Systems and methods for retrieving laterally deliverable transcatheter prosthetic valves - Patents.com

Abstract

The delivery / retrieval system includes a control device and a retrieval element. The control device is removably coupleable to the side-deliverable prosthetic valve and is operable to (i) apply a distal force to drive the compressed prosthetic valve forward through the delivery sheath and into the heart chamber, and (ii) apply a proximal force to retract the expanded prosthetic valve from the heart chamber and into the retrieval sheath. A proximal end portion of the retrieval element is coupleable to the proximal end portion of the control device. The distal end portion of the retrieval element defines an engagement member operable to engage and apply a proximal force to the proximal subannular anchoring element of the valve to retract the valve into the retrieval sheath. The guide member is operable to guide at least one edge of the valve as it is retracted into the retrieval sheath.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 313,490, filed February 24, 2022, entitled "Systems and Methods for Retrieving Side-Deliverable Transcatheter Prosthetic Valves," the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE

[0002] The embodiments described herein relate generally to transcatheter prosthetic valves, and more particularly to systems and methods for retrieving side-deliverable transcatheter prosthetic valves.

[0003] Prosthetic heart valves can present challenges when delivered, deployed, and / or retrieved into the heart, especially when delivered by catheter through a patient's vasculature rather than a surgical approach. Delivering a conventional transcatheter prosthetic valve generally involves radially compressing the valve and loading the valve into a delivery catheter with the central annular axis of the valve parallel to the length or longitudinal axis of the delivery catheter. The valve is deployed from the end of the delivery catheter and expanded radially outward from the central annular axis. However, the expanded size (e.g., diameter) of a conventional valve can be limited by the inner diameter of the delivery catheter, which is limited by the patient's vasculature. Minimizing the size of the delivery catheter and increasing the expanded diameter of a conventional valve are conflicting concerns and present challenges (e.g., trying to compress too much material and structure into too small a space). Moreover, the orientation of conventional valves during deployment can present additional challenges when attempting to align the valve with the native annulus.

[0004] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, which can allow for an increased expanded diameter compared to conventionally delivered valves. In lateral delivery, for example, the valve can be in a compressed or delivery configuration and loaded into a delivery catheter with the central annular axis of the valve substantially perpendicular and / or perpendicular to the length 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 the central annular axis and longitudinal axis, respectively) and can be uncompressed or stretched longitudinally (e.g., parallel to the length or longitudinal axis of the delivery catheter). The compressed valve (e.g., in a delivery configuration) can be loaded into the lumen of the delivery catheter in a lateral or orthogonal orientation and driven forward through the lumen and deployed from the end of the delivery catheter. Furthermore, in some instances, the lateral or orthogonal orientation of the deployed lateral delivery valve relative to and / or within the delivery catheter generally results in the valve being deployed in a desired orientation relative to the native valve annulus.

[0005] However, in some instances, due to challenges associated with placing the valve in the native annulus, worsening of the patient's condition, identifying device defects, and / or the like, it may be desirable to retrieve, or at least partially retrieve, the valve before it is fully seated in the native annulus. In some such instances, it may be difficult to return the valve to the compressed or delivery configuration and to retract the valve into the delivery catheter or into another conduit. For example, in some implementations, loading of the valve into the delivery catheter may be assisted by various devices to compress the valve within the lumen of the delivery catheter to a size suitable for disposal. However, because these devices are not present in the heart to assist in compressing the valve for retrieval purposes, a relatively large force may be required to compress and at least partially retrieve the valve. Moreover, in some instances, one or more portions, edges, faces, etc. of the valve may get caught on the distal edge of the delivery catheter (or a separate retrieval catheter), thereby impeding retraction of the valve into the delivery catheter.

[0006] Thus, there is a need for systems and methods for retrieving, or at least partially retrieving, a side-deliverable transcatheter prosthetic valve from a heart chamber. Summary of the Invention

[0007] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The embodiments described herein are directed to a side-deliverable transcatheter prosthetic heart valve, as well as devices, systems, and / or methods for retrieving such a side-deliverable prosthetic valve. In some embodiments, a delivery / retrieval system for a side-deliverable prosthetic valve includes at least a control device and a retrieval element. The control device is configured to be attached to the prosthetic valve. The control device is operable to (i) apply a distal force to drive the prosthetic valve in a compressed configuration forward through the lumen of the delivery sheath into the heart chamber, and (ii) apply a proximal force to retract the prosthetic valve in an expanded configuration disposed within the heart chamber into the distal end of the retrieval sheath. The retrieval element can extend through the lumen of the retrieval sheath. A proximal end portion of the retrieval element can be coupled to a proximal end portion of the control device. The distal end portion of the retrieval element forms an engagement member and a guide member. The engagement member is configured to engage and apply a proximal force to the proximal subannular anchoring element of the prosthetic valve to retract the prosthetic valve from the heart chamber and into the distal end of the retrieval sheath, and the guide member is configured to guide at least one edge of the prosthetic valve as it is retracted into the distal end of the retrieval sheath. [Brief description of the drawings]

[0008] [Figure 1] 1-5 are schematic illustrations of a laterally deliverable transcatheter prosthetic valve selectively coupled to a delivery and / or retrieval system (or a portion thereof), according to one embodiment. [Diagram 2] Same as above. [Diagram 3] Same as above. [Figure 4] Same as above. [Diagram 5] Same as above.

[0009] [Figure 6]6-9 are schematic illustrations of the prosthetic valve of FIG. 1 during an optional retrieval process. [Figure 7] Same as above. [Figure 8] Same as above. [Figure 9] Same as above.

[0010] [Figure 10] FIG. 10 is a side perspective view of a prosthetic valve according to one embodiment.

[0011] [Figure 11] FIG. 11 is a perspective view from below of the artificial valve shown in FIG.

[0012] [Figure 12] 12 is a side perspective view of the supranulular region of the outer support frame of the prosthetic valve shown in FIG.

[0013] [Figure 13] 13 is a distal perspective view of the transannular region of the outer support frame of the prosthetic valve shown in FIG. 10. FIG.

[0014] [Figure 14] 14 is a distal perspective view of the subannular region of the outer support frame of the prosthetic valve shown in FIG.

[0015] [Figure 15] 15 is a top perspective view of the inner frame of the flow control component included in the artificial valve shown in FIG. 10. FIG.

[0016] [Figure 16] FIG. 16 is a side perspective view of the leaflet band of the inner flow control component, with the leaflet pockets sutured into the structural band, and shown in a cylindrical configuration suitable for coupling to the inner frame of FIG.

[0017] [Figure 17] FIG. 17 is a bottom view of the leaflet band of FIG. 16 in a cylindrical configuration, illustrating partial coaptation of the leaflets to form a partially occluded fluid seal.

[0018] [Figure 18] FIG. 18 is a side perspective view of the prosthetic valve of FIG. 10 removably coupled to a distal end portion of a control device included in a delivery system.

[0019] [Figure 19] 19 and 20 are bottom perspective views of the prosthetic valve of FIG. 10 illustrating the process of transitioning a proximal anchoring element of the prosthetic valve between a first configuration and a second configuration in response to actuation of an actuator, such as one or more tethers. [Figure 20] Same as above.

[0020] [Figure 21] 21-24 illustrate a process of deploying a side-deliverable transcatheter prosthetic valve into the annulus of a native valve of a human heart, according to one embodiment. [Figure 22] Same as above. [Figure 23] Same as above. [Figure 24] Same as above.

[0021] [Diagram 25] Figures 25-28 provide various views of the delivery portion of a delivery / retrieval system in accordance with one embodiment, illustrating that by decoupling from the control device / catheter, the retrieval portion of the delivery / retrieval system can be driven forward over the control device / catheter and manipulated to retrieve the prosthetic valve. [Figure 26] Same as above. [Figure 27] Same as above. [Figure 28] Same as above.

[0022] [Figure 29] 29 and 30 show various views of an exchange catheter configured to engage with the control catheter of the control device shown in FIGS. 25-28 and to allow at least a portion of the delivery / retrieval system to be driven forward over the control device. [Diagram 30] Same as above.

[0023] [Diagram 31] FIG. 31 is a side perspective view of a retrieval sheath included in the delivery / retrieval system of FIGS. 25-30, shown having a retrieval handle coupled to its proximal end portion.

[0024] [Diagram 32] 32 is an enlarged side view of the retrieval handle of FIG. 31 shown partially coupled to a retrieval sheath.

[0025] [Diagram 33] 33 is a side view of the distal end portion of the retrieval sheath of FIG.

[0026] [Diagram 34] Figures 34 and 35 are side and plan views, respectively, of a distal end portion of a retrieval element included in the delivery / retrieval system of Figures 25-33, showing an engagement member (Figure 34) and a guide member (Figure 35). [Diagram 35] Same as above.

[0027] [Diagram 36] FIG. 36 is a bottom view of the retrieval element of FIGS. 34 and 35 in a compressed state as it is driven forward into the heart chamber.

[0028] [Figure 37] 37 and 38 are side perspective views of a distal portion of the delivery / retrieval system of FIGS. 25-36 selectively engaged to a prosthetic valve. [Figure 38] Same as above.

[0029] [Figure 39] FIGS. 39 and 40 are side fluoroscopic black and white photographs showing the delivery / retrieval system of FIGS. 25-38 engaged with a prosthetic valve. [Diagram 40] Same as above.

[0030] [Diagram 41] FIG. 41 is a side view of a retractor included in the delivery / retrieval system of FIGS.

[0031] [Diagram 42] FIG. 42 is a side view of the retractor of FIG. 41 temporarily coupled to the retrieval handle, the proximal end portion of the control device, and the proximal end portion of the retrieval element.

[0032] [Diagram 43] FIG. 43 is a flow chart illustrating a method for retrieving a laterally deliverable transcatheter prosthetic valve from an atrium of the heart, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Disclosed embodiments are directed to a laterally deliverable transcatheter prosthetic heart valve and / or components thereof, and to methods of deploying and / or retrieving the prosthetic valve and / or components thereof. In some embodiments, a delivery / retrieval system for a laterally deliverable prosthetic valve includes at least a control device and a retrieval element. The control device can be attached to the prosthetic valve. The control device is operable to (i) apply a distal force to drive the prosthetic valve in a compressed configuration forward through the lumen of the delivery sheath into the heart chamber, and (ii) apply a proximal force to retract the prosthetic valve in an expanded configuration disposed within the heart chamber into the distal end of the retrieval sheath. The retrieval element can extend through the lumen of the retrieval sheath. A proximal end portion of the retrieval element can be coupled to a proximal end portion of the control device. The distal end portion of the retrieval element forms an engagement member and a guide member. The engagement member can engage and apply a proximal force to the proximal sub-annular anchoring element of the prosthetic valve to retract the prosthetic valve from the heart chamber and into the distal end of the retrieval sheath, and the guide member can guide at least one edge of the prosthetic valve as it is retracted into the distal end of the retrieval sheath.

[0034] In some embodiments, a delivery / retrieval system for a laterally deliverable prosthetic valve includes at least a retrieval sheath defining a lumen, a control device extendable through the lumen of the retrieval sheath, and a retrieval element extendable outwardly of the control device through the lumen of the retrieval sheath. The control device is releasably coupleable to an annular surface of the prosthetic valve. A distal end portion of the retrieval element includes an engagement member that can engage a proximal subannular anchoring element of the prosthetic valve when the prosthetic valve is at least partially disposed within the heart chamber. With the control device releasably coupled to the annular surface of the prosthetic valve and the engagement member engaged to the proximal subannular anchoring element, the control device and retrieval element can retract the prosthetic valve into the distal end of the retrieval sheath in response to a proximal force.

[0035] In some embodiments, an apparatus for retrieving a laterally deliverable prosthetic valve from a patient's heart chamber includes at least a retrieval catheter, a guide member, and an engagement member. Each of the guide member and engagement member is coupled to and extends distally from a distal end of the retrieval catheter. The guide member is formed from a braided tube of a shape memory alloy. The guide member has a compressed state for delivery through a retrieval sheath into the heart chamber and an expanded state when located within the heart chamber and distal to the retrieval sheath. The engagement member is partially embedded within the guide member such that a portion of the engagement member extends outwardly from the guide member, allowing a portion of the engagement member to engage a subannular region of the prosthetic valve.

[0036] In some instances, it may be desirable to retrieve any prosthetic valve after at least partial deployment, after full deployment, and / or after implantation. For example, in some implementations, a method for using a delivery / retrieval system to retrieve a side-deliverable prosthetic valve at least partially disposed within a patient's heart chamber includes decoupling a delivery portion of the delivery / retrieval system from a proximal end portion of a control device disposed outside the patient. A distal end portion of the control device is disposed within the heart chamber and is releasably coupled to an annular surface of the prosthetic valve. A retrieval sheath is advanced over the control device to position a distal end portion of a retrieval element within the heart chamber distal to the retrieval sheath. The distal end portion of the retrieval element includes an engagement member. A first portion of a retractor is coupled to the proximal end portion of the retrieval sheath, and a second portion of the retractor is coupled to the proximal end portions of the control device and the retrieval element, respectively. A proximal subannular anchoring element of the prosthetic valve is engaged with the engagement member of the retrieval element and the retractor is actuated to move the control device and the retrieval element proximally relative to the retrieval sheath. The movement of the control device and the retrieval element applies a proximal force to the prosthetic valve operable to retract the prosthetic valve into the distal end of the retrieval sheath.

[0037] Any of the prosthetic valves described herein may be relatively low-bulk transcatheter prosthetic heart valves. The prosthetic heart valves herein may have a valve frame and a flow control component attached within a central lumen, opening, and / or channel of the valve frame that extends along a central axis of the valve or valve frame that is coaxial or at least substantially parallel to the direction of blood flow through the valve. The valve frame may provide structural support for the prosthetic valve and / or at least the flow control component attached to the prosthetic valve. The valve frame may also provide one or more components or elements for anchoring or otherwise securing the prosthetic valve within the annulus of the native valve. The flow control component (e.g., a bi- or tri-cusp sleeve, valve, and / or the like) may be configured to permit blood flow in a first direction through the inflow end of the valve and out of the outflow end of the valve, and may be configured to block blood flow in a second direction opposite the first direction.

[0038] Any delivery and / or retrieval system and / or method for delivery and / or retrieval described herein can be used and / or implemented with conventionally deliverable valves and with orthogonally / laterally deliverable valves, unless expressly stated otherwise. 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 deployed / pre-deployed 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, and is driven forward through the patient's vascular system into a heart chamber. In general, conventionally delivered / conventionally deliverable valves are configured to be radially compressed, e.g., with respect to a central axis or with respect to the direction of blood flow through the valve, and are configured to be inserted into and / or driven forward through a delivery catheter such that the central axis of the compressed valve is parallel to the longitudinal or length 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. The delivery orientation of the valve generally means that the valve is completely released from the delivery catheter when it is located in the atrium of the heart and reoriented with respect to the valve annulus, which may limit the size of the valve in some instances. Thus, in some implementations, conventional delivery can be used for valves with relatively small diameters, such as prosthetic pulmonary valves and / or aortic valves.

[0039] Orthogonally or laterally delivered / deliverable valves are configured to be compressed in at least one of the lateral (orthogonal to the direction of blood flow through the valve) or axial (parallel or aligned to the direction of blood flow). In some embodiments, any valve can be compressed in two directions, lateral and axial, without compressing the valve in a direction along the length or longitudinal axis (orthogonal to the direction of blood flow). For orthogonal or lateral delivery, the compressed valve can be inserted and / or driven forward through a delivery catheter such that the central axis of the compressed valve is substantially orthogonal or perpendicular to the longitudinal or length axis of the delivery catheter. In other words, for 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, an orthogonally delivered and / or laterally delivered prosthetic valve is compressed and / or delivered laterally (e.g., at approximately a 90° angle) compared to the traditional process of compressing and delivering a transcatheter prosthetic valve.

[0040] In some implementations, orthogonal or lateral delivery can allow for delivery of a larger diameter valve compared to the diameter of a conventionally delivered valve. In addition, the orientation of the valve delivered orthogonally to the annulus of the native heart valve (e.g., after release from the delivery catheter) can allow a distal portion of the valve to be inserted at least partially into / through the annulus while a proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints encountered with some known conventional delivery techniques. For example, a relatively large laterally deliverable prosthetic valve in an expanded configuration can have a height of approximately 5-60 millimeters (mm) and a diameter of approximately 20-80 mm, and in a compressed configuration can have a height of approximately 5-12 mm, a width (e.g., laterally) of approximately 8-12 mm, and a length (e.g., longitudinally or lengthwise) of approximately 25-80 mm. Moreover, orthogonal or lateral delivery can allow the valve to be deployed from the inferior vena cava (IVC) into the native mitral or tricuspid annulus without positioning the delivery catheter at an acute angle to the native valve, as is common with traditional transcatheter delivery.

[0041] Any of the prosthetic heart valves described herein can include an outer support frame that includes and / or defines a supranulnar region, a subannular region, and a transannular region coupled therebetween. The supranulnar region can, for example, form an upper collar portion of the outer support frame and can include any number of features configured to engage with native tissue, an inner flow control component 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 with subannular (ventricular) tissue when the prosthetic valve is seated within the native annulus. The transannular region can be coupled between the supranulnar region and the subannular region. The transannular region can form a shape, such as a funnel, a cylinder, a truncated cone, or a circular hyperboloid, when the outer support frame is in an expanded configuration.

[0042] In some embodiments, the outer support frame includes and / or is at least partially formed of a wire, braided wire, or laser cut wire frame, and is at least partially coated with a biocompatible material. For example, the outer support frame, and / or at least its transannular region, can include and / or form a set of compressible wire cells, such as braided wire cells, laser cut wire cells, photolithographically manufactured wire cells, 3D printed wire cells, wire cells formed from single strand wires intermittently connected to form a wave, zigzag, or spiral shape, and / or combinations thereof. In some implementations, the compressible wire cells can have a substantially orthogonal orientation and cell shape relative to the central axis to minimize distortion of the wire cells when the outer support frame is in a delivery configuration (e.g., a compressed, rolled, and / or folded configuration).

[0043] Any of the prosthetic heart valves (and / or their outer frame) described herein may 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 within the annulus of the native valve. For example, in some implementations, the prosthetic valve and / or outer frame may include one or more of a distal subannular anchoring element (e.g., which may extend into the right ventricular outflow tract (RVOT)) configured to engage ventricular tissue located distal to the annulus, a proximal subannular anchoring element configured to engage ventricular tissue located proximal to the annulus (e.g., located between the septal and posterior leaflets of the heart), a septal anchoring element configured to engage at least one of the native septal wall and the native septal leaflets when the prosthetic heart valve is seated within 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 implementations, one or more of the subannular anchoring elements can stabilize the valve against rolling forces, twisting forces, and / or the like (e.g., tilt, angle, twist, rolling, etc.) within at least some of the annulus that may affect a desired location or positioning of the prosthetic valve within the annulus.

[0044] Any prosthetic valve and / or any outer frame thereof may also include distal and / or proximal upper anchoring elements configured to be positioned into a supranulnar position, e.g., in contact with and / or adjacent to supranulnar tissue of the right atrium. In some implementations, the upper anchoring elements may be configured to apply a force against the supranulnar tissue and the lower anchoring elements may be configured to apply a counter force against the subannular tissue, thereby anchoring the prosthetic valve within the native annulus. In some implementations, the anchoring elements may include and / or be formed from wire loops or wire frames, integrated frame sections, and / or stents extending from the frame (e.g., spaced approximately 10-40 mm from the tubular frame).

[0045] Any of the prosthetic valves described herein may include an inner flow control component having a leaflet frame with two to four flexible leaflets attached on a top surface thereof. The two to four leaflets are configured to permit blood flow in a first orientation through the inflow end of the flow control component (and / or valve) and out of the outflow end of the flow control component (and / or valve) and to prevent blood flow in a second orientation opposite the first orientation. The leaflet frame may include any number of walls and / or panels of diamond-shaped or eye-shaped wire cells formed from a heat-set shape memory alloy material, such as a nickel-titanium alloy (e.g., Nitinol). The leaflet frame may be configured to bendable along a z-axis (e.g., longitudinal axis) from a rolled or cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical y-axis (e.g., central axis) to a compressed configuration. In some implementations, the leaflet frame can include a pair of hinge regions, fold regions, connection points, etc., that may allow the leaflet frame to fold flat along the z-axis before it is compressed along the vertical y-axis. The leaflet frame can be a single piece structure, for example, with two or more living hinges (e.g., stress concentrating risers and / or any suitable structure configured to allow elastic / non-permanent deformation of the leaflet frame), or a two-piece structure where the hinge regions are formed using a secondary attachment technique (e.g., sutures, fabric, molded polymeric components, etc.). In some embodiments, the internal flow control component in the expanded configuration can form a shape, such as a funnel, a cylinder, a truncated cone, or a circular hyperboloid. In some embodiments, the inner flow control component comprises a leaflet frame having a frusto-conical side profile with an outer diameter R of approximately 20 mm to 60 mm, an inner diameter r of approximately 10 mm to 50 mm, and a height of approximately 5 mm to 60 mm, where diameter R is greater than diameter r. In some embodiments, the leaflet frame is comprised of a wire, braided wire, or laser cut wire frame.

[0046] Any prosthetic valve and / or its components may be manufactured 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 its components may be manufactured from a biocompatible metal, metal alloy, polymer-coated metal, and / or the like. Suitable biocompatible metals and / or metal alloys may include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloy, nickel-titanium alloy (e.g., Nitinol), and / or the like. Additionally, any outer frame or inner frame described herein may be formed from a superelastic or shape-memory alloy, such as a nickel-titanium alloy (Nitinol, etc.). Synthetic biocompatible materials include, for example, polyesters, polyurethanes, elastomers, thermoplastics, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketones (PEEK), silicone polycarbonate urethanes, polypropylene, polyethylene, low density polyethylene (LDPE), high density polyethylene (HDPE), ultra high density polyethylene (UHDPE), polyolefins, polyethylene glycols, polyethersulfones, polysulfones, polyvinylpyrrolidones, poly The polymers may include polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron®), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylons), polytetrafluoroethylene (PTFE) (e.g., Teflon), expanded PTFE, expanded PTFE, siloxane polymers and / or oligomers, polylactones, and / or the like, or block copolymers using the same.

[0047] Any of the prosthetic valves and / or components thereof may include and / or be formed with one or more biocompatible coatings and / or the like. Suitable polymeric coatings may include, for example, polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), translucent styrene isoprene butadiene (SIBS) copolymers, polylactic acid, polyester, polylactide, D-lactic acid polylactic acid (DLPLA), polylactic-co-glycolic acid (PLGA), and / or the like. Some such polymeric coatings may form a suitable carrier matrix for drugs, such as, for example, Sirolimus, Zotarolimus, Biolimus, Novolimus, Tacrolimus, Paclitaxel, Probucol, and / or the like.

[0048] Any of the outer valve frame, inner flow control frame, and / or portions or components thereof may be partially or completely covered internally or externally with natural or synthetic biocompatible and / or biological materials, such as pericardium or the like. For example, where a thin, durable synthetic material is envisioned (e.g., for the cover), synthetic polymeric materials such as expanded PTFE, PET, or polyester (or any other material described herein) may optionally be used. Suitable biological materials or tissues for use with the cover or the like may include, for example, chemically stabilized pericardial tissues of animals, such as bovine (bovine pericardium), ovine (ovine pericardium), porcine (porcine pericardium), horse (equine pericardium), etc. For example, suitable tissues include, but are not limited to, tissues used in Duraguard®, Peri-Guard®, and Vascu-Guard® products, all products currently used in surgical procedures, products sold as generally derived from cattle less than 30 months of age, and / or the like. In some implementations, the valve can be constructed such that the inner surface of the outer valve frame (e.g., a wire frame cell) is lined with pericardial tissue and / or the outer surface is lined with a woven synthetic polyester material (or vice versa), or both the inner and outer surfaces are lined with pericardial tissue and the outer surface is lined with a woven synthetic polyester material.

[0049] Any of the delivery and / or retrieval systems described herein can include an outer catheter (e.g., a delivery catheter), a control catheter, and / or other suitable portions that may include one or more members, components, features, and / or the like configured to facilitate delivery of the valve and / or at least partial retrieval of the valve from the annulus of the native heart valve. For example, in some implementations, the retrieval system (or at least a portion thereof) can be selectively coupled to a control catheter of the delivery / retrieval system and driven forward through the delivery catheter to position a distal end portion within the atrium of the heart, proximate or adjacent to a prosthetic valve disposed within the atrium. In some embodiments, such a retrieval system can include at least a retrieval sheath having a retrieval element advanceable therethrough. The retrieval element can be and / or can include, for example, a self-expanding element, a structure, a scoop, a basket, a hook, and / or the like (or a combination thereof). In some implementations, the retrieval element can selectively engage a subannular portion of the prosthetic valve with the control catheter coupled to and / or engaged to the suprannular portion of the prosthetic valve. In some instances, the retrieval element and control catheter can be manipulated to apply a proximal force to the prosthetic valve operable to retract and / or pull the prosthetic valve into the retrieval sheath. In some embodiments, the retrieval element can include one or more guide members or features configured to guide the prosthetic valve into the retrieval sheath, thereby reducing the likelihood of the valve becoming caught, hooked, hooked, and / or stuck relative to the distal end of the retrieval sheath.

[0050] Any method for delivering and / or deploying a prosthetic heart valve described herein may include delivering a prosthetic heart valve to a native annulus of a human heart, which includes driving a delivery catheter forward into at least one of: (i) the tricuspid valve or pulmonary artery of the heart via the femoral vein through the inferior vena cava (IVC) or the superior vena cava (SVC) via the jugular vein; and (ii) the mitral or aortic valve of the heart by a transatrial approach (e.g., at or below the fossa ovalis) via an IVC-femoral approach or an SVC-cervical approach. The prosthetic valve is removably 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 driven forward through the lumen of the delivery catheter. The prosthetic valve is then released from the distal end of the delivery catheter, which is placed into the atrium of the heart using the IVC-femoral or SVC-cervical approach. When the prosthetic valve is released from the delivery catheter, it is allowed to transition to an expanded or released configuration.

[0051] 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 location 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 RVOT of the right ventricle. In some implementations, the method can include partially inserting the prosthetic valve into the annulus (e.g., into the annulus of a native tricuspid valve) with a proximal portion of the prosthetic valve at least partially compressed and disposed within the delivery catheter and a distal portion of the prosthetic valve in contact with the native annular tissue. 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 portion of the delivery / retrieval system (or a combination thereof). In some embodiments, the method can include transitioning one or more anchoring elements to a desired location and / or state to engage with the native tissue surrounding at least a portion of the annulus. In some implementations, one or more tissue anchors may be attached to the valve and native tissue to secure the valve in a desired position.

[0052] Any of the methods for at least partially retrieving a prosthetic valve described herein can include extending a self-expanding retrieval element from a distal end of a retrieval sheath disposed in the atrium of the heart, where the retrieval element is configured to engage a portion of the prosthetic valve, such as a proximal subannular anchoring element. Retracting the prosthetic valve into the retrieval sheath can facilitate compression of the heart valve toward a delivery configuration (compressed configuration). The combination of the prosthetic valve and retrieval element is retracted into a retrieval catheter (e.g., using a cable, a control catheter, an actuator, a retrieval element, and / or any other suitable part of the delivery-retrieval system). In some implementations, the method may include, before drawing the heart valve into the cavity of the retrieval element and thereafter into the delivery and / or retrieval catheter, optionally precompressing the valve by (a) suturing a proximal subannular anchoring element to an underside of an atrial collar or member, or (b) pinching the proximal sidewall waist of the prosthetic valve, or (c) both. Similarly, in some implementations, the method may optionally include precompressing a connecting member or yoke at the distal end of the control catheter, which may reduce lateral expansion of the connecting member or yoke and may partially fold the valve and / or bias the valve such that it may be folded by application of less external force than may be used to fold the valve.

[0053] In some implementations, placing the prosthetic valve in a compressed configuration for loading and / or driving forward through a delivery sheath can include, for example, the use of one or more loading fixators, compression devices, jigs, etc., which can, for example, reduce forces associated with compressing the valve, inserting the valve into a delivery sheath, and / or driving a compressed valve at least partially forward through a delivery sheath. However, for retrieval, these devices, components, features, etc. may not be available because the valve is disposed within a patient's heart chamber. Moreover, the shape and / or orientation of the valve can favor delivery over retrieval.

[0054] Thus, any system and / or method for retrieving a laterally deliverable prosthetic valve may include and / or use one or more components, features, devices, etc., configured to facilitate retraction of the prosthetic valve into a delivery and / or retrieval sheath. For example, a delivery / retrieval system may include a retrieval sheath that may be driven forward over a control catheter and that replaces, for example, a delivery sheath used to deliver the prosthetic valve. In some implementations, such a retrieval sheath may have a larger diameter than the delivery sheath it replaces, thus providing a larger opening into which the valve is retracted. In some implementations, the delivery / retrieval system may include a retraction device or the like that may provide a mechanical advantage associated with the proximal force used to retract the valve into the retrieval sheath. Such a retraction device may be, for example, a ratchet mechanism or the like. In other implementations, the delivery / retrieval system may include any other suitable devices, components, and / or features that may facilitate retrieval of the valve.

[0055] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0056] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. With respect to the use of substantially any plural and / or singular term herein, one of ordinary skill in the art can translate from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. Various singular / plural permutations may be expressly set forth herein for clarity.

[0057] In general, the terms used herein, and in particular the terms used in the appended claims (e.g., the body of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," etc.). Similarly, when used herein, the terms "including" and / or "comprising" specify the presence of stated features, integers (or fractions thereof), steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers (or fractions thereof), steps, operations, elements, components, and / or groups thereof. When used herein, the term "including" means "including but not limited to."

[0058] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It will be understood that any suitable conjunction and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, contemplates the possibility of including one of the terms, either of the terms, or both / all of the terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B," or "A and B."

[0059] All ranges disclosed herein also include all possible subranges and combinations of subranges, unless expressly stated otherwise. Any range described should be recognized as fully describing the same range, unless expressly stated otherwise, and should be recognized as capable of being divided into at least equal subportions. As will be understood by those skilled in the art, a range includes each individual member.

[0060] The terms "prosthetic heart valve" and / or "prosthetic valve" can refer to a combination of a frame and leaflets or flow control structures or components, and can encompass both complete replacement of an anatomical part (e.g., a new mechanical valve that replaces a native valve) and medical devices that take the place of and / or supplement, repair or improve an existing anatomical part (e.g., the native valve is left 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 specific context in which the term is used.

[0061] The prosthetic valves disclosed herein can include members (e.g., frames) that can seat within the native annulus and can be used as attachment elements for leaflet structures, flow control components, or flexible reciprocating sleeves or sleeve valves. Depending on the embodiment, such leaflet structures or flow control components may or may not be included. Such members may be referred to herein as "annular support frames," "tubular frames," "wire frames," "valve frames," "frames," "flanges," "collars," and / or any other similar term.

[0062] The term "flow control component" may refer, in a non-limiting sense, to a two-, three-, or four-leaflet valve structure made of a flexible biocompatible material, such as treated or untreated pericardium, that can be sutured, bonded, and / or attached to an annular support frame to function as a prosthetic heart valve. Such a valve may be a tricuspid, mitral, aortic, or pulmonary heart valve, etc., that opens to blood flowing from the atrium to the ventricle during diastole and closes during systole due to ventricular pressure applied against the outer surface. The repeated successive openings and closings may be described as "reciprocating motion." It is envisioned that the flow control component may include a wide variety of (bio)prosthetic heart valves and / or prosthetic heart components. For example, such (bio)prosthetic valves can include ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disk valves (e.g., Bjork-Shiley), stented pericardial heart valves (bovine, porcine, ovine) (Edwards line of bioprosthetic valves, St. Jude prosthetic valves), as well as homograft and autograft valves. Bioprosthetic pericardial valves can include the bioprosthetic aortic valve, the bioprosthetic mitral valve, the bioprosthetic tricuspid valve, and the bioprosthetic pulmonary valve.

[0063] The term "anchoring element" or "tab" or "arm" refers to a structural member that extends from a portion of the valve or valve frame (e.g., away from a side wall or body or collar of the valve) to provide an anchoring or stabilizing function to the valve. When used in conjunction 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 integral with the valve (or valve frame) at a distal, proximal, septal, and / or anterior location, respectively. A distal location on the valve refers to the portion of the valve that is first delivered from the delivery catheter and furthest from the practitioner, which may be located at or near the distal subannular native tissue, such as the ventricular outflow tract. A proximal location on the valve refers to the portion of the valve that is last delivered from the delivery catheter and closest to the practitioner, which may be located at or near the proximal subannular native tissue, such as the tissue closest to the inferior vena cava. A septal location on the valve refers to a portion located at a point between a proximal and distal location of the valve, which may be located at or near the septal subannular native tissue, such as the septal leaflets or septal wall. An anterior location on the valve refers to a portion located at a point between a proximal and distal location of the valve, which may be located at or near the anterior tissue opposite the septal tissue. When used in conjunction with the terms "inferior" or "subannular," it will be understood that the anchoring or stabilizing element so described is attached to and / or integral with the sidewall, body, and / or frame (or a portion thereof) of the valve at or along the inferior or subannular region of the valve. Conversely, when used in conjunction with the terms "upper" or "supraannular," it will be understood that the anchoring or stabilizing element so described is attached to and / or integral with the valve or frame at or along the supraannular region, collar, or atrial cuff of the valve.

[0064] Any of the disclosed valve embodiments may be delivered by a transcatheter approach. The term "transcatheter" is used to define the process of accessing, controlling, and / or delivering a medical device or instrument within a catheter lumen and deployed to a heart chamber (or other desired location within the body), and to define an article 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 and the 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 the SVC, via the intercostal (rib) and / or subxiphoid space, and / or the like. Moreover, transcatheter cardiac access can also include a transatrial (e.g., fossa ovalis or inferior) approach to the left atrium and / or left ventricle. Transcatheter may be synonymous with transluminal and is functionally related to the term "percutaneous" when it comes to the delivery of heart valves.

[0065] The mode of cardiac access may be based at least in part on the "body cavity" used to define blood conduits or vessels within the body, and the particular application of the disclosed embodiments of the prosthetic valve may determine the body cavity of interest. For example, an aortic valve replacement would be implanted within or adjacent to the aortic valve annulus. Similarly, a tricuspid or mitral valve replacement would be implanted at the tricuspid or mitral valve annulus, respectively. Although certain features described herein may be particularly advantageous for a given implantation site, any of the valve embodiments described herein may be implanted in any body cavity, unless the combination of features is structurally impossible or excluded by claim language.

[0066] The terms "expandable" and "compressible" as used herein may refer to the ability of a prosthetic heart valve or a component of a prosthetic heart valve to 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 may be "expandable" to an implantation size or configuration or to a deployed size or configuration. Thus, an expandable / compressible structure is not intended to refer to a structure that may be slightly expanded / compressed, for example, due to temperature changes or other incidental causes, unless the context clearly indicates otherwise. Conversely, the property of non-expandable / non-compressible should not be interpreted as meaning completely rigid or dimensionally stable, for example, since some slight expansion / compression may be observed in a conventional non-expandable / non-compressible heart valve.

[0067] The prosthetic valves disclosed herein, and / or components thereof, are generally transitionable between two or more configurations, states, shapes, and / or configurations. For example, the prosthetic valves described herein can be compressible and / or expandable between any suitable number of configurations. Although various terms may be used to describe or refer to these configurations, the various terms are not intended to be limiting unless the context clearly dictates otherwise. For example, the prosthetic valve may be described as being disposed in a "delivery configuration," where the delivery configuration may be any suitable configuration that permits or enables delivery of the prosthetic valve. Examples of delivery configurations may include a compressed configuration, a folded configuration, a rolled configuration, and / or similar configurations, or any suitable combination thereof. Similarly, the prosthetic valve may be described as being disposed in an "expanded configuration," where the expanded configuration may be any suitable configuration that is not expressly intended for delivery of the prosthetic valve. Examples of expanded configurations may include a released configuration, a relaxed configuration, a deployed configuration, a non-delivery configuration, and / or similar configurations, or any suitable combination thereof. Some of the prosthetic valves described herein, and / or components or features thereof, can have numerous additional configurations that may relate to various modes, levels, states, and / or portions of actuation, deployment, engagement, and the like. Examples of such configurations can include actuation configurations, seating configurations, fixation configurations, engagement configurations, and / or the like, or any suitable combination thereof. Although specific examples are provided above, it will be understood that these are not intended to be an exhaustive list of configurations. Other configurations may be possible. Moreover, various terms may be used to describe the same or substantially similar configurations, and thus, use of a particular term is not intended to be limiting and / or to be interpreted to the exclusion of other terms, unless the terms and / or configurations are mutually exclusive or the context clearly dictates otherwise.

[0068] Any of the embodiments of the prosthetic valve described herein may be delivered via conventional transcatheter delivery techniques or via lateral / orthogonal delivery techniques. For example, conventional delivery of the prosthetic valve may be such that the central cylindrical axis of the valve is substantially parallel to the length or longitudinal axis of the delivery catheter being used to deliver the valve. Typically, the valve is radially compressed relative to the central cylindrical axis and driven forward through the lumen of the delivery catheter. The valve is deployed from the end of the delivery catheter and expanded radially outward from the central cylindrical axis. The delivery orientation of the valve generally means that the valve is fully released from the delivery catheter when located within the atrium of the heart and reoriented relative to the valve annulus, which may limit the size of the valve in some instances.

[0069] As used herein, the term "orthogonal" refers to an intersection angle of 90 degrees between two straight lines or two planes. As used herein, the term "substantially orthogonal" refers to an intersection angle of 90 degrees plus or minus an appropriate tolerance. For example, "substantially orthogonal" can refer to an intersection angle ranging from 75 degrees to 105 degrees. As used herein, the terms "orthogonal delivery," "orthogonally delivered," "lateral delivery," "laterally delivered," and / or the like, can be used interchangeably to describe such delivery methods and / or to describe valves delivered using such methods. Orthogonal delivery of a prosthetic valve can be such that the central cylindrical axis of the valve is substantially orthogonal to the longitudinal axis of the delivery catheter. In orthogonal delivery, the valve is compressed (or otherwise reduced in size) in a direction substantially parallel to the central cylindrical axis and / or in a direction transverse to the central cylindrical axis. Thus, the longitudinal axis (e.g., longitudinal axis) of an orthogonally delivered valve is substantially parallel to the longitudinal axis of the delivery catheter. In other words, an orthogonally delivered prosthetic valve is compressed and / or delivered at an angle of approximately 90 degrees as compared to conventional processes for compressing and delivering transcatheter prosthetic valves. Moreover, in some instances, the orientation of a valve delivered orthogonally to the valve annulus can allow a distal portion of the valve to be at least partially inserted into the annulus of a native heart valve while a proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints encountered with some known conventional delivery techniques.

[0070] The examples and / or embodiments described herein are intended to facilitate understanding of the structure of the embodiments, the function of the embodiments, and / or aspects of the embodiments, as well as the manner in which the embodiments may be practiced, and / or are intended to further enable those skilled in the art to practice the embodiments according to the present disclosure. Similarly, the methods and / or methods for using the embodiments described herein are provided by way of example only, and not by way of limitation. The particular uses described herein are not provided to exclude other uses, unless the context explicitly states otherwise. For example, any of the prosthetic valves described herein can be used to replace native valves of the human heart, including, for example, the mitral valve, tricuspid valve, aortic valve, and / or pulmonary valve. Although some prosthetic valves are described herein in the context of replacing the native mitral valve or the native tricuspid valve, it will be understood that such prosthetic valves can be used to replace any native valve, unless the context explicitly states otherwise, and unless the skilled artisan clearly recognizes that one or more components and / or features render the prosthetic valve unsuitable for such use for any reason. The specific examples, embodiments, methods, and / or uses described herein are not to be construed as limiting the scope of the inventions or inventive concepts herein, but rather the examples and embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concepts to those skilled in the art.

[0071] The embodiments herein and / or various features or advantageous details thereof will be more fully described with reference to the non-limiting embodiments illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques may be omitted so as not to unnecessarily obscure the embodiments herein. Like reference numerals generally refer to like elements throughout. Various embodiments, components, and / or features of prosthetic valves (e.g., side-deliverable transcatheter prosthetic heart valves) will be described first, followed by a description of a retrieval system for optionally retrieving a prosthetic valve at least partially deployed within a heart, and a method for using such a system.

[0072] 1-5 are various schematic illustrations of a side-deliverable transcatheter prosthetic heart valve 100 (also referred to herein as a "prosthetic valve" or simply as a "valve") configured to be coupled to, engaged with, and / or otherwise used with a delivery / retrieval system 180, according to one embodiment. The prosthetic valve 100 is configured to be deployed to a desired location within a body (e.g., the body of a human patient) and configured to permit blood flow in a first direction from an inflow end of the prosthetic valve 100 to an outflow end of the prosthetic valve 100 through a flow control component and to prevent blood flow in a second direction opposite the first direction. For example, the prosthetic valve 100 can be configured to be deployed within a native tricuspid or mitral valve annulus of a human heart and can be configured to supplement and / or replace the function of the native valve. In some embodiments, the valve 100 and / or delivery / retrieval system 180 may be similar and / or substantially identical to the valves and / or delivery / retrieval systems described in WIPO Patent Publication No. WO2021 / 035032, entitled "Delivery and Retrieval Devices and Methods for Side-Deliverable Transcatheter Prosthetic Valves," filed on August 20, 2020 (referred to herein as "'032PCT"), the disclosure of which is incorporated by reference in its entirety.

[0073] The prosthetic valve 100 is compressible and expandable between an expanded configuration (FIGS. 1 and 2) for implantation at a desired location within the body (e.g., the human heart) and a compressed or delivery configuration (FIGS. 3 and 4) for introduction into the body, such as via a delivery catheter 182 of a delivery / retrieval system 180. For example, the prosthetic valve 100 may be compressible and expandable in at least one direction relative to a long axis 102 of the valve 100 (also referred to herein as the "horizontal axis," "longitudinal axis," or "length axis"). For example, the valve 100 may be compressible / expandable along a central axis 104, where when in the expanded configuration (FIG. 1) the valve 100 has a first height or size along the central axis 104, and when in the compressed configuration (FIG. 3) the valve 100 has a second height or size along the central axis 104 that is smaller than the first height or size. In some embodiments, the prosthetic valve 100 can be compressible and expandable in at least two directions relative to the longitudinal axis 102 of the valve 100. For example, the valve 100 can be compressible / expandable (as described herein) along a central axis 104 and compressible / expandable along a lateral axis 106 that is perpendicular to both the longitudinal axis 102 and the central axis 104 (see, e.g., FIGS. 1 and 2). In such embodiments, the valve 100 can have a first height and a first width when in an expanded configuration (FIGS. 1 and 2) and a second height and a second width when in a compressed configuration (FIGS. 3 and 4), the second height and width being smaller than the first height and first width, respectively.

[0074] 1, 2, and 5, the valve 100 has an extent in any direction perpendicular or lateral to the longitudinal axis 102 (e.g., along the central axis 104 and / or along 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 mm to 60 mm. In some embodiments, the valve 100 can have an expanded length (e.g., along the longitudinal axis 102) and expanded width (e.g., along the lateral axis 106) of approximately 20 mm to 80 mm or approximately 40 mm 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 lateral to the longitudinal axis 102 (e.g., along the central axis 104 and / or along the lateral axis 106) that is less than the diameter of the lumen of the delivery catheter 182, thereby allowing the valve 100 to be delivered therethrough. For example, in some embodiments, the valve 100 can have a compressed height (e.g., along the central axis 104) and compressed width (e.g., along the lateral axis 106) of approximately 6 mm to 15 mm, or approximately 8 mm to 12 mm, or approximately 9 mm to 10 mm. The valve 100 can be compressed by compressing, by rolling, by folding, and / or by any other suitable technique, or combinations thereof. In some implementations, the length of the valve 100 (e.g., along the longitudinal axis 102) is not compressed for or during delivery. Rather, in some implementations, the length of the valve 100 may increase in response to compression of the valve 100 along the central axis 104 and / or along the lateral axis 106 .

[0075] In some embodiments, the valve 100 (and / or at least a portion thereof) may be heat molded and / or otherwise formed into any desired shape, such as, for example, a generally tubular shape, a generally hourglass shape, and / or the like. In some embodiments, the valve 100 may include an upper atrial cuff or flange for sealing against the atrium, an lower ventricular cuff or flange for sealing against the ventricle, and a trans-annular section or region (e.g., a body section, a tubular section, a cylindrical section, etc.) disposed therebetween. The trans-annular region may have an hourglass-shaped cross-section over approximately 60%-80% of its circumference to fit against the native annulus along the anterior and posterior annular segments, and may remain substantially vertically flat along 20%-40% of the circumference of the annulus to fit against the septal annular segment. Although valve 100 is shown in Figures 1-5 as having a given shape, it will be understood that the size and / or shape of valve 100 (and / or at least a portion thereof) may be based on the size and / or shape of the anatomy of the native tissue.

[0076] For example, the valve 100 can be concentric (e.g., radially symmetric about the central y-axis 104) or eccentric (e.g., radially asymmetric about the central y-axis 104). In some eccentric embodiments, the valve 100 or its outer frame can have a complex shape determined by the anatomical structure to which the valve 100 is attached. For example, in some instances, the valve 100 can be deployed in a native tricuspid valve annulus having a rounded oval shaped periphery with a substantially vertical septal wall, which is known to expand along an anterior-posterior line in diseased states. In some instances, the valve 100 can be deployed in a native mitral valve annulus (e.g., near the anterior leaflet) having a rounded oval shaped periphery with a substantially vertical septal wall, which is known to expand in diseased states. Thus, the valve 100 can have a complex shape, at least in part, as determined by the native valve annulus and / or by the diseased state of the native valve. By way of example, the valve 100 or its outer frame may have a D-shape (when viewed in plan) to allow for flat conformity with the anatomy (e.g., a substantially vertical septal wall) into which the valve 100 will be deployed. In some embodiments, the valve 100 or its outer frame may have a periphery with a rounded elliptical shape, such as a hyperbolic paraboloid, to account for the location of the natural septal leaflets, anterior leaflets, posterior leaflets, and / or the natural septal wall, to avoid natural electrical bundles, such as the atrioventricular (AV) node, and / or structures associated with the AV node, such as Koch's triangle, AV bundle, etc., to avoid interference with coronary blood flow, such as the coronary sinuses, to accommodate variations in the septal wall, which are known to be substantially vertical but which expand along the anterior-posterior axis toward the free wall in diseased states, and / or the like.

[0077] 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 / or at least the annular support frame 110 of the valve 100 may include, be coupled to, and / or otherwise engage a delivery / retrieval system 180. The annular support frame 110 (also referred to herein as a "tubular frame," "valve frame," "wire frame," "outer frame," or "frame") may have a supranulular region 120, a subannular region 130, and a transannular region 112 disposed therebetween and / or coupled thereto. In some embodiments, the frame 110 may be constructed integrally and / or of a unitary structure. In some embodiments, one or more of the supranulular region 120, the subannular region 130, and / or the transannular region 112 can be separate, independent, and / or modular components that are coupled together to collectively form the frame 110. For example, in some embodiments, the supranulular region 120 can be, for example, an atrial collar or cuff coupled to the top, upper, and / or top annular edge of the transannular region 112, and the subannular region 130 can be the bottom, lower, and / or bottom annular portion or section of the transannular region 112 of the frame 110.

[0078] In some implementations, the modularity and / or at least partial modularity allows the frame 110 to be adapted to a given size and / or shape of the anatomical structure to which the valve 100 is attached. For example, one or more of the supranulnar region 120, the subannular region 130, and / or the transannular region 112 can be designed and / or adapted such that the support frame 110 has any desired height, outer diameter, and / or inner diameter, such as any of those described above. Moreover, such modularity allows the frame 110 to bend, flex, 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) without substantial plastic or permanent deformation.

[0079] The support frame 110 and / or the supranulnar region 120, the subannular region 130, and / or the transannular region 112 can be formed from or be any suitable material. In some embodiments, the frame 110 and / or one or more portions or regions thereof can be formed from a shape memory or superelastic metal, metal alloy, plastic, and / or the like. For example, the frame 110 (e.g., one or more of the supranulnar region 120, the subannular region 130, and the transannular region 112) can be formed from 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 Nitinol wire that has been bent, twisted, formed, and / or manipulated into a desired shape. In yet other embodiments, the frame 110 (and / or any regions thereof) can be formed of or from a desired material using any suitable additive or subtractive manufacturing process, such as the various processes described above. Moreover, the frame 110 and / or one or more of the supranulular region 120, the subannular region 130, and the transannular region 112 can be formed from a metal or other structural frame material that can be coated with a biocompatible material, such as, for example, pericardial tissue (e.g., Dura-Guard®, Peri-Guard®, Vascu-Guard®, etc.), polymers (e.g., polyester, Dacron®, etc.), and / or the like, as described above.

[0080] The supranulular region 120 of the frame 110 can be or form a cuff or collar that can be attached or bonded to, for example, an upper edge or portion of the transannular region 112. When the valve 100 is deployed inside the human heart, the supranulular region 120 can be an atrial collar shaped to fit against the native deployment site. For example, in a tricuspid and / or mitral valve replacement, the supranulular region 120 (e.g., an atrial collar) can have various portions configured to fit against the native valve and / or atrial floor portions surrounding the tricuspid and / or mitral valves, respectively. In some implementations, the supranulular region 120 can be deployed onto the atrial floor to guide blood from the atrium into the flow control component 150 of the valve 100 and to seal against blood leakage (paravalvular leakage) around the frame 110.

[0081] In some embodiments, the supranulular region 120 can be a wire frame laser cut from any suitable material. In some embodiments, the supranulular region 120 can be formed from a tube or sheet of a shape memory or superelastic material, such as Nitinol, and can be, for example, heat set into a desired shape and / or configuration. In some embodiments, forming the supranulular region 120 in this manner can allow the supranulular region 120 to be bent, flexed, folded, compressed, and / or otherwise reconfigured without substantial plastic deformation and / or fatigue that may result in the fracture or rupture of one or more portions thereof. Additionally, the wire frame of the supranulular region 120 can be coated with any suitable biocompatible material, such as any of those described above.

[0082] The supranulnar region 120 includes a distal portion and a proximal portion. In some embodiments, the distal portion can include a distal supranulnar anchoring element and / or the like that can engage with native tissue on the distal side of the annulus when the prosthetic valve 100 is seated within the annulus. In some embodiments, the proximal portion can include a proximal supranulnar anchoring element and / or the like that can engage with native tissue on the proximal side of the annulus when the prosthetic valve 100 is seated within the annulus. In some embodiments, the distal portion and / or the distal supranulnar anchoring element can be sized and / or shaped to correspond to the size and / or shape of a distal portion of the atrial floor of the heart within which the prosthetic valve 100 is disposed. Similarly, the proximal portion and / or the proximal supranulus anchoring element may be sized and / or shaped to correspond to the size and / or shape of the proximal portion of the atrial floor of the heart.

[0083] Although not shown in FIGS. 1-5, the supranulular region 120 can be shaped and / or formed to include any number of features configured to engage native tissue and / or to engage one or more other portions of the valve 100, the delivery / retrieval system 180, and / or the like. For example, in some embodiments, the supranulular region 120 can include and / or be formed with 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 native tissue and the inner portion can provide structure for attaching the flow control component 150 to the support frame 110, with one or more covers, spacers, struts, splines, and / or structures disposed therebetween. In some implementations, a portion of the supranulular region 120 may be at least temporarily coupled to and / or at least temporarily receive a portion of the delivery / retrieval system 180, at least a portion of an actuator, at least a portion of a guidewire, and / or the like.

[0084] The trans-annular region 112 of the support frame 110 is coupled to the supranulular region 120 and extends from the supranulular region 120 and at least partially through the annulus of the native valve when the prosthetic valve 100 is seated therein. In some embodiments, the trans-annular region 112 can be coupled (e.g., welded, glued, sewn, bonded, and / or the like) to the supranulular region 120 in a manner that allows a desired amount of movement and / or bending between the trans-annular region 112 and the supranulular region 120. For example, in some implementations, the trans-annular region 112 and / or portions thereof can be sutured to the supranulular region 120 (and / or portions thereof).

[0085] The annular passage region 112 can be shaped and / or formed into a ring, a cylindrical tube, a conical tube, a D-shaped tube, and / or any other suitable annular shape. In some embodiments, the annular passage region 112 can have a side shape that is a frustum of a cone, an inverted frustum of a cone (narrow at the top and wide at the bottom), a concave cylindrical shape (walls curved inward), a convex cylindrical shape (walls bulging outward), a tilted hourglass, a curved graduated hourglass, a ring or cylinder with a flared top or bottom, or both. Moreover, the annular passage region 112 can form and / or define an opening or central channel 114 that extends along the central axis 104 (e.g., y-axis). The central channel 114 (e.g., central axial lumen or central axial 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. 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 supranulular region 120 (and / or subannular region 130) and / or the size, shape, and / or configuration of the native annulus within which the supranulular region 120 (and / or subannular region 130) is configured to be deployed. For example, the transannular region 112 can have a peripheral surface for engaging native annular tissue that can apply tension against an inner surface of the native annulus to provide structural patency to a weakened native annulus.

[0086] In some embodiments, the annulus-passing region 112 can be a wire frame laser cut from any suitable material. For example, the annulus-passing region 112 can be formed from a tube or sheet of a shape memory or superelastic material, such as Nitinol, and can be heat set, for example, into a desired shape and / or configuration. Although not shown in FIGS. 1-5, in some embodiments, the annulus-passing region 112 can include and / or be formed by two laser cut halves that can be formed into a desired shape and / or configuration and joined together to form the annulus-passing region 112. The annulus-passing region 112 can be formed to include a set of compressible wire cells with a substantially orthogonal orientation and / or cell shape relative to the central axis 104 (FIG. 1) to minimize distortion of the wire cells when the annulus-passing region 112 is in a vertically compressed, rolled, or folded compressed configuration. In some embodiments, forming the annulus-passing region 112 in this manner may enable the annulus-passing region 112 to bend, flex, fold, deform, and / or otherwise reconfigure (without substantial plastic deformation and / or without substantial undue fatigue) in response to lateral bending 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 below.

[0087] As discussed above with reference to the supranulnar region 120, the wire frame of the transannular region 112 can be covered with any suitable biocompatible material, such as any of those discussed above. In some implementations, at least the wire frames of the supranulnar region 120 and the transannular region 112 can be flexibly joined (e.g., sutured) to form the wire frame portion of the support frame 110, which is covered in a biocompatible material. Stated differently, at least the supranulnar region 120 and the transannular region 112 can be covered with a biocompatible material before or after bonding. In embodiments in which the wire frames are covered after bonding, the biocompatible material can facilitate and / or support the bond therebetween.

[0088] The subannular region 130 of the frame 110 can be and / or form, for example, a cuff or collar along the opposite end of the transannular region 112 from the supranulular region 120. For example, the subannular region 130 can be and / or form a ventricular collar shaped to fit the native deployment site when the valve 100 is deployed within a human heart. For example, in tricuspid and / or mitral valve replacement, the subannular region 130 or collar can have various portions configured to fit against the native valve and / or ventricular roof portions surrounding the tricuspid and / or mitral valves, respectively. In some implementations, the subannular region 130, or at least a portion thereof, can engage against the ventricular roof surrounding the native annulus to fixate the valve 100 within the native annulus, to stabilize the valve 100 within the annulus, to prevent displacement of the valve 100, to sandwich or compress the annulus or adjacent tissue between the supranulular region 120 and the subannular region 130 (or a lower portion of the transannular region 112), and / or to seal against blood leakage (paravalvular leakage and / or systolic regurgitation) around the frame 110.

[0089] In some embodiments, the subannular region 130 is a lower or subannular portion of the transannular region 112 (e.g., the transannular region 112 and the subannular region 130 are integrally and / or unitarily formed). Stated another way, the lower or subannular portion of the transannular region 112 can form and / or include the subannular region 130. In other embodiments, the subannular region 130 is a separate and / or independent component that can be attached or coupled to a lower edge or 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 may be a wire frame that is laser cut from any suitable material, such as a shape memory or superelastic material like Nitinol, and heat set into a desired shape and / or configuration, as described above with reference to the supranullar region 120, and may be coated with any suitable biocompatible material and attached to the lower edge of the transannular region 112. In some implementations, forming the subannular region 130 in this manner may allow the subannular region 130 to bend, flex, fold, compress, and / or otherwise reconfigure without substantial plastic deformation and / or fatigue that may result in fracture or rupture of one or more portions thereof.

[0090] The subannular region 130 of the frame 110 can be shaped and / or formed to include any number of features configured to engage with native tissue, one or more other portions of the valve 100, one or more other portions of the delivery / retrieval system 180, one or more actuators (not shown), and / or the like. For example, as shown in FIG. 1, the subannular region 130 can include and / or be formed with a distal portion having a distal anchoring element 132 and a proximal portion having a proximal anchoring element 134. In some embodiments, the anchoring elements 132, 134 are integrally and / or unitarily formed with the subannular region 130 and / or with the lower or subannular portion of the transannular region 112.

[0091] In some embodiments, distal anchoring element 132 can optionally include a guidewire coupler 133 configured to selectively engage and / or receive a portion of a guidewire or a portion of a guidewire catheter. Guidewire coupler 133 is configured to allow a portion of the guidewire or guidewire catheter to extend through an opening in guidewire coupler 133, thereby allowing valve 100 to be driven forward over or along the guidewire and / or guidewire catheter during delivery and deployment.

[0092] The distal anchoring element 132 is configured to engage a desired portion of native tissue distal to the native annulus to facilitate seating, attachment, and / or deployment of the valve 100 within the native valve annulus. For example, in some implementations, the distal anchoring element 132 can be a protrusion or projection extending from the frame 110 (e.g., from the subannular region 130 and / or from an inferior portion of the transannular region 112) relative to the annulus to a distal subannular location (e.g., to the RVOT for tricuspid valve replacement and / or the like). In such implementations, the distal anchoring element 132 can be shaped and / or biased to apply a force to the subannular tissue operable for the distal anchoring element 132 to at least partially fix, stabilize, and / or anchor a distal end portion of the valve 100 within the native annulus. In some embodiments, the distal anchoring element 132 can extend from the distal portion of the subannular region 130 (or the lower portion of the transannular region 112) by approximately 10 mm to 40 mm.

[0093] The proximal anchoring element 134 is configured to engage subannular tissue proximal to the native annulus to facilitate seating, attachment and / or deployment of the valve 100 within 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 mm to 40 mm from the proximal portion of the subannular region 130 (or the lower portion of the transannular region 112).

[0094] In other embodiments, the proximal anchoring element 134 can be configured to transition, move, and / or otherwise reconfigure between two or more configurations. For example, the proximal anchoring element 134 can transition between a first configuration in which the proximal anchoring element 134 extends a first amount or distance from the subannular region 130 and a second configuration in which the proximal anchoring element 134 extends a second amount or distance from the subannular region 130 that is different from the first amount or distance. For example, 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., in a position close to, adjacent to, and / or in contact with the trans-annular region 112 and / or the supra-annular region 120 of the frame 110) and a second configuration in which the proximal anchoring element 134 is expanded, elongated, deployed, unfolded, and / or unconstrained (e.g., extending away from the trans-annular region 112). In some implementations, the proximal anchoring element 134 in an expanded or deployed configuration (e.g., second configuration) can extend approximately 10 mm to 40 mm from the transannular region 112, and in a compressed or undeployed configuration (e.g., first configuration) can contact the transannular region 112 or extend less than about 10 mm from the transannular region 112. Moreover, in some implementations, 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 / retrieval system 180, and / or the like, as described in more detail herein.

[0095] In some implementations, the proximal anchoring element 134 can transition from a first configuration to a second configuration upon deployment to selectively engage native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure to aid in anchoring the valve 100 within 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 native tissue. For example, in some embodiments, the proximal anchoring element 134 can include one or more features configured to engage and / or intertwine with native tissue, chordae tendineae, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structure when in the second configuration, as described in more detail herein with reference to certain embodiments.

[0096] Although not shown in FIGS. 1-5 , the subannular region 130 can include and / or be formed with any number of additional anchoring elements, such as, for example, a septal anchoring element and / or the like. For example, the septal subannular anchoring element can be configured to engage subannular septal tissue, septal leaflet tissue, and / or any other suitable tissue at, near, and / or along the septum of the heart. In some implementations, when the valve 100 is at least partially inserted into the annulus, the septal anchoring element can extend down along the septal wall to, for example, pin the native septal leaflet at a location spaced apart from the coapting leaflets of the prosthetic valve 100 and / or stabilize the valve against any in-annular rolling and / or twisting forces (e.g., tilt, angle, twist, roll, etc.) that may affect the desired position or placement of the prosthetic valve within the annulus.

[0097] Although not shown in Figures 1-5, frame 110 may also have and / or form additional functional elements (e.g., loops, anchors, etc.) for attaching accessory components, such as biocompatible covers, tissue anchors, removable deployment / retrieval control members (e.g., actuators, tensioning members, portions of delivery / retrieval system 180, and / or other suitable guides, knobs, attachments, rigging, etc.), and the like.

[0098] The flow control component 150 may refer, without limitation, to a device for controlling fluid flow therethrough. In some embodiments, the flow control component 150 may be a two, three, four, or more leaflet valve structure formed from a flexible biocompatible material, such as treated or untreated pericardium. The leaflets may be sutured or bonded to a support structure, such as an inner frame, which may be sutured or bonded to the outer frame 110. The leaflets may be configured to move between an open state and a closed or substantially sealed state to allow blood to flow through the flow control component 150 from the inflow end of the valve 100 in a first direction and to prevent blood from flowing from the outflow end of the valve 100 in a second direction opposite the first direction. For example, the flow control component 150 can be configured to allow the valve 100 to function as a heart valve, such as a tricuspid, mitral, aortic, or pulmonary valve, that can be open to blood flowing from the atrium to the ventricle during diastole and closed by systolic ventricular pressure applied against the exterior surface.

[0099] The inner frame and / or portions or aspects thereof can be similar to the outer frame 110 and / or portions or aspects thereof, at least in form and / or function. For example, the inner frame can be a laser cut frame, such as formed from a shape memory material, such as Nitinol. Moreover, the inner frame can be compressible upon delivery and configured to return to its original (uncompressed) shape upon release (e.g., after delivery). In some embodiments, the inner frame can include and / or form any suitable number of compressible and elastically deformable diamond-shaped or eye-shaped wire cells and / or the like. The wire cells can have a substantially orthogonal orientation and cell shape relative to the axis of the flow control component 150 to minimize distortion of the wire cells when the inner frame is in a compressed configuration.

[0100] 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 disposed in a compressed configuration (see, e.g., FIGS. 3 and 4). Although not shown in FIGS. 1-5, in some embodiments, the inner frame of the flow control component 150 can include and / or be formed of two halves that can be joined together to allow the inner frame to elastically deform in response to lateral compression or bending along or in the direction of the lateral axis 106 (FIG. 3), as described in more detail herein.

[0101] 1-5, the flow control component 150 is mounted within the central channel 114 of the frame 110. More specifically, the flow control component 150 is attached and / or coupled to the supranulcular region 120 (e.g., an inner portion thereof) and configured to extend into 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 supranulcular region 120 via tissue, via a biocompatible mesh, via one or more woven or knitted fabrics, via one or more superelastic or shape memory alloy structures, which intervening structures are sewn, sutured, and / or otherwise secured to a portion of the supranulcular region 120. In some embodiments, the flow control component 150 may be coupled to the supranulular region 120 such that a portion of the flow control component 150 is disposed above and / or otherwise extends beyond the supranulular region 120 (e.g., extends away from the annulus toward the atrium). In some embodiments, the portion of the flow control component 150 that extends above and / or beyond the supranulular region 120 may form a ridge, ledge, wall, step, and / or the like. In some implementations, such an arrangement may promote ingrowth of natural tissue onto the supranulular region 120 without occluding the flow control component 150.

[0102] The flow control component 150 can be at least partially positioned within the central channel 114 such that an axis of the flow control component 150, which extends 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 eccentric within the central channel 114. In some embodiments, the central channel 114 can have a larger diameter and / or perimeter length compared to the diameter and / or perimeter length of the flow control component 150. Although not shown in FIGS. 1-5, in some embodiments, the valve 100 can include a spacer or the like that can be positioned within the central channel 114 adjacent to the flow control component 150. In other embodiments, the spacer may 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 instances, the spacer may be used to facilitate coupling of the flow control component 150 to the frame 110.

[0103] 5 illustrates the valve 100 seated within the annulus of a native heart valve after delivery and deployment of the valve 100 using a delivery / retrieval system 180. As described above, the valve 100 is compressible and expandable between an expanded configuration (FIGS. 1 and 2) and a compressed configuration (FIGS. 3 and 4). The valve 100 is in an expanded configuration prior to loading into the delivery / retrieval system 180 and is compressed as it is delivered through a delivery catheter 182. More specifically, the valve 100 is configured to be delivered orthogonally transcatheter through the delivery catheter 182 to a desired location within the body, where the valve 100 is compressed orthogonally or laterally relative to the dimensions of the valve 100 in the expanded configuration (e.g., along the central axis 104 and / or the lateral axis 106). During delivery, the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter 182. In some embodiments, the devices and methods for delivering the valve 100 to a desired location within the body (e.g., via the delivery / retrieval system 180) can be similar and / or substantially identical to the delivery systems described in the '032 PCT, incorporated by reference above. Thus, some and / or aspects of the devices and / or procedures used to deliver the valve 100 to the annulus of a native heart valve, for example, as shown in FIG. 5, will not be described in further detail herein.

[0104] 5, the valve 100 can be delivered, for example, to the atrium of a human heart (or other space or chamber of a human heart). In some implementations, for example, the valve 100 (e.g., the supranulnar member / region 120) can be removably coupled to a control device 170 included in a delivery / retrieval system 180, which can be used to drive the compressed valve 100 forward through a lumen of a delivery catheter 182, as described in detail with reference to the delivery / retrieval system of the '032 PCT. Moreover, the valve 100 can be driven forward along or over a guidewire and / or guidewire catheter through the delivery catheter 182 to a desired location within the heart (e.g., the annulus of a native heart valve). In some embodiments, at least a portion of the control device 170 and / or the like can extend through one or more lumens of the delivery catheter, thereby enabling 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 during deployment.

[0105] After being introduced into the atrium and released from the delivery catheter 182, the valve 100 can transition to an expanded configuration for deployment into the annulus of a native valve, such as, for example, the pulmonary valve (PV), mitral valve (MV), aortic valve (AV), and / or tricuspid valve (TV). Deployment of the valve 100 can include positioning the distal anchoring element 132 of the subannular region 130 into the ventricle (RV, LV) below the annulus, with the remainder of the valve 100 located in the atrium (RA, LA). In some instances, the distal anchoring element 132 can be driven forward over and / or along a guidewire or guidewire catheter (not shown) to a desired location within the ventricle, such as, for example, the outflow tract of a ventricle. For example, in some implementations, the valve 100 can be delivered into the annulus of the native tricuspid valve (TV), and at least a portion of the distal anchoring element 132 can be positioned within the RVOT. In other implementations, the valve 100 can be delivered to the annulus of a native mitral valve (MV) and at least a portion of the distal anchoring element 132 can be positioned in a subannular position distal to the annulus, and / or in any other suitable position within which the distal anchoring element 132 can be engaged against native tissue, valve leaflets, chordae tendineae, etc.

[0106] In some implementations, the prosthetic valve 100 can be temporarily maintained in a partially deployed state. For example, the valve 100 can be partially inserted into the valve annulus and held at an angle relative to the annulus to allow blood to flow from the atrium to the ventricle partially through the native annulus around the valve 100 and partially through the valve 100, thereby allowing assessment of valve function.

[0107] 5, the valve 100 is positioned or seated into the annulus (PVA, MVA, AVA, and / or TVA) of the native valve (PV, MV, AV, and / or TV) with the subannular region 130 (e.g., ventricular collar) disposed in a subannular position, the transannular region 112 of the valve frame 110 extending through the annulus, and the supranulular region 120 (e.g., atrial collar) remaining in a supranulular position. In some instances, with the distal subannular anchoring element 132 positioned in the RVOT, at least a proximal end portion of the valve 100 can be pushed into the annulus using a delivery / retrieval system 180, a control device 170, and / or any other suitable members, tools, etc., as described in detail in the '032 PCT.

[0108] In some implementations, the proximal anchoring element 134 can be maintained in its first configuration when the valve 100 is seated within the annulus. For example, as described above, the proximal anchoring element 134 can be in a compressed, contracted, and / or retracted configuration such that the proximal anchoring element 134 is in contact with, adjacent to, and / or proximate to the transannular region 112 and / or supranulular region 120 of the frame 110, thereby constraining the entire circumference of the subannular region 130 of the frame 110 such that the subannular region 130 and the transannular region 112 of the frame 110 can be inserted into and / or through the annulus.

[0109] In some embodiments, the control device 170 of the delivery / retrieval system 180 can be configured to drive 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, linking members, joints, connecting members, tensioning members, etc. that can apply a force (or release an applied force) to a portion of the proximal anchoring element 134 to transition the proximal anchoring element 134 between the first and second configurations. For example, the subannular region 130 of the support frame 110 can be formed with the proximal anchoring element 134 biased to an uncompressed and / or expanded configuration, and the control device 170 can be actuated via one or more cables, tethers, etc. to apply a force that can drive the proximal anchoring element 134 to transition to the compressed and / or retracted configuration.

[0110] In some implementations, the control device 170 can be fixed and / or locked when the proximal anchoring element 134 is compressed and / or retracted (e.g., the first configuration), thereby at least temporarily maintaining the proximal anchoring element 134 in the first configuration. As described above, in some implementations, the proximal anchoring element 134 can be in the first configuration for delivery and deployment of the valve 100 prior to seating of the valve 100 against the native annulus. After the valve 100 is seated within the annulus, a user can actuate the control device 170 by manipulating a portion of the delivery / retrieval system 180. In this example, by actuating the control device 170, the control device 170 can release and / or remove the force applied to the proximal anchoring element 134 (e.g., via a cable, tether, etc.), thereby returning the proximal anchoring element 134 to its original or biased configuration (e.g., the second configuration).

[0111] As discussed above, the distal anchoring element 132 can be configured to engage native tissue distal to the annulus, and the proximal anchoring element 134 can be configured to engage native tissue proximal to the annulus (e.g., when in the second or expanded configuration), thereby fixedly seating the valve 100 within the native annulus, as shown in Figure 5. In some implementations, any other or additional portions of the valve 100 can similarly engage native tissue to fixedly seat the valve 100 within the native annulus and / or form a seal between the support frame 110 and the tissue forming the native annulus (e.g., the anterior anchoring element can engage subannular tissue anterior to the annulus, or the supranulular region 120 can include any number of supranulular anchoring elements for engaging supranulular tissue (not shown in Figures 1-5)). With the valve 100 secured within the annulus, the delivery / retrieval system 180 may be disconnected from the valve 100 and retracted / removed from the patient, thereby leaving the prosthetic valve 100 in place.

[0112] Although the valve 100 has been described above with reference to FIG. 5 as being delivered into the heart and deployed from the delivery catheter 182 and seated / implanted within the valve annulus, in some instances it may be desirable to retrieve and / or remove the side-deliverable prosthetic valve upon delivery, upon deployment, and / or after seating of the prosthetic valve within the valve annulus. For example, in some instances it may be desirable to retrieve and / or remove the prosthetic valve from the heart due to a valve-related defect, a patient condition, one or more anatomical abnormalities, and / or the like. In some such implementations, the delivery / retrieval system (e.g., the delivery / retrieval system 180) may include a retrieval element and / or any additional / other elements that may be used to engage the prosthetic valve and retrieve the valve into a delivery catheter, a retrieval sheath, and / or the like.

[0113] For example, Figures 6-9 are schematic illustrations of one or more retrieval portions, components, features, and / or aspects of the delivery / retrieval system 180 shown in Figures 1-5. The retrieval portions, components, etc. can be configured to allow for retrieval of the prosthetic valve 100 during delivery, during deployment, and / or after seating of the prosthetic valve within the valve annulus.

[0114] 6 shows the valve 100 and a delivery portion of a delivery / retrieval system 180 being used to deliver and / or deploy the valve 100 into the valve annulus. As described above, the delivery / retrieval system 180 includes a delivery catheter 182 configured to provide access to the heart chamber (e.g., via an IVC or SVC approach). A proximal end portion of the delivery catheter 182 is coupled to a handle 188 that may facilitate loading and / or manipulation of the valve 100 during delivery or deployment. For example, the handle 188 may be similar to the handle of the delivery / retrieval system described in the '032 PCT, incorporated by reference above.

[0115] 6 further illustrates a control device 170 extending through the delivery catheter 182. For example, the control device 170 can include a control catheter 171 having a distal end coupled to and / or including a connecting member 178 and a proximal end coupled to a handle 188. A set of tethers 175 can be routed through the control catheter 171 and through the connecting member 178 and can be wound around a portion of the valve 100 and routed back through the connecting member 178 and through the control catheter 171. In some implementations, the looped configuration of the tethers 175 allows the connecting member 178 to be detachably coupled to, for example, the supra-annular member 120 of the valve 100, as described above. The tethers 175 may be routed such that an end of each tether 175 is disposed at and / or coupled to a handle 188 such that a user may manipulate the connecting members 178 and / or the coupling between the connecting members 178 and the supra-annular members 120 of the valve 100. Moreover, by pulling a single end of each tether 175 proximally, the tethers 175 may be detached to decouple the connecting members 178 from the valve 100 (e.g., after the valve 100 has been successfully seated within the annulus).

[0116] 6 illustrates the distal end of the delivery catheter 182 disposed within a heart chamber with the valve 100 released or deployed outside and / or distal to the delivery catheter 182. Thus, the valve 100 is in an expanded or deployed configuration. In some instances, it may be desirable to retrieve the valve 100 (e.g., release the valve from the body) after the valve 100 is released from the distal end of the delivery catheter 182. However, with the valve 100 in the expanded configuration, retracting and / or retrieving the valve 100 into the delivery catheter 182 requires that the valve 100 be transitioned to or toward a compressed configuration for insertion into the delivery catheter 182.

[0117] 7-9 illustrate a process for retrieving the valve 100, for example, by using the retrieval portion of the delivery / retrieval system 180. In some instances, the retrieval process can begin with removing one or more components contained within the delivery portion of the delivery / retrieval system 180. For example, in some instances, the handle 188 can be decoupled from the delivery catheter 182, from the control device 170, and / or the like. In some embodiments, for example, the handle 188 can have a split member design that can separate the handle into one or more members. Although not shown in FIG. 6, one or more tethers, tension members, actuators, etc., coupled to one or more portions of the valve 100 can also be removed. For example, the tether used to drive the proximal anchoring element 134 can be decoupled from the valve 100 and removed from one or more lumens of the control catheter 171. Similarly, the guidewire and guidewire catheter along which the valve 100 is driven during delivery can be retracted and / or removed.

[0118] In some implementations, the delivery catheter 182 can also be removed from the patient without removing the control catheter 171. For example, in implementations in which a relatively large valve is being retrieved, it may be desirable to remove the delivery catheter 182 so that a larger diameter retrieval sheath can be advanced along the control catheter 171 into the heart chamber. In other implementations, the delivery catheter 182 can remain in place and the retrieval components of the delivery / retrieval system 180 can retrieve the valve 100 into the lumen of the delivery catheter 182 (e.g., when retrieving a relatively small valve).

[0119] 7 illustrates that the control device 170 and tether 175 remain attached, i.e., coupled, to the valve 100. For example, as in the delivery and deployment case, the control catheter 171 can still extend through the delivery catheter 182 with the connecting member 178 at its distal end still coupled to the valve 100 within the heart chamber. With the desired portion of the delivery / retrieval system 180 removed, the retrieval portion of the delivery / retrieval system 180 can be used to engage and retrieve the valve 100.

[0120] 7 illustrates, for example, a retrieval sheath 190, a retrieval element 191, a retrieval handle 194, and an exchange catheter 196. The exchange catheter 196 is configured to couple to a proximal end of the control catheter 171. For example, in some embodiments, the distal end of the exchange catheter 196 can include a threaded male coupler that can be inserted into a lumen of the control catheter 171 and form a threaded coupling with the lumen of the control catheter 171. In some embodiments, the exchange catheter 196 can, for example, extend the length of the control catheter 171 (e.g., proximally), thereby allowing the retrieval sheath 190 and retrieval handle 194 to be driven forward over the exchange catheter 196 and over at least a portion of the control catheter 171, as described in more detail herein.

[0121] As discussed above, the control device 170, and more specifically the connecting member 178, can remain attached to and / or in contact with the supranulnar member 120 of the valve 100 via the tether 175. With the delivery handle 188 detached, FIG. 7 illustrates that the ends of each tether 175 are unattached or unanchored and can extend beyond the proximal end of the control catheter 171. In some embodiments, the exchange catheter 196 can include and / or define one or more features that can engage and / or couple to the tether 175 to secure the end portion thereof. For example, the exchange catheter 196 can include and / or define a skive that can selectively receive the end portion of the tether 175 to secure the end portion via a clamping force or the like. In other embodiments, the exchange catheter can include any other suitable coupler, retaining member, and / or engagement feature. In this manner, control of the distal end portion of the control device 170 (eg, the connecting member 178 and the valve 100 attached to the connecting member 178) can be maintained during the retrieval process.

[0122] As shown, a proximal end portion of the retrieval sheath 190 is coupled to a retrieval handle 194. The sheath of the retrieval sheath 190 can be, for example, a flexible catheter having any suitable size and / or diameter. In some implementations, for example, the retrieval sheath 190 and retrieval handle 194 can replace and / or function similar to the delivery catheter 182 and / or the delivery handle 188 (now removed). In these implementations, the retrieval sheath 190 can be a catheter having at least a larger inner diameter than the delivery catheter 182. In other implementations, the delivery catheter 182 can remain in place and the retrieval sheath 190 can be driven forward through the lumen of the delivery catheter 182 (e.g., the retrieval sheath 190 has an outer diameter smaller than the inner diameter of the delivery catheter 182). In some instances, it may be desirable to use a retrieval sheath that is larger than the delivery catheter 182 to facilitate and / or accommodate compression of the valve 100 without the use of a loading device.

[0123] Retrieval handle 194 coupled to the proximal end of retrieval sheath 190 may have any suitable shape, size, and / or configuration, for example, to provide at least a portion of a user interface for retrieval sheath 190. The proximal end portion of retrieval handle 194 is shown as having a coupler 195A configured to allow one or more devices to couple and / or otherwise engage with retrieval handle 194. For example, in some embodiments, coupler 195A may be a collet or the like that may be used to secure one or more devices of delivery / retrieval system 180, as described in more detail herein.

[0124] Retrieval element 191 is shown in FIGS. 7-9 as being driven forward through and / or at least partially disposed within retrieval sheath 190. Retrieval element 191 can be any suitable device, element, member, or the like having any suitable size. For example, retrieval element 191 can be and / or can include a catheter having a distal end, the distal end including and / or coupled to engagement member 192 and guide member 193. Retrieval element 191 (e.g., a retrieval catheter) can define a lumen therethrough, the lumen having a sufficiently large diameter to allow retrieval element 191 to be disposed on and driven forward along control catheter 171 while being disposed within and / or movable through retrieval sheath 190.

[0125] The engagement member 192 coupled to the distal end of the retrieval element 191 (e.g., and / or retrieval catheter or catheter portion thereof) can be any suitable device, member, feature, etc. For example, in some implementations, the engagement member 192 can be a hook, a latch member, a protrusion, and / or any other suitable feature. The engagement member 192 can be formed from a shape memory material, such as, for example, a superelastic metal alloy such as Nitinol or the like. Thus, in some implementations, the engagement member 192 can be configured to transition between two or more configurations, such as at least a delivery configuration and a deployed or engaged configuration. In such implementations, the engagement member 192 can have a relatively low bulk profile when in the delivery configuration and can be capable of transitioning (e.g., when extended distally of the retrieval sheath 190 and / or the control catheter 171) to a deployed or engaged configuration in which the engagement member 192 forms and / or assumes a hook or other desired shape.

[0126] The engaging member 192 is configured to engage with one or more portions of the valve 100. For example, the engaging member 192 may engage, latch, couple, etc., with one or more portions of the subannular member 130 of the valve 100, such as the proximal subannular anchoring element 134. More specifically, the portion of the subannular member 130 forming the proximal subannular anchoring element 134 may have and / or form a rim (e.g., a wire rim coated in a biocompatible material, fabric, etc.) that may be engaged and / or latched by the engaging member 192, as described in more detail herein.

[0127] The guide member 193 coupled to the distal end of the retrieval element 191 (e.g., and / or retrieval catheter or catheter portion thereof) can be any suitable device, member, feature, etc. For example, in some embodiments, the guide member 193 can be a scoop, a tang, a flange, and / or any other suitable feature. In the embodiment shown in FIGS. 6-9, for example, the guide member 193 is a scoop formed from one or more braided, mesh, and / or tubing materials. In some embodiments, the braided / mesh material can be, for example, a braided tube or the like, such as formed from a shape memory material, such as a superelastic metal alloy like Nitinol. Thus, in some implementations, the guide member 193 can be configured to transition between two or more configurations and / or states, such as at least a delivery configuration and / or state, a deployment configuration and / or state, or a guiding configuration and / or state. In such implementations, guide member 193 may be in a relatively compact and / or compressed state when in a delivery configuration (e.g., a compressed configuration and / or state), and guide member 193 may be driven forward, for example, through retrieval sheath 190 and / or through delivery catheter 182. Guide member 193 may be expandable to a deployed or guide configuration (e.g., an expanded configuration and / or state) when released from (e.g., distal to) retrieval sheath 190 and / or delivery catheter 182. In the deployed or guide configuration, the braid / mesh material of guide member 193 may expand to form a scoop or scoop-like shape. Moreover, the engagement member 192 may be coupled, embedded, and / or integral with the guide member 193 such that a portion of the engagement member 192 extends outwardly from the guide member 193 (e.g., such that a hook or the like of the engagement member extends outwardly from the guide member 193).

[0128] The guide member 193 is configured to guide one or more portions of the valve 100 into the retrieval sheath 190 (or delivery catheter 182). For example, during retrieval, the valve 100 can be pulled proximally toward the distal end of the retrieval sheath 190. With the valve 100 in the expanded configuration, the valve 100 can be retracted toward and / or into the retrieval sheath 190 (or delivery catheter 182) to initiate a transition of the valve 100 from the expanded configuration to the compressed configuration. As the valve 100 is compressed, one or more portions, edges, etc. of the valve 100 may become lodged onto the distal end of the retrieval sheath 190, preventing retrieval. Thus, the guide member 193 in the expanded configuration can guide one or more portions, edges, etc. of the valve 100 into the retrieval sheath 190 (or delivery catheter 182) to limit and / or substantially prevent lodging.

[0129] 8 and 9 show the retractor 197 of the delivery / retrieval system 180. The retractor 197 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the retractor 197 can be a ratchet mechanism and / or the like that can be operated to apply a force to one or more components coupled to it. In some embodiments, the ratchet mechanism (or other retractor) can provide a mechanical advantage that can help compress the valve 100 and can also help retract the valve 100 into the retrieval sheath 190.

[0130] The retractor 197 includes a first end portion 198A coupled to a coupler 195A (e.g., “first coupler”) and a second end portion 198B coupled to a second coupler 195B. As described above, the first coupler 195A is coupled to and / or contained within a proximal end portion of the retrieval handle 194. The second coupler 195B, which may be similar or substantially identical to the first coupler 195A, is at least temporarily coupled to and / or disposed about a proximal end portion of the control catheter 171. In some implementations, the first coupler 195A of the handle 194 can be in a relatively fixed or locked position relative to the delivery catheter 182, relative to the retrieval sheath 190, and / or relative to the patient. The second coupler 195B may be fixed and / or coupled to the proximal end portion of the control catheter 171 and to the proximal end portion of the retrieval element 191 and may be maintained in a fixed or locked position relative thereto.

[0131] 8 illustrates the retractor 197 in a first configuration in which a first distance is defined between the first end portion 198A and the second end portion 198B of the retractor 197. Thus, a first distance (or substantially a first distance) is defined between the first coupler 195A and the second coupler 195B. Moreover, the second coupler 195B can, for example, lock or otherwise maintain the control catheter 171 and the retrieval element 191 in a fixed relative position (i.e., relative to each other and movable relative to the retrieval sheath 190). FIG. 8 also illustrates that the position of the retrieval element 191 can cause the engagement member 192 to contact the proximal subannular anchoring element 134. In other words, the engagement member 192 can hook onto and / or around an edge, rim, or the like of the proximal subannular anchoring element 134.

[0132] 9 illustrates the retractor 197 in a second configuration defining a second distance between the first and second end portions 198A, 198B of the retractor 197 that is greater than the first distance. For example, a user can engage and / or manipulate the retractor 197 to apply a force operable to drive the second end portion 198B relative to the first end portion 198A. In some embodiments, the retractor 197 can be a ratchet mechanism that can be manipulated and / or driven to increase the distance between the end portions 198A, 198B. ​​With the coupler 195A coupled to the retrieval handle 194 and the coupler 195B coupled to the control catheter 171 and to the retrieval element 191, increasing the distance between the end portions 195A, 195B will drive the distal end portion of the control catheter 171 and the distal end portion of the retrieval element 191 relative to the retrieval sheath 190. In some implementations, proximal movement of at least the retrieval element 191 can be such that the engagement member 192 applies a force to the proximal subannular anchoring element 134 that can assist in transitioning the valve 100 from the expanded configuration shown in FIG. 8 to the compressed configuration.

[0133] 9 illustrates that the valve 100 transitions to the compressed configuration as the valve 100 is retrieved and / or retracted into the retrieval sheath 190. As discussed above, the guide member 193 may be configured to guide and / or direct one or more portions or edges of the valve 100 into the retrieval sheath 190. For example, the guide member 193 may be configured to guide the proximal subannular anchoring element 134 and / or an edge of the inner frame of the flow control component 150 over a distal edge of the retrieval sheath 190 and into a lumen defined by the retrieval sheath 190. Additionally, the retractor 197 configuration may provide a mechanical advantage operable in generating a desired degree of force associated with and / or required to retract the valve 100 into the retrieval sheath 190 while substantially simultaneously maintaining the valve 100 in a compressed state. In this manner, the delivery / retrieval system 180 can be used to retrieve a valve that has been at least partially deployed within a heart chamber.

[0134] Provided below are descriptions of certain aspects or embodiments of a side-deliverable transcatheter prosthetic valve (e.g., prosthetic valve). The transcatheter prosthetic valve (or aspects or portions thereof) described below with respect to certain embodiments can be substantially similar, at least in form and / or function, to valve 100 (or corresponding aspects or portions). Thus, certain aspects and / or portions of certain embodiments may not be described in further detail herein. A description of the valve and a process for delivering and / or deploying the valve using at least a delivery portion of a delivery / retrieval system is provided below, followed by a description of using the retrieval portion of the delivery / retrieval system to retrieve, retract and / or remove the valve from a heart chamber.

[0135] 10-20 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. 10 illustrates a top perspective view of the valve 200. In some implementations, the valve 200 can be deployed, for example, within the annulus of a native tricuspid and / or mitral valve. The valve 200 is configured to permit blood flow from an inflow end of the valve 200 in a first orientation and to prevent blood flow from an outflow end of the valve 200 in a second orientation opposite the first orientation. For example, the prosthetic valve 200 can be a side-deliverable transcatheter prosthetic heart valve configured to be deployed into the annulus of a native tricuspid or native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0136] The valve 200 is compressible and expandable in at least one direction relative to the x-axis of the valve 200 (also referred to herein as the "horizontal axis", "longitudinal axis", "long axis", and / or "length axis"). The valve 200 is compressible and expandable between an expanded configuration for implantation into a desired location within the body (e.g., the human heart) and a compressed configuration for introduction into the body using a delivery catheter (not shown in FIG. 10). In some embodiments, the horizontal x-axis of the valve 200 is orthogonal (90 degrees), substantially orthogonal (75 degrees to 105 degrees), or substantially tilted (45 degrees to 135 degrees) relative to the central (vertical) y-axis when in the expanded and / or compressed configurations. Moreover, the horizontal x-axis of the valve 200 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter within which the valve 200 is disposed.

[0137] In some embodiments, the valve 200 has an expanded or deployed height of approximately 5 mm to 60 mm, approximately 5 mm to 30 mm, approximately 5 mm to 20 mm, approximately 8 mm to 12 mm, or approximately 8 mm to 10 mm, and an expanded or deployed diameter (e.g., length and / or width) of approximately 25 mm to 80 mm, or approximately 40 mm to 80 mm. In some embodiments, the valve 200 has a compressed height (y-axis) and compressed width (z-axis) of approximately 6 mm to 15 mm, approximately 8 mm to 12 mm, or approximately 9 mm to 10 mm. In some implementations, the length (e.g., length along the x-axis) of the valve 200 is not compressed or reduced in order to extend along the length of the central cylindrical axis (e.g., longitudinal or lengthwise axis) of the delivery catheter.

[0138] 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 may have a D-shaped cross-section with a flat portion or surface at or near the anterior leaflet configured to substantially match the annulus of the native mitral valve. In the example shown in FIGS. 10-20, valve 200 is eccentric, with one or more components offset relative to the y-axis, i.e., an asymmetric region.

[0139] 10 and 11 show a valve 200 including an annular outer support frame 210 and a collapsible flow control component 250 mounted internally to the annular outer support frame 210. The annular outer support frame 210 (also referred to herein as the "outer frame") is formed from a shape memory material, such as nickel titanium alloy (nitinol), and is therefore configured to self-expand from a compressed configuration to an expanded configuration. The outer frame 210 includes a transannular member 212 and / or a transannular body that surrounds, forms and / or defines a central (internal) channel about and / or along a vertical or central axis (y-axis). The outer frame 210 includes a supra-annular member 220 circumferentially attached at a top edge of the transannular member 212 and a sub-annular member 230 circumferentially attached to a bottom edge of the transannular member 212. 10 and 11, at least the outer support frame 210 of the valve 200 is covered, wrapped and / or surrounded by a biocompatible covering 240. The biocompatible covering 240 may be a mesh material, pericardial tissue, a woven synthetic polyester material, and / or any other suitable biocompatible material such as those described above.

[0140] The biocompatible covering 240 disposed on or along the supranulular region 220 can form a drum 245 that extends between and / or is coupled to the outer and inner loops of the supranulular region 220. In this manner, the drum 245 can cover the 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 as having an attachment member 238 that can extend along or across a portion of the drum 245 (or supranulular member 220). As described in more detail herein, the attachment member 238 can facilitate temporary and / or removable attachment to a portion of a delivery / retrieval system, such as, for example, a control device, an actuator, or the like.

[0141] The supranulular member 220 is shaped to fit the natural deployment site. For example, in a tricuspid valve replacement, the supranulular member 220 or atrial collar may have a tall posterior wall portion to fit against the septal region of the natural valve, and may have a distal portion and a proximal portion. The distal portion may be larger than the proximal portion to allow for a larger flat space above the supranulular region of the (atrial) ventricular outflow tract (VOT). For example, in a mitral valve replacement, the supranulular member 220 of the outer frame 210 may be D-shaped or shaped like a hyperbolic paraboloid to mimic the natural structure. In some embodiments, the supranulular member 220 of the outer frame 210 may be substantially similar, at least in form and / or function, to the supranulular member 120 described above. As such, some and / or aspects of the supranulular member 220 may not be described in further detail herein.

[0142] 12 illustrates a laser cut wireframe portion (uncoated) of the supranulnar member 220. As illustrated, the supranulnar 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 (formed at least in part by the outer loop 221) of the supranulnar member 220 is configured to engage with distal supranulnar tissue, and the proximal portion 224 (formed at least in part by the outer loop 221) is configured to engage with proximal supranulnar tissue. The distal portion 222 and the proximal portion 224 can have a rounded and / or curved shape, where the radius of curvature of the proximal portion 224 is larger compared to the radius of curvature of the distal portion 222. The distal portion 222 can, for example, define a distal anchoring loop 223 that can engage distal supranular tissue to at least partially stabilize and / or anchor the frame 210 within the native annulus. Although not shown in FIGURE 12, the proximal portion 224 can similarly define a proximal upper anchoring element that can engage proximal supranular tissue to at least partially stabilize and / or anchor the frame 210 within the native annulus.

[0143] The inner loop 225 of the supranulular 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. 10 , the inner loop 225 can be coupled to a biocompatible material 226 that can be used to couple the inner frame 251 of the flow control component 250 to the inner loop 225 of the support frame 210. In some implementations, the suspension of the inner loop 225 from the outer loop 221 can 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, for example, as described above with reference to the frame 210.

[0144] The one or more splines 227 of the supra-annular member 220 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the supra-annular member 220 can include a proximal spline 227 and one or more distal splines 227. The distal spline 227 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 to, and / or otherwise engage with an actuator, a control device, and / or a portion of a delivery system. For example, the proximal spline 227 can include, form, and / or be coupled to waypoints 228 that can be used to couple and / or receive one or more portions of a control device and / or delivery system, as described above with reference to the frame 110.

[0145] As shown in FIGS. 10-12, in this embodiment, the supra-annular member 220 has an arcuate configuration with the splines 227 projecting away from other portions of the sub-annular member 220. For example, a laser cut frame of the supra-annular member 220 can be formed with splines 227 (FIG. 12) having an arcuate configuration. In some implementations, the arcuate splines 227 can apply a force to the drum 245 that curves 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 improving the performance of the valve 200 and / or reducing fatigue in or along the drum 245. Stated another way, the pressure exerted on the atrial side of drum 245 during atrium contraction (diastole) is insufficient to reverse the arcuate configuration of drum 245 (e.g., no oil can deflection occurs) due to arcuate splines 227. The arcuate configuration of drum 245 also allows it to withstand the greater pressure exerted on the ventricular side of drum 245 during ventricular contraction (systole) without substantial deflection. Moreover, the arcuate shape of splines 227 can facilitate the insertion and retrieval of one or more portions of a delivery system through waypoints 228, with waypoints 228 positioned at a desired angle and / or orientation.

[0146] 13 is a distal perspective view illustrating the transannular member 212 of the outer frame 210 of the valve 200. In some embodiments, the transannular member 220 of the outer frame 210 can be substantially similar, at least in form and / or function, to the transannular regions and / or transannular members 112 described above. As such, some and / or aspects of the transannular member 212 may not be described in further detail herein.

[0147] The annular passage member 212 can be shaped and / or formed into a ring, a cylindrical tube, a conical tube, and / or any other suitable annular shape. In some embodiments, the annular passage member 212 can have a side shape of a concave cylindrical shape (with walls curved inward), a slanted hourglass, a curved hourglass with graduations, a ring or cylinder with a flared top or bottom, or both. Moreover, the annular passage member 212 can form and / or define an opening or central channel 214 extending along the central axis 204 (e.g., y-axis). The central channel 214 (e.g., central axial lumen or central axial channel) can be sized and configured to receive the flow control component 250 over a portion of the diameter of the central channel 214. In some embodiments, the annular passage 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 support frame 210, as described above, and also based at least in part on the size, shape, and / or configuration of the native annulus within which the annular passage region 212 is configured to be deployed.

[0148] The annular crossing member 212 can be and / or can include a wire frame that is laser cut from Nitinol or the like and heat set, for example, into a desired shape and / or configuration. The annular crossing region 212 can be formed to include a set of compressible wire cells 213 having a substantially perpendicular orientation and / or cell shape relative to a central axis extending through the central channel 214 to minimize distortion of the wire cells when the annular crossing region 212 is in a vertically compressed, rolled, or folded compressed configuration. As shown in FIG. 13, the annular crossing member 212 includes a first laser cut half 215 (e.g., an anterior portion) and a second laser cut half 216 (e.g., a posterior portion) that can be formed into a desired shape and joined together to form the annular crossing member 212. The anterior portion 215 and the posterior portion 216 may be joined at one or more hinge points 217 along the distal and proximal portions of the trans-annular member 212. More specifically, the anterior portion 215 and the posterior portion 216 may be joined along the distal side of the trans-annular member 212 via two sutures forming two hinge or attachment points 217 and along the proximal side of the trans-annular member 212 via one suture forming one hinge or attachment point 217.

[0149] In some embodiments, forming the annulus-passing member 212 in this manner may allow the annulus-passing region 212 to bend, flex, fold, deform, and / or otherwise reconfigure (without substantial plastic deformation and / or substantial undue fatigue) in response to lateral bending 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. Moreover, the use of sutures to bind at the hinge points 217 may allow a desired amount of slippage between the sutures and the anterior and posterior portions 215, 216, thereby limiting and / or substantially preventing binding, sticking, and / or breakage in response to bending along the lateral or z-axis.

[0150] 13, the proximal portion of the transannular member 212 includes a single hinge or commissure point 217. In some embodiments, the transannular member 212 can define a gap or space 218 below the proximal hinge or commissure point 217 that can provide space to allow a proximal anchoring element of the subannular member 230 to transition between a first configuration and a second configuration, as described in more detail herein.

[0151] 14 is a distal perspective view illustrating the subannular member 230 of the outer frame 210 of the valve 200. In some embodiments, the subannular member 230 of the frame 210 can be similar, at least in form and / or function, to the subannular region and / or subannular member 130 described above. As such, some and / or aspects of the subannular member 230 may not be described in further detail herein.

[0152] 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, 234 are integrally and / or unitarily 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 as 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 disposed therein) through an opening, hole, aperture, port, etc. defined by the guidewire coupler 233 (see, e.g., FIGS. 18-20 ). A guidewire catheter 284 extends through guidewire coupler 233, allowing valve 200 to be driven forward over or along a guidewire disposed within guidewire catheter 284. In some implementations, guidewire catheter 284 may extend below valve 200 and beyond distal anchoring element 232 and provide a desired stiffness during delivery and / or deployment.

[0153] Anchoring elements 232 and / or 234 are configured to engage a desired portion of native tissue to attach frame 210 to the annulus of the native valve in which frame 210 is deployed. For example, distal anchoring element 232 can extend (e.g., approximately 10 mm to 40 mm) from subannular member 230 into the RVOT or into other ventricular locations. Distal anchoring element 232 can be shaped and / or biased such that distal anchoring element 232 applies a force against subannular tissue operable to at least partially secure a distal end portion of frame 210 within the native annulus.

[0154] The proximal anchoring element 234 can be configured to engage subannular tissue proximal to the native annulus to aid in anchoring the frame 210 within the annulus. As described above, the subannular member 230 of the frame 210 can be and / or can include a laser cut wire frame formed of a shape memory material, such as Nitinol, heat set into a desired shape, and then wrapped with a biocompatible material (e.g., fabric and / or the like). The proximal anchoring element 234 is configured to transition, move, and / or otherwise reconfigure between a first configuration 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. Stated another way, the proximal anchoring element 234 can be a movable anchoring element configured (e.g., by an actuator) to move and / or otherwise transition between a first configuration and a second configuration, e.g., to reduce the circumferential length of the subannular member 220 upon delivery and / or deployment.

[0155] As described above, the proximal anchoring element 234 can be compressed, contracted, retracted, undeployed, folded, and / or constrained (e.g., proximate, adjacent, and / or in contact with the transannular region 212 of the support frame 210 and / or with the supra-annular member 220) when in a first configuration, and can be expanded, elongated, deployed, unfolded, and / or unconstrained (e.g., extending away from the transannular member 212) when in a second configuration. In some embodiments, the proximal anchoring element 234 can be biased to the second configuration and / or heat set in the second configuration. Moreover, in some implementations, the space 218 defined by the transannular member 212 of the outer frame 210 is configured to provide sufficient room to allow the proximal anchoring element 234 to transition between the first and second configurations.

[0156] The proximal anchoring element 234 can be configured to move in any suitable direction from a first extended configuration to a second compressed configuration based at least in part on how the proximal anchoring element 234 is coupled to an actuator and / or the like. For example, the proximal anchoring element 234 can be moved inwardly toward the medial flow control component 250, and / or can be moved upwardly toward the supranulular member 220 and / or a portion thereof, and / or can be moved toward an anterior or posterior portion of the valve 200. Moreover, because the transannular member 212 of the frame 210 is coupled to the subannular member 230, actuation of an actuator, control device, etc., in some instances, drives one or more portions of the transannular member 212, as described in further detail herein.

[0157] A collapsible (inner) flow control component 250 is mounted inside the outer frame 210. The flow control component 250 has a collapsible and compressible inner wire frame 35 (also referred to as the "inner leaflet frame" or "inner frame") having two (or more) bending regions, hinge regions, bond regions, elastically deformable regions, etc. A set of two to four flexible leaflets 256 are mounted in or on the inner frame 251 (not shown in FIG. 10). In some embodiments, the flow control component 250 has cusps or pockets for three leaflets 256 mounted in the inner frame 251, as described in more detail herein.

[0158] The inner flow control component 250, like the outer frame 210, is bendable and compressible. For example, the inner frame 251 is bendable (e.g., bendable at bend regions or the like) along or in the z-axis from a cylindrical configuration to a flattened cylindrical configuration (or bilayer band), where the bend regions are located distal and proximal to the inner frame 251. The flow control component 250, like the outer frame 210, is also compressible vertically (y-axis) to a shortened or compressed configuration. Bending (compressing) in the z-axis and compressing vertically in the y-axis allows the valve 200 to maintain a relatively large dimension along the horizontal direction (x-axis). In some implementations, the outer frame 210 and the flow control component 250 are shortened along the z-axis until the side walls touch or nearly touch. This also allows the outer frame 210 and flow control component 250 to maintain a radius along the horizontal axis (x-axis) while minimizing the number of wire cells that may be damaged by forces applied when bending and / or compressing the valve 200 when loading it into a delivery catheter.

[0159] The flow control component 250 has a smaller diameter and / or perimeter length compared to the diameter and / or perimeter length of the central channel of the outer frame 210. The flow control component 250 is attached 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. 10). In some implementations, a spacer element 245 is disposed within and / or across the central channel, which may facilitate attachment of a portion (e.g., an otherwise unsupported portion) of the flow control component 250 to the outer support frame 210 and / or may facilitate ingrowth of native tissue onto at least a portion of the supraannular member 220 of the valve 200.

[0160] In certain embodiments, the inner frame 251 can have a diameter of approximately 25 mm to 30 mm, the outer frame 210 (or its transannular member 212) can have a diameter of approximately 50 mm to 80 mm, and the supranulular member 220 (or atrial collar) extends approximately 20 mm to 30 mm beyond the top edge of the transannular member 212 to provide a seal of the atrial floor against paravalvular leak (PVL). The flow control component 250 and outer frame 210 can be bendable (e.g., in the z-axis) and / or compressible (e.g., in the y-axis) to reduce the overall size of the valve 200 to fit within a 24 Fr to 36 Fr (8 mm to 12 mm inner diameter) delivery catheter (not shown in this FIG. 10).

[0161] 15-19 illustrate at least a portion of a flow control component 250 included within valve 200. For example, FIG. 15 is a top perspective view of an inner leaflet frame 251. In some embodiments, the inner leaflet frame 251 is formed from two separate wire frame sheets or members that are joined together at lateral connection points 251, 253 (e.g., folding regions, elastically deformable regions, joined edge portions, etc.). The inner leaflet frame 251 is shown in an expanded or cylindrical configuration (e.g., before being folded and / or compressed).

[0162] Although not shown, the inner leaflet frame 251 can transition from an expanded or cylindrical configuration to an at least partially folded configuration. The inner leaflet frame 251 can have wire frame sidewalls that allow for rotation or hinge at least at the lateral connection points 251, 253. The inner leaflet frame 251 can be configured to fold in response to the valve 200 being folded for delivery and / or in response to being compressed. For example, when transitioning to a fully folded configuration, the wire frame sidewalls can rotate, hinge, and / or fold at their lateral connection points 251, 253. Additionally, the inner leaflet frame 251 can be vertically compressed to a compressed configuration. The wire frame sidewalls can form cells (e.g., diamond-shaped cells or the like) that can be oriented in a compressed direction to 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.

[0163] In some embodiments, the inner leaflet frame 251 of the flow control component 250 can be formed from a straight wire frame or from a laser cut sheet before being further assembled into a cylindrical structure (e.g., as shown in FIG. 15). The inner leaflet frame 251 can be formed into a cylindrical structure or configuration (or a conical structure or configuration) with edge portions of the straight wire frame sheets connected or joined at lateral connection points 251, 253 (e.g., hinge regions, fold regions, etc.). Moreover, the inner leaflet frame 251 can be expanded (e.g., driven, formed, bent, etc.) from a straight sheet configuration into a cylindrical structure or configuration.

[0164] 16 and 17 illustrate structural band 255 made of pericardial tissue with leaflet pockets 256 sutured into structural band 255. FIGS. 16 and 17 are side perspective and bottom views, respectively, illustrating structural band 255 and leaflets 256 prior to assembly and / or attachment onto and / or into inner frame 251 to form collapsible (foldable, compressible) flow control component 250. FIG. 16 illustrates structural band 255 formed from pericardial tissue after leaflet pockets 256 have been sutured into structural band 255 and assembled into a cylindrical leaflet configuration, with leaflet pockets 256 disposed on the inner surface of structural band 255. The leaflet pocket 256 can be sewn into the structural band 255 with an open edge extending outward and with the sewn edge forming a closed top parabolic edge that provides attachment. FIG. 17 is a bottom view of the flow control component 250. The cylindrical structural band 255 and the leaflet component 256 are shown partially mated toward forming an occlusive fluid seal. Although not shown, the cylindrical structural band 255 can be attached to or within the inner leaflet frame 251 (FIG. 15) to collectively form the flow control component 250, which is attached to the inner loop 225 of the supranulular member 220 of the outer support frame 210, as described in detail above with reference to FIGS. 10 and 11.

[0165] 18-20 are various views illustrating a prosthetic valve 200 removably coupled to a control device 270 that is used to drive the valve forward and / or backward through a delivery catheter and / or to drive one or more portions of the valve 200, such as at least the subannular member 230 of the valve frame 210, as described herein. FIG. 18 is a side perspective view of the prosthetic valve 200 removably coupled to the control device 270. 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 a distal end. The control catheter 271 may be a multi-lumen steerable catheter, for example, having one or more components of the control device 270 extending therethrough, as described in detail in the '032 PCT, incorporated by reference above. The connecting member 278 is removably couplable to the supranulus member 220 of the valve frame 210, thereby connecting the valve 200 to the control catheter 271. As described in further detail herein, the control catheter 271 may be operable, for example, to drive the prosthetic valve 200 forward through a delivery catheter (not shown) and / or to control or steer the prosthetic valve 200 during deployment, retrieval and / or withdrawal (e.g., after at least partial deployment) of the prosthetic valve 200 into the delivery catheter, and / or the like.

[0166] 18 shows the connecting member 278 having a wishbone or yoke configuration, other configurations are possible. Thus, the connecting member 278 can have a first portion, a first side, and / or a first arm, and a second portion, a second size, and / or a second arm located opposite the first portion, the first side, and / or the first arm. The connecting member 278 can be configured to transition between an expanded configuration and a compressed configuration, for example, to drive the control catheter 271 (and the connecting member 278 disposed at its distal end) forward through a delivery catheter. The connecting member 278 can be formed from any suitable material, such as a shape-memory-compatible material such as Nitinol or the like.

[0167] In some embodiments, the connecting member 278 can contact and / or be removably coupled to the drum 245 of the supranulnar member 220 and / or to the frame 210 or any other suitable portion of the valve 200. The connecting member 278 can be removably coupled to the valve 200 via sutures, via tethers, via cables, via clips, via couplers, and / or via any other removably coupled. 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, wound through a set of openings defined along the connecting member 278 (yoke) or by each side or arm of the connecting member 278, wound around one or more attachment members 238 of the valve 200, and extending back into the corresponding lumens of the control catheter 271. The attachment member 238 can be formed by, coupled to, and / or extending from the supra-annular member 220 (e.g., drum 245). In some embodiments, the attachment member 238 of the valve 200 can be a tether, suture, cable, frame structure, and / or the like that can be coupled to and / or extending from a wire frame portion of the supra-annular member 220, i.e., of the drum 245 (or other biocompatible cover). Additionally, the attachment member 238 can form a pair of loops 239 or the like around which the tether 275 of the control device 270 can be routed or wrapped.

[0168] The looped arrangement of tether 275 through and / or around connecting member 278 and attachment member 238 of valve 200 is such that each of the proximal and distal ends of tether 275 extends through and out of (e.g., proximally of) single control arm 277 of control portion 272. In this manner, a proximal force can be applied to each of the proximal and distal ends of tether 275, increasing tension along tether 275, thereby pulling connecting member 238 toward drum 245, thereby securing connecting member 278 to the valve. Conversely, by applying a proximal force to only one of the proximal and distal ends of tether 275, tether 275 can be disengaged from connecting member 278 and tether 275 can be pulled from control device 270, thereby allowing connecting member 278 to be decoupled, i.e., removed, from valve 200.

[0169] 18 further illustrates a guidewire catheter 284 of the delivery system, for example, extending through waypoints 228 or openings in the supranullar member 230 and / or its drum 245, and through the guidewire coupler 233 of the distal anchoring element 232. As shown in FIGS. 19 and 20, the guidewire catheter 284 can extend below the flow control component 250 of the valve 200. Prior to and / or as part of delivery, the guidewire catheter 284 can be driven forward and / or inserted through the valve 200 and can be driven forward over a guidewire already placed to a desired location within the heart. Thus, delivering the valve 200 in a compressed configuration through a delivery catheter includes driving the guidewire catheter 284 forward along the guidewire. The guidewire catheter 284 can extend through the guidewire coupler 233 of the distal anchoring element 232, and can extend beyond such guidewire coupler 233 (e.g., the distal end of the guidewire catheter 284 can be located distal to the guidewire coupler by about 0.1 centimeters (cm) to about 1.0 cm, or more).

[0170] The guidewire catheter 284 can be, for example, stiff enough to (at least partially) limit and / or define the range of motion of the valve 200 during delivery. For example, the guidewire catheter 284 can define an axis about which the valve 200 can rotate during delivery, but the guidewire catheter 284 can substantially limit or prevent movement of the valve 200 in other directions. In some implementations, the configuration of the connecting member 278 (e.g., yoke) and the guidewire catheter 284 can provide greater control over 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 can improve visualization during image-guided delivery. For example, in some instances, radiopaque markers or wires can be placed against the annular plane of the native valve and can define landmarks during image-guided delivery. In such instances, radiopaque markers on the guidewire catheter 284 and / or on 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 landmarks that correspond to the annular surface of the native valve. Thus, image-guided delivery allows a user to visualize the valve 200 during delivery and / or deployment, and allows the user to visualize when the valve 200 is seated within the annulus (e.g., the radiopaque marker bands of the valve 200 are inferior or subannular relative to the radiopaque landmarks).

[0171] 18 further illustrates tethers 276A, 275B (e.g., tethers, sutures, cables, tension members, and / or the like) extending from control catheter 271 (e.g., through one or more lumens thereof) through waypoint 228. Control device 270 can include a single tether or multiple tethers (e.g., one tether, two tethers, three tethers, four tethers, five tethers, six tethers, seven tethers, eight tethers, nine tethers, ten tethers, or more, each of which can be removably coupled to one or more attachment points on valve 200). In this embodiment, for example, control device 270 includes two tethers 276A, 276B. The tethers 276A, 276B can be configured to drive and / or translate 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.

[0172] 19 and 20 are bottom views of the valve 200 and show tethers 276A, 276B extending from the control catheter 271 and extending through waypoints 228 of the supranullar member 220 and releasably attached to the subannular member 230 and / or to the proximal subannular anchoring element 234. The tethers 276A, 276B can be wound around and / or through attachment points along the subannular member 230 and then routed back through the waypoint 228 and through the control catheter 271 with both ends of each tether 276A, 276B external to the patient, such that the tethers 276A, 276B can be manipulated to actuate the valve 200 and / or transition the shape of the proximal anchoring element 234, the subannular member 230, and / or other portions of the valve 200 to facilitate seating at least a proximal portion of the valve 200 within the native annulus. Stated another way, increasing the amount of tension along the tethers 276A, 276B can be operable to transition at least the subannular member 230 (or a portion thereof) between a first configuration and a second configuration. In this manner, tethers 276A, 276B can be actuated (or tensioned) and / or released in a manner similar to that described above with reference to tether 275.

[0173] FIG 19 is a bottom perspective view of the valve 200 and control device 270 showing the subannular member 230 (and / or its proximal subannular anchoring element 234) in at least a partially extended or unactuated configuration. FIG 20 is a bottom perspective view of the valve 200 and control device 270 showing the subannular member 230 (and / or its proximal subannular anchoring element 234) partially actuated, e.g., such that the proximal anchoring element 234 of the subannular member 230 is drawn toward the flow control component 250. More specifically, the first tether 276A can be actuated by pulling an end of the tether 276A proximally, as shown in FIG 20, which can place the tether 276A in tension and draw the attachment points through which the tether 276A is routed closer together. Similarly, the second tether 276B can be actuated by pulling an end of the tether 276B in a proximal direction, which can place the tether 276B in tension and draw the attachment points through which the tether 276B is routed closer together. In this embodiment, for example, the first tether 276A can be operable to pull the proximal anchoring element 234 inwardly toward the flow control component 250, while the second tether 276B can be operable to pull a side or lateral region of the subannular member 230 inwardly toward the longitudinal centerline of the valve 200. Additionally, each of the tethers 276A, 276B can pull a corresponding portion of the subannular member 230 toward the supranullar member 220 based at least in part on the connection member 278 of the control device 270 being releasably attached to the supranullar member 230 (see, e.g., FIG. 18 ).

[0174] During deployment, an operator can actuate a proximal end portion of control device 270 (e.g., disposed external to the body) to, for example, pull tethers 276A and / or 276B in a proximal direction, thereby folding or compressing proximal anchoring element 234 toward flow control component 250 and / or otherwise reconfigure subannular member 230 from a first configuration to a second configuration. Actuating control device 270 can also cause proximal portions of the posterior and anterior walls of transannular member 212 to fold, compress, and / or draw inwardly toward flow control component 250 (see, e.g., FIG. 20 ). After the valve 200 is deployed within the annulus of the native valve, the control device 270 may be removed or uncoupled from the valve 200, the guidewire catheter 284 (and the guidewire extending therethrough) may be retracted through a waypoint or opening in the supranullar member 220, and the delivery system may be uncoupled from the valve 200 and withdrawn from the patient, thereby leaving the deployed prosthetic valve 200 in place within the annulus of the native heart valve.

[0175] As mentioned above, any valve herein can be configured for lateral delivery into the annulus of a native heart valve. For example, FIGS. 21-24 illustrate a process for delivering and deploying a side-deliverable prosthetic valve. FIG. 21 is a side perspective view of a valve 300 at least compressed vertically (e.g., along a central axis and / or in the direction of blood flow through the valve 300). For example, the valve 300 can include a frame 310 having horizontally arranged diamond-shaped cells rather than the traditional vertically arranged diamond-shaped cells, which can facilitate vertical compression (e.g., top-to-bottom compression). In some implementations, the valve 300 can also be folded or compressed laterally. In the compressed configuration, the valve 300 can be loaded into a delivery catheter 382 in a side-deliverable or orthogonal-deliverable position or orientation. In some implementations, lateral or orthogonal delivery can allow for delivery of a valve having a larger diameter compared to the diameter that can be delivered using traditional radial compression (e.g., compressing radially toward the central axis). Additionally, orthogonal delivery can provide access to the tricuspid annulus, for example, from the IVC, allowing a lateral or orthogonal delivered valve 300 to be directly delivered (e.g., distal subannular tabs or anchoring elements 332 can be aligned with and / or inserted into the tricuspid annulus).

[0176] 22 is a side perspective view of the valve 300 partially delivered or partially released from the delivery catheter 382, ​​where the valve 300, or at least a portion thereof, is allowed to transition from a compressed configuration to an expanded configuration. For example, in some instances, the valve 300 can be driven forward through the delivery catheter 382 and delivered from the delivery catheter 382 toward the native valve annulus using a control device (also referred to herein as "control device 370"), a stiff pulling / pushing rod, a multi-lumen catheter, and / or the like. A guidewire 385 is shown extending from the delivery catheter 382 through the native tricuspid valve annulus into, for example, the right ventricle RVOT. In some implementations, the guidewire 385 can extend to and / or through the pulmonary valve in the RVOT.

[0177] 22 further shows that as the valve 300 is released from the delivery catheter 382, ​​the distal subannular tab or anchoring element 332 is driven forward along the guidewire 385, through the annulus of the native tricuspid valve, and at least partially into the RVOT. The distal subannular tab or anchoring element 332 is configured to provide anchoring for the valve 300 as it is positioned and / or when blood flow through the valve 300 is being assessed upon deployment.

[0178] 23 is a side perspective view of the valve 300 fully deployed or released from the delivery catheter 382 into a more expanded configuration. The valve 300 is at least partially positioned and / or at least partially secured to the annulus using the distal subannular tabs or anchoring elements 332 against the distal subannular surface of the annulus. In some instances, the valve 300 can be temporarily held at a high angle above the native annulus prior to fully deploying the valve 300 using the control catheter 370. This allows blood flow to transition from natural flow through the native valve to flow through the prosthetic valve. For example, as the valve 300 is deployed, the natural blood flow through the native tricuspid valve transitions to include at least partial flow around the prosthetic valve 300 and into the native annulus, and then transitions to at least partial flow through the inflow end and out the outflow end of the prosthetic valve 300 (indicated by the arrows labeled "INFLOW" and "OUTFLOW" in FIGS. 23 and 24, respectively) and into the native annulus. FIG. 24 further illustrates a proximal subannular anchoring element ("proximal anchoring element 334"), tabs, lower tension arms, etc., which may facilitate attachment or anchoring of the valve 300 after it is fully deployed into the native annulus. In some implementations, the proximal anchoring element 334 may be movable and / or otherwise reconfigurable and may be in a first configuration before the proximal side or end of the valve 300 is inserted into the native valve annulus.

[0179] 24 is a side perspective view of the valve 300 fully extracted or released from the delivery catheter 382 and then seated within the annulus of a native tricuspid valve. In some implementations, after the valve 300 is inserted into the annulus, the proximal anchoring element 334 may be allowed to transition to a second or expanded configuration, which may, for example, increase the diameter and / or circumferential length of the subannular region or portion of the valve 300. In some implementations, the valve 300 may be anchored using at least the distal subannular tab or element 332 and the proximal subannular tab or element 334. In some embodiments, the valve 300 may also include a distal supranuclear (atrial) anchoring element, which may also facilitate anchoring of the valve 300 into the annulus. Delivery of the valve 300 as described herein allows for a smooth transition from native blood flow to full and / or complete blood flow, with blood entering through the inflow end of the prosthetic valve 300 and exiting the outflow end of the prosthetic valve, and thus flowing through the native valve annulus.

[0180] The valves 100, 200, and / or 300 are generally described above as being delivered into the heart, deployed from a delivery catheter, and seated within the annulus of the native heart to function as a prosthetic heart valve. As described above, after the prosthetic valve 100, 200, and / or 300 is seated, the delivery system used to deliver the valve is removed from the patient, leaving the prosthetic valve 100, 200, and / or 300 in place. However, in some implementations, it may be desirable to retrieve and / or remove a side-deliverable prosthetic valve upon delivery, upon deployment, and / or after the prosthetic valve is seated within the annulus. In some such implementations, a retrieval system and / or retrieval portion of a delivery / retrieval system (sharing one or more common elements) may be used to engage the prosthetic valve and retrieve the valve into a delivery catheter, into a retrieval sheath, and / or the like.

[0181] For example, FIGS. 25-42 illustrate a retrieval portion and / or aspects of a delivery / retrieval system 480 (referred to herein as "retrieval system 480") configured to retrieve a prosthetic valve during delivery, during deployment, and / or after the prosthetic valve is seated into the valve annulus, according to one embodiment. In some instances, the retrieval process for a valve, such as valve 200 shown in FIGS. 10-20, can begin with removing one or more components included within the delivery portion of delivery / retrieval system 480. For example, FIGS. 25-28 illustrate components included within the delivery portion of delivery / retrieval system 480 and used to deliver and / or deploy valve 400 into the annulus of a native heart valve. As described above with reference to delivery / retrieval system 180, delivery / retrieval system 480 can include a delivery catheter (not shown) configured to provide access to a heart chamber (e.g., via an IVC approach or via an SVC approach).

[0182] 25 illustrates a delivery and / or control handle 488, which may facilitate loading and / or manipulation of the valve 400, for example, during delivery or deployment. In some embodiments, the delivery and / or control handle 488 may be similar to any handle in the delivery / retrieval system described in the '032 PCT, incorporated by reference above, and thus portions and / or aspects of the delivery and / or control handle 488 may not be described in further detail herein. In some embodiments, the delivery and / or control handle 488 may be operably coupled to and / or part of the control device 470. For example, a proximal end portion of the control catheter 471 of the control device 470 may be coupled to and / or disposed within the delivery and / or control handle 488. Moreover, the proximal control end of the control device 470 may be coupled to and / or extend from a delivery and / or control handle 488, which may enable insertion of one or more components into one or more lumens in the control catheter 471 of the control device 470, as described in the '032 PCT incorporated by reference above.

[0183] 26 is a top perspective view of a distal end portion of control device 470, showing control catheter 471 coupled to and / or including connecting member 478. One or more tethers 475 can be used to removably couple connecting member 478, for example, to a supra-annular member of the valve. More specifically, tether 475 can be routed from a delivery and / or control handle 488, through control catheter 471 and through connecting member 478, and can be wrapped around an attachment member of the valve, through connecting member 478, through control catheter 471, and back through delivery and / or control handle 488. The wound configuration of the tethers 475 allows the connecting members 478 to be removably coupled to the supra-annular member 420 of the valve, with the ends of each tether 475 disposed at and / or coupled to a delivery and / or control handle 488, thereby enabling a user to manipulate the connecting members 478 and / or the coupling between the connecting members 478 and the valve, as described above with reference to the delivery / retrieval system 180 shown in Figures 1-9.

[0184] FIG. 27 illustrates the delivery and / or control handle 488 decoupled from the control device 470 and / or the like. For example, the delivery and / or control handle 488 can have a split body design, allowing the delivery and / or control handle 488 to be separated into at least a first portion 488A and a second portion 488B. FIG. 28 illustrates that the tether 475 can remain routed through the control catheter 471 even when the delivery and / or control handle 488 is detached. Although not shown in FIGS. 25-28, one or more tethers (other than tether 475), tension members, actuators, etc., coupled to one or more portions of the valve 400 can also be detached. For example, a tether used to drive a proximal anchoring element can be decoupled from the valve and detached from one or more lumens of the control catheter 471. Similarly, the guidewire and guidewire catheter along which the valve is advanced during delivery can be retracted and / or detached. In some implementations, the delivery catheter can also be removed from the patient without removing the control catheter 471. For example, in implementations where a relatively large valve is being retrieved, it may be desirable to remove the delivery catheter to allow a larger diameter retrieval sheath to be driven forward along the control catheter 471 into the heart chamber. In other implementations, the delivery catheter can remain in place and the retrieval components of the delivery / retrieval system 480 can retrieve the valve into the lumen of the delivery catheter (e.g., when retrieving a relatively small valve).

[0185] Although portions of the delivery / retrieval system 480 have been removed, FIGS. 28-30 show that the control catheter 471 (with connecting member 478 disposed at its distal end) and tether 475 remain attached, i.e., coupled, to the valve. For example, as with delivery and deployment, the control catheter 471 can still extend through the patient's vasculature with connecting member 478 at its distal end disposed within the heart chamber and still coupled to the valve. With the desired delivery portion of the delivery / retrieval system 480 releasably detached, one or more retrieval portions of the delivery / retrieval system 480 can be employed to engage and retrieve the valve 400.

[0186] 28-30 illustrate an exchange catheter 496 that is configured to couple to the control catheter 471, thereby allowing a retrieval portion of the delivery / retrieval system 480 to be disposed over the control catheter 471. FIG. 29 illustrates a proximal end of the exchange catheter 496, which includes, for example, a threaded male coupler that may be inserted into a lumen of the control catheter 471 to form a threaded connection therebetween. In this manner, the distal end portion of the exchange catheter 496 may couple to a proximal end portion of the control catheter 471, for example, to extend the length of the control catheter 471 (e.g., proximally). In some implementations, the additional proximal length may allow the delivery and / or retrieval system 480, and / or one or more portions thereof, to be driven forward over the exchange catheter 496 and over at least a portion of the control catheter 471, as described in more detail herein.

[0187] With the delivery and / or control handle 488 removed, the ends of each tether 475 are unattached, i.e., unanchored, and extend beyond the proximal end of the control catheter 471. FIG. 30 shows a control catheter 471 coupled to an exchange catheter 496 that includes and / or defines features configured to engage and / or couple to the tethers 475 to secure the end portions. For example, the exchange catheter 496 can include and / or define a skive 496A that can selectively receive the end portions of the tethers 475 to secure them via a clamping force or the like. In other embodiments, the exchange catheter 496 can include any other suitable coupler, retaining member, and / or engagement feature. In this manner, control of the distal end portion of the control device 470 (e.g., the connecting member 478 and also the valve 400 attached to the connecting member 478) can be maintained during the retrieval process.

[0188] 31-33 show a retrieval sheath 490, a retrieval element 491, and a retrieval handle 494 contained within the retrieval portion of the delivery / retrieval system 480. FIG. 31 shows a proximal end portion of the retrieval sheath 490 coupled to the retrieval handle 494. The retrieval sheath 490 can be, for example, a flexible catheter having any suitable size and / or diameter. In some implementations, for example, the retrieval sheath 490 and retrieval handle 494 can substitute for and / or function similarly to the delivery sheath and to the delivery and / or control handle 488 (now removed). In some such embodiments, the retrieval sheath 490 and retrieval handle 494 can be similar and / or substantially identical to the delivery sheaths and / or handles described in the '032 PCT, incorporated by reference above. In some implementations, the retrieval sheath 490 can be a steerable catheter, or at least a partially steerable catheter, having at least a larger inner diameter compared to the delivery sheath it replaces. In other implementations, the delivery sheath can remain in place and the retrieval handle 494 can be coupled to its proximal end. In some instances, it may be desirable to use a retrieval sheath 490 that is larger than the delivery sheath used to deliver the valve, thereby facilitating and / or addressing compression of the valve 400 without the use of a loading device and / or the like. For example, in some instances, the retrieval sheath 490 can be a 38 Fr catheter and the delivery sheath can be a 28 Fr catheter. In some instances, the larger diameter retrieval sheath 490 can enable retrieval of a relatively large valve, for example. In other instances, the retrieval handle 494 can be coupled to an existing (pre-deployed) delivery sheath, for example, when retrieving a relatively small valve.

[0189] The retrieval handle 494 coupled to the proximal end of the retrieval sheath 490 may have any suitable shape, size, and / or configuration and may, for example, provide at least a portion of a user interface for the retrieval sheath 490. For example, the retrieval handle 494 may have a size, shape, and / or configuration similar to the previously removed delivery handle and / or control handle 488. FIG. 32 illustrates a proximal end portion of the retrieval handle 494 that includes a coupler 495A configured to couple and / or otherwise engage one or more devices to the retrieval handle 494. For example, in some embodiments, the coupler 495A may be a collet or the like that may be used to secure one or more devices of the delivery / retrieval system 480, as described in more detail herein. A distal end portion of the retrieval handle 494 is coupled to the retrieval sheath 490. In some embodiments, the distal end portion of the retrieval handle 494 can include one or more control features and / or the like that allow a user to steer or at least partially steer (e.g., in at least one direction or in at least one plane) the distal end portion of the retrieval sheath 490.

[0190] FIG. 32 illustrates the retrieval element 491 extending through a proximal end of the retrieval handle 494, and FIG. 33 illustrates the distal end of the retrieval sheath. As illustrated, the retrieval element 491 can be and / or include a catheter movable through the retrieval sheath 490 and through the retrieval handle 494. In some embodiments, a lumen defined by the catheter of the retrieval element 491 can receive at least a portion of the control catheter 471 such that the retrieval element 491 can be selectively moved over the control catheter 471. In some implementations, a dilator can be disposed at the distal end of the retrieval sheath 490 to facilitate driving the retrieval sheath 490 forward through the body and into a heart chamber.

[0191] 34-40 show various views of a distal end portion of retrieval element 491. Retrieval element 491 can be any suitable device, element, member, and / or the like having any suitable size. As discussed, retrieval element 491 can be and / or can include a catheter defining a lumen having a sufficiently large diameter such that retrieval element 491 can be disposed on and driven forward along control catheter 471.

[0192] FIG. 34 is a side view illustrating an engagement member 492 and a guide member 493 coupled to and / or extending from a distal end portion of a catheter (retrieval element 491). The engagement member 492 coupled to the distal end of the retrieval element 491 can be any suitable device, member, feature, etc. For example, FIG. 34 illustrates an engagement member 492 arranged and / or configured as a hook extending from the distal end of the retrieval element 491. In some embodiments, the engagement member 492 is formed from a shape memory material, such as, for example, Nitinol or the like. Thus, in some implementations, the engagement member 492 can be configured to transition between two or more configurations, such as at least a delivery configuration and a deployment / engagement configuration. In such implementations, the engagement member 492 may have a relatively low bulk profile when in a delivery configuration and may be capable of transitioning to a deployment / engagement configuration (e.g., when extended distally of the retrieval sheath 490 and / or control catheter 471) in which the engagement member 492 forms and / or assumes a hook or other desired shape.

[0193] 34 and 35 show guide member 493 coupled to a distal end of retrieval element 491 (catheter) in an expanded configuration, and FIG. 36 shows guide member 493 coupled to a distal end of retrieval element 491 in a compressed configuration. Guide member 493 can be any suitable device, member, feature, etc. For example, guide member 493 can be a scoop, tang, flange, and / or any other suitable feature extending from retrieval element 491 in a curved or arcuate path. FIGS. 34-36 show guide member 493 formed from one or more woven, mesh, and / or tubular memory materials, such as Nitinol. Thus, guide member 493 can be configured to transition between two or more configurations, such as at least a deployed / guide configuration (FIGS. 34 and 35) and a delivery configuration (FIG. 36). In such implementations, guide member 493 can be relatively compact and / or compressed when in a delivery configuration, such that guide member 493 can be driven forward, for example, through retrieval sheath 490. Guide member 493 can expand to a deployed / guide configuration when released from retrieval sheath 490 (e.g., when distal of retrieval sheath 490). In the deployed / guide configuration, the woven / mesh material of guide member 493 can expand to form a scoop or a scoop-like shape (see, e.g., FIGS. 34 and 35).

[0194] 37-40 show a retrieval element 491 being used to engage the valve 400 for the retrieval process. The valve 400 can be similar or substantially similar to the valve 200 described in detail above with reference to, for example, FIGS. 10-20. Thus, the valve 400 can have and / or form an outer support frame 410 with a flow control component 450 mounted therein. FIGS. 37 and 38 show an outer support frame 410 having a supranular member 420 and a subannular member 430. As described above with reference to the valve 200, the supranular member 420 of the valve 400 can be removably coupled to a distal end portion (e.g., a connecting member 478) of the control catheter 471. The subannular member 430 is shown forming a proximal subannular anchoring element 434 that is similar or substantially similar to the subannular anchoring element 234 of the valve 200.

[0195] 37 and 38 are side views showing the engagement member 492 and guide member 493 extending distally from the retrieval sheath 490 into an operative position and / or configuration relative to the valve 400. For example, the engagement member 492 is shown as engaging and / or hooking to one or more portions of the subannular member 430 of the valve 400, such as the proximal subannular anchoring element 434. More specifically, the proximal subannular anchoring element 434 can have and / or form a rim (e.g., a wire rim covered with a biocompatible material, fabric, etc.) that can be engaged and / or hooked by the engagement member 492.

[0196] The guide member 493 is shown in the deployed / guiding configuration extending from or near a proximal end at the retrieval sheath 490 to a distal end below or substantially below the valve 400. The guide member 493 can thus be configured to guide one or more portions of the valve 400 into the retrieval sheath 490. For example, during retrieval, the valve 400 can be pulled proximally toward the distal end of the retrieval sheath 490. With the valve 400 in the expanded configuration (FIG. 37), the valve 400 can be retracted toward and / or into the retrieval sheath 490 to begin transitioning the valve 400 from the expanded configuration to the compressed configuration, as shown in FIG. 38. As the valve 400 is compressed, one or more portions, edges, etc. of the valve 400 can get caught on the distal end of the retrieval sheath 490, thereby impeding retrieval. Thus, the expanded configuration of the guide member 493 can limit and / or substantially prevent such snagging by guiding one or more portions, edges, etc. of the valve 400 into the retrieval sheath 490.

[0197] Figures 39 and 40 are lateral black and white fluoroscopic photographs showing valve 400 within a heart chamber. Control catheter 471 is shown extending from retrieval sheath 491 and from retrieval element 491, with connecting member 478 contacting and coupled to supra-annular member 420 of valve 400. Figure 39 shows engagement member 492 and guide member 493 distal to retrieval sheath 490 but not yet engaged to valve 400, while Figure 40 shows engagement member 492 hooking against an edge, rim, and / or wire frame structure of proximal subannular anchoring element 434. With the connecting member 478 of the control catheter 471 in contact against the supra-annular member 420 of the valve 400 and the engagement member 492 of the retrieval element 491 in contact against the proximal sub-annular anchoring element 494, the control catheter 471 and retrieval element 491 can be actuated proximally to pull, retract, and / or retrieve the valve 400 into the retrieval sheath 490, as described in more detail below.

[0198] 41 and 42 show a retractor 497 of the delivery / retrieval system 480 that can be used to retrieve the valve 400 into the retrieval sheath 490 by driving the control catheter 471 and retrieval element 491 proximally. The retractor 497 can be of any suitable shape, size, and / or configuration. For example, in the embodiment shown in FIGS. 41 and 42, the retractor 497 is shown as a ratchet mechanism and / or the like that is operable to apply a force against one or more components coupled to it. In some embodiments, the ratchet mechanism (or other retractor 497) can provide a mechanical advantage that can assist in applying a force to compress the valve 400 and to retract the valve 400 into the retrieval sheath 490. As discussed above, in some instances, because no loading devices or the like are disposed within the heart chamber, the forces encountered in retrieving the valve 400 may be greater than those encountered in delivering the valve 400. Thus, the retractor 497 may enable a user to apply forces associated with retracting the valve 400 into the retrieval sheath 490 that may be difficult to achieve in other embodiments, such as manual retraction (e.g., by hand or the like).

[0199] FIG. 41 illustrates a retractor 497 having a first end 498A, a second end 498B, and a ratcheting handle 499. FIG. 42 illustrates a first end portion 498A coupled to a coupler 495A (e.g., “first coupler”) at a proximal end portion of a retrieval handle 494. A second end portion 498B is shown coupled to a second coupler 495B, which is coupled to a proximal end portion of a control catheter 471 and to a proximal end portion of a retrieval element 491. The second coupler 495B, which may be similar or substantially identical to the first coupler 495A, is at least temporarily coupled to and / or at least temporarily disposed about the proximal end portion of the control catheter 471. In some implementations, the first coupler 495A of the handle 494 can be in a fixed or locked position relative to the ratcheting handle 499 of the retractor 497. The second coupler 495B can be fixed and / or coupled to and maintained in a fixed or locked position relative to the proximal end portion of the control catheter 471 and also to the proximal end portion of the retrieval element 491.

[0200] The retractor 497 can be configured to transition between any number of configurations, each of which may correspond to a different distance defined between the first end portion 498A and the second end portion 498B. Thus, in some instances, a first distance can be defined between the end portions 498A, 498B of the retractor 497 (and thus between the first coupler 495A and the second coupler 495B) when the retrieval element 491 is in a desired position relative to the valve 400, but before the valve 400 is retracted into the retrieval sheath 490. When the valve 400 is ready to be retracted into the retrieval sheath 490, the user can manipulate the ratcheting handle 499 to, for example, actuate the second end portion 498B of the retractor 497 relative to the first end portion 498A of the retractor 497.

[0201] With coupler 495A coupled to retrieval handle 494 and control catheter 471, and coupler 495B coupled to retrieval element 491, the distance between end portions 495A, 495B is increased (e.g., the second distance is greater than the first distance), thereby driving the distal end portions of control catheter 471 and retrieval element 491 relative to retrieval sheath 490. In some implementations, driving at least retrieval element 491 proximally can cause engagement member 492 to apply a force to proximal subannular anchoring element 434, which can assist in transitioning valve 400 from the expanded configuration shown in FIG.

[0202] As discussed above, the guide member 493 may be configured to guide and / or direct one or more portions or edges of the valve 400 into the retrieval sheath 490. For example, the guide member 493 may be configured to guide the proximal subannular anchoring element 434 and / or an edge of the inner frame of the flow control component 450 over a distal edge of the retrieval sheath 490 and into a lumen defined by the retrieval sheath 490. Additionally, the retractor 497 configuration may provide a mechanical advantage operable to generate a desired amount of force associated with and / or otherwise required for retraction of the valve 400 into the retrieval sheath 490 while the valve 400 is substantially simultaneously compressed. In this manner, the delivery / retrieval system 480 may be used to retrieve a valve that has been at least partially deployed within a heart chamber. In some instances, once the valve 400 has been retracted into the retrieval sheath 490 and / or retrieved, the delivery / retrieval system 480 can be pulled and withdrawn from the patient's body.

[0203] Although not shown in FIGS. 25-42, the valve 400 can include one or more features configured to facilitate retrieval of the valve 400 into the retrieval sheath 490. For example, as described above, the valve 400 can include a wire frame structure, such as covered with a biocompatible material, cloth, fabric, tissue, etc. The biocompatible material can be secured to the wire frame structure, such as by suturing and / or sewing to a material located around the wire frame structure. In some embodiments, one or more sutures can be used or sewn on or within the biocompatible material, such as between two or more cells in the wire frame structure, to limit and / or substantially prevent edges of the cells from catching, hanging, and / or otherwise engaging the distal end of the retrieval sheath 490.

[0204] As another example, in some embodiments, the valve 400 can include a posterior septal (PS) tab that can help stabilize the valve 400 within the annulus of the native valve. In such embodiments, the PS tab can extend proximally and can include one or more sutures configured to limit and / or restrain the movement of the PS tab. However, in some instances, the PS tab can catch or engage with the distal end of the retrieval sheath 490 upon retrieval. Thus, in some embodiments, the valve can include one or more sutures configured to break, tear, rip, and / or otherwise loosen in response to forces associated with retrieval of the valve 400. For example, when the PS tab catches and / or engages with the distal end of the retrieval sheath 490, the forces associated with the contact can be sufficient to disengage the one or more sutures that are limiting the movement of the PS tab. In the absence of the suture or sutures, the PS tab is allowed to bend, flex, and / or fold on itself, allowing the PS tab to be driven forward beyond the distal edge of the retrieval sheath 490 and into the lumen at the distal edge.

[0205] In some implementations, the retrieval process can include pre-compressing the valve 400 and / or the connecting members 478 of the control device 470 prior to retracting the valve 400 into the retrieval sheath 490. For example, pre-compressing the valve 400 can include (i) suturing the proximal subannular anchoring elements to the underside of the atrium or to the underside of a supranulular collar or member, and / or (ii) pinching the proximal sidewall waist of the prosthetic valve. Similarly, in some implementations, the connecting members 478 or yoke at the distal end of the control catheter 471 can be pre-compressed or pre-tensioned, which can reduce the lateral extent of the connecting members 478 and partially fold the valve 400 and / or otherwise bias the valve 400 to fold with less external force than would otherwise be used to fold the valve 400.

[0206] 43, a flow chart is shown illustrating a method 10 according to one embodiment for selectively retrieving a side-deliverable transcatheter prosthetic valve during delivery and / or deployment using a delivery / retrieval system. The valve can be substantially similar to any valve described herein, such as valves 100, 200, 300, and / or 400, and / or any valve described in the '032 PCT, which are incorporated herein by reference. For example, the valve can include an outer support frame and a (internal) flow control component mounted within and / or to the outer support frame. The outer support frame can include, for example, a supranulular member or region, a subannular member or region, and a transannular member or region coupled therebetween. The flow control component is mounted to the outer support frame such that the flow control component extends through a portion of the transannular member or region, as described above. Moreover, the valve is compressible along a central axis parallel to the direction of fluid flow through the valve, and along lateral axes perpendicular and / or perpendicular to the central axis.

[0207] The delivery / recovery system can be similar or substantially identical to any of the delivery / recovery systems described herein (e.g., delivery / recovery systems 180 and / or 480). Thus, the delivery / recovery system can include a delivery portion or component that is used to deliver the valve into the heart chamber, and a retrieval portion or component that is selectively or optionally used to retrieve the valve from the heart chamber.

[0208] 43, the method 10 includes at 11 decoupling a delivery portion of the delivery / retrieval system from a proximal end portion of a control device disposed external to the patient, and further disposing a distal end portion of the control device within the heart chamber and releasably coupling to a surface on the annulus of the prosthetic valve. For example, in some implementations, the delivery portion may include a delivery sheath, a delivery and / or control handle, and / or any other suitable components, devices, etc. In some instances, decoupling the delivery portion of the delivery / retrieval system may provide access to the proximal end portion of the control device so that the retrieval portion of the delivery / retrieval system may be assembled and / or used.

[0209] Optionally, at 12, an exchange catheter is coupled to the proximal end portion of the control device. In some embodiments, for example, the exchange catheter can form a threaded coupling to the proximal end portion of the control catheter of the control device. The exchange catheter can be configured to extend the proximal length of the control catheter, thereby allowing the retrieval portion of the delivery / retrieval system to be driven forward over and / or along the control catheter. Moreover, in some implementations, the control device used during delivery can be held in place while other portions of the delivery portion are detached. As described in detail above, the distal end portion of the control device can include a connection member removably secured to a supranulus member of the valve via a set of tethers. The tethers can be routed through the control device and coupled to the valve with the ends of each tether extending proximally beyond the control catheter. In such implementations, the exchange catheter may include and / or define features (e.g., skives and / or the like) that may couple to and / or secure the end portion of the tether, thereby allowing a user to control the distal end portion of the control device, and thus at least partially control the valve. Thus, in some implementations, the optional step of coupling the exchange catheter to the proximal end portion of the control device may also include securing the end portion of the tether via the exchange catheter.

[0210] At 13, the retrieval sheath is driven forward over the control catheter to position the distal end portion of the retrieval element distal to the retrieval sheath within the heart chamber. In some embodiments, the retrieval element can be and / or include a retrieval catheter having a lumen for receiving the control catheter of the control device. In some such embodiments, the retrieval element and retrieval sheath are each driven forward over the control catheter. In other such embodiments, the retrieval sheath can be driven forward over the control catheter and, once the distal end portion of the retrieval sheath is in a desired location within the heart chamber, the retrieval element can be driven forward over the control catheter and into the retrieval sheath. In some embodiments, a dilator is used to facilitate driving the retrieval sheath through the patient's vasculature, and the dilator is withdrawn from the patient prior to driving the retrieval element forward. Moreover, the distal end portion of the retrieval element (e.g., the distal end portion of the retrieval catheter) can include an engagement member and a guide member, each of which is disposed distal to the retrieval sheath within the heart chamber when the retrieval element is driven forward to the desired location. In some implementations, the proximal end portion of the retrieval element can be coupled to the proximal end portion of the control device (e.g., via a coupler, via a collet, and / or the like).

[0211] At 14, a first portion of the retractor is coupled to a proximal end portion of the retrieval sheath, and a second portion of the retractor is coupled to a proximal end portion of the control device and to a proximal end portion of the retrieval element. More specifically, the proximal end portion of the retrieval sheath can include and / or be coupled to a retrieval handle, as described above with reference to retrieval sheath 490. The proximal end portion of the retrieval handle can include a coupler, collet, and / or the like, to which the first end portion of the retractor is coupled. Additionally, the second end portion of the retractor can be coupled to a coupler, collet, etc., coupling, for example, the proximal end portion of the retrieval element and the proximal end portion of the control catheter, as described above with reference to delivery / retrieval system 480.

[0212] At 15, the proximal subannular anchoring element of the prosthetic valve is engaged using and / or by an engaging member of the retrieval element. For example, in some implementations, the engaging member can be actuated to engage the proximal subannular anchoring element after the retractor is coupled to the proximal end portion of the retrieval sheath, the proximal end portion of the control device, and the proximal end portion of the retrieval element. As discussed above, the engaging member can be, for example, a hook or the like that can hook onto an edge, rim, etc. of the proximal subannular anchoring element.

[0213] At 16, by actuating the retractor with the engagement member engaged to the proximal subannular anchoring element, the control device and the retrieval element can each be driven proximally relative to the retrieval sheath, and the valve can be retracted into the retrieval sheath. For example, in some examples, the retractor can include a ratcheting handle or other actuator that can be manipulated to, for example, increase the distance between the first and second end portions of the retractor. As described above, the first end of the retractor can be coupled to a coupler at a proximal end portion of the retrieval handle, and the second end of the retractor can be coupled to a coupler connected to the proximal end portion of the retrieval element and to the proximal end portion of the control device. In this manner, the retractor can be configured to increase the distance between the first and second ends, and thus increase the distance between the couplers. Movement of the second end portion relative to the first end portion is operable to drive the control device and the retrieval element proximally relative to the retrieval sheath. With the control device coupled to the supranulnar member of the valve and the retrieval element coupled to the subannular member of the valve, the control device and retrieval element are actuated proximally relative to the retrieval sheath to draw the valve toward the distal end portion of the retrieval sheath and / or into the retrieval sheath. In some instances, drawing the valve into the retrieval sheath can compress the valve, thereby disposing the valve into a lumen defined by the retrieval sheath. In other words, the control device and retrieval element can draw the prosthetic valve into the retrieval sheath with sufficient force (e.g., proximal force) to overcome resistance to proximal movement due to the prosthetic valve contacting the distal end of the retrieval sheath. In this manner, the distal end of the retrieval sheath can function as a die or other surface that presses, pinches, folds, compresses, and / or otherwise shifts the prosthetic valve as it is driven into the lumen of the retrieval sheath.

[0214] In some implementations, the connecting members of the control device can be compressed prior to driving the prosthetic valve into the retrieval sheath. For example, the ends of the tethers securing the connecting members to the prosthetic valve can be pulled distally, thereby squeezing, compressing, and / or otherwise transitioning the connecting members into a compressed or pinched configuration. With the connecting members coupled against the annular surface of the prosthetic valve, pre-compressing and / or pre-tensioning the connecting members can pinch a proximal supra-annular portion of the prosthetic valve, thereby initiating the process of transitioning the prosthetic valve from its deployed or expanded state to its delivery / retrieval or compressed state, as described above with reference to connecting members 478.

[0215] In some implementations, method 10, at 17, optionally includes guiding at least one subannular edge of the prosthetic valve through the guide member as the prosthetic valve is retracted into the distal end of the retrieval sheath. For example, as described above with reference to retrieval element 491, the guide member can be and / or form a scoop, tang, flange, and / or the like that can contact and / or guide the subannular portion of the valve into the retrieval sheath. More specifically, the subannular portion of the valve can include one or more edges and / or features that, in some instances, tend to snag against the distal end of the retrieval sheath. Thus, the guide member can be configured to guide such edges and / or features to limit and / or substantially prevent snagging against the distal end of the retrieval sheath. In this manner, method 10 can be used to retrieve the prosthetic valve from the heart chamber. In some instances, with the valve retrieved and / or retracted into the retrieval sheath, the delivery / retrieval system can be retracted and removed from the patient's body.

[0216] Although various embodiments have been described above, it will be understood that they are presented by way of example only and are not limiting. Likewise, it will be understood that the specific terms used herein are for the purpose of describing the particular embodiments and / or features or components thereof and are not intended to be limiting. Unless expressly stated otherwise, various modifications, changes, and / or variations may be made in form and / or detail without departing from the scope of the present disclosure and / or without altering the function and / or advantages of the present disclosure. In addition to those enumerated herein, functionally equivalent embodiments, implementations, and / or methods will be apparent to those skilled in the art from the above description and are intended to be included within the scope of the present disclosure.

[0217] Where the above-described schemes, embodiments, and / or implementations show particular components arranged in particular orientations or at particular locations, such arrangement of components may be modified. Although various embodiments have been described as having particular features and / or combinations of components, other embodiments are possible having any combination of features and / or any combination of components from any embodiment described herein, except mutually exclusive combinations. The embodiments described herein may include various combinations and / or subcombinations of the functions, components, and / or features of the various embodiments described.

[0218] Where the methods described above indicate that certain events occur in a particular order, the order of certain events may be modified. Additionally, certain events may be performed not only sequentially as described above, but also simultaneously through parallel processes, if possible. Although methods have been described as having certain steps and / or combinations of steps, other methods are possible, such as having any combination of steps from any method described herein, except for mutually exclusive combinations and / or unless otherwise clearly indicated by the context.

Claims

1. 1. A delivery / retrieval system for a laterally deliverable prosthetic valve, comprising: a control device configured to be attached to the prosthetic valve, the control device operable (i) to apply a distal force to drive the prosthetic valve in a compressed configuration forward through a lumen of a delivery sheath and into a heart chamber, and (ii) to apply a proximal force to retract the prosthetic valve in an expanded configuration and disposed within the heart chamber into a distal end of a retrieval sheath; a retrieval element extendable through the lumen of the retrieval sheath, a proximal end portion of the retrieval element being coupleable to a proximal end portion of the control device, and a distal end portion of the retrieval element forming an engagement member and a guide member, the engagement member configured to engage a proximal sub-annular anchoring element of the prosthetic valve and to apply a proximal force to the proximal sub-annular anchoring element of the prosthetic valve to retract the prosthetic valve from the heart chamber into the distal end of the retrieval sheath, and the guide member configured to guide at least one edge of the prosthetic valve as it is retracted into the distal end of the retrieval sheath; A delivery / recovery system comprising:

2. The system of claim 1 , wherein the guide member is a self-expanding element formed from a shape memory alloy.

3. 3. The system of claim 2, wherein the guide member is in a first configuration when disposed within the retrieval sheath and is transitionable to a second configuration when driven forward beyond the distal end of the retrieval sheath into the heart chamber.

4. the delivery sheath has a first diameter; The system of claim 1 , wherein the retrieval sheath has a second diameter greater than the first diameter.

5. the retrieval element comprises a retrieval catheter; The system of claim 1 , wherein the engagement member and the guide member are attached at a distal end of the retrieval catheter.

6. The system of claim 5 , wherein the retrieval catheter defines a lumen configured to receive at least a portion of the control device.

7. the control device includes a control catheter and a connecting member coupled to a distal end of the control catheter; The system of claim 1 , wherein the connecting member is configured to releasably couple to an annular surface of the prosthetic valve via a set of tethers.

8. 8. The system of claim 7, further comprising an exchange catheter configured to couple to a proximal end of the control catheter, the exchange catheter defining a skive configured to secure an end portion of each tether from the set of tethers.

9. 2. The system of claim 1, further comprising a retractor removably coupleable to a retrieval handle disposed at a proximal end of the retrieval sheath and disposed at the proximal end portion of each of the control device and the retrieval element, the retractor configured, in response to being actuated, to move each of the control device and the retrieval element proximally relative to the retrieval handle, the proximal movement applying a proximal force to the prosthetic valve operable to retract the prosthetic valve into the distal end of the retrieval sheath.

10. 1. A delivery / retrieval system for a laterally deliverable prosthetic valve, comprising: a retrieval sheath defining an internal lumen; a control device extendable through the lumen of the retrieval sheath and removably coupleable to an annular surface of the prosthetic valve; a retrieval element extendable through the lumen of the retrieval sheath to outside of the control device, a distal end portion of the retrieval element including an engagement member configured to engage a proximal subannular anchoring element of the prosthetic valve when the prosthetic valve is at least partially positioned within a heart chamber; the control device is removably coupled to the annular surface of the prosthetic valve; A delivery / retrieval system wherein the engagement member is engaged with the proximal sub-annular anchoring element, thereby enabling the control device and the retrieval element to retract the prosthetic valve into the distal end of the retrieval sheath in response to a proximal force.

11. the control device includes a control catheter and a connecting member coupled to and extending distally from a distal end of the control catheter; The system of claim 10 , wherein the connecting member is configured to releasably couple to the annular surface of the prosthetic valve via a set of tethers.

12. 12. The system of claim 11, wherein the retrieval element includes a retrieval catheter defining a lumen configured to receive the control catheter, whereby the connecting member is located distal to the distal end of the retrieval catheter.

13. The system of claim 12 , wherein the engagement member is coupled to and extends distally from a distal end of the retrieval catheter.

14. the retrieval element further includes a guide member coupled to and extending distally from the distal end of the retrieval catheter; 14. The system of claim 13, wherein the guide member is configured to guide a sub-annular region of the prosthetic valve into the distal end of the retrieval sheath.

15. The system of claim 14 , wherein the guide member is a self-expanding element formed from a shape memory alloy.

16. the engagement member is partially embedded within the guide member; 15. The system of claim 14, wherein a portion of the engagement member extends outward from the guide member such that the portion of the engagement member is capable of engaging with the proximal sub-annular anchoring element.

17. The system of claim 16 , wherein the portion of the engagement member is a hook.

18. a retrieval handle coupled to a proximal end of the retrieval sheath; a retractor removably coupleable to the retrieval handle and to a proximal end portion of each of the control device and the retrieval element, the retractor configured, in response to being actuated, to collectively move the control device and the retrieval element proximally relative to the retrieval handle, the proximal movement applying a proximal force to the prosthetic valve operable to retract the prosthetic valve into the distal end of the retrieval sheath; The system of claim 10 further comprising:

19. 17. The system of claim 16, wherein the retractor is configured such that the proximal force applied to the prosthetic valve as a result of the control device and the retrieval element being collectively moved proximally is sufficient to transition the prosthetic valve from a deployed configuration to a delivery configuration as the prosthetic valve is retracted into the distal end of the retrieval sheath.

20. 1. An apparatus for retrieving a laterally deliverable prosthetic valve from a cardiac chamber of a patient, comprising: A retrieval catheter; a guide member coupled to and extending distally from the distal end of the retrieval catheter, the guide member being formed from a braided tube of a shape memory alloy and having a compressed state for delivery through the retrieval sheath into the heart chamber and an expanded state when positioned within the heart chamber and distal to the retrieval sheath; an engagement member coupled to and extending distally from the distal end of the retrieval catheter, the engagement member being partially embedded within the guide member such that a portion of the engagement member extends outward from the guide member, thereby enabling the portion of the engagement member to engage a subannular region of the prosthetic valve; 1. An apparatus comprising:

21. 21. The device of claim 20, wherein the guide member in the expanded state forms a scoop.

22. 21. The device of claim 20, wherein the portion of the engaging member is a hook configured to hook onto a proximal sub-annular anchoring element of the prosthetic valve.

23. 21. The device of claim 20, wherein the retrieval catheter defines an inner lumen configured to receive a control device, such that a connecting member located at a distal end portion of the control device is located distal to the retrieval catheter and is removably connectable to an annular surface of the prosthetic valve.

24. 24. The apparatus of claim 23, wherein the portion of the engagement member is configured to engage a proximal sub-annular anchoring element of the prosthetic valve such that a proximal force applied collectively to the proximal end portion of the retrieval catheter and the proximal end portion of the control device is operable to retract the prosthetic valve into the distal end of the retrieval sheath.

Images