Double-frame replacement heart valve

Abstract

The present invention provides a method for using prostheses, such as replacement heart valves, to be delivered and / or controlled to a desired location within the body. [Solution] A foldable and expandable frame comprising rows of cells may include a plurality of axial connecting portions extending between the top and bottom ends of the cells, each axial connecting portion being shaped to bend to accommodate transient changes in cell height during uneven compression of the replacement heart valve. The frame is advantageous when advancing the replacement heart valve through a funnel-shaped compression tool. The axial connecting portions are sufficiently flexible to accommodate changes in the frame shape during compression, while also being sufficiently resilient to reinforce the structural integrity of the frame in the fully deployed state. The replacement heart valve is preferably a double-frame heart valve, where the axial connecting portions form part of the inner frame, and the outer frame is provided to engage with tissue and form a seal.

Description

Technical Field

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 148,501, filed Feb. 11, 2021, and U.S. Provisional Application No. 63 / 273,402, filed Oct. 29, 2021, the entire contents of each of which are incorporated herein by reference.

[0002] Certain embodiments disclosed herein generally relate to prostheses for implantation within the lumen or body cavity and delivery systems for the prostheses. In particular, the prostheses and delivery systems relate, in some embodiments, to replacement heart valves such as replacement mitral heart valves or replacement tricuspid heart valves.

Background Art

[0003] The human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve and function essentially as one-way valves that operate in synchrony with the beating of the heart. The valves allow blood to flow downstream but block blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, inhibiting the ability to control the blood flow through the valve. Such disorders can reduce the blood pumping efficiency of the heart and result in debilitating and life-threatening conditions. For example, valve insufficiency can result in conditions such as heart hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing diseased heart valves.

[0004] Prostheses exist to correct problems associated with faulty heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace faulty natural heart valves. In recent years, considerable effort has been made to develop replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than open-heart surgery. Replacement valves are designed to be delivered by minimally invasive procedures, and even percutaneous procedures. Such replacement valves often consist of a tissue-based valve body connected to an expandable frame that is subsequently delivered to the annulus of the natural valve. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2015 / 0238315 [Patent Document 2] U.S. Patent No. 8403983 [Patent Document 3] U.S. Patent No. 8414644 [Patent Document 4] U.S. Patent No. 8652203 [Patent Document 5] U.S. Patent Application Publication No. 2011 / 0313515 [Patent Document 6] U.S. Patent Application Publication No. 2012 / 0215303 [Patent Document 7] U.S. Patent Application Publication No. 2014 / 0277390 Specification [Patent Document 8] U.S. Patent Application Publication No. 2014 / 0277422 [Patent Document 9] U.S. Patent Application Publication No. 2014 / 0277427 [Patent Document 10] U.S. Patent Application Publication No. 2018 / 0021129 [Patent Document 11] U.S. Patent Application Publication No. 2018 / 0055629 [Patent Document 12] U.S. Patent Application Publication No. 2019 / 0262129 [Patent Document 13] U.S. Patent Application Publication No. 2015 / 0328000 [Patent Document 14] U.S. Patent Application Publication No. 2016 / 0317301 [Patent Document 15] U.S. Patent Application Publication No. 2019 / 0008640 [Patent Document 16] U.S. Patent Application Publication No. 2019 / 0008639 [Patent Document 17] U.S. Patent Application Publication No. 2020 / 0108225 [Overview of the project] [Problems that the invention aims to solve]

[0006] The development of prostheses, including replacement heart valves, that can be compacted for delivery and subsequently expandable in a controllable manner for controlled placement has proven particularly challenging. Additional challenges relate, for example, to the ability to implant such prostheses into intraluminal tissues, such as luminal or intraluminal tissues of any body, using non-traumatic methods.

[0007] Furthermore, delivering a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to the mitral valve, can also be difficult. Gaining access to perform procedures in the heart or other anatomical locations may require percutaneous delivery of the device through tortuous vascular structures or through open or hemithoracotomy. The ability to control the deployment of the prosthesis at the desired location can also be challenging. [Means for solving the problem]

[0008] Examples of the present disclosure cover, but are not limited to, delivery systems such as replacement heart valve delivery systems. Further examples cover, but are not limited to, methods of use for delivering and / or controllingly deploying prostheses such as replacement heart valves to desired locations within the body. Some configurations provide methods for delivering replacement heart valves and replacement heart valves to natural heart valves such as mitral, aortic, or tricuspid valves.

[0009] In some implementations, a delivery system and method are provided for delivering a replacement heart valve to the location of the natural mitral valve. The delivery system and method may utilize a transseptal approach. In some implementations, components of the delivery system facilitate bending of the delivery device of the delivery system to maneuver the prosthesis from the septum to a location within the natural mitral valve. In some implementations, a capsule is provided for housing the prosthesis for delivery to the location of the natural mitral valve. The capsule may also be configured to recapture the prosthesis after initial deployment if a different target implantation site is desired. In other implementations, the delivery system and method may be adapted for delivery of implants to locations other than the natural mitral valve.

[0010] A suture-based release mechanism adapted for use with a delivery device for the delivery of an implant (e.g., a replacement heart valve or valve prosthesis) may include a dual coaxial slide shaft or subassembly. The inner shaft may be a manifold to which the suture or tether (e.g., the end of a suture loop of a continuous suture or tether strand) is attached. The outer shaft may include one or more release windows that push the suture or tether (e.g., the end of a suture loop) out of the manifold for release.

[0011] The suture-based release mechanism can be incorporated into the delivery device. In other words, the delivery device includes a suture-based release mechanism with a double coaxial slide shaft or subassembly that operates in conjunction to facilitate the transition of the implant between a tethered configuration and a detethered (e.g., released) configuration upon activation of an actuator (e.g., a rotatable knob) of the proximal handle of the delivery device. The delivery device can include a plurality of sutures or tether portions that are fixedly attached at one end to the distal end portion of the delivery device, inserted through an opening of the implant, and then releasably coupled to a retaining member at the distal end portion of the delivery device. Thus, the sutures or tether portions are connected only at the distal end portion of the delivery device and do not extend to the proximal handle of the delivery device. The actuator of the proximal handle can be configured to translate one of the double coaxial slide shafts relative to the other.

[0012] In some configurations, a delivery device for delivering an implant includes a shaft assembly having a proximal end portion and a distal end portion. The proximal end portion of the shaft assembly includes a handle that includes at least one actuator. The delivery device also includes at least one suture (e.g., a plurality of suture portions). A first end of at least one suture (e.g., each of the plurality of suture portions) is permanently coupled to the distal end portion of the shaft assembly. A second end of at least one suture (e.g., each of the plurality of suture portions) is removably coupled to at least one retaining member (e.g., a tab, finger, hook) of the distal end portion of the shaft assembly after being inserted through a coupling member (e.g., a hole, aperture) of the implant. In use, activation of at least one actuator causes the second end of at least one suture (e.g., each of the plurality of suture portions) to be detached from at least one retaining member of the distal end portion of the shaft assembly.

[0013] The delivery device may include additional shafts, lumens, or subassemblies (e.g., an outer sheath subassembly, a rail subassembly, an intermediate shaft subassembly, and / or a nose cone subassembly) to facilitate the delivery of the implant to the desired implantation site. The outer sheath subassembly may be adapted to recapture the implant in situ and then redeploy the implant at the new implantation site. The rail subassembly may facilitate the bending of the delivery device to reach the desired implantation site. The intermediate shaft subassembly may be adapted to hold a portion of the implant in a compressed configuration until it reaches the desired implantation site and is ready for deployment. The nose cone subassembly may facilitate access to the desired implantation site and guidance of the delivery device to the desired implantation site. The delivery device may include a handle with actuators (e.g., knobs) adapted to control the movement (axial, bending, rotational movement) of the various subassemblies of the delivery device. The implant may be an artificial replacement heart valve, and the desired implantation site may be within the annulus of a natural heart valve (e.g., mitral valve, tricuspid valve, aortic valve).

[0014] In some embodiments, the suture-based release mechanism includes an outer release shaft or subassembly having proximal and distal ends, and an inner manifold shaft or subassembly having proximal and distal ends. The manifold shaft is coaxially positioned within the release shaft. The suture-based release mechanism can include a plurality of suture portions (which can be formed of continuous pieces of suture or tether wire) adapted to be removably tethered to the implant (e.g., inserted through an opening in a mechanism of a valve prosthesis such as a replacement heart valve or wrapped around a feature of the valve prosthesis). The plurality of suture loops can be coupled to the manifold shaft. For example, a first end of each of the plurality of suture portions (e.g., loops) can be adapted to be removably coupled to at least one suture loop receiving member (e.g., tab, peg, finger) of the manifold shaft positioned proximal to the distal end (e.g., tip) of the manifold shaft. A second end of each of the plurality of suture loops can be permanently (e.g., non-removably) coupled to the distal end of the manifold shaft. Relative sliding movement of the manifold shaft with respect to the release shaft from a locked configuration to an unlocked configuration causes release of the first end of each of the plurality of suture loops from the at least one suture loop receiving member, thereby enabling the first end of each of the plurality of suture loops to be untethered from the implant.

[0015] The relative sliding movement can include distal movement of the manifold shaft while the release shaft is stationary. The suture-based release mechanism (or delivery device comprising the release mechanism) can include a spring within a handle of the delivery device configured to maintain the release mechanism in a default locked configuration, the spring exerting a distal spring force on the release shaft that must be overcome to transition the release mechanism to an unlocked configuration.

[0016] At least one suture loop receiving member may comprise a plurality of tabs circumferentially arranged around the distal portion of the manifold shaft, each of which is fitted to receive a first end of at least one of the plurality of suture loops. The distal portion of the release shaft may include a plurality of windows, each of which is fitted to align with each of the plurality of tabs of the manifold shaft. By sliding the manifold shaft distally while keeping the release shaft fixed in place, the distal edge of each window of the release shaft pushes the second end of each suture loop proximal along each of the plurality of tabs of the manifold shaft until the second end of each suture loop is released from each of the tabs, thereby allowing the implant (e.g., a replacement heart valve) to be detached from the delivery device.

[0017] At least one suture loop receiving member (e.g., tab, peg, finger) of the manifold shaft may be located within each of the openings or windows proximal to the distal end of the manifold shaft. The second end of each of the multiple suture loops may be permanently or irremovably bonded to a cog at the distal end of the manifold shaft, which includes multiple tether cleats, and then permanently glued or sealed between suture retaining rings positioned on both sides of the tether cleats.

[0018] Multiple suture loops may include three, four, five, six, seven, eight, nine, or more suture loops. The number of suture loops may correspond to the number of proximal holes (or other openings) located on the proximal end of the implant. During assembly, the first end of each of the multiple suture loops may be inserted through the respective holes on the proximal end of the implant before being passed through the release window of the release shaft and removably coupled to at least one suture loop receiving member of the manifold shaft.

[0019] In one implementation having nine suture loops, at least one suture loop receiving member (e.g., tab, peg, finger) of the manifold shaft or subassembly may comprise three tabs circumferentially arranged around the distal portion of the manifold shaft, each of the three tabs being adapted to receive one or more first ends of the plurality of suture loops. In this implementation, each tab receives three first ends of the three suture loops. In this implementation, the distal portion of the release shaft may include three windows, each of the three windows being adapted to align with each of the three tabs of the manifold shaft. In such an implementation, the second end of each of the nine suture loops may be irremovably coupled to a cog at the distal end of the manifold shaft. A portion of each of the nine suture loops may loop through a corresponding hole positioned at the proximal end of the replacement heart valve. By sliding the manifold shaft distally while keeping the release shaft fixed in place, the distal edge of each window of the release shaft pushes the second end of each of the nine suture loops proximal along each of the three tabs of the manifold shaft until the second end of each of the nine suture loops is released from each of the three tabs, thereby allowing the implant (e.g., a replacement heart valve) to be detached from the delivery device.

[0020] The release shaft may include at least one radially inwardly projecting retaining member configured to be received within at least one slot of the manifold shaft, so as to prevent the release shaft from rotating relative to the manifold shaft and thereby maintain alignment between each window and its respective tab. Each of the tabs may have substantially the same length or different lengths.

[0021] According to several implementations, a method for fabricating or manufacturing a suture-based release mechanism for facilitating implant delivery includes the steps of: permanently attaching a first end of a suture loop to the distal end of an inner tube; passing a free second end of the suture loop through a hole in an implant; inserting the free second end of the suture loop through a window positioned along the distal end portion of an outer tube coaxially surrounding the inner tube; locating the free second end of the suture loop on a tab positioned along the distal end portion of the inner tube to removably connect the free second end of the suture loop to the tab; and advancing the distal end of the outer tube distally to align with the distal end of the inner tube so as to prevent the second end of the suture loop from coming off the tab until the implant is in a desired position for implantation.

[0022] According to some implementations, a method for fabricating a suture-based release mechanism to facilitate implant delivery includes the steps of: permanently attaching a first end of a suture loop to the distal end of an inner tube; passing the loop end of the suture loop through a hole in the implant; inserting the loop end of the suture loop through a slot positioned along a proximal tether retaining component in the distal portion of the inner tube to removably connect the loop end of the suture loop to the proximal tether retaining component; and inserting the free end of a release suture through the loop end of the suture loop to fix the suture loop to the inner tube.

[0023] The process described above may be repeated for multiple suture loops formed from a single continuous suture or tether strand. The distal end of the inner tube may comprise multiple circumferentially spaced tether cleats. These tether cleats may form multiple proximal members around which a single continuous suture or tether strand is wound to form multiple proximal suture loop ends. The assembly member may comprise multiple circumferentially spaced pegs or cleats to form multiple distal members around which a single continuous suture or tether strand is wound to form multiple distal suture loop ends. The words “suture” and “tether” may be used interchangeably herein.

[0024] The proximal and distal suture loop ends may be circumferentially offset from each other such that each strand portion connects the proximal suture loop end to the distal suture loop end, which is offset circumferentially in an alternating meandering manner. For example, a strand may be wrapped around a first proximal member to form a first proximal suture loop end, then returned to a first distal member spaced apart (or circumferentially offset) from the first proximal member, and wrapped around the first distal member to form a second suture loop end (the first distal suture loop end), and then returned to a second proximal member spaced apart (or circumferentially offset) from the first distal member to form a third suture loop end (the second proximal suture loop end) in a meandering manner. This process is repeated until a desired number of suture loop ends are created. The two ends of a single continuous suture or tether strand may form multiple suture loops, which can then be joined to a hole or other retaining member on the proximal end of the implant, and subsequently tied together (and optionally glued or otherwise bonded together).

[0025] According to several implementations, a method for facilitating the delivery of an implant into a patient's body using a suture-based release mechanism includes the step of advancing the distal end portion of a delivery device to a desired implantation site. The delivery device includes a double coaxial slide shaft (e.g., an inner shaft and an outer shaft). At least one suture loop is pre-attached to the implant during the manufacture of the delivery device, and the first end of the suture loop is irremovably coupled to the distal end of the inner shaft of the double coaxial slide shaft during the manufacture of the delivery device. The second end of the suture loop is inserted through a retaining member of the implant (e.g., a small hole) and then irremovably coupled to a suture retaining member of a manifold. The distal end portion of the outer shaft of the two shafts includes a release window adapted to push the second end of the suture loop out of the suture retaining member as the inner shaft slides relative to the outer shaft. The method also includes the steps of advancing the inner shaft distally relative to the outer shaft to cause the second end of the suture loop to detach from the suture retaining member and from the release window, and withdrawing the shaft to allow the second end of the suture loop to detach from the implant retaining member, thereby allowing the implant to remain in the desired implantation site when the delivery system is removed from the patient.

[0026] In some implementations, the loop end of the suture loop is inserted through a retaining member of the implant (e.g., a small hole nearest to the inflow strut of the frame), and then inserted through a slot in the proximal tether retaining component of the inner shaft. The release suture may be inserted through the loop end of the suture loop after the loop end of the suture loop has been inserted through the slot. The method also includes the steps of advancing the inner shaft distally relative to the outer shaft, removing the release suture from the loop end of the suture loop, and detaching the loop end of the suture loop from the retaining member of the implant, thereby allowing the implant to remain in the desired implantation site when the delivery device is removed from the patient.

[0027] During implant delivery, the outer release shaft or subassembly may be held distally by a spring in the handle at the proximal end of the delivery device, and the suture loop is fixed to the inner manifold shaft or subassembly. When the user advances the manifold / release knob on the handle, the outer release shaft moves forward with the inner manifold shaft via the spring-driven compression force until the release shaft handle adapter strikes a rigid stop member in the handle. Continued advancement of the inner manifold shaft extends it distally, while the outer release shaft remains in place by contact with the rigid stop member in the handle. The distal edge of the release shaft window abuts against the end of the suture loop, pushing it proximal and releasing it from the suture receiving member (e.g., tab, finger, peg) on ​​the underlying inner manifold shaft. The suture loop is released or detached from the valve hole by the release and retraction of the manifold shaft (for example, by rotating the manifold / release knob proximally). The suture loop is removed from the body along with the delivery system. The suture loop may be formed from a single continuous tether strand, where the two ends of the continuous tether strand are tied together and glued after the suture loop is formed.

[0028] According to some configurations, a valve prosthesis adapted to uneven compression during loading into a capsule includes a self-expanding frame configured to transition between a compression configuration and an expansion configuration. The frame includes at least one row of cells forming a ring. The valve prosthesis may also include a plurality of artificial valve leaflets coupled to the frame. The frame includes a plurality of pre-curved axial connecting portions, each axial connecting portion extending between the apex and basal ends of each cell in at least one row of cells. Each axial connecting portion is adapted to bend in a predetermined manner to adapt to changes in cell height during uneven compression of the valve prosthesis.

[0029] According to some configurations, the valve prosthesis includes a self-expandable frame configured to transition between a compression configuration and an expansion configuration. The frame includes a plurality of rows of cells formed by struts, the cells forming a chevron-shaped cell structure. At least one cell in the most distal row of the plurality of rows of cells may include an axial strut connecting the distal vertex of the cell to the distal vertex of the cell that is in contact with the boundary in the row immediately above the most distal row. The axial strut includes an arched spring structure adapted to prevent ellipticization of the cell during the transition between the compression configuration and the expansion configuration, and vice versa.

[0030] The arch spring structure may include a double arch spring structure in which the axial strut comprises two axial strut segments connected at their proximal and distal ends but separated along their length. Each cell in the most distal row may include an axial strut connecting the distal vertex of the cell to the distal vertex of the cell touching the respective boundary in the row immediately above the most distal row. Each axial strut of the cell in the most distal row comprises an arch spring structure adapted to prevent ellipticization of the cell during transitions between compression and expansion configurations and vice versa. The arch spring structure may be asymmetric or symmetric.

[0031] According to some configurations, a double-frame valve prosthesis includes an inner frame comprising an inlet portion having an inlet end, an outlet portion having an outlet end, and a middle portion extending between the inlet and outlet portions. The inlet end of the inner frame comprises a plurality of inlet struts (e.g., axial proximal struts or beams) comprising a plurality of holes (e.g., two, three, or more holes). The outlet end of the inner frame comprises a plurality of anchors (e.g., distal anchors or ventricular anchors). The valve prosthesis also includes an outer frame comprising an inlet portion having an inlet end, an outlet portion comprising an outlet end, and a middle portion extending between the inlet and outlet portions. The inlet end of the outer frame comprises a plurality of inlet struts (e.g., axial proximal struts or beams) comprising a plurality of holes. At least one of the plurality of holes in each of the plurality of inlet struts of the outer frame is configured to engage with at least one of the plurality of holes in the plurality of inlet struts of the inner frame.

[0032] The valve prosthesis may also include a skirt assembly positioned between the inner and outer frames. The skirt assembly includes a single piece of fabric material having varying diameters, a single piece of fabric material including a body portion, a plurality of proximal extensions extending from the body portion, and a plurality of distal extensions extending from the body portion. In some configurations, the plurality of proximal extensions are positioned between the inlet portion of the inner frame and the inlet portion of the outer frame. The body portion of the skirt assembly may be positioned outside the middle portion of the outer frame. The plurality of distal extensions may be positioned between the outlet portion of the inner frame and the outlet portion of the outer frame.

[0033] In some implementations, one or more of the multiple proximal extensions include a tab configured to be positioned between one or more of the multiple inflow struts of the inner frame and one or more of the multiple inflow struts of the outer frame. In some implementations, one or more of the multiple distal extensions include a hole configured to allow blood to flow into the volume between the inner frame and the outer frame.

[0034] In some implementations, multiple proximal extensions and / or multiple distal extensions have a trapezoidal shape. In some implementations, multiple proximal extensions are sutured together with one or more sutures when the valve prosthesis is assembled. In some implementations, multiple distal extensions are sutured together with one or more sutures when the valve prosthesis is assembled.

[0035] One or more sutures may include at least one interlock stitch instead of a knot. At least one edge of the fabric material of the skirt assembly may be melted (e.g., using a laser or soldering iron) to create a smooth edge surface. In some implementations, the valve assembly is positioned within an inner frame, and the valve assembly includes a plurality of prosthetic leaflets, each leaflet being sutured to the skirt assembly using two different stitch lines (e.g., a double stitch line).

[0036] In some configurations, each inlet strut of the outer frame includes a bendable tab, which is not attached to the inlet strut of the outer frame along at least a portion of the bendable tab, so that the bendable tab can bend along a plane independent of each inlet strut of the outer frame. The bendable tab may include at least one hole configured to engage with at least one of a plurality of holes in a plurality of axial inlet struts of the inner frame.

[0037] In some implementations, the inlet ends of the outer frame and the inlet ends of the inner frame are mechanically attached together via a dovetail joint configuration or a "puzzle piece" fitting configuration.

[0038] In some implementations, the inlet struts at the inlet ends of the outer frame and the inlet struts at the inlet ends of the inner frame are mounted together, and at least two nearest ends of the axial inlet struts are positioned at an offset distance from each other (e.g., staggered heights). Each adjacent inlet strut may be offset, or offset in pairs or in other numbered groups.

[0039] In some implementations, at least some of the anchors include attachable anchor dampeners that do not contain foam. The attachable anchor dampeners may be configured to have a first portion configured to engage with the leaflets of a natural heart valve. The first portion may be more rigid than a second portion configured to contact the septum or annulus of the heart. The second portion may be configured to provide a cushioned contact surface.

[0040] In some implementations, at least some of the anchors include a metal cushion anchor tip configured to distribute and dampen the load exerted on the natural tissue in contact with the anchor tip. The metal cushion anchor tip may contain a nitinol material. In one configuration, the metal cushion anchor tip is a whisk-like structure formed from a plurality of wire hoops.

[0041] In some implementations, at least some of the anchors include anchor tips configured to provide a cushioning effect in a radially outward direction, thereby reducing the possibility of conduction disturbance caused by anchors in contact with the septum of the heart and providing rigidity in a radially inward direction to facilitate the capture of the leaflets of the natural heart valves.

[0042] According to some configurations, a double-frame valve prosthesis comprising an inner frame and an outer frame having one or more co-organizing features for facilitating alignment and positioning of the double frames of the double-frame valve prosthesis during compression and expansion, the double-frame valve prosthesis comprising an inner frame and an outer frame having one or more co-organizing features (e.g., a hammerhead proximal bore design and / or the distal vertices of the inner and outer frames being offset circumferentially). [Brief explanation of the drawing]

[0043] [Figure 1] This document illustrates one embodiment of a delivery system for implants such as double-frame heart valve prostheses. [Figure 2] A perspective view of a double-flame valve prosthesis that can be delivered using the delivery system described herein is shown. [Figure 2A] Figure 2 shows a side view of the inner frame of the double-frame valve prosthesis. [Figure 2B] Figure 2 shows a side view of the outer frame of the double-frame valve prosthesis. [Figure 2C] A side perspective view of a fully assembled double-frame valve prosthesis, including the skirt assembly and padding, is shown. [Figure 2D-1] This paper demonstrates how structural instability (e.g., strut buckling) can occur during compression of a standard chevron cell frame structure. [Figure 2D-2] This paper demonstrates how structural instability (e.g., strut buckling) can occur during compression of a standard chevron cell frame structure. [Figure 2D-3] This paper demonstrates how structural instability (e.g., strut buckling) can occur during compression of a standard chevron cell frame structure. [Figure 2E-1] This figure shows one embodiment of an inner frame having an asymmetrical "bow spring" structural mechanism in a compression configuration. [Figure 2E-2]The figure shows one embodiment of an inner frame having an asymmetrical "bow spring" structural mechanism in a partial compression configuration. [Figure 2E-3] This figure shows one embodiment of an inner frame having an asymmetrical "bow spring" structural mechanism in an extended configuration. [Figure 2E-4] This figure shows one embodiment of an inner frame having an asymmetrical "bow spring" structural mechanism in an extended configuration. [Figure 2F-1] This shows an embodiment of the inner frame having a more asymmetrical "bow spring" structural mechanism. [Figure 2F-2] This document describes an embodiment of an inner frame having a "bow spring" structural mechanism with minimal asymmetry. [Figure 2G-1] A diagram shows one embodiment of an inner frame having a symmetrical "bow spring" structural mechanism. [Figure 2G-2] A diagram shows one embodiment of an inner frame having a symmetrical "bow spring" structural mechanism. [Figure 2G-3] A diagram shows one embodiment of an inner frame having a symmetrical "bow spring" structural mechanism. [Figure 2G-4A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-4B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-5] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-6] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-7] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-8] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-9A]The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-9B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-10] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-11A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-11B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-11C] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-12] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-13] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-14] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-15] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-16] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-17] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-18A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-18B]The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-19] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-20A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-20B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-21A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-21B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-22] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-23A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-23B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-24A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-24B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-25A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-25B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-26A]The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-26B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-26C] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-27A] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2G-27B] The diagram shows an embodiment of the anchor tip of the frame of a replacement heart valve, such as the inner frame of a double-frame valve prosthesis. [Figure 2H] A side view of one embodiment of an outer frame, including co-organizing frame features to facilitate improved operation with the inner frame described herein throughout the temporary loading and deployment configuration, is shown. [Figure 2I-1] Various bore designs are shown, configured to reduce rotational and / or translational movement between the outer and inner frames of a double-frame valve prosthesis. [Figure 2I-2] Various bore designs are shown, configured to reduce rotational and / or translational movement between the outer and inner frames of a double-frame valve prosthesis. [Figure 2I-3] Various bore designs are shown, configured to reduce rotational and / or translational movement between the outer and inner frames of a double-frame valve prosthesis. [Figure 2J-1] This shows an outer frame that does not possess specific co-organization frame features. [Figure 2J-2] The outer frame has co-organizing features designed to straddle the inner frame axial struts to facilitate alignment. [Figure 2J-3] Another embodiment of a frame for a heart valve prosthesis is shown, in which the heights of the nearest struts on the frame (e.g., tether mounting struts) are alternately varied or offset. [Figure 2J-4] Another embodiment of a frame for a heart valve prosthesis is shown, in which the heights of the nearest struts on the frame (e.g., tether mounting struts) are alternately varied or offset. [Figure 2K-1] This demonstrates how the outer frame can undergo detrimental interactions with anchors on the inner frame of a double-frame valve prosthesis during crimping. [Figure 2K-2] This paper demonstrates how the implementation of the outer frame can be designed so that the distal outflow portion of the outer frame avoids interaction with the inner frame anchor during crimping. [Figure 2L-1] This shows an implementation of the outer frame design of a dual-frame valve prosthesis, illustrating options for the connection or mounting structure between the proximal bore and the connecting strut of the outer frame. [Figure 2L-2] This shows an implementation of the outer frame design of a dual-frame valve prosthesis, illustrating options for the connection or mounting structure between the proximal bore and the connecting strut of the outer frame. [Figure 2L-3] This shows an implementation of the outer frame design of a dual-frame valve prosthesis, illustrating options for the connection or mounting structure between the proximal bore and the connecting strut of the outer frame. [Figure 2L-4] This shows embodiments of tabs and / or holes in a frame, such as the outer frame of a double-frame valve prosthesis. [Figure 2L-5] This shows embodiments of tabs and / or holes in a frame, such as the outer frame of a double-frame valve prosthesis. [Figure 2L-6] This shows embodiments of tabs and / or holes in a frame, such as the outer frame of a double-frame valve prosthesis. [Figure 2M-1] This shows various implementation configurations of a double-frame valve prostasis with different radius of curvature profiles when the inner and outer frames are engaged. [Figure 2M-2] This shows various implementation configurations of a double-frame valve prostasis with different radius of curvature profiles when the inner and outer frames are engaged. [Figure 2N-1] An example of an outer frame is shown. [Figure 2N-2] An example of an outer frame is shown. [Figure 2N-3] Here is another example of an outer frame. [Figure 2N-4] Here is another example of an outer frame. [Figure 2O] Figure 2O-1 shows a double-frame valve prostasis with the inner and outer frames engaged in a pre-expansion state with the outer frame not deployed, and Figure 2O-2 shows a double-frame valve prostasis with the inner and outer frames engaged in a capsule retracted state with the outer frame deployed. [Figure 2P-1] This shows an embodiment of engaging an inner frame and an outer frame to form a double-frame heart valve prosthesis. [Figure 2P-2] This shows an embodiment of engaging an inner frame and an outer frame to form a double-frame heart valve prosthesis. [Figure 2P-3-4] Various embodiments for engaging the inner and outer frames to form a double-frame heart valve prosthesis are shown. [Figure 2P-5] This shows an embodiment of engaging an inner frame and an outer frame to form a double-frame heart valve prosthesis. [Figure 2P-6] This shows an embodiment of engaging an inner frame and an outer frame to form a double-frame heart valve prosthesis. [Figure 2P-7] This shows an embodiment of engaging an inner frame and an outer frame to form a double-frame heart valve prosthesis. [Figure 3A] Figure 1 shows a perspective view of one embodiment of the outer subassembly of the delivery device in the delivery system. [Figure 3B] Figure 3A shows a side cross-sectional view of the capsule subassembly of the outer sheath subassembly. [Figure 3C] Figure 3A shows a perspective view of the capsule stent or distal hypotube of the outer sheath subassembly. [Figure 3D]This illustrates how a portion of the liner extending along the length of the outer sheath subassembly may have built-in slack that facilitates the flexible bending of the outer subassembly. [Figure 3E] Another embodiment of the distal capsule tip of the capsule subassembly is shown. [Figure 3F] Another embodiment of the distal capsule tip of the capsule subassembly is shown. [Figure 3G] Another embodiment of the distal capsule tip of the capsule subassembly is shown. [Figure 4A] Figure 1 shows a perspective view of the rail subassembly of the delivery device in the delivery system. [Figure 4B] Figure 4A shows a side cross-sectional view of the rail subassembly. [Figure 4C] This diagram schematically illustrates how the outer compression coil and tension wire may be longer than the inner compression coil and tension wire of the rail subassembly. [Figure 4D-1-4D-2] This diagram schematically illustrates the wall penetration welding technique performed during the manufacturing of rail subassemblies (compared to the previous direct welding technique). [Figure 5A] Figure 1 shows a perspective view of the intermediate shaft subassembly of the delivery device in the delivery system. [Figure 5B] Figure 5A shows a side cross-sectional view of the intermediate shaft subassembly. [Figure 5B-1-5B-3] An embodiment of the distal end of an intermediate shaft subassembly is shown. [Figure 5B-4-5B-6] Another embodiment of the distal end of the intermediate shaft subassembly is shown. [Figure 5C] This shows a side cross-sectional view of the distal end portion of the shaft assembly, including the intermediate shaft subassembly. [Figure 6A] Figure 1 shows a perspective view of the release subassembly of the delivery device in the delivery system. [Figure 6B] Figure 6A shows a side cross-sectional view of the release subassembly. [Figure 6C] This shows an enlarged side view of the distal end portion of the release subassembly. [Figure 6D] This shows a side cross-sectional view of the distal end portion of the release subassembly. [Figure 6E] This shows a bottom view of the distal end of the release subassembly. [Figure 7A] Figure 1 shows a perspective view of the manifold subassembly of the delivery device in the delivery system. [Figure 7B] Figure 7A shows a side cross-sectional view of the manifold subassembly. [Figure 7C] This shows a magnified view of the distal end portion of the manifold subassembly. [Figure 7D] This shows a bottom view of the distal end portion of the manifold subassembly. [Figure 7E] This shows the flat cut pattern of the distal end portion of the manifold subassembly. [Figure 8A] This shows the distal end portion of the release and manifold assembly in a locked configuration. [Figure 8B] This shows the distal end portion of the release and manifold assembly in the unlocked configuration. [Figure 8C] This demonstrates the mooring and unmooring of sutures using a release and manifold assembly. [Figure 8D] This shows a suture loop that is anchored to a small hole in the valve prosthesis and simultaneously to the manifold subassembly of the delivery device. [Figure 9A] Figure 1 shows a perspective view of the handle of the delivery device. [Figure 9B] This shows a side cross-sectional view of the handle of the delivery device. [Figure 10] Figure 1 shows the components of the introducer assembly of the delivery system. [Figure 11] Figure 1 shows how the handle of the delivery device interfaces with one embodiment of the stabilizer assembly of the delivery system. [Figure 11A] A perspective view of the stabilizer assembly without the delivery device attached is shown. [Figure 11B]Figure 11A shows a top view of the stabilizer assembly. [Figure 12] A schematic diagram of the transfemoral artery and transseptal delivery approaches is shown. [Figure 13] A schematic diagram of a valve prosthesis positioned within the natural mitral valve is shown (shown without the skirt assembly to facilitate visualization of the interface with the natural heart valve structure). [Figure 14A] This specification illustrates the steps of deploying a valve prosthesis using the delivery devices described herein, focusing on the positioning of various subassemblies of the delivery devices relative to each other and to the valve prosthesis in different steps. [Figure 14B] This specification illustrates the steps of deploying a valve prosthesis using the delivery devices described herein, focusing on the positioning of various subassemblies of the delivery devices relative to each other and to the valve prosthesis in different steps. [Figure 14C] This specification illustrates the steps of deploying a valve prosthesis using the delivery devices described herein, focusing on the positioning of various subassemblies of the delivery devices relative to each other and to the valve prosthesis in different steps. [Figure 14D] This specification illustrates the steps of deploying a valve prosthesis using the delivery devices described herein, focusing on the positioning of various subassemblies of the delivery devices relative to each other and to the valve prosthesis in different steps. [Figure 14E] This specification illustrates the steps of deploying a valve prosthesis using the delivery devices described herein, focusing on the positioning of various subassemblies of the delivery devices relative to each other and to the valve prosthesis in different steps. [Figure 14F] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 14G] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 14H] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 14I] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 14J] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 14K] The steps of deploying and recapturing a valve prosthesis using the delivery device described herein are illustrated with reference to an exemplary implantation site within the heart. [Figure 15A] A side perspective view of the fully assembled double-frame valve prosthesis configuration, including the skirt assembly and padding, is shown. [Figure 15B] Figure 15A shows a side view of a fully assembled double-flame valve prosthesis. [Figure 15C] This shows the artificial valve leaflets stitched to the inner frame of a double-frame valve prosthesis. [Figure 15D-1] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15D-2] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15D-3] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15D-4] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15D-5]This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15E-1] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15E-2] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15E-3] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 15E-4] This shows double stitching applied to the artificial valve leaflet to securely attach it to the inner frame of the double-frame valve prosthesis. [Figure 16A] Figures 15A and 15B show side perspective views of the inner frame of the double-frame valve prosthesis. [Figure 16B] Figures 15A and 15B show side perspective views of the outer frame of the double-frame valve prosthesis. [Figure 17A] Figures 15A and 15B show the skirt assembly of the double-flame valve prosthesis in a flat configuration. [Figure 17B] Figures 15A and 15B show the skirt assembly of the double-flame valve prosthesis in a flat configuration. [Figure 17C] Figures 15A and 15B show the skirt assembly of the double-flame valve prosthesis in a flat configuration. [Figure 17D] Figures 15A and 15B show side views of the skirt assembly of the double-frame valve prosthesis in a partially folded configuration. [Figure 17E-1] Figures 17A to 17D show the softened edges of the fabric material used in the skirt assembly. [Figure 17E-2] Figures 17A to 17D show the softened edges of the fabric material used in the skirt assembly. [Figure 17F] To eliminate knots, Figures 17A to 17D show the process of applying interlock stitches to the fabric material used in the skirt assembly. [Figure 18A] This shows a magnified view of the distal end portion of a manifold subassembly to which sutures or tether loops are attached. [Figure 18B] Figure 18A shows a perspective side view of the distal end portion of the manifold subassembly configuration. [Figure 18C] Figure 18A shows a perspective bottom view of the distal end portion of the manifold subassembly configuration. [Figure 18D] Figure 18A shows a perspective view of the arrangement of tethers or sutures fixed to the distal end portion of the manifold subassembly configuration. [Figure 18E] Figure 18A shows a perspective view of the manifold subassembly, illustrating how the tether or suture placement retaining portion can be removed from the distal end of the manifold subassembly configuration. [Figure 18F] Figure 18A shows a perspective view of the manifold subassembly, illustrating how the tether or suture placement retaining portion can be removed from the distal end of the manifold subassembly configuration. [Figure 19A] A perspective side view of the distal end portion of another configuration of the manifold subassembly is shown. [Figure 19B] Figure 19A shows a plan view of the distal end portion of the manifold subassembly configuration. [Figure 20A] A side view of the configuration of the delivery device handle is shown. [Figure 20B] Figure 20A shows a side cross-sectional view of the handle. [Figure 20C] Figure 20A shows an enlarged cross-sectional view of the handle. [Figure 20D] Figure 20C shows an orientation mechanism connected to the outer lumen, in which a double-flame valve prosthesis rotates to facilitate the clocking of the prosthesis at the desired planting location. [Figure 20E]Figure 20C shows an orientation mechanism connected to the outer lumen, in which a double-flame valve prosthesis rotates to facilitate the clocking of the prosthesis at the desired planting location. [Figure 20F] Figure 20C shows an orientation mechanism connected to the outer lumen, in which a double-flame valve prosthesis rotates to facilitate the clocking of the prosthesis at the desired planting location. [Figure 20G] Figure 20C shows an orientation mechanism connected to the outer lumen, in which a double-flame valve prosthesis rotates to facilitate the clocking of the prosthesis at the desired planting location. [Figure 20H] A schematic diagram of a clocking mechanism utilizing direct fluorescence visualization is shown. [Figure 20I] A schematic diagram of a clocking mechanism utilizing direct fluorescence visualization is shown. [Figure 21] A perspective view of the configuration of the delivery device handle is shown. [Figure 22] This shows the configuration of the implants in the patient's heart. [Figure 23A] Figure 22 shows the implant being rotated inside the patient's heart. [Figure 23B] Figure 22 shows the implant being rotated inside the patient's heart. [Figure 23C] Figure 22 shows the implant being rotated inside the patient's heart. [Modes for carrying out the invention]

[0044] This specification and drawings provide aspects and features of the present disclosure in the context of several embodiments of methods configured for use within a patient's vascular structure, such as replacement heart valves, delivery systems, and replacement of a patient's natural heart valve. These embodiments may be discussed in relation to the replacement of a specific valve, such as the aortic valve, tricuspid valve, or mitral valve, in a patient. However, it should be understood that the features and concepts discussed herein are applicable to products other than heart valve implants. For example, the controlled positioning, deployment, and fixation features described herein can be applied to medical implants for use in other locations within the body, such as in arteries, veins, or other body cavities or locations, e.g., other types of expandable prostheses. Furthermore, specific features such as valves and delivery systems should not be taken as limitations, and features of any one embodiment discussed herein can be combined with features of other embodiments as desired and appropriate. Some of the embodiments described herein are described in relation to transfemoral artery delivery approaches, but it should be understood that these embodiments may be used in other delivery approaches, such as transapical or transjugular vein approaches. Furthermore, it should be understood that some of the features described in relation to certain embodiments may be incorporated together with other embodiments, including features described in relation to different delivery approaches.

[0045] Delivery system Figure 1 shows one embodiment of the delivery system 10. The delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve, to a location within the body of a subject (e.g., a human or animal subject). The replacement heart valve can be delivered to the location of the mitral annulus or tricuspid annulus or other heart valves of the subject's heart in various ways, such as by open-chest surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the subject's vascular structure. An exemplary transfemoral approach is described in Patent Document 1, published on August 27, 2015, and is incorporated herein by reference in its entirety. Although the delivery system 10 is described in relation to a percutaneous delivery approach, more specifically a transfemoral delivery approach, it should be understood that the features of the delivery system 10 may be applicable to other delivery approaches, including a delivery system for a transapical delivery approach.

[0046] The delivery system 10 may be used to deploy a prosthesis, such as a replacement heart valve, to a target location within the body, as described elsewhere in this specification. The delivery system 10 may include multiple components, devices, or subassemblies. As shown in Figure 1, the delivery system 10 may include a delivery device 15, a stabilizer assembly 1100, and an introducer assembly 1000 (not shown in Figure 1, but shown in Figure 10). The delivery device 15 includes a shaft assembly 12 and a handle 14. The implant (e.g., a valve prosthesis or replacement heart valve) 30 may be advantageously pre-attached to the delivery device 15 during manufacturing or assembly so that the clinician does not need to attach the implant 30 before use. The delivery device 15 may be configured to facilitate the delivery of the implant (e.g., a valve prosthesis) 30 to a desired target location (e.g., a mitral or tricuspid annulus) and the implantation of the implant (e.g., a valve prosthesis) 30 there. The implant (e.g., a replacement heart valve) 30 may be pre-mounted in or within the distal end portion of the shaft assembly 12, and may be removably anchored to one or more retaining components of the shaft assembly 12 during manufacturing or assembly. The delivery device 15 with the pre-mounted implant 30 can then be packaged, sterilized, and shipped for use by one or more clinicians. According to some embodiments, the implant 30 is not supplied pre-crimped within the shaft assembly 12 delivery device 15. In other embodiments, the implant 30 is pre-loaded or supplied pre-crimped within the shaft assembly 12.

[0047] Implants for use with delivery systems Figure 2 shows an exemplary frame structure of an implant (e.g., a valve prosthesis) 30 that can be pre-loaded into and delivered by a delivery device 15. The implant 30 includes a double-frame assembly comprising an inner frame 32 and an outer frame 34 that are aligned and joined together during manufacturing. Figure 2A shows one embodiment of the inner frame 32. The inner frame 32 may include a proximal or inflow portion 32A, an intermediate or middle portion 32B, and a distal or outflow portion 32C. In an extended configuration, the inner frame 32 may be molded to have a substantially hourglass shape, with the intermediate portion 32B having a smaller cross-sectional width than the proximal portion 32A and the distal portion 32C. The proximal portion 32A may include tabs 33 and / or holes 35 to facilitate engagement with other structures or materials (e.g., the outer frame 34, a skirt or fabric assembly, an artificial valve assembly, and / or a tether or retaining suture of the delivery device 15). The distal portion 32C may include an anchor 37 extending outward and upward to facilitate anchoring at a desired target location (e.g., the annulus of a natural heart). The inner frame 32 may have a chevron cell structure as shown in Figure 2A. However, other cell structures may be used. The inner frame 32 may include an artificial valve assembly coupled to the inner frame 32, comprising a plurality of artificial valve leaflets (not shown). Figure 2B shows one embodiment of the outer frame 34. The outer frame 34 may also include a proximal or inflow portion 34A, an intermediate or middle portion 34B, and a distal or outlet portion 34C. Similar to the proximal portion 32A of the inner frame 32, the proximal portion 34A of the outer frame 34 may also include one or more holes 35 to facilitate coupling to one or more structures or materials (e.g., the inner frame 32, a skirt or fabric assembly, and / or a tether or retaining suture of the delivery device 15). For ease of understanding, in Figures 2, 2A, and 2B, the prosthesis 30 is shown only as the illustrated bare metal frame structure. Figure 2C shows one embodiment of a fully assembled implant (e.g., a valve prosthesis) 30, including a skirt assembly 38 positioned between the frames 32, 34 and the padding 39 surrounding the anchor 37.The implant (e.g., prosthesis) 30 can take any number of different forms or designs.

[0048] Additional details and exemplary designs of implants (e.g., prostheses or replacement heart valves) are described in Patent Documents 2-12 (e.g., hourglass shape of the inner frame). These patents and publications in their entirety are incorporated herein by reference and form part of this specification. Further details and embodiments of replacement heart valves or prostheses, as well as methods for implanting them, are described in Patent Documents 12-15, each of which in its entirety is incorporated herein by reference and forms part of this specification.

[0049] Structural characteristics of the frame Figures 2D-1 to 2D-3 illustrate how structural instability (e.g., strut buckling) can occur in a standard chevron cell frame structure during compression (e.g., during crimping, while under load). Structural instability (e.g., ellipticization) of the cells and struts of the chevron cell frame can occur when the diameter of the chevron cell frame is progressively reduced (e.g., when it is funnel-shaped), such as when the frame is loaded into a shaft assembly of a delivery device that has a smaller diameter than the frame in the extended configuration. This structural instability can interfere with the implantation procedure and, in extreme cases, can reduce the structural integrity of the frame. Structural instability can cause unexpected stress or strain on the frame, which can impair durability and lead to device failure. Referring to Figure 2D-1, the chevron cell structure drives internal forces through its constituent struts when it is crimped or funnel-shaped. When a chevron cell frame is partially funneled or crimped, the internal forces are maximum, with some cells partially open and others partially closed. Conventional chevron cell structures can be inherently unstable systems, and parts or sections of the frame undergoing a reduction in diameter begin to elongate forward. Forward elongation can be the reverse of shortening. In some implementations, forward elongation may mean the same thing as stretching. Still fully expanded parts or sections of the frame resist forward elongation, which may result in strut buckling. When partially funneled, for example, the axial beams or struts 202 of the fully expanded part of the frame may buckle in unpredictable directions, potentially leading to an elliptic cascade, as shown in Figure 2D-2 (bottom view of a partially funneled or partially crimped inner frame with a conventional chevron cell structure) and Figure 2D-3 (side perspective view of a partially funneled or partially crimped inner frame with a conventional chevron cell structure). When partially funnel-shaped, the axial beam or strut 202 may be under compression, while the axial beams or struts 203 and 204 may be under tension.

[0050] Figures 2E-1 to 2E-4, 2F-1 and 2F-2, and 2G-1 to 2G-3 illustrate various embodiments of an inner frame having a chevron cell structure that includes a structural mechanism or feature configured to dynamically absorb or compensate for the forward elongation of a partially crimped section of the inner frame. The structural mechanism is designed to be compressible or expandable in a controlled manner, thereby changing the frame from an unstable system to a stable system during loading or deployment. In some embodiments, the structural mechanism is designed to compensate for internal compressive forces of slotted strut members and to provide dynamic frame stability, thereby ensuring improved frame integrity and patient safety. In some embodiments, the structural mechanism provides frame stability by increasing the external and / or circumferential bending stiffness, similar to the frame stability of a diamond cell structure, but without increasing the crimp length, as may be required for a diamond cell structure. In some embodiments, the structural mechanism advantageously prevents or reduces the possibility of elliptical loading and deployment (for example, by creating non-uniform out-of-plane radial expansion of slotted strut members (e.g., axial beams or struts)).

[0051] According to some embodiments, an expandable and compressible frame may include a plurality of structural mechanisms (e.g., axial (longitudinal) connecting parts, such as strut components in one or more chevron or diamond-shaped cells in the distal or outflow end portion of the expandable frame) that enable or reduce (e.g., shorten) the length in a predictable manner. The structural mechanisms are configured to cause at least a portion of the frame (e.g., a particular cell or strut) to buckle, deform, or bend in a predictable manner or in a desired direction (e.g., when the frame is unevenly compressed by a funnel-shaped loader (e.g., one portion of the frame is compressed while another remains expanded), or when the frame is unevenly compressed when it is recaptured in a delivery device). The structural mechanisms may include bendable axial struts that can shorten and accommodate temporary uneven shapes. The structural mechanisms may be included only in a portion of the frame's cells, but a predictable bend may cause similar bending or crimping in adjacent cells or portions, thereby resulting in controlled bending and compression of the frame. In some configurations, the structural mechanism can be biased in a specific configuration or shape to bend, deform, or crimp in a desired direction.

[0052] In some configurations, the implant (e.g., a replacement heart valve) includes a self-expandable frame configured to transition between a compression configuration and an expansion configuration. The frame includes multiple rows of cells (e.g., chevron-shaped cells) formed by cell struts. At least one cell in the most distal row of the multiple rows of cells includes a structural component adapted to prevent ellipticization of the cell during the transition between the compression and expansion configurations and vice versa. The structural component may include, for example, an axial strut connecting the distal vertex of at least one cell to the distal vertex of a cell that is adjacent to the boundary in the row immediately above the most distal row. Rows other than the most distal row may include structural components in addition to, or as a substitute for, the most distal row.

[0053] Figures 2E-1 to 2E-4 illustrate one embodiment of an inner frame 32 having an axially asymmetric "bow spring" structural mechanism. Figure 2E-1 shows the inner frame 32 in a crimped configuration, and Figure 2E-2 shows the inner frame 32 in an extended configuration. The bow spring structural mechanism is incorporated into one or more of the axial struts 202 extending between the chevron cells. Figure 2E-3 shows a side perspective view of the inner frame 32 in a partially crimped or partially compressed configuration, where the proximal or inflow portion 32A of the inner frame 32 is crimped or compressed, but the distal or outflow portion 32C of the inner frame 32 is still fully extended. Referring to Figure 2E-3, the V-shaped struts forming at least the most distal row of the cell or the top boundary of the ring are folded or compressed prior to the V-shaped struts forming the most distal row of the cell or the bottom boundary of the ring. Therefore, the distance between the endpoints of the arch spring axial struts 202 shortens during crimping. The arch spring axial struts can be removed, but this may make the frame more fragile. Figure 2E-4 shows a top view of Figure 2E-3 with the inner frame 32 in the same configuration. As shown in Figures 2E-3 and 2E-4, the arch spring axial struts 202 are designed to dynamically compensate for compression during device loading to avoid elliptic deformation. The arch spring axial struts 202 deform in a stable and predictable manner. Advantageously, the arch spring axial struts 202 may not stretch when crimped so that the frame crimp length does not increase during loading or deployment. The laser-cut pattern of the arch spring axial struts 202 may include narrow slots to facilitate non-extension (e.g., non-forward extension) of the frame during loading, deployment, and / or recapture. The arch spring axial strut 202 may be constructed at an angle less than or perpendicular to the major axis of the frame 32, as desired and / or as necessary. The performance of the arch spring feature (e.g., the arch spring axial strut 202) is controlled by the geometric shape of the intended bending region. Within this bending region, the length, wall thickness, strut width, laser-cut arc, and / or tapered region directly affect the degree of bending and strain exerted on the material.Embodiments shown in Figures 2E-1 to 2E-4 illustrate an axial bow spring strut 202 having a tapered strut width that decreases to a minimum at the midpoint of the bow spring arc, and an arch shape generated by a laser-cut pattern that directs the intended bending region to bend in the desired direction. The ratio of the wall thickness to the strut width of the bow spring features ensures that the bending is predictable and almost unidirectional. In some implementations, the length of the axial bow spring strut 202 is adjusted to ensure that the required compression progression is within the material limits.

[0054] The arch spring embodiments in Figures 2E-1 to 2E-4 demonstrate a mechanism for compensating for the forward extension of a frame under compression, where the arch spring axial strut 202 dynamically decreases in length. The arch spring axial strut 202 in Figures 2E-1 to 2E-4 comprises a single curved strut that bends arch-shaped to one side in a predictable manner. As can be seen in the transition between Figures 2E-2 and 2E-4, the bending of the arch spring axial strut 202 becomes more pronounced, and all bending is uniform and arch-shaped in a single direction. The principle of the mechanism works equally in reverse, and a pre-formed arch spring mechanism under tension may dynamically extend to compensate for the progressive forward extension of a chevron-style frame design when loaded / deployed from its delivery device or system.

[0055] A bow spring mechanism (e.g., a bow spring axial strut 202) may be suitable for frames made of Nitinol or any other superelastic shape memory alloy. This mechanism may also be employed in frames made of steel, cobalt-chromium, or other alloys, ensuring that the conical crimp implant remains circular as it decreases diametrically along its length. Using this design in frames made of these materials may be beneficial in applications where it is desirable to force a local area of ​​the frame radially inward or outward, such as to create an hourglass shape (inward) or anchoring projection (outward).

[0056] The ability of an axial strut (e.g., a bow-spring axial strut 202), which is part of an unstable chevron cell structure under compression, to dynamically reduce its length during the loading of a device (e.g., an implant), can be achieved through various mechanisms, one of which is the bow-spring concept. Another mechanism for achieving dynamic length changes is to introduce a number of latitudinal laser-cut windows into the axial beam that can be closed or opened to balance the compressive forces exerted on the strut during loading. Another mechanism for achieving dynamic length changes of the axial beam is incorporated into a slot-and-pin mechanism, where the proximal section of the axial beam or strut terminates in a pin that engages with a slot in the distal section of the axial beam or strut. When the frame is loaded, the pin can translate along the slot, thereby balancing the forward extension of the chevron design, and when fully extended and subjected to anatomical forces, the pin can lock, ensuring a reliable frame structure.

[0057] The degree of axial asymmetry can vary. Figure 2F-1 shows one embodiment of the inner frame 32 having a more asymmetrical "bow spring" structure, and Figure 2F-2 shows one embodiment of the inner frame 32 having a "bow spring" structure with minimal asymmetry. The bow spring structure may also be axially symmetric. Figures 2G-1, 2G-2, and 2G-3 show various diagrams of one embodiment of the inner frame 32 having a symmetrical double "bow spring" structure. The double bow spring structure comprises a pair of struts that bend in an arc on opposite sides, similar to how a coin purse functions. Figure 2G-1 shows an enlarged view of one symmetrical double "bow spring" structure where the inner frame is in a crimped or compressed configuration. Figure 2G-2 shows the inner frame 32 in an extended configuration. Figure 2G-3 shows an inner frame 32 in a partially crimped or partially compressed configuration, where the proximal or inlet portion 32A of the inner frame 32 is crimped or compressed, but the distal or outlet portion 32C of the inner frame 32 remains fully expanded. If the frame has a curved profile within the region of interest, as in the case of the hourglass profile of the inner frame 32 described herein, out-of-plane frame expansion can convert the slot in the chevron cell into a double bow spring mechanism. The double bow spring mechanism converts a compressive load, which would otherwise lead to uncontrolled buckling if left unsuppressed or uncompensated, into controlled bending of a bow spring strut.

[0058] Features of Anka According to some embodiments, the anchor 37 of an expandable frame (e.g., the inner frame 32 of a double-frame replacement heart valve) may be formed without using a foam cushion on the anchor tip that contacts the natural cardiac tissue. The anchor may include a non-foam and / or non-fabric dampener made of a flexible material (e.g., metal or metal alloy material) attached to an anchor tip that can be bent, deformed, or contoured to provide a cushioning effect. In some embodiments, the dampener or anchor tip is designed to be "softer" or more cushioned in one direction to reduce conduction disturbances (e.g., conduction disturbances caused by pressure applied to the septum by a rigid anchor tip portion) and rigider in the other opposite direction to maintain capture of the natural valve leaflets. The anchor tip may also have a reduced anchor profile to facilitate easier procedural navigation and installation of the replacement heart valve. The anchor tip may be further designed not to puncture the anatomical structures of the heart (e.g., without sharp edges and providing a cushioning effect). The anchor tip may also be designed to reduce the catheter loading force or to make the loading force more predictable.

[0059] Figures 2G-4A, 2G-4B, 2G-5, 2G-6, 2G-7, 2G-8, 2G-9A, 2G-9B, 2G-10, 2G-11A, 2G-11B, 2G-11C, 2G-12, 2G-13, 2G-14, 2G-15, 2G-16, and 2G-17 show various illustrations of embodiments of non-traumatic anchor tip of the expandable frame of a replacement heart valve. In particular, Figures 2G-4A, 2G-4B, 2G-5, and 2G-6 show embodiments of the attachable tip or attachable anchor damper 37A, while Figures 2G-7, 2G-8, 2G-9A, 2G-9B, 2G-10, 2G-11A, 2G-11B, 2G-11C, 2G-12, 2G-13, 2G-14, 2G-15, 2G-16, and 2G-17 show other embodiments of the attachable anchor tip or padded tip 37B. The embodiments shown in Figures 2G-4A, 2G-4B, 2G-5, 2G-6, 2G-7, 2G-8, 2G-9A, 2G-9B, 2G-10, 2G-11A, 2G-11B, 2G-11C, 2G-12, 2G-13, 2G-14, 2G-15, 2G-16, and 2G-17 may or may not incorporate the use of foam padding, and may or may not incorporate the use of a cloth cover. Therefore, the cloth cover may be optional according to these embodiments. The anchor tip may be incorporated into all, some, or one of the anchors.

[0060] More specifically, Figures 2G-4A and 2G-4B show one embodiment of a mountable anchor tip or dampener 37A that can be attached to the anchor 37 of the inner frame 32 of a double-flame valve prosthesis. The dampener 37A may be a single thin polymer (e.g., plastic or elastomer) or a metal strip (e.g., or other material that is sufficiently flexible to be easily bent). For example, the dampener 37A in Figure 2G-4B has a thin strip shape that is bent over the distal tip of the anchor 37 (e.g., the tip that extends upward when in an extended configuration) to form a saddle-like design. In some configurations, the dampener 37A is formed from a flat raw material (e.g., a thin metal material). Alternatively, the dampener 37A may be formed from tubing, 3D printed, and / or from wire material. The material may include, but is not limited to, nitinol, cobalt-chromium, stainless steel, or polymer materials. When the dampener 37A comes into contact with anatomical tissue, the flexibility of the material increases the radius of the bent loop portion, thereby creating a "cushion" effect. The dampener 37A can be attached to the anchor 37 by adhesive, welding, sutures, or other attachment mechanisms. For example, the dampener 37A can be connected to the anchor 37 using threads or wires inserted through one or more suture holes 37A-1 formed on the end portion of the dampener 37A. Different shapes or designs can be implemented. For example, Figure 2G-5 shows another embodiment of the dampener 37A having multiple slits 37A-3 to reduce vibration when the dampener 37A is subjected to external impact. Multiple slits 37A-3 can also increase the surface area by causing a fan-shaped spread from the contact surface. Such a dampener 37A can also provide a cushioning effect while protecting the tip of the anchor 37. The dampener 37A can be connected to the anchor 37 of the inner frame 32, as shown in Figure 2G-6, by wrapping around the end portion 37A-4 and / or suturing around the end portion 37A-4 of the dampener 37A using thread or wire 37A-2 inserted through one or more suture holes 37A-1 formed on the end portion 37A-4 of the dampener 37A.

[0061] Figures 2G-7, 2G-8, 2G-9A, 2G-9B, 2G-10, 2G-11A, 2G-11B, 2G-1C, 2G-12, 2G-13, 2G-14, 2G-15, 2G-16, and 2G-17 are also included. The attached tips shown in Figures 2G-4A, 2G-4B, 2G-5, and 2G-6 are similar embodiments of the attached anchor tips shown in Figures 2G-4A, 2G-4B, 2G-5, and 2G-6, except that the attached tips in Figures 2G-12, 2G-13, 2G-14, 2G-15, 2G-16, and 2G-17 may be made of flat / thin raw material or thicker rigid material. For example, Figure 2G-7 shows a tubular attached tip 37B which may have a horizontally formed slit 37B-3A on one side (e.g., the front side) that allows inward curvature while preventing outward curvature. The slit cut 37B-3A may help maintain rigidity for capturing the valve leaflet. The tubular attached tip 37B further includes an open cut 37B-3B on the opposite side (e.g., radially inward facing the inner frame 32) that allows inward curvature. The slits 37B-3A and open cuts 37B-3B can be formed, for example, by laser cutting a flexible hypotubule. The tubular, attachable tip 37B can distribute and dampen the load, reducing the force applied to the patient's body, while the slits 37B-3A can maintain rigidity for valve leaflet capture. An optional padded anchor tip can be attached to the top of the tube to distribute and dampen the load.

[0062] Figure 2G-8 shows a double half-loop attachable tip 37B design, including an outer half-loop 37B-4A (loop further from the inner frame 32) and an inner half-loop 37B-4B (loop closer to the inner frame 32) that provide asymmetrical rigidity. The half-loop shape can advantageously facilitate load distribution. The inner half-loop 37B-4B may be thicker than the outer half-loop 37B-4A and therefore may be stiffer to maintain reliable leaflet capture. The outer half-loop 37B-4A may optionally incorporate multiple relief cuts 37B-3C. The outer half-loop 37B-4A is designed to provide a cushioning effect that helps reduce conduction disturbances and decrease the amount of force applied to anatomical structures (e.g., septum, annulus). Like other attachable ends, the attachable end 37B of the double half-loop may have one or more suture holes 37B-1A for attaching the half-loop to the inner frame 32 or anchor end 37 by suture or other attachment method. Furthermore, the attachable end 37B of the double half-loop may have upper suture holes 37B-1C and lower suture holes 37B-1B for suturing the outer half-loop 37B-4A and the inner half-loop 37B-4B together. The half-loops may be laser-cut from a flat sheet or tube (the same tube or different tubes of different thicknesses such that the inner tube is thicker) and may be shaped to the same form using the same tool. One or both of the half-loops may optionally be covered by a sleeve (e.g., a cloth sleeve).

[0063] Figures 2G-9A and 2G-9B show a side view and a front view, respectively, of another embodiment of an attachable anchor tip 37B that includes a half-loop terminating at a flexible, spring-shaped end. The attachable anchor tip 37B of Figures 2G-9A and 2G-9B can be firmly and permanently attached to the anchor 37 by suturing one end, which has a suture hole 37B-1, to the anchor 37, while the opposite end (e.g., the spring-shaped end) may remain free and unattached. The spring-shaped end of the half-loop attachable tip 37B allows the entire anchor to be deflected away from sensitive anatomical structures (e.g., the septum), thereby providing a cushioning effect, reducing the force applied to the anatomical structure along the conduction pathway, and mitigating conduction disturbances. The entire anchor tip design may be laser-cut from a flat sheet, after which the half-loop portion may be shaped into a half-loop shape without the need to shape the spring-shaped end. Figure 2G-10 shows an attachable tip 37B of an anchor tip loop, similar to the embodiments in Figures 2G-4A and 2G-4B, but further including a wire 37C-1 wrapped around at least a portion of the loop, providing further spring and cushioning effects. The wire may extend only along the outside and top of the loop (e.g., the sides configured to contact the septum or valve annulus) and not along the entire loop. The wire 37C-1 allows the anchor tip to be deflected away from sensitive anatomical structures rather than being firmly pressed into them. The inward side of the loop (e.g., the leaflet side) may not have wire wrapping to maintain leaflet capture capability. The attachable tip 37B in Figure 2G-10 may also be fabricated by laser cutting a flat sheet to have a loop shape, and the wire 37C-1 may be wrapped through a hole cut through the thickness of the loop. The end of the loop can be sutured to the anchor 37 via the suture hole 37B-1 or other attachment mechanism, as described above.

[0064] Figures 2G-11A, 2G-11B, 2G-11C, 2G-12, 2G-13, 2G-14, and 2G-15 show other embodiments of the anchorable tip 37B of the inner frame. The anchorable tips shown in these embodiments may have three or more arms. Referring to, for example, Figures 2G-11A and 2G-11C, the anchorable tip 37B may include a first opposing arm 37C-2 ​​having suture holes 37B-1 at each end for attachment to an anchor, and a second opposing arm 37C-3 having an arm of generally continuous width and a free, unattached end. The attachable tip 37B may be formed of wire, thin metal, or any flexible polymer or metallic material so as to bend over the distal tip of the anchor, as shown in Figure 2G-11C. The first opposing arm 37C-2 ​​may be attached to the anchor 37 by suturing a suture or thread 37B-2 through a suture hole 37B-1, while the second opposing arm 37C-3 may be free at their ends, as shown in Figure 2G-11B. Figures 2G-12 to 2G-15 show various embodiments of the attachable tip design similar to that in Figure 2G-11A. Specifically, the attachable tip 37B in Figure 2G-12 may have a circular end on the second opposing arm 37C-3, and the attachable tip 37B in Figure 2G-13 may be similar to the attachable tip in Figure 2G-12 but may have a circular shape in the center by a central hole 37B-4, forming a larger surface area for contact with anatomical structures. Figures 2G-14 and 2G-15 are variations of Figures 2G-12 and 2G-13, respectively, having three or more second opposing arms 37C-3. The number of free and unattached arms may vary.

[0065] Figures 2G-16 and 2G-17 show attachable tips for attachment to the end of the inner frame 32 or anchor 37, similar to the embodiments described above. The attachable tips in Figures 2G-16 and 2G-17 have a symmetrical configuration so that they can be folded so that the upper and lower tips can contact and be attached to the inner frame 32 by suturing through suture holes 37B-1.

[0066] Figures 2G-18A, 2G-18B, 2G-19, 2G-20A, 2G-20B, 2G-21A, 2G-21B, 2G-22, 2G-23A, 2G-23B, 2G-24A, 2G-24B, 2G-25A, 2G-25B, 2G-26A, 2G-26B, 2G-26C, 2G-27A, and 2G-27B illustrate various embodiments of anchor tips of anchors designed to capture the leaflets of natural heart valves (e.g., natural leaflets of the mitral or tricuspid valve). The anchor tip configuration can advantageously provide cushioning without the use of foam or fabric components, or reduce the amount of foam or fabric components. According to some embodiments, the anchor tip represents a modification to the existing frame material (e.g., a modification to some or all of the anchors of the frame itself) instead of being attached to the anchor, as in the embodiments described above. The anchor tip design may be incorporated into one, some or all of the anchors of the frame. In some implementations, the anchor tip comprises a non-fabric and / or non-foam anchor tip made of a flexible material (e.g., metal or a metallic alloy material such as Nitinol) that can be bent, contoured or compressed to provide a cushioning effect to at least a portion of the anchor tip.

[0067] Figures 2G-18A and 2G-18B show a double-layer hoop anchor forming two independent hoops stacked on top of each other. The hoops can be cut from the anchor tube stock and then shaped to separate the independent hoops from the plane and double the contact surface area (best shown in Figure 2G-18B). Figure 2G-19 shows a double inward spiral anchor formed by two independent spirals positioned side by side, which can be formed by cutting the anchor tube stock. The spirals can be deflected to provide a cushioning effect. This anchor design may not require any shaping or welding. The spiral thickness D of the double inward spiral anchor can be, for example, 100 μm to 200 μm.

[0068] Figures 2G-20A and 2G-20B each show a heart-shaped hoop anchor 37 formed by a single hoop having two lobes, such that the center of the heart shape can deflect to alleviate the anchor load. In particular, Figure 2G-20A may have a length L that narrows to allow passage through the chordae tendineae and a height H1 that deflects as a shock absorber to reduce impact load and wear on the valve leaflets or annulus. Furthermore, the heart-shaped hoop anchor 37 of Figure 2G-20A may have a sleeve or fabric sock 37C around the anchor 37. The heart-shaped hoop anchor 37 of Figure 2G-20B may optionally have a snap configuration in which the top member 37CC of the hoop snaps into the base 37CD of the hoop in order to shape and / or reduce the crimp length (e.g., by a few millimeters). When the crimp is released, such a hoop snap becomes free. The heart-shaped hoop anchor design in either Figure 2G-20A or Figure 2G-20B may not require any shaping or welding.

[0069] Figures 2G-21A and 2G-21B each show a rabbit ear-shaped cushion anchor configuration formed by two adjacent outward-facing spirals that flex and separate under load to distribute the load and mitigate contact between the anchor and the anatomical structure of the heart. Figure 2G-21A shows a narrower (e.g., L1 is approximately 2 mm, L2 is approximately 6-7 mm) and higher (e.g., H2 is 3-4 mm) anchor profile compared to Figure 2G-21B, thereby allowing the tendon to slide through or detach from the tendon more easily. On the other hand, the wider version of Figure 2G-21B may allow for a wider, more distributed load when the anchor 37 or inner frame 32 is positioned relative to the natural valve annulus or leaflet. One or both of the spirals may be covered by a fabric sleeve of optional choice to facilitate spreading. Shaping or welding may not be required.

[0070] Figure 2G-22 shows a foldable loop cushion anchor design formed by two outward-facing loops similar to the embodiment in Figure 2G-21A, having additional support from ledge 37D that creates a more rigid (e.g., more rigid) loop when contacting from the distal end and a softer loop when contacting from the proximal end, thereby allowing for easier disengagement from interaction with the anatomical structure of the chordae tendineae when drawing out the valve prosthesis. The anchor may optionally be covered by a fabric sleeve or sock 37C.

[0071] Figures 2G-23A and 2G-23B each illustrate wire-wrapped anchor tip designs, where the anchor has multiple holes 37B-1 (e.g., laser-cut holes) through which a wire 37C-1 can be loosely wrapped, creating a soft, "cushioned" tip for the anchor 37. Specifically, Figure 2G-23A may optionally include a sleeve or cloth sock 37C covering the wire 37C-1, and the wire end 37F may be welded or crimped as a stopper 37E. Figure 2G-23B may include a radiopaque marker 37G to indicate deflection from valve ring contact. The wire end 37F in Figure 2G-23B may be welded together. The wire 37C-1 in Figures 2G-23A and 2G-23B may be made of nitinol, cobalt-chromium, stainless steel, polymer, or radiopaque metal, etc. This anchor tip design may not require any shaping.

[0072] Figures 2G-24A and 2G-24B show an anchor with a thin-walled hoop cut into the end of the anchor tip, where the hoop can deflect to distribute the load over a larger surface area when the anchor is in contact with an object (e.g., the anatomical structure of a natural heart). In the illustrated embodiment, a circular shape (e.g., having a diameter R of 2mm to 4mm) is cut into the end of the anchor tip. When compressed by contact with tissue, the circular shape forms an elliptical shape (as shown in Figure 2G-24B, where the diameter L3 is, for example, 3mm to 7mm). The thin-walled hoop can also deflect around or between tendons when in contact. In particular, the anchor tip of Figure 2G-24B can withstand larger contact loads because it has a larger contact surface area to distribute the load. This anchor tip design may not require shaping or welding.

[0073] Figures 2G-25A and 2G-25B illustrate zigzag spring anchors, each providing load distribution and cushioning by having a zigzag pattern cut into the tip of the anchor 37. The zigzag spring anchor in Figure 2G-25A may have an inclined zigzag pattern that creates an angle greater than 0° but less than 90°, with a length or width L4 (e.g., 2mm to 3mm) and a height H3 (e.g., 3mm to 5mm), while the zigzag spring anchor in Figure 2G-25B is formed by a curve or bend (e.g., at a right angle of 90° or approximately 90°). This anchor tip design may not require shaping or welding.

[0074] Figures 2G-26A, 2G-26B, and 2G-26C show a whisk-tipped anchor formed by looping multiple wires 37C-4 over holes 37J near the periphery of a small circular plate 37H and passing them through the holes 37J to form two to four or five or more wire hoops, where a central rectangular hole 37I in the plate 37H can be fitted over the end of the anchor arm and can be sutured over the end of the anchor arm. Figure 2G-26A shows a side view of the whisk-tipped anchor, and Figure 2G-26B shows a top view of the circular plate 37H and an enlarged side view of the anchor arm including the tip configured to receive the hole 37I in the plate 37H. The ends of the wires 37C-4 can be laser-welded to the circular plate 37H. The looped wires 37C-4 can optionally be covered with a sleeve or cloth sock 37C. Figure 2G-26C shows a top view of the whisk-shaped tip anchor, seen from the top of wire 37C-4. The wire may contain nitinol or other shape memory material. In the case of nitinol wire, A is different from the inner frame 32. f Temperature can be used for nitinol wire (for example, A, which is closer to body temperature). f (Temperature) This can make it easier for the nitinol wire to provide a softer anchor cushion.

[0075] Figure 2G-27A shows a cylindrical braided tip anchor formed by a cylindrically braided fine wire 37N, which is looped over the anchor 37 to provide cushioning during anchor loading. The fine wire may be nitinol wire, cobalt-chromium wire, stainless steel wire, polymer wire, or radiopaque metal wire, and the wire may be tubular. Furthermore, an optional sleeve or cloth sock 37C may be looped around the fine wire 37N. Figure 2G-27B shows another embodiment of a cylindrical braided tip anchor having a conical shape formed by an inverted cylindrical braided tip. In both the cylindrical braided tip anchors of Figures 2G-27A and 2G-27B, the inner frame 32 or the end of the anchor 37 may be divided into two pinch arms 37P to secure the wire end with an optional crimp sleeve 37O. In the case of nitinol wire, the inner frame 32 is different from A f Temperature can be used for nitinol wire (for example, A, which is closer to body temperature). f (Temperature) This can make it easier for the nitinol wire to provide a softer anchor cushion.

[0076] Co-organization of dual-frame functions According to some embodiments, it is desirable to provide complementary features on the structural components (e.g., inner and outer frames) of a dual-frame transcatheter device (e.g., an artificial implant or replacement heart valve). These complementary features may be intended to ensure co-organization of the inner and outer frames. The co-organizing or complementary features may be in contact or not in the expanded and / or crimped state. However, these co-organizing features may, advantageously, interact to help facilitate alignment of the inner and outer frames during the loading and deployment steps and during any subsequent re-capture steps.

[0077] Co-organization or complementary features can be beneficial to device performance, ensuring an organized frame for lower loading / re-capture forces, a symmetrical device profile during deployment for procedure consistency, and reduced strain concentration within the frame, which generally results from asymmetric loading and degrades device durability. Without such co-organization or complementary features, structural components (e.g., inner and outer frames) may act detrimentally to each other (e.g., through competition for space), potentially leading to undesirable asymmetrical arrangements that result in more difficult procedures or device degradation (e.g., artificial implants).

[0078] Transcatheter implants (e.g., heart valve replacements) are typically designed with two states or configurations in mind: an expanded state (e.g., after implantation at the desired site) and a crimped state (e.g., within the delivery device during manufacturing or recapture). Between these two states, the implant undergoes some level or morphological transition, such as diameter reduction (e.g., during loading) or expansion (e.g., during implant deployment). This transient state between expanded and crimped is often a design afterthought and can be important as it may affect the ease and / or safety of the implantation procedure. In some cases, multi-frame (e.g., double-frame) implants may have undesirable inter-frame interactions that create instability within the implant, potentially leading to the implant appearing asymmetrically undesirable relative to anatomical structures during deployment, which can make successful implantation difficult. Other consequences of negative interactions between frames may include damage to the implant fabric or skirt fabric material (e.g., resulting in leakage) and / or damage to the frame (leading to reduced frame durability and potentially fatigue or failure).

[0079] Various co-organizing or complementary frame features may be designed so that the inner and outer frames, or parts of the frame, remain aligned and organized throughout the transient state. Figure 2H shows a side view of one embodiment of an outer frame 34 that includes co-organizing frame features. The co-organizing frame features include features of the proximal portion 34A and the distal portion 34C of the outer frame 34. Specific co-organizing frame features are discussed in more detail below. In some implementations, co-organizing or complementary frame features are designed to engage with each other only during the transient state. Co-organizing or complementary frame features may be designed to progressively join the frame in an organized manner, for example, by working together to reduce degrees of freedom, protect a delicate section or part of the implant, or act like a seal.

[0080] As an example, the outer frame of a double-frame implant may include structural components configured to engage with a portion of the inner frame of the double-frame implant to reduce the possibility of rotation and / or translational movement between the outer and inner frames during expansion and / or compression of the double-frame implant (e.g., during transitional states). Figures 2I-1 to 2I-3 illustrate various proximal bore designs configured to reduce rotation and / or translational movement between the outer and inner frames of a double-frame implant. Figure 2I-1 shows an enlarged view of the proximal portions 32A, 34A of an embodiment of the inner frame 32 and outer frame 34 during a transient state, where the proximal portions 32A, 34A are in a crimped configuration, but the distal portions 32C, 34C are still expanded. As shown, the proximal bore of the outer frame 34 may include a hammerhead design that provides uniform spacing between the bore. The hammerhead design includes a thickened sidewall with flat edge surfaces of the upper and lower bore of the outer frame 34. The thickened flat sides of the holes are configured to contact and abut each other to provide uniform spacing (due to the uniform dimensions of the design). Figure 2I-2 shows a portion of the flat cut pattern of one embodiment of the outer frame 34, showing one hole portion with a hammerhead design adapted to restrict only the rotational degrees of freedom of movement. Figure 2I-3 shows a portion of the flat cut pattern of one embodiment of the outer frame 34, showing two adjacent hole portions with a hammerhead design configured to restrict the rotational and / or translational degrees of freedom of movement. As shown, the hole portions (shown at the top of Figures 2I-2 and 2I-3) include two central extensions (e.g., bumps, protrusions, tabs) on one side of the central hole, configured to engage with cutout features (e.g., recesses, notches, dents) on the opposite side of the adjacent central hole to restrict movement of translational height when adjacent hole portions are engaged. The upper and lower holes include thickened side portions, where one side is wider / thicker than the other. Other designs and shapes may be used to facilitate co-organization between the hole portions of the outer frame 34.

[0081] Figures 2J-1 and 2J-2 help illustrate another example of coorganizing frame features (e.g., slots, openings, or guide structures) of the outer frame designed to straddle the inner frame axial struts in order to facilitate alignment of the outer and inner frames during the transition between expanded and compressed configurations (e.g., the inner frame axial struts extend outward within the coorganizing frame features of the outer frame). The outer frame may have multiple coorganizing frame features spaced circumferentially around the outer frame so as to straddle multiple inner frame axial struts. Figure 2J-1 shows a double frame design without coorganizing frame features. As shown, the overlapping axial beams of the outer frame, which have high curvature in the expanded state, result in a non-uniform geometric shape in the transient state. Figure 2J-2 shows a double frame design with coorganizing frame features. The outer frame 34 includes the hammerhead proximal hole design shown in Figure 2I-1 above. The complementary or co-organizing frame features of the inner frame 32 are the axial beams or struts 212 of the proximal or inflow configuration 32A of the inner frame 32. The complementary or co-organizing frame features of the outer frame 34 may be broad diamond cell joints in the proximal or inflow configuration 34A of the outer frame 34, overlapping with the tightly rounded segments of the shape profile. In some embodiments, the co-organizing frame features of the outer frame 34 include C-shaped or U-shaped joints (e.g., forming slots or guide receptacles or other mechanisms) designed to straddle the corresponding inner frame axial struts 212 for alignment. When the double-frame implant is loaded into the delivery device, the rounded outer frame C-shaped joints bend inward and straddle the inner frame axial struts 212, which act as vertical rails, helping to keep the outer frame 34 fully or nearly fully aligned with the inner frame 32 throughout loading, recapture, and repositioning. Once the implant is fully crimped, the curvature of the co-organized frame features of the outer frame (e.g., C-shaped or U-shaped joints) becomes straight, and they are disengaged from the inner frame axial struts 212.When the implant is in a fully extended configuration, co-organized frame features may not engage (or interact).

[0082] Figure 2K-1 illustrates how an outer frame without co-organizing frame features may undergo detrimental interactions with the anchor 37 on the inner frame of a double-frame valve prosthesis during crimping. Figure 2K-2 shows how one embodiment of the outer frame 34 may be designed to include co-organizing frame features so that the distal outflow portion 34C of the outer frame 34 avoids interaction with the inner frame anchor 37 during crimping. The distal outflow portion 34C of the outer frame 34 may be molded and fitted so that the distal apex of the distal cell of the outer frame 34 does not align with or overlap with the distal anchor (e.g., ventricular anchor) 37 of the inner frame 32. The anchor 37 may instead be designed to be positioned between the distal apex of the distal cell of the outer frame 34 during crimping.

[0083] Characteristics of proximal / inflow / inlet struts Figure 2J-3 shows one embodiment of the medial frame 32 design in which the proximal or inlet struts are uneven, staggered, or offset in height to reduce the total force (i.e., maximum force) required to retrieve and recapture a fully or partially atrially dilated replacement heart valve or valve prosthesis. The offset, staggered, or uneven height distributes the force during recapture rather than having one large spike at once for all struts to be pulled into the delivery system simultaneously, as would occur if the heights were all uniform and there was no offset (e.g., axially symmetric). Figure 2J-4 is a graph showing the expected force reduction results using the offset height design of Figure 2J-3. Referring to Figure 2J-3, the proximal or inlet struts 202 of the medial frame 32 may have different heights (e.g., height difference H4) in such a way that adjacent struts are offset from each other. The alternating offset heights allow half of the strut 202 to be drawn into the delivery system first, and the other half later, thus generating two small spikes in the recapture force instead of one large spike, as shown in Figure 2J-4. The force reduction can be, for example, 25% to 50%. That is, the offset configuration can cause the strut 202 to seat sequentially inside the pusher 506 or capsule tip of the capsule subassembly 306, reducing the recapture force, decreasing the tension on the recapture suture, decreasing the force on the double-frame valve, and reducing compression during the recapture process. Thus, a reduction in the force required to load and recapture the valve prosthesis is expected. The reduction in recapture force can result in reduced tension on the suture during recapture and reduced compression on the intermediate shaft subassembly 22 during recapture. The staggered or offset heights may also help reduce the risk of the struts getting caught on the distal tip or distal edge of the capsule subassembly 306 when the implant 30 is recaptured within the capsule subassembly 306. The height of the struts 202 can be varied, for example, by changing the strut length (e.g., the height above the connection point to the main frame body (e.g., the cell structure)) or the angle.There can be two different heights, where the height of each strut around the circumference of the frame is alternating. There can be three or more different heights (e.g., three different heights, four different heights), where each strut is a different pair or group of different heights.

[0084] In some configurations, the outer frame of a double-frame implant may include a cantilever or hinged mounting tab that allows mounting between the outer and inner frames in a manner that can form an angle between the mounting portions of the outer and inner frames, because the mounting portion of the outer frame bends on a plane independent of the mounting portion of the inner frame, thereby reducing the radius of curvature of the double-frame implant along the area to which the outer and inner frames are mounted. Figures 2L-1 to 2L-3 show various examples of mounting or connection structures between the proximal bore and the connecting strut of the outer frame of a double-frame valve prosthesis. Figure 2L-1 shows that the bottom bore (e.g., the most distal or lowest) of the bore 35 of the proximal tab 33 of the proximal portion 34A of the outer frame 34 may be connected by a bridge 34G to the proximal end of one or more struts 34E, 34F of the outer frame 34. The strut may include at least two outer strut legs 34E connected to the bridge 34G. The strut may further include at least two inner leg struts 34F, one end of each inner leg strut 34F being coupled to the upper inner portion of each of the at least two outer leg struts 34E. The bridge 34G may have a predetermined length between the lowest hole 35 and the joint C. Furthermore, at least two outer legs 34E may extend downward from the joint C. At least one of the multiple holes in each of the multiple tabs of the outer frame 34 engages with at least one of the multiple holes in the multiple tabs of the inner frame, and the bridge 34G of each connecting structure is in surface contact with each tab of the inner frame 32. In some examples, this design may require contact with the holes of the inner frame when the outer frame 34 and the inner frame 32 are aligned and engage together, which may force a large radius of curvature profile, resulting in height strain during crimping and concentrated fatigue strain on the inverse taper of the joint C between the bridge 34G and the proximal end of the strut.

[0085] Figure 2L-2 shows another example of a link element or connecting structure of the outer frame 34. In this example, the bridge 34G is substantially shorter than the bridge 34G shown in Figure 2L-1. The bridge 34G is not connected to the bottom or distally most distal hole, but is connected to the nearest or upper hole via the outer framework 34I of tabs 33 that extend from the bridge 34G and surround the more distal holes, thereby forming a “pop tab” configuration, like the tab used to open a can of soda water. The bridge 34G in Figure 2L-2 may have the same or shorter length as the bridge 34G in Figure 2L-1. Similar to the embodiment in Figure 2L-1, at least two outer leg struts 34E in Figure 2L-2 may extend downward from the joint C. The bridge 34G in Figure 2L-2 can advantageously separate the plane of movement so that the tab 33 can bend along a plane independent of the outer framework 34I, bridge 34G, and / or outer leg strut 34E and independent of the mounting portion of the inner frame 32. Thus, the mounting portion of the outer frame 34 can bend at an angle with respect to the mounting portion of the inner frame 32, thereby facilitating a reduction in the radius of curvature along the proximal inflow region of the double-frame implant or valve prosthesis.

[0086] Figure 2L-3 shows yet another example of a link element or connecting structure of the outer frame 34. As shown in Figure 2L-3, the bridge 34G and joint C are completely removed from the structure. At least two outer leg struts 34E are connected to the sides of the uppermost or nearest hole, but not to the sides of the other holes, thus forming a “paper clip” configuration extending downward from the outer tab 33B, and the inner tab 33A may be spaced apart from at least two outer legs 34E along at least a portion of the edge of the inner tab 33A.

[0087] According to some embodiments, the geometrical mounting configurations of Figures 2L-2 and 2L-3 advantageously eliminate the requirement for hole connections with connecting struts by creating independent planes (e.g., flexible or cantilever tab portions) for hole mounting between one or more mounting holes in the inner frame 32 and the outer frame 34, and providing further flexibility for future profile design of the outer and inner frames. For example, an inlet strut on the flexible or cantilever tab portion of the outer frame may act as a cantilever, keeping the outer frame 34 closed until the capsule subassembly 306 is fully retracted.

[0088] Figures 2L-4 to 2L-6 show various embodiments of the tabs 33 and / or holes 35 of the proximal or inlet struts of the outer frame. According to some implementations, these embodiments can advantageously prevent or reduce the possibility of the suture or tether loop becoming cow-hitched, looped, or “locked” around the tip of the proximal or inlet strut during the removal of the suture or tether between the step of releasing the valve prosthesis from attachment to the delivery system. Instead, the suture or tether loop can be easily removed from the outer frame 34 of the valve prosthesis through the uppermost or nearest hole 35A. In particular, Figures 2L-4 and 2L-5 show link elements or connecting structures of the outer frame 34 similar to Figure 2L-2, forming a “pop tab” configuration, like the tab used to open a can of soda water. However, the embodiments of Figures 2L-4 to 2L-6 may also be incorporated into a “paper clip” configuration or other configurations. Embodiments in Figures 2L-4 and 2L-5 may be formed by laser cutting. The uppermost or nearest hole 35A may have a semicircular shape (as shown in Figure 2L-4), an elliptical shape (as shown in Figure 2L-5), or a bean shape (as shown in Figure 2L-6). The uppermost or nearest hole 35A may have a generally rounded geometric shape as shown in these figures. Furthermore, the height H5 of the mounting hole centerline of the nearest hole 35A may be varied (e.g., reduced) so that the suture or tether cannot get caught, loop, or hitch over the proximal tip of the proximal strut or entrance strut. Referring to Figure 2L-6, the nearest hole 35A has a radius R that is larger than the radius R in Figure 2L-4 but smaller than the radius R in Figure 2L-5. In one embodiment, the radius R may be about 0.1 mm to 0.3 mm. Heights H6 and H7 are combined to make a height H5. Height H5 can be reduced by reducing either or both of heights H6 and H7. Height H6 may be in the range of 0.230 mm to 0.330 mm in some embodiments, and height H7 may be in the range of 0.520 mm to 0.580 mm in some embodiments.By reducing either or both of heights H6 and H7, and therefore height H5, the thickness of the suture or tether, in conjunction with the reduced height, prevents looping, snagging, or hitching of the suture or tether on the proximal tip of the proximal strut or inlet strut. The proximal tip of the proximal strut or inlet strut may also have a rounded or chamfered outer apex geometric shape. For example, the proximal tip of the proximal strut or inlet strut may have a radius of curvature R2. According to some embodiments, the radius of curvature R2 is designed to be smaller than the height H5. The lateral geometric shape of the proximal strut or inlet strut may be straight in some embodiments (as shown in Figures 2L-2 to 2L-5), in contrast to a “snowman” lateral shape (as shown in Figure 2L-1).

[0089] As described above, varying the tab configuration, particularly the hole configuration, can bring about different advantages, such as ease of manufacturing the outer frame, ease of installation of the replacement heart valve (e.g., by suturing), and reduction of tensile stress. According to some embodiments, a series of operations (e.g., posterior, anterior, lateral, and medial operations) may be performed during the tether / suture release step to provide an indicator of any possibility of hitching or looping.

[0090] Figures 2M-1 and 2M-2 show various radius of curvature profiles of a double-frame valve when the inner and outer frames are engaged. For example, when the outer frame embodiment of Figure 2L-1 is engaged with the inner frame, the outer profile may have a radius of curvature as shown in Figure 2M-1, while when the embodiment of Figure 2L-2 or Figure 2L-3 is engaged with the inner frame, the outer profile may have a smaller radius of curvature than that of Figure 2M-1, as shown in Figure 2M-2. A large radius of curvature can make it difficult for the physician to capture the chordae tendineae below the mitral valve annulus, for example, because the outer frame of the double-frame valve prosthesis may need to be deployed at the same time that the ventricular anchor reaches its full diameter. Therefore, by changing the configuration of the outer frame, more specifically by changing the configuration of the outer frame, the radius of curvature of the double-frame heart valve prosthesis can be adjusted to delay the deployment of the outer frame, in addition to reducing the crimp strain at locations that receive radial and circumferential bending combined by the curvature of the profile, such as joint C. Thus, the double-frame valve prosthesis may be designed such that the radius of curvature decreases at the proximal end when in the extended configuration, as shown in Figure 2M-2.

[0091] According to several embodiments, the implementations shown in Figures 2L-2 and 2L-3, and Figure 2M-2, provide flexibility for creating a new cork profile for a double-frame valve prosthesis. The connection structures shown in Figures 2L-2 and 2L-3, and the gentler profile or radius of curvature in Figure 2M-2, can allow for delayed release of the outer frame during delivery, which can reduce both crimp strain and fatigue strain. Delayed release can be achieved by using the inlet strut as a cantilever that keeps the outer frame closed until the delivery capsule (e.g., the capsule subassembly 306 described below) is fully retracted. The reduced radius of curvature can result in a significant reduction in fatigue strain at joint C and improved crimp strain distribution.

[0092] Figures 2N-1 and 2N-2 show the outer frame with the “pop tab” connection structure design of Figure 2L-2 in the extended configuration, and show the reduced radius of curvature profile of this design. Figures 2N-3 and 2N-4 show the outer frame with the “paper clip” connection structure design of Figure 2L-3 in the extended configuration, and show the reduced radius of curvature profile of this design.

[0093] Figure 2O-1 shows a double-frame valve prosthesis with the inner frame 32 and outer frame 34 engaged in a pre-expansion state before the outer frame 34 is deployed. Figure 2O-2 shows a double-frame valve prosthesis with the inner frame 32 and outer frame 34 engaged in a capsule retracted state with the outer frame 34 deployed. As described herein, the deployment of the outer frame 34 can be delayed, as shown in Figure 2O-2, by modifying the link or connection structure (e.g., shape, connection, etc.) of the proximal portion of the outer frame 34.

[0094] In some examples, the outer and inner frames of a double-frame valve prosthesis may be engaged by aligning and attaching one or more of its multiple small holes 35, for example, in a “snowball” manner for fixing the inner and outer frames. The larger diameter of the outer frame may help engage with the natural anatomical structure for the purpose of sealing and securing a large valve ring in the natural anatomical structure. The smaller inner diameter of the inner frame may help hold the tissue valve leaflets of the prosthetic valve, providing a smaller prosthetic valve diameter, which can reduce tissue bulk, pulsating frame load, and frame radial crimp force. The double-frame valve prosthesis structure can provide the aforementioned advantages by creating a significant difference between the expanded diameters of the inner and outer frames.

[0095] In certain embodiments, the proximal hole portions of the inner and outer frames are engaged with each other by adapting a “snowman” method to align the holes of each frame, and sutures are wrapped multiple times through the aligned inner and outer holes to hold the frame struts together on the valve inlet side. To maintain a significant difference in the expanded diameter between the inner and outer frames assembled using the “snowman” method described above, sharp bends are required to create space between the inner and outer frames, resulting in increased strain and crimp loads. Referring, for example, to Figures 2P-1 and 2P-2, these show that the respective holes 35 of the inner frame 32 and outer frame 34 are engaged with each other by sutures looped a predetermined number of times around each hole to ensure attachment of the holes. Here, the outer frame 34 may have an attachment configuration corresponding to the example in Figure 2L-1 described above.

[0096] Figures 2P-3 and 2P-4 show another example of connecting or engaging the inner frame 32 and outer frame 34 of a double-frame valve prosthesis. For example, the inner frame 32 and outer frame 34 may include corresponding or complementary engaging or mounting features that allow an angle to be formed between the engaging portions of the inner frame 32 and outer frame 34 at the mounting point. In the example of Figures 2P-3 and 2P-4, the inner locking tab member 33A of the tab 33 of the outer frame 34 has a puzzle-piece locking tab end configured to fit into a corresponding slot on the corresponding tab or proximal inlet end of the strut 202 of the inner frame 32, thereby providing a compact mechanical lock between the strut of the inner frame 32 and the inner locking tab member 33A of the outer frame 34. As shown in Figure 2P-3, the "puzzle piece lock tab" design can advantageously allow for a larger angle between the inner and outer frames at the mounting point than in the embodiments of Figures 2P-1 and 2P-2, which can provide a gentler curve profile to the outer frame 34, thereby reducing strain and crimp loads.

[0097] In certain embodiments, the inner locking tab member 33A includes a joint (e.g., a dovetail-shaped joint) that fits (e.g., a simple planar fit) into a slot of corresponding shape in the strut 202 of the inner frame 32, and thus the load from the suture is reduced by the mechanical lock between the interacting metal components of the frame. The connection or engagement may involve the use of a single suture lashing to keep the two frames coplanar at the joint or mechanical fitting interface, or optionally involve an off-center / off-axis laser cut, as shown in Figure 2P-4, which can reduce the amount of suture used by providing a tapered or inclined fit between the tabs 33 of the outer frame 34 and the inner frame 32, while keeping the tabs 33 of the outer frame 34 and the inner frame 32 coplanar by the spring force of the tabs that hold the frames together. Figure 2P-4 also shows a detailed cross-sectional view along section line BB. The detailed cross-sectional view shows in more detail how the interface between the inner lock tab 33A and the strut tab opening of the inner frame 32 can be optionally tilted by off-axis laser cutting to lock the metal tabs of the inner and outer frames together without the need for any sutures.

[0098] In another example, referring to Figures 2P-5 and 2P-6, the proximal ends of the inner and outer frames may be connected or joined using a dovetail joint connection structure. This embodiment may provide a dovetail joint in which the proximal end or strut of the inner frame 32 has a dovetail shape (e.g., cut by a vertical laser cutting operation), while the strut of the outer frame 34 has an angled cut that matches the angle of the dovetail joint member on the inner frame 32, thereby forming a dovetail joint or mated fit that allows the parts to fit together in one direction but prevents the parts from being pulled apart in any other direction. The dovetail angle of the inner frame 32 and the out-of-center taper angle of the strut of the outer frame 34 may be adjusted to allow different angles between the inner frame 32 and the outer frame 34 (e.g., 45 degrees, 60 degrees, 90 degrees, or other angles). Two alternative optional techniques to prevent the inner and outer frames from separating (for example, the inner frame dovetail member moving backward from the dovetail groove on the outer frame under load conditions) include, as shown in Figure 2P-6, (1) the holes 35 in the inner and outer frames may optionally be engaged with each other by a tensile suture or tether that wraps through them, and / or (2) the outer frame may be provided with snap locks 34J that are integrally or detachably connected to the struts of the outer frame to ensure the attachment of the inner frame 32 and the outer frame 34.

[0099] The joint structures shown in Figures 2P-3 and 2P-4 or 2P-5 and 2P-6 advantageously facilitate the achievement of a larger angle between the inner and outer frames at the mounting point, while simultaneously reducing the valve space in the crimp length direction and avoiding full reliance on suture wrapping for fixation. The joint structures shown in Figures 2P-3 and 2P-4 or 2P-5 and 2P-6 can also advantageously provide easier access and sewing during the manufacture of the connecting structure. Figure 2P-7 shows an enlarged view of another example of a dovetail joint structure. As shown, one or more dovetail tabs can be formed to provide secure engagement.

[0100] Delivery device Referring briefly back to Figure 1, the delivery device 15 may include a shaft assembly 12 having a proximal end and a distal end, with a handle 14 coupled to the proximal end of the shaft assembly 12. The delivery device 15 may be used to hold an implant (e.g., a prosthesis, a replacement heart valve) to advance it through the vascular structure to the therapeutic site. In some embodiments, the shaft assembly 12 may hold at least a portion of an expandable implant (e.g., a prosthesis, a replacement heart valve) in a compressed state to advance the implant into the body. The shaft assembly 12 may then be used to enable controlled expansion of the implant at the desired implantation site (e.g., the therapeutic site). In some embodiments, the shaft assembly 12 may be used to enable sequential, controlled expansion of the implant, as will be discussed in detail below.

[0101] The shaft assembly 12 of the delivery device 15 may include one or more subassemblies, such as an outer sheath subassembly 20, a rail subassembly 21, an intermediate shaft subassembly 22, a release subassembly 23, a manifold subassembly 24, and / or a nose cone subassembly, as will be described in more detail below. In some embodiments, the shaft assembly 12 of the delivery device 15 may not have all of the subassemblies disclosed herein. The delivery device 15 may include multiple layers of concentric subassemblies, shafts, or lumens. The description of the various lumen or shaft subassemblies begins with the outermost layer. In some embodiments, the subassemblies disclosed below may be in a different radial order than that discussed.

[0102] Outer subassembly Figure 3A shows a perspective view of one embodiment of the outer sheath subassembly 20 of the delivery device 15 of the delivery system 10. The outer sheath subassembly 20 surrounds the implant retention area and forms a radial outer cover or sheath to prevent at least a portion of the implant (e.g., a replacement heart valve or valve prosthesis) 30 from expanding radially until it is ready for implantation. Specifically, the outer sheath subassembly 20 can prevent the distal end portion of the implant 30 from expanding radially.

[0103] The outer sheath subassembly 20 may include an outer proximal shaft 302 having a proximal end portion operably coupled (for example, via a threaded outer sheath adapter 303) to the capsule knob 905 of the handle 14 (which may be the most distal knob as shown in Figures 9A and 9B) such that rotation of the capsule knob 905 causes proximal and distal translational motion (e.g., clockwise and counterclockwise rotation) of the outer sheath subassembly 20. The capsule subassembly 306 may be attached to the distal end of the outer proximal shaft 302. The components of the outer sheath subassembly 20 may form the outermost lumen through which other subassemblies pass.

[0104] The outer proximal shaft 302 may be a tube formed of plastic, but may be formed of a metal hypotube or other material. The outer proximal shaft 302 may include an outer jacket or liner made of fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), ePTFE, or other polymer material to smooth and / or provide hemostatic properties to the outer surface of the outer proximal shaft 302. The outer proximal shaft 302 may include a connector (e.g., a flexible reflow member) at its distal end to facilitate connection or coupling to the capsule subassembly 306. At least a portion of the outer proximal shaft 302 may comprise a laser-cut hypotube having a universally flexible pattern (e.g., a suspended spiral pattern or a suspended coil).

[0105] Figure 3B shows a side cross-sectional view of the capsule subassembly 306. The capsule subassembly 306 may include a distal hypotube or capsule stent 308, an internal liner inside the hypotube 308, a distal capsule tip 309, and one or more external liners or jackets 311 surrounding the hypotube 308. One or more external liners or jackets 311 may include polyether block amide (e.g., PEBAX® material), or other suitable polymer or thermoplastic elastomer material such as polytetrafluoroethylene (PTFE) or evolved polytetrafluoroethylene (ePTFE). The internal liner may include PTFE, which can be pre-compressed before application to the inside of the hypotube 308. The distal capsule tip 309 may include a non-traumatic tip adapted to act as a funnel to facilitate recapture (e.g., crimping) of a valve prosthesis or other implant. The distal capsule tip 309 may be composed of polyetheretherketone (PEEK) or other thermoplastic, polymer, or metallic material. The distal capsule tip 309 may be loaded with a radiopaque material (e.g., 5% to 40% barium sulfate) to facilitate detection (e.g., fluorescence generation) under radiographic imaging (e.g., fluoroscopy). The distal capsule tip 309 may be fitted into the open distal end of the hypotube 308.

[0106] Figure 3C shows a perspective view of the distal hypotubule, or capsule stent 308. The capsule stent 308 may be formed from one or more materials such as PTFE, ePTFE, polyether block amide (e.g., PEBAX), polyetherimide (e.g., Ultem® material), PEEK, urethane, nitinol, stainless steel, and / or any other biocompatible material. The capsule stent 308 is preferably flexible while still maintaining sufficient radial strength to hold the implant (e.g., replacement valve) 30 within the capsule stent 308 without substantially radial deformation that could increase friction between the capsule stent 308 and the implant encapsulated therein. The capsule stent 308 is also preferably columnar strength sufficient to resist buckling, and sufficient tear resistance to reduce or eliminate the possibility of tearing the implant and / or damage to the capsule stent 308. The proximal and / or distal ends of the distal hypotube or capsule stent 308 may include a number of laser-cut windows 313 adapted to generate fluorescence and / or echogenicity at the proximal and / or distal ends to facilitate visualization under specific imaging modalities (e.g., non-invasive ultrasound imaging or invasive fluoroscopy imaging). In some implementations, the presence of the laser-cut windows 313 eliminates the need for any separate radiopaque elements or components to be added to the hypotube 308 to facilitate imaging. The laser-cut windows 313 may also facilitate adhesion of the outer jacket 311 to the capsule stent 308 and inner liner by allowing glue or other adhesives to flow through the laser-cut windows 313. One or more layers of connecting members made of PEBAX or other suitable material may surround the laser-cut windows 313 to facilitate coupling of the hypotube or capsule stent 308 to the distal capsule tip 309.

[0107] The hypotube 308 may be formed from a plastic or metallic material. In some implementations, the hypotube 308 may be a metallic hypotube. In the case of metallic, the metallic material of the hypotube 308 may include metallic alloys such as cobalt-chromium, stainless steel, titanium, or nickel-titanium alloy materials. The coil configuration or cut pattern of the outer proximal shaft 302 and / or the hypotube 308 may allow the outer proximal shaft 302 to follow the rail subassembly 21 in any desired direction. The cut pattern of the outer proximal shaft 302 and / or the hypotube 308 may be modified (e.g., cuts per turn, pitch, spine distance) to control tensile resistance, compressive resistance, flexibility, and torque resistance. For example, the number of cuts per turn may range from 1.5 to 5.5, the pitch may range from 0.005 inches to 0.15 inches, and the spine distance may range from 0.015 inches to 0.125 inches. The hypotube 308 can provide advantageous tension and compression. One or more outer liners or jackets 311 can make the capsule subassembly 306 more flexible. The capsule hypotube 308 can be bent in multiple directions. In some implementations, the distal end of the outer liner or jacket 311 can be positioned proximal to the distal end of the hypotube 308.

[0108] The capsule subassembly 306 may have a diameter similar to or different from that of the lateral proximal shaft 302. In some embodiments, the capsule subassembly 306 has a uniform or substantially uniform diameter along its length. In some embodiments, the capsule subassembly 306 may be 28 French or smaller in size (e.g., 27 French). In some embodiments, the capsule subassembly 306 may include a distal portion with a larger diameter and a proximal portion with a smaller diameter. The capsule subassembly 306 may be configured to hold the implant (e.g., a valve prosthesis) 30 in a compressed position within the capsule subassembly 306 (e.g., within an implant retention area 316 occupying approximately 2 inches (or approximately 50 mm) from the most distal end of the capsule subassembly 306). Additional structural and operational details of the capsule subassembly, such as those described with respect to capsules in Patent Documents 15 and 16 incorporated herein by reference, may be incorporated into the capsule subassembly 306.

[0109] The outer sheath subassembly 20 is configured to slide independently (translate) relative to the other assemblies by the rotation of the capsule knob 905. Furthermore, the outer sheath subassembly 20 can slide (translate) distally and proximal relative to the rail subassembly 21 together with the intermediate shaft subassembly 22, the manifold subassembly 24, the release subassembly 23, and / or the nose cone subassembly.

[0110] Figure 3D schematically illustrates how excess material may be included so as to facilitate the flexible bending of the capsule subassembly 306 (e.g., to navigate sharp curves in the heart or surrounding vascular structures) by incorporating slack along a portion of the length of one or more components of the capsule subassembly 306 (e.g., the inner liner 310) along a portion of its length (e.g., a portion of the length proximal to the implant retention area 316).

[0111] Figures 3E to 3G show alternative embodiments of the distal capsule tip of the capsule subassembly 306. Compared to the distal capsule tip 309 in Figure 3B (which has a linear end or a vertically flush-cut distal end), the distal capsule tip 309A, as shown in Figure 3E, is formed by alternating protruding and recessed lobes 309A-1 and 309A-2, and has a convex end (e.g., a lobed or wavy shape). Such a convex end of the distal capsule tip 309A allows for the stepwise deployment or recapture of the anchor 37. Figure 3F shows a side section of the distal capsule tip 309A, schematically illustrating the stepwise or offset deployment or recapture of the anchor 37 by the lobed design of the distal capsule tip 309A. Figure 3G is a plan view showing that when recapturing anchors, the capsule subassembly 306 can recapture, for example, one or more (e.g., two, three, or more) anchors 37 first, and then the remaining anchors 37 (individually, in pairs, trios, or other groupings) in subsequent stages (e.g., two or three stages). Stepped recapture or deployment can favorably distribute the recapture force, linearize the anchors 37 over time, and reduce the overall force amplitude at any point during recapture (e.g., by 20% to 40%). In this example, three lobes are illustrated at the 12 o'clock, 4 o'clock, and 8 o'clock positions. Such a configuration allows some anchors to begin unbending earlier than others during the recapture process in which the capsule is advanced over the J-shaped anchors. This staggered or stepped arrangement of anchor recapture distributes the force required to unbend the anchors and advance the capsule, thereby reducing the peak load or force. Other numbers of robes or robe shapes may be used.

[0112] Rail subassembly Figure 4A shows a perspective view of the rail subassembly 21 of the delivery device 15 of the delivery system 10 of Figure 1. Figure 4A shows substantially the same figure as Figure 3A, except that the outer sheath subassembly 20 has been removed, thereby exposing the rail subassembly 21. Figure 4B further shows cross-sections of the proximal and distal ends of the rail subassembly 21 to see the pull wires that facilitate the operation of the rail subassembly 21. The rail subassembly 21 may include a rail shaft 402 (or rail) that is generally attached (and operably coupled) to the handle 14 at its proximal end. The rail shaft 402 may consist of a rail proximal shaft 404 that is directly attached to the handle 14 at its proximal end, and a rail hypo tube 406 attached to the distal end of the rail proximal shaft 404 (e.g., via a connector, a ring-shaped structure, or an insert 407). The rail subassembly 21 is operably coupled to the handle 14 via a primary curvature adapter 403A (controlling the medial-outer trajectory of the distal end portion of the rail subassembly 21 via one or more distal tensile wires 410A), via a secondary curvature adapter 403B (controlling the anterior-posterior trajectory of the distal end portion of the rail subassembly 21 via one or more proximal tensile wires 410B), and via a rail adapter 405 (including a lateral needleless injection port for facilitating flushing and degassing functions). The rail proximal shaft 404 may include a suspended spiral cut pattern along most of its length to facilitate compression. The rail hypotube 406 may further include a non-traumatic rail tip 408 at its distal end. The non-traumatic rail tip 408 does not need to have a slit, is configured to extend up to 1 inch beyond the distal end of the rail hypotube 406, and is configured not to be embedded within the outer shaft subassembly 20 to avoid friction and fatigue and extend its use. These components of the rail subassembly 21 can form a rail lumen through which other inner subassemblies can pass.

[0113] Figure 4B shows a side section view of the rail subassembly 21 of Figure 4A. As shown in Figure 4B, one or more tension wires 410 are attached to the inner surface of the rail hypotube 406 and can be used to apply force to the rail hypotube 406 and steer the rail subassembly 21. The tension wires 410 may extend distally from the primary and secondary bending knobs 915 (shown in Figures 9A and 9B) in the handle 14 to the rail hypotube 406. In some embodiments, the tension wires 410 may be attached to different longitudinal locations on the rail hypotube 406, thus providing multiple bending locations within the rail hypotube 406 and enabling multi-dimensional steering. For example, the rail hypotube 406 may provide primary bends or curves along the inner / outer track and secondary bends or curves along the forward / backward track.

[0114] The rail hypotube 406 may include several circumferential slots (e.g., laser-cut within the hypotube) to facilitate bending and flexibility. The rail hypotube 406 can generally be divided into several different sections. At the nearest end, there is an uncut (or unslotted) hypotube section corresponding to the location of the insert 407. Moving distally, the next section is the proximal slotted hypotube section 406P. This section includes several circumferential slots cut within the rail hypotube 406. Generally, two slots are cut around each circumferential location, forming approximately half of the circumference. Thus, two backbones are formed between the slots extending to the length of the rail hypotube 406. This is the section that can be guided by the proximal tension wire 410B. Moving further distally, there is a location to which the proximal tension wire 410 is connected and thus can avoid slots. This section is located immediately distal to the proximal slotted section 406P and may correspond to the location of an insert or pull wire connector 411.

[0115] The distal slotted hypotube section 406D is located distal to the proximal tension wire connection area. This section is similar to the proximal slotted hypotube section 406P, but may have significantly more cut-out slots over considerable length. Therefore, the distal slotted hypotube section 406D is more flexible and may have a greater bending angle compared to the proximal slotted hypotube section 406P. In some embodiments, the proximal slotted section 406P may be configured to undergo a bend of approximately 90 degrees with a bending radius of 0.25 inches to 1 inch (e.g., 0.25 inches to 0.75 inches, 0.4 inches to 0.6 inches, 0.5 inches to 1 inch, their overlapping range, or any value within the enumerated range), while the distal slotted section 406D may bend of approximately 180 degrees with a bending radius of 0.25 inches to 1 inch (e.g., 0.25 inches to 0.75 inches, 0.4 inches to 0.6 inches, 0.5 inches to 1 inch, their overlapping range, or any value within the enumerated range). Furthermore, as shown in Figures 4A and 4B, the spine of the distal slotted hypotube section 406D is circumferentially offset from the spine of the proximal slotted hypotube section 406P. Thus, the two sections achieve different bending patterns, enabling three-dimensional maneuverability of the rail subassembly 21. In some embodiments, the spine may be offset by 30, 45, or 90 degrees, but is not limited to any particular offset. At the distal end of the distal slotted hypotube section 406D is a distal pull wire connection area, which is again a non-slotted section of the rail hypotube 406.

[0116] In some embodiments, one distal tension wire 410A may extend to the distal section of the rail hypotube 406 (e.g., the rail tip 408), and two proximal tension wires 410B may extend to the proximal section of the rail hypotube 406, but other numbers of tension wires may be used and the invention is not limited to a specific number of tension wires. For example, two distal tension wires 410A may extend to a distal location, and a single proximal tension wire 410B may extend to a proximal location. In some embodiments, a ring-shaped structure or insert, known as a tension wire connector, such as an insert 411, mounted inside the rail hypotube 406 can be used as a mounting location for the proximal tension wires 410B. In some embodiments, the tension wires 410 may be directly connected to the inner surface of the rail hypotube 406.

[0117] The distal tension wire 410A may generally be connected to the distal end of the rail hypotube 406 (either by itself or through the rail end connector 408). The proximal tension wire 410B may be connected (either by themselves or through the insert 411) at a point approximately one-quarter, one-third, or half the length from the proximal end to the rail hypotube 406. In some embodiments, the distal tension wire 410A may pass through a small-diameter tension wire lumen (e.g., tube, hypotube, cylinder) mounted on the inside of the rail hypotube 406. This can prevent the tension wire 410 from pulling the rail hypotube 406 at a location proximal to the distal connection. Furthermore, the lumen may include a compression coil to reinforce the proximal portion of the rail hypotube 406 and prevent undesirable bending. Thus, in some embodiments, the lumen is located only on the proximal portion (e.g., proximal half) of the rail hypotube 406. In some embodiments, multiple lumens, such as those spaced longitudinally or adjacent to each other, may be used for each distal tension wire 410A. In some embodiments, a single lumen is used for each distal wire 410A. In some embodiments, the lumen may extend within the distal portion (e.g., distal half) of the rail hypotube 406. In some embodiments, the lumen is mounted on the outer surface of the rail hypotube 406. In some embodiments, no lumen is used. In some embodiments, one or more compression coils 413 extend from insert 407 to insert 411. The compression coils 413 may be configured to bypass the load over the length between the distal primary bending point and the proximal secondary bending point. The compression coils 413 promote independent bending planes so that both planes of the bending do not act when it is desirable that one plane of the bending bends. The compression coils 413 may allow the proximal slotted hypotube section 406P to retain rigidity for a particular bend of the distal slotted hypotube section 406D. The compression coil 413 can be configured to isolate the force so that only the primary curvature is bent.

[0118] In the case of a pair of proximal tension wires 410B, the wires can be spaced approximately 180° apart from each other, allowing for bidirectional maneuvering. Similarly, when a pair of distal tension wires 410A are used, the wires can be spaced approximately 180° apart from each other, allowing for bidirectional maneuvering. In some embodiments, the pair of distal tension wires 410A and the pair of proximal tension wires 410B can be spaced approximately 90° apart from each other. The use of opposing wires can provide an anti-bending mechanism. In some embodiments, the pair of distal tension wires 410A and the pair of proximal tension wires 410B can be spaced approximately 0° apart from each other. However, other locations can be used for tension wires as well, and are not limited to tension wires at specific locations. In some embodiments, the distal tension wire 410A can pass through a lumen mounted within the lumen of the rail hypotube 406. This prevents axial forces on the distal tension wire 410A from causing bending within the proximal section of the rail hypotube 406. The rail subassembly 21 is positioned to be slidable (e.g., translationally movable) on top of the radially inward subassembly. As the rail hypotube 406 is bent, it also presses against the other subassemblies, bending them in the same way, so that the other subassemblies of the delivery device 15 can be configured to steer as a single unit working together with the rail subassembly 21, thus providing full steerability of the distal end of the delivery device 15. Additional structural and operational details of the rail subassembly, such as those described with respect to rail assemblies in Patent Documents 15 and 16 incorporated herein by reference, may be incorporated into the rail subassembly 21.

[0119] Figure 4C schematically illustrates how the outer compression coil 413A and proximal tension wire 410B1 have a longer length than the inner compression coil 413B and proximal tension wire 410B2 of the rail subassembly 21 so as not to occupy the same space, in order to reduce lumen blockage during bending and / or facilitate bending in one direction.

[0120] Figure 4D-2 schematically illustrates a manufacturing method that includes wall-through welding performed during the manufacture of a rail subassembly (compared to the previous direct wire welding technique). Figure 4D-1 shows the prior art welding technique, and Figure 4D-2 shows one embodiment of the wall-through welding technique. The wall-through welding technique can be advantageously used to weld a tension wire 410 to an insert (e.g., inserts 407, 411, tip 408) within the lumen of the rail hypo tube 406. According to some embodiments, wall-through welding advantageously does not involve direct welding to the tension wire 410. Direct welding to the wire 410 (as shown in Figure 4D-1) can result in annealing and embrittlement of a large portion or the entire circumference of the tension wire (which has a hard temper for strength) if it is overheated. Referring to Figure 4D-2, wall penetration welding may involve intentionally forming a through-hole between the outer and inner diameters of the lumen wall and facilitating wall penetration welding in a manner that controls the wall thickness to limit the circumferential range of heating of the tensile wire that penetrates the hypo tube or lumen wall (e.g., less than 20% of the circumference, less than 25% of the circumference, less than 30% of the circumference). In some embodiments, wire penetration welding allows welding along a single line (e.g., a line extending between tensile wires) rather than along multiple lines (e.g., one line for each tensile wire).

[0121] Intermediate shaft subassembly Moving radially inward, the next subassembly is the intermediate shaft subassembly 22. Figure 5A shows a perspective view of the intermediate shaft subassembly 22 of the delivery device 15 of the delivery system 10. Figure 5B shows a side view of the intermediate shaft subassembly 22. The intermediate shaft subassembly 22 may include a distal intermediate shaft hypotube 502, the distal intermediate shaft hypotube 502 which is typically attached at its proximal end to an intermediate shaft proximal tube 504 (e.g., via laser welding or a heat shrink connector), and a distal outer retaining member or pusher 506 positioned at the distal end of the intermediate shaft hypotube 502. The distal intermediate shaft hypotube 502 is typically attached at its proximal end to an intermediate shaft proximal tube 504 (e.g., via laser welding or a heat shrink connector), and the intermediate shaft proximal tube 504 may be attached at its proximal end to a handle 14 (e.g., via an intermediate shaft adapter 505). These components of the intermediate shaft subassembly 22 may form a lumen (e.g., an intermediate lumen) for other inner subassemblies to pass through.

[0122] The intermediate shaft subassembly 22 may be positioned within the lumen of the rail subassembly 21 (e.g., the rail lumen). The intermediate shaft hypotube 502 may be formed from a metal alloy (e.g., cobalt-chromium, nickel-chromium-cobalt alloy, nickel-cobalt-based alloy, nickel-titanium alloy, stainless steel, and titanium). The intermediate shaft hypotube 502 may have a suspended spiral cut pattern. In an alternative embodiment, the intermediate shaft hypotube 502 includes a high-density polyethylene (HDPE) tube that is pre-compressed in the longitudinal direction. Figure 5A shows a diagram similar to Figure 4A, but the rail subassembly 21 has been removed, thereby exposing the intermediate shaft subassembly 22.

[0123] Like other subassemblies, the intermediate shaft hypotube 502 and / or intermediate shaft proximal tube 504 may include a tube or lumen, such as a subcutaneous tube or hypotube (not shown). The tube may be made from any number of different materials, including nitinol, stainless steel, and medical-grade plastics. The tube may be a single piece or multiple pieces joined together. Using a tube made of multiple pieces may allow the tube to provide different properties along different sections of the tube, such as rigidity and flexibility. The intermediate shaft hypotube 502 may be a metal hypotube. The intermediate shaft hypotube 502 may have several slots / apertures cut into the hypotube. In some embodiments, the cut pattern may be the same throughout. In some embodiments, the intermediate shaft hypotube 502 may have different sections with different cut patterns. The intermediate shaft hypotube 502 is covered or encapsulated with a layer of ePTFE, PTFE, or other material, so that the outer surface of the intermediate shaft hypotube 502 is generally smooth. At least a portion of the length of the intermediate shaft proximal tube 504 may be covered with heat shrink tubing or wrap.

[0124] The pusher 506 may be configured to hold a portion of the implant (e.g., prosthesis) 30, such as the proximal end of the implant 30, in a compact configuration in the radial direction. For example, the pusher 506 may be a ring or cover configured to radially cover the proximal end portion of the implant 30 (e.g., the suture hole portion or the proximal inlet portion).

[0125] Figures 5B-1 to 5B-3 show one embodiment of the distal pusher 506 of the intermediate shaft subassembly 22, with Figure 5B-3 being a cross-sectional view along line 5B-3-5B-3 of Figure 5B-2. Figures 5B-4 to 5B-6 show another embodiment of the distal pusher 506A of the intermediate shaft subassembly 22, with Figure 5B-6 being a cross-sectional view along line 5B-6-5B-6 of Figure 5B-5. The distal pusher 506 in Figures 5B-1 to 5B-3 and the distal pusher 506A in Figures 5B-4 to 5B-6 have substantially the same outer and inner diameters φ1 and φ2, forming a cylindrical shape when viewed from the top. However, the distal pusher 506A does not have a lip and cup portion 507 having a height H7, and therefore has a flat top surface 509 compared to the distal pusher 506, which has a thin wall with a radius of curvature R1 on its top surface. Therefore, the total height H6 of the distal pusher 506 in Figures 5B-1 to 5B-3 is reduced by approximately H7. Furthermore, by removing the material comprising the lip and cup portion 507, only a flat surface facing the inlet side of the valve prosthesis may remain during capsule retraction for valve deployment. The distal pusher 506A may have increased space (e.g., increased cross-sectional area) for fitting the inlet strut of the outer frame 34 into the inside of the pusher 506A. The distal pusher 506A may also provide reduced docking force (e.g., approximately 50% reduction in docking force compared to the distal pusher 506) when the suture portion attached to the nearest or inlet strut applies tension to the outer frame 34 in contact with the flat pusher surface without the lip or bump, pulling the hole 35 upward.

[0126] Figure 5C shows a side section view showing an enlarged view of the distal end of the intermediate shaft subassembly 22, which shows the proximal end portion (e.g., the nearest portion, or simply the suture hole 35) of the implant 30 held within the pusher 506. The pusher 506 may also be considered part of the implant retention area 316 and may be located at the proximal end of the implant retention area 316. The pusher 506 may include a frustoconical or cup shape, which is riveted or fastened to the distal end of the intermediate shaft hypotube 502 on its opposing side. The pusher 506 may be formed of PEEK material, steel material, platinum iridium, or other fluorescent material to facilitate radiographic imaging. The pusher 506 may also be formed of other thermoplastic, polymer, or metallic materials. The pusher 506 may be loaded with a radiopaque material (e.g., 5% to 40% barium sulfate) to facilitate detection (e.g., fabricated fluorescence) under radiographic imaging (e.g., fluoroscopy). The intermediate shaft subassembly 22 may be arranged to be independently slidable (e.g., translationally movable) relative to other subassemblies. The intermediate shaft adapter 505 is operably coupled to the depth knob 920 to cause ventricular / atrial movement within the heart (e.g., for implementations where the implant 30 is a mitral valve or tricuspid valve replacement). Additional structural and operational details of the intermediate shaft subassembly 22 may be incorporated into the intermediate shaft subassembly 22, such as those described with respect to intermediate assemblies in Patent Documents 15 and 16 incorporated herein by reference.

[0127] Release and Manifold Subassembly In some configurations, the delivery device includes a suture-based release mechanism, which comprises a plurality of suture portions that are coupled only to the distal end portion of the delivery device and do not extend along the delivery device to a proximal handle that controls the operation of the suture-based release mechanism. The first end of each of the plurality of suture portions may be fixedly attached to the distal end portion of the delivery device, and the second end of each of the plurality of suture portions may be releasably attached to the distal end portion of the delivery device after being inserted through a retaining member (e.g., an opening or hole) of an implant (e.g., a replacement heart valve). The suture portions may be released from the implant (e.g., detached) by operator action of an actuator on the handle of the delivery device.

[0128] The suture-based release mechanism may include a double coaxial slide shaft or lumen. It should be understood that references to a lumen in this disclosure may refer to a shaft or tube comprising a lumen. The double coaxial slide shaft may be operably coupled to an actuator on the handle of the delivery device. The first end of each of the multiple suture portions may be fixedly attached to the distal tip of the inner lumen of the double coaxial slide shaft. The second end of each of the multiple suture portions may be releasably coupled to one or more retaining members of the distal end portion of the inner shaft. The translational motion of the outer shaft relative to the inner shaft of the double coaxial slide shaft or lumen, by the operation of the actuator on the handle, may cause the suture portions to be disengaged or detached from one or more retaining members of the distal end portion of the inner shaft.

[0129] Moving radially inward from the intermediate shaft subassembly 22, Figure 6A shows a perspective view of the release subassembly 23 of the delivery device 15 of the delivery system 10. Figure 6B shows a side section view of the release subassembly 23 of Figure 6A. The release subassembly 23 works in conjunction with the manifold subassembly 24 to facilitate the retention and release of the implant or prosthesis 30. The release subassembly 23 extends through the central lumen of the intermediate shaft subassembly 22. The release subassembly 23 includes a release shaft 602 containing the lumen. The manifold subassembly 24 extends through the lumen of the release subassembly 23. The intermediate shaft subassembly 22 functions as a compression member backstop, and the manifold subassembly 24 functions as a tension member so that the intermediate shaft subassembly 22 prevents the implant 30 from retracting when the capsule subassembly 306 is pulled back and the manifold subassembly prevents the deployment / expansion (or distal movement of the implant 30) of the implant 30.

[0130] The distal portion of the release shaft 602 may include laser-cut portions having various spine patterns. For example, the most distal portion of the release shaft 602 (e.g., about 1 cm) may include a double-spine laser-cut pattern, and a portion of the most distal portion proximal to it (e.g., about 5 cm proximal to the most distal portion) may include a universal laser-cut spine pattern. The double-spine pattern portion may extend only through the primary distal curved portion of the rail hypotube 406, while the universal spine pattern portion may extend through both the primary and secondary curved portions of the rail hypotube 406. At least a portion of the length of the release shaft 602 may be surrounded by heat-shrink wrap or a liner. The proximal end of the release shaft 602 is operably coupled to the handle 14 (e.g., via the release adapter 604). The release subassembly 23 also includes a distal release tip 605 coupled to the distal end of the release shaft 602 via a coupler 607, the distal release tip 605 may be formed of PEBAX or other thermoplastic elastomer material. The distal release tip 605 may be welded to the distal end of the release shaft 602. The release adapter 604 includes a release snap 606 on its opposing outer side. The release snap 606 engages with the distal portion of the manifold adapter 704 after the tether or suture is released, preventing the manifold subassembly 24 and the release subassembly 23 from moving relative to each other, which could cause the window 610 of the distal release tip 605 to close and inadvertently hold one of the sutures or tethers. Thus, the release snap 606 converts the release / manifold mechanism from a normal closed configuration to an open configuration, allowing the manifold subassembly 24 and the release subassembly 23 to move together proximal. The release subassembly 23 further includes a release spring 608 extending between the release adapter 604 and the location of the manifold subassembly 24 within the manifold adapter 704.

[0131] Figures 6C, 6D, and 6E show enlarged side, side section, and bottom views of the distal release tip 605, respectively. The distal release tip 605 works in cooperation with the distal end portion of the manifold subassembly 24 to facilitate the prevention of premature release of the implant 30 and to facilitate the release (e.g., release) of the implant 30 when it is ready for final implantation. The distal release tip 605 includes three spaced windows 610 and three slots 612 around the distal release tip 605, each slot 612 positioned between two adjacent windows 610. The windows 610 can be laser-cut within the distal release tip 605. The three windows 610 can be equally spaced circumferentially, and the slots 612 can be equally circumferentially positioned between adjacent windows 610. Each distal end of the slot 612 includes an inwardly projecting retaining member 614 (e.g., tab, projection, lock, anchor). The inwardly projecting tabs 614 are adapted to align with and extend within the corresponding slots of the manifold subassembly 24 in order to control axial movement (e.g., to provide positive datums for distal and proximal advancement) and to prevent rotation of the release subassembly 23 relative to the manifold subassembly 24.

[0132] Moving radially inward, Figure 7A shows a perspective view of the manifold subassembly 24 of the delivery device 15. Figure 7B shows a side section view of the manifold subassembly 24 of Figure 7A. The manifold subassembly 24 extends through and along the lumen of the release subassembly 23. The manifold subassembly 24 includes a proximal subassembly 701 and a distal subassembly 703. The proximal subassembly 701 includes a proximal shaft 702 having a proximal end that extends into the handle 14 of the delivery device 15 and is operably coupled to the handle 14 via a manifold adapter 704. The proximal shaft 702 may be coupled to the distal subassembly 703 by a manifold cable 705. The manifold cable 705 may include a multilayer cable consisting of two, three, four, five, or more layers. In some implementations, the manifold cable 705 comprises a three-layer cable with two outer layers that function for tension and work together to prevent the outer layers from unwrapping, and an inner layer comprising a single filler coil that provides compression and prevents folding. In some implementations, each layer is wound in opposite directions to adjacent layers (e.g., clockwise, counterclockwise, clockwise or counterclockwise, clockwise, counterclockwise). Wire size, wire tension, pitch, number of fillers in each layer, material, and material properties may vary. The inner coil may contain 1 to 10 fillers tightly wound with gaps of 0 to 0.005 inches. The intermediate and outer coils may each contain 1 to 10 fillers and be tightly wound with gaps of 0 to 0.010 inches. The manifold cable 705 may be formed from one or more materials, including, for example, tinol, steel materials such as stainless steel, and / or cobalt-chromium materials. The temper (e.g., strength) of the wire can range from 100 KSI to 420 KSI (kips / square inch), and the final tensile strength of the manifold cable 705 can exceed 110 pounds. The cross-section of the wire may be flat or round. Three-ply cables may be configured to prevent diameter changes during stretching.In other configurations, the proximal shaft 702 extends all the way to the proximal end of the distal subassembly 703 and is joined to it.

[0133] Figure 7C shows an enlarged view of the distal subassembly 703 of the manifold subassembly 24. Figure 7D shows a bottom view of the distal subassembly 703 of the manifold subassembly 24. As shown, the distal subassembly 703 includes a proximal tether retaining component 706 and a distal tether retaining component 707. The distal tether retaining component 707 may be coupled to the distal end of the proximal tether retaining component 706 (e.g., it may be permanently joined, it may be welded). As best shown in Figure 7D, the distal tether retaining component 707 may include a cog, the cog including tether cleats 708 extending outward at circumferential spacing around the cog. An opening or gap 709 exists between adjacent tether cleats 708 to receive a portion of the tether or suture 710. The distal tether retaining component 707 may be formed from metal through an electrical discharge machining process. The proximal tether retaining component 706 may also be formed of metal and may be formed by laser cutting or electrical discharge machining processes. The distal tether retaining component 707 may include proximal and distal sealing members 711, 713 (e.g., retaining rings) that seal the opening or gap 709 between the tether cleats 708, to prevent the tether or suture 710 from being removed or disconnected from the distal tether retaining component 707, by sealing (e.g., welding, gluing, or other means) the opposing upper and lower sides of the distal tether retaining component 707 during manufacturing. According to some embodiments, the tether 710 is intended to be permanently coupled to the distal tether retaining component 707 (i.e., not removable from the distal tether retaining component 707). The number of tether cleats 708 may correspond to the number of holes on the implant 30 (e.g., upper holes in the outer frame 34). In the illustrated embodiment, there are nine tether cleats 708, but other numbers of tether cleats 708 may be used.

[0134] The tether or suture 710 may be a continuous piece of tether or suture that, during assembly in manufacturing, forms a proximal loop and a distal loop offset along its continuous length. The proximal loop is wrapped around the tether cleat 708, and the distal loop is supplied through a small hole on the proximal end of the implant or prosthesis 30 (e.g., an upper hole on the outer frame 34) and then removably coupled to a delivery device 15 (e.g., a proximal tether retaining component 706 of the manifold subassembly 24).

[0135] During assembly, the continuous tether or suture 710 may be joined to the distal tether retaining component 707 according to the following exemplary implementation. One end of the continuous tether or suture 710 may be started distally to the distal tether retaining component 707. With one end remaining there, the tether 710 is then wrapped around the first tether cleat 708, then fed back through an opening or gap 709 on the other side of the first tether cleat 708 to form the first proximal loop, and then returned distally to the distal tether retaining component 707 to begin forming the first distal loop. The process is repeated for each of the tether cleat 708 until all proximal and distal loops are formed, and the second end of the continuous tether 710 is brought close to the first end of the continuous tether 710, and the two ends are tied together and joined to form a single continuous strand. The tether assembly process may be facilitated by an assembly component, which may be positioned distally at an appropriate spacing distance from the distal tether retaining component 707 and may include a peg, around which a portion of the continuous tether 710 may be wrapped to form a distal loop at a uniform distance from the distal tether retaining component 707. The proximal loop may be prevented from being released from the tether cleat 708 by proximal and distal sealing members 711, 713. The continuous tether 710 may include ultra-high molecular weight polyethylene (UMHWPE) force fiber suture, aramid suture, or aramid and UMHWPE blend suture material. In some embodiments, the aramid material may be advantageously bonded to prevent floss and / or fretting breakage due to asymmetric loading of the suture during separation. According to some embodiments, the continuous tether 710 does not extend along the entire length of the delivery device or system (e.g., all the way to the handle) because stretching under load may be significant, and any additional mechanisms to compensate may increase complexity, potentially making it unreliable and / or unuser-friendly.

[0136] Figure 7E shows the flat cut pattern of the proximal tether retaining component 706 of the distal subassembly 703. As shown, the proximal portion of the proximal tether retaining component 706 has a double-spine laser cut pattern. The double-spine laser cut pattern of the proximal tether retaining component 706 may match the double-spine laser cut patterns of the rail subassembly 21 and the release subassembly 23. The distal end portion of the proximal tether retaining component 706 has three circumferentially spaced slots 714 and three openings or windows 715. The slots 714 are configured to be circumferentially aligned with the slot 612 of the distal release tip 605, and the openings or windows 715 are configured to be circumferentially aligned with the window 610 of the distal release tip 605. Other numbers of slots 714 and openings 715 (e.g., two, four, five, six, seven, eight, nine) may also be used in other embodiments. Each opening 715 includes a tab, finger, or peg 716 extending a certain distance within the opening 715 from its distal edge. The length of each tab 716 is sufficient so that one or more distal tether loops can be looped over the top (or proximal end) of each tab 716 and pushed distally to hold one or more distal tether loops. As shown, the three tabs 716 each have different lengths to facilitate the initial tether assembly process. However, in other configurations, the three tabs 716 may have equal or substantially equal lengths. Each tab 716 can receive one or more distal tether loops. In one implementation where nine distal tether loops are present, each tab 716 can hold three distal tether loops. The slots 714 may be equally spaced circumferentially around the longitudinal axis of the proximal tether retaining component 706, and may be sized and spaced to align with the corresponding slots 612 of the release subassembly 23 to receive the respective inwardly projecting retaining members 614.

[0137] Operation of the suture-release mechanism Figures 8A and 8B show the distal end portions of the release and manifold subassemblies in the locked and unlocked configurations, respectively. The locked configuration shown in Figure 8A is the default configuration after assembly. The release and manifold subassemblies are intended to remain in the locked configuration until the clinician determines that the implant 30 is in the final desired implantation site. In the locked configuration, the proximal end of tab 716 is positioned proximal to the proximal edge of the release window 610 so that the distal tether loop wrapped around tab 716 does not detach from tab 716, potentially causing premature release of the tether 710. For simplification and to avoid diagrammatic confusion, only one distal tether loop is shown wrapped around one of the tabs 716, but two, three, or more tether loops may be hooked or wrapped around each of the tabs 716. The spring 608 shown in Figure 6A (which is biased in the compression configuration) keeps the release adapter 604 and the manifold adapter 704 separated and forces the release subassembly 23 distally in the compression configuration so that the release subassembly 23 and the manifold subassembly 24 do not move longitudinally relative to each other, thereby keeping the release subassembly 23 and the manifold subassembly 24 in the locked configuration shown in Figure 8A until the operator is ready to release the suture or tether. As will be discussed in relation to Figures 9A and 9B, the safety member of the handle (e.g., a pin) 927 also prevents the manifold subassembly 24 from moving distally from the locked configuration until ready.

[0138] Once the clinician has confirmed that the implant 30 is in the final desired implantation location and all verification processes have been performed and confirmed, the safety member 927 is removed from the handle and the spring 608 is placed in a more compressed state. As the release knob 925 is rotated distally, the spring 608 is further compressed, pushing the manifold subassembly 24 distally away from the release subassembly 23 into the unlocked configuration shown in Figure 8B. As shown in Figure 8B, the manifold subassembly 24 is pushed sufficiently distally relative to the release subassembly 23 so that at least one proximal end of the tab 716 is within the release window 610, so that the distal tether loop of the tether 710 may detach from the tab 716, especially during continuous distal advancement of the manifold subassembly 24. Figure 8C shows how one of the tether or suture loops transitions from an anchored state to an unanchored or released state when the release and manifold subassembly transition between the locked and unlocked configurations. Furthermore, as shown in Figure 8C, the corresponding slots 612 and 714 are aligned to prevent rotation of the manifold subassembly 24 relative to the release subassembly 23 (by the inwardly protruding retaining member 614), thereby maintaining the alignment of the tab 716 within the window 610 of the release subassembly 23. Figure 8D shows the implant 30 fully anchored between a hole on the proximal end of the implant (e.g., the upper hole in the outer frame 34 of the valve prosthesis 30) and the manifold subassembly 24 of the delivery device 15. As shown, there are portions connected to nine tether loops or nine holes, although the number may vary as desired and / or as needed.The suture or tether retention mechanism described in relation to Figures 8A to 8D is advantageous in that the tether or suture 710 does not need to extend through and along the longer portion of the delivery device 15 (e.g., to the proximal handle 14), thereby advantageously preventing or reducing the possibility of the suture or tether portion getting caught or snagged on intervening components within the delivery device, preventing or reducing the possibility of the suture or tether portion becoming entangled due to the reduced length, reducing the complexity of the actions required for the operator to release the tether, simplifying assembly and manufacturing, and / or reducing the amount of suture or tether material required. Instead, the suture or tether portion is advantageously attached only to the distal end portion of the delivery device.

[0139] handle Figure 9A shows a perspective view of the handle 14 of the delivery device 15. Figure 9B shows a side cross-sectional view of the handle 14. The handle 14 includes several actuators, such as a rotatable knob, which can operate on different components of the delivery system 10 (e.g., causing movement of each subassembly of the shaft assembly 12). The distal end of the handle 14 includes a capsule knob 905. One-way rotation of the capsule knob 905 causes axial proximal movement of the outer sheath subassembly 20 to detach the distal portion (e.g., the ventricular portion) of the implant 30 from the capsule subassembly 306 from the sheath and deploy it. The opposite-way rotation of the capsule knob 905 causes distal movement of the outer sheath subassembly 20 (including the capsule subassembly 306) to recapture, retrieve, or reinsert the implant 30 from the capsule subassembly 306 into the sheath. The outer sheath subassembly 20 can be individually translated relative to other subassemblies in the delivery device 15. Referring again to Figure 5C, the distal end of the implant 30 may be released first, while the proximal end of the implant 30 (e.g., the nearest bore 35 but not the proximal circumferential shoulder of the outer frame) may remain radially compressed within the pusher 506 of the intermediate shaft subassembly 22. Since the capsule assembly 306 is very robust and provides both tensile and compressive strength, only the nearest portion of the implant 30 (e.g., bore 35) needs to be held by the pusher 506, and the length of the pusher 506 may be relatively short. The tether 710, as well as the release subassembly 23 and the manifold subassembly 24, also remain within the intermediate shaft subassembly 22 until the release knob 925 is rotated.

[0140] Moving proximal, the handle 14 includes a stabilizer mounting area 910 adapted to interface with a clamp of a stabilizer assembly 1100 configured to control the inner / outer position of the delivery device 15. Further proximal, there are primary curvature rail knobs 915A and secondary curvature rail knobs 915B. Rotation of the primary curvature rail knob 915A causes curvature of the primary curvature portion, or the distal slotted hypotube section 406D of the rail hypotube 406, resulting in a change in the inner / outer trajectory. Rotation of the secondary curvature rail knob 915B causes curvature of the primary curvature portion, or the proximal slotted hypotube section 406P of the rail hypotube 406, resulting in a change in the forward / backward trajectory. However, the number of curvature rail knobs 915 may vary depending on the number of pull wires used.

[0141] In some embodiments, proximal to the secondary curved rail knob 915B is a depth knob 920 that controls the simultaneous distal or proximal movement of the outer assembly 20, intermediate shaft subassembly 22, release subassembly 23, manifold subassembly 24, and nose cone subassembly (thereby moving the delivery device 15 to the ventricle or atrium for mitral or tricuspid valve implantation). The depth knob 920 can move the subassemblies together with the rail subassembly 21. Further proximal is a release knob 925 (sometimes called a manifold knob because the release knob 925 controls the simultaneous longitudinal movement of both the release subassembly 23 and the manifold subassembly 24 until the release subassembly 23 encounters a rigid stop member within the handle 14, after which only the manifold subassembly 24 continues to move longitudinally distal to the release subassembly 23). The release knob 925 may be rotated proximal to apply tension to the manifold subassembly 24 during loading, recapture, or retrieval of the implant 30. The release knob 925 may be rotated distally to position the proximal portion (e.g., the atrial portion) of the implant 30 after the capsule subassembly 306 has been retracted and the distal portion (e.g., the ventricular portion) of the implant 30 has been positioned. Distal movement of the release knob 925 releases tension from the manifold subassembly 24. As discussed above, the safety stop member 927 prevents the release knob 925 from moving distally enough to allow the release of the implant 30 until the safety stop member 927 is removed from the handle 14.When the safety stop member 927 is removed, the continued distal movement of the release knob 925 causes the manifold subassembly 24 to move distally relative to the release subassembly 23 (after the release subassembly 23 has come into contact with a mechanical stop member in the handle 14 that prevents further distal movement of the release subassembly 23), facilitating the release of the tether 710 from the manifold subassembly 24 (for example, the distal tether loop can be pushed out from the tab 716 of the proximal tether retaining member 706 of the manifold subassembly 24 by the window 610 of the release subassembly 23). The nearest knob is the nose cone knob 930, whose rotation causes proximal and distal movement of the nose cone subassembly.

[0142] Nose cone subassembly The nose cone subassembly is the most radially inwardly oriented subassembly and may include a nose cone shaft having a distal end connected to the nose cone 87 (labeled in Figure 14C). For example, the knob 930 may be part of the nose cone subassembly extending from the proximal end of the handle 14. Thus, the user can rotate the knob 930 to independently translate the nose cone shaft distally or proximal relative to the other shaft. This is advantageous for translating the nose cone 87 proximal into the outer sheath assembly 20 / capsule subassembly 306, and thus facilitates the removal of the delivery device 15 from the patient. The nose cone 87 may have a tapered tip. The nose cone 87 may be made of thermoplastic or elastomer (e.g., PEBAX or polyurethane) to ensure non-traumatic entry and minimize damage to venous and vascular structures. The nose cone 87 may also be radiopaque to provide visibility under fluoroscopy. The nose cone assembly is preferably located within the lumen of the manifold subassembly 24. The nose cone assembly may include a lumen through which the guide wire passes. Additional structural and operational details of the handle and nose cone assembly, such as those described with respect to the handle and nose cone assembly in Patent Documents 15 and 16 incorporated herein by reference, are incorporated herein by reference to the handle 14 and nose cone subassembly.

[0143] Introducer Assembly Figure 10 shows the components of the introducer assembly 1000 of the delivery system 10. The introducer assembly 1000 includes an introducer sheath 1005, a dilator 1010, an introducer 1012, and a loader 1015. The dilator 1010 helps to expand the vascular structure for insertion of the delivery device 15 and / or the introducer sheath 1005. The dilator 1010 may be removed and replaced with an additional dilator (e.g., a dilator of a different diameter) if desired and / or required. After the dilator 1010 is removed, the introducer 1012 (which may be inserted into the introducer sheath 1005 and advanced along the introducer sheath 1005, so that the tapered distal end of the introducer 1012 extends beyond the open distal end of the introducer sheath 1005) and the introducer sheath 1005 are advanced together through the incision into the dilated vascular structure. In the transfemoral artery delivery approach, the vascular structure is the femoral vein in the leg of the subject. The introducer sheath 1005 may include lateral portions for facilitating heparinized saline or other flushing fluid. The introducer sheath 1005 may be configured to remain stationary relative to the leg of the subject. The loader 1015 is adapted to be inserted into the proximal end of the introducer sheath 1005 to open an invasive one-way valve within the introducer sheath 1005 before insertion of the delivery device 15, thereby facilitating the insertion of the delivery device 15 through the introducer sheath 1005. The loader 1015 can also advantageously reduce friction between the delivery device 15 and the introducer sheath 1005 while the delivery device 15 is being inserted and while the delivery device 15 is being manipulated during the implantation procedure. In some implementations, the introducer 1012 and introducer sheath 1005 may not be used, and the delivery device 15 may be inserted directly into the expanded vascular structure.

[0144] Stabilizer assembly Figure 11 shows how the handle 14 of the delivery device 15 interfaces with one embodiment of the stabilizer assembly 1100 of the delivery system 10. Figure 11A shows a perspective view of the stabilizer assembly 1100 without the delivery device 15 attached. Figure 11B is a top view of the stabilizer assembly 1100 of Figure 11A. The stabilizer assembly 1100 includes a clamp 1105, a guide assembly 1110, a rail 1115, and a base 1120. The clamp 1105 is configured to connect to the stabilizer mounting area 910 of the handle 14 of the delivery device 15. The guide assembly 1110 is configured to cause a change in the inner / outer position of the delivery device 15 by moving along the rail 1115. The rail 1115 can be mounted on and fixed to the base 1120. Further details regarding the stabilizer assembly 1100 can be found in Patent Document 17, published on January 10, 2020, the entire contents of which are incorporated herein by reference.

[0145] Delivery method Figure 12 shows a schematic diagram of a transseptal delivery approach. As shown in Figure 12, in one embodiment, the delivery system 10 may be placed in the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. Transseptal puncture may then be performed using known techniques to gain access to the left atrium 1078. The delivery system 10 may then be advanced toward the left atrium 1078 and then toward the left ventricle 1080. Figure 12 shows the delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In embodiments of this disclosure, a guidewire is not required to position the delivery system 10 in the appropriate location, but in other embodiments, one or more guidewires may be used.

[0146] Therefore, the ability to maneuver the delivery system 10 through complex areas of the heart to position the replacement mitral valve in a position matching the natural mitral valve may be advantageous to the user. This operation can be performed with or without the use of a guidewire having the system disclosed above. The distal end of the delivery system 10 can be advanced into the left atrium 1078. The user can then manipulate the rail subassembly 21 to direct the distal end of the delivery system 10 to the appropriate area. The user can then continue to guide the bent delivery system 10 into the left atrium 1078 through a transseptal puncture. The user can then further manipulate the delivery system 10 to create a larger bend within the rail subassembly 21. Furthermore, the user can apply torque to the entire delivery system 10 to further manipulate and control its position. In a fully bent configuration, the user can position the replacement valve in the appropriate location. This may advantageously enable delivery of the replacement valve to an in situ implantation site, such as the natural mitral valve, via a broader approach, such as a transseptal approach.

[0147] Figure 13 shows a schematic diagram of a portion of one embodiment of a replacement heart valve (implant 30) positioned within the natural mitral valve of heart 83. Further details on how the implant 30 may be positioned within the natural mitral valve are described in Patent Document 13, published November 19, 2005, which includes, but is not limited to, Figures 13A to 15 and paragraphs

[0036] to

[0045] , and is incorporated herein by reference in its entirety. A portion of the natural mitral valve is schematically illustrated, representing a typical anatomical structure including the left atrium 1078 located above the annulus 1106 and the left ventricle 1080 located below the annulus 1106. The left atrium 1078 and the left ventricle 1080 communicate with each other through the annulus 1106. Furthermore, the natural mitral leaflet 1108 is schematically shown in Figure 13, and the natural mitral leaflet 1108 has chordae tendineae 1111 that connect the downstream end of the mitral leaflet 1108 to the papillary muscle of the left ventricle 1080. It can be mentioned that a portion of the implant 30, positioned upstream of the annulus 1106 (towards the left atrium 1078), is positioned above the annulus. Generally, portions within the annulus 1106 are mentioned as being positioned within the annulus. The downstream portion of the annulus 1106 is mentioned as being positioned directly below the annulus (towards the left ventricle 1080).

[0148] As shown in Figure 13, the implant 30 may be positioned such that the end or tip of the distal anchor 37 is on the ventricular side of the mitral annulus 1106. The distal anchor 37 may be positioned such that the end or tip of the distal anchor 37 is on the ventricular side of the natural leaflet beyond where the chordae tendineae 1111 connect to the free end of the natural leaflet. The distal anchor 37 may extend between at least a portion of the chordae tendineae 1111 and, in some circumstances, may contact or engage with the ventricular side of the annulus 1106. Also, in some circumstances, the distal anchor 37 may not contact the annulus 1106, but may still contact the natural leaflet 1108. In some circumstances, the distal anchor 37 may extend beyond the ventricular side of the annulus 1106 and / or leaflet 1108 and contact the tissue of the left ventricle 1080.

[0149] Figures 14A–14E illustrate the operation of the delivery device 15 by showing various deployment and implantation steps of an implant (e.g., a replacement heart valve) 30 using the delivery device 15 described herein. Figures 14A–14E show the positioning of various subassemblies of the delivery device 15 relative to each other and relative to the implant 30 at various steps of the procedure. The subassemblies are shown in side section views to facilitate visualization of the various subassemblies. For simplification and illustrative purposes, various parts of the implant 30 (e.g., the skirt assembly 38 and the padding 39) are not shown. Figure 14A shows the delivery device 15 in an implantation procedure, with the replacement heart valve 30 fully held in a compressed configuration within the capsule subassembly 306 of the outer subassembly 20. As shown, the nearest portion of the replacement heart valve 30 (e.g., the bore portion) is held within the pusher 506 of the intermediate shaft subassembly 22, and the rest of the replacement heart valve 30 is compressed by the capsule subassembly 306. Referring to Figure 14B, the capsule subassembly 306 is retracted proximal (for example, by rotating the capsule knob 905 on the handle 14 toward the proximal handle 14 of the delivery device 15) to a position where the replacement heart valve 30 is no longer constrained by the capsule subassembly 306 and the replacement heart valve 30 can partially self-expand. The most proximal portion of the replacement heart valve 30 (for example, the bore portion) remains constrained in a compressed configuration by the pusher 506 of the intermediate shaft subassembly 22 so that the entire replacement heart valve 30 is not yet fully deployed.

[0150] As can be understood, the deployment of the distal and intermediate portions of the replacement heart valve 30 may occur gradually over time and may not be immediate and complete. For example, the distal anchor 37 of the inner frame 32 of a double-frame structure may be deployed first before the deployment of the outer frame 34, for example, as shown in Figure 5C (while the intermediate portions of the outer frame 34 and inner frame 32 remain bound within the capsule subassembly 306). The distal anchor 37 of the inner frame 32 may be positioned through the chordae tendineae and / or directly beneath the annulus of the natural heart valve (e.g., the mitral valve) to capture the natural leaflets of the heart valve between the distal anchor 37 and the body of the outer frame so as to keep the natural leaflets in an open configuration and anchor the entire replacement heart valve 30. Such configurations and positions are shown in Figure 14J.

[0151] Referring to Figure 14C, the manifold subassembly 24 and the release subassembly 23 are advanced distally by the rotation of the release knob 925 (as previously described herein), while the intermediate shaft subassembly 22 remains fixed so that the nearest portion of the replacement heart valve 30 (e.g., the bore portion) is advanced distally from the pusher 506 of the intermediate shaft subassembly 22, thereby deploying the replacement heart valve 30 into a fully extended configuration. However, since the manifold subassembly 24 and the release subassembly 23 are in a “locked” configuration as previously described herein in relation to Figures 8A–8D, the replacement heart valve 30 remains anchored to the manifold subassembly 24 by the tether 710.

[0152] Referring to Figure 14D, the manifold subassembly 24 is moved distally relative to the release subassembly 23 (to transition the release subassembly 23 and the manifold subassembly 24 to the unlocked configuration described in relation to Figures 8A-8D), and the suture loop end of the tether 710, which was previously coupled to the tab 716 of the manifold subassembly 24, is detached or released. Referring to Figure 14E, the manifold subassembly 24 and the release subassembly 23 are moved proximal together until the free suture loop end of the tether 710 is pulled out from the proximal borehole 35 of the replacement heart valve 30, and then the delivery device 15 is removed from the implantation site, thereby leaving the replacement heart valve 30 in its final implantation site. Before the delivery device 15 is removed, the manifold subassembly 24 and the release subassembly 23 may be retracted into the outer sheath subassembly 20, or the outer sheath subassembly 20 may be advanced to cover the distal ends of the manifold subassembly 24 and the release subassembly 23. However, the distal ends of the manifold subassembly 24 and the release subassembly 23 may instead remain distal (outside) of the outer sheath subassembly 20 when the delivery device 15 is removed.

[0153] Figures 14F–4K illustrate the various steps of implant (e.g., replacement heart valve) 30 deployment and recapture using the delivery device 15 described herein. For simplification and illustrative purposes, only the inner frame 32 and outer frame 34 of the implant 30 are illustrated (e.g., the skirt assembly 38 and padding 39 shown in Figure 2C are not illustrated). The capsule subassembly 306 favorably facilitates recapture of the implant 30 after initial deployment. Figure 14F shows the initial deployment of the implant 30 from the delivery device 15. For example, initial deployment may be performed within the mitral annulus after a transfemoral and / or transseptal approach. Note that the implant 30 is anchored to the delivery device 15 when the implant 30 is initially fully deployed and in a fully expanded configuration. In some cases, clinicians may determine that the initial deployment site is not ideal after performing various examinations (e.g., using various imaging modalities and measurements). For example, the ideal position may be higher (e.g., towards the atrium) or lower (e.g., towards the ventricle) than the initial deployment site. To prevent damage to the implant 30 and the heart, the implant 30 may be recaptured before moving the implant 30 to a new implantation site. Recapture of the implant 30 may be performed by advancing the capsule subassembly 306 of the outer sheath subassembly 20 distally over the implant 30, thereby transitioning the implant 30 into a compressed configuration. Figures 14G and 14H illustrate the various stages of recapture of the implant 30. As shown in Figure 14G, the capsule subassembly 306 is advanced distally (e.g., by rotating the capsule knob 905 in a first direction) to capture the proximal portion of the implant 30. Figure 14H shows the complete recapture of the implant 30, where the capsule subassembly 306 has been fully advanced distally (e.g., until it contacts the nose cone 87 of the nose cone subassembly, or until the implant 30 is fully held within the capsule subassembly 306). The configuration in Figure 14H corresponds to the configuration in Figure 14F, but it is located within the heart.

[0154] After moving the distal end of the delivery device 15 to a new location, the capsule subassembly 306 of the outer sheath subassembly 20 is retracted again in the proximal direction (for example, by rotating the capsule knob 905 from the first direction to the opposite second direction), as shown in Figure 14I, so that the distal portion of the implant 30 can be detached from the sheath (for example, at the new implantation site in the mitral or tricuspid annulus). Next, the manifold and release subassemblies 23, 24 are advanced together distally (for example, by rotating the release knob 925), as shown in Figure 14J, to position the nearest portion of the implant 30 (for example, the proximal bore, post, or strut) from the pusher 506 of the intermediate shaft subassembly 22. After confirming that the fully deployed implant 30 is in the ideal and appropriate final implantation site, the tether 710 (e.g., the tether loop end) can be released from the manifold subassembly 24 by the continuous rotation of the release knob 925 (as shown in Figure 14K), as a result the release knob 925 translates further distally until the release subassembly 23 encounters a physical stopping member within the handle 14, and the manifold subassembly 24 continues to translate distally relative to the release subassembly 24. The delivery device 15 can be retracted and removed from the heart, then removed from the vascular structure, and then completely removed from the object.

[0155] Skirt assembly and method of manufacturing or assembling it Figures 15A and 15B show different diagrams of the configuration of a fully assembled implant (e.g., a valve prosthesis) 1230, including a skirt assembly 1238 (shown in Figures 17A-17D) positioned between frames 1232, 1234 (shown in Figures 16A and 16B) and padding 1239 surrounding anchor 1237. Implant 1230 is similar in configuration to implant 30, illustrated and described in relation thereto in Figures 2-2K-2. Reference numbers of the same or substantially the same features may share the same last two digits.

[0156] Figure 15C shows artificial valve leaflets stitched to the inner frame 32 of a double-frame valve prosthesis (e.g., implants 30, 1230). The inner frame 32 of the double-frame valve prosthesis may include an artificial valve assembly comprising a plurality of flexible valve leaflets 1108A arranged to fold in a three-leaflet configuration, and a reinforcing strip 1108B, the reinforcing strip 1108B which secures the plurality of artificial valve leaflets 1108A to the inner frame 32 and secures the pointed edge portion 1108C of each artificial valve leaflet 1108A to the first end of the reinforcing strip 1108B. The double-frame valve prosthesis (e.g., implant 1230) may be implanted to replace any heart valve (e.g., mitral valve, tricuspid valve, aortic valve, pulmonary valve), and the inner frame 32 of the double-frame valve prosthesis may be configured to have an “hourglass” profile or shape when in an expanded configuration, as described elsewhere in this specification. While the stitching of prosthetic valve leaflets and the implementation of valve assemblies are generally described herein with reference to double-frame valve prostheses, these methods may also be used for the assembly / manufacturing of single-frame implants or implants with more than two frames (e.g., three or more frames). For example, aortic and pulmonary artery prosthetic valve implants may incorporate a single frame (e.g., a single-frame valve with an hourglass profile) instead of a double frame.

[0157] Figures 15D-1 to 15D-5 show double stitching applied to an artificial valve leaflet to securely attach it to the inner frame of a double-frame valve prosthesis, but the double stitching line 1108D can be incorporated into stitching for any artificial valve (e.g., single frame or three or more frames), not just a double-frame valve prosthesis. The double stitching line 1108D can be seen in Figures 15D-1 to 15D-3 by following or connecting two separate rows of dots in the figures. A method for attaching an artificial valve leaflet 1108A to other components of a double-frame valve prosthesis (e.g., a skirt assembly and / or a portion or component of the frame assembly) includes the step of folding over a portion of the artificial valve leaflet edge or fabric skirt edge to cover exposed suture portions and prevent direct contact between the suture portions or potentially abrasive skirt edges and the artificial valve leaflet (e.g., the abdominal portion of the artificial valve leaflet). A skirt assembly (e.g., skirt assemblies 1238, 1248) may include multiple skirt portions. For example, the skirt assembly may include a first portion comprising a double stitch line having pre-drilled laser holes configured to align with the holes in the double stitch line of the artificial valve leaflet. In other implementations, there are no pre-drilled laser holes, and the stitching is sewn at the discretion of the fabric or tissue without pre-formed (e.g., laser-drilled) holes. The first portion may include a reinforcing fabric skirt strip 1248A adapted to facilitate attachment of the skirt assembly to the artificial valve leaflet. The skirt assembly may also include a main portion 1248B adapted to facilitate attachment to the frame structure.In some implementations, the first portion of the skirt assembly (e.g., reinforcement fabric skirt strip 1248A) sutured to the prosthetic leaflet 1108A can be folded over itself (either outwardly or inwardly) to cover the first line of exposed suture 1109A, thereby preventing contact of the leaflet 1108A with the potentially abrasive skirt edge formed by the cut of the reinforcement fabric skirt strip 1248A and also preventing any portion of the sutures 1109A, 1109B from contacting the leaflet 1108A, which may cause wear over time. FIGS. 15D-4 and 15D-5 show examples of different portions of the reinforcement fabric skirt strip 1248A of the skirt assembly folded over itself to prevent exposure or contact of the suture 1109 with the leaflet 1108A.

[0158] For example, a method of assembling the prosthetic leaflet 1108A into a dual-frame valve structure includes securing at least one component or portion of a skirt assembly (e.g., skirt assembly 1238) to the inner frame via the first line of suture 1109A using a reinforcement strip (e.g., reinforcement strip 1248A), securing the prosthetic leaflet 1108A to the reinforcement strip 1248A via the primary suture or the first line of suture 1109A, folding the reinforcement strip 1248A over the first line of suture 1109A to cover the first line of suture 1109A, and then suturing the folded portion of the reinforcement strip 1248A of the skirt assembly with a second line of suture (e.g., secondary suture) 1109B, wherein the second line of suture 1109B is parallel and spaced from the first line of suture 1109A and does not contact any portion of the prosthetic leaflet 1108A. The primary suture 1109A and the secondary suture 1109B create two or more stitch lines 1108D (e.g., double stitch line or two stitch lines). Also, the assembly method can be applied to a single-frame valve structure in addition to the dual-frame valve structure.

[0159] Referring to FIGS. 15E-1 to 15E-4, an alternative or additional method of assembling the valve tip 1108A into a double-frame valve structure (e.g., implants 30, 1230) includes folding the tip edge portion or tab 1108C of the valve tip 1108A inwardly and applying a suture 1109 to secure the folded tip edge portion or tab 1108C to the reinforcement cloth strip 1237A of the skirt assembly. In this implementation, neither the suture 1109 nor the skirt assembly (e.g., the reinforcement cloth strip 1237A) contacts the belly portion of the valve tip 1108A. Also, this method of assembly can be similarly applied to a single-frame valve structure.

[0160] In some implementations, the double stitch line 1108D may include a second stitch line at the tip edge portion 1108C of each artificial valve tip 1108A, and the second stitch line is attached to other components of the double-frame valve prosthesis to increase the holding strength of the stitch line and more evenly distribute the stress throughout the opening and closing of the valve while minimizing excess bulk. The folded tip edge portion or tab 1108C positioned between the cloth of the skirt assembly and the exposed suture portion advantageously acts as a barrier to prevent wear of the valve tip when the artificial valve opens and closes over time. The valve tip 1108 can be formed of bovine or porcine pericardial tissue (e.g., RESILIA® bovine pericardial tissue). RESILIA bovine pericardial tissue can advantageously resist calcification.

[0161] FIG. 16A shows the configuration of an inner frame 1232 coupled to an artificial valve assembly 1231 having a plurality of artificial valve tips (not shown). FIG. 16B shows the configuration of an outer frame 1234. The inner frame 1232 may be similar to the configuration of the inner frame 32, and the outer frame 1234 may be similar to the configuration of the outer frame 34 illustrated and described in relation to FIGS. 2 to 2K-2. Reference numerals for the same or substantially the same features may share the same last two digits.

[0162] Figures 17A to 17D show the configuration of the skirt assembly 1238. The skirt assembly 1238 may include fabric material. For example, the skirt assembly 1238 may include a single piece of fabric or multiple pieces of fabric joined together. The skirt assembly 1238 may include a proximal or inlet portion 1238A, an intermediate or middle portion 1238B, and a distal or outlet portion 1238C.

[0163] As shown in Figure 17B, the skirt assembly 1238 may include various diameters. For example, the skirt assembly 1238 may include multiple diameters D1, D2, D3, D4, D5, D6, and D7. In some configurations, the third diameter D3 may be the largest diameter. In some configurations, the seventh diameter D7 may be the smallest diameter. The first, second, fourth, fifth, and sixth diameters D2, D3, D4, D5, and D6 may be between the third diameter D3 and the seventh diameter D7. The multiple diameters D1, D2, D3, D4, D5, D6, and D7 may be the same diameter, or each of the diameters may be different. According to some implementations, the technique of the skirt assembly 1238 described herein advantageously facilitates transitions between various diameters within a single piece of fabric without cutting the fabric into multiple components. Advantageously, by having the skirt assembly 1238 as an integrated component with various diameters D1, D2, D3, D4, D5, D6, and D7, the amount of fabric used can be reduced, and the thickness of the skirt assembly 1238 can be reduced. By reducing the thickness of the skirt assembly 1238, the loading and retrieval forces exerted on the implant 1230 during delivery and retrieval can be reduced.

[0164] As shown in the illustrated configuration, the skirt assembly 1238 may include a plurality of portions or extensions 1240A, 1240C to vary the diameter of the skirt assembly 1238. For example, the intermediate portion 1238B may include the main body portion 1240B, the inlet portion 1238A may include a plurality of proximal portions or extensions 1240A extending from the main body portion 1240B, and the outlet portion 1238C may include a plurality of distal portions or extensions 1240C extending from the main body portion 1240B. The proximal extensions 1240A may be configured to be positioned between the inner frame 1232 and the outer frame 1234. For example, the outer frame 1234 may include a plurality of openings 1234D (as shown in Figure 16B), and the proximal extension 1240A may be received by the plurality of openings 1234D so that the proximal extension 1240A can be positioned between the inner frame 1232 and the outer frame 1234. The main body portion 1240B may be configured to be positioned outside the outer frame 1234 when the implant 1230 is assembled. The distal extension 1240C may be configured to be positioned between the inner frame 1232 and the outer frame 1234 on the inflow side of the implant 1230. For example, the distal extension 1240C may be inserted through a distal space relative to the distal edge of the outer frame 1234 so that the distal extension 1240C can be positioned between the inner frame 1232 and the outer frame 1234 on the outflow side of the implant 1230.

[0165] In the illustrated configuration, the skirt assembly 1238 has a plurality of trapezoidal portions 1240A, 1240C. In other configurations, the skirt assembly 1238 may include portions 1240A, 1240C having a square, triangular, circular, or any other preferred shape. The plurality of proximal extensions 1240A may include 18 proximal extensions 1240A. In other configurations, the plurality of proximal extensions 1240A may include any number of proximal extensions (e.g., fewer than 18 or 19 or more proximal extensions). The plurality of distal extensions 1240C may include 9 distal extensions. In other configurations, the plurality of distal extensions 1240C may include any number of distal extensions (e.g., fewer than 9 or 10 or more distal extensions).

[0166] As shown in Figure 17C, the skirt assembly 1238 may include a plurality of features 1242A, 1242B, 1242C, 1242D, 1242E, 1242F, 1242G, and 1242H configured to assist in the assembly of the skirt assembly 1238 and the implant 1230. For example, the plurality of features may include a plurality of tabs 1242A extending from one or more of the proximal extensions 1240A. The tabs 1242A may be configured to be positioned between the holes 1235 of the inner frame 1232 and the outer frame 1234. Advantageously, the tabs 1242A can prevent corrosion of the holes 1235. In the illustrated configuration, the plurality of tabs 1242A may include nine tabs 1242A on alternating proximal extensions 1240A. In some configurations, multiple tabs 1242A may be located on each of the proximal extensions 1240A, or on less than half of the proximal extension 1240A.

[0167] In some configurations, multiple features may include keying features 1242B. Keying features 1242B may be positioned on one or more sides of the proximal extensions 1240A. Keying features 1242B can indicate which side of the proximal extensions 1240A should be positioned on the top of adjacent proximal extensions 1240A when the skirt assembly 1238 is folded and sewn into the folded configuration, as further described below with reference to Figure 17D.

[0168] In some configurations, multiple features may include multiple holes 1242C within the distal extension 1240C. For example, each distal extension 1240C may include one or more holes 1242C. In the illustrated configuration, each distal extension 1240C has a single hole 1242C. Multiple holes 1242C may allow blood to flow within the enclosed volume of the implant 1230 (e.g., the volume between the inner frame 1232 and the artificial valve assembly 1231, and the outer frame 1234 and the skirt assembly 1238). Multiple holes 1242C may be sized to allow blood to flow into the implant 1230 through the holes 1242C, but to prevent or limit blood from flowing out of the implant 1230. Hole 1242C can be positioned between anchors 1237 of the inner frame 1232 (shown in Figure 16A) when the implant 1230 is assembled, so that anchors 1237 do not restrict blood flow through hole 1242C. Furthermore, hole 1242C can assist manufacturers in properly attaching the skirt assembly 1238 to the inner and outer frames 1232, 1234 by ensuring that hole 1242C is positioned between anchors 1237.

[0169] In some configurations, multiple features may include at least one tapered section 1242D. At least one tapered section 1242D may be positioned outside the outer frame 1234. In some configurations, at least one tapered section 1242D may include two tapered sections 1242D that can be sutured together when the implant 1230 is assembled.

[0170] In some configurations, the features may include a first alignment feature 1242E and a second alignment feature 1242F. The first alignment feature 1242E may be positioned on at least one side of at least one distal extension 1240C and / or adjacent to a hole 1242C. In the illustrated configuration, each distal extension 1240C includes a pair of first alignment features 1242E positioned on both sides of the hole 1242C. The first alignment features 1242E may be configured to align with the distal portion of the anchor 1237 to ensure proper placement of the skirt assembly 1238 relative to the inner and outer frames 1232, 1234. One alignment feature 1242E may include a plurality of holes, a plurality of dots, and / or other visual or tactile indicators.

[0171] The second alignment feature 1242F may be positioned on at least one distal extension 1240C. In the illustrated configuration, each distal extension 1240C includes the second alignment feature 1242F along the edge of the distal extension 1240C. The second alignment feature 1242F may be configured to align with the inner skirt of the prosthetic valve assembly 1231 to ensure proper placement of the skirt assembly 1238 on the inner and outer frames 1232, 1234. The second alignment feature 1242F may include a plurality of holes, a plurality of dots, and / or other visual or tactile indicators.

[0172] Figure 17D shows a skirt assembly 1238 in a folded configuration, having a distal extension 1240C and a tapered section 1242D that are sewn together. When the skirt assembly 1238 is folded, adjacent proximal extensions 1240A can overlap, and / or adjacent distal extensions 1240C can overlap so that adjacent proximal extensions 1240A and / or adjacent distal extensions 1240C can be sewn together.

[0173] In some embodiments, the fabric material of the skirt assembly may be treated to soften edges that may be roughened when laser cutting is applied. Figures 17E-1 and 17E-2 show the softened edges of the fabric material used in the skirt assemblies of Figures 17A to 17D. The roughened edges can be softened by applying a soldering iron with heat within a threshold temperature to the edge of a single piece of fabric material. For example, the soldering iron can be applied to melt the fabric fibers into a single smooth molten edge 1238D. Alternatively, the z-axis feature of the laser can be applied to blur the laser focus to create a thicker area of ​​molten fabric that is smooth along the edge.

[0174] Figure 17F illustrates the process of applying an interlock stitch to the fabric material used in the skirt assembly in Figures 17A–17D to eliminate knots. In current methods, transcatheter cardiac valves are generally hand-stitched using sutures, and therefore typically have knots that act as speed bumps for the delivery system to cross when the valve is crimped. In some implementations, an interlock stitching technique may be applied to eliminate knots. The interlock stitch may utilize the fabric structure of the suture itself, puncturing and interlocking within the strands of the suture itself, thereby securing the suture without creating bulky knots. In some implementations, referring to Figure 17F, the needle tip may be punctured into the center of the fabric structure of the suture to form an interlock structure, thereby creating a secure start or end point for the suture. The interlock method may include the steps of (1) sewing through the force fiber with a needle, (2) pulling the suture taut, (3) sewing through the force fiber with a needle to create an interlock stitch on the opposite side, and finally pulling the suture taut again (4) to complete the interlock stitch.

[0175] Configuration of the additional tether retention assembly Figures 18A to 18F show the configuration of the distal subassembly 1303. The distal subassembly 1303 may be similar in configuration to the distal subassembly 703 illustrated in Figures 7A to 7E and described in relation thereto. Reference numbers of the same or substantially the same features may share the same last two digits.

[0176] As shown in Figures 18A to 18C, the distal tether retaining component 1307 may be configured to hold a tether or suture 710. The tether or suture 710 may include a plurality of distal loops 1320. The distal tether retaining component 1307 may be spaced apart from the proximal tether retaining component 1306. For example, the distal subassembly 1303 may include an intermediate component 1312 between the proximal tether retaining component 1306 and the distal tether retaining component 1307. In some configurations, the intermediate component 1312 may include a tube. The intermediate component 1312 may be made of a metallic material such as stainless steel. In some configurations, the proximal tether retaining component 1306 may have a larger diameter than the intermediate component 1312 and / or the manifold cable 705. In some configurations, the distal tether retaining component 1307 may have a larger diameter than the intermediate component 1312 and / or the manifold cable 705.

[0177] As shown in Figure 18A, the distal tether retaining component 1307 may include a plurality of slots 1318 along a portion of the distal tether retaining component 1307 that extends radially beyond the intermediate component 1312 and / or the manifold cable 705. The plurality of slots 1318 may include a length that extends along the longitudinal axis of the distal subassembly 1303. The illustrated configuration has nine slots 1318 within the distal tether retaining component 1307. Other numbers of slots 1318 (e.g., two, four, five, six, seven, eight) may also be used in other configurations. The slots 1318 may be configured to receive a portion of the tether or suture 710 and to prevent the tether or suture 710 from being removed from or disconnected from the distal tether retaining component 1307.

[0178] As shown in Figures 18B and 18C, the proximal tether retaining component 1306 may include a number of slots 1314 along a portion of the proximal tether retaining component 1306 that extends radially beyond the intermediate component 1312 and / or the manifold cable 705. The number of slots 1314 may include a length extending along the longitudinal axis of the distal subassembly 1303. The number of slots 1314 in the proximal tether retaining component 1306 may correspond to the number of slots 1318 in the distal tether retaining component 1307. The illustrated configuration has nine slots 1314 within the proximal tether retaining component 1306. Other numbers of slots 1314 (e.g., two, four, five, six, seven, eight) may also be used in other configurations. In some configurations, one or more of the slots 1314 may be configured to receive the distal loop 1320 of the tether or suture 710. In other configurations, one or more of the slots 1314 may consist of two or more distal loops 1320 of a tether or suture 710. In some configurations, the slot 1314 of the proximal tether retaining component 1306 may be aligned with the slot 1318 of the distal tether retaining component 1307. In other configurations, the slot 1314 of the proximal tether retaining component 1306 may be offset from the slot 1318 of the distal tether retaining component 1307.

[0179] Figure 18D shows a tether or suture 710 fixed to the distal subassembly 1303. As previously mentioned, slot 1314 can receive the distal loop 1320 of the tether or suture 710. A release (or lock) tether / suture 1322 may extend through the distal loop 1320, thus preventing the implants 30, 1230 from being released from the distal subassembly 1303 until ready. For example, the free end 1324 of the release tether / suture 1322 may be inserted through the distal loop of the tether or suture 710 to fix the tether or suture 710 to the implants 30, 1230.

[0180] Figures 18E and 18F show a tether or suture 710 removed from the distal subassembly 1303. The release tether / suture 1322 can be withdrawn such that the free end 1324 of the release tether / suture 1322 passes through the distal loop 1320, and thus the implants 30, 1230 are released from their tethered attachment to the distal subassembly 1303. In some embodiments, multiple release (or lock) tether / sutures 1322 can be used (e.g., one for each distal loop 1320, or one for multiple distal loops 1320).

[0181] Figures 19A and 19B show another configuration of the proximal tether holding component 1406 and the intermediate component 1412, similar to the embodiments of the proximal tether holding components 706, 1306 and the intermediate component 1312 illustrated and described in relation to Figures 7A - 7E and 18A - 18F. Reference numerals for the same or substantially the same features may share the same last two digits.

[0182] The plurality of slots 1414 of the proximal tether holding component 1406 can include three slots 1414. Each of the slots 1414 can be configured to receive one or more distal loops 1320 of a tether or suture 710 (not shown). In some configurations, as shown in Figure 19A, the shaft extending between the intermediate component 1412 and the manifold cable 705 can include a plurality of apertures 1426. The apertures 1426 can be circumferentially spaced. As shown, the apertures 1426 can be aligned with the slots 1414. In some configurations, the apertures 1426 can be at least partially offset from the slots 1414.

[0183] Locking or Implant Orientation Control Figures 20A to 20C show a configuration of handle 1514 similar to the embodiment of handle 14 illustrated and described in relation thereto in Figures 1 and 11. Handle 1514 may be configured to rotate implants 30, 1230 during delivery. For example, implants 30, 1230 may be rotated to reinforce the sealing of implants 30, 1230 and / or to avoid erosion in certain anatomical areas (e.g., the aortic root in the atrium) to avoid certain anatomical structures.

[0184] As shown in the figures, the handle 1514 may include a capsule knob 1505 (similar to the capsule knob 905 shown and described in relation thereto in Figures 9A and 9B), an orientation mechanism 1516 configured to rotate implants 30, 1230 (not shown) during implantation, and a linear guide 1524. For example, the orientation mechanism 1516 may include an orientation knob 1516 extending from the side of the handle 1514, which can be rotated around the longitudinal axis of the orientation knob 1516. In some configurations, the handle 1514 may include a rotation mechanism 1518 coupled to the orientation knob 1516. When the orientation knob 1516 is rotated, the rotation mechanism 1518 can also rotate. In some configurations, the rotation mechanism 1518 may include a worm gear mechanism 1520 and an adapter 1522. The orientation knob 1516 may be coupled to a worm gear mechanism 1520 and configured to rotate the worm gear mechanism 1520 when the orientation knob 1516 is rotated. The worm gear mechanism 1520 may be coupled to a linear guide 1524 so that when the orientation knob 1516 is rotated, the worm gear mechanism 1520 can rotate the linear guide 1524. The adapter 1522 may be coupled to a linear guide 1524 so that when the linear guide 1524 is rotated, the linear guide 1524 can rotate the adapter 1522. The adapter 1522 may be coupled to an outer proximal shaft 302 of a capsule assembly 306 (not shown). When the linear guide 1524 rotates the adapter 1522, the adapter 1522 can rotate the outer proximal shaft 302. In some configurations, the adapter 1522 may be configured to control the linear motion of the outer proximal shaft 302 when the capsule knob 1505 is rotated.

[0185] In some configurations, the orientation knob 1516 can rotate the lateral proximal shaft 302 of the capsule assembly 306. During delivery of implants 30, 1230, the orientation knob 1516 may be actuated to rotate the lateral proximal shaft 302 of the capsule subassembly 306 and the implants 30, 1230 within the capsule assembly 306 in order to position the implants 30, 1230 within the patient.

[0186] In some configurations, the orientation knob 1516 may include multiple indicators on its outer surface. The indicators on the orientation knob 1516 may correlate with the rotation of the implants 30, 1230. For example, the indicators may show a certain degree to which the implants 30, 1230 have been rotated. In some configurations, the orientation knob 1516 may be directly coupled to the lateral proximal shaft 302 of the capsule assembly 306 so that the lateral proximal shaft 302 can be directly rotated by rotating the orientation knob 1516. In some configurations, the orientation mechanism 1516 may be a lever configured to be pushed and / or pulled to rotate the implants 30, 1230 during delivery.

[0187] Figures 20D, 20E, 20F, and 20G further illustrate an embodiment of the orientation mechanism of Figure 20C connected to the outer lumen 20A, in which an implant (e.g., implants 30, 1230) can be rotated. A detailed gear mechanism has been described above in relation to Figures 20B and 20C, and therefore a detailed description of the gear mechanism of the orientation mechanism is omitted here. As shown in Figures 20F to 20G, by rotating the orientation mechanism or knob 1516, implants 30, 1230 (not shown) can be rotated during implantation via the gear mechanism to position the implant to have a desired rotational orientation (for example, to avoid the possibility of conduction interference caused by contact of a portion of the implant with a particular tissue). As previously stated, the gear mechanism may include a worm gear mechanism 1520 and a capsule adapter 1522. The orientation knob 1516 may be coupled to the worm gear mechanism 1520 and configured to rotate the worm gear mechanism 1520 when the orientation knob 1516 is rotated. The worm gear mechanism 1520 may be coupled to the linear guide 1524 so that when the orientation knob 1516 is rotated, the worm gear mechanism 1520 can rotate the linear guide 1524 (and thus the outer sheath subassembly 20 and the capsule subassembly 306 and the implant positioned therein). The rotation of the outer sheath subassembly 20 may passively cause the rotation of other subassemblies and implants because they are operably coupled to the outer sheath subassembly 20, but they do not have to be directly rotated by the rotation of the orientation knob 1516.

[0188] The implant (e.g., a double-frame valve prosthesis or replacement heart valve) may be pre-loaded in a desired orientation based on a prior procedure plan. For example, the predicted location of the bundle of His may be identified, and the predicted amount of secondary curvature considered necessary to implant the implant within the heart valve location may be determined. The orientation of the implant may be set during loading based on the determination to avoid contact between the anchor or other implant portions and the bundle of His. Furthermore, or alternatively, real-time clocking may be performed via the orientation mechanism 1516 based on direct or indirect fluorescence markers. Referring to Figures 20H to 20I, these show virtual representations of implants 30, 1230 superimposed on images (e.g., fluoroscopic images) of the patient's body (e.g., the anatomical structure of the heart) taken before rotation is performed, and implants 30, 1230 are positioned by rotating the orientation knob 1516 to avoid contact between one or more anchors 37 or other parts of implants 30, 1230 and, for example, the patient's His bundle represented by marker 3000 superimposed on the image. Rotation (orientation) of implants 30, 1230 can be performed during the procedure (e.g., by rotating from Figure 20H to Figure 20I) before implant deployment to prevent (or reduce the possibility of) anchors 37 contacting the His bundle or other undesirable tissue contact sites based on the location of marker 3000. In other words, the orientation mechanism 1516 can be used not only during implantation, as described with reference to Figures 23A to 23C, but also before implant delivery by marking points to be avoided 3000 on images taken before performing implant delivery, for example, the patient's His bundle. With respect to indirect visualization, the relationship (e.g., angular offset θ) between the anchorless zone on the implant and the fluoroscopy indicator can be determined. Next, a marker 3000 can be marked to identify the location on the His bundle, and the angular offset θ can be drawn on a preoperative image of the patient's heart (e.g., a CT scan). Then, the view of the implant can be set to place a fluoroscopy plane perpendicular to the fluoroscopy indicator. Next, the implant can be loaded to match the determined angular offset θ.Next, the clinician can position the implant in the desired orientation by centering the fluoroscopic indicator in the view within the fluoroscopic image, without switching to a direct fluoroscopic view. The fluoroscopic indicator may be an existing feature of the implant or not a separate indicator. In this case, the loading step may not be necessary.

[0189] Figure 21 shows another configuration of handle 1614 similar to the embodiments of handles 14, 1514 illustrated and described in relation thereto in Figures 1, 11, and 20A to 20C. Reference numbers of the same or substantially the same features may share the same last two digits. Handle 1614 may be configured to rotate implants 30, 1230 during delivery. Orientation knob 1616 may extend along the longitudinal axis of handle 1614 and may be configured to rotate around the longitudinal axis of handle 1614. Orientation knob 1616 may be configured to rotate the lateral proximal shaft 302 and implants 30, 1230 when the orientation knob 1616 is rotated.

[0190] Figures 22–23C show implant 30 delivered to the heart. As shown, the heart may contain a hotspot 2000. The hotspot 2000 is located within the interventricular septum of the heart near the aortic valve and contains conduction fibers (e.g., the right and / or left branches of the bundle of His). When implant 30 is delivered to the tricuspid valve of the heart, the anchor 37 of implant 30 may come into contact with conduction fibers within the hotspot 2000. If the anchor 37 of implant 30 comes into contact with conduction fibers, this may cause atrioventricular block ("AV block") within the tricuspid valve. Advantageously, either of the orientation knobs 1516, 1616 described herein may be used to rotate or clock implant 30 during delivery, so that the anchor 37 of implant 30 does not come into contact with conduction fibers. For example, clocking the implant may favorably avoid the main fiber bundle running along the right interventricular septum near the aortic valve. Furthermore, the clocking function may facilitate the use of asymmetrical implant designs, which may offer additional benefits such as enhanced sealing ability or avoidance of erosion in critical areas such as the aortic root within the atrium. While implant 30 is shown and described, other implants (e.g., implant 1230 or other implants described herein) may also be delivered or “clocked” as described herein.

[0191] Additional descriptions and terminology From the above description, it will be understood that the present invention discloses an approach for products and implant delivery systems. While some components, techniques, and aspects have been described with a degree of originality, it is evident that many modifications can be made to the specific designs, constructions, and methodologies described above without departing from the spirit and scope of this disclosure.

[0192] Section headings used herein are provided solely for readability and are not intended to limit the scope of embodiments disclosed within a particular section to the features or elements disclosed in that section. Certain features described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation can be implemented individually or in any preferred subcombination in multiple implementations. Furthermore, features may be described above as functioning in a particular combination, but in some cases, one or more features from a claimed combination may be removed from that combination, and the combination may be described as any subcombination or a variation of any subcombination. In some embodiments, a delivery system or delivery device comprises various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, a delivery system includes a single delivery device having a single implant. Multiple features or components are provided in alternative embodiments.

[0193] Furthermore, methods may be depicted in drawings or described in a specific order within the specification, but such methods do not need to be performed in a specific order or sequence shown, nor do all methods need to be performed to achieve the desired result. Other methods not depicted or described may be incorporated into exemplary methods and processes. For example, one or more additional methods may be performed before, after, simultaneously with, or between any of the described methods. Furthermore, methods may be reconfigured or rearranged in other implementations. Also, the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged in multiple products. Furthermore, other implementations are within the scope of this disclosure.

[0194] Conditional phrases such as "can," "could," "might," or "may," unless otherwise stated or understood in the context in which they are used, are generally intended to indicate that a particular embodiment includes or does not include certain features, elements, and / or steps. Therefore, such conditional phrases are generally not intended to imply that features, elements, and / or steps are required in any way in one or more embodiments.

[0195] Spatially relative terms such as “proximal,” “distal,” “down,” “below,” “bottom,” “up,” and “top” may be used herein to facilitate descriptions of the relationship between one element or feature and another, as shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation, in addition to the orientation depicted in the figures. For example, if the device in the figure is inverted, an element described as “below” or “directly below” another element or feature may be oriented “above” the other element or feature. Thus, the exemplary term “down” may encompass both upward and downward orientations. The device may be oriented in other ways (rotated by 90 degrees or in other orientations), and the spatially relative descriptors used herein shall be interpreted accordingly.

[0196] The terms “First” and “Second” may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context suggests otherwise. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element discussed below may be called the second feature / element, and similarly, the second feature / element discussed below may be called the first feature / element without departing from the teachings of the invention.

[0197] Throughout this specification and the subsequent claims, unless otherwise required by context, the word “comprise,” and variations such as “comprises” and “comprising,” mean that various components may be jointly employed in methods and articles (e.g., compositions and apparatus including devices and methods). For example, the term “comprising” would be understood to imply the inclusion of any described element or step, rather than the exclusion of any other element or step.

[0198] Conjunctional phrases such as "at least one of X, Y, and Z" are generally understood in contexts where they are used to convey that an item, term, etc., may be one of X, Y, or Z, unless otherwise specified. Therefore, such conjunctional phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0199] As used herein, the degree expressions "approximately," "about," "generally," and "substantially" represent values, quantities, or characteristics close to the stated value, quantity, or characteristic that further perform the desired function or achieve the desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to quantities that are within the ranges of 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the stated quantity. If the stated quantity is 0 (e.g., none, not present), the above-listed ranges may be specific ranges and not within specific percentages of the value. For example, within the ranges of 10% or less by weight / volume, 5% or less by weight / volume, 1% or less by weight / volume, 0.1% or less by weight / volume, and 0.01% or less by weight / volume of the stated quantity.

[0200] Some embodiments are described in reference to the accompanying drawings. While the drawings are drawn to a certain scale, other dimensions and proportions are also intended and within the scope of the disclosed invention, and therefore such scale should not be limiting. Distances, angles, etc., are illustrative only and do not necessarily have a precise relationship to the actual dimensions and layout of the illustrated devices. Components may be added, replaced, and / or rearranged. Furthermore, any specific features, aspects, methods, characteristics, properties, qualities, attributes, or elements disclosed herein in relation to various embodiments may be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein may be carried out using any device suitable for performing the enumerated steps.

[0201] In some configurations, the delivery system includes one or more of the following: means for introducing the delivery device, means for stabilizing the delivery device, means for maneuvering the delivery device, and means for releasing the implant from the delivery device.

[0202] While several embodiments and their variations have been described in detail, other modifications and methods of use will be obvious to those skilled in the art. Therefore, it should be understood that various applications, modifications, materials, and substitutions can be derived from the equivalents without departing from the original disclosure or claims of the invention herein.

Claims

1. A frame for a replacement heart valve prosthesis, The frame body is configured to transition between a compressed configuration and an expanded configuration, and the frame body is configured The proximal part, The first diameter and A first set of multiple V-shaped struts extending circumferentially around the periphery of the longitudinal axis, A second set of V-shaped struts positioned between individual V-shaped struts of the first set of V-shaped struts, A plurality of small holes, wherein at least some of the plurality of small holes are configured to connect the frame body to the inner frame, A proximal portion comprising, A middle section comprising a second diameter, a first plurality of axial struts, and a second plurality of axial struts, wherein the first plurality of V-shaped struts are connected to the first plurality of axial struts, and the second plurality of V-shaped struts are connected to the second plurality of axial struts, A distal portion comprising a third diameter and a plurality of third V-shaped struts extending circumferentially around the periphery of the longitudinal axis, wherein the plurality of third V-shaped struts are connected to the plurality of first axial struts and the plurality of second axial struts. Equipped with, The first diameter is smaller than the second diameter and the third diameter. A frame for a replacement heart valve prosthesis, wherein each individual V-shaped strut among the first plurality of V-shaped struts is provided with at least one of the plurality of small holes.

2. The frame of a replacement heart valve prosthesis according to claim 1, wherein the first plurality of V-shaped struts, the second plurality of V-shaped struts, the first plurality of axial struts, the second plurality of axial struts, and the third plurality of V-shaped struts form a plurality of cells having a length extending from the proximal end of the middle portion of the frame body to the distal end of the distal portion of the frame body.

3. A frame for a replacement heart valve prosthesis according to claim 1, wherein each of the third plurality of V-shaped struts has distal vertices with space between them, and the frame body largely avoids interaction with anchors extending from an inner frame configured to be coupled to the frame body.

4. The frame of a replacement heart valve prosthesis according to claim 1, wherein each of the first plurality of V-shaped struts has a proximal apex, and each proximal apex has at least one of the plurality of small holes.

5. The frame of a replacement heart valve prosthesis according to claim 4, wherein at least some of the plurality of holes are configured to receive a tether for a delivery system.

6. The frame of a replacement heart valve prosthesis according to claim 4, further comprising tabs configured to connect the frame body to a delivery system, at least some of the proximal vertices.

7. The frame of a replacement heart valve prosthesis according to claim 1, wherein each of the first plurality of V-shaped struts, the second plurality of V-shaped struts, the first plurality of axial struts, the second plurality of axial struts, and the third plurality of V-shaped struts overlaps when the frame body transitions to the compression configuration.

8. A frame for a replacement heart valve prosthesis, A frame body configured to transition between a compressed configuration and an extended configuration, A plurality of outer strut legs extending circumferentially around a longitudinal axis, wherein the plurality of outer strut legs comprises a first outer strut leg and a second outer strut leg, and the first outer strut leg and the second outer strut leg are connected in a bridge, An axial strut positioned between the first outer strut leg and the second outer strut leg, Each outer strut leg extends from at least two inner strut legs toward the axial strut, The frame body is equipped with, A plurality of small holes, wherein at least some of the plurality of small holes are configured to connect the frame body to the inner frame, A frame for a replacement heart valve prosthesis, equipped with the necessary components.

9. The frame of a replacement heart valve prosthesis according to claim 8, wherein a portion of the frame body is configured to deform such that at least a portion of the frame body forms a frustoconical shape.

10. The frame of a replacement heart valve prosthesis according to claim 9, wherein the frame body is configured to be recaptured by a delivery device, and the frame body is further configured to deform into the frustoconical shape when the frame body is recaptured.

11. The frame of a replacement heart valve prosthesis according to claim 9, wherein the frame body is configured to be loaded onto a delivery device, and the frame body is further configured to deform into the frustoconical shape when the frame body is loaded onto the delivery device.

12. The frame of a replacement heart valve prosthesis according to claim 8, wherein the axial strut and the inner strut legs form a substantially X shape.

13. The frame of a replacement heart valve prosthesis according to claim 8, wherein the individual outer strut legs, the axial strut, and the at least two inner strut legs form a cell having a length extending from the proximal end of the middle portion of the frame body to the distal end of the distal portion of the frame body.

14. The frame of the replacement heart valve prosthesis according to claim 13, wherein the cell has a generally elongated hexagonal shape.

15. Frame of a replacement heart valve prosthesis according to claim 8, wherein a first individual medial strut leg and the first lateral strut leg form a first distal apex, a second individual medial strut leg and the second lateral strut leg form a second distal apex, and the frame body further comprises a space between the first distal apex and the second distal apex such that the frame body substantially avoids interaction with the anchor.

16. The frame of a replacement heart valve prosthesis according to claim 8, wherein at least some of the plurality of holes are configured to receive a tether for a delivery system.

17. Frame of a replacement heart valve prosthesis according to claim 8, wherein at least some of the bridges further comprises tabs configured to connect the frame body to a delivery system.

18. The frame for a replacement heart valve prosthesis according to claim 8, wherein the frame further comprises a proximal diameter and a median diameter, and when the frame body is in the extended configuration, the median diameter is larger than the proximal diameter.

19. The frame for a replacement heart valve prosthesis according to claim 18, wherein the frame further comprises a distal diameter, and when the frame body is in the extended configuration, the mid-diameter is approximately the same as the distal diameter.

20. The frame of a replacement heart valve prosthesis according to claim 8, wherein the first lateral strut leg, the second lateral strut leg, and the bridge form a furculate shape.

Images