve in an expanded configuration from the heart chamber into the annulus of a native valve; a supranulular support movable through the lumen of the delivery sheath, the supranulular support configured to releasably couple to a distal supranullar portion of the prosthetic valve, the supranulular support configured to transition from a first state to a second state when the prosthetic valve is in the expanded configuration, the supranulular support in the second state forming a substantially constant length connection between the delivery sheath and the distal supranullar portion of the prosthetic valve; A delivery system comprising:

12. 12. The delivery system of claim 11, further comprising a delivery catheter having a distal end configured to be advanced through a patient's vasculature into the heart chamber and a proximal end positioned outside the patient, wherein the delivery sheath is movable through a lumen of the delivery catheter.

13. 12. The delivery system of claim 11, wherein the control device is configured to removably couple to the proximal supranuclear portion of the prosthetic valve via a set of tethers.

14. The delivery system of claim 11 , wherein the supranullar support is at least one tether.

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

16. 12. The delivery system of claim 11, wherein a distal end portion of the supranuclear support is removably coupleable to an attachment point at or along the distal supranuclear region of the prosthetic valve.

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

18. the prosthetic valve includes a valve frame and a flow control component mounted to the valve frame; 17. The delivery system of claim 16, wherein the attachment point is at least one suture attached to a distal portion of the supranuclear region of the valve frame.

19. 20. The delivery system of claim 18, wherein the supranullar support is configured to removably couple to the attachment point such that a distal end portion of the supranullar support extends through an opening at or along the distal supranullar portion of the prosthetic valve.

20. 20. The delivery system of claim 19, wherein the distal end of the supranullar support forms a loop configured to be disposed around a guidewire catheter that is removably coupled to a subannular region of the valve frame.

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

22. 1. A method for delivering and deploying a laterally deliverable prosthetic valve into the annulus of a native heart valve, comprising: Removably coupling a control device to a supra-annular member of the prosthetic valve; removably coupling a supra-annular support to the supra-annular member of the prosthetic valve; advancing the control device and the prosthetic valve in a compressed configuration through a lumen of a delivery catheter, thereby positioning a distal end portion of the control device and the prosthetic valve within a heart chamber, the prosthetic valve being in an expanded configuration when within the heart chamber; transitioning the supranullar support from a first state to a second state; Seating the prosthetic valve on the annulus of the native valve while the supranuclear support is in the second state; After the seating, decoupling each of the control device and the supra-annular support from the supra-annular member of the prosthetic valve; A method comprising:

23. 23. The method of claim 22, wherein the supranullar support comprises at least one support catheter.

24. transitioning the supranullar support from the first state to the second state includes exerting a distal force on a proximal end portion of the support catheter; 24. The method of claim 23, wherein seating the prosthetic valve in the annulus of the native valve while the supranuclear support is in the second state comprises transmitting at least a portion of the distal force via the support catheter to the supranuclear member of the prosthetic valve, thereby pushing at least a portion of the prosthetic valve into the annulus of the native valve.

25. 23. The method of claim 22, wherein the supranullar support is at least one tether, and detachably coupling the supranullar support to the supranullar member of the prosthetic valve comprises detachably coupling the at least one tether to an attachment point along the supranullar member of the prosthetic valve.

26. A proximal end of the at least one tether is proximal to the delivery catheter, and the method includes:

26. The method of claim 25, further comprising exerting a proximal force on the proximal end of the at least one tether to increase tension along the at least one tether, the increasing tension along the at least one tether operable to transition the at least one tether from the first state to the second state.

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

28. the attachment point is attached to a distal portion of the supranuclear element, and the method comprises:

27. The method of claim 26, further comprising actuating the distal portion of the supranullar member in response to the proximal force being exerted on the proximal end of the at least one tether, the actuating being operable to move the distal portion of the supranullar member in a proximal direction away from autologous tissue defining or surrounding at least a distal portion of an annulus of the native valve.

29. 26. The method of claim 25, wherein detachably coupling the at least one tether to the attachment point is such that a distal end of the at least one tether extends through an opening along a distal portion of the prosthetic valve to allow a loop at the distal end of the at least one tether to be disposed around a guidewire catheter detachably coupled to a subannular member of the prosthetic valve.

30. After seating the prosthetic valve on the annulus of the native valve, the method includes: moving the guidewire catheter proximally so that a distal end of the guidewire catheter is at least partially disposed in the delivery catheter and decoupled from the subannular member of the prosthetic valve; releasing the loop at the distal end of the at least one tether from the guidewire catheter in response to the guidewire catheter being moved in the proximal direction; 30. The method of claim 29, further comprising:

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