Device and method for tightening an artificial heart valve delivered laterally to be delivered and deployed within the natural annulus.

Abstract

To provide an artificial valve that can be delivered laterally. [Solution] A laterally deliverable artificial valve comprising a valve frame and a flow control component fitted within a central channel of the valve frame and configured to allow blood flow through the central channel in a direction along the central axis of the artificial valve, wherein the actuator is detachably attached to a proximal inferior annular anchor element of the valve frame.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the priority and benefit of U.S. Provisional Patent Application No. 63 / 510,754, filed Jun. 28, 2023 (title “Devices and Methods for Cinching a Side - Delivered Prosthetic Heart Valve for Deployment in a Native Annulus”), and U.S. Provisional Patent Application No. 63 / 514,421, filed Jul. 19, 2023 (title “Devices and Methods for Cinching a Side - Delivered Prosthetic Heart Valve for Delivery and Deployment in a Native Annulus”), and incorporates herein by reference the entire disclosures of each of them.

Background Art

[0002] Background

[0002] The embodiments described herein generally relate to transcatheter prosthetic heart valves, and more specifically, to devices, systems, and / or methods for cinching a side - delivered transcatheter prosthetic heart valve, for example, during deployment into the native annulus of a natural valve.

[0003]

[0003] Artificial heart valves can present challenges in delivery, deployment, and / or retrieval within the heart, particularly in catheter-based delivery via the patient's vascular structure rather than by surgical means. Traditional transcatheter delivery of artificial valves generally involves radially compressing the valve and loading the valve into the delivery catheter so that the valve's central annular axis is parallel to the longitudinal or longitudinal axis of the delivery catheter. In other words, traditional artificial valves are loaded into the delivery catheter so that the radial range of the valve aligns with and / or fits within the radial range of the lumen extending through the delivery catheter. The valve is deployed from the end of the delivery catheter and expands radially outward from the central annular axis. However, the patient's vascular structure imposes limitations on the diameter of the delivery catheter, which further imposes limitations on the radial range of the lumen extending through the delivery catheter, and therefore limits the expanded size (e.g., diameter) of the artificial valve delivered using the traditional radial compression delivery method. The competing interest of minimizing the size of the delivery catheter presents the challenge of increasing the expansion diameter of the radially compressed valve (e.g., attempting to compress excessive material and structure into a space that is too small). Furthermore, the traditional valve orientation during deployment can present additional challenges when attempting to align the valve with the natural valve annulus.

[0004]

[0004] Some transcatheter prosthetic valves can be configured for lateral and / or orthogonal delivery, and can have a larger expanded diameter compared to valves delivered conventionally. For example, in lateral delivery, the valve can be compressed or delivered in a compressed or delivered configuration and loaded into the delivery catheter such that the central annular axis of the valve is substantially perpendicular and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter. More specifically, the valve can be compressed axially (e.g., along the central annular axis) and laterally (e.g., perpendicular to the central annular axis and longitudinal axis of the valve, respectively), and not compressed or can be extended longitudinally (e.g., parallel to the longitudinal or longitudinal axis of the delivery catheter). A compressed valve (e.g., a valve in delivery configuration) can be loaded into the lumen of the delivery catheter in a laterally or orthogonal orientation (relative to the orientation of valves delivered conventionally), where the central annular axis of the valve is substantially perpendicular and / or orthogonal to the longitudinal or longitudinal axis of the delivery catheter (e.g., the longitudinal axis of the valve is parallel to the longitudinal or longitudinal axis of the delivery catheter). Once loaded, the compressed valve can be advanced through the lumen of the delivery catheter and released from the end of the delivery catheter (for example, into a cardiac chamber such as the atrium). Furthermore, in some cases, the lateral or perpendicular orientation of the released lateral delivery valve relative to the delivery catheter generally results in the valve being oriented as desired relative to the natural annulus.

[0005]

[0005] Lateral delivery may allow for the delivery of larger valves to the heart and / or simplify the process of aligning or orienting the valve to the natural annulus (compared to traditional delivery), but challenges remain in seating a laterally deliverable prosthetic valve to the natural annulus. For example, a traditional radially compressed valve may be maintained in a state of at least partial compression while a portion of the prosthetic valve is inserted through the annulus. Once in the desired position, the prosthetic valve can transition to a radially uncompressed state, thereby seating a traditionally delivered valve to the natural annulus. On the other hand, in some tricuspid valve replacements, seating a laterally deliverable prosthetic valve may involve inserting the distal portion of the valve into the annulus so that the distal wall of the valve contacts the distal wall of the annulus, with the distal inferior annular anchor located below the annulus and situated in or near the ventricular outflow tract (RVOT), and the upper annular portion of the valve, such as the atrial cuff, above the annulus. Once positioned, the valve can be pivoted relative to the annular plane to insert its proximal portion into / through the natural valve ring, thereby seating the valve.

[0006]

[0006] However, in some cases it may be desirable to facilitate the delivery and / or deployment of the prosthetic valve by acting and / or tightening at least the proximal inferior annular portion of the prosthetic valve for the delivery and / or deployment of the valve into and through the natural annulus. After the prosthetic valve has been seated, its proximal inferior annular portion may be released, actuated, and / or otherwise made deactivated, uncinched, or returned to or substantially returned to a biased configuration. Furthermore, in some cases it may be desirable to actuate and / or tighten the proximal inferior annular portion of the prosthetic valve in such a way that it is possible to release the proximal inferior annular portion of the prosthetic valve while avoiding and / or limiting undesirable contact with the natural tissue defining the annulus (otherwise the proximal inferior annular portion of the prosthetic valve may be pushed toward the atrium (e.g., toward the ventricle), resulting in the prosthetic valve being incompletely or otherwise partially seated on the annulus. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007]

[0007] Therefore, for example, there is a need for a device, system, and / or method for tightening a laterally deliverable transcatheter artificial heart valve during deployment into the annulus of a natural valve. [Means for solving the problem]

[0008] overview

[0008] Embodiments described herein relate to laterally deliverable transcatheter heart valves, and devices, systems, and / or methods for tightening laterally deliverable transcatheter heart valves, for example, during deployment to the annulus of a natural valve. In some implementations, the laterally deliverable valve includes a valve frame and a flow control component mounted in a central channel extending along the central axis of the valve. The flow control component is configured to allow blood flow through the central channel in a direction along the central axis of the valve. An actuator is configured to be removably attached to a proximal inferior annular anchor element of the valve frame. A first portion of the actuator is removably attached to the inner surface of the valve frame at at least one position distal to the proximal inferior annular anchor element. The first portion is configured to respond to a proximal force by pulling the proximal inferior annular anchor element inward toward the central axis to form a first configuration. A second portion of the actuator is at least partially removably attached to the outer surface of the valve frame. The second part is configured to respond to a proximal force by pulling the proximal subannular anchor element outward away from the central axis, thereby changing it from the first form to the second form. [Brief explanation of the drawing]

[0009] Brief explanation of the drawing [Figure 1]

[0009] This is a schematic diagram of a transcatheter prosthesis that can be delivered laterally, selectively coupled to a delivery system (or a part thereof) used to deliver and deploy a prosthesis to the annulus of a natural heart valve, according to one embodiment. [Figure 2]

[0009] This is a schematic diagram of a transcatheter prosthesis that can be delivered laterally, selectively coupled to a delivery system (or a part thereof) used to deliver and deploy a prosthesis to the annulus of a natural heart valve, according to one embodiment. [Figure 3]

[0009] This is a schematic diagram of a transcatheter prosthesis that can be delivered laterally, selectively coupled to a delivery system (or a part thereof) used to deliver and deploy a prosthesis to the annulus of a natural heart valve, according to one embodiment. [Figure 4]

[0009] This is a schematic diagram of a transcatheter prosthesis that can be delivered laterally, selectively coupled to a delivery system (or a part thereof) used to deliver and deploy a prosthesis to the annulus of a natural heart valve, according to one embodiment. [Figure 5]

[0009] This is a schematic diagram of a transcatheter prosthesis that can be delivered laterally, selectively coupled to a delivery system (or a part thereof) used to deliver and deploy a prosthesis to the annulus of a natural heart valve, according to one embodiment. [Figure 6]

[0010] This is a schematic side view of an actuator coupled to an artificial valve having a proximal anchor element shown in a tightened or extended state, according to one embodiment. [Figure 7]

[0011] Figure 6 is a schematic side view of the actuator and artificial valve, showing the proximal anchor element actuated in a tightening or compression manner. [Figure 8]

[0011] This is a schematic bottom view of the actuator and artificial valve of Figure 6, showing the proximal anchor element actuated in a tightening or compression manner. [Figure 9]

[0012] This is a schematic side view of an actuator coupled to an artificial valve having a proximal anchor element shown in a tightened or extended state, according to one embodiment. [Figure 10]

[0013] Figure 9 is a schematic side view of the actuator and artificial valve, showing the proximal anchor element actuated in a tightening or compression manner. [Figure 11]Schematic bottom view of the actuator and prosthetic valve of FIG. 9 showing a proximal anchor element actuated in a clamping or compression configuration. [Figure 12]

[0014] Schematic side view of the actuator and prosthetic valve of FIG. 9 showing a proximal anchor element actuated and / or returned in a clamping release or expansion configuration. [Figure 13]

[0015] View of the prosthetic valve and delivery system of FIG. 9 showing the process of loading the prosthetic valve into the delivery system while the proximal anchor element is in a clamping or compression configuration. [Figure 14]

[0015] View of the prosthetic valve and delivery system of FIG. 9 showing the process of loading the prosthetic valve into the delivery system while the proximal anchor element is in a clamping or compression configuration. [Figure 15]

[0015] View of the prosthetic valve and delivery system of FIG. 9 showing the process of loading the prosthetic valve into the delivery system while the proximal anchor element is in a clamping or compression configuration. [Figure 16]

[0016] Side perspective view of a side deliverable trans-catheter prosthetic valve according to one embodiment. [Figure 17]

[0016] Bottom perspective view of a side deliverable trans-catheter prosthetic valve according to one embodiment. [Figure 18]

[0017] Side perspective view of the upper annular region of the outer support frame of the prosthetic valve shown in FIG. 16. [Figure 19]

[0018] Distal perspective view of the transverse annular region of the outer support frame of the prosthetic valve shown in FIG. 16. [Figure 20]

[0019] Distal perspective view of the lower annular region of the outer support frame of the prosthetic valve shown in FIG. 16. [Figure 21]

[0020] Top perspective view of the inner frame of the flow control component included in the prosthetic valve shown in FIG. 16. [Figure 22]

[0021] Figure 21 shows a side perspective view of a valve leaflet band of an inner flow control component having valve leaflets sewn to a structural band, shown in a cylindrical form suitable for coupling to the inner frame. [Figure 23]

[0022] Figure 22 is a bottom view of the valve leaflet band, which has a cylindrical shape, and shows a partial joining of the valve leaflets to form a partially closed fluid seal. [Figure 24]

[0023] Figure 16 shows a side perspective view of the artificial valve, which is detachably coupled to the distal end of a control device included in the delivery system. [Figure 25]

[0024] This is a side perspective view of the distal end of the prosthetic valve and the control device shown in Figure 24, illustrating the process of deploying the prosthetic valve onto the annulus of a natural heart valve. [Figure 26]

[0025] This is a schematic side view of a laterally deliverable artificial valve according to one embodiment. [Figure 27]

[0025] This is a schematic bottom view of a laterally deliverable artificial valve according to one embodiment. [Figure 28]

[0026] Figure 26 is a schematic side view of the artificial valve, shown with an actuator and / or clamping assembly attached to the artificial valve to move the lower annular region or component of the artificial valve between at least the first and second embodiments. [Figure 29]

[0027] This is a front view showing a laterally deliverable artificial valve deployed within the annulus of a natural heart valve according to one embodiment. The lower annular region or component of the artificial valve in its extended form after delivery is shown. [Figure 30]

[0027] This is a front view showing a laterally deliverable prosthetic valve deployed within the annulus of a natural heart valve according to one embodiment. It shows a lower annular region or member in a recessed or compressed form for seating the prosthetic valve in and / or through the natural annulus. [Figure 31]

[0027] This is a front view showing a laterally deliverable artificial valve deployed within the annulus of a natural heart valve according to one embodiment. It shows the lower annular region or member that has (substantially) returned to an extended form after the artificial valve has seated. [Figure 32]

[0028] This is a bottom view showing a laterally deliverable artificial valve according to one embodiment, in which the lower annular region or component (or valve frame thereof) of the artificial valve is detachably coupled to an actuator configured to facilitate the deployment of the artificial valve in the natural valve annulus by moving the lower annular region or component between at least a first and a second embodiment. [Figure 33]

[0028] This is a bottom view showing a laterally deliverable artificial valve according to one embodiment, in which the lower annular region or component (or the valve frame thereof) of the artificial valve is detachably coupled to an actuator configured to facilitate the deployment of the artificial valve in the natural valve annulus by moving the lower annular region or component between at least a first and a second embodiment. [Figure 34]

[0029] This is a bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) according to one embodiment, showing a sequence of activating and / or tightening one or more portions of the prosthetic valve to reduce the periphery and / or outer circumference of the prosthetic valve in order to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve. [Figure 35]

[0029] A bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) according to one embodiment, showing a sequence of activating and / or tightening one or more portions of the prosthetic valve to reduce the periphery and / or outer circumference of the prosthetic valve in order to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve. [Figure 36]

[0029] A bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) according to one embodiment, showing a sequence of activating and / or tightening one or more portions of the prosthetic valve to reduce the periphery and / or outer circumference of the prosthetic valve in order to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve. [Figure 37]

[0029] A bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) according to one embodiment, showing a sequence of activating and / or tightening one or more portions of the prosthetic valve to reduce the periphery and / or outer circumference of the prosthetic valve in order to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve. [Figure 38]

[0030] This is a bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) configured to actuate and / or tighten a lower annular region or component of the prosthetic valve to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve, according to one embodiment. [Figure 39]

[0030] This is a bottom perspective view of a laterally deliverable prosthetic valve coupled to a delivery / deployment system (or a portion thereof) configured to actuate and / or tighten a lower annular region or component of the prosthetic valve to facilitate the deployment of the prosthetic valve in the annulus of a natural heart valve, according to one embodiment. [Figure 40]

[0031] Figures 38 and 39 are side views of the artificial valve, showing the operating / tightened state and the non-operating / untightened state, respectively. [Figure 41]

[0031] Figures 38 and 39 are side views of the artificial valve, shown in the operating / tightened state and the non-operating / untightened state, respectively. [Figure 42]

[0032] This is a bottom perspective view of a laterally deliverable artificial valve coupled to a delivery / deployment system (or a portion thereof) configured to actuate and / or tighten a lower annular region or component of the artificial valve, according to one embodiment. The artificial valve (or a portion thereof) is shown in a non-actuated / untightened state. [Figure 43]

[0032] This is a bottom perspective view of a laterally deliverable artificial valve coupled to a delivery / deployment system (or a portion thereof) configured to actuate and / or tighten a lower annular region or component of the artificial valve, according to one embodiment. The artificial valve (or a portion thereof) is shown in the actuated / tightened configuration. [Figure 44]

[0033] This is a flowchart showing a method for deploying a laterally deliverable artificial valve according to one embodiment. [Figure 45]

[0034] This flowchart shows a method for deploying a laterally deliverable artificial valve according to another embodiment. [Figure 46]

[0035] This is a flowchart showing a method for connecting an actuator to a laterally deliverable artificial valve according to one embodiment. [Modes for carrying out the invention]

[0010] Detailed explanation

[0036] The disclosed embodiments relate to laterally deliverable transcatheter heart valves and / or components thereof, as well as devices, systems, and / or methods for tightening laterally deliverable transcatheter heart valves, for example, during deployment to the annulus of a natural valve. In some embodiments, the laterally deliverable valve includes a valve frame and a flow control component mounted in a central channel extending along the central axis of the valve. The flow control component is configured to allow blood flow through the central channel in a direction along the central axis of the valve. An actuator is configured to be removably attached to a proximal inferior annular anchor element of the valve frame. A first portion of the actuator is removably attached to the inner surface of the valve frame at at least one position distal to the proximal inferior annular anchor element. The first portion is configured to respond to a proximal force by pulling the proximal inferior annular anchor element inward toward the central axis to a first configuration. A second portion of the actuator is at least partially removably attached to the outer surface of the valve frame. The second part is configured to respond to a proximal force by pulling the proximal subannular anchor element outward away from the central axis, thereby changing it from the first form to the second form.

[0011]

[0037] In some embodiments, a laterally deliverable prosthetic valve includes a valve frame having an upper annular member, a lower annular member, and a transverse annular member coupled between them. The transverse annular member includes a set of wire struts defining a set of rhomboid cells. In some implementations, a method of coupling an actuator to the valve frame of the prosthetic valve includes inserting a tether of the actuator at a transit point defined by the upper annular member. The tether is removably attached to a set of mounting points mounted on the inner surface of the transverse annular member, along one strut from the set of struts. The tether is also removably attached to a proximal lower annular anchor element formed at least partially by the lower annular member of the valve frame. The distal end portion of the tether is positioned around a guidewire catheter extending through the transit point of the upper annular member, which is then inserted through a guidewire coupler mounted on the distal portion of the lower annular member to temporarily secure the distal end portion of the tether to the distal portion of the lower annular member.

[0012]

[0038] In some embodiments, a laterally deliverable prosthetic valve includes (i) a valve frame having an upper annular member, a lower annular member, and a transverse annular member coupled thereto, and (ii) a flow control component mounted on the valve frame and at least partially located within the transverse annular member. In some implementations, a method for deploying the prosthetic valve within the annulus of a natural heart valve includes detachably coupling the valve frame to a portion of the delivery system. A first force is applied to a first portion of the actuator to pull the proximal inferior annular anchor element of the lower annular member inward to a first configuration. In the delivery configuration, the prosthetic valve is advanced through the lumen of a delivery catheter included in the delivery system. The prosthetic valve is released from the distal end of the delivery catheter positioned in the atrium and seats within the annulus of the natural heart valve while the proximal inferior annular anchor element is in the first configuration. After seating the prosthetic valve within the annulus, the method includes applying a second force to a second portion of the actuator to pull the proximal inferior annular anchor element outward from the first configuration to the second configuration.

[0013]

[0039] In some implementations, a method for deploying a laterally deliverable prosthetic valve into the annulus of a native heart valve involves detachably coupling a portion of the delivery system to the valve frame. The prosthetic valve, in delivery configuration, is advanced through the lumen of a delivery catheter contained within the delivery system. The prosthetic valve is released from the distal end of the delivery catheter, which is positioned in the atrium. The prosthetic valve seats within the annulus of the native heart valve while the proximal anchor element of the valve frame is in the first configuration. After seating the prosthetic valve, the proximal anchor element transitions from the first configuration to a second configuration to secure the valve within the annulus.

[0014]

[0040] In some implementations, the method may include, after releasing the prosthetic valve, placing the proximal anchor element into a first configuration. In some implementations, the method may include tightening the proximal anchor element to place the proximal anchor element into a first configuration, and then compressing the prosthetic valve after tightening to place the prosthetic valve into a delivery configuration. In such implementations, the prosthetic valve in the delivery configuration may be loaded into the lumen of the delivery catheter such that the longitudinal axis of the prosthetic valve is substantially parallel to the longitudinal axis of the delivery catheter.

[0015]

[0041] In some implementations, a portion of the delivery system includes an actuator and / or a control device. The tether of the actuator / control device is detachably coupled to a proximal anchor element and is configured to actuate the proximal anchor element between a first and a second form in response to a proximal-directed force applied to the tether. In some embodiments, the artificial valve includes a transverse annular member coupled between an upper annular member and a lower annular member. The transverse annular member may include a wire frame forming several wire cells, each wire cell being rhomboid in shape and having an orientation and cell geometric shape configured to allow axial compression of the valve into the delivery form. In some implementations, the proximal anchor element of the lower annular member being in the first form includes actinguate the proximal anchor element to the first form without substantially compressing the wire cells of the transverse annular member axially.

[0016]

[0042] In some implementations, the actuator / control device includes one or more additional tethers that can be detachably coupled to the proximal anchor element. In such implementations, a tether (e.g., a first tether) may be configured to actuate and / or tighten the proximal anchor element to bring it into a first configuration. The method may further include, after seating the artificial valve on the valve ring, increasing tension along a second tether to transition the proximal anchor element from the first tightened and / or distal configuration to the second untightened and / or proximal configuration. In some implementations, the actuator and / or second tether may include a lock, etc., which engages with a portion of the outer frame and thereby locks the proximal anchor element into the second configuration.

[0017]

[0043] In some implementations, the method may further include inserting a guidewire catheter into transit points defined by guidewire couplers on the upper and lower annular members of the valve. The tether of the actuator / control device is routed through a set of attachment points along the struts of the transverse annular member of the valve and attachment points on the proximal anchor element. A loop at the distal end of the tether is positioned around the portion of the guidewire catheter distal to the guidewire coupler to temporarily secure the distal end of the tether to the lower annular member of the valve. In some implementations, the method further includes retracting the guidewire catheter after seating the prosthetic valve in the annulus and transitioning the proximal anchor element from a first to a second configuration. The tether is released as a result of retracting the guidewire catheter and separated from the proximal anchor element.

[0018]

[0044] In some implementations, a method for delivering and / or deploying a laterally deliverable prosthetic valve to the annulus of a native heart valve involves removably coupling a portion of the delivery system to the outer frame of the valve. The proximal inferior annular anchor element of the outer frame is tightened to put the proximal inferior annular anchor element into a first form. After tightening, the valve in the delivery form is advanced through the lumen of a delivery catheter included in the delivery system. The prosthetic valve is released from the distal end of the delivery catheter positioned in the atrium. The prosthetic valve seats within the annulus of the native heart valve while the proximal inferior annular anchor element is in the first form. After seating the prosthetic valve, the proximal inferior annular anchor element transitions from the first form to a second form to secure the valve within the annulus.

[0019]

[0045] Any of the prosthetic valves described herein may be relatively thin, laterally deliverable transcatheter prosthetic heart valves (hereinafter also referred to herein as “prosthetic valves” or simply “valves”). The prosthetic valves herein may have a valve frame and flow control components mounted within a central lumen, aperture, and / or channel of the valve frame, extending along the central axis of the valve or valve frame which is coaxial or at least substantially parallel to the direction of blood flow through the valve. The valve frame can provide structural support for the prosthetic valve and / or at least the flow control components mounted thereon. The valve frame can also provide one or more components or elements for fixing the prosthetic valve to the annulus of a natural valve or for other means of fixation. The flow control components (e.g., two-leaflet or three-leaflet sleeve, valve, etc.) may be configured to allow blood flow in a first direction through the inlet end of the valve and out through the outlet end of the valve, and to block blood flow in a second direction opposite to the first direction.

[0020]

[0046] The prosthetic valves described herein are configured for transcatheter delivery to the cardiac chambers. For example, the prosthetic valves can be transitioned (e.g., via balloon inflation or via one or more self-expanding structures) between a compressed or delivery form for introduction into the body via a delivery catheter (e.g., a 24-36 French (FR) delivery catheter) and an expanded or deployed / expanded form for implantation and / or deployment into a natural heart valve. More specifically, the prosthetic valves described herein are configured for orthogonal or lateral transcatheter delivery to the heart, in contrast to conventional transcatheter delivery.

[0021]

[0047] Generally, valves delivered via traditional transcatheter delivery are configured to be inserted into and / or advanced within the delivery catheter, for example, by being compressed radially with respect to the central axis or blood flow direction through the valve, and by the central axis of the compressed valve being parallel to the longitudinal or longitudinal axis of the delivery catheter used to deliver the valve. The valve unfolds from the end of the delivery catheter and expands or is expandable radially outward from the central cylindrical axis. The orientation of valve delivery generally means that the valve is completely released from the delivery catheter while in the atrium, and then reoriented relative to the annulus, which may, in some cases, limit the size of the valve. Therefore, in some implementations, traditional delivery can be used for valves with relatively small diameters, such as prosthetic pulmonary artery and / or aortic valves.

[0022]

[0048] Valves delivered orthogonally or laterally are configured to be compressed in at least one of the following directions: laterally (perpendicular to the direction of blood flow through the valve) or axially (parallel to or aligned with the direction of blood flow). In some embodiments, any valve can be compressed in two directions—laterally and axially—without compressing the valve in the direction along the longitudinal axis of the valve (perpendicular to the direction of blood flow through the valve). By orthogonal or lateral delivery, the compressed valve can be inserted into and / or advanced within a delivery catheter such that the central axis of the compressed valve is substantially perpendicular, perpendicular, and / or lateral to the longitudinal axis of the delivery catheter. In other words, in orthogonal or lateral delivery, the longitudinal axis of the valve may be substantially parallel to the longitudinal axis of the delivery catheter through which the valve is delivered. Thus, prosthetic valves delivered orthogonally and / or laterally are compressed and / or delivered laterally (e.g., at an angle of approximately 90 degrees) compared to the traditional process of delivering transcatheter prosthetic valves by compression.

[0023]

[0049] In some implementations, orthogonal or lateral delivery of the prosthetic valve allows the valve to be deployed from the inferior vena cava (IVC) to the annulus of the natural mitral or tricuspid valve without substantially altering the valve's orientation or positioning the delivery catheter at an acute angle to the natural valve (which is otherwise common in traditional transcatheter delivery). In addition, the orthogonal or lateral delivery of the prosthetic valve to the annulus allows the distal portion of the valve to be at least partially inserted into the annulus of the natural heart valve, while the proximal portion of the valve remains at least partially within the delivery catheter, thereby avoiding at least some of the size constraints faced by some known traditional delivery techniques. For example, a relatively large laterally deliverable prosthetic valve in expanded form can have a height of about 5–60 mm and a diameter of about 20–80 mm, while in compressed form it can have a height of about 5–12 mm, a width of about 8–12 mm (e.g., lateral), and a length of about 25–80 mm (e.g., longitudinal or lengthwise).

[0024]

[0050] Valves configured for orthogonal delivery can allow for the deployment of relatively large valves, while traditional radially compressible valves can be maintained in at least partially compressed form and / or state during delivery and deployment, which in some cases can facilitate the process of seating some traditionally delivered prosthetic valves onto the annulus of a natural heart valve. For example, such a valve can be at least partially compressed radially to allow a portion of the prosthetic valve to drop onto the annulus (e.g., compressed so that the diameter and / or circumference of at least a portion of the prosthetic valve is smaller than the diameter and / or circumference of the natural annulus). Once in the desired position, the prosthetic valve can and / or be transitioned to a radially expanded or radially uncompressible state, thereby seating the prosthetic valve onto the annulus of the natural heart valve.

[0025]

[0051] On the other hand, the process of deploying and / or seating some orthogonally delivered prosthetic valves may include inserting the distal portion of the prosthetic valve into the annulus and then pivoting the remaining portion of the valve to a desired position. In some cases, this difference in the process of seating the valve into the annulus may give rise to a desire for additional features and / or methods to facilitate the deployment (seating) of an orthogonally delivered valve into the natural annulus. For example, it may be desirable to actuate and / or tighten one or more portions of the prosthetic valve to allow the valve to pivot or drop into the annulus. In some embodiments, the actuate and / or tighten may be similar to, or part of, a process of transitioning the prosthetic valve into a compressed or delivered form, or it may be unrelated to a process of transitioning the prosthetic valve into a compressed or delivered form. Accordingly, embodiments and / or methods described herein relate to a delivery / deployment system configured to selectively actuate and / or tighten one or more portions of a laterally deliverable prosthetic valve to facilitate deployment into the natural annulus.

[0026]

[0052] Any of the artificial heart valves described herein may include an outer support frame that includes and / or forms an upper annular region, an lower annular region, and a transverse annular region coupled between them. The upper annular region may, for example, form the upper collar portion of the outer support frame and may include any number of features configured to engage with natural tissue, internal flow control components of the artificial valve, and / or delivery, actuators, and / or retrieval mechanisms. The lower annular region may form one or more anchor elements configured to engage with the lower annular (ventricular) tissue when the artificial valve is seated on the natural annulus. The transverse annular region may be coupled between the upper and lower annular regions. When the outer support frame is in an expanded configuration, the transverse annular region may form shapes such as a funnel, cylinder, flattened cone, or circular hyperboloid.

[0027]

[0053] In some embodiments, the outer support frame includes and / or is at least partially formed from wire, braided wire, or laser-cut wire frames and is at least partially covered with a biocompatible material. For example, the outer support frame and / or at least its transverse annular region may include and / or be formed from 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 intermittently connected single strand wires into corrugated, zigzag, or helical shapes, and / or combinations thereof. In some implementations, the compressible wire cells may have an orientation and cell geometric shape substantially perpendicular to the central axis to minimize strain on the wire cells when the outer support frame is in a delivery configuration (e.g., compressed, rolled, and / or folded configuration).

[0028]

[0054] Any of the artificial heart valves described herein (and / or their outer frame) may include a single or multiple anchor elements (e.g., inferior annular anchor elements, superior annular anchor elements, and / or combinations thereof) configured to fix the valve to the annulus of the natural valve. For example, in some implementations, the artificial valve and / or outer frame may include a distal inferior annular anchor element configured to engage with ventricular tissue distal to the annulus (e.g., which may extend into the right ventricular outflow tract (RVOT)); a proximal inferior annular anchor element configured to engage with ventricular tissue proximal to the annulus (e.g., between the septal and posterior leaflets of the heart); a septal anchor element configured to engage with at least one of the natural septum or natural septal leaflets when the artificial heart valve seats within the annulus (e.g., to keep at least the natural septal leaflet away from the implanting leaflet of the artificial valve); and / or one or more of any other suitable anchor elements. In some implementations, one or more of the lower annular anchor elements may stabilize the valve against annular adduction forces and / or torsional forces (e.g., tilting, angling, twisting, rolling, etc.) that may affect the desired position or positioning of the prosthetic valve within the valve annulus. Furthermore, any of the prosthetic valves described herein may include lower annular portions and / or anchor elements that can be actuated and / or otherwise transitioned between two or more embodiments to facilitate the deployment of the prosthetic valve into the valve annulus, as will be described in more detail herein with respect to a particular embodiment.

[0029]

[0055] The prosthetic valve and / or its outer frame may also include distal and / or proximal superior anchor elements configured to be positioned in contact with and / or adjacent to the superior annular tissue of, for example, the atrium (e.g., the right atrium). In some implementations, the superior anchor elements may be configured to apply force to the superior annular tissue, and the inferior anchor elements may be configured to apply force in the opposite direction to the inferior annular tissue, thereby securing the prosthetic valve to the natural annulus.

[0030]

[0056] Any of the artificial valves described herein may include an internal flow control component having a leaflet frame fitted with 2 to 4 flexible leaflets. The 2 to 4 leaflets are configured to allow blood flow in a first direction, through the inlet end of the valve and out of the outlet end, and to block blood flow in a second direction opposite to the first direction. The leaflet frame may include any number of panels or walls of rhomboid or eye-shaped wire cells made from a heat-set shape memory alloy material, such as nickel-titanium alloy (e.g., Nitinol®). The leaflet frame may be configured to be foldable from a round or cylindrical form to a flattened cylindrical form along the z-axis (e.g., longitudinal axis) and compressible to a compressed form along the vertical y-axis (e.g., central axis). In some implementations, the leaflet frame may include a pair of hinge regions, folding regions, connection points, etc., which may allow the leaflet frame to be folded flattened along the z-axis before the leaflet frame is compressed along the vertical y-axis. The valve leaflet frame may be a one-piece structure having two or more living hinges (e.g., stress concentration risers and / or any suitable structure configured to allow elastic / non-permanent deformation of the valve leaflet frame) or a two-piece structure in which a hinge region is formed using a secondary attachment method (e.g., sutures, fabric, molded polymer components, etc.). In some embodiments, the extended form of the internal flow control component forms a shape such as a funnel, cylinder, flattened cone, or circular hyperboloid. In some embodiments, the internal flow control component has a valve leaflet frame having a flattened conical side profile with an outer diameter R of about 20 to 60 mm, an inner diameter r of about 10 to 50 mm, a diameter R greater than the diameter r, and a height of about 5 to 60 mm. In some embodiments, the valve leaflet frame is composed of wire, braided wire, or laser-cut wire frame.

[0031]

[0057] Artificial valves and / or their components may be fabricated from any suitable biocompatible material or combination of biocompatible materials. For example, the outer valve frame, the inner valve frame (e.g., of the inner flow control component), and / or their components may be fabricated from biocompatible metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible metals and / or metal alloys include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, and nickel-titanium alloys (e.g., Nitinol®). Furthermore, either the outer frame or the inner frame described herein may be formed from a superelastic or shape memory alloy such as a nickel-titanium alloy (e.g., Nitinol®). Examples of synthetic biocompatible materials include polyester, polyurethane, elastomer, thermoplastic, thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, polyether ether ketone (PEEK), silicone-polycarbonate urethane, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefin, polyethylene glycol, polyether sulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, polyester, polyethylene terephthalate (PET) (e.g., Dacron®), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyester, polyamide (nylon), polytetrafluoroethylene (PTFE) (e.g., Teflon), stretched PTFE, foamed PTFE, siloxane polymers and / or oligomers, polylactone, etc., or block copolymers using them.

[0032]

[0058] Artificial valves and / or their components may include and / or be formed by one or more biocompatible coatings. Suitable polymer coatings include, for example, polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), translute styrene isoprene butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactic polylactic acid (DLPLA), and polylactic acid-co-glycolic acid (PLGA). Some such polymer coatings can form suitable carrier matrices for drugs such as sirolimus, zotarolimus, biolimus, novolimus, tacrolimus, paclitaxel, and probucol.

[0033]

[0059] The outer valve frame, the inner flow control frame, and / or any part or component thereof may be partially or completely covered internally or externally with natural or synthetic biocompatible and / or biological materials such as pericardium. For example, where a thin and durable synthetic material is considered (e.g., for covering), synthetic polymer materials such as foamed PTFE, PET, or polyester (or any other material described herein) may be optionally used. Suitable biological materials or tissues to be used for covering (or similar) include, for example, chemically stabilized pericardial tissues of animals such as cattle (bovine pericardium), sheep (sheep pericardium), pigs (pig pericardium), or horses (horse pericardium). Suitable tissues include, but are not limited to, the tissues used in Duraguard®, Peri-Guard®, and Vascu-Guard® products, all products currently used in surgical procedures, and products commercially available that are generally harvested from cattle less than 30 months old. In some implementations, the valve may be configured such that the inner surface of the outer valve frame (e.g., a wire frame cell) is covered with pericardial tissue and the outer surface is covered with a synthetic polyester fabric material such as Dacron® (or vice versa), or both the inner and outer surfaces are covered with pericardial tissue or a synthetic polyester fabric material.

[0034]

[0060] In some embodiments, a laterally deliverable artificial heart valve comprises an outer frame having an upper annular member, a lower annular member, and a transverse annular member coupled thereto, and flow control components mounted on the outer frame and at least partially located within the transverse annular member. In some implementations, a method for deploying the artificial valve within the annulus of a natural heart valve involves removably coupling the outer frame to a portion of the delivery system. The artificial valve in delivery mode is advanced through the lumen of a delivery catheter included in the delivery system. The delivery catheter has a distal end that is positioned within the atrium as the artificial valve is advanced. The artificial valve is released from the distal end of the delivery catheter and seats within the annulus of the natural heart valve while the proximal anchor element of the lower annular member of the outer frame is in a first or tightened mode. After the artificial valve is seated within the annulus, the proximal anchor element is transitioned from the first or tightened mode to a second untightened mode and / or otherwise becomes transitionable toward it. The proximal anchor element may be biased or pre-positioned to the second form and may be actuated, tightened, positioned, and / or otherwise moved to the first form before delivery or after release from the delivery catheter (e.g., after the prosthetic valve has been released but before it has seated in the natural annulus).

[0035]

[0061] Any method for delivering and / or deploying an artificial heart valve as described herein may include delivering the artificial heart valve to the natural annulus of a human heart, including (i) the tricuspid valve or pulmonary artery of the heart via the inferior vena cava (IVC) through the femoral vein or the superior vena cava (SVC) via the jugular vein, or (ii) a transatrial approach (e.g., the fossa ovalis or lower) to at least one of the mitral valve or aortic valve of the heart via an IVC-femoral or SVC-cervical approach. The artificial valve is removably coupled to a portion of the delivery system, positioned in a compressed or delivery configuration (e.g., for orthogonal and / or lateral delivery), loaded into a delivery device and / or delivery catheter, and advanced through the lumen of the delivery catheter. The artificial valve can then be released from the distal end of the delivery catheter positioned in the atrium using an IVC-femoral or SVC-cervical approach. Once released from the delivery catheter, the artificial valve can transition to an expanded or released configuration.

[0036]

[0062] Any method for delivering and / or deploying an artificial valve described herein may include positioning the valve or a portion thereof in a desired position relative to natural tissue. For example, the method may include inserting the distal inferior annular anchor element of the artificial valve through the annulus of a natural tricuspid valve into, for example, the RVOT of the right ventricle. In some implementations, the method may include partially inserting the artificial valve into the annulus (e.g., of a natural tricuspid valve) such that the distal portion of the artificial valve is in contact with natural annular tissue, while the proximal portion of the artificial valve is at least partially compressed and positioned within the delivery catheter. In some embodiments, the method may include rotating the artificial heart valve along an axis parallel to the plane of the annulus using a maneuverable control catheter, a yoke, a set of tethers, an actuator, and / or any other part (or combination thereof) of the delivery / deployment system. In some embodiments, the method may include moving one or more anchor elements to a desired position and / or state to engage with natural tissue surrounding at least a portion of the annulus. In some implementations, one or more tissue anchors may be attached to the valve and natural tissue to fix the valve in a desired position.

[0037]

[0063] Any delivery / deployment system described herein may include an external catheter (e.g., a delivery catheter), a control catheter, and / or other suitable parts, such as one or more members, components, features, etc., configured to facilitate the delivery and / or deployment of the valve to the annulus of a natural heart valve. For example, in some implementations, the delivery / deployment system may include any number of actuators, control devices, supports, etc., that can be at least temporarily coupled to the prosthetic valve to support, stabilize, actuate, tighten, and / or otherwise control one or more portions of the prosthetic valve, for example, during deployment. In some implementations, such devices and / or features may be and / or include tethers, sutures, tensioning or tensioning members, rods, cables, wires, catheters, hypotubes, connectors, couplers, etc. In such implementations, the device and / or feature can engage with one or more portions of the artificial valve to support, stabilize, actuate, tighten, and / or otherwise control the artificial valve (e.g., during deployment), and then, once the artificial valve is seated on the annulus of the natural valve in a desired manner, orientation, etc., it can be separated from and / or removed from the artificial valve. For example, some embodiments described herein may include one or more actuators, devices and / or features configured to be removably coupled to the lower annular portion of the artificial valve for at least partially actinguate, tightening, controlling, etc., the artificial valve and / or at least one or more portions thereof.

[0038]

[0064] The terms used herein are intended to describe, and not to limit, specific embodiments, implementations, and / or concepts (including any features or aspects thereof). Unless otherwise specified, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Any description, discussion, or use of a particular term is intended to provide context and facilitate understanding, and is not intended to replace or supersede any commonly used or known definition as commonly understood by those skilled in the art, unless otherwise specified. Furthermore, different terms may be used to describe similar or substantially identical embodiments, implementations, and / or concepts (including any features or aspects thereof), and therefore, the use of a particular term is not intended to limit and / or exclude other terms unless it is explicitly stated that these terms are mutually exclusive or not, or that this is clearly not the case in the context.

[0039]

[0065] Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. With regard to substantially any use of plural and / or singular terms herein, those skilled in the art can paraphrase from plural to singular and / or singular to plural as appropriate to the context and / or use. Furthermore, any reference to singular components, features, aspects, etc. herein is not intended to imply the exclusion of two or more such components, features, aspects, etc. (and / or vice versa) unless otherwise specified. For clarity, various singular / plural substitutions may be explicitly stated herein.

[0040]

[0066] In general, terms used herein and in the appended claims are intended as “open” terms unless otherwise specified. For example, the term “including” should be interpreted as “including, but not limited to,” and the term “having” should be interpreted as “having at least,” etc. Similarly, the terms “comprises” and / or “comprising” may specify the existence of the described features, elements, components, integers (or fractions thereof), steps, actions, etc., but do not exclude the existence or addition of one or more other features, elements, components, integers (or fractions thereof), steps, actions, and / or groups thereof, etc., unless such combinations are mutually exclusive.

[0041]

[0067] When used herein, the term "and / or" includes any combination of one or more of the related items listed. Furthermore, any appropriate separate word and / or phrase presenting two or more alternative terms should be understood, whether in the specification or claims, to consider the possibility of including one of the terms, any of the terms, or both / all of the terms. For example, the phrase "A and / or B" would be understood to include the possibility of "A" alone, "B" alone, or a combination of "A and B".

[0042]

[0068] All scopes disclosed herein include, unless otherwise specified, all possible sub-scopes and combinations thereof. Unless otherwise specified, each listed scope should be understood to be sufficiently descriptive and to allow for the division of the same scope into at least equal sub-scopes. As will be understood by those skilled in the art, the scope includes individual components.

[0043]

[0069] As used herein, the terms “about,” “approximately,” and / or “substantially,” when used in relation to a stated value and / or geometric structure or relationship, are intended to convey that the value or feature thus defined is the nominally stated value or feature. In some cases, the terms “about,” “approximately,” and / or “substantially” may generally mean and / or generally intend to mean a stated value or feature within a desirable tolerance range (e.g., ±10% of the stated value or feature). For example, a value of about 0.01 may include 0.009 to 0.011, a value of about 0.5 may include 0.45 to 0.55, a value of about 10 may include 9 to 11, and a value of about 1000 may include 900 to 1100. Similarly, if a first surface and a second surface are nominally parallel, the first surface may be described as substantially parallel to the second surface. While the stated values, structures, and / or relationships may be desirable, it should be understood that some differences may arise as a result of, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force applied by parts of a device, conduit, lumen, etc.). Therefore, the terms “about,” “approximately,” and / or “substantially” may be used herein to describe such tolerances and / or considerations.

[0044]

[0070] The terms “artificial heart valve” and / or “artificial valve” can refer to a combination of a frame and valve leaflets or flow control structures or components, and may encompass both medical devices that completely replace an anatomical site (e.g., a new mechanical valve replaces a natural valve) and medical devices that replace and / or assist, repair, or improve an existing anatomical site (e.g., the natural valve is left in place). As used herein, the term “valve” may be used to refer to either an “artificial valve” or a “natural valve,” and will be understood within the specific context in which the term is used.

[0045]

[0071] Artificial valves disclosed herein may include components (e.g., “frames”) that can seat within a natural valve ring and can be used as valve leaflet structures, flow control components, or mounting elements for flexible reciprocating sleeves or sleeve valves. Depending on the embodiment, such components may or may not include such valve leaflet structures or flow control components. Such components may be referred herein as “annular support frames,” “wire frames,” “valve frames,” “flanges,” “collars,” “cuffs,” and / or any other similar terms.

[0046]

[0072] The term “flow control component” can, in a non-limiting sense, refer to a valve leaflet structure having two, three, or four leaflets of a flexible, biocompatible material such as treated or untreated pericardium, which can be sewn, joined, and / or fitted to an annular support frame in order to function as an artificial heart valve. Such a valve may be a heart valve such as a tricuspid, mitral, aortic, or pulmonary valve, which opens to blood flowing from the atria to the ventricles during diastole and closes from the systolic ventricular pressure applied to its outer surface. The repeated opening and closing in sequence can be described as “reciprocating.” Flow control components are intended to include a wide variety of (bio)prosthetic artificial heart valves and / or components. For example, such (bio) prostheses may include ball valves (e.g., Starr-Edwards), bilobed valves (St. Jude), inclined disc valves (e.g., Bjork-Shiley), stent pericardial valves (bovine, porcine, sheep) (Edwards line bioprostheses, St. Jude prostheses), as well as allograft valves and autograft valves. Bioprosthetic pericardial valves may include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0047]

[0073] The terms “anchor element,” “tab,” or “arm” refer to a structural element that extends from a portion of the valve or valve frame (e.g., extending away from the side wall, body, or collar of the valve) to provide an anchoring or stabilizing function to the valve. In some implementations, anchor elements, tabs, arms, etc. may include and / or be formed from wire loops or wire frames, integrated frame sections, stents, and / or any other suitable structures that extend from the frame (e.g., about 10–40 mm away from the periphery of at least a corresponding portion of the frame). When used with terms such as distal, proximal, septal, anterior, superior annular, inferior annular, etc., in the case of the inferior annular, etc., it should be understood that the anchor or stabilizing element described in this way is attached to and / or integrated with the valve (or valve frame) at or near such a location. The distal position on the valve refers to the portion of the valve furthest from the operator, which may first exit the delivery catheter and be placed in or near the distal inferior annular natural tissue, such as the ventricular outflow tract. The proximal position on the valve refers to the portion of the valve closest to the operator, which may be located in or near the proximal inferior annular natural tissue, such as the tissue closest to the inferior vena cava after the delivery catheter has exited. The septal position on the valve refers to the portion of the valve located between the proximal and distal positions, which may be located in or near the septal inferior annular natural tissue, such as the septal leaflet or septum. The anterior position on the valve refers to the portion of the valve located between the proximal and distal positions, which may be located in or near the anterior tissue opposite the septal tissue. When used with the terms "inferior" or "inferior annular," it should be understood that the anchor or stabilizing element described in this way is attached to and / or integrated with the valve's lateral wall, body, and / or frame in or along the inferior or inferior annular region of the valve. Conversely, when used with the terms "superior" or "superior annular," it should be understood that the anchor or stabilizing element described in this way is attached to and / or integrated with the valve or frame in or along the superior annular region, collar, or atrial cuff of the valve.

[0048]

[0074] 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 the lumen of a catheter deployed into a cardiac chamber (or other desired location in the body), and the item delivered or controlled by such a process. Transcatheter access is known to include cardiac access such as via the lumen of the femoral artery and / or vein and IVC, via the lumen of the brachial artery and / or vein, via the lumen of the carotid artery and SVC, and via the intercostal space and / or subxiphoid space. Furthermore, transcatheter cardiac access may also include transatrial (e.g., fossa ovale or lower) approaches to the left atrium and / or ventricle. Transcatheter may be synonymous with transluminal and, as it relates to the delivery of cardiac valves, is functionally related to the term “percutaneous.”

[0049]

[0075] As used herein, terms such as “orthogonal delivery,” “orthogonally delivered,” “lateral delivery,” “laterally delivered,” and “laterally deliverable” may be used interchangeably to describe such delivery methods and / or valves delivered by such methods. The term “orthogonal” refers to a 90-degree intersection angle between two lines or planes (e.g., two lines or planes are perpendicular). As used herein, the term “substantially orthogonal” refers to an intersection angle of 90 degrees ± a suitable tolerance. For example, “substantially orthogonal” may refer to an intersection angle in the range of 75 to 105 degrees. Orthogonal and / or lateral delivery of an artificial valve may be such that the central axis of the valve is substantially perpendicular to the longitudinal or longitudinal axis of the delivery catheter through which the valve is delivered (e.g., the valve is oriented laterally to a traditional radially compressed valve).

[0050]

[0076] The mode of cardiac access can be at least partially based on “body channels” used to define blood conduits or blood vessels within the body, and the specific application of the disclosed embodiments of the prosthetic valve can determine the body channel in question. For example, aortic valve replacement is implanted within or adjacent to the aortic annulus. Similarly, tricuspid or mitral valve replacement is implanted in the tricuspid or mitral annulus, respectively. While some features described herein may be particularly advantageous for a given implantation site, any embodiment of the valve described herein can be implanted in any body channel unless a combination of features is structurally impossible or excluded by the language of the claims.

[0051]

[0077] As used herein, the terms “expandable” and / or “compressible” may refer to an artificial heart valve or component of an artificial heart valve that can expand and / or compress from a first size or form to a second size or form. For example, an artificial valve may be “compressible” to a delivery size or form and / or “expandable” to an implantable or deployed size or form. Therefore, unless the context clearly indicates otherwise, an “expandable” / “compressible” structure is not intended to refer to a structure that may undergo slight expansion / compression due to, for example, temperature changes or other such accidental causes. Conversely, “non-expandable” / “incompressible” should not be interpreted as meaning that it is completely rigid or dimensionally stable, since, for example, some expansion / compression may be observed in conventional “non-expandable” / “incompressible” heart valves.

[0052]

[0078] Artificial valves and / or their components disclosed herein can generally transition between two or more forms, states, shapes, and / or configurations. For example, the artificial valves described herein may be compressible and / or expandable between any suitable number of forms. Various terms may be used to describe or refer to these forms and are not intended to be limiting unless the context clearly states otherwise. For example, an artificial valve may be described as being in a “delivery form,” which may be any suitable form that enables or allows the delivery of the artificial valve. Examples of delivery forms include compressed form, folded form, rolled form, and / or similar forms, or any suitable combination thereof. Similarly, an artificial valve may be described as being in an “expanded form,” which may be any suitable form that is not explicitly intended for the delivery of the artificial valve. Examples of expanded forms include released form, relaxed form, unfolded form, non-delivery form, and / or similar forms, or any suitable combination thereof. Some artificial valves and / or their components or features described herein may have several additional forms that can be associated with various modes, levels, states and / or parts such as operation, deployment, and engagement. Examples of such forms include the operating form, the seated form, the fixed form, the engaged form, and / or similar forms, or any suitable combination thereof.

[0053]

[0079] The embodiments, methods, and / or implementations described herein, and / or various features or convenient details thereof, will be described in more detail with reference to non-limiting examples shown in the accompanying drawings and detailed in the following description. The examples and / or embodiments described herein are intended to facilitate understanding of the structure, function, and / or aspects of the embodiments, the ways in which the embodiments can be carried out, and / or to further enable those skilled in the art to carry out the embodiments described herein. Similarly, the methods and / or ways of using the embodiments described herein are provided only as examples and not as limitations. Specific uses described herein are not provided to exclude other uses unless specifically indicated in the context. Specific examples, embodiments, methods, and / or uses described herein should not be construed as limiting the scope of the present invention or the concept of the invention herein. Rather, the examples and embodiments are provided so as to ensure that this disclosure is thorough and complete and fully conveys the scope of the concept of the invention to those skilled in the art.

[0054]

[0080] For example, any of the prosthetic valves described herein may be used to replace natural valves of the human heart, including, for example, the mitral valve, tricuspid valve, aortic valve, and / or pulmonary valve. While some prosthetic valves are described herein as replacements for natural mitral valves or natural tricuspid valves, it should be understood that such prosthetic valves can be used to replace any natural valve unless otherwise explicitly stated, or unless one or more components and / or features would otherwise be clearly recognized by a person skilled in the art as unsuitable for such use.

[0055]

[0081] Following a discussion of various embodiments, components, and / or features of artificial valves (e.g., transcatheter-deliverable artificial heart valves), a discussion is made of delivery / deployment systems and methods for delivering and / or deploying artificial valves to the annulus of a natural heart valve using such systems. Descriptions of well-known components and processing techniques may be omitted so as not to obscure the embodiments herein. Similar reference numbers refer to similar elements throughout.

[0056]

[0082] Figures 1-5 are schematic diagrams of various laterally deliverable transcatheter artificial heart valve 100 (also referred to herein as the “artificial valve” or simply the “valve”) according to one embodiment. As will be described in more detail herein, the valve 100 generally includes an annular support frame 110 and flow control components 150 mounted within the annular support frame 110. In addition, Figures 1-5 show at least a portion of a delivery / deployment system 180 which can at least temporarily connect to and / or otherwise engage with the valve 100 and / or a portion thereof to facilitate the delivery and / or deployment of the valve 100 to a desired location in the body. For example, the delivery / deployment system 180 may be used to deliver and deploy an artificial valve 100 to the annulus of a natural valve of the human heart (e.g., the tricuspid valve, mitral valve, aortic valve, and / or pulmonary valve of the human heart), and once deployed, the artificial valve 100 is configured to allow blood flow in a first direction (e.g., through or via a flow control component 150) from the inlet end of the artificial valve 100 to the outlet end of the artificial valve 100, and to block blood flow in a second direction opposite to the first direction. Thus, the artificial valve 100 may be configured to complement and / or replace the function of a natural valve. In some embodiments, the valve 100 and / or delivery / deployment system 180 may be similar to and / or substantially the same as the valve and / or delivery / deployment system described in WIPO Patent Publication No. 2021 / 040996 (also known herein as “'996PCT”) (title “Side-Deliverable Transcatheter Prosthetic Valves and Methods for Delivering and Anchoring the Same”), filed on 6 August 2020, and International Publication No. 2021 / 035032 (also known herein as “'032PCT”) (title “Delivery and Retrieval Devices and Methods for Side-Deliverable Transcatheter Prosthetic Valves”), each of which is incorporated herein by reference in its entirety.

[0057]

[0083] The artificial valve 100 is compressible and expandable between an expanded form (Figures 1 and 2) for implantation in a desired location in the body (e.g., a human heart) and a compressed or delivery form (Figures 3 and 4) for introduction into the body, for example, via a delivery catheter 182 of a delivery / deployment system 180. The artificial valve 100 may be compressible and expandable in at least one direction with respect to the longitudinal axis 102 of the valve 100 (also referred herein as the “horizontal axis,” “long axis,” or “length axis”). For example, the valve 100 may be compressible / expandable along the central axis 104, having a first height or size along the central axis 104 when in the expanded form (Figure 1), and a second height or size smaller than the first height or size along the central axis 104 when in the compressed form (Figure 3). In some embodiments, the artificial valve 100 may be compressible and expandable in at least two directions with respect to the longitudinal axis 102 of the valve 100. For example, the valve 100 may be compressible / expandable along the central axis 104 (as described above) and may be compressible / expandable along the longitudinal axis 102 and the transverse axis 106 perpendicular to the central axis 104, respectively (see, for example, Figures 1 and 2). In such embodiments, the valve 100 may have a first height and a first width when in the expanded state (Figures 1 and 2), and a second height and a second width which are smaller than the first height and first width when in the compressed state (Figures 3 and 4).

[0058]

[0084] When in the expanded configuration shown in Figures 1, 2, and 5, the valve 100 has a range greater than the diameter of the lumen of the delivery catheter 182 used to deliver the valve 100, in any direction perpendicular to the longitudinal axis 102 or laterally (e.g., along the central axis 104 and / or transverse axis 106). For example, in some embodiments, the valve 100 may have an expanded height of 5 to 60 mm (e.g., along the central axis 104). In some embodiments, the valve 100 may have an expanded length (e.g., along the longitudinal axis 102) and width (e.g., along the transverse axis 106) of about 20 to 80 mm, or about 40 to 80 mm. When in the compressed configuration shown in Figures 3 and 4, the valve 100 has a range smaller than the diameter of the lumen of the delivery catheter 182 in any direction perpendicular to the longitudinal axis 102 or laterally (e.g., along the central axis 104 and / or transverse axis 106), allowing the valve 100 to be delivered through it. For example, in some embodiments, the valve 100 may have a compressed height (e.g., along the central axis 104) and a compressed width (e.g., along the transverse axis 106) of about 5–15 mm, about 8–12 mm, or about 9–10 mm. The valve 100 may be compressed by compressing, rolling, folding, and / or any other suitable method or a combination 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 can be increased in accordance with the compression of the valve 100 along the central axis 104 and / or the transverse axis 106.

[0059]

[0085] In some embodiments, the valve 100 (and / or at least a portion thereof) may be thermoformed and / or otherwise formed into any desired shape, such as a substantially tubular shape, a substantially hourglass shape, etc. In some embodiments, the valve 100 may include an upper annular section or region (e.g., an upper atrial cuff or flange for atrial sealing), a lower annular section or region (e.g., an lower ventricular cuff or flange for ventricular sealing), and a transverse annular section or region (e.g., a body section, a tubular section, a cylindrical section, etc.) positioned between them. The transverse annular region may have an hourglass cross-section over about 60–80% of its circumference to coincide with the natural annulus along the posterior and anterior annular segments, while remaining substantially vertically flattened along 20–40% of its annular circumference to coincide with the septal annular segment.

[0060]

[0086] Although the valve 100 is shown in Figures 1-5 as having a general shape, it should be understood that the size and / or shape of the valve 100 (and / or at least a portion thereof) can be based on the size and / or shape of the anatomical structure of the natural tissue. For example, the valve 100 may be central (radially symmetric with respect to the central axis 104) or eccentric (e.g., radially asymmetric with respect to the central axis 104). In some eccentric embodiments, the valve 100 or its outer frame may have a complex shape determined by the anatomical structure in which the valve 100 is fitted. For example, in some cases, the valve 100 may expand into the annulus of a natural tricuspid valve having a rounded elliptical outer circumference with a substantially vertical septum, which is known to expand along the anterior-posterior line in diseased conditions. In some cases, the valve 100 may expand into the annulus of a natural mitral valve having a rounded elliptical outer circumference with a substantially vertical septum (e.g., near the anterior leaflet), which is known to expand in diseased conditions.

[0061]

[0087] As such, the valve 100 may have a complex shape determined at least in part by the disease state of the natural valve annulus and / or the natural valve. For example, the valve 100 or its outer frame may have a D-shape (viewed from above) so that a flattened or substantially flattened portion can be adapted to the anatomical structure (e.g., a substantially vertical septum) into which the valve 100 unfolds. In some embodiments, the valve 100 or its outer frame may have a rounded elliptical outer circumference, such as a hyperbolic paraboloid, to take into account the position of the self-septal cusp, anterior and / or posterior cusp, and / or the self-septum, to avoid the natural electrical flux and / or Koch's triangle, AV node-related structures such as the AV bundle, to avoid coronary blood flow obstructions such as the coronary sinus, and to adapt to differences in the septum, which is known to be substantially vertical but expands toward the free wall along the anterior-posterior axis in disease states.

[0062]

[0088] As shown in the figures, the valve 100 generally includes an annular support frame 110 and a flow control component 150 mounted within the annular support frame 110. In addition, 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 with a delivery / deployment system 180. The annular support frame 110 (also referred to herein as the “valve frame,” “wire frame,” “outer frame,” “support frame,” “frame,” etc.) may have an upper annular region 120, a lower annular region 130, and a transverse annular region 112 positioned and / or coupled between them. In some embodiments, the frame 110 may be constructed monolithically and / or individually. In some embodiments, the upper annular region 120, the lower annular region 130, and / or the transverse annular region 112 are separate, independent, and / or modular components that can be combined to collectively form the frame 110. For example, in some embodiments, the upper annular region 120 may be an atrial collar, cuff, or portion connected to the apex, superior, and / or superior annular margin of the transverse annular region 112, and the lower annular region 130 may be a ventricular collar, cuff, or portion connected to the bottom, inferior, and / or inferior annular margin of the transverse annular region 112. Alternatively, the lower annular region 130 may be and / or be formed by the bottom, inferior, and / or inferior annular portion or section of the transverse annular region 112.

[0063]

[0089] In some implementations, a modular and / or at least partially modular configuration may allow the frame 110 to be adapted to a given size and / or shape of an anatomical structure to which the valve 100 is mounted. For example, the upper annular region 120, the lower annular region 130, and / or transverse annular region 112 may 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. Furthermore, such a modular configuration may allow the frame 110 to bend, flex, compress, fold, round, and / or be reconfigured in other ways without plastic or permanent deformation of its own. For example, the frame 110 may be compressible for delivery or into a delivery configuration and, upon release, return to its original shape (uncompressible, expanded, or released configuration) substantially without plastic or permanent deformation.

[0064]

[0090] The support frame 110 and / or the upper annular region 120, the lower annular region 130, and / or the transverse annular region 112 may be made from or formed thereof of any suitable material. In some embodiments, the frame 110 and / or one or more parts or regions thereof may be made from or formed thereof of shape memory or superelastic metals, metal alloys, plastics, etc. For example, the frame 110 (e.g., the upper annular region 120, the lower annular region 130, and / or the transverse annular region 112) may be made from or formed thereof of nitinol, etc. In some embodiments, the frame 110 (and / or any of its regions) may be laser-cut from a nitinol sheet or tube. In other embodiments, the frame 110 (and / or any of its regions) may be made from or formed thereof of a nitinol wire that is bent, twisted, formed, and / or manipulated into a desired shape. In yet another embodiment, the frame 110 (and / or any of its regions) may be made from or formed thereof of a desired material using any suitable additive or subtractive manufacturing process such as those described above. Furthermore, the frame 110, and / or one or more of the upper annular region 120, lower annular region 130, and transverse annular region 112, may be formed of or from metal or other structural frame material, which is then covered with a biocompatible material such as, for example, pericardial tissue (Dura-Guard®, Peri-Guard®, Vascu-Guard®, etc.) or polymer (e.g., polyester, Dacron®, etc.).

[0065]

[0091] The upper annular region 120 of the frame 110 may be and / or form a cuff or collar that can be attached to or joined to, for example, the upper edge or upper portion of the transverse annular region 112. When the valve 100 is deployed in the human heart, the upper annular region 120 may be an atrial collar shaped to match its original deployment position. In tricuspid and / or mitral valve replacement, for example, the upper annular region 120 (e.g., atrial collar or cuff) may have various portions configured to match a portion of the atrial bed surrounding the native valve and / or the tricuspid and / or mitral valve, respectively. In some implementations, the upper annular region 120 may be deployed in the atrial bed to direct blood from the atrium to the flow control component 150 of the valve 100 and to seal against blood leakage around the frame 110 (e.g., through the annulus but outside the flow control component 150) (perivalvular leakage).

[0066]

[0092] In some embodiments, the upper annular region 120 may be and / or include a wireframe laser-cut from any suitable material. In some embodiments, the upper annular region 120 may be formed from a tube or sheet of a shape-memory or superelastic material, such as nitinol, and may be heat-set to a desired shape and / or form. In some embodiments, forming the upper annular region 120 in such a manner may allow the upper annular region 120 to bend, flex, fold, compress, and / or reconfigure in other ways without substantially plastic deformation and / or fatigue that may result in failure or breakage of one or more of its parts. Furthermore, the wireframe of the upper annular region 120 may be covered with any suitable biocompatible material, such as any of those described above.

[0067]

[0093] The supraannular region 120 includes a distal portion and a proximal portion. In some embodiments, the distal portion may be and / or include a distal supraannular anchor element that can engage with the distal supraannular natural tissue of the annulus when the prosthetic valve 100 is seated within the annulus. In some embodiments, the proximal portion may be and / or include a proximal supraannular anchor element that can engage with the proximal supraannular natural tissue of the annulus when the prosthetic valve 100 is seated within the annulus. In some embodiments, the distal portion and / or the distal supraannular anchor element may be sized and / or shaped to correspond to the size and / or shape of the distal portion of the atrial bed of the heart in which the prosthetic valve 100 is placed. Similarly, the proximal portion and / or the proximal supraannular anchor element may be sized and / or shaped to correspond to the size and / or shape of the proximal portion of the atrial bed of the heart. In some embodiments, the distal portion (or distal upper annular anchor element) and / or the proximal portion (or proximal upper annular anchor element) may be operated to transition between two or more forms and / or states (e.g., during unfolding).

[0068]

[0094] Although not shown in Figures 1-5, the upper annular region 120 may be shaped and / or formed to include any number of features configured to engage with natural tissue, one or more other parts of the valve 100, one or more parts of the delivery / deployment system 180, etc. For example, in some embodiments, the upper annular region 120 may include and / or be formed an outer portion and an inner portion suspended from and / or coupled to the outer portion. In some implementations, the outer portion may be sized and / or shaped to engage with natural tissue, the inner portion may provide a structure for mounting the flow control component 150 to the support frame 110, and one or more covers, drums, spacers, struts, splines, and / or structures may be positioned between them. In some implementations, a portion of the upper annular region 120 may be at least temporarily coupled to and / or at least temporarily accept a portion of the delivery / deployment system 180, at least a portion of an actuator and / or control device, at least a portion of a guidewire (or guidewire catheter), etc. (as described in further detail herein).

[0069]

[0095] The transverse annular region 112 of the support frame 110 is coupled to the upper annular region 120, and when the artificial valve 100 is seated, it extends from the upper annular region 120, at least partially through the valve ring of the natural valve. In some embodiments, the transverse annular region 112 may be coupled to the upper annular region 120 to allow a desired amount of movement and / or deflection between them (e.g., welded, joined, sewn, tied, etc.). For example, in some implementations, the transverse annular region 112 and / or a portion thereof may be sewn and / or sutured to the upper annular region 120 (and / or a portion thereof).

[0070]

[0096] The transverse annular region 112 may be shaped and / or formed into a ring, cylindrical tube, conical tube, D-shaped tube, and / or any other suitable annular shape. In some embodiments, the transverse annular region 112 may have a flattened cone shape, an inverted flattened cone shape (narrower at the top and wider at the bottom), a concave cylinder (walls curved inward), a convex cylinder (walls bulging outward), an hourglass shape, a curved and / or stepped hourglass shape, and / or a side profile of a ring or cylinder having a flared top, a flared bottom, or both. In some embodiments, the transverse annular region 112 may have a shape and / or size that is at least partially based on the size, shape, and / or form of the upper annular region 120 (and / or lower annular region 130) and / or the natural valve ring configured to unfold it. For example, the transverse annular region 112 may have an outer surface for engaging with the natural annular structure, which can be stretched taut to the inner surface of the natural valve ring to provide structural openness to the weakened natural annular ring. Furthermore, the transverse annular region 112 may form and / or define an aperture or central channel 114 extending along the central axis 104 (e.g., the y-axis). The central channel 114 (e.g., an axial lumen or channel) may be sized and configured to accommodate a flow control component 150 over at least a portion of the diameter of the central channel 114.

[0071]

[0097] In some embodiments, the transverse annular region 112 may be and / or include a wireframe laser-cut from any suitable material. For example, the transverse annular region 112 may be formed from a tube or sheet of a shape-memory or superelastic material such as Nitinol, and may be heat-set to a desired shape and / or form. Although not shown in Figures 1-5, in some embodiments, the transverse annular region 112 may include and / or be formed together two laser-cut halves, which may be formed to a desired shape and / or form and joined together to form the transverse annular region 112. Furthermore, the wireframe of the transverse annular region 112 may include any number of struts (e.g., wires) that form and / or define a set of compressible wire cells. Compressible wire cells may be rhomboid or eye-shaped cells having an orientation substantially perpendicular to the central axis 104 (Figure 1) and / or a cell geometric shape, for example, to minimize strain along the strut or wire cell when the transverse annular region 112 is in a vertically compressed form, a rolled-up form, or a folded-up form. In some embodiments, forming the transverse annular region 112 in this manner allows the transverse annular region 112 to bend, flex, fold, deform, and / or be reconfigured in response to lateral folding along or in the direction of the transverse axis 106 (Figure 4) and / or vertical compression along or in the direction of the central axis 104 (Figure 3), as will be described in more detail herein (without substantially plastic deformation and / or excessive fatigue).

[0072]

[0098] As described above with reference to the upper annular region 120, the wireframe of the transverse annular region 112 can be covered with any suitable biocompatible material, such as any of those described above. In some implementations, the wireframes of at least the upper annular region 120 and the transverse annular region 112 may be flexibly joined (e.g., sewn or sutured) and then covered collectively or separately with a biocompatible material. In other words, at least the upper annular region 120 and the transverse annular region 112 may be covered with a biocompatible material before or after joining. In embodiments where the wireframes are covered after joining, the biocompatible material may facilitate and / or support the joining between them.

[0073]

[0099] The lower annular region 130 of the frame 110 may be and / or form a cuff or collar along the end of the transverse annular region 112 opposite the upper annular region 120. For example, when the valve 100 is deployed in the human heart, the lower annular region 130 may be and / or form a ventricular collar shaped to match its original deployment position. For example, in tricuspid and / or mitral valve replacement, the lower annular region 130 or collar may have various parts configured to match a portion of the ventricular ceiling surrounding the native valve and / or the tricuspid and / or mitral valve. In some implementations, the lower annular region 130 or at least a portion thereof can engage with the ventricular ceiling surrounding the native annulus, fixing the valve 100 to the native annulus, stabilizing the valve 100 on the annulus, preventing the valve 100 from falling out, sandwiching or compressing the native annulus or adjacent tissue between the upper annular region 120 and the lower annular region 130 (or the lower portion of the transverse annular region 112), and / or sealing against blood leakage around the frame 110 (perivalvular leakage and / or regurgitation during systole).

[0074]

[0100] In some embodiments, the lower annular region 130 is a lower or lower annular portion of the transverse annular region 112 (for example, the transverse annular region 112 and the lower annular region 130 are formed monolithically and / or individually). In other words, a lower or lower annular portion of the transverse annular region 112 may form and / or include the lower annular region 130. In other embodiments, the lower annular region 130 is a separate and / or independent component that can be attached to or joined to the lower edge or portion of the transverse annular region 112, as described above with respect to the upper annular region 120. In such embodiments, for example, the lower annular region 130 may be and / or include a wireframe which, as described above with respect to the upper annular region 120, is laser-cut from any suitable material such as a shape-memory or superelastic material like Nitinol, heat-set to a desired shape and / or form, covered with any suitable biocompatible material, and attached to the lower edge of the transverse annular region 112. In some implementations, forming the lower annular region 130 in this manner may allow the lower annular region 130 to bend, flex, fold, compress, and / or be reconfigured in other ways without substantially plastic deformation and / or with excessive or undesirable fatigue that could lead to defects or failure of one or more of its parts.

[0075]

[0101] The lower annular region 130 of the frame 110 is shaped and / or formed to include any number of features configured to engage with natural tissue, one or more other parts of the valve 100, one or more parts of the delivery / deployment system 180, one or more parts of the actuator and / or control device 170 (or one or more actuators / control devices), etc. For example, as shown in Figure 1, the lower annular region 130 may and / or be formed to include a distal portion having a distal anchor element 132 and a proximal portion having a proximal anchor element 134. In some embodiments, the anchor elements 132 and 134 are formed integrally and / or monolithically with the lower annular region 130 and / or the lower or lower annular portion of the transverse annular region 112.

[0076]

[0102] The distal anchor element 132 is configured to engage with a desired portion of the natural tissue distal to the natural valve annulus to facilitate the seating, mounting, and / or deployment of the valve 100 in the annulus of the natural valve. The distal anchor element 132 can extend approximately 10–40 mm from the distal portion of the inferior annular region 130 (or the lower portion of the transverse annular region 112). In some implementations, the distal anchor element 132 may be a projection or protrusion extending from the frame 110 (e.g., the lower portion of the inferior annular region 130 and / or the transverse annular region 112) into a distal inferior annular position relative to the annulus (e.g., including RVOT for tricuspid valve replacement and / or similar). In such implementations, the distal anchor element 132 may be shaped and / or biased to apply a force to the inferior annular tissue that is capable of at least partially fixing, stabilizing, and / or fixing the distal end portion of the valve 100 to the natural valve annulus.

[0077]

[0103] The distal anchor element 132 may optionally include a guidewire coupler 133 configured to selectively engage with and / or accept a portion of the guidewire or guidewire catheter. The guidewire coupler 133 is configured to allow a portion of the guidewire or guidewire catheter to extend through the aperture of the guidewire coupler 133, thereby allowing the valve 100 to advance on or along the guidewire and / or guidewire catheter during delivery and deployment.

[0078]

[0104] The proximal anchor element 134 is configured to engage with the inferior annular tissue on the proximal side of the natural valve annulus to facilitate the deployment, seating, mounting, and / or fixation of the valve 100 within the annulus. The proximal anchor element 134 may extend only about 10 to 40 mm from the proximal portion of the inferior annular region 130 (or the lower portion of the transverse annular region 112).

[0079]

[0105] In some embodiments, the proximal anchor element 134 may be configured to transition, move, and / or reconfigure in any other way between two or more forms. For example, the proximal anchor element 134 may transition between a first form in which the proximal anchor element 134 extends by a first amount or distance from the lower annular region 130, and a second form in which the proximal anchor element 134 extends by a second amount or distance different from the first amount or distance from the lower annular region 130. In some implementations, the proximal anchor element 134 in an expanded or unfolded form (e.g., the second form) may extend by about 10 to 40 mm from the transverse annular region 112, while in a compressed or unfolded form (e.g., the first form) may be in contact with the transverse annular region 112 or extend by less than about 10 mm from the transverse annular region 112. In some embodiments, the proximal anchor element 134 may have a first form in which the proximal anchor element 134 is compressed, tightened, contracted, retracted, unfolded, folded, and / or constrained (e.g., in a position near, adjacent to, and / or in contact with, the transverse annular region 112 and / or upper annular region 120 of the frame 110), and a second form in which the proximal anchor element 134 is expanded, stretched, unfolded, untightened, unfolded, i.e., spread out, and / or unconstrained (e.g., extending away from the transverse annular region 112). In some embodiments, the proximal anchor element 134 may have a first or tightened form in which the proximal anchor element 134 is folded, flipped over, or pulled below the prosthetic valve 100, and a second or untightened form in which the proximal anchor element 134 extends away from the prosthetic valve 100 (e.g., enlarged around the lower annular region 130). In some embodiments, the proximal anchor element 134 may have a first or clamping configuration in which the proximal anchor element 134 is folded, flipped over, or pulled along a side of the valve or transverse annular region 112 (e.g., a partition wall side or a free wall side).

[0080]

[0106] In some implementations, at least a portion of the transverse annular region 112 can be at least partially reconfigured based on the state and / or configuration of the proximal anchor element 134. For example, compressing the proximal anchor element 134 can also at least partially compress or reconfigure at least the proximal portion of the transverse annular region 112. Furthermore, in some implementations, the proximal anchor element 134 can transition from a first configuration to a second configuration in response to the operation of the actuator and / or control device 170, and / or other suitable parts of the delivery / deployment system 180, as will be described in more detail herein.

[0081]

[0107] In some implementations, the proximal anchor element 134 may transition from a first to a second form during deployment to selectively engage with natural tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structures, thereby assisting in the fixation of the valve 100 to the natural annulus. The proximal anchor element 134 (and / or the distal anchor element 132, and / or any other part of the inferior annular region 130) may include any suitable features, surfaces, members, etc., configured to facilitate engagement between the proximal anchor element 134 (and / or the distal anchor element 132, and / or any other part of the inferior annular region 130) and natural tissue. For example, in some embodiments, the proximal anchor element 134 may include one or more features (e.g., protrusions, projections, ridges, wavy curves, beads, fingers, hooks, etc.) configured to engage with and / or entangle with natural tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structures when in the second form.

[0082]

[0108] Although the proximal anchor element 134 has been described above as being configured to transition between two or more forms, in other embodiments the proximal anchor element 134 may and / or have a substantially constant form. In such embodiments the proximal anchor element 134 may be flexible and / or movable within a relatively limited range of motion, but otherwise have a single constant form.

[0083]

[0109] Although not shown in Figures 1-5, the inferior annular region 130 may include and / or be formed of any number of additional anchor elements, such as septal anchor elements. For example, the inferior annular region 130 may include a posterior-septal (PS) tab or anchor element that can engage with posterior-septal tissue to help stabilize the valve in the annulus of the natural valve. In some embodiments, a septal inferior annular anchor element is included, which may be configured to engage with the inferior annular septal tissue, septal cusp tissue, and / or any other suitable tissue in, near, and / or along the septum of the heart. In some implementations, once the valve 100 is at least partially inserted into the valve annulus, the septal anchor element extends downward from the septum to retain its own septal leaflet, for example, away from the joint leaflet of the prosthetic valve 100, and / or stabilizes the valve against any annular adduction force and / or any annular torsional force (e.g., tilting, angling, twisting, rolling, etc.) that would affect the desired position or positioning of the prosthetic valve within the valve annulus.

[0084]

[0110] In some embodiments, anchor elements contained in or extending from the inferior annular region 130 may be configured with a predetermined atrial or ventricular bias, which in some implementations may be designed, selected, and / or adjusted to allow the inferior annular anchor element to engage with the natural ventricular tissue with a desired force. For example, in some embodiments, the distal inferior annular anchor element 132 may have a slight atrial bias, meaning that the anchor element 132 is positioned or extends at an angle in the superior annular direction (e.g., toward the valve annulus). In other embodiments, the distal inferior annular anchor element 132 may have a slight ventricular bias, meaning that the anchor element 132 is positioned or extends at an angle in the inferior annular direction (e.g., away from the valve annulus). In yet another embodiment, the distal inferior annular anchor element 132 may have a neutral bias, meaning that the anchor element 132 is not positioned at an angle and / or otherwise extends substantially linearly or neutrally. Similarly, any other inferior annular anchor element may have an atrial, ventricular, or neutral bias, which may be designed, selected, and / or tuned to allow the anchor element to engage with the natural ventricular tissue with a desired force.

[0085]

[0111] Although not shown in Figures 1-5, the frame 110 may also have and / or have additional functional elements (e.g., loops, anchors, mounting points, etc.) for attaching accessory components such as a biocompatible cover, tissue anchors, and a releasable deployment / retrieval control unit (e.g., actuators and / or control devices 170, tension members, torque cables, hypotubes, parts of the delivery / deployment system 180, support members or tethers, and / or other suitable guides, knobs, fasteners, rigging, etc.).

[0086]

[0112] The flow control component 150 may, in a non-limiting sense, refer to a device for controlling the flow of fluid through it. In some embodiments, the flow control component 150 may be a valve leaflet structure having two, three, four, or more leaflets, made of a flexible biocompatible material such as treated or untreated pericardium. The leaflets may be sewn or joined to a support structure such as an inner frame, which in turn may be sewn or joined to an outer frame 110. The leaflets may be configured to move between an open state and a closed or substantially sealed state, allowing blood to flow through the flow control component 150 in a first direction through the inlet end of the valve 100, and blocking blood flow in a second direction opposite to the first direction through the outlet end of the valve 100. For example, the flow control component 150 may be configured to function as a cardiac valve such as a tricuspid valve, mitral valve, aortic valve, or pulmonary valve, which can be opened to allow blood to flow from the atrium to the ventricle during diastole and closed from the systolic ventricular pressure applied to the outer surface.

[0087]

[0113] The inner frame and / or a portion or aspect thereof may be similar to the outer frame 110 and / or a portion or aspect thereof, at least in form and / or function. For example, the inner frame may be a laser-cut frame formed from or made of a shape memory material such as Nitinol. Furthermore, the inner frame may be compressible for delivery and configured to return to its original (uncompressible) shape when released (e.g., after delivery). In some embodiments, the inner frame may include a plurality of parts or components that are joined together to form the inner frame collectively. Such arrangement configurations may allow the inner frame to transition between a compressed and uncompressed state without excessive or undesirable plastic deformation, fatigue, etc. In some embodiments, the inner frame may include and / or be formed of any appropriate number of compressible and elastically deformable rhombic or eye-shaped wire cells, etc. The wire cells may have an orientation and cell geometric shape substantially perpendicular to the axis of the flow control component 150 in order to minimize strain on the wire cells when the inner frame is in a compressed state.

[0088]

[0114] In some embodiments, the flow control component 150 and / or its inner frame may have a substantially cylindrical or tubular shape when the valve 100 is in an extended configuration (see, for example, Figure 2), and may be configured to be elastically deformable when the valve 100 is in a compressed configuration (see, for example, Figures 3 and 4). Not shown in Figures 1-5, in some embodiments, the inner frame of the flow control component 150 may include and / or be formed of two halves that can be coupled to each other to allow the inner frame to be elastically deformable in response to lateral compression or folding along or in the direction of the transverse axis 106 (Figure 3), as will be described in more detail herein.

[0089]

[0115] As shown in Figures 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 mounted and / or bonded to the upper annular region 120 (e.g., its inner portion) and configured to extend within and / or through the central channel 114 formed and / or defined by the transverse annular region 112. In some embodiments, the flow control component 150 may be bonded to the upper annular region 120 via tissue, biocompatible mesh, one or more woven or knitted fabrics, one or more superelastic or shape memory alloy structures, which are sewn, sutured, and / or otherwise fixed to a portion of the upper annular region 120. In some embodiments, the flow control component 150 may be bonded to the upper annular region 120 such that a portion of the flow control component 150 is positioned above the upper annular region 120 and / or otherwise extends beyond it (e.g., away from the annulus and towards the atrium). In some embodiments, portions of the flow control component 150 extending above and / or beyond the upper annular region 120 can form ridges, shelves, walls, stepped sections, and the like. In some implementations, such arrangements can promote inward growth of natural tissue over the upper annular region 120 without obstructing the flow control component 150.

[0090]

[0116] The flow control component 150 may be at least partially positioned within the central channel 114 such that the axis of the flow control component 150, extending in the direction of blood flow through the flow control component 150, is substantially parallel to the central axis 104 of the frame 110. In some embodiments, the arrangement of the support frame 110 may be such that the flow control component 150 is centered within the central channel 114. In other embodiments, the arrangement of the support frame 110 may be such that the flow control component 150 is off-center within the central channel 114. In some embodiments, the central channel 114 may have a diameter and / or circumference larger than the diameter and / or circumference of the flow control component 150. Although not shown in Figures 1-5, in some embodiments, the valve 100 may include a spacer, etc., which can be positioned within the central channel 114 adjacent to the flow control component 150. In other embodiments, the spacer may be a cover, etc., which is coupled to a portion of the frame 110 and configured to cover a portion of the central channel 114. In some cases, spacers can be used to facilitate the coupling of the flow control component 150 to the frame 110.

[0091]

[0117] Referring again to Figure 1, the valve 100 includes and / or is coupled to an actuator and / or control device 170 and a delivery / deployment system 180 (and / or its interface or part). The actuator and / or control device 170 (hereinafter interchangeably referred to as “actuator” or “control device”) may be any suitable member, mechanism, and / or device configured to actuate at least a portion of the valve 100. For example, in some embodiments, the actuator 170 and / or a portion of the actuator 170 may be configured to be at least temporarily coupled to the upper annular region 120 of the support frame 110 (e.g., a spline and / or other portion) and to actuate one or more portions of the valve 100. More specifically, the actuator 170 may be configured to actuate one or more portions of the valve 100, such as at least a proximal anchor element 134 in the lower annular region 130 of the support frame 110, to move the proximal anchor element 134 between its first and second forms. In some implementations, the actuator 170 may include one or more cables, tethers, link mechanisms, joints, connections, etc., which can apply (or remove) a force to a portion of the proximal anchor element 134 that moves the proximal anchor element 134 between a first and a second configuration. For example, the lower annular region 130 of the support frame 110 may be formed with the proximal anchor element 134 biased to an uncompressed and / or extended configuration, and the actuator 170 can be operated via one or more cables, tethers, etc., to apply a force that moves the proximal anchor element 134 to a compressed and / or retracted configuration.

[0092]

[0118] As described above, in some implementations, the proximal anchor element 134 may be in a first form for delivery and deployment before the valve 100 is seated on the natural valve ring. Once the valve 100 is seated on the natural valve ring, the user can operate a part of the delivery system to activate the actuator 170. In this example, activating the actuator 170 causes the actuator 170 to release and / or remove the force applied to the proximal anchor element 134 (e.g., via a cable, tether, etc.), thereby allowing the proximal anchor element 134 to return to its original or biased form (e.g., a second form), as described above.

[0093]

[0119] The delivery / deployment system 180 shown in Figure 1 may include any number of components having any suitable shape, size, and / or form. In some implementations, the delivery / deployment system 180 may be and / or include a distal end portion used, for example, to position and / or deliver the valve 100 to a desired location in the patient's body (e.g., the annulus of a natural heart valve). In some embodiments, the delivery / deployment system 180 may include a delivery catheter, such as a 22-34 FR delivery catheter having any suitable corresponding internal lumen diameter sufficient to receive the artificial valve 100 in a compressed or delivery configuration. Furthermore, the delivery / deployment system 180 may include a secondary catheter (also called a control catheter), which may be a multi-lumen catheter configured to engage with the valve 100 to advance the valve 100 within the delivery catheter. In some embodiments, each lumen of the multi-lumen secondary catheter may include, for example, a cable, a tether, and / or receive any other suitable components associated with and / or included in the actuator 170. Each cable, tether, and / or component may be coupled to a portion of the valve 100 or a support frame 110 and configured to actuate a portion thereof, as will be further described in this specification with reference to specific embodiments.

[0094]

[0120] Furthermore, the lumen of the multi-lumen secondary catheter (e.g., the central lumen) may include and / or accept one or more components configured to engage with the lower annular region 130 of the valve 100, such as a torque cable, a guidewire, and / or a guidewire catheter. For example, a guidewire and / or guidewire catheter (with the guidewire positioned inside) can extend through the central lumen of the secondary catheter to a desired position (e.g., RVOT) relative to the natural tissue, providing a path for the valve 100 to move along it during delivery and / or deployment. As another example, a torque cable may extend through the central lumen of the secondary catheter and can selectively engage with one or more portions of the valve 100. The torque cable may be any suitable cable configured to be detachably coupled to the upper annular region 120 of the frame 110 (e.g., a transit point coupled to and / or formed by the upper annular region 120). In some embodiments, the torque cable is a relatively rigid cable, which is preferable to facilitate the delivery and / or deployment of the valve 100 and the retraction of the valve 100. Thus, the delivery / deployment system 180 or its interface shown in Figure 1 may include any of the above-described components that can be used in and / or otherwise facilitate the delivery of the valve 100, the deployment and / or operation of the valve 100 or a portion thereof (e.g., the proximal anchor element 134), and / or the retraction of the valve 100. Furthermore, the delivery / deployment system 180 (or its interface) may be configured to separate, disengage, and / or otherwise release the valve 100 after it has been deployed to the natural valve ring, as will be described in more detail herein with reference to specific embodiments.

[0095]

[0121] As described above, the valve 100 is compressible and expandable between an expanded and a compressed state. When in the expanded state, the valve 100 may have a first height or size along the central axis 104, and when in the compressed state, it may have a second height or size along the central axis 104 that is smaller than the first height or size. The valve 100 may also be compressed in additional directions. For example, the valve 100 may be compressed along a transverse axis 106 perpendicular to the longitudinal axis 102 and the central axis 104, respectively (see, for example, Figures 2 and 3). When the valve 100 is in the compressed state, the delivery system (or at least a part thereof) may be operated to advance the valve 100 into the heart.

[0096]

[0122] Figure 5 shows the valve 100 seated on the annulus of a natural heart valve after delivery and deployment. As described above, the prosthetic valve 100 may be a replacement prosthetic valve for any of the natural valves of the human heart—the pulmonary valve, mitral valve, aortic valve, and / or tricuspid valve (PV, MV, AV, TV). More specifically, the valve 100 is configured for transcatheter delivery, orthogonal / lateral delivery to a desired location in the body through a delivery catheter 182. During delivery through the delivery catheter 182, the valve 100 is compressed orthogonal and / or lateral (e.g., along the central axis 104 and / or transverse axis 106, as described above) with respect to the dimensions of the valve 100 in its expanded form, and the longitudinal axis 102 of the valve 100 is substantially parallel to the longitudinal axis of the delivery catheter 182. In some implementations, for example, the valve 100 (e.g., the upper annular region 120) may be detachably coupled to a control device 170 included in the delivery / deployment system 180, which may be used to advance the compressed valve 100 into the atrium (RA, LA) through the lumen of the delivery catheter 182, as described in detail with reference to the delivery / deployment system of '032PCT'.

[0097]

[0123] For example, the distal end portion of the control device 170 includes and / or can be coupled to a connecting member that is detachably coupled to and in contact with a portion of the valve 100 (e.g., the upper annular region 120), while the proximal end portion of the control device 170 is located proximal to and outside of the delivery catheter 182. This arrangement allows a distally directed force applied to or on the proximal end portion of the control device 170 to advance the valve 100 through the delivery catheter 182 along or over the guidewire and / or guidewire catheter (e.g., located within and / or extending through the guidewire coupler 133). Once in the atrium and released from the delivery catheter 182, the valve 100 can transition to an expanded form for deployment into the annulus of a natural valve, such as the pulmonary valve, mitral valve, aortic valve, and / or tricuspid valve. In some embodiments, at least a portion of a control device 170, for example, can extend through one or more lumens of the delivery catheter 182 to a distal and intraatrial position relative to the delivery catheter 182, thereby enabling a user (e.g., a doctor, surgeon, technician, etc.) to manipulate one or more portions of the valve 100 to deploy the distal end of the control device 170, and therefore to the valve annulus.

[0098]

[0124] Deployment and / or seating of the valve 100 may include, for example, positioning the distal anchor element 132 of the inferior annular region 130 within the ventricle (right ventricle (RV) or left ventricle (LV)) below the annulus, while the rest of the valve 100 is within the atrium (RA, LA). In some cases, the distal anchor element 132 can be advanced along and / or on a guidewire or guidewire catheter (not shown) to a desired location within the ventricle, such as the ventricular outflow tract. For example, in some implementations, the valve 100 can be delivered to the annulus of a natural tricuspid valve, and at least a portion of the distal anchor element 132 may be positioned within the RVOT. In other implementations, the valve 100 can be delivered to the annulus of a natural mitral valve, and at least a portion of the distal anchor element 132 may be positioned in an inferior annular position distal to the annulus and / or any other suitable position where the distal anchor element 132 can engage with natural tissue, leaflets, tendons, etc. In some implementations, the distal portion or surface of the valve 100 may be positioned in contact with and / or adjacent to the distal surface of the annular tissue when the distal anchor element 132 is positioned within the ventricle (e.g., within the RVOT). With the distal portion of the valve 100 in the desired position, the control device 170 may be operated to actuate one or more portions of the valve 100, such as the proximal anchor element 134, between its first and second forms. For example, the control device 170 may include one or more cables, tethers, linkage mechanisms, joints, connectors, tension members, etc., which can apply (or remove) a force to a portion of the proximal anchor element 134 that can actuate the proximal anchor element 134 to move between its first and second forms. For example, the control device 170 can be activated via one or more cables, tethers, etc., to apply a force to compress and / or move the proximal anchor element 134 into a retracted state, and can be activated and / or operated in other ways to release or reduce the force to move—or enable—the proximal anchor element 134 from the compressed and / or retracted state to an expanded or uncompressible state.

[0099]

[0125] With the lower annular region 130 of the valve (or valve frame 110) in a desired position / shape, the control device 170 can be operated to push or pivot the proximal portion of the valve 100 into the annulus, thereby seating the prosthetic valve 100. For example, the control device 170 may be and / or include a maneuverable control catheter that can be operated (maneuvered) to apply force to the proximal portion of the valve 100 toward the annulus, thereby pivoting the valve 100 or at least the proximal portion of the valve 100 toward and / or into the annulus. In some implementations, the prosthetic valve 100 may be temporarily held in a partially deployed state. For example, the valve 100 may be partially inserted into the annulus and held at a certain angle to the annulus, allowing blood to flow from the atrium to the ventricle, partially through the natural annulus around the valve 100 and partially through the valve 100, thereby allowing evaluation of valve function.

[0100]

[0126] Figure 5 shows a valve 100 (PV, MV, AV, TV) that is positioned and / or seated within the annulus (PVA, MVA, AVA, TVA) of a natural valve, such that the inferior annular region 130 (e.g., ventricular collar) is positioned in the inferior annular position, the transverse annular region 112 of the valve frame 110 extends through the annulus, and the superior annular region 120 (e.g., atrial collar) remains in the superior annular position. Once the valve 100 is seated in the natural annulus (PVA, MVA, AVA, TVA), the user can operate a portion of the delivery / deployment system 180 to activate a control device 170, thereby causing the control device 170 to release and / or remove the force applied to the proximal anchor element 134 (e.g., via a cable, tether, etc.). The proximal anchor element 134 can then return to its original or biased form (e.g., a second form).

[0101]

[0127] As described above, the upper annular region 120 of the valve frame 110 (e.g., the atrial cuff) may be configured to engage with the natural atrial tissue, the distal anchor element 132 may be configured to engage with the natural ventricular tissue distal to the annulus, and the proximal anchor element 134 may be configured to engage with the natural ventricular tissue proximal to the annulus (e.g., when in the second or expanded configuration), thereby ensuring that the valve 100 is securely seated in the natural annulus, as shown in Figure 5. In some implementations, any other or additional parts of the valve 100 may also engage with natural tissue to ensure that the valve 100 is securely seated in the natural annulus and / or to form a seal between the support frame 110 and the tissue forming the natural annulus (e.g., anterior anchor elements may engage with the inferior annular tissue anterior to the annulus, or the upper annular region 120 may include any number of upper annular anchor elements for engaging with the upper annular tissue (not shown in Figures 1-5)).

[0102]

[0128] With the valve 100 fixed to the valve annulus, the delivery / deployment system 180 (including the control device 170, guidewire and / or guidewire catheter, and / or any other part or component of the delivery / deployment system 180) can be separated from the valve 100, and the prosthetic valve 100 can be retracted / removed from the patient, leaving it in place. As described above, in some implementations, the arrangement of the actuator 170 may be such that its distal end is wrapped around or looped around the guidewire and / or guidewire catheter. In such implementations, the distal end of the actuator 170 can be released by retracting the guidewire and guidewire catheter into the delivery / deployment system 180 (for example, proximal to the valve 100), thereby allowing the actuator 170 to be retracted and / or withdrawn from the valve 100 into or through the delivery / deployment system 180. In other implementations, the distal end of the actuator 170 can be separated from the mounting point in any suitable manner.

[0103]

[0129] Figures 6-8 are schematic diagrams of an artificial valve 200 and / or at least its annular support frame 210, detachably coupled to an actuator and / or control device 270, according to one embodiment. In some embodiments, the support frame 210 and / or actuator 270 may be substantially similar, at least in form and / or function, to the support frame 110 and / or actuator 170 described above with reference to Figures 1-5, respectively. Therefore, several parts and / or aspects of the support frame 210 and / or actuator 270 are not described in further detail herein.

[0104]

[0130] As shown in the figures, the annular support frame 210 (also referred to herein as the “valve frame,” “wire frame,” “outer frame,” “support frame,” or “frame”) may include and / or have an upper annular member 220 (or region), a lower annular member 230 (or region), and a transverse annular member 212 (or region) positioned and / or joined between them. In the embodiments shown in Figures 6-8, the upper annular member 220, the lower annular member 230, and the transverse annular member 212 are separate, independent, and / or modular components, which are joined together to collectively form the frame 210. Each of the upper annular member 220, the lower annular member 230, and the transverse annular member 212 is a wire frame laser-cut from any suitable material such as shape memory or superelastic material like Nitinol. In some implementations, each of the upper annular member 220, the lower annular member 230, and the transverse annular member 212 may be laser-cut from a sheet of Nitinol and heat-set, for example, to a desired shape and / or form. As described above, forming the upper annular member 220, the lower annular member 230, and the transverse annular member 212 in such a manner can provide a desired amount of flexibility and / or resistance to plastic or permanent deformation, thereby enabling the frame 210 to be folded and / or compressed for delivery. Furthermore, the wireframe portions of the upper annular member 220, the lower annular member 230, and the transverse annular member 212 can be covered with any suitable biocompatible material, such as any of the materials described above.

[0105]

[0131] In some embodiments, the upper annular member 220 of the frame 210 may be similar, at least in form and / or function, to the upper annular region 120 (or member) described above with reference to Figures 1-5. For example, the upper annular member 220 may be and / or form a cuff or collar that can be attached to or coupled to, for example, the upper edge or upper portion of the transverse annular member 212, as will be described in more detail herein. In some implementations, the upper annular member 220 may be deployed on the atrial bed to direct blood from the atrium into the flow control component mounted on the frame 210, as will be described in detail above. The upper annular member 220 may be shaped and / or formed to include any number of features configured to engage with natural tissue and / or one or more other parts of the frame 210 and / or the actuator / control device 270. For example, in some embodiments, the upper annular member 220 may include and / or form an outer portion or loop, an inner portion or loop, and one or more splines positioned between the outer portion or loop and the inner portion or loop.

[0106]

[0132] In some embodiments, the outer portion or loop (referred to herein as the “outer loop”) may be shaped and / or sized to engage with natural tissue. More specifically, the upper annular member 220 (or its outer loop) may have a distal portion 222 configured to engage with distal upper annular tissue and a proximal portion 224 configured to engage with proximal upper annular tissue. In some embodiments, the distal portion 222 and the proximal portion 224 may have a rounded and / or curved shape, with the radius of curvature of the proximal portion 224 being greater than that of the distal portion 222. In some implementations, the distal portion 222 may, for example, form a distal upper anchor element that engages with distal upper annular tissue to at least partially stabilize and / or fix the frame 210 to the natural valve annulus. Similarly, the proximal portion 224 can form, for example, a proximal superior anchor element, which can engage with the proximal superior annular tissue to at least partially stabilize and / or fix the frame 210 to the natural valve annulus.

[0107]

[0133] The inner portion or loop of the upper annular member 220 (referred to herein as the “inner loop”) may be substantially circular and may be coupled to the outer loop by one or more splines and / or suspended from there. As will be further described herein with reference to specific embodiments, the inner loop may be coupled to the inner frame of a flow control component in order to at least partially mount the flow control component to the support frame 210. In some implementations, by suspending the inner loop from the outer loop (via one or more splines), as will be further described herein, the inner loop can be at least partially isolated from at least a portion of the forces associated with transitioning the frame 210 between an expanded and a compressed state. Furthermore, by mounting the flow control component to the inner loop of the upper annular member 220, the amount of force transmitted to the flow control component when the frame 210 is transitioned between its expanded and a compressed state can also be at least partially isolated and / or reduced.

[0108]

[0134] One or more splines of the upper annular member 220 may be of any suitable shape, size, and / or form. For example, in some embodiments, the upper annular member 220 may include distal and proximal splines. As described above, splines may be configured to support an inner loop and / or otherwise connect the inner loop to the outer loop. In some embodiments, the upper annular member 220 may include splines (e.g., proximal splines) configured to receive, connect to, and / or otherwise engage with the actuator / control device 270 and / or delivery / deployment system 180. For example, in some embodiments, the proximal splines may form connection points, mounting points, transit points, and / or any other suitable features that can be temporarily and / or detachably coupled to the actuator / control device 270, as will be described in further detail herein with reference to specific embodiments.

[0109]

[0135] In some embodiments, the lower annular member 230 of the frame 210 may be similar, at least in shape and / or function, to the lower annular region 130 described above with reference to Figures 1-5. For example, the lower annular member 230 of the frame 210 may be and / or form a cuff or collar that can be attached to or coupled to, for example, the lower edge or upper portion of the transverse annular member 212, as will be described in more detail herein. When the frame 210 is deployed in the human heart, the lower annular member 230 may be a ventricular collar shaped to match its original deployment position. For example, in tricuspid and / or mitral valve replacement, the lower annular member 230 or collar may have various portions configured to match the portion of the ventricular ceiling surrounding the natural valve and / or the tricuspid and / or mitral valve, respectively. In some implementations, the lower annular member 230 or at least a portion thereof engages with the ventricular ceiling surrounding the natural valve annulus to fix the frame 210 to the natural valve annulus, prevent the frame 210 from falling off, and can sandwich or compress the natural valve annulus or adjacent tissue between the upper annular member 220 and the lower annular member 230, and / or seal against blood leakage around the frame 210 (perivalvular leakage and / or regurgitation during contraction).

[0110]

[0136] The lower annular member 230 may be shaped and / or formed to include natural tissue, one or more other parts of the frame 210, and / or any number of features configured to engage with the actuator 270. For example, in some embodiments, the lower annular member 230 may include and / or be formed a distal portion having a distal anchor element 232 and a proximal portion having a proximal anchor element 234. In some embodiments, the lower annular member 230 may include and / or be formed any other suitable anchor element (not shown in Figures 6-8). In some embodiments, the anchor elements 232 and 234 are formed integrally and / or monolithically with the lower annular member 230. The distal anchor element 232 and the proximal anchor element 234 of the lower annular member 230 may be any suitable shape, size, and / or form, such as any of those described in detail in the '996 PCT and / or '032 PCT, and / or any of those described herein with respect to a particular embodiment.

[0111]

[0137] In some embodiments, the distal portion of the lower annular member 230 and / or the distal anchor element 232 may optionally include a guidewire coupler configured to selectively engage with and / or accept a portion of a guidewire or guidewire assembly. The guidewire coupler is configured to allow a portion of the guidewire or guidewire catheter to extend through the aperture of the guidewire coupler, thereby allowing the frame 210 to advance on or along the guidewire during delivery and deployment. In some embodiments, as will be described in further detail herein, the guidewire coupler and the guidewire or guidewire catheter extending through it may be releasably coupled to a portion of the actuator 270 to collectively form a quick-release mechanism that allows that portion of the actuator 270 to be separated from the valve 200.

[0112]

[0138] The anchor elements 232 and / or 234 of the lower annular member 230 may be configured to engage with desired portions of natural tissue in order to mount the frame 210 onto the annulus of the natural valve into which the frame is deployed. For example, in some implementations, the distal anchor element 232 may be a projection or protrusion extending from the lower annular member 230, for example, into the RVOT. In such implementations, the distal anchor element 232 may be shaped and / or biased to apply a force to the lower annular tissue that is capable of fixing the distal end portion of the frame 210 to the natural annulus at least partially. In some implementations, the proximal anchor element 234 may be configured to engage with the lower annular tissue on the proximal side of the natural annulus to assist in fixing the frame 210 within the annulus.

[0113]

[0139] In some implementations, at least the proximal anchor element 234 may be configured to transition, move, and / or otherwise reconfigure between a first configuration in which the proximal anchor element 234 extends by a first amount or distance from the lower annular member 230 and a second configuration in which the proximal anchor element 234 extends by a second amount or distance from the lower annular member 230. As described above, the lower annular member 230 of the frame 210 may be and / or include a laser-cut frame formed of a shape memory material such as nitinol, which is heat-set to a desired shape. In some embodiments, heat-setting the lower annular member 230 may include forming one or more twists in a portion of the laser-cut wire, thereby further allowing one or more portions of the lower annular member 230 to be biased in different directions and / or orientations. For example, generally, the lower annular member 230 of the frame 210 may be formed to have a high degree of flexibility in a direction that allows the lower annular member 230 to be folded and / or compressed (e.g., with respect to the longitudinal axis of the lower annular member 230). However, in some embodiments, a portion of the lower annular member 230 may be twisted and / or otherwise oriented to have a high degree of flexibility in a direction that allows the proximal anchor element 234 to be actuated and / or to transition between its first and second forms (e.g., in a direction perpendicular to the longitudinal axis of the lower annular member 230 and perpendicular to the folding and / or compression direction).

[0114]

[0140] In some embodiments, the proximal anchor element 234 may be in a compressed, contracted, retracted, unfolded, folded, actuated, tightened, and / or constrained state (e.g., near, adjacent to, and / or in contact with, the transverse annular member 212 and / or upper annular member 220 of the support frame 210) when in a first embodiment, and in an expanded, elongated, unfolded, unfolded, deacted, untightened, and / or unconstrained state (e.g., extending away from the transverse annular member 212) when in a second embodiment. In some embodiments, the proximal anchor element 234 may be biased and / or heat-set to the second embodiment. Furthermore, in some implementations, as will be described in more detail herein, the proximal anchor element 234 may be able to move in response to the operation of the actuator 270.

[0115]

[0141] In some implementations, the proximal anchor element 234 may transition from a first to a second form during deployment, selectively engaging with natural tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structures to assist in the fixation of the frame 210 to the natural valve annulus. The proximal anchor element 234 (and / or distal anchor element 232) may include any suitable features, surfaces, members, etc., configured to facilitate engagement between the proximal anchor element 234 (and / or distal anchor element 232) and natural tissue. For example, in some embodiments, the proximal anchor element 234 may include one or more features configured to engage with and / or entangle with natural tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structures when in the second form, as will be further described herein with reference to specific embodiments.

[0116]

[0142] In some embodiments, the transverse annular member 212 of the frame 210 may be similar, at least in shape and / or function, to the transverse annular region 112 described above with reference to Figures 1-5. For example, the transverse annular member 212 is positioned between the upper annular member 220 and the lower annular member 230. In some embodiments, the transverse annular member 212 may be coupled to each of the upper annular member 220 and the lower annular member 230, allowing a desired amount of movement and / or deflection between them (e.g., welded, joined, sewn, tied, etc.). For example, in some implementations, the transverse annular member 212 and / or a portion thereof may be sewn to each of the upper annular member 220 and the lower annular member 230 (and / or a portion thereof). The transverse annular member 212 may be shaped and / or formed into a ring, cylindrical tube, conical tube, D-shaped tube and / or any other suitable annular shape, as described above with respect to the transverse annular region 112 (or member). In some embodiments, the transverse annular member 212 may have a shape and / or size that is at least partially based on the size, shape and / or form of the upper annular member 220 and / or lower annular member 230 of the support frame 210, the flow control component configured to be coupled to the support frame 210, and / or the natural valve ring configured to be deployed. For example, the transverse annular member 212 may have an outer surface for engaging with the natural annular structure, which can be stretched taut on the inner surface of the natural valve ring to provide structural openness to a weakened natural annular ring.

[0117]

[0143] In some embodiments, the transverse annular member 212 may be and / or include a wireframe laser-cut from any suitable material. For example, the transverse annular member 212 may be formed from a tube or sheet of a shape-memory or superelastic material such as Nitinol, and may be heat-set to a desired shape and / or form. Although not shown in Figures 6-8, in some embodiments, the transverse annular member 212 may include and / or be formed from two laser-cut halves, which may be formed to a desired shape and / or form and joined together to form the transverse annular member 212. Furthermore, the wireframe of the transverse annular member 212 may include and / or include any number of struts that define a set of compressible wire cells. The compressible wire cells may be, for example, rhomboid or eye-shaped cells having an orientation and / or cell geometric shape substantially perpendicular to the central axis of the artificial valve 200. In some embodiments, forming the transverse annular member 212 in this manner may allow the frame 210 to bend, flex, fold, deform, and / or be reconfigured in response to transverse folding along or in the direction of the transverse axis (e.g., extending between the two halves of the transverse annular member 212) and / or vertical compression along or in the direction of the central axis (e.g., extending along the blood flow direction through the valve 200) (without substantially plastic deformation and / or excessive fatigue).

[0118]

[0144] As described above, the upper annular member 220, the lower annular member 230, and the transverse annular member 212 are independent and / or modular components that can be combined to collectively form the frame 210. In some embodiments, the upper annular member 220 is configured to engage with the upper annular tissue of the natural valve and is shaped and / or biased to form a substantially fluid seal with the atrial bed to limit and / or substantially prevent leakage around the frame (e.g., perivalvular leakage). Similarly, the lower annular member 230 is configured to engage with the lower annular tissue of the natural valve and is shaped and / or biased to form a substantially fluid seal with the ventricular ceiling to limit and / or substantially prevent leakage around the frame. Furthermore, in some implementations, the transverse annular member 212 may have an outer circumference that is slightly larger than the natural annular tissue, for example, to form at least a partial seal between the transverse annular member 212 of the frame 210 and the natural tissue forming the wall of the valve annulus. In such an implementation, redundancy can be provided when an incomplete or partial seal is formed by the upper annular member 220, the lower annular member 230, and / or the transverse annular member 212, by forming a seal against the atrial bed, the ventricular ceiling, and the valve annular wall.

[0119]

[0145] In some implementations, the distal and proximal anchor elements 232 and 234 can apply a force to the inferior annular tissue that is capable of pulling the upper annular member 220 of the frame 210 toward the atrial bed, thereby promoting seal formation. In such implementations, for example, the inferior annular member 230 and / or transverse annular member 212 do not need to form a seal with the natural tissue, or can form a partial seal, due to the seal formed by the upper annular member 220.

[0120]

[0146] As shown in Figures 6-8, the actuator / control device 270 (hereinafter interchangeably referred to as “actuator 270” or “control device 270”) can be at least temporarily coupled to the upper annular member 220 and the lower annular member 230. In some embodiments, the actuator 270 or a portion thereof can also be at least temporarily coupled to a portion of the transverse annular member 212. The actuator 270 may be any suitable member, mechanism, and / or device configured to actuate at least a portion of the frame 210. Furthermore, a portion of the actuator 270 may extend through a portion of the delivery system used to deliver the artificial valve 200, including the frame 210. In this way, the user can actuate the actuator 270 by operating the proximal end portion of the actuator 270.

[0121]

[0147] In some embodiments, the actuator 270 and / or a portion of the actuator 270 may be configured to at least temporarily connect to and / or extend through a spline of the upper annular member 220 (e.g., a mounting point, a transit point, a connector, a threaded coupler, etc.) and to actuate one or more portions of the frame 210. The actuator 270 may be configured to actuate at least the proximal anchor element 234 of the lower annular member 230 of the support frame 210 in order to move the proximal anchor element 234 between its first and second forms (as described above).

[0122]

[0148] In some implementations, the actuator / control device 270 may include one or more cables, tethers, linking mechanisms, joints, connectors, etc., which can apply (or remove) a force to a portion of the proximal anchor element 234 (or more generally, a portion of the lower annular member 230) that is operable to move at least the proximal anchor element 234 between a first and a second configuration. For example, the actuator 270 may be coupled to the upper annular member 220 and may include one or more tethers, cables, and / or members that extend through a transit point and / or one or more openings or apertures and are coupled to the proximal anchor element 234. As described above, the lower annular member 230 may be formed with the proximal anchor element 234 biased in an uncompressed, untightened, and / or extended configuration. In this way, the actuator 270 may be operated to apply a force via one or more cables, tethers, etc., that is operable to move the proximal anchor element 234 into a compressed, tightened, and / or retracted configuration.

[0123]

[0149] More specifically, the user can operate the proximal end portion of the actuator 270 to actuate the distal end portion of the actuator 270, which is coupled to the frame 210. For example, actinguate the actuator 270 may involve pulling one or more cables, tethers, and / or members in a proximal direction (e.g., away from the frame 210 and / or increasing tension within the frame), as indicated by arrow AA in Figure 7. The coupling of the distal end portion of the actuator 270 to the frame 210 may involve the proximal movement of the cables, tethers, etc., pulling at least the proximal anchor element 234 toward the central axis of the frame 210, as indicated by arrow BB in Figure 7. In some implementations, the proximal movement of the cables, tethers, etc., can apply force to the proximal anchor element 234, which is operable to fold, flip, or bend the proximal anchor element 234 beneath the transverse annular member 212 (e.g., toward the distal end portion of the valve 200). As such, by operating the actuator 270, a force can be applied to the proximal anchor element 234 that is capable of compressing, retracting, restraining, tightening, and / or placing the proximal anchor element 234 into an operating state, as shown in Figure 7.

[0124]

[0150] In some implementations, acting the actuator 270 may also be operable to pull the proximal-front portion of the lower annular member 230 and / or the transverse annular wall, and the proximal-rear portion of the lower annular member 230 and / or the transverse annular wall, toward or toward the longitudinal axis of the valve 200. For example, Figure 8 shows that acting the actuator 270 (e.g., moving the actuator 270 or tether in the AA direction) compresses and / or moves the proximal anchor element 234 toward the central portion of the valve frame 210, as indicated by arrow BB, and compresses the rear and front side walls toward the central portion of the valve frame 210, as indicated by arrow CC. In such a case, acting the actuator 270 can reduce the perimeter of at least the lower annular member 230, allowing the desired portion of the valve frame 210 to be inserted into the valve ring of the natural valve.

[0125]

[0151] As described above, the proximal anchor element 234 may be in and / or positioned in a first form (tightened) for delivery and deployment before the frame 210 (or valve 200) is seated on the natural valve annulus (e.g., before being loaded into the delivery catheter or after being released from the distal end of the delivery catheter). Once the frame 210 is seated on the natural valve annulus, the user can operate the proximal portion of the actuator 270 to activate and / or release the actuator 270. In this example, the activation can cause the actuator 270 to release and / or remove at least a portion of the force applied to the proximal anchor element 234 (e.g., via a cable, tether, etc.), thereby allowing the proximal anchor element 234 (and / or one or more portions of the anterior and / or posterior walls) to return to its biased form or second form (see, for example, Figure 6), as described above.

[0126]

[0152] In some embodiments, the actuator 270 may include a first tether that can be tensioned (e.g., pulled proximally) to actuate and / or tighten the proximal anchor element 234 to a first form, and / or include a second tether that can be tensioned (e.g., pulled proximally) to actuate, release, and / or expand the proximal anchor element 234 to a second form. For example, after the artificial valve 200 is seated on the natural valve annulus, the first tether may be released and / or actuated to release tension along the first tether, allowing the proximal anchor element 234 to transition toward the second form. However, in some cases, the proximal anchor element 234 may come into contact with natural tissue or be otherwise hindered when returning to the second biased form. As such, the actuator 270 may include a second tether that can be operated and / or tensioned to pull or otherwise facilitate the proximal anchor element 234 transition from a first form to a second form, as will be described in more detail herein.

[0127]

[0153] While it has been stated above that one or more portions of the frame 210 and / or the lower annular member 230 are compressed to move inward toward the central axis of the frame 210 in response to the operation of the actuator 270, in other embodiments the actuator 270 may be detachably coupled to one or more portions of the frame 210 and configured to move such portions in any suitable manner. For example, in some implementations the actuator 270 (e.g., one or more tethers as described above) may be coupled to the proximal anchor element 234 so that, upon operation of the actuator 270, the proximal anchor element 234 folds or wraps around or beneath at least a portion of the transverse annular member 212 of the frame 210 either forward or backward, or in both directions, depending on the mode of operation. As described above, by folding and / or wrapping the proximal anchor element 234 around or beneath at least a portion of the transverse annular member 212, the outer circumference or diameter of at least the lower annular member 230 can be reduced, allowing the frame 210 to be inserted into and / or at least partially through the annulus of a natural heart valve. In some embodiments, the actuator 270 (e.g., a clamping tether) moves through the upper annular member 220 via a waypoint and is fixed and / or attached at one or more mounting points to the proximal anchor elements 234 of the transverse annular member 212 and / or the lower annular member 230. In some embodiments, the clamping tether may be fixed along the wire frame struts of the transverse annular member 212, rather than extending across one or more wire cells or otherwise not being fixed between the upper annular member 220 and the lower annular member 230. In some cases, such a configuration can limit and / or substantially prevent axial clamping of the valve 200 (e.g., clamping that reduces the height of the valve 200).

[0128]

[0154] Figures 9-12 are schematic diagrams of an artificial valve 300 and / or at least its annular support frame 310, detachably coupled to an actuator and / or control device 370 according to one embodiment. In some embodiments, the artificial valve 300 and / or actuator / control device 370 may be substantially similar in form and / or function to the artificial valves 100 and / or 200 and / or actuator / control devices 170 and / or 270 described above. Therefore, several parts and / or aspects of the artificial valve 300 and / or actuator / control device 370 may not be described in further detail herein.

[0129]

[0155] The annular support frame 310 (also referred to herein as the “valve frame,” “wire frame,” “outer frame,” “support frame,” or “frame”) comprises an upper annular member 320 (or region), a lower annular member 330 (or region), and a transverse annular member 312 (or region) positioned and / or joined between them. Each of the upper annular member 320 (or region), the lower annular member 330 (or region), and the transverse annular member 312 (or region) includes a wire frame, which is laser-cut from any suitable material such as a shape-memory or superelastic material like Nitinol, and at least partially covered with any suitable biocompatible material such as any of the above. As such, the frame 310 and / or its members / regions may have a desired degree of flexibility and / or resistance to plastic or permanent deformation, which may allow the frame 310 to be folded, compressed, actuated, tightened, and / or reconfigured in other ways for delivery to and / or deployment of a natural heart valve annulus.

[0130]

[0156] The upper annular member 320 of frame 310 may be, for example, a cuff or collar that can be attached to or coupled to the upper edge or portion of the transverse annular member 312, and / or may form such a cuff or collar. Since the upper annular member 320 of frame 310 may be similar in at least form and / or function to the upper annular region 120 (or member) and / or upper annular member 220 described above, several parts and / or embodiments of the upper annular member 320 may be specified in context but may not be described in further detail herein. For example, the upper annular member 320 may include and / or form an outer loop configured to selectively contact and / or engage with natural tissue (e.g., via one or more anchor elements and / or other features), an inner loop configured to couple flow control components to the support frame 310, and one or more splines configured to couple the inner loop to the outer loop or suspend it from there. In addition, one or more splines may be configured to at least temporarily receive, couple to, and / or otherwise engage with the actuator 370 and / or the delivery / deployment system (e.g., via one or more connection points, mounting points, transit points, interfaces, and / or any other suitable features), as described in further detail herein.

[0131]

[0157] The lower annular member 330 of frame 310 may be and / or form a cuff or collar, which may be attached to or joined to the lower edge or portion of the transverse annular member 312, and may be shaped and / or formed to include natural tissue, one or more other parts of frame 310, and / or any number of features configured to engage with actuator 370. Since the lower annular member 330 may be similar in at least form and / or function to the lower annular region 130 (or member) and / or lower annular member 230 described above, multiple parts and / or embodiments of the lower annular member 330 may be specified in context but may not be described in further detail herein. For example, the lower annular member 330 may include and / or form a distal portion having at least a distal anchor element 332 and a proximal portion having a proximal anchor element 334 (and any additional anchor elements not shown in Figures 9-12). The anchor elements 332 and / or 334 of the lower annular member 330 may be configured to engage with desired portions of natural tissue to at least partially secure the frame 310 within the valve ring of the natural valve into which the frame is deployed. The anchor elements 332 and 334 may be of any suitable shape, size, and / or form, for example, any of those described above with respect to any of the lower annular regions / members described herein with respect to a particular embodiment, and / or any of those described in the '996 PCT and / or '032 PCT.

[0132]

[0158] For example, the distal anchor element 332 may be a tab, projection, or protrusion extending from the distal end portion of the inferior annular member 330, which may be shaped and / or configured to engage with and / or apply force to the distal inferior annular tissue of the natural valve annulus (e.g., the tissue of the RVOT or the tissue forming the RVOT) to facilitate the deployment, seating, and / or fixation of the prosthetic valve 300 in the annulus. In some embodiments, the distal anchor element 332 may include a guidewire coupler (not shown) configured to selectively engage with and / or accept a portion of a guidewire or guidewire catheter, thereby allowing the frame 310 to advance on or along the guidewire or guidewire catheter during delivery and deployment. In some embodiments, the guidewire coupler and the guidewire or guidewire catheter extending through it may provide and / or form a structure or feature that allows a portion of the actuator 370 to be releasably coupled (for example, collectively forming a quick-release mechanism as described above with reference to the prosthetic valves 100 and / or 200).

[0133]

[0159] The proximal anchor element 334 of the lower annular member 330 may be a tab, projection, or projection extending from the proximal end portion of the lower annular member 330, which may be shaped and / or configured to engage with and / or apply force to the proximal lower annular tissue of the natural valve ring, thereby assisting in the fixation of the frame 310 to the valve ring. In some implementations, at least the proximal anchor element 334 may be configured to transition, move, and / or reconfigure in any way between a first state and / or configuration and a second state and / or configuration (for example, in response to the operation of one or more parts of the actuator 370). For example, the proximal anchor element 334 in the first embodiment may be in an activated and / or tightened state (e.g., in a position near, adjacent to, or under or along the side of the transverse annular member 312, a flow control component, folded / flipped, and / or in contact with it), and the proximal anchor element 334 in the second embodiment may be in an inactivated and / or untightened state (e.g., extending proximal away from the transverse annular member 312). In some implementations, the proximal anchor element 334 may transition from the first embodiment to the second embodiment after the prosthetic valve 300 has seated in the annulus and selectively engaged with natural tissue, tendons, trabeculae, annular tissue, leaflet tissue, and / or any other anatomical structures, assisting in the fixation of the prosthetic valve 300 to the natural annulus. The function, form, and / or features of the proximal anchor element 334 are described in further detail herein with respect to the relationship between the proximal anchor element 334 and the actuator 370.

[0134]

[0160] The transverse annular member 312 of the frame 310 is coupled to the upper annular member 320 and the lower annular member 330 and positioned between them. Since the transverse annular member 312 may be similar in at least shape and / or function to the transverse annular region 112 (or member) and / or transverse annular member 212 described above, multiple parts and / or embodiments of the transverse annular member 312 may be specified in context but may not be described in further detail herein. The transverse annular member 312 may have any suitable shape, size and / or form. For example, the transverse annular member 312 may have a shape and / or size that is at least partially based on the size, shape and / or form of the upper annular member 320 and / or lower annular member 330 of the support frame 310, the flow control component, the natural valve ring configured for the deployment of the artificial valve 300, and / or any suitable combination thereof. Furthermore, as described above with reference to the transverse annular region 112 (or member) and / or transverse annular member 212, the transverse annular member 312 may include one or more members comprising a set of compressible wire cells formed from a shape memory or hyperelastic material and having an orientation substantially perpendicular to the central axis of the artificial valve 200 and / or a cellular geometric shape. As such, the transverse annular member 312 may have a configuration that allows the frame 210 to bend, flex, fold, deform, and / or be reconfigured in other ways (without substantially plastic deformation and / or excessive fatigue) in response to lateral folding along or in the direction of the transverse axis and / or vertical compression along or in the direction of the central axis, for example, as placed in a delivery configuration.

[0135]

[0161] As shown in Figures 9-12, the actuator / control device 370 may be included in the delivery / deployment system and is configured to be at least temporarily coupled to the frame 310. The actuator 370 may be any suitable member, mechanism, and / or device configured to actuate and / or control at least a portion of the frame 310. More specifically, the actuator 370 may be a control device and / or a portion thereof, which can be coupled to the frame 310 and is used to deliver the artificial valve 300 in compressed or delivered form through a delivery catheter, and once released from the delivery catheter, may be used to operate, control, and / or actuate the artificial valve 300 to deploy it into the annulus of a natural heart valve (e.g., a tricuspid valve or any other valve of the heart). In some embodiments, the actuator 370 and / or a portion of the actuator 370 may be configured to be at least temporarily coupled to and / or extend through a spline or other portion of the upper annular member 320 (e.g., a mounting point, a transit point, a connector, a threaded coupler, etc.) and at least temporarily coupled to a proximal anchor element 334 of the lower annular member 330, thereby enabling the actuator 370 to move the proximal anchor element 334 between its first and second forms.

[0136]

[0162] For example, the actuator / control device 370 and / or a portion thereof may be configured to be at least temporarily coupled to the upper annular member 320. In some embodiments, the actuator / control device 370 may include a yoke or other connecting member configured to be detachably coupled and engaged with the upper annular member 320. For example, the actuator / control device 370 may include one or more tethers, sutures, etc., configured to detachably couple the yoke or other connecting member to the upper annular member 320 (e.g., a drum or another suitable surface or portion of the upper annular member 320). In addition, the actuator 370 may include one or more cables, tethers, link mechanisms, joints, connectors, etc., which may extend through a spline or other part of the upper annular member 320 (e.g., mounting points, via points, connectors, threaded couplers, etc.) and be detachably coupled to the proximal anchor element 334 of the lower annular member 330. As such, the actuator 370 may be operated and / or actuated to move the proximal anchor element 334 between its first and second forms.

[0137]

[0163] For example, the lower annular member 330 may be formed together with a proximal anchor element 334 biased to an uncompressed, expanded, and / or untightened state, as shown in Figure 9. In this way, the actuator 370 may be operated to apply a force via one or more cables, tethers, etc., that is operable to move the proximal anchor element 334 into a compressed, retracted, and / or tightened state. As shown in Figures 9-11, the actuator 370 includes, for example, a first tether 373A and a second tether 373B that are detachably coupled to the proximal anchor element 334. As described above with reference to actuators 170 and / or 270, the proximal end portion of the first tether 373A may be operated and / or actuated to pull the distal end portion of the first tether 373A in a proximal direction (for example, away from the frame 310 and / or to increase its tension), as shown, for example, by arrow DD in Figures 10 and 11.

[0138]

[0164] The coupling of the distal end portion of the first tether 373A to the frame 310 is such that the proximal movement of the first tether 373A pulls the proximal anchor element 334 toward the central axis of the frame 310, thereby shaping the proximal anchor element 334 into a first form. For example, as described above with reference to actuator 270, the first tether 373A can move along the upper annular member 320 via a transit point and can be fixed, mounted, and / or have a defined path through one or more mounting points of the transverse annular member 312, the lower annular member 330, and / or the proximal anchor element 334. The arrangement of the mounting points may be such that at least a portion of the mounting points can direct and / or define the path of the first tether 373A so that the force applied to the proximal anchor element 334 is directed in a predetermined and / or desired direction. For example, the first tether 373A can traverse a path through one or more attachment points distal to the proximal anchor element 334 (e.g., along the transverse annular member 312 and / or the lower annular member 330) so that an increase in tension along the first tether 373A applies a force to the proximal anchor element 334 that is capable of pulling, flipping, and / or folding the proximal anchor element 334 distally and / or otherwise in a distal position (e.g., being flipped and / or folded under a portion of the lower annular member 330 and / or being tightened backward (distally) relative to a biased state or position). In addition, the first tether 373A can be routed and / or fixed along the struts of the wire frame / wire cell of the transverse annular member 312, rather than extending across the wire cell or otherwise not being fixed between the upper annular member 320 and the lower annular member 330, thereby further limiting and / or substantially preventing tightening or compression of at least the proximal portion of the valve 300 in the vertical and axial directions, as described above with reference to the artificial valve 200.The proximal anchor element 334 is shown and described as being flipped over and / or folded under the lower annular member 330 and / or otherwise tightened backward, but in some embodiments the proximal anchor element 334 may be pulled, flipped over and / or folded to a position along the side of the transverse annular member 312 (e.g., the septal side or free wall side of the transverse annular member 312).

[0139]

[0165] As indicated by arrow FF in Figure 11, the actuator 370 may also be operated to pull the proximal-front portion of the lower annular member 330 and / or the transverse annular wall and the proximal-rear portion of the lower annular member 330 and / or the transverse annular wall toward or toward the central portion and / or longitudinal axis of the valve 300. In some implementations, the first tether 373A may be routed to tighten the proximal anchor element 334 and tighten, compress, and / or constrict the front / rear portion or wall (as indicated by arrows EE and FF in Figures 10 and 11, respectively). In other implementations, the actuator 370 may include one or more tethers (other than the first tether 373A) that can be operated and / or pulled to move the front / rear portion or wall independently of, or at least partially independently of, the operation of the proximal anchor element 334.

[0140]

[0166] By operating the actuator 370, the perimeter of at least the lower annular member 330 can be reduced, allowing a desired portion of the artificial valve 300 to be inserted into or "dropped" into the annulus of the natural valve. For example, the proximal anchor element 334 may be in a first configuration and / or positioned before the artificial valve 300 is seated on the natural annulus. Once the artificial valve 300 is seated on the natural annulus, the user can operate the proximal portion of the actuator 370 to operate and / or release at least a portion of the actuator 370. More specifically, the actuator 370 can be operated to release or reduce the amount of tension along the first tether 373A, thereby reducing or eliminating the force applied to the proximal anchor element 334, which is operable to maintain the proximal anchor element 334 in a first configuration. Thus, the proximal anchor element 334 may be able to return to or toward its second or biased configuration.

[0141]

[0167] Alternatively, in the embodiments shown in Figures 9-12, the actuator 370 includes a second tether 373B that can be actuated or pulled to assist and / or facilitate the transition of the proximal anchor element 334 to a second or biased form after the tension along the first tether 373A has been released. For example, in some cases, the proximal anchor element 334 may come into contact with and / or be otherwise hindered when returning to the second biased form. As such, the second tether 373B may be actuated to increase the tension along the second tether 373B, which is operable to pull the proximal anchor element 334 from the first form to the second form or otherwise facilitate its transition. As described above with reference to the first tether 373A, the second tether 373B can be directed and / or trajectoryed to pass at least through the transverse annular member 312 and detachably coupled to the proximal anchor element 334, such that a proximal-directed force (indicated by arrow GG in Figure 12) that increases tension along the second tether 373B pulls, flips, and / or spreads the proximal anchor element 334 in the proximal direction (indicated by arrow HH in Figure 12). For example, in some embodiments, the second tether 373B can extend through attachment points, openings, via points, etc., formed by the transverse annular member 312, allowing at least a portion of the second tether 373B to be positioned outside the artificial valve 300, thereby allowing the second tether 373B to pull the proximal anchor element 334 back into a second or biased configuration.

[0142]

[0168] In some embodiments, the second tether 373B may include one or more locking features that can at least temporarily lock the proximal anchor element 334 to a second form or one or more other forms. For example, as shown in Figure 10, the second tether 373B may include a set of locks 379 along the length of the second tether 373B. The locks 379 may be, for example, knots, beads, bumps, projections, and / or any other suitable features positioned at desired locations along the second tether 373B corresponding to one or more desired locations or forms of the proximal anchor element 334. Furthermore, the second tether 373B may be routed through one or more locking features of the frame 310 (e.g., mounting points, openings, couplers, reinforcing rings, etc., of the transverse annular member 312 and / or the upper annular member 320) that can selectively engage with the locks 379 of the second tether 373B. For example, the second tether 373B may be distal when the proximal anchor element 334 is in the first configuration, or may be pulled distally. In this position or state, the lock 379 may be distal to the lock feature of the frame 310.

[0143]

[0169] However, in some implementations, the second tether 373B can be pulled proximal by activating the second tether 373B to pull the proximal anchor element 334 into a second or biased form or assisting its transition, thereby further pulling the lock 379 along the second tether 373B over and / or through the lock feature of the frame 310. In some embodiments, the lock 379 along the second tether 373B may be at least partially compressible, allowing the lock 379 (e.g., having at least slightly larger size) to pass through the lock feature (e.g., having at least slightly smaller size). Thus, once the proximal anchor element 334 is in a second form (or any other suitable form such as a form tightened perpendicular or axially toward the atrial direction), the lock 379 may become proximal to the lock feature of the frame 310. Furthermore, releasing tension along the second tether 373B may result in at least partially receiving tension that allows the portion of the second tether 373B between the proximal anchor element 334 and the locking feature of the frame 310 to contact the lock 379 of the second tether 373B with the proximal side of the locking feature of the frame 310, thereby restricting and / or substantially preventing the proximal anchor element 334 from moving toward the first or clamping configuration.

[0144]

[0170] Although not shown in Figures 9-12, the actuator 370 and / or its first and second tethers 373A and 373B may include and / or be formed one or more quick-release mechanisms that allow the actuator 370 to be separated from the prosthetic valve 300 after the prosthetic valve 300 has been seated and secured in the valve ring. For example, as described above, the delivery system may include a guidewire and / or guidewire catheter that can extend from the actuator / control device 370, through a transit point on the upper annular member 320, under the flow control components, and through the guidewire coupler of the distal anchor element 332. In some embodiments, at least the first tether 373A may include and / or form a loop at its distal end, which may be positioned around a portion of the guidewire or guidewire catheter distal to the mounting point along the lower annular member 330 and the guidewire coupler. In this manner, by withdrawing the guidewire or guidewire catheter to a position proximal to the attachment point along the lower annular member 330, at least the distal end of the first tether 373A is separated and / or released, thereby allowing the first tether 373A to be retracted into the actuator 370 and / or delivery system.

[0145]

[0171] In some embodiments, the second tether 373B may also be coupled to and / or at least partially form a quick-release mechanism. For example, in some embodiments, the second tether 373B may include a first portion that is detachably or releasably coupled to the second portion. The first portion of the second tether 373B may be routed through the delivery system such that its proximal end is proximal to the delivery catheter and its distal end is detachably or releasably coupled to the second portion of the second tether 373B. The second portion of the second tether 373B may be, for example, a distal portion that is coupled (e.g., releasably or permanently) to the proximal anchor element 334 and extends a relatively short distance from the proximal anchor element 334 to be detachably or releasably coupled to the first portion of the second tether 373B. For example, the second portion may include and / or form one or more loops, couplers, connectors, etc., that can engage and / or be detachably coupled to the first portion of the second tether 373B. Accordingly, the second portion of the second tether 373B can form a releasable connector, loop, suture, tether, etc., allowing the actuator 370 to be separated from the artificial valve 300. In some embodiments, the releasable connector, loop, suture, tether, etc. may be similar to and / or substantially identical to any of those described in U.S. Patent Application Publication No. 2022 / 0160504 (hereinafter referred to herein as “'504”) (title “Proximal Tab for Side-Delivered Transcatheter Heart Valves and Method of Delivery”), filed on 7 February 2022, the entire disclosure of which is incorporated herein by reference.

[0146]

[0172] In some embodiments, the distal anchor element 332 may include a guidewire coupler (not shown) configured to selectively engage with and / or accept a portion of a guidewire or guidewire catheter, thereby allowing the frame 310 to advance on or along the guidewire or guidewire catheter during delivery and deployment. In some embodiments, the guidewire coupler and the guidewire or guidewire catheter extending through it may provide and / or form a structure or feature that allows a portion of the actuator 370 to be releasably coupled (for example, collectively forming a quick-release mechanism as described above with reference to the artificial valve 100 and / or 200).

[0147]

[0173] As described above, the proximal anchor element 334 is in a first or tightened state before the prosthetic valve 300 is seated on the annulus of the natural valve. In some implementations, the process of delivering and deploying the prosthetic valve 300 to the annulus may include moving and / or tightening the proximal anchor element 334 after the prosthetic valve 300 has been released from the distal end of the delivery catheter (and before the prosthetic valve 300 is seated on the annulus). However, in other implementations, the process of delivering and deploying the prosthetic valve 300 may include moving and / or tightening the proximal anchor element 334 before loading the prosthetic valve 300 into the delivery system.

[0148]

[0174] For example, Figures 13-15 illustrate the process of delivering an artificial valve 300 using a delivery / deployment system 380. As shown, the actuator / control device 370 may be removably coupled to the artificial valve 300 before loading the artificial valve 300 into the delivery / deployment system 380. The delivery / deployment system 380 and / or at least a part or function thereof may be substantially similar to the delivery systems described in '032PCT.

[0149]

[0175] With the actuator 370 coupled to the artificial valve 300, the user can actuate the actuator 370 by pulling the first tether 373A proximal, thereby increasing the tension along the first tether 373A. Thus, the first tether 373A can pull the proximal anchor element 334 into a first configuration, as described in detail above. With the proximal anchor element 334 in a first or tightened configuration, as shown in Figure 13, a force can be applied to the artificial valve 300 to fold the valve in a direction along the lateral direction. Once tightened and folded, the artificial valve 300 can be inserted into a compression device 390, which includes a set of inner walls defining a tapered lumen, as shown in Figure 14. As such, as described in detail in '032PCT, the inner walls may be configured to compress the artificial valve 300 at least in a direction along the central axis as the artificial valve 300 is advanced through the compression device 390. In some implementations, the folded and / or inverted arrangement of the proximal anchor element 334 in the first or clamping configuration may be such that resistance and / or interference associated with advancing the prosthetic valve 300 distally within the compression device 390 is limited.

[0150]

[0176] The compression device 390 can be configured to compress the prosthetic valve 300 into a compressed and / or delivery form, allowing the prosthetic valve 300 to advance in the loading device 360. The loading device 360 ​​can then be coupled to a portion of the delivery / deployment system 380 (e.g., a delivery handle 381 from which the delivery catheter 382 extends). The loading device 360 ​​can be configured to establish hemostasis together with a lumen 383 extending through the portion of the delivery / deployment system 380, as described in detail in '032PCT'. After hemostasis is established, the loading device 360 ​​can be operated to allow the prosthetic valve 300 to advance in the lumen 383 of the delivery catheter 382, ​​as shown in Figure 15. Although not shown in Figures 13-15, the distal end of the delivery catheter 382 may be positioned, for example, in a cardiac chamber (atrium). In this way, the actuator / control device 370 can advance the prosthetic valve 300 in the delivery catheter 382 and release the prosthetic valve 300 into the cardiac chamber (atrium) from the distal end of the delivery catheter 382 while the proximal anchor element 334 is in a first or tightening configuration.

[0151]

[0177] The following provides a description of several aspects or embodiments of transcatheter-deliverable prosthetic valves (e.g., prosthetic valves) and / or delivery systems and methods for delivering such prosthetic valves. The prosthetic valves (or aspects or parts thereof) described below in relation to a particular embodiment may be substantially similar in form and / or function to the valves 100, 200, and / or 300 (or their corresponding aspects or parts) schematically represented above. Similarly, the delivery systems and / or methods (or aspects or parts thereof) described below in relation to a particular embodiment may be substantially similar in form, function, and / or process to the delivery / deployment systems 180 and / or 380 or processes (or aspects, parts, and / or processes) using such systems schematically represented above. Therefore, some aspects and / or parts of a particular embodiment may not be described in further detail herein.

[0152]

[0178] Figures 16-25 show a laterally deliverable (orthogonally deliverable) transcatheter artificial heart valve 400 (hereinafter also referred to as the “artificial valve” or “valve”) according to one embodiment. Figures 16 and 17 are top and bottom perspective views of the valve 400, respectively. In some implementations, the valve 400 may be deployed, for example, in the annulus of a natural tricuspid valve and / or mitral valve. The valve 400 is configured to allow blood flow in a first direction through the inflow end of the valve 400 and to block blood flow in a second direction opposite to the first direction through the outflow end of the valve 400. For example, the artificial valve 400 may be a laterally deliverable transcatheter artificial heart valve configured to be deployed in the annulus of a natural tricuspid valve or natural mitral valve of a human heart to complement and / or replace the function of a natural valve.

[0153]

[0179] The valve 400 is compressible and expandable in at least one direction with respect to its x-axis (also referred herein as the “horizontal axis,” “longitudinal axis,” “major axis,” and / or “length axis”). The valve 400 is compressible and expandable between an expanded form for implantation in a desired location within the body (e.g., a human heart) and a compressed form (not shown in Figures 16-25) for introduction into the body using a delivery catheter. In some embodiments, the horizontal x-axis of the valve 400 is perpendicular (90 degrees), substantially perpendicular (75-105 degrees), or substantially oblique (45-135 degrees) to the central (vertical) y-axis when in the expanded and / or compressed form. Furthermore, the horizontal x-axis of the valve 400 in the compressed form is substantially parallel to the longitudinal cylindrical axis of the delivery catheter in which the valve 400 is placed.

[0154]

[0180] In some embodiments, the valve 400 has an expanded or unfolded height of approximately 5–60 mm, approximately 5–30 mm, approximately 5–20 mm, approximately 8–12 mm, or approximately 8–10 mm, and an expanded or unfolded diameter (e.g., length and / or width) of approximately 25–80 mm, or approximately 40–80 mm. In some embodiments, the valve 400 has a compressed height (y-axis) and width (z-axis) of approximately 5–15 mm, approximately 8–12 mm, or approximately 9–10 mm. In some implementations, the length of the valve 400 (e.g., along the x-axis) can extend along the length of the central cylindrical axis of the delivery catheter (e.g., longitudinal or longitudinal axis), so as not to be compressed or otherwise shortened.

[0155]

[0181] In some embodiments, the valve 400 may be central or eccentric (e.g., radially symmetric or radially asymmetric along or with respect to the y-axis). In some eccentric embodiments, the frame 410 may have a D-shaped cross-section with a flattened portion or surface configured to substantially coincide with the annulus of the natural mitral valve at or near the anterior leaflet. In the examples shown in Figures 16-25, the valve 400 is eccentric, with one or more components being offset or asymmetrical with respect to the y-axis.

[0156]

[0182] Figures 16 and 17 show a valve 400 including an annular outer support frame 410 and a foldable flow control component 450 mounted within the annular outer support frame 410. The annular outer support frame 410 (also referred to herein as the “outer frame”) is a self-expanding structure that transitions from a compressed to an expanded state, as it is made from a shape memory material such as a nickel-titanium alloy (nitinol). The outer frame 410 has a transverse annular member 412 and / or body that defines, forms, and / or defines the boundary of a central (internal) channel around and / or along a vertical axis or central axis (y-axis). The outer frame 410 has an upper annular member 420 circumferentially attached to the upper edge of the transverse annular member 412 and a lower annular member 430 circumferentially attached to the bottom edge of the transverse annular member 412. At least the outer support frame 410 of the valve 400 is covered, wrapped, and / or surrounded by a biocompatible cover 440. The biocompatible cover 440 may be any other suitable biocompatible material, such as mesh material, pericardial tissue, synthetic polyester fabric material, and / or those described above.

[0157]

[0183] A biocompatible cover 440 positioned on or along the upper annular member 420 may form a drum 445 extending between the outer and inner loops of the upper annular member 420 and / or coupled to the outer and inner loops. As such, the drum 445 may cover a space otherwise not occupied by the flow control components 450. The drum 445 may have and / or form a pair of spokes 445A that can be used to increase the stiffness of the drum 445. The drum 445 is further shown to have mounting members 438 that can extend along or across a portion of the drum 445 (or the upper annular member 420). As will be described in more detail here, the mounting members 438 can facilitate temporary and / or removable attachment to a portion of a delivery / deployment system, such as a control device or actuator.

[0158]

[0184] The superior annular member 420 is shaped to match its original deployment position. In tricuspid valve replacement, for example, the superior annular member 420 or atrial collar may have a tall posterior wall portion to match 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 accommodate the larger flat space above (atrium) the inferior annular region of the ventricular outflow tract (VOT). In mitral valve replacement, for example, the superior annular member 420 of the lateral frame 410 may be D-shaped or have a shape such as a hyperbolic paraboloid that mimics the original structure. In some embodiments, the superior annular member 420 of the lateral frame 410 may be substantially similar in at least shape and / or function to any of the superior annular members described above. Therefore, several parts and / or embodiments of the superior annular member 420 may not be described in further detail herein.

[0159]

[0185] Figure 18 shows (uncovered) a laser-cut wireframe portion of the upper annular member 420. As shown, the upper annular member 420 includes a distal portion 422, a proximal portion 424, an outer loop 421, an inner loop 425, and at least one spline 427. In some embodiments, the outer loop 421 may be shaped and / or sized to engage with natural tissue. For example, the distal portion 422 of the upper annular member 420 (at least partially formed by the outer loop 421) is configured to engage with distal upper annular tissue, and the proximal portion 424 (at least partially formed by the outer loop 421) is configured to engage with proximal upper annular tissue. The distal portion 422 and the proximal portion 424 may have a rounded and / or curved shape, with the radius of curvature of the proximal portion 424 being greater than the radius of curvature of the distal portion 422. The distal portion 422 can, for example, engage with the distal supraannular tissue to form a distal anchor loop 423 that can at least partially stabilize and / or fix the frame 410 to the native annulus. The proximal portion 424 can similarly engage with the proximal supraannular tissue to form a proximal supraannular anchor element that can at least partially stabilize and / or fix the frame 410 to the native annulus.

[0160]

[0186] The inner loop 425 of the upper annular member 420 may be substantially circular, oval, teardrop-shaped, and / or any other suitable shape. The inner loop 425 may be coupled to the outer loop by one or more splines 427 and / or suspended from there. As shown in Figures 16 and 17, the inner loop 425 may be coupled to a biocompatible material 426, which may be used to couple the inner frame 451 of the flow control component 450 to the inner loop 425 of the support frame 410. In some implementations, by suspending the inner loop 425 from the outer loop 421, the inner loop 425 (and the flow control component 450 coupled to the inner loop 425) can be at least partially isolated from at least a portion of the forces associated with transitioning the frame 410 between an expanded and compressed state, for example, as described above with respect to the frame 410.

[0161]

[0187] One or more splines 427 of the upper annular member 420 may be of any suitable shape, size, and / or form. For example, in some embodiments, the upper annular member 420 may include a proximal spline 427 and one or more distal splines 427. The distal splines 427 can connect the distal portion of the inner loop 425 to the distal portion of the outer loop 421. Similarly, the proximal splines 427 can connect the proximal portion of the inner loop 425 to the proximal portion of the outer loop 421. In some embodiments, the proximal splines 427 may be configured to receive, connect to, and / or engage with a portion of an actuator, control device, and / or delivery system. For example, the proximal splines 427 may include, form, and / or connect to a transit point 428 which can be used to connect and / or receive one or more portions of a control device and / or delivery system, as described above with reference to frames 110, 210, and / or 310.

[0162]

[0188] As shown in Figures 16-18, in this embodiment, the upper annular member 420 has an arched shape in which the splines 427 protrude away from the rest of the upper annular member 420. For example, the laser-cut frame of the upper annular member 420 may be formed by the arched splines 427. In some implementations, the arched splines 427 can apply force to the drum 445, bending the drum 445 into an arched shape and increasing tension across the area of ​​the drum 445. The increased tension, either alone or together with the spokes 445A, increases the relative stiffness of the drum 445, thereby reducing and / or limiting the amount of drum deformation, for example, during expansion or contraction, thereby improving the performance of the valve 400 and / or reducing fatigue in or along the drum 445. In other words, the pressure generated on the atrial side of the drum 445 during atrial contraction (diastole) is not sufficient to reverse the arched shape of the drum 445 due to the arched spline 427 (i.e., not causing distortion like that of an oil can). The arched shape of the drum 445 can also withstand the greater pressure generated on the ventricular side of the drum 445 during ventricular contraction (systole) without substantially distorting it. Furthermore, the arch within the spline 427 may be such that the transit point 428 is positioned at a desired angle and / or orientation to facilitate the insertion or retrieval of one or more parts of the delivery system through the transit point 428.

[0163]

[0189] Figure 19 is a distal perspective view showing a transverse annular member 412 of the outer frame 410 of the valve 400. In some embodiments, the transverse annular member 412 of the outer frame 410 may be substantially similar in at least shape and / or function to any of the transverse annular regions / members described above. Therefore, several parts and / or embodiments of the transverse annular member 412 may not be described in further detail herein.

[0164]

[0190] The transverse annular member 412 can be shaped and / or formed into a ring, cylindrical tube, conical tube and / or any other suitable annular shape. In some embodiments, the transverse annular member 412 may have a side profile of a ring or cylinder having a concave cylinder (with walls curved inward), an hourglass, a curved stepped hourglass, a flared top, a flared bottom, or both. Furthermore, the transverse annular member 412 can form and / or define an aperture or central channel 414 extending along a central axis 404 (e.g., the y-axis). The central channel 414 (e.g., a central axial lumen or channel) may be sized and configured to receive a flow control component 450 over a portion of the diameter of the central channel 414. In some embodiments, the transverse annular member 412 may have a shape and / or size that is at least partially based on the size, shape and / or form of the natural valve ring, and / or the upper annular member 420 and / or lower annular member 430 of the support frame 410, as described above.

[0165]

[0191] The transverse annular member 412 may be and / or include a wire frame laser-cut from nitinol or the like and heat-set to a desired shape and / or form. The transverse annular member 412 or its wire frame may include a set of struts 411 that form and / or define a set of compressed wire cells 413 having an orientation substantially perpendicular to a central axis extending through a central channel 414 and / or a cellular geometric shape, in order to minimize strain along the struts 411 and / or any other part of the wire frame when the transverse annular member 412 is in a vertically compressed form, a rolled-up form or a folded-up form. As shown in Figure 19, the transverse annular member 412 may include a first laser-cut half 415 (e.g., a front side) and a second laser-cut half 416 (e.g., a rear side), which can be formed to a desired shape and joined together to form the transverse annular member 412. The first laser-cut half 415 (front) and the second laser-cut half 416 (rear) can be joined at one or more hinge points 417 along the distal and proximal portions of the transverse annular member 412. More specifically, the first laser-cut half 415 (front) and the second laser-cut half 416 (rear) can be joined along the distal side of the transverse annular member 412 by two sutures forming two hinges or joining points 417, or along the proximal side of the transverse annular member 412 by one suture forming a single hinge or joining point 417.

[0166]

[0192] In some embodiments, forming the transverse annular member 412 in this manner allows the transverse annular member 412 to bend, flex, fold, deform, and / or be reconfigured in response to lateral folding along or in the direction of the transverse axis or z axis and / or vertical compression along or in the direction of the central axis or y axis (without substantially plastic deformation and / or excessive fatigue). Furthermore, by joining at the hinge point 417 using sutures, a desired amount of sliding can be allowed between the sutures and the front / rear sides 415 / 316, thereby further limiting and / or substantially preventing bonding, sticking, and / or malfunctions in response to folding along the transverse axis or z axis. In addition, as will be described in more detail herein, by including a single hinge or connection point 417 in the proximal portion of the transverse annular member 412, a gap or space 418 can be defined below the proximal hinge or connection point 417, which can provide space for the proximal anchor element of the lower annular member 430 to transition between the first and second embodiments.

[0167]

[0193] Figure 20 is a distal perspective view showing the lower annular member 430 of the outer frame 410 of the valve 400. In some embodiments, the lower annular member 430 of the frame 410 may be similar in at least shape and / or function to any of the lower annular regions and / or members described above. Therefore, several parts and / or aspects of the lower annular member 430 may not be described in further detail herein.

[0168]

[0194] As shown in the figures, the lower annular member 430 of the frame 410 includes and / or is formed of a distal portion having a distal anchor element 432 and a proximal portion having a proximal anchor element 434. The anchor elements 432 and 434 are formed integrally with and / or monolithically with the lower annular member 430. The distal anchor element 432 and the proximal anchor element 434 of the lower annular member 430 may be of any suitable shape, size, and / or form. The distal anchor element 432 is shown to include a non-traumatic end that forms a guidewire coupler 433 configured to selectively engage with and / or receive a portion of the guidewire catheter 484 (in which the guidewire is located) through an opening, hole, aperture, port, etc., defined by the guidewire coupler 433 (see, for example, Figures 24 and 25). With the guidewire catheter 484 extending through the guidewire coupler 433, the valve 400 is made capable of advancing on or along the implanted guidewire positioned within the guidewire catheter 484. In some implementations, the guidewire catheter 484 can extend beyond the distal anchor element 432 below the valve 400, providing the desired stiffness during delivery and / or deployment.

[0169]

[0195] The anchor elements 432 and / or 434 are configured to engage with a desired portion of the natural tissue to mount the frame 410 onto the annulus of the natural valve from which it is deployed. For example, the distal anchor element 432 may extend from the inferior annular member 430 to the RVOT or other ventricular location (e.g., about 10–40 mm). The distal anchor element 432 is shaped and / or can be biased to apply a force to the inferior annular tissue that is operable to at least partially secure the distal end portion of the frame 410 to the natural annulus.

[0170]

[0196] The proximal anchor element 434 may be configured to engage with the lower annular tissue on the proximal side of the natural valve annulus to assist in fixing the frame 410 within the annulus. As described above, the lower annular member 430 of the frame 410 may be and / or include a laser-cut wireframe formed of a shape memory material such as nitinol, which is heat-set to a desired shape and wrapped in a biocompatible material (e.g., fabric). The proximal anchor element 434 is configured to transition, move, and / or otherwise reconfigure between a first form in which the proximal anchor element 434 extends by a first amount or distance from the lower annular member 430 and a second form in which the proximal anchor element 434 extends by a second amount or distance from the lower annular member 430. In other words, the proximal anchor element 434 may be a movable anchor element configured to move (e.g., by an actuator) and / or otherwise transition between the first and second forms to reduce the perimeter of the lower annular member 430 during delivery and / or deployment.

[0171]

[0197] As described above, the proximal anchor element 434 can be compressed, contracted, retracted, unfolded, folded, and / or constrained (e.g., in the vicinity of, adjacent to, and / or in contact with, the transverse annular member 412 and / or upper annular member 420 of the support frame 410) when in the first state, and expanded, elongated, unfolded, and / or unconstrained (e.g., extending away from the transverse annular member 412) when in the second state. In some embodiments, the proximal anchor element 434 can be biased and / or heat-set to the second state. Furthermore, in some implementations, the space 418 defined by the transverse annular member 412 of the outer frame 410 is configured to provide sufficient clearance to allow the proximal anchor element 434 to transition between the first and second states.

[0172]

[0198] The proximal anchor element 434 may be configured to move in any suitable direction from a first extended state to a second compressed state, at least in part, based on how the proximal anchor element 434 is coupled to an actuator or the like. For example, the proximal anchor element 434 may be moved inward toward the inner flow control component 450, moved upward toward the upper annular member 420 and / or a portion thereof, and / or moved toward the front or rear side of the valve 400. Furthermore, with the transverse annular member 412 of the frame 410 coupled to the lower annular member 430, the operation of an actuator, control device, etc. may, in some cases, move one or more portions of the transverse annular member 412, as will be described in more detail herein.

[0173]

[0199] The foldable (internal) flow control component 450 is mounted within the outer frame 410. The flow control component 450 has a foldable and compressible internal wire frame 451 (also called the “internal valve leaflet frame” or “internal frame”) having two (or more) folding regions, hinge regions, coupling regions, elastically deformable regions, etc. A set of two to four flexible valve leaflets 456 is mounted within or on the internal frame 451. In some embodiments, the flow control component 450 has three valve leaflets 456 (e.g., components, cusps, pockets, etc.) mounted within the internal frame 451, as will be described in more detail herein.

[0174]

[0200] Flow control components 450, such as the outer frame 410, are foldable and compressible. For example, the inner frame 451 is foldable along or in the z-axis from a cylindrical form to a flattened cylindrical form (or a two-layer band) (e.g., foldable in a folding region), where the folding region is located on the distal and proximal sides of the inner frame 451. The flow control components 450 are also compressible perpendicular to the z-axis (y-axis) to a shortened or compressed form, like the outer frame 410. By folding (compressing) in the z-axis direction and compressing perpendicularly in the y-axis, the valve 400 can maintain relatively large dimensions along the horizontal (x-axis). In some implementations, the outer frame 410 and the flow control components 450 are reduced along the z-axis until their side walls touch or nearly touch. This also allows the outer frame 410 and the flow control components 450 to maintain a radius along the horizontal axis (x-axis), minimizing the number of wire cells that could be damaged by the forces applied during folding and / or compression when loading the valve 400 into the delivery catheter.

[0175]

[0201] The flow control component 450 has a diameter and / or circumference smaller than the diameter and / or circumference of the central channel of the outer frame 410. The flow control component 450 is mounted on or inside the outer frame 410 such that the central axis or vertical axis (y-axis) of the inner frame 451 is parallel to the central axis or vertical axis (y-axis) of the outer frame 410. In some embodiments, the y-axis defined by the inner frame 451 is parallel to the y-axis defined by the outer frame 410, but offset from it (see, for example, Figures 16 and 17). In some implementations, the drum 445 (or spacer element) is positioned in and / or across the central channel to facilitate the mounting of a portion of the flow control component 450 (e.g., an otherwise unsupported portion) to the outer support frame 410 and / or the inward growth of natural tissue over at least a portion of the upper annular member 420 of the valve 400.

[0176]

[0202] In some embodiments, the inner frame 451 may have a diameter of about 25–30 mm, the outer frame 410 (or its transverse annular member 412) may have a diameter of about 50–80 mm, and the upper annular member 420 (or atrial collar) may extend about 20–30 mm beyond the upper edge of the transverse annular member 412 to provide a perivalvular leakage (PVL) seal to the atrial bed. The flow control components 450 and the outer frame 410 may be foldable (e.g., in the z-axis direction) and / or compressible (e.g., in the y-axis direction) to reduce the overall size of the valve 400 so that it fits within the inner diameter of a delivery catheter of 24–36 FR (inner diameter 8–12 mm).

[0177]

[0203] Figures 21-23 show at least a portion of the flow control components 450 included in the valve 400. For example, Figure 21 is a top perspective view of the inner valve leaf frame 451. In some embodiments, the inner valve leaf frame 451 is formed of two separate wire frame sheets or members joined at lateral connection points 452 and 453 (e.g., folding regions, elastically deformable regions, joined edge portions, etc.). The inner valve leaf frame 451 is shown in an expanded or cylindrical form (e.g., before being folded and / or compressed).

[0178]

[0204] Although not shown, the inner valve leaflet frame 451 can transition from an expanded or cylindrical form to at least a partially folded form. The inner valve leaflet frame 451 may have wire frame sidewalls that allow rotation or hinged movement at at least at the lateral connection points 452 and 453. The inner valve leaflet frame 451 may be configured to fold in response to the valve 400 being folded and / or compressed for delivery. For example, when transitioning to a fully folded form, the wire frame sidewalls can rotate, hinged, and / or fold at their lateral connection points 452 and 453. In addition, the inner valve leaflet frame 451 can be compressed perpendicular to the compressed form. The wire frame sidewalls can form cells (e.g., rhombic cells) that can be oriented in the direction of compression to allow elastic compression of the inner frame 451. In some embodiments, the inner frame 451 can be compressed perpendicular to a pleated or accordion (compressed) form.

[0179]

[0205] In some embodiments, the inner leaflet frame 451 of the flow control component 450 may be formed from a linear wire frame or laser-cut sheet before being further assembled into a cylindrical structure (for example, as shown in Figure 21). The inner leaflet frame 451 may be formed into a cylindrical structure or form (or conical structure or form) in which the edge portions of the linear wire frame sheet are connected or joined at lateral connection points 452 and 453 (e.g., hinge regions, folding regions, etc.). Furthermore, the inner leaflet frame 451 may be expanded from a linear sheet form into a cylindrical structure or form (e.g., pushed, formed, bent, etc.). Although the inner leaflet frame 451 is shown as including two wire frame sheets, members, and / or halves joined to form two hinge points and / or hinge points, in some embodiments the inner leaflet frame may be formed from a single component or three or more components which are heat-set, machined, and / or otherwise joined to form and / or define one or more hinge points. For example, an internal valve leaflet frame can be formed from a single nitinol tube and may have hinge points formed by heat-setting the material in a desired manner. In another example, an internal valve leaflet frame may be made from a sheet of material (e.g., nitinol) and formed into a substantially cylindrical shape with the free ends of the material joined together (e.g., by sutures) to form a single hinge point. In such an example, a second hinge point can be formed on the opposite side of the sutured hinge point by heat-setting or processing the material in a desired manner. In yet another example, an internal valve leaflet frame may be made from three or more sheets or members which are joined together (e.g., by sutures) to form a corresponding number of hinge points.

[0180]

[0206] Figures 22 and 23 are a side perspective view and a bottom view, respectively, of a structural band 455 made of pericardial tissue with valve leaflets 456 (e.g., components, cusps, pockets, etc.) sewn to the structural band 455. The structural band 455 and valve leaflets 456 are shown before assembly and / or placement on and / or inside the inner frame 451 to form a collapsible (foldable, compressible) flow control component 450. The structural band 455 is formed from pericardial tissue with the valve leaflets 456 sewn to the structural band 455, and after assembly into a cylindrical valve leaflet shape, the valve leaflets 456 are positioned on the inner surface of the structural band 455. The valve leaflets 456 can be sewn to the structural band 455 such that the open edge extends outward and the sewn edge forms the upper edge of the closed parabola. The cylindrical structural band 455 and the valve leaflet 456 are shown partially joined in Figure 23 to form a closed fluid seal. Although not shown, the cylindrical structural band 455 can be mounted on or inside the inner valve leaflet frame 451, as will be described in detail with reference to Figures 16 and 17, to collectively form a flow control component 450, which is further mounted on the inner loop 425 of the upper annular member 420 of the outer support frame 410.

[0181]

[0207] Figures 24 and 25 are perspective side views showing an artificial valve 400, which is detachably coupled to an actuator or control device 470 (interchangeably referred to as “actuator” or “control device”) used to advance, control, and / or retract the valve in a delivery catheter, and / or actuate one or more parts of the valve 400, such as at least the lower annular member 430 of the valve frame 410, as described herein. The actuator or control device 470 and / or at least a part thereof includes a control catheter 471 having a connecting member 478 coupled and / or positioned at its distal end. The control catheter 471 may be a maneuverable multi-lumen catheter through which one or more components of the control device 470 extend, for example, as described in detail in the '032PCT' referenced above. The connecting member 478 is detachably coupled to the upper annular member 420 of the valve frame 410, thus connecting the valve 400 to the control catheter 471. As will be described in more detail herein, the control catheter 471 can be operated, for example, to advance the prosthetic valve 400 in a delivery catheter (not shown), to control or steer the prosthetic valve 400 during deployment, and to retrieve and / or retract the prosthetic valve 400 into the delivery catheter (for example, after at least partial deployment).

[0182]

[0208] Figure 24 shows a connecting member 478 having a wishbone or yoke configuration, but other configurations are possible. As such, the connecting member 478 may have a first portion, sides and / or arms, and a second portion, sides and / or arms opposite to the first portion, sides and / or arms. The connecting member 478 may be configured to transition between an expanded configuration and a compressed configuration, for example, to allow a control catheter 471 (and the connecting member 478 located at its distal end) to advance through the delivery catheter. The connecting member 478 can be formed from any suitable material, such as shape-memory material like nitinol.

[0183]

[0209] In some embodiments, the connecting member 478 may contact and / or be detachably coupled to the drum 445 of the upper annular member 420 and / or the frame 410 or any other suitable part of the valve 400. The connecting member 478 may be detachably coupled to the valve 400 via sutures, tethers, cables, clips, couplers, and / or any other detachable couplings. For example, in some embodiments, the control device 470 may include a pair of tethers 475 extending from one or more lumens defined by the control catheter 471. The tethers 475 are shown to extend from the control catheter 471, loop along each side or arm of the connecting member 478 (yoke) or through a pair of openings defined thereby, loop around one or more mounting members 438 of the valve 400, and extend back into the corresponding lumens of the control catheter 471. The mounting member 438 may be formed by, coupled to, and / or extend from, the upper annular member 420 (e.g., drum 445). In some embodiments, the mounting member 438 of the valve 400 may be a tether, suture, cable, frame structure, etc., which may be coupled to and / or extend from a wire frame portion of the upper annular member 420 or, for example, a drum 445 (or other biocompatible cover). Furthermore, the mounting member 438 may form a pair of loops 439, etc., around which the tether 475 of the control device 470 can be routed or the tether can be wound in a loop.

[0184]

[0210] The loop-shaped arrangement of the tether 475 through and / or around the connecting member 478 and mounting member 438 of the valve 400 is such that the proximal and distal ends of the tether 475 each extend through the patient's body and outward from the patient (e.g., proximal to the patient). In this configuration, a proximal force can be applied to each of the proximal and distal ends of the tether 475, increasing the tension along the tether 475, thereby pulling the connecting member 478 toward the drum 445, and thereby securing the connecting member 478 to the valve. Conversely, a proximal force applied to only one of the proximal or distal ends of the tether 475 can disengage the tether 475 from the connecting member 478, allowing the tether 475 to be pulled away from the control device 470, thereby further separating or removing the connecting member 478 from the valve 400.

[0185]

[0211] Figure 24 further illustrates a guidewire catheter 484 of the delivery system, for example, extending through the via point 428 or opening of the upper annular member 420 and / or its drum 445 and through the guidewire coupler 433 of the distal anchor element 432. The guidewire catheter 484 may extend below the flow control component 450 of the valve 400. Before and / or as part of delivery, the guidewire catheter 484 may be advanced in the valve 400 and / or inserted therein and advanced on a guidewire 485 already positioned at a desired location in the heart. As such, delivering the compressed valve 400 through the delivery catheter involves advancing the guidewire catheter 484 along the guidewire 485. The guidewire catheter 484 may extend beyond the guidewire coupler 433 of the distal anchor element 432 (for example, the distal end of the guidewire catheter 484 may be distal to the guidewire coupler 433 by about 0.1 cm to about 1.0 cm or more).

[0186]

[0212] The guidewire catheter 484 may be rigid enough to restrict and / or define (at least partially) the range of motion of the valve 400 during delivery. For example, the guidewire catheter 484 may define an axis that allows the valve 400 to rotate during delivery, but substantially restricts or obstructs its movement in other directions. In some implementations, the arrangement of the connecting member 478 (e.g., a yoke) and the guidewire catheter 484 may allow for greater control over the position of the valve 400 during delivery. The guidewire catheter 484, and / or one or more parts of the valve 400 (e.g., the lower annular member 430), may also include radiopaque markers to enable enhanced visualization during image-guided delivery. For example, in some cases, radiopaque markers or wires may be positioned relative to the annular plane of the natural valve to define landmarks during image-guided delivery. In such examples, radiopaque markers on the guidewire catheter 484 and / or other parts of the valve 400 (e.g., the lower annular member 430) can be used to align, orient, position, and index the valve 400 relative to a landmark, which further corresponds to the annular plane of the natural valve. Thus, image-guided delivery can enable the user to visualize the valve 400 during delivery and / or deployment, and to visualize when the valve 400 is seated within the valve annulus (e.g., when the radiopaque marker band of the valve 400 is below or in the lower annular direction relative to the radiopaque landmark).

[0187]

[0213] Figure 24 further shows at least one tether 476 (e.g., a tether, suture, cable, tension member, etc.) extending from the control catheter 471 (e.g., through one or more of its lumens) through the via point 428. The control device 470 may 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 may be detachably coupled to one or more attachment points on the valve 400). The tether 476 may be configured to actuate and / or transition one or more parts of the valve 400, such as the lower annular member 430 and / or at least its proximal anchor element 434. In some embodiments, the tether 476 can extend through a waypoint 428 and can be wound in a loop around and / or through an attachment point along the lower annular member 430 or at least the proximal anchor element 434, and then routed to return through the waypoint 428 and the control catheter 471. As such, both ends of each tether 476 are on the outside of the patient, thereby allowing operation of the tether 476 to actuate the valve 400 and / or to transition the shape of the proximal anchor element 434, the lower annular member 430, and / or other parts of the valve 400, thereby facilitating the seating of at least the proximal side of the valve 400 on the natural annulus. In other words, increasing the amount of tension along the tether 476 may be operable to transition at least the lower annular member 430 (or a part thereof) between the first and second forms. As such, the tether 476 can be actuated (or tensioned) and / or released in a manner similar to that described above with respect to the tether 475. In other embodiments, the distal end portion of the tether can form a loop or the like, which may be positioned on or around a portion of the guidewire catheter 484 (for example, the portion proximal to the guidewire coupler 433). In such embodiments, this arrangement can be releasably fixed or secured to, for example, the distal end portion of the tether 476, as described above with reference to valves 100, 200, and / or 300.

[0188]

[0214] Figure 25 shows the valve 400 and control device 470 while deployed in the natural annulus of the heart. As described above, the control device 470 can advance the valve 400 into the atrium through the delivery catheter 482. In some implementations, the delivery catheter 482 can remain in a substantially constant position relative to the atrium or the IVC through which it extends, while the distal end of the control device 470 and the valve 400 are advanced distally toward the annulus along the guidewire catheter 484 (for example, away from the delivery catheter 482). In such a case, the length of the portion of the control catheter 471 distal to the delivery catheter 482 is increased. Since the valve 400 is no longer constrained by the delivery catheter 482, releasing the valve 400 into the atrium allows the valve 400 to transition from a compressed to an expanded state.

[0189]

[0215] The control device 470 can be operated or steered to place the valve 400 into an expanded form at a desired deployment angle in which the distal anchor element 432 is positioned below the annulus and in the vicinity, adjacent to, and / or at least partially inside, the ventricular outflow tract (e.g., RVOT). At the deployment angle, at least the proximal portions of the upper annular member 420 (or region) and the lower annular member 430 (or region) of the valve frame 410 remain within the atrium. In some implementations, the distal surface of the transverse annular member 412 of the valve frame 410 may be positioned in contact with natural tissue, forming the distal surface or wall of the annulus. In some cases, the valve 400 can be temporarily held in this partially deployed position (e.g., at the deployed angle), allowing the user to confirm the positioning of the valve 400 relative to the angle (e.g., by visualizing a radiopaque marker under fluoroscopy) and / or allow the blood flow through the valve annulus to begin transitioning from flowing entirely through the natural valve to flowing through the flow control component 450. In some cases, this may also allow the user to confirm that the flow control component 450 is functioning in the desired manner before the valve 400 is fully seated on the valve annulus.

[0190]

[0216] Once the position and / or function of valve 400 is confirmed, the control device 470 can be operated and / or steered to pivot valve 400 relative to the valve ring so that the proximal portion of valve 400 is inserted into and / or dropped into the valve ring. Although not shown in Figure 25, the proximal anchor element 434 may be in and / or transition to a compressed, actuated, and / or tightened state (e.g., via a tether 476 or any other suitable actuator) such that the perimeter and / or extent of the lower annular member 430 of the valve frame 410 is smaller than the perimeter or extent of the valve ring. In some implementations, the proximal anchor element 434 may transition to a tightened state after the valve has been released from the distal end of the delivery catheter and is able to expand to an extended state. For example, the proximal anchor element 434 may be actuated to a tightened state after the function of the flow control component 450 has been confirmed.

[0191]

[0217] In other implementations, the proximal anchor element 434 can be moved to a tightened state before compressing the valve 400 to a compressed state. For example, after coupling the control device 470 to the valve 400, the tether 476 can be actuated to increase the tension along the tether 476, thereby further moving the proximal anchor element 434 from an untightened state to a tightened state by pulling, flipping, folding, and / or other means. In some cases, once the proximal anchor element 434 is in a tightened state, the tether 476 can be locked and / or fixed at least temporarily (e.g., via a portion of the delivery system, control device, etc.) to maintain the proximal anchor element 434 in a tightened state at least temporarily. The valve 400 can then be folded and / or compressed laterally and compressed axially to place the valve 400 in a delivery state (e.g., a tightened compressed state). As described in detail above, the valve 400 in delivery configuration can then be loaded into the delivery system, and the control device 470 can be used to advance the valve 400 in delivery configuration along the guidewire catheter 484 within the lumen of the delivery catheter. Furthermore, the valve 400 may be configured to expand or at least partially expand when released from the distal end of the delivery catheter while the proximal anchor element 434 remains in a tightened configuration or substantially in a tightened configuration.

[0192]

[0218] With the proximal anchor element 434 in the tightened position, the control device 470 and / or control catheter 471 can be operated and / or steered by a distally directed force applied to the control device 470 by the user such that the connecting member 478 pushes the proximal portion of the valve 400 toward the valve annulus. In some implementations, pivoting the valve 400 may involve "steering" the control catheter 471 such that the distal portion of the control catheter 471 bends relative to the distal end of the delivery catheter 482, allowing the connecting member 478 to seat the proximal portion of the valve 400 within the valve annulus. Once seated, the control device 470 may be activated and / or steered to release tension along one or more of the tethers 476 (e.g., one or more tightening tethers), allowing the proximal anchor element 434 to move to or toward an expanded untightened position. In some embodiments, the control device 470 may include one or more tethers that are activated after the valve 400 is seated, as described in detail above with reference to at least the valve 300, to pull the proximal anchor element 434 into an expanded unclamped form or otherwise assist its transition. The delivery / deployment system, including the control device 470 (and its tethers 476), is then separated from the valve 400 and retracted / removed from the patient, as described above with respect to the valves 100, 200, and / or 300, leaving the prosthetic valve 400 in the annulus.

[0193]

[0219] As described above, any of the artificial valves described herein may include a lower annular region, member, element, etc. that can be actuated, tightened, and / or otherwise moved between two or more forms to facilitate the delivery, deployment, and / or seating of the artificial valve in the natural annulus. In some implementations, the lower annular region, member, element, etc. may include features similar to and / or similar to those described above and / or those described in the '996 PCT and / or '032 PCT incorporated above by reference.

[0194]

[0220] For example, Figures 26-28 show an artificial valve 500 according to one embodiment. The valve 500 includes an outer support frame 510 and a flow control component 550 mounted therein. The outer support frame includes an upper annular member 520, a lower annular member 530, and a transverse annular member 512 connected between them. The lower annular member 530 includes a distal anchor element 532 and a proximal anchor element 534.

[0195]

[0221] Figure 26 is a schematic side view showing how the periphery (outer circumference) of the transverse annular member 512 of the valve 500 can be tightened inward (as indicated by the arrow and dashed line). Figure 27 is a schematic bottom view showing how the periphery (outer circumference) of the lower annular member 530 of the valve 500 can be tightened inward, flipped, and / or folded (as indicated by the arrow and dashed line). Tightening of the transverse annular member 512 and / or lower annular member 530 allows the valve 500 to be designed with an oversized transverse and lower annular periphery (e.g., 2-20%, often 10-15%), promoting a tight fit of the valve 500 within the natural valve ring and providing a good seal to prevent periphery leakage (PVL). In some implementations, the tightening process pulls the proximal side wall 519 inward, reducing the periphery of the transverse annular member 512 and / or lower annular member 530. This allows any excess valve to fall onto the natural valve ring during the deployment of the valve 500. Once the valve 500 is seated as desired, the transverse annular member 512 and / or the lower annular member 530 can be pushed out / pulled back and / or otherwise expanded to their full or nearly full circumference, thereby forming a tight, sealing fit of the artificial valve 500 on the natural valve ring. In some implementations, the proximal anchor element 534 of the lower annular member 530 can also be tightened, flipped over, and / or folded inward and / or upward, together with and / or independently of the transverse annular member 512.

[0196]

[0222] Figure 28 is a schematic side view of a valve 500 at least temporarily coupled to an actuator and / or control device 570, shown as a non-limiting example of a mechanism for performing a tightening process to reduce the periphery (outer circumference) of the transverse annular member 512 and / or lower annular member 530. The actuator / control device 570 (interchangeably referred to as “actuator 570” or “control device 570”) may be and / or include one or more tethers that travel from a delivery catheter and / or control catheter (not shown) through a way guide, via point, mounting point, through hole, eyelet and / or any other suitable component (referred to herein as “via point 528”) of the valve 500 and coupled to one or more mounting points 536 along the lower annular member 530 and / or transverse annular member 512. In this embodiment, the actuator 570 (e.g., a clamping tether) moves through the upper annular member 520 via the transit point 528 and is fixed and / or attached at one or more mounting points 536 to the proximal side wall 519 of the transverse annular member 512 and / or the proximal anchor element 534 of the lower annular member 530.

[0197]

[0223] In some embodiments, the tightening tether may be fixed along the wireframe struts of the transverse annular member 512 (rather than extending across the wire cell). In some cases, such an embodiment can limit and / or substantially prevent axial tightening of the valve 500 (e.g., tightening that reduces the height of the valve 500). As such, by acting on the actuator 570 (e.g., pulling the tightening tether proximal toward the operator), the proximal side wall 519 of the transverse annular member 512 is pulled inward, reducing the circumference of the transverse annular member 512 (e.g., without substantially reducing the height of the valve 500), thereby allowing the valve 500, which may be too large, to fall into the natural valve ring during deployment. In some implementations, the actuator 570 may be actuated to tighten the transverse annular member 512 and / or the lower annular member 530 before compressing the valve 500 for delivery through the delivery catheter. In such an implementation, after the transverse annular member 512 and / or lower annular member 530 are tightened, the valve 500 may be folded and / or compressed in the direction along the transverse axis of the valve 500 and compressed in the direction along the central axis of the valve 500, thereby placing the valve 500 in a delivery configuration (e.g., a tightened and compressed configuration). As described in detail above, the valve 500 in the delivery configuration can be advanced through the delivery catheter (e.g., by a portion of the actuator / control device 570) and released into the cardiac chamber (e.g., an atrium) from the distal end of the delivery catheter. Once released, the valve 500 can transition to an expanded configuration, while the transverse annular member 512 and / or lower annular member remain in or substantially in a tightened configuration, allowing any excess valve 500 to fall into the natural annulus.

[0198]

[0224] Next, once the valve 500 is seated as desired, the actuator 570 can be actuated (for example, by advancing or retracting / releasing the tightening tether) or released, allowing the proximal side wall 519 of the transverse annular member 512 to be pushed back and / or otherwise expanded to its full or nearly full circumference, thereby forming a tight sealing fit of the artificial valve 500 in the natural valve ring. Similarly, the proximal anchor element 534 can be actuated (for example by the actuator 570) and / or released together with the transverse annular member 512 or independently thereof. In some embodiments, a first portion of the actuator 570 (e.g., a first tether) can be actuated to tighten the proximal sidewall 519 and / or the proximal anchor element 534, and a second portion of the actuator 570 (e.g., a second tether) can be actuated to pull, release, and / or return the proximal sidewall 519 and / or the proximal anchor element 534 to an untightened or extended configuration.

[0199]

[0225] Figures 29-31 show the artificial valve 600 during at least part of the process for deploying the artificial valve 600 onto the natural valve ring according to one embodiment. Figures 29 and 30 show the artificial valve 600 having an outer support frame including an upper annular member 620, a lower annular member 630, and a transverse annular member 612. The lower annular member 620 may include lateral portions or flares 603 and 604 on the free wall (left) side and the septum (right) side, respectively, which can transition between an extended position (Figure 29) and a retracted or tightened position (Figure 30) to allow the valve 600 to slide through the natural valve ring. Figure 31 shows the valve 600 deployed, seated, and / or otherwise extended through the natural valve ring and the lateral portions and / or flares 603 and 604 on the free wall (left) side and the septum (right) side, respectively, as it transitions from the retracted position (Figure 30) to the extended position (Figure 31) or toward thereafter. As such, the lateral portions and / or flares 603 and 604 extend radially to provide an anchoring mechanism (for example, to natural tissue forming and / or defining a natural valve ring). The lateral portions and / or flares 603 and 604 can be actuated using any of the acting devices and / or methods described herein (e.g., tethers, cables, etc.).

[0200]

[0226] Figures 32 and 33 are bottom views showing a portion of an artificial valve 700 coupled to an actuator and / or control device 770 according to one embodiment. The artificial valve 700 has a lower annular member 730 having and / or which can form a wire loop (and attached sidewall), which is retracted inward to reduce the circumference or outer periphery of the valve body and facilitate the deployment of the valve 700 in the natural annulus. Figures 32 and 33 show that the valve 700 may be detachably coupled to the actuator / control device 770, which may and may include one or more tethers, sutures, tension members, cords, cables, etc., which are advanced through the delivery catheter 782 and positioned within the cardiac chamber. The actuator / control device 770 (interchangeably referred to as “actuator 770” or “control device 770”) extends through the delivery catheter 782 and may be used to actuate the lower annular member 730 and / or any other suitable portion of the valve 700 (e.g., by pulling the actuator 770 proximal). The actuator 770 can be coupled to the lower annular member 730 via mounting points 736 positioned at any suitable location along the lower annular member 730. In some embodiments, the arrangement of the mounting points 736 can at least partially control how the lower annular member 730 is moved and / or tightened, as described herein with reference to specific embodiments. The lower annular member 730 is shown together with a distal anchor element 732 and a proximal anchor element 734. In some implementations, the actuator 770 may also be used to actuate the proximal anchor element 734 and / or the distal anchor element 732. In some implementations, once the valve 700 is deployed to the annulus of the natural valve, the actuator 770 may be removed or separated from the valve 700 and retracted through the delivery catheter 782.

[0201]

[0227] Figures 34–37 are bottom perspective views of an artificial valve 800, detachably coupled to an actuator 870 used to actuate one or more portions of the valve 800, according to one embodiment. The valve 800 has a lower annular member 830 having and / or which can form (and be attached to the side wall) a wire loop which is retracted inward to facilitate the delivery and / or deployment of the valve 800 in the natural valve ring by reducing at least the periphery or outer circumference of the lower annular member 830. In this embodiment, the actuator 870 may be and / or include a set of tethers, tension members, sutures, cables, and / or any other suitable connectors (referred to herein as “tethers 873”) that can be attached to one or more mounting points along the lower annular member 830 (e.g., a proximal anchor element 834 of the lower annular member 830 and / or any other suitable portion of the lower annular member 830). The actuator 870 may also include and / or be at least partially located inside a catheter 877 which can be inserted into a transit point, opening, mounting point, through hole, etc., formed by the upper annular member of the valve frame. In some implementations, the actuator 870 may be and / or include a separate tether 873 used to actuate (e.g., fold) the proximal anchor element 834, to actuate (e.g., fold) the partition sidewall of the valve 800, and / or to actuate (e.g., fold) the free wall sidewall of the valve 800.

[0202]

[0228] Figures 34–37 show a set of tethers 873 extending from a catheter 877 that extends through and / or at least partially below the upper annular member of the valve frame. For example, the catheter 877 can be a relatively small viapoint catheter and / or any other suitable tube, conduit, port, etc., through which the tether 873 can extend. The proximal end of the tether 873 (not shown) can be actuated outside the patient to move the distal end of the tether 873 relative to the distal end of the catheter 877 (for example, in the direction toward and / or toward the distal end of the catheter 877), thereby further manipulating the shape of the proximal anchor element 834, the lower annular member 830 and / or any suitable part of the valve 800, facilitating the seating of the proximal side of the valve 800 into the natural annulus. In some implementations, during delivery, the transit catheter 877 is located within the lumen of the delivery catheter and may be maintained proximal to the compressed valve 800 to avoid the transit catheter 877 being stacked on top of the compressed valve 800 within the delivery catheter.

[0203]

[0229] The actuator 870 may include, for example, 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 may be detachably coupled to one or more mounting points of the valve 800). The actuator 870 and / or tether 873 may include a cutting element to allow the actuator 870 and / or tether 873 to be withdrawn after the valve 800 has been deployed and secured to the natural valve annulus. In some embodiments, the distal end portion of the tether 873 may form a loop or the like, allowing the distal end portion of the tether 873 to be looped around one or more parts such as the valve 800, a release pin, a guidewire, or a guidewire catheter. In such embodiments, acting one or more portions of the valve 800, releasing a pin, and / or retracting the guidewire / guidewire catheter may be operable to release the distal end portion of the tether 873, thereby allowing the tether 873 to be separated from the attachment point. The catheter 877 may also be contained within and / or housed in or extending through a portion of the delivery system, such as a pusher catheter, a control catheter (e.g., a multi-lumen control catheter), so that the catheter 877 can fall to a lower annular position through a waypoint, through hole, opening, etc., of the valve 800, while the pusher catheter, control catheter, and / or other portions of the delivery system are too large to pass through the waypoint. As such, the pusher catheter, control catheter, and / or other portions of the delivery system can be used to control the placement of at least a portion of the valve 800. For example, a pusher catheter, a control catheter, and / or other parts of the delivery system can be used to push down the proximal side of the valve 800 onto the surface of the upper annular member to seat it on the natural valve ring while the lower annular member 830 is in the operating configuration.

[0204]

[0230] Figure 34 is a bottom perspective view of the valve 800 and actuator 870, showing the lower annular member 830 in at least partially extended or non-operated configuration. Figure 35 is a bottom perspective view of the valve 800 and actuator 870, showing the lower annular member 830 partially actuated so that, for example, the tether 873 pulls the proximal anchor element 834 of the lower annular member 830 toward the catheter 877 and / or the flow control components of the valve 800. Figure 36 is a bottom perspective view of the valve 800 and actuator 870, showing the tether 873 pulled into the catheter 877 (or substantially into the catheter 877) to compress, fold, tighten and / or actuate the lower annular member 830 so that the proximal anchor element 834, and, for example, the proximal portions of the septal and free walls of the valve 800, are pulled toward the catheter 877 and / or the flow control components of the valve 800. Figure 37 is a bottom side perspective view of the valve 800 and actuator 870, showing the lower annular member 830 in operation, the catheter 877 extending below the lower annular member 830 of the valve frame, and the tether 873 of the actuator 870 retracted or pulled toward and / or into the catheter 877.

[0205]

[0231] Figure 37 shows that the catheter 877 can also be used to pull the valve 800 into the ventricle (for example, via the retracted tether 873), avoiding the need to push the compressible valve into the natural annulus. More specifically, by extending the viapoint catheter 877 through the viapoint such that its end portion is below the upper annular member of the valve 800 (and possibly below the lower annular member 830 of the valve 800), the amount of vertical compression and / or vertical tightening of the valve 800 when the actuator 870 is actuated can be reduced and / or limited. For example, a proximal force applied to the tether 873 of the actuator 870 can pull the distal end portion of the tether 873 into and / or toward the viapoint catheter 877. With the transit catheter 877 positioned on, near, or below the lower annular member 830 of the valve 800, the lower annular member 830 of the valve 800 is pulled inward toward the end of the transit catheter 877, rather than inward and upward through the transit point of the upper annular member. In this manner, the transit catheter 877 can facilitate a "planar tightening" in which the lower annular member 830 is tightened to reduce its periphery and / or outer circumference, while limiting and / or minimizing the amount of axial compression / tightening of the transverse annular member (e.g., limiting and / or minimizing the reduction in the height of the valve 800). In some cases, such planar tightening can limit and / or substantially prevent the lower annular member 830 of the valve 800 from being pulled up to the valve ring while the valve 800 is seated, thereby further limiting and / or reducing undesirable contact between the proximal anchor element 834 and the natural annular tissue when the actuator 870 and / or its tether 873 release the proximal anchor element 834 (for example, allowing the proximal anchor element 834 to return to or toward a non-operating, untightened and / or uncompressed form).Although not shown in Figures 34-37, the actuator 870 may also include one or more tethers, which are, for example, located outside the catheter 877 and configured to pull or actuate the proximal anchor element 834 to a deactivated, uncompressed, and / or uncompressed form (for example, as described above with reference to actuator 370) or to return to it.

[0206]

[0232] Figures 38–41 show various diagrams of an artificial valve 900 detachably coupled to a portion of a delivery / deployment system according to one embodiment. The delivery / deployment system includes at least one actuator and / or control device 970 detachably coupled to the valve 900 and configured to facilitate the delivery and / or deployment of the valve 900 to the natural valve ring. The valve 900 may be similar to and / or substantially identical to any of the valves described herein (e.g., valve 400). Accordingly, multiple portions and / or embodiments of the valve 900 are not described in further detail herein.

[0207]

[0233] As shown in Figures 38 and 39, the valve 900 (or its valve frame) has an upper annular member 920, a lower annular member 930, and a transverse annular member 912 coupled between them. The upper annular member 920 forms and / or defines a transit point 928 configured to receive a portion of an actuator / control device 970 (hereinafter interchangeably referred to as “actuator 970” or “control device 970”). The lower annular member 930 forms a distal anchor element 932 and a proximal anchor element 934. The proximal anchor element 934 is configured to move between two or more forms (e.g., in response to the operation of the control device 970) to facilitate the delivery and / or deployment of the valve 900.

[0208]

[0234] As described above with reference to the transverse annular member 412, the transverse annular member 912 includes a wire frame laser-cut from nitinol or the like and heat-set to, for example, a desired shape and / or form. The transverse annular member 912 or its wire frame may include a set of struts 911 that form and / or define a set of compressible wire cells 913, as shown in Figure 40. The struts form and / or define the compressible wire cells 913 such that their orientation and / or geometric shape is substantially perpendicular to the central axis of the valve 900 in order to minimize strain along any other part of the struts 911 and / or wire frame when the transverse annular member 912 is in a delivery configuration (e.g., a compressed configuration and / or a tightened compressed configuration as described in further detail herein). Each strut 911 extends from the upper or upper annular portion of the transverse annular member 912 to the lower or lower annular portion and defines a portion of an adjacent wire cell 913 (Figure 40). The wire cells 913 may be substantially rhomboid.

[0209]

[0235] Returning to Figures 38 and 39, the actuator / control device 970 is shown coupled to the upper annular member 920 of the valve 900. The guidewire catheter 984 and a portion of the actuator / control device 970 are shown extending through a transit point 928 of the upper annular member 920. The guidewire catheter 984 passes beneath the valve 900, through a guidewire attachment 935 along the distal edge or end portion of the valve 900, and through a distal anchor element 932. The guidewire attachment 935 could be, for example, a suture or tether attached to the lower annular member 930, which forms a loop, etc., through which the guidewire catheter 984 extends. As will be described in more detail herein, such an arrangement allows the guidewire catheter 984 to function as a quick-release component for the actuator 970 after the valve 900 has seated in the annulus.

[0210]

[0236] The actuator / control device 970 includes a set of tethers 973 configured to be detachably coupled to one or more portions of the valve 900. For example, the control device 970 may include a first tether 973A, a second tether 973B, and a third tether 973C. The tethers 973 extend through a via point 928 of the upper annular member 920 and / or otherwise are positioned below the drum or its surface. In this embodiment, the first tether 973A and the second tether 973B are shown to be routed through the via point 928 of the valve 900 and a series of mounting points 946 (e.g., loops formed by sutures, etc.). More specifically, the valve 900 includes a series of mounting points 946 on an inner wall or inner surface extending along one of the struts 911 of the transverse annular member 912 forming an adjacent pair of wire cells 913 (rather than spreading across the open space of the wire cells 913). In some cases, such a configuration can limit and / or substantially prevent tightening of the valve 900 along the central axis (for example, tightening that reduces the height of the valve 900). As shown in Figures 38 and 39, the first tether 973A extends from the via point 928 through the attachment point 946 along the septum side surface of the transverse annular member 912, and the second tether extends from the via point 928 through the attachment point 946 along the free wall side surface of the transverse annular member 912.

[0211]

[0237] In this embodiment, the first tether 973A is configured to tighten the lower annular member 930 of the valve 900 in the front-rear direction. In other words, the first tether 973A is configured to tighten the lower annular member 930 of the valve 900 by pulling the septum side and free wall side of the lower annular member 930 inward toward the longitudinal centerline of the valve 900. As shown in the figure, the first tether 973A extends (as described above) through a pair of mounting points 946 along the septum side of the transverse annular member 912 and along the lower annular member 930. In this embodiment, for example, the first tether 973A extends through four mounting points on the lower annular member 930, which are rectangular in shape. Furthermore, the distal end portion of the first tether 973A forms a loop that is wound or positioned around the distal guidewire catheter 984 relative to the guidewire attachment 935 (for example, around the portion of the guidewire catheter between the guidewire attachment 935 and the distal anchor element 932). In this way, the distal (loop-shaped) end of the first tether 973A is substantially fixed at or near the position where the guidewire catheter 984 passes through the guidewire attachment 935. Therefore, a proximal force applied to the first tether 973A increases the tension along the first tether 973A, which pulls the sides of the lower annular member 930 (and the corresponding sides of the transverse annular member 912) inward toward the longitudinal centerline of the valve 900 (for example, based at least partially on the position and / or configuration of a pair of anchor points 946). Furthermore, by looping the distal end of the first tether 973A around the guidewire catheter 984, a "quick-release" configuration and / or arrangement is formed, which releases and / or separates the distal end portion of the first tether 973A by retracting the guidewire catheter 984 to a position proximal to the guidewire attachment 935.

[0212]

[0238] In this embodiment, the second tether 973B is configured to tighten the proximal lower annular anchor element 934 of the valve 900. In other words, the second tether 973B is configured to tighten the lower annular member 930 of the valve 900 by pulling, flipping, folding, and / or tightening the proximal anchor element 934 inward toward and / or at least partially beneath it. As shown in the figure, the second tether 973B extends (as described above) along the inner surface of the free wall side of the transverse annular member 912 and through at least one attachment point 946 on or along the proximal anchor element 934. In addition, the distal end portion of the second tether 973B forms a loop that is wound or positioned around the guidewire catheter 984 distal to the guidewire attachment 935 (for example, around the portion of the guidewire catheter between the guidewire attachment 935 and the distal anchor element 932). In this way, the distal (loop-shaped) end of the second tether 973B is fixed in substantially the same position as the first tether 973A. Therefore, a proximal force applied to the second tether 973B increases the tension along the second tether 973B, which pulls, flips, folds, and / or tightens the proximal anchor element 934 distally inward toward and / or at least partially directly beneath the flow control component. Furthermore, by looping the distal end of the second tether 973B around the guidewire catheter 984, a “quick-release” configuration and / or arrangement is formed, thereby releasing and / or separating the distal end portion of the second tether 973 by retracting the guidewire catheter 984 to a proximal position relative to the guidewire attachment 935.

[0213]

[0239] Figure 40 is a side view of valve 900 in an activated and / or tightened configuration and / or state, with the side of the lower annular member 930 pulled inward and the proximal anchor element 934 pulled distally. That is, the tethers 937A and 973B are actuated, pulled, and / or tensioned to activate and / or tighten the lower annular member 930 and the proximal anchor element 934. The proximal anchor element 934 is shown and described as being pulled inward, pulled distally, pulled directly below the flow control component, etc., but in some embodiments, the arrangement of at least the second tether 973B may be such that the proximal anchor element 934 is pulled toward the side of the transverse annular member 912 (e.g., the septum side or the free wall side) to place the proximal anchor element 934 in an activated and / or tightened configuration and / or state.

[0214]

[0240] As described above, in some implementations, after the valve is released from the distal end of the delivery catheter and made expandable, the lower annular member 930 and the proximal anchor element 934 can transition to a tightened configuration. In other implementations, the lower annular member 930 and the proximal anchor element 934 can transition to a tightened configuration before compressing the valve 900 into a compressed or delivery configuration. For example, after coupling the control device 970 to the valve 900, the tethers 973A and 973B can be activated to increase the tension along the tethers 973A and 973B, which then pulls, flips, folds, tightens, and / or transitions the lower annular member 930 and the proximal anchor element 934 (each) from a relaxed configuration to a tightened configuration. In some cases, once in the tightened configuration, the tethers 973A and 973B can be locked and / or fixed at least temporarily (e.g., via a portion of the delivery system, control device 970, etc.) to maintain the lower annular member 930 and the proximal anchor element 934 in the tightened configuration at least temporarily. The valve 900 can then be folded and / or compressed laterally and compressed axially to place the valve 900 in the delivery configuration (e.g., the tightened compressed configuration). The valve 900 in the delivery configuration can then be loaded into the delivery system as described above with respect to the delivery system and valve 300 and / or the delivery system and valve described in '032PCT, and the valve 900 in the delivery configuration can be advanced along the guidewire catheter 984 and through the lumen of the delivery catheter using the control device 970. In such an implementation, the valve 900 may be configured to expand or at least partially expand when released from the distal end of the delivery catheter, while the lower annular member 930 and the proximal anchor element 934 remain in a tightened state or substantially remain in a tightened state.

[0215]

[0241] As described above, the arrangement of the tethers 973A and 973B, positioned within the transverse annular member 912 and extending along the corresponding struts of the transverse annular member 912, can limit and / or substantially prevent tightening of the valve 900 along the central axis (e.g., tightening that reduces the height of the valve 900). As shown in the figure, the arrangement of the actuator 970 allows the valve 900 to be activated and / or moved to a tightened state without substantially compressing the wire cell 913 of the transverse annular member 912 in the axial or transverse annular direction. In some cases, such "planar tightening" can limit and / or substantially prevent the proximal anchor element 934 from coming into contact with the annular tissue when the proximal anchor element 934 transitions from its compressed, activated and / or tightened state to its uncompressed, unactivated and / or untightened state. In some cases, such contact may resist the seating of the valve 900 on the annulus by otherwise pushing the proximal portion of the valve 900 away from the annulus toward the atrium, and / or otherwise, may cause damage to the prosthetic valve 900 and / or annular tissue. In some cases, such contact may restrict and / or resist the return of the proximal anchor element 934 to an uncompressible, non-operating, and / or untightened state, thereby further resulting in improper, undesirable, and / or unsecured seating of the valve 900 on the annulus.

[0216]

[0242] As such, the actuator 970 shown in Figures 38-41 includes a third tether 973C that can be actuated, pulled, and / or tensioned to assist the proximal anchor element 934 in transitioning from a first tightened mode and / or state to a second untightened mode and / or state. For example, Figure 40 shows that the third tether 973C is directed and / or traversed through and / or around at least the upper annular member 920 and the transverse annular member 912 and is detachably coupled to the proximal anchor element 934. Not shown, the third tether 973C can traverse through any number of mounting points along any suitable part of the valve 900. For example, the transverse annular member 912 may include one or more mounting points along the inner surface and / or outer surface through which the third tether 973C can traverse. As described above with reference to the first tether 973A and the second tether 973B, the mounting point may be positioned such that the third tether 973C is routed at least partially along the strut of the transverse annular member 912, and that the third tether 973C can actuate the proximal anchor element 934 without substantially tightening the valve 900 axially.

[0217]

[0243] As shown in Figures 40 and 41, the transverse annular member 912 may include a waypoint 919, through which at least a portion of the third tether 973C can extend. In some implementations, the arrangement may be such that the third tether 973C passes under the upper annular member 920 and not, for example, through a waypoint 928 of the upper annular member 920. In other embodiments, the third tether 973C may pass through only the waypoint 928 of the upper annular member 920, or through both waypoints 928 and 919. Figure 40 shows the third tether 973C being pulled or stretched distally and / or otherwise in a distal position or configuration when the proximal anchor element 934 is tightened. As indicated by the arrows in Figure 41, the third tether 973C can be actuated to move the proximal anchor element 934 from a first tightened configuration to a second untightened configuration, or at least to facilitate such transition, by being pulled proximal, and / or otherwise tensioned. More specifically, a proximal force can be applied to the third tether 973C, thereby increasing tension along the third tether 973C and pulling, flipping, and / or spreading the proximal anchor element 934 proximal to its untightened and / or biased configuration and / or state.

[0218]

[0244] The third tether 973C is also shown to include one or more locks 979 positioned along the length of the third tether 973C. The locks 979 may be, for example, knots, beads, bumps, projections, and / or any other suitable features positioned at desired locations along the third tether 973C corresponding to one or more desired locations or forms of the proximal anchor element 934. Furthermore, the via point 919 of the transverse annular member 912 may form and / or be configured as a corresponding locking mechanism that can selectively engage with the locks 979 of the third tether 973C. For example, the third tether 973C is in a distal position when the proximal anchor element 934 is in a first tightening configuration (Figure 40). In the distal position, the locks 979 (or at least one lock 979) are distal to the via point 919 of the transverse annular member 912 (e.g., a locking mechanism). Figure 41 shows a third tether 973C being pulled in the proximal direction (e.g., to the proximal position) to pull the proximal anchor element 934 to a second untightened and / or biased configuration or to assist in its transition. At the proximal position, the lock 979 (or at least one lock 979) is proximal to the transit point 919 (e.g., the locking mechanism) of the transverse annular member 912.

[0219]

[0245] In some embodiments, the arrangement of the lock 979 and the via point 919 may be such that the lock 979 is slightly larger than the via point 919 and at least partially compressible, and that the lock 979 (e.g., having at least slightly larger size) can be pulled through the via point 919 (e.g., a lock feature having at least slightly smaller size). Thus, once the proximal anchor element 934 is in a second form (or any other suitable form such as a form that is tightened vertically or axially in the direction of the atrium), the lock 979 can be pulled through the via point 919 and positioned proximal to it. In such a case, releasing tension along the third tether 973C may cause the lock 979 of the third tether 973C to contact the proximal side of the transverse annular member 912 forming the via point 919, thereby restricting and / or substantially preventing the proximal anchor element 934 from returning to the first or tightened form.

[0220]

[0246] Although the via point 919 is described as forming a corresponding lock feature configured to engage at least temporarily and / or selectively with the lock along the third tether 973C, in other embodiments the lock feature may be separate from and / or unrelated to the via point 919 while performing substantially the same function. In yet another embodiment, the third tether 973C does not need to include the lock 979.

[0221]

[0247] Tethers 973A and 973B have distal ends and form a loop that allows the distal end to be positioned around a portion of the guidewire catheter 984, thereby collectively forming a “quick-release” mechanism for temporarily securing the distal end. A third tether 973C may similarly form and / or include a “quick-release” mechanism, coupling, and / or arrangement configuration with one or more features such as the valve 900, actuator 970, and guidewire catheter 984. For example, in some embodiments, the third tether 973C may include a first portion that is removably or releasably coupled to the second portion. The first portion of the third tether 973C can be routed through the delivery system such that its proximal end is proximal to the delivery catheter and its distal end is releasably or removably coupled to the second portion of the third tether 973C. The second portion of the third tether 973C may be, for example, a distal portion, which is coupled (for example, releasably or permanently) to the proximal anchor element 934 and extends a relatively short distance from the proximal anchor element 934 to be releasably or detachably coupled to the first portion of the third tether 973C. For example, the second portion may include and / or be formed of one or more loops, couplers, connectors, etc., which can be engaged and / or detachably coupled to the first portion of the third tether 973C. Thus, as described in detail in Publication 504, the second portion of the third tether 973C may form a releasable connector, loop, suture, tether, etc., thereby making it possible to separate the third tether 973C from the artificial valve 900. In other embodiments, the third tether 973C may be configured to have a path through the attachment point, the proximal anchor element 934, and the via point 919 such that both ends of the third tether 973C are positioned outside the patient and proximal to the patient.

[0222]

[0248] Figures 38 and 39 show the first tether 973A and the second tether 973B as having their paths defined through the mounting points in a particular manner, but it should be understood that other methods of defining the paths of the tethers are possible. For example, Figures 42 and 43 are bottom views of an artificial valve 1000 detachably coupled to a portion of a delivery / deployment system according to one embodiment. The delivery / deployment system includes at least one actuator and / or control device 1070 detachably coupled to the valve 1000 and configured to facilitate the deployment of the valve 1000 to the natural valve ring. The valve 1000 and the actuator / control device 1070 may be similar to and / or substantially identical to any of the valves and / or actuators described herein (e.g., valve 900 and actuator / control device 970, respectively). Accordingly, multiple parts and / or embodiments of the valve 1000 and multiple parts and / or embodiments of the actuator 1070 are not described in further detail herein.

[0223]

[0249] The valve 1000 (or its valve frame) comprises an upper annular member, a lower annular member 1030, and a transverse annular member 1012 coupled between them. The transverse annular member 1012 includes a wire frame laser-cut from nitinol or the like and heat-set to, for example, a desired shape and / or form. The transverse annular member 1012 or its wire frame includes a set of struts forming and / or defining a set of compressible wire cells that are substantially rhomboid in shape and having an orientation substantially perpendicular to the central axis of the valve 1000 and / or a cellular geometric shape, as described above with respect to the transverse annular member 912. The lower annular member 1030 forms a proximal anchor element 1034. Although not shown, the lower annular member 1030 may include a guidewire attachment configured to receive a portion of a guidewire catheter, as described above with reference to the valve 900 shown in Figures 38-41.

[0224]

[0250] The actuator 1070 includes a first tether 1073A and a second tether 1073B. Figure 42 shows that the tethers 1073A and 1073B are routed through a series of mounting points extending along the struts of the transverse annular member 1012 that form an adjacent pair of wire cells (rather than, for example, extending across the open space of the wire cells). In some cases, such a configuration can limit and / or substantially prevent tightening of the valve 1000 along the central axis (for example, tightening that lowers the height of the valve 1000), as described in detail above. More specifically, in this embodiment, the first tether 1073A is routed through two mounting points along the lower annular member 1030, rather than through the four mounting points shown in Figures 38 and 39. In addition, the second tether 1073B is routed not from the transverse annular member to the proximal anchor element and then to the distal end of the valve, as shown in Figures 38 and 39, but from the transverse annular member 1012 to the distal end of the valve 1000 (e.g., a guide wire coupler or another suitable mounting point at the distal end of the valve 1000), then to the proximal anchor element 1034, and then back to the distal end of the valve 1000.

[0225]

[0251] However, as shown in Figure 43, the specific routing of tethers 1073A and 1073B allows tethers 1073A and 1073B to tighten the lower annular member 1030 of the valve 1000 without substantially compressing the wire cells of the transverse annular member 1012 in the axial or transverse annular direction. In some cases, such “planar tightening” can limit and / or substantially prevent the proximal anchor element 1034 from contacting the annular tissue when the proximal anchor element 1034 transitions from its compressed or operating state to its uncompressed or unoperated state, as described in detail above with reference to the valve 900 shown in Figures 38-41. Not shown in Figures 42 and 43, the actuator / control device 1070 may include a third tether, etc., which can be actuated to transition the proximal anchor element 1034 from a first tightening state to a second untightening state and / or to assist in such transition, as described above with reference to the third tether 973C.

[0226]

[0252] Figure 44 is a flowchart showing a method 10 for deploying a laterally deliverable transcatheter prosthetic valve according to one embodiment. The laterally deliverable transcatheter prosthetic valve may be similar to and / or substantially identical to any of the prosthetic valves described herein. For example, the prosthetic valve may include an outer support frame and (internal) flow control components mounted within and / or on the outer support frame. The outer support frame (or “valve frame”) may include, for example, an upper annular member or region, a lower annular member or region, and a transverse annular member or region coupled between them. The flow control components are mounted on the valve frame so as to extend through a portion of the transverse annular member or region, as described above.

[0227]

[0253] Method 10 includes, in 11, removably coupling an upper annular member of the outer frame to a portion of the delivery system. For example, in some embodiments, the upper annular member may include mounting members that can be used to temporarily couple the delivery system to a valve. In other embodiments, the upper annular member may form and / or define mounting points, transit points, and / or any other suitable couplers that can be removably coupled to that portion of the delivery system.

[0228]

[0254] In 12, the prosthetic valve in delivery configuration is advanced through the lumen of the delivery catheter, which is part of the delivery system, while the distal end of the delivery catheter is positioned in the atrium. As described above with reference to valve 100, the prosthetic valve can be configured for delivery and loaded into the lumen of the delivery catheter. In some cases, configuring the valve for delivery may include, for example, folding the valve laterally or along the transverse axis, or compressing the valve axially or in the blood flow direction or along the central axis of the valve. In some cases, the upper annular member of the outer frame is removably coupled to that part of the delivery system before being advanced through the lumen of the delivery catheter. In such cases, for example, that part of the delivery system can be used to advance the prosthetic valve in delivery configuration through the lumen of the delivery catheter.

[0229]

[0255] In 13, the prosthetic valve is released from the distal end of the delivery catheter. In some cases, the prosthetic valve may be partially released from the delivery catheter to allow the distal end portion of the valve (e.g., the distal anchor element of the inferior annular member) to be inserted into the annulus of the natural valve before the valve is completely released. In other cases, the prosthetic valve may be completely released from the delivery catheter before the portion of the prosthetic valve is inserted into the annulus. Furthermore, the release of the prosthetic valve allows the released portion (or the entire valve) to transition from the delivery configuration to the expanded or deployed configuration.

[0230]

[0256] In 14, the prosthetic valve seats within the annulus of the natural heart valve while the proximal inferior annular anchor element is in the first configuration. As described above with reference to specific embodiments, the proximal inferior annular anchor element may transition to the first or clamp configuration before being loaded into the delivery system and / or before being advanced through the delivery system, or after being released from the distal end of the delivery catheter. The proximal inferior annular anchor element may be in the first configuration in response to the operation of an actuator detachably coupled thereto. For example, the actuator may be one or more tethers that can be tensioned to actuate, move, and / or otherwise position the proximal inferior annular anchor element to the first configuration such that at least the circumference and / or outer circumference of the inferior annular member is reduced to a size similar to or smaller than the circumference and / or outer circumference of the annulus.

[0231]

[0257] As described in detail above with respect to specific embodiments, the actuator and / or its tether can route through one or more mounting points of the valve to limit and / or substantially prevent tightening of the valve along the central axis (e.g., tightening that lowers the height of the valve). In other embodiments, the tether can route through a catheter or tube extending through the upper annular member such that its end portion is in, near, or past the lower annular member of the valve frame, and this may be operable to limit and / or substantially prevent tightening of the valve along the central axis. In some cases, such “planar tightening” can limit and / or substantially prevent the proximal lower annular anchor element from coming into contact with the annular tissue as the proximal lower annular anchor element transitions from its compressed or operating state to its uncompressed or non-operating state, as described in detail above.

[0232]

[0258] In 15, after the artificial valve has been seated on the annulus, the proximal inferior annular anchor element is transitioned from a first form to a second form. For example, in some implementations, an actuator may be operated to move the proximal inferior annular anchor element from a first form to a second form. In some implementations, a user or operator may reduce the amount of tension of one or more tethers, allowing the proximal inferior annular anchor element to return to a biased or extended state or form. In some implementations, the actuator may be operated to move the proximal inferior annular anchor element from a first (compressed) form through an extended form to a clamping form in which the proximal natural tissue of the annulus is compressed or pinched between the proximal inferior annular anchor element of the inferior annular member and the proximal portion of the upper annular member, thereby securing the valve to the annulus. In some implementations, once the valve has been seated and / or secured within the annulus of the natural valve, that part of the delivery system can be separated and / or removed from the valve and withdrawn from the patient's body. In some implementations, the actuator may include a first portion or first tether that can be actuated to tighten the proximal inferior annular anchor element, and a second portion or second tether that can be actuated to return or assist in returning the proximal inferior annular anchor element to its biased or untightened state.

[0233]

[0259] Figure 45 is a flowchart showing a method 20 for deploying a laterally deliverable artificial valve according to one embodiment. The laterally deliverable artificial valve may be similar to and / or substantially identical to any of the artificial valves described herein. For example, the artificial valve may include an outer support frame and (internal) flow control components mounted within and / or on the outer support frame. The outer support frame (or “valve frame”) may include, for example, an upper annular member or region, a lower annular member or region, and a transverse annular member or region coupled between them. The flow control components are mounted on the valve frame so as to extend through a portion of the transverse annular member or region, as described above.

[0234]

[0260] Method 20 includes, in 21, detachably coupling an upper annular member of the outer frame to a portion of the delivery system. For example, in some embodiments, the upper annular member may include mounting members that can be used to temporarily couple the delivery system to a valve. In other embodiments, the upper annular member may form and / or define mounting points, transit points, and / or any other suitable couplers that can be detachably coupled to that portion of the delivery system. For example, that portion of the delivery system may include connecting members or yokes that are detachably coupled to one or more mounting points on the drum of the upper annular member, as described above with reference to a particular embodiment.

[0235]

[0261] In 22, a first force is applied to a first portion of the actuator, pulling the proximal inferior annular anchor element of the valve frame inward until it is in a first configuration. The proximal inferior annular anchor element may be formed at least partially by the lower annular member of the valve frame. The first portion of the actuator may be or include one or more tethers that can exert tension in response to the applied force. The distal end portion of the tether may be coupled to the proximal inferior annular anchor element in an engaging and / or detachable manner, while the proximal end portion of the tether is located outside the body, allowing the tether to be operated by a user (e.g., a doctor, physician, technician, surgeon, etc.). For example, the first force may be a proximal-directed force applied to the proximal end portions of one or more tethers, thereby exerting tension on the tether. The tension along the tether then causes the proximal inferior annular anchor element to actuate, move, pull, and / or transition between any number of configurations. In this implementation, the first embodiment is a compression or tightening configuration in which the proximal inferior annular anchor element is pulled inward (e.g., toward the central axis of the prosthetic valve), folded, moved, and / or otherwise reconfigured. In such a configuration, the periphery and / or outer circumference of at least the inferior annular member of the valve frame is reduced to a size similar to or smaller than the periphery and / or outer circumference of the annulus of a natural heart valve.

[0236]

[0262] As described in detail above with respect to specific embodiments, the actuator and / or a first part thereof (e.g., a tether) can be routed through one or more mounting points on the valve frame to limit and / or substantially prevent tightening of the valve along the central axis (e.g., tightening that lowers the height of the valve). For example, the first part of the actuator or the tether can be routed through a waypoint on the upper annular member, through any number of mounting points mounted on the inner surface of the transverse annular member, and along one strut from a set of struts forming a portion of the transverse annular member. In other embodiments, the tether can be routed through a catheter or tube extending through the upper annular member such that its end portion is on, near, or past the lower annular member of the valve frame, and this may be operable to limit and / or substantially prevent tightening of the valve along the central axis. In some cases, such “planar tightening” can limit and / or substantially prevent compression of the transverse annular member along the central axis, otherwise the proximal inferior annular anchor element may come into contact with or catch on the annular tissue when it transitions from one or more of its forms, states, positions, etc., as described in detail above.

[0237]

[0263] In 23, while the distal end of the delivery catheter is positioned in the atrium, the prosthetic valve is advanced through the lumen of the delivery catheter, which is included in the delivery system. As described above with reference to valve 100, the prosthetic valve can be placed in a delivery configuration and loaded into the lumen of the delivery catheter. In some cases, placing the valve in a delivery configuration may include, for example, folding the valve laterally or along the transverse axis, or compressing the valve axially or in the blood flow direction or along the central axis of the prosthetic valve. In some cases, the upper annular member of the outer frame is removably coupled to that part of the delivery system before being advanced through the lumen of the delivery catheter, and that part of the delivery system is used to advance the prosthetic valve in a delivery configuration through the lumen of the delivery catheter. As described above with reference to a particular embodiment, the proximal lower annular anchor element can be pulled to a first configuration before the prosthetic valve is compressed and loaded into the delivery system and / or advanced through the delivery system.

[0238]

[0264] In 24, the prosthetic valve is released from the distal end of the delivery catheter. In some cases, the prosthetic valve may be partially released from the delivery catheter to allow the distal portion of the valve (e.g., the distal anchor element of the inferior annular member) to be inserted into the annulus of the natural valve before the valve is completely released. In other cases, the prosthetic valve may be completely released from the delivery catheter before the portion of the prosthetic valve is inserted into the annulus. Furthermore, the release of the prosthetic valve allows the released portion (or the entire prosthetic valve) to transition from a delivery configuration to an expanded or deployed configuration. In some implementations, the proximal inferior annular anchor element may be maintained in a first or compressed configuration while the prosthetic valve is released from the delivery catheter.

[0239]

[0265] Method 20 further includes seating the prosthetic valve on the annulus of a natural heart valve while the proximal inferior annular anchor element is in the first configuration in 25. As described above with reference to specific embodiments, with the proximal inferior annular anchor element in the first or clamped configuration, at least the periphery and / or outer circumference of the inferior annular member is reduced to a size similar to or smaller than the periphery and / or outer circumference of the annulus. The reduction in the periphery and / or outer circumference of the inferior annular member allows at least a portion of the prosthetic valve to "drop" into the annulus and / or move within the annulus in other ways. Furthermore, clamping and / or transitioning the proximal inferior annular anchor element to the first configuration without substantially compressing the transverse annular member of the valve frame (e.g., a "planar clamping" configuration) limits and / or reduces the possibility of the prosthetic valve improperly seating due to the inferior annular member (or a portion thereof) being within the annulus rather than below it.

[0240]

[0266] In 26, after the artificial valve has been seated within the annulus, a second force is applied to the second part of the actuator to pull the proximal inferior annular anchor element outward from the first form to the second form. For example, the second part of the actuator may be or include one or more tethers that can apply tension in response to the applied force. The distal end portion of the tether may be coupled to the proximal inferior annular anchor element in an engaging and / or detachable manner, while the proximal end portion of the tether is located outside the body, allowing the tether to be operated by a user (e.g., a doctor, physician, technician, surgeon, etc.). For example, the second force may be a proximal-directed force applied to the proximal end portion of one or more tethers, thereby applying tension to the tether. The tension along the tether then causes the proximal inferior annular anchor element to actuate, move, pull, and / or transition between any number of forms. In this implementation, the second embodiment is an elongation or detangulation form in which the proximal inferior annular anchor element is pulled outward (e.g., away from the central axis of the artificial valve), spread, moved, and / or reconfigured in other ways. In such a form, the periphery and / or outer circumference of at least the inferior annular member of the valve frame is increased to a size larger than, for example, the periphery and / or outer circumference of the valve ring.

[0241]

[0267] As stated above, a first portion of the actuator (e.g., a tether) is routed to pass through one or more internal mounting points (e.g., mounting points along the inner surface of the transverse annular member), while a second portion of the actuator (e.g., a tether) may be routed to pass through one or more portions of the artificial valve and at least one mounting point attached to the outer surface of the transverse annular member (or proximal subannular anchor element). For example, the second portion of the actuator may be one or more tethers that are selectively routed to pass through the valve such that a proximal force applied to the tether (e.g., a second force) pulls the proximal subannular anchor element away from the central axis of the valve (e.g., outward).

[0242]

[0268] In some implementations, a second part of the actuator can be operated such that the proximal inferior annular anchor element moves from a first (compression) form through an extension form to a clamping form (e.g., the second form) in which the proximal natural tissue of the annulus is compressed or pinched between the proximal inferior annular anchor element of the inferior annular member and the proximal portion of the upper annular member, thereby fixing the valve to the annulus. In some implementations, once the valve is seated and / or fixed within the annulus of the natural valve, that part of the delivery system can be separated and / or removed from the valve and withdrawn from the patient's body.

[0243]

[0269] Figure 46 is a flowchart showing a method 30 for coupling an actuator to the valve frame of a laterally deliverable artificial valve according to one embodiment. The laterally deliverable artificial valve may be similar to and / or substantially identical to any of the artificial valves described herein. For example, the artificial valve may include an outer support frame and (internal) flow control components mounted within and / or on the outer support frame. The outer support frame (or “valve frame”) may include, for example, an upper annular member or region, a lower annular member or region, and a transverse annular member or region coupled between them. The flow control components are mounted on the valve frame so as to extend through a portion of the transverse annular member or region, as described above.

[0244]

[0270] Method 30 includes inserting the actuator tether into a waypoint defined by the upper annular member of the valve frame in 31. For example, the upper annular member includes a drum that covers or forms the surface of the wireframe portion of the upper annular member. The upper annular member further includes and / or defines an opening or waypoint in, along, or through the drum that can allow one or more components to pass from the outside (upper) side of the upper annular member to the inside (lower) side of the upper annular member.

[0245]

[0271] In 32, the tether is detachably attached to a set of mounting points mounted on the inner surface of the transverse annular member, along one strut from a set of struts. For example, the transverse annular member may include and / or be formed by a wire frame covered with a biocompatible material (e.g., a wire frame laser-cut from a tube or sheet of shape memory material). More specifically, the transverse annular member or its wire frame may include a set of struts forming and / or defining a set of compressible wire cells, as described above with respect to the transverse annular member 912. The struts form and / or define the compressible wire cells such that their orientation and / or geometric shape is substantially perpendicular to the central axis of the prosthetic valve, thereby minimizing strain along any other part of the strut and / or wire frame (e.g., related to compressing and / or tightening the prosthetic valve). In some embodiments, each strut may extend at an angle from the upper or upper annular portion of the transverse annular member to the lower or lower annular portion, and may define, for example, a substantially rhomboid portion of an adjacent wire cell. In some embodiments, at least one of the mounting points is distal to the proximal subannular anchor element.

[0246]

[0272] In 33, the tether is removably attached to a proximal inferior annular anchor element, which is at least partially formed by the lower annular member of the valve frame of the prosthetic valve. For example, the proximal inferior annular anchor element may include and / or form an attachment point to which the tether is removably attached. In some embodiments, the attachment point along the strut and the attachment point of the proximal inferior annular anchor element are loops through which the tether can extend and / or define its path. In other embodiments, the attachment point may be any suitable fixture, coupler, anchor, tie, etc., that can secure the tether to one or more surfaces of the prosthetic valve or valve frame while allowing the tether to move proximal and / or distally (e.g., forward or retract).

[0247]

[0273] In 34, the distal end of the tether is positioned around a guidewire catheter extending through a transit point in the upper annular member. The guidewire catheter may be similar to any of the guidewire catheters described above. As described above with reference to guidewire catheter 984, the guidewire catheter may extend through the transit point such that a portion of the guidewire catheter is below the flow control components of the prosthetic valve. In 35, after positioning the distal end of the tether around the guidewire catheter, the portion of the guidewire catheter distal to the tether can be inserted into a guidewire coupler attached to the distal portion of the lower annular member to at least temporarily secure the distal end of the tether to the distal portion of the lower annular member.

[0248]

[0274] As described above with reference to specific embodiments, the distal end of the tether is secured by looping and / or positioning it around / around the guidewire catheter. Furthermore, the arrangement of attachment points along the inner surface of the transverse annular member may be such that at least one attachment point is distal to the proximal inferior annular anchor element. In this way, the attachment point secures a portion of the tether in front of or proximal to the proximal inferior annular anchor element, and the guidewire catheter secures a portion of the tether behind or distal to the proximal inferior annular anchor element. In such a case, a proximal force applied to the tether acts to pull the proximal inferior annular anchor element inward toward the central axis of the prosthetic valve (by traversing the tether through its attachment point). In some implementations, the proximal inferior annular anchor element may be pulled to a position where its attachment point is between the most distal attachment point along the inner surface of the transverse annular member and the guidewire catheter. In some embodiments, the proximal inferior annular anchor element, the most distal anchor element along the inner surface of the transverse annular member, and the attachment points of the portion of the guidewire catheter around which the tether is positioned may be located at substantially similar positions along the central axis of the prosthetic valve (e.g., substantially coplanar). As described above with reference to specific embodiments, coupling the actuator to the prosthetic valve by method 30 may allow the proximal inferior annular anchor element to be actuated, tightened, and / or otherwise reconfigured without substantially compressing the transverse annular member in the direction along the central axis (e.g., without substantially reducing the height of the transverse annular member).

[0249]

[0275] While various outlines, embodiments, and / or implementations have been described above, it should be understood that these are presented only as examples and not as limitations. Similarly, it should be understood that certain terms used herein are intended solely to describe, and not to limit, specific embodiments and / or features or components thereof. Various modifications, changes, and / or variations in form and / or details may be made without departing from the scope and / or spirit of this disclosure and / or without changing their function and / or merit unless otherwise specified. Functionally equivalent embodiments, implementations, and / or methods, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing description and are intended to be included within the scope of this disclosure. Embodiments (and / or their features, components, forms, etc.) may be described above in relation to several implementations, but it should be understood that such implementations are presented only as examples and not as limitations. Any embodiment (and / or its features, components, forms, etc.) may be used in and / or adapted for use in other implementations unless otherwise specified.

[0250]

[0276] The specific forms of various components can also be modified. For example, the size and specific shapes of various components may differ from those of the illustrated embodiments, but still provide the functions described herein. More specifically, the size and shape of various components may be specifically selected for the desired or intended use. Therefore, it should be understood that the embodiments and / or the size, shape, and / or arrangement of their components may be adapted to a given use unless otherwise specified in the context.

[0251]

[0277] Where the above-described outlines, embodiments, and / or implementations show several components arranged in several orientations, forms, or positions, the arrangement of the components may be modified. While various embodiments have been described as having specific features, forms, and / or combinations of components, other embodiments are also possible that have any combination of features, forms, and / or components from any of the embodiments described herein, except for mutually exclusive combinations. The embodiments described herein may include various combinations and / or subcombinations of the functions, components, forms, and / or features of the different embodiments described.

[0252]

[0278] Where the above-described method indicates that some events, steps, and / or procedures occur in a specific order, the order of some events, steps, and / or procedures may be modified. In addition, some of the events, steps, and / or procedures may be executed simultaneously in parallel processes, if possible, as well as sequentially, as described above. While the methods have been described as having specific steps and / or combinations of steps, other methods are also possible that have any combination of steps from any of the methods described herein, except for mutually exclusive combinations and / or unless otherwise specifically stated in the context.

Claims

1. A laterally deliverable artificial valve, A valve frame defining a central channel extending along the central axis of the artificial valve, comprising a valve frame including a proximal inferior annular anchor element, A flow control component is installed within the central channel and configured to allow blood flow through the central channel in a direction along the central axis, An actuator configured to be removably attached to the proximal lower annular anchor element, wherein the actuator includes a first portion removably attached to the inner surface of the valve frame at at least one distal position to the proximal lower annular anchor element, the first portion being configured to respond to a proximal force by pulling the proximal lower annular anchor element inward toward the central axis to form a first shape, and Includes, An artificial valve comprising a second portion at least partially detachably attached to the outer surface of the valve frame, wherein the actuator is configured to respond to a proximal force by pulling the proximal subannular anchor element outward away from the central axis, thereby changing it from the first configuration to the second configuration.

2. The artificial valve is compressible along the central axis and a transverse axis perpendicular to the central axis in order to take a compressed form for lateral delivery into the cardiac chamber via a delivery catheter. When the artificial valve is in the compressed state within the delivery catheter, the central axis and the transverse axis are each perpendicular to the longitudinal axis of the delivery catheter. The artificial valve according to claim 1, wherein the artificial valve is configured to transition from a compressed state to an expanded state when the artificial valve is released from the delivery catheter into the cardiac chamber.

3. The artificial valve according to claim 2, wherein the valve frame includes an upper annular member, a lower annular member, and a transverse annular member coupled therebetween, the transverse annular member including a plurality of wire struts defining the central channel and a plurality of rhomboid cells, the rhomboid cells having an orientation that allows compression of the artificial valve along the central axis.

4. The artificial valve according to claim 3, wherein the first portion of the actuator includes a tether detachably attached to the proximal lower annular anchor element, a portion of which is located within the central channel and detachably attached to the inner surface along one strut from the plurality of struts.

5. The artificial valve according to claim 4, wherein the portion of the tether, which is removably attached to the inner surface, is configured such that, by a proximal force, the tether pulls the proximal lower annular anchor element inward toward the central axis without substantially compressing the transverse annular member in the direction along the central axis.

6. The artificial valve according to claim 2, wherein the valve frame includes an upper annular member, a lower annular member, and a transverse annular member coupled therebetween, and the proximal lower annular anchor element is at least partially formed by the proximal portion of the lower annular member.

7. The first portion of the actuator that pulls the proximal lower annular anchor element inward toward the central axis to form the first shape reduces the circumference of the lower annular member, thereby facilitating the seating of the artificial valve into the annulus of a natural heart valve, according to claim 6.

8. The second portion of the actuator that forms the second form by pulling the proximal lower annular anchor element outward so as to move away from the central axis, increases the circumference of the lower annular member such that the circumference of the lower annular member is larger than the circumference of the valve ring of the natural heart valve, according to claim 7.

9. A method for deploying a laterally deliverable prosthetic valve within the annulus of a natural heart valve, wherein the prosthetic valve comprises (i) a valve frame having an upper annular member, a lower annular member, and a transverse annular member coupled thereto, and (ii) a flow control component mounted on the valve frame and at least partially positioned within the transverse annular member, the method is The valve frame is detachably coupled to a portion of the delivery system, Applying a first force to the first part of the actuator, pulling the proximal lower annular anchor element of the lower annular member inward until it takes on a first form, The delivery system involves advancing the artificial valve in a delivery configuration within the lumen of a delivery catheter, wherein the distal end of the delivery catheter is located within the atrium. To release the artificial valve from the distal end of the delivery catheter, While the proximal inferior annular anchor element is in the first configuration, the artificial valve is seated on the annulus of the natural heart valve, After seating the artificial valve within the valve ring, a second force is applied to the second portion of the actuator to pull the proximal lower annular anchor element outward from the first form to the second form. Methods that include...

10. After applying the first force to pull the proximal lower annular anchor element to the first form, and before advancing the prosthetic valve through the lumen of the delivery catheter, the method further In order to give the artificial valve the delivery configuration, the artificial valve is compressed in a first direction along the transverse axis of the artificial valve and in a second direction along the central axis of the artificial valve, wherein the transverse axis is perpendicular to the central axis. The artificial valve in the delivery configuration is loaded into the lumen of the delivery catheter such that the longitudinal axis of the artificial valve is substantially parallel to the longitudinal axis of the delivery catheter. Includes, The method according to claim 9, wherein the longitudinal axis of the artificial valve is perpendicular to the central axis and the transverse axis of the artificial valve, respectively.

11. The proximal lower annular anchor element is at least partially formed by the proximal portion of the lower annular member, In the first embodiment, the proximal inferior annular anchor element is configured such that the circumference of the inferior annular member is smaller than the circumference of the valve ring of the natural heart valve. The method according to claim 9, wherein the proximal lower annular anchor element in the second embodiment is such that the circumference of the lower annular member is larger than the circumference of the valve ring of the natural heart valve.

12. The first portion of the actuator includes a first tether, the second portion of the actuator includes a second tether, and the method further includes, The first tether is releasably coupled to the proximal inferior annular anchor element, wherein the first force is a force directed proximal to the first tether, thereby causing the first tether to pull the proximal inferior annular anchor element inward toward the central axis of the artificial valve. The second tether is releasably coupled to the proximal inferior annular anchor element, wherein the second force is a force directed proximal to the second tether, thereby causing the second tether to pull the proximal inferior annular anchor element outward away from the central axis of the artificial valve. The method according to claim 9, including the method described in claim 9.

13. The method according to claim 12, wherein the transverse annular member includes a plurality of wire struts defining a plurality of rhomboid cells, the rhomboid cells having an orientation that allows compression of the artificial valve in a direction along the central axis.

14. The method according to claim 13, wherein a portion of the first tether extends through the transverse annular member and is releasably attached to the inner surface of the transverse annular member along one of the plurality of struts.

15. The method according to claim 14, wherein the portion of the first tether is releasably attached to the inner surface of the transverse annular member at at least one position distal to the proximal lower annular anchor element.

16. The method according to claim 14, wherein the portion of the first tether, which is releasably attached to the inner surface along the strut, is configured to pull the proximal lower annular anchor element inward toward the central axis by applying a proximal force to the first tether, without substantially compressing the transverse annular member in the direction along the central axis.

17. moreover, Locking the proximal lower annular anchor element in the second configuration. The method according to claim 12, including the method described in claim 12.

18. The method according to claim 17, wherein locking the proximal lower annular anchor element includes pulling the second tether in the proximal direction such that the lock along the second tether engages with a portion of the valve frame.

19. A method for coupling an actuator to a valve frame of a laterally deliverable artificial valve, wherein the valve frame comprises an upper annular member, a lower annular member, and a transverse annular member coupled therebetween, the transverse annular member comprising a plurality of wire struts defining a plurality of rhomboid cells, and the method is Inserting the actuator tether through the transit point defined by the upper annular member, The tether is detachably attached to multiple mounting points mounted on the inner surface of the transverse annular member along one strut from the plurality of struts, The tether is detachably attached to a proximal lower annular anchor element that is at least partially formed by the lower annular member of the valve frame, The distal end portion of the tether is positioned around the guidewire catheter that extends through the aforementioned transit point of the upper annular member, The guide wire catheter is inserted into the guide wire coupler attached to the distal portion of the lower annular member, and the distal end portion of the tether is temporarily fixed to the distal portion of the lower annular member. Methods that include...

20. The method according to claim 19, wherein the distal end portion of the tether forms a loop that allows the distal end portion of the tether to be positioned around the guidewire catheter.

21. The method according to claim 19, wherein the rhombic cells of the transverse annular member have a geometric shape and orientation that allows the artificial valve to be compressed along the central axis of the artificial valve.

22. The transverse annular member includes at least one proximal hinge point and at least one distal hinge point collectively configured to allow the prosthetic valve to be compressed along the transverse axis of the prosthetic valve, wherein the transverse axis is perpendicular to the central axis, and The method according to claim 21, wherein the artificial valve is compressed in a first direction along the horizontal axis and a second direction along the central axis, thereby providing a delivery configuration for lateral delivery of the artificial valve to the cardiac chamber via a delivery catheter.

23. The method according to claim 22, wherein coupling the actuator to the valve frame allows (i) by applying a proximal force to the tether to cause the tether to pull the proximal lower annular anchor element inward toward the central axis of the artificial valve without substantially compressing the transverse annular member in the direction along the central axis, and (ii) by releasing the proximal force on the tether to allow the proximal lower annular anchor element to move outward toward the central axis.

24. The tether is the first tether of the actuator, the strut is the first strut among the plurality of struts, and the method further includes Inserting the second tether of the actuator into the aforementioned transit point, The second tether is detachably attached to a plurality of mounting points mounted on the inner surface of the transverse annular member along the second strut from the plurality of struts, The second tether is detachably attached to at least one mounting point on the front side of the lower annular member and at least one mounting point on the rear side of the lower annular member. Before inserting the guidewire catheter into the guidewire coupler, the distal end of the second tether is positioned around the guidewire catheter, and the distal end of the second tether is temporarily fixed to the distal portion of the lower annular member. The method according to claim 19, including the method described in claim 19.

25. The method according to claim 24, wherein coupling the actuator to the valve frame allows (i) a proximal force to be applied to the second tether, causing the second tether to pull the front and rear sides of the lower annular member inward toward the central axis of the artificial valve, and (ii) the proximal force on the second tether to be released, allowing the front and rear sides of the lower annular member to move outward toward the central axis.

26. The tether is the first tether of the actuator, and the method further includes, Inserting the second tether of the actuator into the aforementioned transit point, The second tether is detachably attached to at least one mounting point on the outer surface of the transverse annular member, The second tether is to be detachably attached to the proximal lower annular anchor element. The method according to claim 19, including the method described in claim 19.

27. The method according to claim 26, wherein the actuator is coupled to the valve frame, (i) by applying a proximal force to the first tether, the tether pulls the proximal lower annular anchor element inward toward the central axis of the artificial valve without substantially compressing the transverse annular member in the direction along the central axis, and (ii) by applying a proximal force to the second tether, the second tether pulls the proximal lower annular anchor element outward toward the central axis.

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