CN117136038A - Double frame replacement heart valve - Google Patents

Abstract

Embodiments of a replacement heart valve are disclosed. Embodiments may include a collapsible and expandable frame comprising rows of cells. The frame may include a plurality of axial connection portions extending between the top and bottom ends of the unit, wherein each axial connection portion is shaped to bend to accommodate temporary changes in unit height during uneven compression of the replacement heart valve. A frame with these features is advantageous when advancing a replacement heart valve through a funnel-shaped compression tool. The axial connection portion is flexible enough to accommodate changes in the shape of the frame during compression, while also being resilient enough to enhance the structural integrity of the frame in the fully deployed state. The replacement heart valve is preferably a double frame heart valve, wherein the axial connection portion forms part of an inner frame, and wherein an outer frame is provided for engaging tissue and forming a seal.

Description

Double frame replacement heart valve

Cross reference to related applications

The present application claims U.S. provisional application No. 63/148,501 filed on day 11, 2, 2021; and U.S. provisional application No. 63/273,402, filed on 10/29 of 2021, the entire contents of each of which are hereby incorporated by reference.

Technical Field

Certain embodiments disclosed herein relate generally to prostheses for implantation within a lumen or body cavity and delivery systems for the prostheses. In particular, in some embodiments, the prosthesis and delivery system involve replacement of a heart valve, such as replacement of a mitral heart valve or replacement of a tricuspid heart valve.

Background

Human heart valves, including aortic, pulmonary, mitral, and tricuspid valves, function substantially similar to unidirectional valves that operate in synchronization with the pumping heart. The valve allows blood to flow downstream but prevents blood from flowing upstream. Diseased heart valves exhibit damage, such as narrowing or regurgitation of the valve, which inhibits the ability of the valve to control blood flow. Such damage can reduce the blood pumping efficiency of the heart and can lead to debilitating and life threatening conditions. For example, valve insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, a great deal of effort has been expended to develop methods and apparatus for repairing or replacing damaged heart valves.

The prosthesis is present in order to correct the problems associated with a damaged heart valve. For example, mechanical and tissue-based heart valve prostheses may be used to replace damaged native heart valves. Recently, a great deal of effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can cause less trauma to the patient than through open heart surgery. Replacement valves are designed to be delivered by minimally invasive surgery and even percutaneous surgery. Such replacement valves typically comprise a tissue-based valve body that is connected to an expandable frame, which is then delivered to the annulus of the native valve.

The development of prostheses including, but not limited to, replacement heart valves, which can be compressed for delivery and then controllably expanded for controlled placement, has proven to be particularly challenging. Additional challenges relate to the ability of such prostheses to be fixed relative to intraluminal tissue, such as any body lumen or body cavity, in a atraumatic manner.

It is also challenging to deliver the prosthesis to a desired location within the human body, such as delivering a replacement heart valve to the mitral valve. Obtaining access for surgery at the heart or other anatomical location may require percutaneous delivery devices through tortuous vasculature or through open or semi-open surgery. The ability to control the deployment of the prosthesis at the desired location is also challenging.

Disclosure of Invention

Examples of the present disclosure relate to a delivery system, such as, but not limited to, a delivery system for replacement of a heart valve. Further examples relate to methods for delivering and/or controllably deploying a prosthesis, such as, but not limited to, a replacement heart valve, to a desired location within the body. In some configurations, a replacement heart valve and methods for delivering the replacement heart valve to a native heart valve, such as a mitral valve, an aortic valve, or a tricuspid valve, are provided.

In some embodiments, a delivery system and method for delivering a replacement heart valve to a native mitral valve location are provided. The delivery systems and methods may utilize transseptal methods. In some embodiments, components of the delivery system facilitate bending of a delivery device of the delivery system to guide a prosthesis from a septum to a location within a native mitral valve. In some embodiments, a capsule for containing a prosthesis for delivery to a native mitral valve location is provided. The capsule may also be configured to retract the prosthesis after initial deployment if another target implantation site is desired. In other embodiments, the delivery systems and methods may be adapted for delivering an implant to a location other than a native mitral valve.

A suture-based release mechanism adapted for use with a delivery device for delivering an implant (e.g., a replacement heart valve or valve prosthesis) may include a dual coaxial sliding shaft or subassembly. The inner shaft may be a manifold that connects sutures or tethers (e.g., ends of suture loops of continuous sutures or tethers). The outer shaft may contain one or more release windows that push the suture or tether (e.g., the end of the suture loop) off the manifold for release.

A suture-based release mechanism may be incorporated into the delivery device. In other words, the delivery device may include a suture-based release mechanism involving a dual coaxial sliding shaft or subassembly that cooperates to facilitate transitioning of the implant between a tethered configuration and an un-tethered (e.g., released) configuration upon actuation of an actuator (e.g., rotatable knob) of a proximal handle of the delivery device. The delivery device may include a plurality of suture or tether portions fixedly attached at one end to a distal end portion of the delivery device and inserted through an opening of the implant and then releasably coupled to the retaining member at the distal end portion of the delivery device. Thus, the suture or tether portion is only connected at the distal end portion of the delivery device and does not extend to the proximal handle of the delivery device. The actuator of the proximal handle may be configured to translate one of the dual coaxial sliding shafts relative to the other.

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

The delivery device may include additional shafts, lumens, or subassemblies to facilitate delivery of the implant to a desired implantation site (e.g., an outer sheath subassembly, a rail subassembly, an intermediate shaft subassembly, and/or a nose cone subassembly). The outer sheath subassembly may be adapted to retract the implant in situ and then re-deploy the implant at a new implantation site. The rail subassembly may facilitate bending of the delivery device to reach a desired implantation site. The intermediate shaft subassembly may be adapted to hold a portion of the implant in a compressed configuration until a desired implantation site is reached and the implant is ready for deployment. The nose cone subassembly may facilitate access to and guiding of the delivery device to a desired implantation site. The delivery device may include a handle with an actuator (e.g., knob) adapted to control movement (axial, bending, rotational movement) of the various subassemblies of the delivery device. The implant may be a prosthetic replacement heart valve, and the desired implantation site may be located within the annulus of a native heart valve (e.g., mitral valve, tricuspid valve, aortic valve).

In some embodiments, the suture-based release mechanism includes an outer release shaft or subassembly having a proximal end and a distal end, and an inner manifold shaft or subassembly having a proximal end and a distal end. The manifold shaft is coaxially positioned within the release shaft. The suture-based release mechanism may include a plurality of suture portions (which may be formed from a continuous suture or tether) that are adapted to be removably tethered to an implant (e.g., inserted through or wrapped around a feature of a valve prosthesis, such as a replacement heart valve, through an opening of the valve prosthesis). The plurality of suture loops may be coupled to the manifold shaft. For example, the first end of each of the plurality of suture portions (e.g., loops) may 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. The second end of each suture loop of the plurality of suture loops may be permanently (e.g., non-removably) coupled to the distal end of the manifold shaft. The relative sliding movement of the manifold shaft relative to the release shaft from the locked configuration to the unlocked configuration releases the first end of each of the plurality of suture loops from the at least one suture loop receiving member, thereby allowing the first end of each of the plurality of suture loops to be unbuckled from the implant.

The relative sliding movement may comprise movement of the manifold axially distally when the release shaft is stationary. The suture-based release mechanism (or delivery device including the release mechanism) may include a spring in the handle of the delivery device configured to hold the release mechanism in a locked configuration by default, wherein the spring exerts a distal spring force on the release shaft that must be overcome to transition the release mechanism to an unlocked configuration.

The at least one suture loop receiving member may include a plurality of tabs arranged circumferentially about the distal portion of the manifold shaft, wherein each tab of the plurality of tabs is adapted to receive a first end of at least one suture loop of the plurality of suture loops. The distal portion of the release shaft may include a plurality of windows, wherein each window of the plurality of windows is adapted to align with a respective tab of the plurality of tabs of the manifold shaft. While holding the release shaft in place, sliding of the manifold shaft in a distal direction may cause a distal edge of each window of the release shaft to push the second end of each suture loop proximally along a respective tab of the plurality of tabs of the manifold shaft until the second end of each suture loop is released from a respective tab of the plurality of tabs, thereby allowing the implant (e.g., replacement heart valve) to be decoupled from the delivery device.

At least one suture loop receiving member (e.g., tab, peg, finger) of the manifold shaft may be located within a corresponding opening or window proximal of the distal end of the manifold shaft. The second end of each of the plurality of suture loops may be permanently or non-removably coupled to a cog located at the distal end of the manifold shaft containing the plurality of tether clips and then permanently bonded or sealed between suture retaining loops positioned on both sides of the tether clips.

The plurality of suture loops may comprise three, four, five, six, seven, eight, nine or more suture loops. The number of suture loops may correspond to the number of proximal eyelets (or other openings) located on the proximal end of the implant. During assembly, the first end of each suture loop of the plurality of suture loops may be inserted through a respective eyelet of the proximal end of the implant before passing through the release window of the release shaft and being removably coupled to the at least one suture loop receiving member of the manifold shaft.

In one embodiment having nine suture loops, at least one suture loop receiving member (e.g., tab, peg, finger) of the manifold shaft or subassembly may include three tabs arranged circumferentially about the distal portion of the manifold shaft, wherein each of the three tabs is adapted to receive a first end of one or more of the plurality of suture loops. In this embodiment, each tab receives three first ends of three suture loops. In this embodiment, the distal portion of the release shaft may comprise three windows, wherein each of the three windows is adapted to align with a respective one of the three tabs of the manifold shaft. In such embodiments, the second end of each of the nine suture loops may be non-removably coupled to a cog at the distal end of the manifold shaft. A portion of each of the nine suture loops may be looped through a respective eyelet positioned at a proximal end of the replacement heart valve. While holding the release shaft in place, sliding the manifold shaft in a distal direction causes a distal edge of each window of the release shaft to push the second end of each of the nine suture loops proximally along a respective tab of the three tabs of the manifold shaft until the second end of each of the nine suture loops is released from a respective tab of the three tabs, thereby allowing the implant (e.g., replacement heart valve) to be decoupled from the delivery device.

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 to prevent rotation of the release shaft relative to the manifold shaft, thereby maintaining each window aligned with a respective tab. Each tab of the plurality of tabs may have substantially the same length or a different length.

According to several embodiments, a method of making or manufacturing a suture-based release mechanism to facilitate delivery of an implant includes: permanently attaching a first end of the suture loop to a distal end of the inner tube; passing a free second end of the suture loop through a hole of the implant; inserting a free second end of the suture loop through a window located along a distal end portion of an outer tube coaxially surrounding the inner tube; placing the free second end of the suture loop over a tab positioned along a distal end portion of the inner tube to removably couple 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 such that the second end of the suture loop is prevented from disengaging the tab until the implant is in a desired position for implantation.

According to several embodiments, a method of making a suture-based release mechanism to facilitate delivery of an implant includes: permanently attaching a first end of the suture loop to a distal end of the inner tube; passing a loop end of the suture loop through a hole of the implant; inserting a loop end of the suture loop through a slot positioned along a proximal tether retention assembly at the inner tube side distal portion to removably couple the loop end of the suture loop to the proximal tether retention assembly; and inserting a free end of a release suture through a loop end of the suture loop to secure the suture loop to the inner tube.

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 include a plurality of circumferentially spaced tether splints. These tethered splints may form a plurality of proximal members around which a single continuous suture or tether is wrapped to form a plurality of proximal suture loop ends. The assembly member may include a plurality of circumferentially spaced pegs or cleats to form a plurality of distal members around which a single continuous suture or tether is wrapped to form a plurality of distal suture loop ends. The terms "suture" and "tether" are used interchangeably herein.

The proximal and distal suture loop ends may be circumferentially offset from each other such that each strand connects the proximal suture loop end to the circumferentially offset distal suture loop end in an alternating serpentine fashion. For example, the strand is wrapped around a first proximal member to form a first proximal suture loop end and then back down to a first distal member, which may be spaced apart (or circumferentially offset) from the first proximal member, and wrapped around the first distal member to form a second suture loop end (first distal suture loop end) and then back up to a second proximal member spaced apart (or circumferentially offset) from the first distal member to form a third suture loop end (second proximal suture loop end) in a serpentine fashion. This process is repeated until the desired number of suture loop ends are produced. After forming and coupling the plurality of suture loops to an eyelet or other retaining member on the proximal end of the implant, the two ends of a single continuous suture or tether strand may be knotted together (and optionally glued or otherwise adhered together).

According to several embodiments, a method of facilitating delivery of an implant in a patient using a suture-based release mechanism includes advancing a distal end portion of a delivery device to a desired implantation location. The delivery device includes dual coaxial sliding shafts (e.g., inner and outer shafts). At least one suture loop is pre-attached to the implant during manufacture of the delivery device, and a first end of the suture loop is non-removably coupled to a distal end of the inner shaft of the dual coaxial sliding shaft during manufacture of the delivery device. The second end of the suture loop is removably coupled to the suture retaining member of the manifold after having been inserted through the retaining member (e.g., eyelet) of the implant. The distal end portion of the outer shaft of the two shafts contains a release window adapted to push the second end of the suture loop away from the suture retaining member upon relative sliding of the inner shaft with respect to the outer shaft. The method further includes advancing the inner shaft distally relative to the outer shaft to decouple the second end of the suture loop from the suture retaining member and disengage the release window, and withdrawing the shaft to allow the second end of the suture loop to decouple from the retaining member of the implant, thereby allowing the implant to remain in a desired implantation position when the delivery system is removed from the patient.

In some embodiments, after having been inserted through a retention member of the implant (e.g., a proximal-most eyelet of an inflow strut of the frame), a loop end of the suture loop is inserted through a slot of a proximal tether retention assembly of the inner shaft. After the loop end of the suture loop is inserted through the slot, a release suture may be inserted through the loop end of the suture loop. The method may further include advancing the inner shaft distally relative to the outer shaft, withdrawing a release suture from a loop end of the suture loop, and decoupling the loop end of the suture loop from a retaining member of the implant, thereby allowing the implant to remain in a desired implantation position when the delivery device is removed from the patient.

During implant delivery, the outer release shaft or subassembly may be held in a distal position by a spring in the handle at the proximal end of the delivery device, securing the suture loop to the inner manifold shaft or subassembly. When the user advances the manifold/release knob of the handle, the outer release shaft is moved forward with the inner manifold shaft by the biasing spring force of the spring until the release shaft handle adapter encounters a hard stop member in the handle. Continued advancement of the inner manifold shaft extends the inner manifold shaft distally while the outer release shaft remains in place due to contact with the hard stop member in the handle. The distal edge of the release shaft window abuts the suture loop end and pushes the suture loop end proximally releasing it from the suture receiving member (e.g., tab, finger, peg) on the underlying inner manifold shaft. Retraction of the release shaft and the manifold shaft (e.g., by proximally rotating the manifold/release knob) releases or disengages the suture loop from the valve orifice. The suture loop is removed from the body with the delivery system. The suture loop may be formed from a single continuous strand of tether, wherein the two ends of the continuous strand are knotted and bonded together after the formation of the suture loop.

According to several configurations, a valve prosthesis adapted for non-uniform compression during loading into a capsule comprises a self-expanding frame configured to transition between a compressed configuration and an expanded configuration. The frame comprises at least one row of cells forming a ring. The valve prosthesis further includes a plurality of prosthetic valve leaflets coupled to the frame. The frame includes a plurality of pre-curved axial connection portions, each extending between a top end and a bottom end of each of the at least one row of cells. Each axial connection portion is adapted to bend in a predetermined manner to accommodate variations in cell height during uneven compression of the valve prosthesis.

According to several configurations, the valve prosthesis includes a self-expanding frame configured to transition between a compressed configuration and an expanded configuration. The frame comprises a plurality of rows of cells formed by struts, wherein the cells form a herringbone cell structure. At least one cell in the most distal row of the plurality of cell rows includes an axial strut connecting the distal vertex of the cell with the distal vertex of an adjacent cell in the row immediately above the most distal row. The axial struts comprise a bow spring structure adapted to prevent cell ovality during a transition between a compressed configuration and an expanded configuration, and vice versa.

The bow spring structure may comprise a double bow spring structure in which the axial strut comprises two axial strut sections connected at their proximal and distal ends, but separated along their length. Each cell in the most distal row may contain an axial strut connecting the distal apex of the respective cell with the distal apex of the respective adjacent cell in the row directly above the most distal row. Each axial strut of the cells in the most distal row comprises a bow spring structure adapted to prevent cell ovality during a transition between a compressed configuration and an expanded configuration, and vice versa. The bow spring structure may be asymmetric or symmetric.

According to several configurations, a dual frame valve prosthesis includes an inner frame including an inflow portion having an inflow end, an outflow portion having an outflow end, and an intermediate portion extending between the inflow portion and the outflow portion. The inflow end of the inner frame includes a plurality of inflow struts (e.g., axially proximal struts or beams) that include a plurality of perforations (e.g., two, three, or more perforations). The outflow end of the inner frame contains a plurality of anchors (e.g., distal anchors or ventricular anchors). The valve prosthesis also includes an outer frame including an inflow portion having an inflow end, an outflow portion including an outflow end, and an intermediate portion extending between the inflow portion and the outflow portion. The inflow end of the outer frame includes a plurality of inflow struts (e.g., axially proximal struts or beams) that include a plurality of perforations. At least one of the plurality of apertures of each inflow strut of the outer frame is configured to engage with at least one of the plurality of apertures of the plurality of inflow struts of the inner frame.

The valve prosthesis may also include a skirt assembly positioned between the inner frame and the outer frame. The skirt assembly includes unitary webs of different diameters 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 inflow portion of the inner frame and the inflow portion of the outer frame. The body portion of the skirt assembly may be positioned outwardly of the intermediate portion of the outer frame. The plurality of distal extensions may be positioned between the outflow portion of the inner frame and the outflow portion of the outer frame.

In some embodiments, one or more of the plurality of proximal extensions includes a tab configured to be positioned between one or more of the plurality of inflow struts of the inner frame and one or more of the plurality of inflow struts of the outer frame. In some embodiments, one or more of the plurality of distal extensions comprises a hole configured to allow blood to flow into a volume between the inner frame and the outer frame.

In some embodiments, the plurality of proximal extensions and/or the plurality of distal extensions comprise a trapezoidal shape. In some embodiments, the plurality of proximal extensions are stitched together by one or more sutures when the valve prosthesis is assembled. In some embodiments, the plurality of distal extensions are stitched together by one or more sutures when the valve prosthesis is assembled.

One or more sutures may contain at least one interlocking stitch instead of a knot. At least one edge of the cloth of the skirt assembly may be melted (e.g., using a laser or soldering iron) to create a smooth edge surface. In some embodiments, a valve assembly is positioned within the inner frame, the valve assembly including a plurality of prosthetic leaflets, wherein the cusps of each prosthetic leaflet of the plurality of prosthetic leaflets are sutured to the skirt assembly using two different sutures (e.g., double sutures).

In some configurations, the inflow struts of the outer frame each include a bendable tab that is unattached to the inflow struts of the outer frame along at least a portion of the bendable tab such that the bendable tab is bendable along a plane independent of the corresponding inflow struts of the outer frame. The flexible tab may include at least one aperture configured to engage at least one aperture of the plurality of apertures of the plurality of axial inflow struts of the inner frame.

In some embodiments, the inflow end of the outer frame and the inflow end of the inner frame are mechanically attached together by a dovetail joint configuration or "puzzle piece" mating configuration.

In some embodiments, the inflow struts of the inflow end of the outer frame and the inflow struts of the inflow end of the inner frame are attached together, and the proximal-most ends of the at least two axial inflow struts are configured to be positioned at a distance offset from each other (e.g., staggered height). Each adjacent inflow leg may be offset, or they may be offset in pairs or in other numbered groups.

In some embodiments, at least some of the plurality of anchors include an attachable anchor damper that does not include foam. The attachable anchor damper can be configured to have a first portion configured to engage a native heart valve leaflet. The first portion may be more rigid than a second portion configured to contact a diaphragm wall or an annulus of the heart. The second portion may be configured to provide a cushioned contact surface.

In some embodiments, at least some of the plurality of anchors include a metallic cushioned anchor tip configured to distribute and attenuate loads exerted on natural tissue in contact with the anchor tip. The metallic buffer anchor tip may comprise a nitinol material. In one configuration, the metallic buffer anchor tip is an agitator configuration formed from a plurality of wire loops.

In some embodiments, at least some of the plurality of anchors include an anchor tip configured to provide a cushioning effect in a radially outward direction to reduce the likelihood of conduction interference caused by contact of the anchor with a diaphragm wall of the heart, and to provide rigidity in a radially inward direction to facilitate capture of a native heart valve leaflet.

According to several configurations, a dual frame valve prosthesis includes co-tissue features to facilitate alignment and registration during compression and expansion of the dual frame valve prosthesis, including an inner frame and an outer frame that include one or more co-tissue features (e.g., a hammerhead proximal eyelet design and/or distal tip circumferential offset of the inner and outer frames).

Drawings

Fig. 1 illustrates an embodiment of a delivery system for an implant, such as a double-frame heart valve prosthesis.

Fig. 2 shows a perspective view of a dual frame valve prosthesis that can be delivered using the delivery systems described herein.

Fig. 2A shows a side view of the inner frame of the dual frame valve prosthesis of fig. 2.

Fig. 2B shows a side view of the outer frame of the dual frame valve prosthesis of fig. 2.

Fig. 2C shows a side perspective view of a fully assembled double-frame valve prosthesis comprising a skirt assembly and a liner.

Figures 2D-1 to 2D-3 illustrate how structural instability (e.g., strut buckling) occurs during compression of a standard herringbone cell frame structure.

Figures 2E-1 through 2E-4 illustrate various views of an embodiment of an internal frame with an asymmetric "bow spring" structural mechanism in compressed, partially compressed and expanded configurations.

FIGS. 2F-1 and 2F-2 illustrate embodiments of an inner frame having a highly asymmetric "bow spring" structural mechanism and a minimally asymmetric "bow spring" structural mechanism, respectively.

FIGS. 2G-1, 2G-2 and 2G-3 illustrate various views of an embodiment of an internal frame with a symmetrical "bow spring" structural mechanism.

FIGS. 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 illustrate various views of embodiments of anchor tips for replacing a frame of a heart valve, such as an inner frame of a dual frame valve prosthesis.

FIGS. 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 views of embodiments of anchor tips for replacing a frame of a heart valve, such as an inner frame of a double-frame valve prosthesis.

Fig. 2H shows a side view of an embodiment of an outer frame that includes common tissue frame features to facilitate improved operation with the inner frame described herein throughout a temporary loading and deployment configuration.

Figures 2I-1 through 2I-3 illustrate various orifice designs configured to reduce rotational and/or translational movement between an outer frame and an inner frame of a dual frame valve prosthesis.

Fig. 2J-1 illustrates an external frame without some of the common organizational frame features. Fig. 2J-2 illustrates an outer frame with common organizational features designed to span an inner frame axial strut for alignment.

Fig. 2J-3 and 2J-4 illustrate another embodiment of a frame of a heart valve prosthesis, wherein the frame has alternating or offset heights of proximal-most struts (e.g., tether-attached struts).

Fig. 2K-1 illustrates how the outer frame may interact adversely with anchors on the inner frame of a double-frame valve prosthesis during crimping. Fig. 2K-2 shows how an embodiment of the outer frame can be designed such that the distal outflow portion of the outer frame avoids interaction with the inner frame anchors during crimping.

Figures 2L-1 through 2L-3 illustrate various embodiments of the outer frame design of a dual frame valve prosthesis, showing various options for connection or attachment structures between the proximal eyelet of the outer frame and the connecting struts.

Figures 2L-4 through 2L-6 illustrate various embodiments of tabs and/or apertures of an outer frame of a frame, such as a double-frame valve prosthesis.

Figures 2M-1 and 2M-2 illustrate various embodiments of a dual frame valve prosthesis having various radius of curvature profiles when the inner and outer frames are joined.

FIGS. 2N-1 and 2N-2 illustrate one example of an external frame. Fig. 2N-3 and 2N-4 illustrate another example of an external frame.

Fig. 2O-1 illustrates a dual frame valve prosthesis in which the inner and outer frames are engaged in a pre-expanded state in which the outer frame is not deployed. Fig. 2O-2 illustrates a dual frame valve prosthesis in which the inner and outer frames are engaged in a capsule retracted state in which the outer frame is not deployed.

Figures 2P-1 through 2P-7 illustrate various embodiments of joining an inner frame and an outer frame to form a dual frame heart valve prosthesis.

Fig. 3A shows a perspective view of an embodiment of an outer subassembly of a delivery device of the delivery system of fig. 1. Figure 3B shows a side cross-sectional view of the capsule subassembly of the outer sheath subassembly of figure 3A. Fig. 3C shows a perspective view of the capsule holder or distal hypotube of the outer sheath subassembly of fig. 3A. Fig. 3D shows how a portion of the liner extending along the length of the outer jacket subassembly may have built-in slack to facilitate flexible bending of the outer jacket subassembly.

Figures 3E to 3G illustrate another embodiment of the distal capsule tip of the capsule subassembly.

Fig. 4A shows a perspective view of an embodiment of a rail subassembly of a delivery device of the delivery system of fig. 1. Fig. 4B shows a side cross-sectional view of the rail subassembly of fig. 4A. Fig. 4C schematically illustrates how the outer compression coil and the puller wire of the guide rail subassembly may have a longer length than the inner compression coil and the puller wire. Fig. 4D-1 and 4D-2 schematically illustrate a wall penetration welding technique (as compared to existing direct welding techniques) performed during the manufacture of a rail subassembly.

Fig. 5A shows a perspective view of an embodiment of an intermediate shaft subassembly of a delivery device of the delivery system of fig. 1. Fig. 5B shows a side cross-sectional view of the intermediate shaft subassembly of fig. 5A.

Fig. 5B-1 to 5B-3 illustrate an embodiment of the distal end of the intermediate shaft subassembly. Fig. 5B-4 to 5B-6 illustrate another embodiment of the distal end of the intermediate shaft subassembly. Fig. 5C shows a side cross-sectional view of the distal end portion of the shaft assembly including the intermediate shaft subassembly.

Fig. 6A shows a perspective view of an embodiment of a release subassembly of a delivery device of the delivery system of fig. 1. Fig. 6B shows a side cross-sectional view of the release subassembly of fig. 6A. Fig. 6C shows a close-up side view of the distal end portion of the release subassembly. Fig. 6D shows a side cross-sectional view of the distal end portion of the release subassembly. Fig. 6E shows a bottom view of the distal end of the release subassembly.

Fig. 7A shows a perspective view of an embodiment of a manifold subassembly of a delivery device of the delivery system of fig. 1. Fig. 7B shows a side cross-sectional view of the manifold subassembly of fig. 7A. Fig. 7C shows a close-up view of the distal end portion of the manifold subassembly. Fig. 7D shows a bottom view of the distal end portion of the manifold subassembly. Fig. 7E shows a cut-out pattern of the distal end portion of the manifold subassembly.

Fig. 8A and 8B illustrate the distal end portions of the release assembly and manifold assembly in a locked configuration and an unlocked configuration, respectively. FIG. 8C illustrates tethering and unbuckling of a suture using a release assembly and a manifold assembly. Fig. 8D shows the suture loop tethered to the eyelet of the valve prosthesis, while also being tethered to the manifold subassembly of the delivery device.

Fig. 9A shows a perspective view of the handle of the delivery device of fig. 1. Fig. 9B shows a side cross-sectional view of the handle of the delivery device.

Fig. 10 illustrates components of an introducer assembly of the delivery system of fig. 1.

Fig. 11 shows how the handle of the delivery device interfaces with an embodiment of the stabilizer assembly of the delivery system of fig. 1. Fig. 11A shows a perspective view of the stabilizer assembly without the delivery device attached. Fig. 11B shows a top view of the stabilizer assembly of fig. 11A.

Fig. 12 shows a schematic illustration of a transfemoral and transseptal delivery method.

Fig. 13 shows a schematic illustration of a valve prosthesis positioned within a native mitral valve (the skirt assembly is not shown to facilitate visualization of the interface with the native heart valve structure).

Fig. 14A-14E illustrate various steps of deploying a valve prosthesis using a delivery device described herein, with emphasis on positioning various subassemblies of the delivery device relative to each other and to the valve prosthesis in the various steps. Fig. 14F-14K illustrate various steps of deploying and retrieving a valve prosthesis using a delivery device as described herein with reference to an example implantation site within a heart.

Fig. 15A shows a side perspective view of a configuration of a fully assembled double-frame valve prosthesis comprising a skirt assembly and a liner. Fig. 15B shows a side view of the fully assembled double-frame valve prosthesis of fig. 15A.

Fig. 15C shows the prosthetic leaflets sutured to the inner frame of the double-frame valve prosthesis.

Figures 15D-1 to 15D-5 and 15E-1 to 15E-4 illustrate a double suture applied to a prosthetic leaflet to securely attach the prosthetic leaflet to the inner frame of a double frame valve prosthesis.

Fig. 16A shows a side perspective view of the inner frame of the dual frame valve prosthesis of fig. 15A and 15B. Fig. 16B shows a side perspective view of the outer frame of the dual frame valve prosthesis of fig. 15A and 15B.

Fig. 17A-17C illustrate the skirt assembly of the dual frame valve prosthesis of fig. 15A and 15B in a flattened configuration. Fig. 17D shows a side view of the skirt assembly of the dual frame valve prosthesis of fig. 15A and 15B in a partially folded configuration.

Figures 17E-1 and 17E-2 illustrate the softened edges of the cloth for the skirt assembly of figures 17A through 17D.

Fig. 17F illustrates the process of applying interlocking stitches to the cloth for the skirt assembly of fig. 17A-17D to eliminate knots.

Fig. 18A shows a close-up view of a distal end portion of a configuration of a manifold subassembly fitted with a suture loop or tether loop. Fig. 18B shows a perspective side view of the distal end portion of the configuration of the manifold subassembly of fig. 18A. Fig. 18C shows a perspective bottom view of the distal end portion of the configuration of the manifold subassembly of fig. 18A. Fig. 18D shows a perspective view of a tether or suture arrangement secured to a distal end portion of the configuration of the manifold subassembly of fig. 18A. Fig. 18E and 18F show perspective views of the manifold subassembly showing how the retaining portion of the tether or suture arrangement is removed from the distal end portion of the configuration of the manifold subassembly of fig. 18A.

Fig. 19A shows a perspective side view of a distal end portion of another configuration of a manifold subassembly. Fig. 19B shows a plan view of the distal end portion of the configuration of the manifold subassembly of fig. 19A.

Fig. 20A shows a side view of the configuration of the handle of the delivery device. Fig. 20B shows a side cross-sectional view of the handle of fig. 20A. Fig. 20C shows a close-up cross-sectional view of the handle of fig. 20A. FIGS. 20D, 20E, 20F and 20G illustrate the orientation mechanism of FIG. 20C connected to an external lumen within which the dual frame valve prosthesis is rotated to facilitate synchronizing the prosthesis at a desired implantation location. FIGS. 20H and 20I schematically illustrate a timing mechanism visualized using direct fluoroscopy.

Fig. 21 shows a perspective view of the configuration of the handle of the delivery device.

Fig. 22 shows a configuration of an implant within a patient's heart.

Fig. 23A-23C illustrate rotation of the implant of fig. 22 within a patient's heart.

Detailed Description

The present specification and figures provide aspects and features of the present disclosure in the context of several embodiments of replacement heart valves, delivery systems, and methods configured for use in the vasculature of a patient, such as replacement of a native heart valve for a patient. These embodiments may be discussed in connection with replacing a particular valve, such as the aortic, tricuspid, or mitral valve of a patient. However, it should be understood that the features and concepts discussed herein may be applied to products other than heart valve implants. For example, the controlled positioning, deployment and fixation features described herein may be applied to medical implants, such as other types of inflatable prostheses, for use elsewhere in the body, such as arteries, veins, or other body cavities or locations. In addition, the particular features of the valve, delivery system, etc. should not be considered limiting, and features of any of the embodiments discussed herein may be combined with features of other embodiments as desired and appropriate. While certain embodiments described herein are described in connection with a trans-femoral delivery method, it should be understood that these embodiments may be used with other delivery methods, such as trans-transapical or trans-jugular methods. Furthermore, it should be understood that certain features described in connection with some embodiments may be combined with other embodiments, including those described in connection with different delivery methods.

Delivery system

Fig. 1 illustrates an embodiment of a delivery system 10. The delivery system 10 may be used to deploy a prosthesis, such as a replacement heart valve, to a location within a subject (e.g., a human or veterinary subject). The replacement heart valve may be delivered to the subject's heart mitral or tricuspid valve annulus or other heart valve site in a variety of ways, such as by open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the subject's vasculature. An exemplary trans-femoral approach is further described in U.S. patent publication 2015/0238315, published at 8/27 of 2015, the entire contents of which are hereby incorporated by reference in their entirety. Although the delivery system 10 is described in connection with a percutaneous delivery method, and more particularly, a trans-femoral delivery method, it should be understood that features of the delivery system 10 may be applied to other delivery methods, including delivery systems for trans-transapical delivery methods.

The delivery system 10 may be used to deploy a prosthesis, such as a replacement heart valve as described elsewhere in this specification, to a location within a subject. The delivery system 10 may include a plurality of components, devices, or subassemblies. As shown in fig. 1, the delivery system 10 may include a delivery device 15, a stabilizer assembly 1100, and an introducer assembly 1000 (not shown in fig. 1, but shown in fig. 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 advantageously be pre-attached to the delivery device 15 during manufacture or assembly, such that a clinician does not have to attach the implant 30 prior to use. The delivery device 15 may be configured to facilitate delivery and implantation of an implant (e.g., a valve prosthesis) 30 to a desired target location (e.g., a mitral or tricuspid heart valve annulus). The implant (e.g., replacement heart valve) 30 may be pre-attached to or within the distal end portion of the shaft assembly 12 and removably tethered to one or more retention components of the shaft assembly 12 during manufacture or assembly. The delivery device 15 with pre-attached implant 30 may then be packaged, sterilized, and transported for use by one or more clinicians. According to several embodiments, the implant 30 is not pre-crimped in the shaft assembly 12 delivery device 15. In other embodiments, the implant 30 is preloaded or pre-crimped supplied in the shaft assembly 12.

Implant for a delivery system

Fig. 2 shows an example frame structure of an implant (e.g., a valve prosthesis) 30 that may be preloaded into and delivered by a delivery device 15. Implant 30 includes a dual frame assembly including an inner frame 32 and an outer frame 34 that are aligned and coupled together during manufacture. Fig. 2A illustrates an embodiment of an internal frame 32. The inner frame 32 may include a proximal or inflow portion 32A, a medial or intermediate portion 32B, and a distal or outflow portion 32C. The inner frame 32 may be shaped to assume a generally hourglass shape in the expanded configuration, with the cross-sectional width of the intermediate portion 32B being less than the cross-sectional widths of the proximal and distal portions 32A, 32C. Proximal portion 32A may include tabs 33 and/or perforations 35 to facilitate engagement with other structures or materials (e.g., external frame 34, a skirt or fabric assembly, a tether or retaining suture of a prosthetic valve assembly and/or delivery device 15). Distal portion 32C may include outwardly and upwardly extending anchors 37 to facilitate anchoring at a desired target site (e.g., a native heart valve annulus). The inner frame 32 may have a herringbone cell structure as shown in fig. 2A. However, other cell structures may be used. The inner frame 32 may include a prosthetic valve assembly coupled thereto that includes a plurality of prosthetic valve leaflets (not shown). Fig. 2B illustrates an embodiment of the outer frame 34. The outer frame 34 may also include a proximal or inflow portion 34A, a middle or intermediate 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 eyelets 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 fig. 2, 2A, 2B, a prosthesis 30 is shown that only shows a bare metal frame structure. Fig. 2C shows an embodiment of a fully assembled implant (e.g., valve prosthesis) 30 that includes a skirt assembly 38 positioned between frames 32, 34 and a liner 39 surrounding anchors 37. The implant (e.g., prosthesis) 30 may take any number of different forms or designs.

Additional details and example designs of implants (e.g., prostheses or replacement heart valves) are described in U.S. patent nos. 8,403,983, 8,414,644, 8,652,203, and U.S. patent publication nos. 201I/0313515, 2012/0215303, 2014/0277390, 2014/0277422, 2014/0277427, 2018/0021129, 2018/0055629, and 2019/0262129 (e.g., hourglass-shaped inner frames). The entire contents of these patents and publications are hereby incorporated by reference and form a part of the present specification. Further details and embodiments of replacement heart valves or prostheses, and methods of their implantation, are described in U.S. publication nos. 2015/032568, 2016/0317301, 2019/0008640, and 2019/0262129, each of which is hereby incorporated by reference in its entirety and made a part of this specification.

Frame structural features

Figures 2D-1 to 2D-3 illustrate how structural instability (e.g., strut buckling) occurs during compression (e.g., crimping, intermediate loading) of a standard herringbone unit frame structure. Structural instability (e.g., ovality) of the cells and struts of the herringbone cell frame can occur when the diameter of the herringbone cell frame is gradually reduced (e.g., funnel-like), such as when the frame is loaded into a shaft assembly of a delivery device that is smaller in diameter than the frame in an expanded configuration. Such structural instability can interfere with the implantation process and, in extreme cases, can reduce the structural integrity of the frame. Structural instability can create unpredictable stresses or strains on the frame, which can compromise durability, leading to device failure. Referring to fig. 2D-1, the chevron unit structure is because it is curled or funnel-shaped, through which the strut-driving internal force is constituted. The interior is largest when the chevron unit frame is partially funnel-shaped or curled, with some of the units partially open and others partially closed. Conventional herringbone cell structures may become inherently unstable systems in which the portion or section of the frame experiencing the reduced diameter begins to extend. Extension may be an disambiguation of shortening. In some embodiments, extension may be synonymous with extension. The portion or section of the frame that is still fully expanded resists extension and as a result, buckling of the struts may occur. When partially funnel-shaped, for example, the axial beams or struts 202 of the fully expanded portion of the frame may bend in unpredictable directions, which may result in an ovality cascade, as shown in fig. 2D-2 (bottom view of the partially funnel-shaped or partially curled inner frame with conventional chevron-shaped cell structure) and fig. 2D-3 (side perspective view of the partially funnel-shaped or partially curled inner frame with conventional chevron-shaped cell structure). When partially funnel-shaped, the axial beams or struts 202 may be in a compressed state and the axial beams or struts 203, 204 may be in a stretched state.

FIGS. 2E-1 through 2E-4, 2F-1 and 2F-2, and 2G-1 through 2G-3 illustrate various views of an embodiment of an internal frame having a herringbone cell structure that includes a structural mechanism or feature configured to dynamically absorb or compensate for the extension of the partially curled portion of the internal frame. The structural mechanism is designed to compress or expand in a controlled manner, thereby changing the frame from an unstable system to a stable system during loading or deployment. In several embodiments, the structural mechanism is designed to compensate for internal compressive forces on the slotted strut members and provide dynamic frame stability, thereby ensuring improved frame integrity and patient safety. In several embodiments, the structural mechanism provides frame stability by increasing the lateral and/or circumferential bending stiffness similar to a diamond-shaped cell structure but without increasing the curl length as in a diamond-shaped cell structure. In several embodiments, the structural mechanism advantageously prevents or reduces the likelihood of elliptical loading and deployment (e.g., by creating a radially non-uniform out-of-plane expansion of the slotted strut members (e.g., axial beams or struts)).

According to several embodiments, the expandable and compressible frame may contain a plurality of structural mechanisms (e.g., axial (longitudinal) connection portions, such as strut assemblies, within one or more chevron or diamond shaped cells of the distal or outflow end portion of the expandable frame) that are capable of reducing length (e.g., shortening length) in a predictable manner. The structural mechanism is configured to flex, deform, or bend at least a portion of the frame (e.g., certain cells or struts) in a predictable manner or in a desired direction (such as when the frame is compressed in a non-uniform manner by a funnel loader (e.g., when one portion of the frame is compressed while another portion remains expanded), or when the frame is compressed in a non-uniform manner and retracted within the delivery device). The structural mechanism may include bendable axial struts that may shorten and accommodate temporary non-uniform shapes. Although the structural mechanism may be contained only in some of the cells of the frame, the predictable bending may cause adjacent cells or portions to also bend or curl in a similar manner, thereby providing controlled bending and compression of the frame. In some configurations, the structural mechanism may be biased in a particular configuration or shape to bend, deform, or curl in a desired direction.

In some configurations, an implant (e.g., a replacement heart valve) includes a self-expanding frame configured to transition between a compressed configuration and an expanded configuration. The frame includes a plurality of rows of cells (e.g., chevron cells) formed from cell struts. At least one cell in the most distal row of the plurality of rows of cells includes a structural component adapted to prevent cell ovality during a transition between a compressed configuration and an expanded configuration, and vice versa. The structural assembly may comprise, for example, axial struts connecting the distal apices of at least one cell with the distal apices of adjacent cells in the row immediately above the distal-most row. Rows other than the most distal row may contain structural components other than or in lieu of the most distal row.

Fig. 2E-1 to 2E-4 illustrate an embodiment of an inner frame 32 having an axially asymmetric "bow spring" structural mechanism. Fig. 2E-1 shows the inner frame 32 in a rolled configuration, and fig. 2E-2 shows the inner frame 32 in an expanded configuration. The bow spring structure mechanism is built into one or more of the axial struts 202 extending between the chevron units. Fig. 2E-3 illustrate side perspective views of the inner frame 32 in a partially rolled or partially compressed configuration, wherein the proximal or inflow portion 32A of the inner frame 32 is rolled or compressed, but the distal or outflow portion 32C of the inner frame 32 is still fully expanded. Referring to fig. 2E-3, before the V-shaped struts form the lower boundary of the most distal cell row or ring, the V-shaped struts forming at least the upper boundary of the most distal cell row or ring are folded or compressed. Thus, the distance between the ends of the bow spring axial strut 202 shortens during crimping. The bow spring axial struts may be removed, but this may result in the frame being more fragile. Fig. 2E-4 show top views of fig. 2E-3 with the internal frame 32 in the same configuration. As shown in fig. 2E-3 and 2E-4, the bow spring axial strut 202 is designed to dynamically compensate for compression during device loading to avoid ovality. Bow spring axial strut 202 deforms in a stable and predictable manner. Bow spring axial struts 202 may advantageously not elongate when crimped so that the frame crimp length does not increase during loading or deployment. The laser cut pattern of bow spring axial struts 202 may include narrow slots to facilitate non-extension (e.g., non-extension) of the frame during loading, deployment, and/or retraction. The bow spring axial struts 202 may be formed at an angle less than perpendicular or perpendicular to the long axis of the frame 32, as needed and/or desired. The performance of the bow spring feature (e.g., bow spring axial strut 202) is determined by the geometry of the intended bending region. In this bending region, the length, wall thickness, strut width, laser cut arc and/or tapered region directly affect the degree of bending and strain experienced by the material. The embodiment shown in fig. 2E-1 through 2E-4 depicts a bow spring axial strut 202 in which the intended bending zone has a tapered strut width that decreases to a minimum at the midpoint of the bow spring arc and has an arcuate shape resulting from the laser cutting pattern that tends to bend the intended bending zone in the desired direction. The ratio of the wall thickness of the bow spring feature to the strut width ensures that the bending is predictable and mostly unidirectional. In some embodiments, the length of bow spring axial strut 202 is tailored to ensure that the desired compression stroke is within material limits.

The bow spring embodiment of FIGS. 2E-1 through 2E-4 illustrates a mechanism in which the compensation frame extends under compression wherein the length of the bow spring axial strut 202 is dynamically reduced. The bow spring axial strut 202 in fig. 2E-1 through 2E-4 comprises a single curved strut that curves to one side in a predictable manner. As can be seen from the transition between fig. 2E-2 and 2E-4, the curvature in the bow spring axial leg 202 becomes more pronounced and all curvature is in a uniform single direction. The principle of the mechanism works in the opposite way, where the preformed bow spring mechanism can be dynamically elongated under tension to compensate for the progressive extension of the herringbone frame design as it is loaded/deployed from its delivery device or system.

The bow spring mechanism (e.g., bow spring axial strut 202) may be adapted for use with frames constructed from nitinol or any other superelastic shape memory alloy. This mechanism can also be used for frames comprising steel, cobalt-chromium or other alloys, ensuring that the conically curled implant remains circular as it reduces in diameter along its length. The use of such a design in frames made of these materials will remain deformed and is advantageous for use in applications where it is desired to force localized areas of the frame radially inward or outward, such as to create an hourglass shape (inward) or anchoring protrusions (outward).

The ability of an axial strut (e.g., bow spring axial strut 202) to dynamically reduce length (a portion of an unstable chevron unit structure under compression) during loading of a device (e.g., an implant) can be achieved by a number of different mechanisms, one of which the bow spring concept is. Another mechanism to achieve dynamic length variation is to provide a plurality of transverse laser cutting windows in the axial beam that can be closed or opened to balance the pressure exerted by the load on the struts. Another mechanism to achieve dynamic length variation of the axial beam is a built-in slot and pin mechanism, where the proximal section of the axial beam or strut terminates in a pin that pins a slot in the distal section of the axial beam or strut. The pins may translate along the slots when the frame is loaded, thereby balancing the extension of the chevron design, and the pins may lock to ensure a reliable frame structure when fully inflated and subjected to anatomical forces.

The degree of axial asymmetry may vary. Fig. 2F-1 illustrates an embodiment of an inner frame 32 having a highly asymmetric "bow spring" structural mechanism, and fig. 2F-2 illustrates an embodiment of an inner frame 32 having a minimally asymmetric "bow spring" structural mechanism. The bow spring mechanism may also be axisymmetric. FIGS. 2G-1, 2G-2 and 2G-3 illustrate various views of an embodiment of an inner frame 32 having a symmetrical double "bow spring" structural mechanism. The double bow spring mechanism includes a pair of legs bent to opposite sides, similar to the function of a change purse. Fig. 2G-1 shows a close-up view of a symmetrical double "bow spring" structural mechanism with the inner frame in a rolled or compressed configuration. Fig. 2G-2 shows the inner frame 32 in an expanded configuration. Fig. 2G-3 illustrate the inner frame 32 in a partially rolled or partially compressed configuration, wherein the proximal or inflow portion 32A of the inner frame 32 is rolled or compressed, but the distal or outflow portion 32C of the inner frame 32 is still fully expanded. If the frame has a curved profile in the region of interest, as is the case with the hourglass profile of the inner frame 32 described herein, the planar outer frame expansion may translate the slots within the chevron unit into a double bow spring mechanism. The dual bow spring mechanism converts compressive loads that would otherwise result in uncontrolled bending if left unchecked or uncompensated into controlled bending of the bow spring struts.

Anchor feature

According to several embodiments, the anchors 37 of the expandable frame (e.g., the inner frame 32 of a double-frame replacement heart valve) may be formed without the use of foam pads on the anchor tips that contact the native heart tissue. The anchors may include non-foam and/or non-fabric dampers made of a flexible material (e.g., metal or metal alloy material) that are attached to the anchor tips that can be bent, deformed or shaped to provide a cushioning effect. In some embodiments, the bumper or anchor tip is designed to be "softer" or more cushionable in one direction to reduce conductive interference (e.g., caused by pressure applied to the diaphragm wall by the rigid anchor tip portion) and more rigid in another opposite direction to maintain capture of the native valve leaflet. The anchor tips may also have a reduced anchor profile to facilitate easier surgical navigation and placement of replacement heart valves. The anchor tips can be further designed to not puncture the heart anatomy (e.g., without sharp edges and to provide a cushioning effect). The anchor tips can also be designed to reduce loading forces in the catheter or to make loading forces more predictable.

FIGS. 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 illustrate various views of embodiments of atraumatic anchor tips for replacing an expandable frame of a heart valve. Specifically, FIGS. 2G-4A, 2G-4B, 2G-5 and 2G-6 illustrate embodiments of attachable tips or attachable anchor dampers 37A, and FIGS. 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 illustrate other embodiments of attachable anchor tips or filling tips 37B. The embodiments of FIGS. 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 not be used in conjunction with foam filling, and may or may not be used in conjunction with cloth covers. Thus, according to these embodiments, the cloth cover may be optional. The anchor tips may be incorporated into all, some, or one anchor.

In more detail, fig. 2G-4A and 2G-4B illustrate one embodiment of an attachable anchor tip or damper 37A that may be attached to the anchor 37 of the inner frame 32 of the dual frame valve prosthesis. The damper 37A may be a single thin polymer (e.g., plastic or elastomer) or a metal strip (e.g., other material that is soft enough to bend easily). For example, the dampener 37A of fig. 2G-4B has a thin strip shape that bends over the distal tip of the anchor 37 (e.g., the tip that extends upward when in the expanded configuration) to form a saddle-like design. In some configurations, damper 37A is formed from a flat raw material (e.g., a thin metallic material). Alternatively, damper 37A may be formed from tubing, may be 3D printed, and/or may be formed from wire material. The material may include, but is not limited to, nitinol, cobalt chrome, stainless steel, or polymeric materials. When the damper 37A contacts the anatomy, the radius of the curved loop portion increases due to the flexibility of the material, thereby creating a "cushioning" effect. Damper 37A may be adhered to anchor 37 by an adhesive, welding, stitching, or other attachment mechanism. For example, the damper 37A may be tied to the anchor 37 using a wire or lead inserted through one or more suture holes 37A-1 formed in an end portion of the damper 37A. Different shapes or designs may be implemented. For example, fig. 2G-5 illustrate another embodiment of a damper 37A having a plurality of slits 37A-3 to reduce vibration in the presence of an external impact on the damper 37A. The plurality of slits 37A-3 may also fan out the contact surface to increase the surface area. Such a damper 37A may also provide a cushioning effect while protecting the tip of the anchor 37. As shown in fig. 2G-6, the damper 37A may be tied to the anchor 37 of the inner frame 32 by stitching around the end portion 37A-4 of the damper 37A using a wire or lead 37A-2 wrapped around the end portion 37A-4 and/or inserting through one or more suture holes 37A-1 formed in the end portion 37A-4 of the damper 37A.

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 also illustrate embodiments of attachable anchor tips similar to those illustrated in FIGS. 2G-4A, 2G-4B, 2G-5, and 2G-6, except that the attachable anchor tips in FIGS. 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 may be made of flat/thin stock material or a thicker rigid material. For example, fig. 2G-7 illustrate a tubular attachable tip 37B that may have a horizontally formed slit 37B-3A at one side (e.g., front side) that allows inward bending while preventing outward bending. Slit cuts 37B-3A may help to maintain rigidity for leaflet capture. The tubular attachable supervision 37B further includes opening cuts 37B-3B on opposite sides (e.g., facing radially inward of the inner frame 32) that allow for inward bending. The slit 37B-3A and the opening incision 37B-3B may be formed, for example, by laser cutting a flexible hypotube. The tubular attachable tip 37B can distribute and attenuate loads and reduce forces exerted within the patient, and further, the slit 37B-3A can maintain rigidity for leaflet capture. An optional filled anchor tip may be attached to the top of the tube to distribute and attenuate the load.

Fig. 2G-8 show a double half ring attachable tip 37B design that includes an outer half ring 37B-4A (ring away from the inner frame 32) and an inner half ring 37B-4B (ring near the inner frame 32) that provide asymmetric stiffness. The semi-circular shape may advantageously facilitate the distribution of the load. The inner half ring 37B-4B may be thicker than the outer half ring 37B-4A and thus more rigid to maintain reliable leaflet capture. The outer half ring 37B-4A may optionally incorporate a plurality of relief cuts 37B-3C. The outer half ring 37B-4A is designed to provide a cushioning effect to help reduce conduction interference and reduce the amount of force applied to the anatomy (e.g., diaphragm, ring). Similar to other attachable tips, the double half-ring attachable tip 37B may have one or more suture holes 37B-1A for attaching the half-ring to the inner frame 32 or anchor tip 37 by stitching or other attachment methods. Further, the double half ring attachable tip 37B can have an upper suture hole 37B-1C and a lower suture hole 37B-1B for suturing the outer half ring 37B-4A and the inner half ring 37B-4B together. The half rings can be laser cut from a flat plate or tube (which can be the same tube or different tubes of different thickness, making the inner tube thicker) and shaped to the same shape using the same tool. One or both of the half rings may optionally be covered with a sleeve (e.g., a cloth sleeve).

Figures 2G-9A and 2G-9B illustrate side and front views, respectively, of another embodiment of an attachable anchor tip 37B that includes a half-ring terminating in a flexible spring-shaped end. By suturing one end with suture hole 37B-1 to anchor 37, attachable anchor tip 37B of fig. 2G-9A and 2G-9B can be rigidly and fixedly attached to anchor 37, while the opposite end (e.g., spring-shaped end) can remain free and unattached. The spring-shaped end of the half-ring attachable tip 37B can allow the entire anchor to deflect away from sensitive anatomy (e.g., the diaphragm wall), thereby providing a cushioning effect, reducing forces applied to the anatomy along the conductive pathway, and reducing conductive interference. The entire anchor tip design can be laser cut from a flat plate and then the half-ring portions can be shaped into half-rings without the need for the spring-shaped ends to be shaped. Fig. 2G-10 illustrate an anchor tip ring attachable tip 37B similar to the embodiment of fig. 2G-4A and 2G-4B, but further including a wire 37C-1 wrapped over at least a portion of the ring to provide further resiliency and cushioning effects. The leads may extend only along the outside and top of the ring (e.g., the side configured to contact the diaphragm wall or annulus), rather than along the entire ring. The guide wire 37C-1 allows the anchor tip to deflect away from sensitive anatomy rather than being rigidly pressed into it. On the inward side of the loop (e.g., small She Ce), there may be no windings in order to maintain leaflet capturing capability. The attachable tip 37B of fig. 2G-10 may also be made by laser cutting a flat plate to have a ring shape, and the wire 37C-1 may be wound through a hole cut through the thickness of the ring. The ends of the loops may be sutured to anchors 37 through suture holes 37B-1 or other attachment mechanisms as previously described.

FIGS. 2G-11A, 2G-11B, 2G-11C, 2G-12, 2G-13, 2G-14, and 2G-15 illustrate other embodiments of attachable tips 37B of one or more anchors of an inner frame. The attachable tips shown in these embodiments may have more than two arms. For example, referring to fig. 2G-11A and 2G-11C, the attachable tip 37B may include a first opposing arm 37C-2 having a suture hole 37B-1 at each end thereof for attachment to an anchor, and a second opposing arm 37C-3 having an arm of generally continuous width and having a free unattached end. As shown in fig. 2G-11C, the attachable tip 37B may be formed of wire, thin metal, or any flexible polymer or metal material to bend over the anchor distal tip, and the first opposing arm 37C-2 may be attached to the anchor 37 by suturing a suture or wire 37B-2 through the suture hole 37B-1, while the second opposing arm 37C-3 may be free at its end, as shown in fig. 2G-11B. Fig. 2G-12 to 2G-15 illustrate various embodiments of attachable tip designs similar to fig. 2G-11A. That is, the attachable tip 37B of fig. 2G-12 may have a rounded end at the second opposing arm 37C-3, and the attachable tip 37B of fig. 2G-13 may be similar to the attachable tip of fig. 2G-12, but may have a rounded shape at the center, with the central hole 37B-4 forming a larger surface contact with the human body. Figures 2G-14 and 2G-15 are variants of figures 2G-12 and 2G-13, respectively, with more than two second opposing arms 37C-3. The number of free unattached arms can vary.

Similar to the embodiments described above, fig. 2G-16 and 2G-17 show an attachable tip for attachment to an end or anchor 37 of the inner frame 32. The attachable tips of fig. 2G-16 and 2G-17 have a symmetrical configuration such that they can be folded so that they can be sutured through suture hole 37B-1, the upper and lower tips can contact and be attached to inner frame 32.

FIGS. 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 an anchor tip for an anchor designed to capture a native heart valve leaflet (e.g., a native leaflet of a mitral valve or tricuspid valve). The anchor tip configuration may advantageously provide a cushioning function without using or reducing the amount of foam or cloth components. According to several embodiments, the anchor tips represent modifications to the existing frame material (e.g., modifications to the anchors of the frame itself, some or all of the anchors), rather than attachment of the anchors, as in the previously described embodiments. The anchor tip design may be incorporated into one, some or all of the anchors of the frame. In some embodiments, the anchor tips include non-woven and/or non-foam anchor tips made of a flexible material (e.g., a metal or metal alloy material such as nitinol) that can be bent, shaped, or recessed to provide a cushioning effect on at least a portion of the anchor tips.

Figures 2G-18A and 2G-18B illustrate a dual layer hoop anchor that forms two separate hoops stacked upon one another. The hoops can be cut from the anchor tube stock and then shaped to separate the individual hoops out of plane, doubling the contact surface area (as best shown in fig. 2G-18B). Figures 2G-19 illustrate a bi-directional internal screw anchor formed from two independent screws positioned side-by-side, which can be formed by cutting the anchor tube stock. The spiral may deflect to provide a cushioning effect. Such anchor designs may not require any shape setting or welding. The thickness D of the spiral of the bi-directional inner spiral anchor may be, for example, 100 μm to 200 μm.

Figures 2G-20A and 20B each illustrate a heart-shaped hoop anchor 37 formed from a single ring having two lobes such that the center of the heart can deflect to cushion the anchor load. In particular, fig. 2G-20A may have a length L that narrows to slip over chordae tendineae and a height H1 that deflects to reduce impact load and wear on the leaflet or annulus as a shock absorber. In addition, the heart-shaped hoop anchor 37 of FIGS. 2G-20A may have a sleeve or cloth 37C surrounding the anchor 37. The heart-shaped hoop anchors 37 of fig. 2G-20B may optionally have a snap-fit configuration in which the top member 37CC of the hoop snaps into the base 37CD of the hoop for shape setting and/or for reducing the crimp length (e.g., a few millimeters). Once uncrimped, such hoops snap free. The heart-shaped hoop anchor design of figures 2G-20A or 20B may not require any shape setup or welding.

Figures 2G-21A and 2G-21B each illustrate a rabbit ear pad anchor configuration formed of two outwardly facing spirals adjacent to one another that bend and separate upon loading to distribute the load and cushion the anchor from contact with the heart anatomy. Figures 2G-21A illustrate an anchor profile that is narrower (e.g., L1 is about 2mm and L2 is about 6-7 mm) and higher (e.g., H2 is 3-4 mm) than figures 2G-21B, thereby allowing easier sliding through or removal from the chord. On the other hand, the wider version of fig. 2G-21B may allow for a wider, more dispersed load when the anchors 37 or the inner frame 32 are positioned against the native valve annulus or leaflet. One or both spirals may optionally be covered with a cloth sleeve to facilitate deployment. No shape setting or welding may be required.

Figures 2G-22 illustrate a collapsible ring pad anchor design formed of two outwardly facing rings similar to the embodiment of figures 2G-21A with additional support from flanges 37D that create a stiffer (e.g., more rigid) ring when contacted from the distal end and a softer ring when contacted from the proximal end, thereby allowing easier disengagement of interaction with chordae anatomy when the valve prosthesis is pulled out. The anchors may optionally be covered with a cloth sleeve or jacket 37C.

Figures 2G-23A and 2G-23B each illustrate a coiled anchor tip design in which the anchor has a plurality of holes 37B-1 (e.g., laser cut holes) through which the wire 37C-1 can be loosely coiled, thereby forming a soft "cushioned" tip of the anchor 37. In particular, fig. 2G-23A may optionally contain a sleeve or cloth 37C covering the wire 37C-1, and the wire end 37F may be welded or crimped as a stop 37E, and fig. 2G-23B may contain radio-opaque markers 37G to indicate deflection from annular contact. The wire ends 37F of fig. 2G-23B may be soldered together. The leads 37C-1 of FIGS. 2G-23A and 2G-23B may be made of nitinol, cobalt chrome, stainless steel, polymers, radiopaque metals, or the like. Such an anchor tip design may not require any shape setting.

Figures 2G-24A and 2G-24B illustrate an anchor having a thin-walled collar cut into the end of the anchor tip, wherein the collar can deflect so that the load can be distributed when the anchor is contacted with an object (e.g., the native heart anatomy) over a large surface area. In the illustrated embodiment, a circular shape (having a diameter R of, for example, 2-4 mm) is cut into the end of the anchor tip. When compressed by contact with tissue, the circular shape forms an oval shape (as shown in FIGS. 2G-24B, diameter L3 is, for example, 3-7 mm). The thin-walled hoops may also deflect around or between tendons when contacted. In particular, the anchor tips of FIGS. 2G-24B are more tolerant of greater contact loads due to the greater contact surface area to be dispensed. Such an anchor tip design may not require any shape setting or welding.

Figures 2G-25A and 2G-25B illustrate zig-zag spring anchors that each have a zig-zag pattern cut into the tip of anchor 37 to provide load distribution and cushioning. The zigzag spring anchors of fig. 2G-25A may be in an angled zigzag pattern forming an angle greater than 0 deg. but less than 90 deg., having a length or width L4 (e.g., 2-3 mm) and a height H3 (e.g., 3-5 mm), while the zigzag spring anchors of fig. 2G-25B may be curved or bent (e.g., 90 deg. or right angles of about 90 deg.). Such an anchor tip design may not require any shape setting or welding.

FIGS. 2G-26A, 2G-26B and 2G-26C illustrate a stirrer tip anchor formed by encircling and threading a plurality of wires 37C-4 through holes 37J around the periphery of a small circular plate 37H to form two to four or more wire hoops, wherein a central rectangular hole 37I of plate 37H can be fitted and stitched onto the ends of the anchor arms. Fig. 2G-26A show side views of the stirrer tip anchor, and fig. 2G-26B show top views of circular plate 37H and close-up side views of an anchor arm containing a tip configured to receive hole 37I of plate 37H. The ends of the wires 37C-4 may be laser welded to the circular plate 37H. The surrounding wire 37C-4 may optionally be covered by a sleeve or cloth 37C. Fig. 2G-26C show top views of the stirrer tip anchor as seen from the top of lead 37C-4. The lead may include nitinol or other shape memory material. For nitinol wires, a different a than the inner frame 32 may be used for nitinol wires _f Temperature (e.g., af temperature closer to body temperature), which may facilitate the nitinol wire providing a softer anchor pad.

FIGS. 2G-27A illustrate a cylindrical braided tip anchor formed of thin wires 37N braided into a cylindrical shape and looped over anchor 37 to add to the anchorBuffering is provided during loading. The thin wire may be a nitinol wire, cobalt chrome wire, stainless steel wire, polymeric wire, or radiopaque metal wire, and the wire may be tubular. In addition, an optional sleeve or cloth 37C may surround the thin wire 37N. Figures 2G-27B illustrate another embodiment of a cylindrical braided tip anchor having a tapered shape formed by an inverted cylindrical braided tip. In the two cylindrical braided tip anchors of fig. 2G-27A and 2G-27B, the end of the inner frame 32 or anchor 37 can be split into two clamping arms 37P for securing the wire ends with an optional crimp sleeve 37O. For nitinol wires, a different a than the inner frame 32 may be used for nitinol wires _f Temperature (e.g., A closer to body temperature _r Temperature), which may promote the nitinol wire to provide a softer anchor pad.

Co-organizing double frame features

According to several embodiments, it is desirable to provide complementary features on structural components (e.g., inner and outer frames) of a dual-frame transcatheter device (e.g., a prosthetic implant or a replacement heart valve). These complementary features are intended to ensure co-organization of the inner and outer frames. The common tissue or complementary features may or may not be in contact in the inflated and/or curled state. However, these co-organized features may advantageously interact to facilitate alignment of the inner and outer frames during the loading and deployment steps, as well as during any subsequent retraction steps.

Common organization or complementary features may be beneficial to device performance, ensuring organized frames for low loading/retraction forces, symmetrical device contours for procedure consistency during deployment, and reduced strain concentrations in frames that are typically caused by asymmetric loading and reduced device durability. Without such common organization or complementary features, structural components (e.g., inner and outer frames) may interact (e.g., by competing for space) and may result in an undesirable asymmetric arrangement, which may lead to more difficult surgery or degradation of the device (e.g., a prosthetic implant).

Transcatheter implants (e.g., replacement heart valves) are typically designed in two states or configurations: an expanded state (e.g., after implantation at a desired location) and a coiled state (e.g., within a delivery device at the time of manufacture or at the time of retraction). Between these two states, the implant undergoes some degree or form of transformation, such as a reduction in diameter (e.g., during loading) or expansion (e.g., during deployment of the implant). This transition between the inflated and curled state, which is often a post-hoc idea in design, may be important as it may affect the ease and/or safety of the implantation procedure. In some cases, multi-frame (e.g., dual-frame) implants may have undesirable frame-to-frame interactions, which create instability within the implant, and may cause the implant to appear to the anatomy in an undesirable asymmetric manner during deployment, which may complicate achieving a successful implantation procedure. Another consequence of negative interactions between the frames may damage the implant or skirt fabric material (e.g., resulting in leakage) and/or may damage the frames (which may result in reduced frame durability and fatigue or failure).

Various common organization or complementary framing features may be designed to ensure that the inner and outer frames or portions of the frames remain aligned and organized throughout the transition state. Fig. 2H shows a side view of an embodiment of an outer frame 34 that includes common tissue frame features. The common tissue frame features include features of a proximal portion 34A of the outer frame 34 and a distal portion 34C of the outer frame 34. Specific co-organization framework features will be discussed in more detail below. In some embodiments, the common tissue or complementary framework features are designed to engage each other only during the transitional state. The common tissue or complementary frame features may be designed, for example, to reduce degrees of freedom, to connect to protect frangible sections or portions of the implant, or to work like a seal to gradually connect the frames in an organized fashion.

As one example, the outer frame of the dual-frame implant may include structural components configured to engage a portion of the inner frame of the dual-frame implant when the dual-frame implant is expanded and/or compressed (e.g., during a transitional state) so as to reduce the likelihood of rotational and/or translational movement between the outer frame and the inner frame. Figures 2I-1 through 2I-3 illustrate various proximal eyelet designs configured to reduce rotational and/or translational movement between an outer frame and an inner frame of a dual frame implant. Fig. 2I-1 shows a close-up view of the proximal portions 32A, 34A of an embodiment of the inner and outer frames 32, 34 during a transitional state, wherein the proximal portions 32A, 34A are in a curled configuration, but the distal portions 32C, 34C are still inflated. As shown, the proximal eyelets of the outer frame 34 may include a hammerhead design to provide uniform spacing between the eyelets. The hammer head design includes thickened side walls with flat edge surfaces for upper and lower apertures of the outer frame 34. The thickened planar side surfaces of the eyelets are configured to contact and abut one another to provide uniform spacing (due to the uniform size of the design). Fig. 2I-2 shows a portion of a cut-out pattern of an embodiment of the outer frame 34, which shows an eyelet portion with a hammer design adapted to limit rotational movement freedom only. Fig. 2I-3 illustrate a portion of a cut-out pattern of an embodiment of an outer frame 34, showing two adjacent eyelet portions having a hammer design configured to limit rotational and/or translational movement degrees of freedom. As shown, the eyelet portion (shown at the top of fig. 2I-2 and 21-3) includes two central extensions (e.g., nubs, protrusions, tabs) on one side of the central eyelet that are configured to engage with cutout features (e.g., recesses, grooves, indentations) on an opposite side of an adjacent central eyelet to limit translational height movement when the adjacent eyelet portions are engaged. The upper and lower eyelets contain thickened side portions that are wider/thicker on one side than on the other. Other designs and shapes may be used to promote common organization between the eyelet portions of outer frame 34.

Fig. 2J-1 and 2J-2 help to show another example of a common organizational frame feature (e.g., slot, opening, or guide structure) of an outer frame designed to span an inner frame axial strut (e.g., the inner frame axial strut extends outwardly within the common organizational frame feature of the outer frame) to facilitate alignment of the outer frame and the inner frame during transition between an expanded configuration and a compressed configuration, and/or vice versa. The outer frame may have a plurality of common tissue frame features circumferentially spaced around the outer frame to span a plurality of inner frame axial struts. FIG. 2J-1 illustrates a dual frame design without the common organizational frame feature. As shown, the overlapping axial beams of the outer frame with high curvature in the expanded state result in a non-uniform geometry in the transitional state. Fig. 2J-2 illustrates a dual frame design with common organizational frame features. The outer frame 34 contains the hammer proximal eyelet design previously described and shown in fig. 2I-1. The complementary or common tissue frame features of the inner frame 32 are axial beams or struts 212 on the proximal or inflow aspect 32A of the inner frame 32. The complementary or common tissue frame feature of the outer frame 34 may be a wide diamond-shaped cell connection at the proximal or inflow aspect 34A of the outer frame 34 that overlaps with a tightly rounded section of the shape profile. In some embodiments, the common tissue frame features of the outer frame 34 include a C-shaped or U-shaped joint (e.g., forming a slot or guide socket or other mechanism) designed to span the corresponding inner frame axial strut 212 for alignment. When the dual frame implant is loaded into the delivery device, the rounded outer frame C-shaped joints bend inwardly and span the inner frame axial struts 212, which act as vertical rails and help maintain the outer frame 34 in full or nearly full alignment with the inner frame 32 throughout the loading, retrieving, repositioning. Once the implant is fully crimped, the curvature of the outer frame common tissue frame feature (e.g., C-shaped or U-shaped joint) is straightened and disengaged from the inner frame axial struts 212. The common tissue frame features may not engage (or interact) when the implant is in the fully expanded configuration.

Fig. 2K-1 illustrates how an outer frame without common tissue frame features may interact adversely with anchors 37 on the inner frame of a double-frame valve prosthesis during crimping. Fig. 2K-2 illustrates how embodiments of the outer frame 34 may be designed to incorporate common tissue frame features such that the distal outflow portion 34C of the outer frame 34 avoids interaction with the inner frame anchors 37 during crimping. The distal outflow portion 34C of the outer frame 34 may be shaped and adjusted such that the distal apices of the distal units of the outer frame 34 are not aligned with or overlap the distal anchors (e.g., ventricular anchors) 37 of the inner frame 32. The anchors 37 may alternatively be designed to be positioned between the distal apices of the distal units of the outer frame 34 during crimping.

Proximal/inflow/inlet strut features

Fig. 2J-3 illustrate an embodiment of the internal frame 32 design in which the proximal or inlet struts are at uneven, staggered or offset heights in order to reduce the total (i.e., maximum) force required to retrieve and retrieve a fully or partially atrial expanded replacement heart valve or valve prosthesis. The offset, staggered or uneven heights distribute the force during retraction, rather than having a large spike immediately when all struts are simultaneously pulled into the delivery system, as is the case when the heights are uniform and there is no offset (e.g., axisymmetric). Fig. 2J-4 are graphs showing the expected results of force reduction using the offset height design of fig. 2J-3. Referring to fig. 2J-3, the proximal or inlet struts 202 of the inner frame 32 may have different heights (e.g., a height difference H4) in a manner such that adjacent struts are offset relative to one another. The alternating offset heights allow half of the strut 202 to be pulled first into the delivery system and the rest to be pulled later, creating two small spikes in retraction force instead of one large spike as shown in fig. 2J-4. The reduction in force may be, for example, a 25-50% reduction in force. That is, the offset configuration may create a sequential placement of struts 202 within the capsule tip of pusher 506 or capsule subassembly 306, reduce retraction forces, reduce tension on the retraction suture, reduce forces on the dual frame valve, and reduce compression during the retraction process. Thus, the forces required to load and retract the valve prosthesis are expected to be reduced. The reduced retraction force may result in less tension on the suture during retraction and less compression on the intermediate shaft subassembly 22 during retraction. The staggered or offset height may also help reduce the risk of the struts getting stuck on the distal tip or edge of the capsule subassembly 306 when the implant 30 is retracted within the capsule subassembly 306. The height of the strut 202 may be varied by, for example, varying the strut length (e.g., the height above the connection point to the main frame body (e.g., cell structure)), angle, etc. There may be two different heights, wherein the height of each strut alternates around the periphery of the frame. There may be more than two different heights (e.g., three different heights, four different heights), with different pairs or groups of struts having different heights.

According to several configurations, the outer frame of the dual frame implant may include cantilevered or hinged attachment tabs that allow attachment between the outer frame and the inner frame in a manner that allows an angle to be formed between the attachment portions of the outer frame and the inner frame because the attachment portions of the outer frame bend in a plane that is independent of the attachment portions of the inner frame, thereby reducing the radius of curvature of the dual frame implant along the area where the outer frame and the inner frame are attached. Figures 2L-1 through 2L-3 illustrate various examples of attachment or connection structures between a proximal eyelet of an outer frame of a double-frame valve prosthesis and a connection post. Fig. 2L-1 shows that the bottom (e.g., distal-most or lower-most) aperture of the aperture 35 of the proximal tab 33 of the proximal portion 34A of the outer frame 34 may be connected to the proximal ends of one or more struts 34E, 34F of the outer frame 34 by a bridge 34G. The strut may include at least two outer strut legs 34E connected to a bridge 34G. The struts may further comprise at least two inner leg struts 34F, one end of which is coupled to an upper interior of a respective one of the at least two outer leg struts 34E. The bridge 34G may have a predetermined length between the lowermost eyelet of the eyelets 35 and the joint C. In addition, at least two outer legs 34E may extend downwardly from the joint C. The bridge 34G of each connection structure is in contact with a respective tab surface of the inner frame 32 when at least one of the plurality of apertures of each of the plurality of tabs of the outer frame 34 is engaged with at least one of the plurality of apertures of the plurality of tabs of the inner frame. In several instances, when the outer frame 34 and inner frame 32 are aligned and joined together, such a design may need to be tangential to the inner frame aperture, which may force a high radius of curvature profile, which may result in high strain during crimping and concentrated fatigue strain on the inverted taper of the joint C between the bridge 34G and the proximal end of the strut.

Fig. 2L-2 shows another example of a linking element or connection structure of the outer frame 34. In this example, bridge 34G has been substantially shortened as compared to the bridge shown in FIG. 2L-1. The bridge 34G is not connected to the bottom or most distal eyelet but to the most proximal or upper eyelet by an outer frame 34I of a tab 33 extending from the bridge 34G and surrounding the more distal eyelet, thereby forming a "pop-tab" configuration similar to a pull tab for opening a soda can. The bridge 34G in FIG. 2L-2 may have the same or a shorter length than the bridge in FIG. 2L-1. Similar to the embodiment of fig. 2L-1, at least two outer leg struts 34E in fig. 2L-2 may extend downwardly from the joint C. The bridge 34G of fig. 2L-2 may advantageously separate the plane of movement such that the tab 33 may flex along a plane independent of the outer frame 34I, the bridge 34G, and/or the outer leg strut 34E and independent of the attachment portion of the inner frame 32. Thus, the attachment portion of the outer frame 34 may be bent at an angle relative to the attachment portion of the inner frame 32, thereby facilitating a reduction in radius of curvature along the proximal inflow region of the dual frame implant or valve prosthesis.

Fig. 2L-3 illustrate yet another example of a linking element or connection structure of the outer frame 34. As shown in fig. 2L-3, bridge 34G and tab C have been completely removed from the structure. At least two outer leg struts 34E are connected to respective sides of the uppermost or proximal-most eyelet but not to respective sides of the other eyelet, thus forming a "paperclip" structure. Extends downwardly from the outer tab 33B, and the inner tab 33A may be spaced apart from the at least two outer legs 34E along at least a portion of the edge of the inner tab 33A.

According to several embodiments, the geometric implementation of fig. 2L-2 and 2L-3 advantageously eliminates the need for the eyelet to be tangential to the connecting strut by creating a separate plane (e.g., a bendable or cantilevered tab portion) for eyelet attachment between the one or more attachment eyelets of the inner frame 32 and the outer frame 34, and provides greater flexibility for future profile designs of the outer frame and the inner frame. For example, inflow struts on the bendable or cantilevered tab portions of the outer frame may act as cantilevers that hold the outer frame 34 closed until the capsule subassembly 306 is fully retracted.

Figures 2L-4 to 2L-6 illustrate various embodiments of the tab 33 and/or eyelet 35 of the proximal or inlet leg of the outer frame. According to several embodiments, these examples may advantageously prevent or reduce the likelihood of the suture or tether loop knotting, looping, or "locking" around the tip of the proximal or inlet struts during removal of the suture or tether during the step of releasing the valve prosthesis from attachment to the delivery system. Instead, the suture or tether loop may be easily disconnected from the outer frame 34 of the valve prosthesis by the uppermost or proximal eyelet 35A. In particular, FIGS. 2L-4 and 2L-5 illustrate the connecting elements or structures of the outer frame 34, similar to FIGS. 2L-2, forming a "easy pull tab" configuration similar to a pull tab for opening a soda can. However, the embodiments of FIGS. 2L-4 through 2L-6 may also be incorporated into a "paperclip" configuration or other configurations. The embodiments of fig. 2L-4 and 2L-5 may be formed by laser cutting. The uppermost or proximal-most aperture 35A may have a semicircular (semicircle) shape (as shown in fig. 2L-4), an oval shape (as shown in fig. 2L-5), or a bean shape (as shown in fig. 2L-6). As shown in these figures, the uppermost or proximal-most aperture 35A may have a generally circular geometry. Further, the height H5 of the attachment hole centerline of the proximal-most hole eye 35A may vary (e.g., decrease) such that the suture or tether does not hook, loop, or tie off on the proximal side or proximal tip of the entry post. Referring to fig. 2L-6, the radius R of the proximal-most eyelet 35A is greater than the radius of fig. 2L-4, but less than the radius of fig. 2L-5. In one embodiment, the radius R may be about 0.1mm to 0.3mm. Height H6 and height H7 combine to be height H5. One or both of the height H6 and the height H7 may be reduced to reduce the height H5. In some embodiments, the height H6 may range from 0.230mm to 0.330mm, and in some embodiments, the height H7 may range from 0.520 to 0.580mm. By reducing one or both of height H6 and height H7, and thus reducing height H5, the thickness of the suture or tether in combination with the reduced height, prevents the suture or tether from looping, hooking, or knotting on the proximal end of the proximal or access strut. The proximal tip of the proximal or inlet struts may also have a rounded or chamfered outer top geometry. For example, the proximal tip of the proximal or inlet struts may have a radius of curvature R2. According to several embodiments, the radius of curvature R2 is designed to be smaller than the height H5. In some embodiments, the side geometry of the proximal or inlet struts may be straight (as shown in fig. 2L-2 through 2L-5), as opposed to a "snowman" side geometry (as shown in fig. 2L-1).

Different tab configurations, particularly varying the eyelet configuration as described above, may bring about different advantages, such as ease of manufacturing the outer frame, ease of attaching the replacement heart valve (e.g., by sewing), reduced tensile stress, etc. According to several embodiments, during the tether/suture release step, a series of operations (e.g., posterior, anterior, lateral, and medial operations) may be performed to provide an indication of any likelihood of knotting or looping.

Figures 2M-1 and 2M-2 illustrate various radius of curvature profiles of the dual frame valve when the inner and outer frames are engaged. For example, the outer profile may have a radius of curvature as shown in FIG. 2M-1 when the embodiment of FIG. 2L-1 is engaged with the inner frame, and may have a smaller radius of curvature than that of FIG. 2M-1 when the embodiment of FIG. 2L-2 or FIG. 2L-3 is engaged with the inner frame, as shown in FIG. 2M-2. The high radius of curvature may make it difficult for a physician to capture chordae tendineae under the mitral valve annulus, for example, because the outer frame of the double-frame valve prosthesis may have to be deployed at the same time that the ventricular anchor reaches its full diameter. Thus, by changing the configuration of the outer frame, more specifically, the configuration of the outer frame's eyelet and post connections or attachment structures, the radius of curvature of the dual-frame heart valve prosthesis can be adjusted to delay the deployment of the outer frame in addition to reducing the crimping strain at the locations (e.g., at joint C) subject to compound radial and circumferential bends due to the curvature of the profile. Accordingly, the dual frame valve prosthesis may be designed to have a reduced radius of curvature at the proximal end when in the expanded configuration, as shown in fig. 2M-2.

The embodiments shown in figures 2L-2 and 2L-3 and 2M-2 provide flexibility to create new cork profiles for double frame valve prostheses, according to several embodiments. The connection structure shown in fig. 2L-2 and 2L-3, and the more gradual profile or radius of curvature shown in fig. 2M-2, may allow for delayed release of the outer frame during delivery, and may reduce curling and fatigue strain. Delayed release may be achieved by using the inflow struts as cantilevers that keep the outer frame closed until the delivery capsule (e.g., capsule subassembly 306 described below) is fully retracted. The reduced radius of curvature can significantly reduce fatigue strain of joint C and improve the crimping strain distribution.

FIGS. 2N-1 and 2N-2 illustrate an outer frame having the "easy pull tab" connection structure design of FIG. 2L-2 in an expanded configuration and illustrate a reduced radius of curvature profile of such design. FIGS. 2N-3 and 2N-4 illustrate the outer frame of the design with the "paperclip" connection of FIGS. 2L-3 in an expanded configuration and illustrate the reduced radius of curvature profile of such a design.

Fig. 2O-1 illustrates a dual frame valve prosthesis in which the inner frame 32 and the outer frame 34 are engaged in a pre-expanded state in which the outer frame 34 is not deployed. Fig. 2O-2 illustrates a dual frame valve prosthesis in which the inner frame 32 and the outer frame 34 are engaged in a capsule retracted state in which the outer frame 34 is deployed. As described herein, by altering the linking or connecting structure (e.g., shape, connection, etc.) of the proximal portion of the outer frame 34, it is possible to delay the deployment of the outer frame 34, as shown in fig. 2O-2.

In some examples, the outer and inner frames of the dual frame valve prosthesis may be joined by aligning and attaching one or more of its plurality of eyelets 35, for example, in a "snowman" approach in which the inner and outer frames are fixed. The larger diameter of the outer frame may be used to engage the native tissue for sealing and fixation in the large annulus native tissue. The smaller inner diameter of the inner frame may be used to hold tissue leaflets of the prosthetic valve and may provide smaller prosthetic valve diameters to reduce tissue volume, pulsating frame loading, and frame radial crimping forces. The dual frame valve prosthesis structure may provide the above-described advantages by creating a significant difference between the expanded diameters of the inner and outer frames.

In some embodiments, the proximal eyelet portions of the inner and outer frames may be engaged with each other, the eyelets of each frame aligned, and a "snowman" approach of wrapping the suture multiple times through the aligned inner and outer eyelets to hold the frame struts together at the inflow side of the valve. In order to maintain a significant difference in expansion diameter between the inner and outer frames assembled using the "snowman" method described above, a sharp turn is required to create space between the inner and outer frames, resulting in increased strain and crimping load forces. For example, referring to fig. 2P-1 and 2P-2, the figures show the eyelets 35 of each of the inner frame 32 and outer frame 34 engaged with one another by stitching that encircles each eyelet a predetermined number of times to ensure attachment of the eyelets. Here, the outer frame 34 may have an attachment configuration corresponding to the example of fig. 2L-1 described above.

Fig. 2P-3 and 2P-4 illustrate another example of connecting or engaging an inner frame 32 and an outer frame 34 of a dual frame valve prosthesis. For example, the inner frame 32 and the outer frame 34 may include corresponding or complementary engagement or attachment features that allow for an angle to be formed between the engagement portions of the inner frame 32 and the outer frame 34 at the attachment point. In the example of fig. 2P-3 and 2P-4, the inner lock tab member 33A of the tab 33 of the outer frame 34 includes a puzzle lock tab end configured to fit within a corresponding slot on the proximal inflow end of the corresponding tab or post 202 of the inner frame 32, thereby providing a compact mechanical lock between the post of the inner frame 32 and the inner lock tab member 33A of the outer frame 34. As shown in fig. 2P-3, the "puzzle lock tab" design may advantageously form a greater angle between the inner and outer frames at the attachment point and may provide a more gentle curve profile for outer frame 34, thereby reducing strain and crimping load forces, as compared to the embodiments of fig. 2P-1 and 2P-2.

For certain embodiments, the inner lock tab member 33A includes a tab (e.g., a dovetail tab) that fits within a correspondingly shaped slot (e.g., a simple planar fit) of the post 202 of the inner frame 32, thereby reducing suture loading by a mechanical lock between the interacting metal components of the frame. The joining or engagement may involve the use of a single suture tie to keep the two frames coplanar at the joint or mechanical mating interface, or may optionally involve an off-center/off-axis laser cut that may provide a tapered or beveled fit between the tabs 33 of the outer and inner frames 34, 32 to reduce the use of sutures while keeping the tabs 33 of the outer and inner frames 34, 32 coplanar by the spring force of the tabs holding the frames together, as shown in fig. 2P-4. Fig. 2P-4 also show detailed cross-sectional views along section line B-B. Detailed cross-sectional views show in more detail how the interface between the inner lock tab 33A of the inner frame 32 and the post tab opening is optionally beveled with an off-axis laser to lock the metal tabs of the inner and outer frames together without any suture.

In another example, referring to fig. 2P-5 and 2P-6, the proximal ends of the inner and outer frames may be connected or joined using a dovetail joint connection. This embodiment may provide a dovetail joint in which the proximal end or post of the inner frame 32 includes a dovetail shape (e.g., cut with a perpendicular laser cutting operation), while the post of the outer frame 34 has an angled cut to match the angle of the dovetail joint members on the inner frame 32, thereby forming a dovetail joint or mating fit that allows the components to be assembled together in one manner, but prevents the components from being pulled apart in any other manner. The dovetail angle of the inner frame 32 and the eccentric taper angle of the struts of the outer frame 34 may be adjusted to allow for different angles (e.g., 45 degrees, 60 degrees, 90 degrees, or other angles) between the inner frame 32 and the outer frame 34. Two alternative optional techniques for preventing separation of the inner and outer frames (e.g., inner frame dovetails backing out of dovetail slots on the outer frame under load) include: (1) The eyelets 35 of the inner and outer frames may optionally be engaged with one another by a tensioning suture or tether wrapped therein, and/or (2) the outer frame may include snap locks 34J integrally or detachably connected to the struts of the outer frame to secure the attachment of the inner and outer frames 32, 34, as shown in fig. 2P-6.

The joint structure as illustrated in fig. 2P-3 and 2P-4 or fig. 2P-5 and 2P-6 may advantageously facilitate achieving a greater angle between the inner and outer frames at the attachment point while also reducing valve space in the direction of the crimped length and avoiding the complete reliance on suture windings for fixation. The joint structures as illustrated in fig. 2P-3 and 2P-4 or fig. 2P-5 and 2P-6 may also advantageously provide easier access and stitching during manufacture of the connection structure. Fig. 2P-7 show close-up views of another example of a dovetail joint structure. As shown, one or more dovetail tabs may be formed to provide a secure engagement.

Delivery device

Referring briefly back to fig. 1, the delivery device 15 may include a shaft assembly 12 comprising a proximal end and a distal end, wherein the handle 14 is 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 vasculature to a treatment 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 for advancing the implant within the body. The shaft assembly 12 may then be used to allow controlled expansion of the implant at a desired implantation site (e.g., a treatment site). In some embodiments, the shaft assembly 12 may be used to allow sequential controlled expansion of the implants, as discussed in detail below.

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. Delivery device 15 may include multiple layers of concentric subassemblies, shafts, or lumens. Various lumens or shaft subassemblies will be described starting from the outermost layer. In some embodiments, the subassemblies disclosed below may be in a different radial order than discussed.

External subassembly

Fig. 3A shows a perspective view of an embodiment of the outer sheath subassembly 20 of the delivery device 15 of the delivery system 10. The outer sheath subassembly 20 forms a radially outer covering or sheath to encompass the implant holding area and prevent at least a portion of the implant (e.g., a replacement heart valve or valve prosthesis) 30 from radially expanding until ready for implantation. In particular, the outer sheath subassembly 20 may prevent radial expansion of the distal end portion of the implant 30.

The outer sheath subassembly 20 can include an outer proximal shaft 302 with a proximal end portion operatively coupled (e.g., by a threaded outer sheath adapter 303) to a capsule knob 905 (which can be the most distal knob, as shown in fig. 9A and 9B) of the handle 14, such that rotation of the capsule knob 905 causes proximal and distal translation (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 for other subassemblies to pass through.

The outer proximal shaft 302 may be a tube formed of plastic, but may also be formed of metallic hypotubes or other materials. The outer proximal shaft 302 may include an outer sheath or liner made of Fluorinated Ethylene Propylene (FEP) material, polytetrafluoroethylene (PTFE) material, ePTFE material, or other polymeric material to smooth and/or stop bleeding from the outer surface of the outer proximal shaft 302. The outer proximal shaft 302 may include a connector (e.g., a flexible return 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 general flexible pattern (e.g., an interrupted helical pattern or an interrupted coil).

Figure 3B shows a side cross-sectional view of capsule subassembly 306. The capsule subassembly 306 may include a distal hypotube or capsule holder 308, an inner liner inside the hypotube 308, a distal capsule tip 309, and one or more outer liners or sheaths 311 surrounding the hypotube 308. The one or more outer liners or jackets 311 can include polyether block amide (e.g.,materials) or other suitable polymeric or thermoplastic elastomeric materials such as Polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The inner liner may comprise PTFE, which may be pre-compressed prior to application to the interior of hypotube 308. The distal capsule tip 309 may include an atraumatic tip adapted to act as a funnel to facilitate retrieval (e.g., crimping) of a valve prosthesis or other implant. Distal capsule tip 309 may comprise Polyetheretherketone (PEEK) or other thermoplastic, polymeric or metallic materials. Distal capsule tip 309 may be loaded with a radiopaque material (e.g., 5-40% barium sulfate loading) to facilitate detection (e.g., made fluorescent) under radiographic imaging (e.g., fluoroscopy). The distal capsule tip 309 may fit within the open distal end of hypotube 308.

Fig. 3C shows a perspective view of the distal hypotube or capsule holder 308. Capsule holder 308 may be made of one or more materials, such as PTFE, ePTFE, polyether block amide (e.g., PEBAX), polyetherimide (e.g.,material), PEEK, polyurethane, nitinol, stainless steel, and/or any other biocompatible material. The capsule holder 308 is preferably flexible while still maintaining a sufficient degree of radial strength to maintain the implant (e.g., replacement valve) 30 within the capsule holder 308 without significant radial deformation that would increase the capsule holder 308 and the inclusion thereinIs provided. The capsule holder 308 also preferably has sufficient column strength to resist bending, and sufficient tear resistance to reduce or eliminate the likelihood of the implant tearing and/or damaging the capsule holder 308. The proximal and/or distal ends of the distal hypotube or capsule holder 308 may contain a plurality of laser cutting windows 313 adapted to fluoresce and/or echogenically sound the proximal and/or distal ends to facilitate visualization in certain imaging modes (e.g., non-invasive ultrasound imaging or invasive fluoroscopic imaging). In several embodiments, a separate radiopaque element or component is not added to hypotube 308 to facilitate imaging due to the presence of laser cut window 313. The laser cut window 313 may also facilitate the bonding of the outer sheath 311 to the capsule holder 308 and inner liner by allowing glue or other adhesive to flow through the laser cut window 313. One or more layers of connecting members made of PEBAX or other suitable material may surround the laser cut window 313 to facilitate coupling of the hypotube or capsule holder 308 to the distal capsule tip 309.

Hypotube 308 may be made of a plastic or metal material. In some embodiments, hypotube 308 may be a metallic hypotube. If metallic, the metallic material of hypotube 308 may include cobalt chrome, stainless steel, titanium, or a metallic alloy, such as a nickel titanium alloy material. The coil configuration or cutting pattern of the outer proximal shaft 302 and/or hypotube 308 may allow the outer proximal shaft 302 to follow the rail subassembly 21 in any desired direction. The cutting pattern (e.g., cutting per revolution, pitch, spine distance) of the outer proximal shaft 302 and/or hypotube 308 may be modified to control tension, compression, flexibility, and torque resistance. For example, the range of cuts per revolution may be between 1.5 and 5.5, the range of pitches may be between 0.005 "and 0.15", and the range of spine distances may be between 0.015 "and 0.125". Hypotube 308 may advantageously provide both tension and compression. The one or more outer liners or jackets 311 may allow for more flexibility of the capsule subassembly 306. The capsule hypotube 308 may be curved in multiple directions. In some embodiments, the distal tip of the outer liner or sheath 311 may be positioned proximal to the distal tip of the hypotube 308.

The capsule subassembly 306 may have a similar diameter as the outer proximal shaft 302 or a different diameter. In some embodiments, the capsule subassembly 306 has a uniform or substantially uniform diameter along its length. In some embodiments, the size of the capsule subassembly 306 can be 28 french or less (e.g., 27 french). In some embodiments, the capsule subassembly 306 may include a larger diameter distal portion and a smaller diameter proximal portion. The capsule subassembly 306 may be configured to retain the implant (e.g., valve prosthesis) 30 in a compressed position within the capsule subassembly 306 (e.g., within the implant retention area 316 that occupies about 2 inches (or about 50 mm) of the distal-most side of the capsule subassembly 306). Additional structural and operational details of the capsule subassembly, such as those described in connection with the capsules of U.S. publication No. 2019/0008640 and U.S. publication No. 2019/0008639, which are hereby incorporated by reference, may be incorporated into the capsule subassembly 306.

The outer sheath subassembly 20 is configured to be individually slidable (translatable) relative to the other assemblies by rotating the capsule knob 905. Further, the outer sheath subassembly 20 may slide (translate) distally and proximally with respect to the rail subassembly 21 along with the intermediate shaft subassembly 22, the manifold subassembly 24, the release subassembly 23, and/or the nose cone subassembly.

Fig. 3D schematically illustrates how at least a portion of the length of one or more components of the capsule subassembly 306 (e.g., the inner liner 310) may include excess material such that the capsule subassembly 306 includes built-in slack along a portion of its length (e.g., a portion of the length proximate to the implant holding zone 316) to facilitate flexible bending of the capsule subassembly 306 (e.g., navigation of sharp turns within the heart or vasculature surrounding the heart).

Fig. 3E to 3G illustrate an alternative embodiment of the distal capsule tip of the capsule subassembly 306. In contrast to the distal capsule tip 309 of fig. 3B (which has a straight end or a vertically flattened distal end), the distal capsule tip 309A has an uneven end (e.g., a lobed tip or wave shape), as shown in fig. 3E, formed by lobes 309A-1 and 309A-2 that alternately protrude and recess. Such uneven ends of distal capsule tip 309A allow for staged deployment or retraction of anchors 37. Fig. 3F illustrates a side partial cross-sectional view of distal capsule tip 309A and schematically illustrates the staged or offset deployment or retraction of anchors 37 due to the lobed design of distal capsule tip 309A. Fig. 3G is a plan view showing that when retrieving the anchors, capsule subassembly 306 can first retrieve, for example, one or more (e.g., two, three, or more) anchors 37, and then retrieve the remaining anchors 37 (alone or in pairs, three, or other groupings) at a later stage (e.g., two or three stages). Staged retraction or deployment may advantageously distribute the retraction force to straighten the anchors 37 over time, thereby reducing the overall force amplitude (e.g., by 20-40%) at any one time during retraction. In this example, three lobes are shown at 12 o ' clock, 4 o ' clock and 8 o ' clock, respectively. Such a configuration allows some anchors to begin to de-flex before others during the retraction process where the capsule is advanced over the J-shaped anchors. This staggering or staging of anchor retraction distributes the force, allowing the anchors to de-flex and advance the capsule, thereby reducing peak loads or forces. Other numbers or shapes of lobes may be used.

Guide rail subassembly

Fig. 4A shows a perspective view of an embodiment of a rail subassembly 21 of a delivery device 15 of the delivery system 10 of fig. 1. Fig. 4A shows substantially the same view as fig. 3A, but with the outer jacket subassembly 20 removed, thereby exposing the rail subassembly 21. Fig. 4B further shows a cross section of the proximal and distal end portions of the rail subassembly 21 to view the pull wires that facilitate steering of the rail subassembly 21. The rail subassembly 21 may include a rail shaft 402 (or rail) that is typically attached (and operably coupled) at its proximal end to the handle 14. The rail shaft 402 may be comprised of a rail proximal shaft 404 attached directly to the handle 14 at a proximal end and a rail hypotube 406 attached to a distal end of the rail proximal shaft 404 (e.g., via a connector, loop structure, or insert 407). The rail subassembly 21 is operably coupled to the handle 14 by a primary flex adapter 403A (which controls the medial-lateral trajectory of the distal end portion of the rail subassembly 21 by one or more distal pull wires 410A), by a secondary flex adapter 403B (which controls the anterior-posterior trajectory of the distal end portion of the rail subassembly 21 by one or more proximal pull wires 410B), and by a rail adapter 405 (which includes a lateral needleless injection port to facilitate flushing and degassing functions). The rail proximal shaft 404 may contain an interrupted helical cutting pattern along most of its length to facilitate compression. The rail hypotube 406 may further include an atraumatic rail tip 408 at its distal tip. The atraumatic rail tip 408 may not include a slit and is configured to extend up to 1 inch beyond the distal end of the rail hypotube 406 and is configured to not be inserted into the outer shaft subassembly 20 to avoid friction and fatigue and to extend service time. These components of the rail subassembly 21 may form a rail lumen for other internal subassemblies to pass through.

Fig. 4B shows a side cross-sectional view of the rail subassembly 21 of fig. 4A. As shown in fig. 4B, one or more pull wires 410 are attached to the inner surface of the rail hypotube 406, which can be used to apply force to the rail hypotube 406 and manipulate the rail subassembly 21. The puller wire 410 may extend distally from a primary and secondary bending knob 915 (shown in fig. 9A and 9B) in the handle 14 to the guideway hypotube 406. In some embodiments, the pull wire 410 may be attached at different longitudinal locations on the rail hypotube 406, thereby providing multiple bending locations in the rail hypotube 406, allowing for multi-dimensional steering. For example, rail hypotube 406 may provide a primary bend or flex along the medial/lateral trajectory and a secondary bend or flex along the anterior/posterior trajectory.

The rail hypotube 406 may contain a plurality of circumferential slots (e.g., laser cut into the hypotube) to facilitate bending and flexibility. The rail hypotube 406 may generally be divided into a plurality of different sections. At the proximal-most end is an uncut (or ungrooved) hypotube segment corresponding to the location of the insert 407. Moving distally, the next section is the proximal slotted hypotube section 406P. This section includes a plurality of circumferential slots cut into the rail hypotube 406. Typically, two slots are cut around each circumferential location, forming almost half of the circumference. Thus, two trunks are formed between slots extending along the length of rail hypotube 406. This is a section that may be guided by the proximal pull wire 410B. Further distal movement is where the proximal pull wire 410 is connected, and thus a slot may be avoided. This section is just distal to the proximally slotted section 406P and may correspond to the position of the insert or pull wire connector 411.

The distal slotted hypotube segment 406D distally follows the proximal pull wire connection region. This section is similar to the proximally slotted hypotube section 406P, but significantly more slots may be cut over equal lengths. Thus, the distal slotted hypotube segment 406D may provide easier bending and increased bending angles compared to the proximal slotted hypotube segment 406P. In some embodiments, the proximal slotted section 406P may be configured to undergo approximately 90 degrees of bending with a bending radius between 0.25 "and 1" (e.g., between 0.25 "and 0.75", between 0.4 "and 0.6", between 0.5 "and 1", overlapping ranges thereof, or any value within the ranges), while the distal slotted section 406D may be bent approximately 180 degrees with a bending radius between 0.25 "and 1" (e.g., between 0.25 "and 0.75", between 0.4 "and 0.6", between 0.5 "and 1", overlapping ranges thereof, or any value within the ranges). Further, as shown in fig. 4A and 4B, the ridge of the distal slotted hypotube segment 406D is circumferentially offset from the ridge of the proximal slotted hypotube segment 406P. Thus, the two sections will achieve different bending modes, allowing three-dimensional steering of the rail subassembly 21. In some embodiments, the ridges may be offset 30 degrees, 45 degrees, or 90 degrees, although the particular offset is not limiting. The distal-most side of the distal slotted hypotube segment 406D is the distal pull wire connection region, which is also the non-slotted segment of the guideway hypotube 406.

In some embodiments, one distal pull wire 410A may extend to a distal portion of the guideway hypotube 406 (e.g., to the guideway tip 408) and two proximal pull wires 410B may extend to a proximal portion of the guideway hypotube 406; however, other numbers of pull wires may be used, and the particular number of pull wires is not limited. For example, two distal pull wires 410A may extend to a distal position and a single-heel proximal pull wire 410B may extend to a proximal position. In some embodiments, a loop structure or insert (referred to as a pull wire connector) attached inside the guideway hypotube 406 may be used as an attachment location for the proximal pull wire 410B (e.g., insert 411). In some embodiments, the pull wire 410 may be directly connected to the inner surface of the rail hypotube 406.

The distal pulling wire 410A may be connected (either on itself or through the rail tip connector 408) generally at the distal end of the rail hypotube 406. The proximal puller wire 410B may be connected (either by itself or by the insert 411) at a location approximately one quarter, one third, or one half of the way up the guideway hypotube 406 from the proximal end. In some embodiments, the distal pull wire 410A may pass through a small diameter pull wire lumen (e.g., tube, hypotube, cylinder) attached inside the guide rail hypotube 406. This may prevent the puller wire 410 from pulling the guide rail hypotube 406 at a location proximal to the distal connection. Further, the lumen may include a compression coil to strengthen the proximal portion of the rail hypotube 406 and prevent unwanted bending. Thus, in some embodiments, the lumen is positioned only on a proximal portion (e.g., proximal half) of the guideway hypotube 406. In some embodiments, each distal pull wire 410A may use multiple lumens, such as longitudinally spaced apart or adjacent lumens. In some embodiments, each distal lead 410A uses a single lumen. In some embodiments, the lumen may extend into a distal portion (e.g., distal half) of the guide rail hypotube 406. In some embodiments, the lumen is attached to 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 coil 413 may be configured to bypass the load over a length between the distal primary flex point and the proximal secondary flex point. The compression coil 413 facilitates independent flex planes such that neither flex plane will activate when one flex plane is required to flex. The compression coil 413 may allow the proximal slotted hypotube segment 406P to remain rigid for a particular bending of the distal slotted hypotube segment 406D. The compression coil 413 may isolate the force and thus only the primary flex is bent.

For a pair of proximal pull wires 410B, the wires may be spaced approximately 180 ° apart from each other to allow manipulation in both directions. Similarly, using a pair of distal pull wires 410A, the wires may be spaced approximately 180 ° apart from each other to allow manipulation in both directions. In some embodiments, the pair of distal pull wires 410A and the pair of proximal pull wires 410B may be spaced approximately 90 ° apart from each other. Opposing wires may be used to provide a flex resistant mechanism. In some embodiments, the pair of distal pull wires 410A and the pair of proximal pull wires 410B may be spaced approximately 0 ° apart from each other. However, other locations of the pull wire may be used and the particular location of the pull wire is not limiting. In some embodiments, distal pull wire 410A may pass through a lumen attached within the lumen of guide rail hypotube 406. This may prevent the axial force on the distal pull wire 410A from creating a bend in the proximal section of the guideway hypotube 406. The rail subassembly 21 is disposed to be slidable (e.g., translatable) over the radially inner subassembly. When the rail hypotube 406 bends, it presses against the other subassemblies to bend them as well, and thus the other subassemblies of the delivery device 15 may be configured to maneuver with the rail subassembly 21 as a coordinated single unit, providing full maneuverability of the distal end of the delivery device 15. Additional structural and operational details of the rail subassembly, such as those described in connection with the rail subassemblies in U.S. publication No. 2019/0008640 and U.S. publication No. 2019/0008639, which are hereby incorporated by reference, may be incorporated into the rail subassembly 21.

Fig. 4C schematically illustrates how the outer compression coil 413A and the proximal pull wire 410B1 may have a longer length than the inner compression coil 413B and the proximal pull wire 410B2 of the guide rail subassembly 21 such that they do not occupy the same space to reduce lumen blockage during bending, and/or to facilitate easy bending in one direction.

Fig. 4D-2 schematically illustrates a method of manufacture that includes wall penetration welding (as compared to existing direct wire welding techniques) during manufacture of the rail subassembly. Fig. 4D-1 illustrates a prior art welding technique and fig. 4D-2 illustrates an embodiment of a wall penetration welding technique. Wall penetration welding techniques may be advantageously used to weld the puller wire 410 to the insert (e.g., insert 407, 411 tip 408) within the lumen of the guideway hypotube 406. According to several embodiments, wall penetrating welding advantageously does not include welding directly to the pull wire 410. If heated too much, welding directly to the wire 410 (as shown in fig. 4D-1) can result in most or all of the outer Zhou Tuihuo of the pull wire becoming brittle (the pull wire having a high strength temper hardness). Referring to fig. 4D-2, wall penetration welding may involve intentionally forming a through-hole between the outer diameter and the inner diameter of the wall of the lumen, and controlling the wall thickness to facilitate wall penetration welding in a manner that penetrates the hypotube or lumen wall but limits the peripheral heating range of the puller wire (e.g., less than 20% of the periphery, less than 25% of the periphery, less than 30% of the periphery). In some embodiments, wire-passing welding allows welding along a single wire (e.g., a wire extending between the pull wires) rather than welding along multiple wires (e.g., one wire per pull wire).

Intermediate shaft subassembly

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

The intermediate shaft subassembly 22 may be positioned within a lumen (e.g., a rail lumen) of the rail subassembly 21. The intermediate shaft hypotube 502 may be formed from a metal alloy (e.g., cobalt-chromium alloy, nickel-chromium-cobalt alloy, nickel-cobalt-based alloy, nickel-titanium alloy, stainless steel, and titanium). The intermediate shaft hypotube 502 may include an interrupted helical cutting pattern. In an alternative embodiment, intermediate shaft hypotube 502 comprises a longitudinally precompressed High Density Polyethylene (HDPE) tube. Fig. 5A shows a view similar to fig. 4A, but with rail subassembly 21 removed, thereby exposing intermediate shaft subassembly 22.

Similar to other subassemblies, the intermediate shaft hypotube 502 and/or the 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 of one of any number of different materials including nitinol, stainless steel, and medical grade plastics. The tube may be a single piece tube or multiple pieces of tubes joined together. The use of a tube made of multiple parts may allow the tube to provide different properties, such as rigidity and flexibility, along different sections of the tube. The intermediate shaft hypotube 502 may be a metallic hypotube. The intermediate shaft hypotube 502 may have a plurality of slots/holes cut into the hypotube. In some embodiments, the cutting patterns may be identical. In some embodiments, the intermediate shaft hypotube 502 may have different cross sections with different cutting patterns. The intermediate shaft hypotube 502 may be covered or encapsulated with a layer of ePTFE, PTFE, or other material such 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 a heat shrink tube or sleeve.

The pusher 506 may be configured to radially retain a portion of the implant (e.g., prosthesis) 30 in a compressed configuration, such as a proximal end of the implant 30. For example, the pusher 506 may be a ring or cover configured to radially cover a proximal end portion of the implant 30 (e.g., a suture eyelet portion or a proximal-most inflow portion).

Fig. 5B-1 through 5B-3 illustrate an embodiment of a distal propeller 506 of the intermediate shaft subassembly 22, wherein fig. 5B-3 is a cross-sectional view of line 5B-3-5B-3 of fig. 5B-2. Fig. 5B-4 through 5B-6 illustrate another embodiment of a distal propeller 506 of the intermediate shaft subassembly 22, wherein fig. 5B-6 is a cross-sectional view of line 5B-6-5B-6 of fig. 5B-5. The distal pusher 506 of fig. 5B-1 to 5B-3 and the distal pusher 506A of fig. 5B-4 to 5B-6 have substantially the same outer diameter Φ1 and inner diameter Φ2, forming a cylindrical shape when viewed from the top. However, in contrast to the distal propeller 506 having a thin wall with a radius of curvature R1 at the upper surface, the distal propeller 506A does not have a lip and cup portion 507 with a height H7 and therefore has a flat top surface 509. Thus, the overall height H6 of the distal pusher 506 of FIGS. 5B-1 through 5B-3 is reduced by about height H7. Further, the removal of material including the lip and cup portion 507 may leave only a flat surface to oppose the inflow side of the valve prosthesis during capsule retraction for valve deployment. The distal pusher 506A may have increased space (e.g., increased cross-sectional area) to fit the inflow struts of the outer frame 34 inside the pusher 506A. The distal pusher 506A may also provide a reduced abutment force (e.g., about 50% less abutment force as compared to the distal pusher 506) because the suture portions attached to the proximal-most or inflow struts tighten the outer frame 34 against the flat pusher surface without any lips or ridges to pull the eyelet 35.

Fig. 5C illustrates a side cross-sectional view showing a close-up view of the distal end portion of the intermediate shaft subassembly 22, which illustrates the proximal end portion (e.g., the proximal-most portion, or only the suture eyelet 35) of the implant 30 held within the pusher 506. The pusher 506 may also be considered to be part of the implant holding region 316 and may be located at the proximal end of the implant holding region 316. The propeller 506 may comprise a frustoconical or cup shape that is riveted or fastened to the distal end of the intermediate shaft hypotube 502 on opposite sides. The pusher 506 may be formed of a PEEK material, a ferrous material, platinum iridium, or other fluorescent material to facilitate radiographic imaging. The pusher 506 may also be formed from other thermoplastic, polymeric, or metallic materials. The pusher 506 may be loaded with a radiopaque material (e.g., 5-40% barium sulfate loading) to facilitate detection (e.g., made fluorescent) under radiographic imaging (e.g., fluoroscopy). The intermediate shaft subassembly 22 may be disposed to be individually slidable (e.g., translatable) relative to the other subassemblies. The intermediate shaft adapter 505 is operably coupled to a depth knob 920 to effect ventricular/atrial motion within the heart (e.g., for embodiments in which the implant 30 is a mitral or tricuspid valve replacement heart valve). Additional structural and operational details of the intermediate shaft subassembly 22, such as those described in connection with the intermediate subassemblies in U.S. publication No. 2019/0008640 and U.S. publication No. 2019/0008639, which are hereby incorporated by reference, may be incorporated into the intermediate shaft subassembly 22.

Release subassembly and manifold subassembly

According to several configurations, the delivery device includes a suture-based release mechanism including a plurality of suture portions coupled only to a distal end portion of the delivery device and not extending along the delivery device to a proximal handle that controls 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 is releasably attached to the distal end portion of the delivery device after insertion through a retaining member (e.g., an opening or eyelet) of an implant (e.g., a replacement heart valve). The suture portions may be released (e.g., uncoupled) from the implant by an operator actuating an actuator on a handle of the delivery device.

The suture-based release mechanism may comprise a dual coaxial sliding shaft or lumen. It should be understood that references to a lumen in this disclosure may refer to a shaft or tube that includes the lumen. The dual coaxial sliding shaft may be operably coupled to an actuator on a handle of the delivery device. The first end of each of the plurality of suture portions may be fixedly attached to the distal tip of the inner lumen of the dual coaxial sliding shaft. The second end of each of the plurality of suture portions can be releasably coupled to one or more retention members of the distal end portion of the inner shaft. Translation of the outer shaft relative to the inner shaft of the dual coaxial sliding shaft or lumen may decouple or decouple the suture portions from the one or more retaining members of the distal end portion of the inner shaft by actuation of the actuator on the handle.

Moving radially inward from the intermediate shaft subassembly 22, fig. 6A shows a perspective view of the release subassembly 23 of the delivery device 15 of the delivery system 10. Fig. 6B shows a side cross-sectional view of the release subassembly 23 of fig. 6A. The release subassembly 23 operates in conjunction with the manifold subassembly 24 to facilitate 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 that includes a lumen. Manifold subassembly 24 extends through the lumen of release subassembly 23. The intermediate shaft subassembly 22 acts as a compression member stop and the manifold subassembly 24 acts as a tension member such that the intermediate shaft subassembly 22 prevents the implant 30 from backing up when the capsule subassembly 306 is pulled back and the manifold subassembly prevents the deployment/expansion of the implant 30 (or distal movement of the implant 30).

The distal portion of release shaft 602 may include a laser cut portion having various ridge patterns. For example, a distal-most portion (e.g., about 1 cm) of the release shaft 602 may contain a dual-ridge laser cutting pattern, and a proximal portion (e.g., about 5cm proximal of the distal-most portion) of the distal-most portion may contain a universal laser cutting ridge pattern. The dual spine pattern portion may pass through only the primary distal flex portion of the rail hypotube 406 and the universal spine pattern portion may travel through both the primary flex portion and the secondary flex portion of the rail hypotube 406. At least a portion of the length of the release shaft 602 may be surrounded by a heat shrink wrap or 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 by a coupler 607, which may be formed of PEBAX or other thermoplastic elastomeric material. The distal release tip 605 may be welded to the distal end of the release shaft 602. The release adapter 604 includes release tabs 606 on opposite lateral sides. After the tether or suture is released, the release catch 606 engages with the distal portion of the manifold adapter 704 to prevent movement of the manifold subassembly 24 and the release subassembly 23 relative to each other, which movement may cause the window 610 of the distal release tip 605 to close and inadvertently retain one of the suture or tether. Thus, release catch 606 transitions the release/manifold mechanism from the normally closed configuration to the open configuration and allows the manifold subassembly 24 and release subassembly 23 to move proximally together. The release subassembly 23 further includes a release spring 608 that extends between the release adapter 604 and a location within the manifold adapter 704 of the manifold subassembly 24.

Fig. 6C, 6D and 6E show a close-up, side view, side cross-sectional view and bottom view, respectively, of distal release tip 605. Distal release tip 605 cooperates in conjunction with the distal end portion of manifold subassembly 24 to facilitate preventing premature release of implant 30 and to facilitate releasing (e.g., untangling) implant 30 in preparation for final implantation. The distal release tip 605 includes three windows 610 spaced around the outer circumference of the distal release tip 605, and three slots 612, with each slot 612 positioned between two adjacent windows 610. Window 610 may be laser cut into distal release tip 605. The three windows 610 may be circumferentially equally spaced apart and the slots 612 may be circumferentially equally positioned between adjacent windows 610. The distal end of each slot 612 includes an inwardly protruding retaining member 614 (e.g., tab, protrusion, lock, anchor). The inwardly projecting tabs 614 are adapted to align with and extend within corresponding slots of the manifold subassembly 24 in order to control axial movement (e.g., provide positive references for distal and proximal travel) and prevent rotation of the release subassembly 23 relative to the manifold subassembly 24, as will be described in more detail below.

Moving radially inward, fig. 7A shows a perspective view of the manifold subassembly 24 of the delivery device 15. Fig. 7B shows a side cross-sectional view of the manifold subassembly 24 of fig. 7A. The manifold subassembly 24 extends through and along the lumen of the release subassembly 23. 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 by a manifold adapter 704. Proximal shaft 702 may be coupled to distal subassembly 703 by a manifold cable 705. The manifold cable 705 may include a multi-layer cable comprising two layers, three layers, four layers, five layers, or more. In some embodiments, the manifold cable 705 comprises a three-layer cable in which two outer layers are used for tension and act together to prevent the outer layers from expanding, and the inner layer comprises a single wire coil that provides compression and prevents collapse. In some embodiments, each layer is wound in a direction opposite to an adjacent layer (e.g., clockwise, counter-clockwise, clockwise or counter-clockwise, counter-clockwise). Wire size, wire tension, pitch, number of wires in each layer, material and material properties may vary. The inner coil may comprise one to ten wires tightly wound with a gap of 0 to 0.005 ". The intermediate and outer coils may each comprise one to ten wires and are tightly wound with a gap of 0 to 0.010 ". The manifold cable 705 may be formed of one or more materials including, for example, nitinol, a ferrous material such as stainless steel, and/or a cobalt chromium material. The condition (e.g., strength) of the wires may be in the range of 100KSI to 420KSI (kilopounds per square inch) and the ultimate tensile strength of the manifold cable 705 may be greater than 110 lbf. The wire may be flat or circular in cross-section. The tri-layer cable may be configured to prevent diameter variation during stretching. In other embodiments, the proximal shaft 702 extends all the way to and is coupled with the proximal end of the distal subassembly 703.

Fig. 7C shows a close-up view of distal subassembly 703 of manifold subassembly 24. Fig. 7D shows a bottom view of distal subassembly 703 of manifold subassembly 24. As shown, the distal subassembly 703 includes a proximal tether retention assembly 706 and a distal tether retention assembly 707. The distal tether retention assembly 707 may be coupled (e.g., permanently bonded, welded) to a distal end of the proximal tether retention assembly 706. As best shown in fig. 7D, the distal tether retention assembly 707 may include cogs including outwardly extending tether splints 708 circumferentially spaced about the cogs. An opening or gap 709 exists between adjacent tether splints 708 to receive portions of a tether or suture 710. The distal tether retention assembly 707 may be formed from metal by an electrical discharge machining process. The proximal tether retention assembly 706 may also be formed of metal and formed by a laser cutting or electrical discharge machining process. The distal tether retention assembly 707 may include proximal and distal sealing members 711, 713 (e.g., retainer rings) that are sealed (e.g., welded, glued, or otherwise adhered) to opposite upper and lower sides of the distal tether retention assembly 707 during manufacture to seal an opening or gap 709 between the tether clamp plates 708 to prevent the tethers or sutures 710 from being removed or untied from the distal tether retention assembly 707. According to several embodiments, tether 710 is intended to be permanently coupled to (i.e., non-removable from) distal tether retention assembly 707. The number of tether clips 708 may correspond to the number of eyelets on implant 30 (e.g., upper eyelets of outer frame 34). In the illustrated embodiment, the number of tether clips 708 is nine; however, other numbers of tether clips 708 may be used.

Tether or suture 710 may be a continuous tether or suture piece that forms offset proximal and distal loops along its continuous length when assembled during manufacture. The proximal loop is wrapped around the lacing clamp 708, and the distal loop is passed through a corresponding aperture of the proximal end of the implant or prosthesis 30 (e.g., the upper aperture of the outer frame 34), and then removably coupled to the delivery device 15 (e.g., the proximal tether retention assembly 706 of the manifold subassembly 24).

According to the following example embodiments, during assembly, a continuous tether or suture 710 may be coupled to the distal tether retention assembly 707. One end of the continuous tether or suture 710 may begin at a distally spaced position of the distal tether retention assembly 707. With one end held there, the tether 710 is then wrapped around the first tether clamp 708 and then fed back through an opening or gap 709 on the other side of the first tether clamp 708 to form a first proximal loop, and then brought back to a position spaced distally of the distal tether holding assembly 707 to begin forming the first distal loop. The process is repeated for each tether splint 708 until all proximal and distal loops are formed, and the second end of the continuous tether 710 is adjacent to the first end of the continuous tether 710, and the two ends are knotted together and bonded to form a single continuous strand. The tether assembly process may be facilitated by an assembly that may be placed at an appropriate spaced distance distal to the distal tether retention assembly 707 and that contains a peg around which portions of the continuous tether 710 may be wrapped to form a distal loop at a uniform spaced distance from the distal tether retention assembly 707. The proximal and distal sealing members 711, 713 may prevent the proximal loop from unhooking from the tethered cleat 708. Continuous tether 710 may include ultra high molecular weight polyethylene (UMHWPE) force fiber suture, aramid suture, or a hybrid aramid and UMHWPE suture material. In some embodiments, the aramid material may advantageously bond and prevent floss and/or wear failure due to asymmetric loading of the suture during separation. According to several embodiments, the continuous tether 710 advantageously does not extend the entire length of the delivery device or system (e.g., up to the handle), as the elongation under load will be significant, and adding any compensating mechanism adds complexity and may be potentially unreliable and/or user-unfriendly.

Fig. 7E illustrates a cut-out pattern of the proximal tether retention assembly 706 of the distal subassembly 703. As shown, the proximal portion of the proximal tether retention assembly 706 includes a dual-ridge laser cutting pattern. The dual-ridge laser cutting pattern of the proximal tether retention assembly 706 may match the dual-ridge laser cutting pattern of the rail subassembly 21 and the release subassembly 23. The distal end portion of the proximal tether retention assembly 706 includes three circumferentially spaced slots 714 and three openings or windows 715. The slot 714 is configured to be circumferentially aligned with the slot 612 of the distal release tip 605, and the opening or window 715 is configured to be circumferentially aligned with the window 610 of the distal release tip 605. In other embodiments, other numbers of slots 714 and openings 715 (e.g., two, four, five, six, seven, eight, nine) may also be used. Each opening 715 includes a tab, finger, or peg 716 extending a distance from the distal edge of the respective opening 715 into the respective opening 715. The length of each tab 716 is long enough so that one or more distal tether loops may loop over the top (or proximal end) of the respective tab 716 and be pushed distally, thereby retaining the one or more distal tether loops. As shown, the three tabs 716 each have a different length 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 may receive one or more distal tether loops. In one embodiment having nine distal tether loops, each tab 716 may hold three distal tether loops. The slots 714 may be equally circumferentially spaced about the longitudinal axis of the proximal tether retention assembly 706 and may be sized and spaced so as to align with the corresponding slots 612 of the release subassembly 23 to receive the respective inwardly projecting retention members 614.

Operation of suture release mechanism

Fig. 8A and 8B show the distal end portions of the release subassembly and the manifold subassembly in a locked configuration and an unlocked configuration, respectively. The locked configuration shown in fig. 8A is the default configuration after assembly. The release subassembly and manifold subassembly are intended to remain in a locked configuration until the clinician has determined that the implant 30 is in the final desired implant position. In the locked configuration, the proximal end of the tab 716 is positioned proximal to the proximal edge of the release window 610 such that the distal tether loop wrapped around the tab 716 cannot be unhooked from the tab 716, which may result in premature release of the tether 710. To simplify and avoid confusion in the figures, only one distal tether loop is shown wrapped around one tab 716; however, two, three or more tie rings may be hooked to or wrapped around each tab 716. The spring 608 shown in fig. 6A (which is biased into a compressed configuration) keeps the release adapter 604 and manifold adapter 704 apart and forces the release subassembly 23 to compress distally so that the release subassembly 23 and manifold subassembly 24 do not move longitudinally relative to each other, thereby keeping the release subassembly 23 and manifold subassembly 24 in the locked configuration shown in fig. 8A until the operator is ready to release the suture or tether. As discussed in connection with fig. 9A and 9B, the safety member (e.g., pin) 927 of the handle also prevents the manifold subassembly 24 from moving distally out of the lock configuration until ready.

Once the clinician has determined that the implant 30 is at the final desired implant location and has performed and confirmed all verification procedures, the safety member 927 is removed from the handle and the spring 608 is placed in a more compressed state. As release knob 925 is rotated distally, spring 608 is further compressed and pushes manifold subassembly 24 distally out of release subassembly 23 into the unlocked configuration shown in fig. 8B. As shown in fig. 8B, manifold subassembly 24 has been pushed far enough relative to release subassembly 23 that the proximal end of at least one tab 716 is within release window 610 such that the distal tether loop of tether 710 may be unwound from tab 716, particularly as manifold subassembly 24 continues to advance distally. Fig. 8C illustrates how one of the tethers or suture loops transitions from tethered to un-tethered or released when the release subassembly and manifold subassembly effect a transition between a locked configuration and an unlocked configuration. As also shown in fig. 8C, the corresponding slots 612 and 714 are aligned to prevent rotation of the manifold subassembly 24 relative to the release subassembly 23 (due to the inwardly protruding retaining members 614), whereby the retaining tabs 716 are aligned within the windows 610 of the release subassembly 23. Fig. 8D shows the implant 30 fully tethered between an aperture on the proximal end of the implant (e.g., an upper aperture of the outer frame 34 of the valve prosthesis 30) and the manifold subassembly 24 of the delivery device 15. As shown, there are nine tie rings or portions connected to nine eyelets; however, the number may vary as needed and/or desired. The suture or tether retention mechanism described in connection with fig. 8A-8D advantageously eliminates the need for the tether or suture 710 to extend through and along a long portion of the length of the delivery device 15 (e.g., to the proximal handle 14), thereby advantageously preventing or reducing the likelihood of the suture or tether portion being hooked or caught by intervening components within the delivery device, preventing or reducing the likelihood of the suture or tether portion tangling due to the reduced length, reducing the complexity of the operations required by an operator to release the tether, simplifying assembly and manufacture, and/or reducing the amount of suture or tether material required. Instead, the suture or tether portion is advantageously coupled to only the distal end portion of the delivery device.

Handle

Fig. 9A shows a perspective view of the handle 14 of the delivery device 15. Fig. 9B shows a side cross-sectional view of the handle 14. The handle 14 includes a plurality of actuators, such as rotatable knobs, that can manipulate different components of the delivery system 10 (e.g., cause movement of corresponding subassemblies of the shaft assembly 12). The distal end of the handle 14 contains a capsule knob 905. Rotation of the capsule knob 905 in one direction causes the outer sheath subassembly 20 to move proximally in an axial direction in order to extract and deploy a distal portion (e.g., a ventricular portion) of the implant 30 from the capsule subassembly 306. Rotation of the capsule knob 905 in the opposite direction causes the outer sheath subassembly 20 (including the capsule subassembly 306) to move distally in order to retract, retrieve, or reload the implant 30 within the capsule subassembly 306. The outer sheath subassembly 20 may be individually translatable relative to other subassemblies in the delivery device 15. Referring again to fig. 5C, the distal end of the implant 30 may be released first, while the proximal end of the implant 30 (e.g., the proximal-most aperture 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. Because capsule assembly 306 is so strong and provides tensile and compressive strength, only the proximal-most portion of implant 30 (e.g., eyelet 35) needs to be held by pusher 506, and the length of pusher 506 may be relatively short. The tether 710 and release subassembly 23 and manifold subassembly 24 also remain within the intermediate shaft subassembly 22 until the release knob 925 is rotated.

Moving proximally, the handle 14 includes a stabilizer mounting region 910 adapted to interface with a clamp of a stabilizer assembly 1100 configured to control the medial/lateral position of the delivery device 15. Further proximally moved are a primary flex rail knob 915A and a secondary flex rail knob 915B. Rotation of the main flex rail knob 915A causes the main flex portion or the distally slotted hypotube portion 406D of the rail hypotube 406 to flex to effect a change in medial/lateral trajectory. Rotation of the secondary flex rail knob 915B causes the primary flex portion or proximally slotted hypotube portion 406P of the rail hypotube 406 to flex to effect a change in anterior/posterior trajectory. However, the number of flex rail knobs 915 may vary depending on the number of pull wires used.

Proximate to secondary flex rail knob 915B is a depth knob 920 that, in some embodiments, controls the simultaneous movement of outer assembly 20, intermediate shaft subassembly 22, release subassembly 23, manifold subassembly 24, and nose cone subassembly distally or proximally (thereby moving the ventricle or atrium of delivery device 15 for mitral or tricuspid valve implantation). Depth knob 920 may move the subassembly together relative to rail subassembly 21. More recently, is release knob 925 (sometimes also referred to as a manifold knob because it controls simultaneous longitudinal movement of release subassembly 23 and manifold subassembly 24 until release subassembly 23 encounters a hard stop member within handle 14, and then only manifold subassembly 24 continues to move longitudinally in a distal direction relative to release subassembly 23. The release knob 925 can be rotated proximally to exert tension on the manifold subassembly 24 during loading or retrieving of the implant 30. After the capsule subassembly 306 has been retracted to deploy a distal portion (e.g., a ventricular portion) of the implant 30, the release knob 925 can be rotated distally to deploy a proximal portion (e.g., an atrial portion) of the implant 30. Distal movement of the release knob 925 removes 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 release of the implant 30 until the safety stop member 927 is removed from the handle 14. Once the safety stop member 927 has been removed, continued distal movement of the release knob 925 causes distal movement of the manifold subassembly 24 relative to the release subassembly 23 (after the release subassembly 23 abuts a mechanical stop member within the handle 14 that prevents further distal movement of the release subassembly 23) to facilitate release of the tether 710 from the manifold subassembly 24 (e.g., allowing the distal tether loop to be pushed away from the tab 716 of the proximal tether retention member 706 of the manifold subassembly 24 by the window 610 of the release subassembly 23). The most proximal knob is the nose cone knob 930, the rotation of which causes proximal and distal movement of the nose cone subassembly.

Nose cone subassembly

The nose cone subassembly is the most radially inward subassembly and may include a nose cone shaft having a distal end connected to a nose cone 87 (labeled in fig. 14C). For example, knob 930 may be part of a nose cone subassembly extending from the proximal end of handle 14. Thus, the user can rotate knob 930 to translate the nose cone shaft distally or proximally, respectively, relative to the other shafts. This is advantageous for translating the nose cone 87 proximally into the outer sheath assembly 20/capsule subassembly 306, thus facilitating extraction 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 a thermoplastic or elastomer (e.g., PEBAX or polyurethane) for atraumatic access and to minimize damage to the venous vasculature. The nose cone 87 may also be radiopaque to provide visualization under fluoroscopy. The nose cone assembly is preferably positioned in the lumen of the manifold sub-assembly 24. The nose cone assembly may include a lumen for a guide wire to pass therethrough. Additional structural and operational details of the handle and cephalad body assembly, such as those described in connection with the handle and cephalad body assemblies in U.S. publication No. 2019/0008640 and U.S. publication No. 2019/0008639, which are hereby incorporated by reference, may be incorporated into the handle 14 and cephalad body sub-assemblies herein.

Introducer assembly

Fig. 10 illustrates components of an 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. Dilator 1010 helps to dilate the vasculature for insertion of delivery device 15 and/or introducer sheath 1005. If desired and/or required, the dilator 1010 can be removed and replaced with another dilator (e.g., a different diameter dilator). After removal of dilator 1010, introducer 1012 (which may be inserted into and advanced along introducer sheath 1005 such that the tapered distal end of introducer 1012 extends beyond the open distal end of introducer sheath 1005) is advanced through the incision with introducer sheath 1005 into the dilated vasculature. For the trans-femoral delivery method, the vasculature is the femoral vein in the leg of the subject. Introducer sheath 1005 may contain sides to facilitate heparinizing saline or other irrigation fluid. The introducer sheath 1005 may be configured to remain stationary relative to the subject's leg. The loader 1015 is adapted to be inserted into the proximal end of the introducer sheath 1005 to open an active one-way valve in the introducer sheath 1005 prior to insertion of the delivery device 15, thereby facilitating insertion of the delivery device 15 through the introducer sheath 1005. The loader 1015 may also advantageously reduce friction between the delivery device 15 and the introducer sheath 1005 when inserting the delivery device 15 and manipulating the delivery device 15 during an implantation procedure. In some embodiments, the introducer 1012 and introducer sheath 1005 may not be used, and the delivery device 15 may be inserted directly into the expanded vasculature.

Stabilizer assembly

Fig. 11 shows how the handle 14 of the delivery device 15 interfaces with an embodiment of a stabilizer assembly 1100 of the delivery system 10. Fig. 11A shows a perspective view of the stabilizer assembly 1100 without the delivery device 15 attached. Fig. 11B shows a top view of the stabilizer assembly 1100 of fig. 11A. Stabilizer assembly 1100 includes guide clamp 1105, guide assembly 1110, rail 1115, and base 1120. The clamp 1105 is configured to couple to a stabilizer mounting region 910 of the handle 14 of the delivery device 15. The guide assembly 1110 is configured to cause a change in the medial/lateral position of the delivery device 15 by movement along the guide rail 1115. The rail 1115 may be mounted and secured to the base 1120. Additional details regarding the stabilizer assembly 1100 can be found in U.S. patent publication No. 2020/0108225, published at 1/10 of 2020, the entire contents of which are incorporated herein by reference.

Delivery method

Fig. 12 shows a schematic illustration of a transseptal delivery method. As shown in fig. 12, in one embodiment, the delivery system 10 may be placed in the ipsilateral femoral vein 1074 and advanced to the right atrium 1076. Transseptal puncture may then be performed using known techniques to access the left atrium 1078. The delivery system 10 may then be advanced to the left atrium 1078, and then to the left ventricle 1080. Fig. 12 shows the delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In embodiments of the present disclosure, a guidewire is not necessary to position the delivery system 10 in place, although in other embodiments one or more guidewires may be used.

Thus, it is advantageous for a user to be able to maneuver the delivery system 10 through a complex area of the heart in order to position the replacement mitral valve in line with the native mitral valve. This task may be performed with or without the guidewire of the system disclosed above. The distal end of the delivery system 10 may be advanced into the left atrium 1078. The user may then manipulate the rail subassembly 21 to align the distal end of the delivery system 10 to the appropriate area. The user may then continue to pass the curved delivery system 10 through the transseptal puncture and into the left atrium 1078. The user may then further manipulate the delivery system 10 to create a greater bend in the rail subassembly 21. In addition, the user may twist the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In a fully flexed configuration, the user may then place the replacement valve in place. This may advantageously allow the replacement valve to be delivered to the site of implantation in situ, such as the native mitral valve, by more various methods, such as transseptal methods.

Fig. 13 shows a schematic illustration of a portion of an embodiment of a replacement heart valve (implant 30) positioned within a native mitral valve of a heart 83. Further details regarding how the implant 30 is positioned at the native mitral valve are described in U.S. patent publication No. 201/032800, published 11/19 2005, which is hereby incorporated by reference in its entirety, including but not limited to FIGS. 13A-15 and paragraphs [0036] - [0045]. A portion of a native mitral valve is schematically shown and represents a typical anatomy, including a left atrium 1078 positioned above the annulus 1106 and a left ventricle 1080 positioned below the annulus 1106. Left atrium 1078 and left ventricle 1080 communicate with each other through annulus 1106. Also schematically shown in fig. 13 is a native mitral valve leaflet 1108 having chordae tendineae 1111 that connect the downstream end of the mitral valve leaflet 1108 to the papillary muscles of the left ventricle 1080. The portion of the implant 30 disposed upstream (toward the left atrium 1078) of the annulus 1106 may be referred to as a hyper-annular positioning. The portion generally within the annulus 1106 is referred to as the in-loop positioning. The downstream portion of the annulus 1106 is referred to as the sub-annular positioning (toward the left ventricle 1080).

As illustrated in fig. 13, implant 30 may be positioned such that the end or tip of distal anchor 37 is located on the ventricular side of mitral valve annulus 1106. The distal anchor 37 may be positioned such that the end or tip of the distal anchor 37 is located on the ventricular side of the native leaflet beyond where chordae 1111 connect to the free end of the native leaflet. Distal anchors 37 may extend between at least some of chordae 1111 and, in some cases, may contact or engage the ventricular side of the annulus 1106. It is also contemplated that in some cases, the distal anchor 37 may not contact the annulus 1106, although the distal anchor 37 may still contact the native leaflet 1108. In some cases, distal anchors 37 may contact tissue of left ventricle 1080 beyond the ventricular side of annulus 1106 and/or leaflets 1108.

Fig. 14A-14E illustrate the operation of the delivery device 15 by showing various steps of deploying and implanting an implant (e.g., replacement heart valve) 30 using the delivery device 15 described herein. Fig. 14A-14E illustrate the positioning of various subassemblies of delivery device 15 relative to one another and relative to implant 30 during various steps of the procedure. The subassemblies are shown in side cross-sectional views to facilitate visualization of the various subassemblies. For simplicity and illustration, the various portions of implant 30 (e.g., skirt assembly 38 and liner 39) are not shown. Fig. 14A shows the delivery device 15 at some point during implantation, with the replacement heart valve 30 fully retained within the capsule subassembly 306 of the outer subassembly 20 in a compressed configuration. As shown, a proximal-most portion (e.g., an eyelet portion) of the replacement heart valve 30 is held within the pusher 506 of the intermediate shaft subassembly 22, and the remainder of the replacement heart valve 30 is compressed by the capsule subassembly 306. Referring to fig. 14B, the capsule subassembly 306 has been retracted proximally (e.g., toward the proximal handle 14 of the delivery device 15 by rotating the capsule knob 905 of the handle 14) to a position such that the replacement heart valve 30 is no longer constrained by the capsule subassembly 306 and the replacement heart valve 30 has been allowed to partially self-expand. The proximal-most portion (e.g., the eyelet portion) of the replacement heart valve 30 is held constrained in a compressed configuration by the pusher 506 of the intermediate shaft subassembly 22 such that the entire replacement heart valve 30 has not yet fully expanded.

As can be appreciated, the deployment of the distal and intermediate portions of the replacement heart valve 30 can be staged over time rather than being immediately fully deployed. For example, the distal anchors 37 of the inner frame 32 of the dual frame structure may be deployed first (e.g., while the outer frame 34 and the middle portion of the inner frame 32 remain constrained within the capsule subassembly 306) prior to deployment of the outer frame 34, as shown, for example, in fig. 5C. The distal anchors 37 of the inner frame 32 may be positioned through chordae tendineae and/or under the annulus of a native heart valve (e.g., mitral valve) so as to capture native leaflets of the heart valve between the distal anchors 37 and the body of the outer frame, thereby holding the native leaflets in an open configuration and anchoring the replacement heart valve 30 as a whole. Such a configuration and location is shown in fig. 14J.

Referring to fig. 14C, by rotating release knob 925 (as previously discussed herein), manifold subassembly 24 and release subassembly 23 have been advanced distally while intermediate shaft subassembly 22 remains stationary, such that the proximal-most portion (e.g., the eyelet portion) of replacement heart valve 30 is advanced distally out of pusher 506 of intermediate shaft subassembly 22, thereby deploying replacement heart valve 30 into a fully expanded configuration. However, the replacement heart valve 30 remains tethered to the manifold subassembly 24 by the tether 710 because the manifold subassembly 24 and the release subassembly 23 are in a "locked" configuration, as previously described in connection with fig. 8A-8D.

Referring to fig. 14D, the manifold subassembly 24 has been moved distally relative to the release subassembly 23 (to transition the release subassembly 23 and manifold subassembly 24 to the unlocked configuration described in connection with fig. 8A-8D), and the suture loop end of the tether 710 previously coupled to the tab 716 of the manifold subassembly 24 has been uncoupled or released. Referring to fig. 14E, the manifold subassembly 24 and release subassembly 23 are retracted proximally together until the free suture loop end of the tether 710 is pulled out of the proximal eyelet 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 withdrawing the delivery device 15, 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, when the delivery device 15 is withdrawn, the distal ends of the manifold subassembly 24 and the release subassembly 23 may alternatively remain distal (outboard) of the outer sheath subassembly 20.

Fig. 14F-4K illustrate various steps of deploying and retrieving an implant (e.g., a replacement heart valve) 30 using the delivery device 15 described herein. For simplicity and illustration, only the inner frame 32 and outer frame 34 of the implant 30 are shown (e.g., the skirt assembly 38 and liner 39 are not shown as shown in fig. 2C). The capsule subassembly 306 advantageously facilitates retraction of the implant 30 after initial deployment. Fig. 14F illustrates initial deployment of implant 30 from delivery device 15. For example, initial deployment may be performed within the mitral annulus following a transfemoral and/or transseptal approach. It should be noted that the implant 30 remains tethered to the delivery device 15 as the implant 30 is initially fully deployed to the fully expanded configuration. In some cases, the clinician may decide that the initial presentation position is not ideal after performing various tests (e.g., using various imaging modalities and measurements). For example, the ideal position may be higher (e.g., toward the atrium) or lower (e.g., toward the ventricle) than the initial deployed position. To prevent damage to the implant 30 and heart, the implant 30 may be retracted prior to moving the implant 30 to a new implantation position. Implant 30 may be retracted by distally advancing capsule subassembly 306 of outer sheath subassembly 20 over implant 30 to transition implant 30 to the compressed configuration. Fig. 14G and 14H illustrate various stages of retraction of implant 30. As shown in fig. 14G, capsule subassembly 306 has been advanced distally (e.g., by rotating capsule knob 905 in a first direction) to capture a proximal portion of implant 30. Fig. 14H shows full retraction of implant 30, with capsule subassembly 306 fully advanced distally (e.g., until contact is made with nose cone 87 of nose cone subassembly, or until implant 30 is fully retained within capsule subassembly 306). The configuration of fig. 14H corresponds to the configuration of fig. 14F, but in a cardiac position.

After the distal end of delivery device 15 is moved to a new position, capsule subassembly 306 of outer sheath subassembly 20 may again be retracted proximally (e.g., by rotating capsule knob 905 in a second direction opposite the first direction) to withdraw the distal portion of implant 30 (e.g., a new implantation position within the mitral or tricuspid valve ring), as shown in fig. 141. The manifold and release subassemblies 23, 24 may then be advanced distally together (e.g., by rotating the release knob 925) to deploy the proximal-most portion of the implant 30 (e.g., the proximal eyelet, post, or strut) out of the pusher 506 of the intermediate shaft subassembly 22, as shown in fig. 14J. After confirming that the fully deployed implant 30 is in the desired and proper final implantation position, the release knob 925 can be further translated distally by continuing to rotate the release knob 925 until the release subassembly 23 encounters a physical stop member in the handle 14 and the manifold subassembly 24 continues to translate distally relative to the release subassembly 24, resulting in release of the tether 710 (e.g., tether loop end) from the manifold subassembly 24 (as shown in fig. 14K). The delivery device 15 may be retracted and withdrawn from the heart and then withdrawn from the vasculature and then taken together from the subject.

Skirt assembly and method of manufacture or assembly

Fig. 15A and 15B show different views of the configuration of a fully assembled implant (e.g., valve prosthesis) 1230, including a skirt assembly 1238 (shown in fig. 17A-17D) positioned between frames 1232, 1234 (shown in fig. 16A and 16B) and a cushion 1239 surrounding the anchor 1237. Implant 1230 may be similar in configuration to implant 30 shown and described with respect to fig. 2-2K-2. Reference numerals of the same or substantially the same features may share the same last two digits.

Fig. 15C shows the prosthetic leaflets sutured to the inner frame 32 of a double-frame valve prosthesis (e.g., implants 30, 1230). The inner frame 32 of the dual frame valve prosthesis may include a prosthetic valve assembly composed of a plurality of flexible leaflets 1108A arranged to fold in a three-bladed arrangement and a reinforcement band 1108B for securing the plurality of prosthetic leaflets 1108A to the inner frame 32 and securing the cusp edge portion 1108C of each prosthetic leaflet 1108A to a first end portion of the reinforcement band 1108B. The dual frame valve prosthesis (e.g., implant 1230) can be implanted to replace any heart valve (e.g., mitral valve, tricuspid valve, aortic valve, pulmonary valve), and the inner frame 32 of the dual frame valve prosthesis can be configured to have an "hourglass" profile or shape when in an expanded configuration, as described elsewhere herein. Although the prosthetic leaflet sewing and valve assembly embodiments are described herein with reference to a dual frame valve prosthesis, the leaflet sewing and valve assembly embodiments may also be used to assemble/manufacture a single frame implant or an implant having more than two frames (e.g., three or more frames). For example, aortic and pulmonary prosthetic valve implants can incorporate a single frame (e.g., a single frame valve with an hourglass profile) rather than a double frame.

15D-1 through 15D-5 illustrate a double suture applied to a prosthetic leaflet to securely attach to the inner frame of a double frame valve prosthesis; however, the double suture 1108D may be incorporated into a suture for any prosthetic valve (e.g., a single frame or more than two frames), not just a double frame valve prosthesis. In fig. 15D-1 through 15D-3, double stitch 1108D can be seen by following or connecting the points of the two separate rows in the figure. Methods of assembling the prosthetic leaflet 1108A to other components of a double frame valve prosthesis (e.g., the skirt assembly and/or portions or components of the frame assembly) include folding portions of the prosthetic leaflet edges or cloth skirt edges so as to cover the exposed suture portions and prevent direct contact between the suture portions or potentially worn skirt edges and the prosthetic leaflets (e.g., the abdomen of the prosthetic leaflets). The skirt assembly (e.g., skirt assemblies 1238, 1248) may include a plurality of skirt portions. For example, the skirt assembly may include a first portion including a double suture having pre-drilled laser holes configured to align with the holes of the double suture of the prosthetic leaflet. In other embodiments, no laser holes are pre-drilled and the stitching is by hands-free cloth or tissue stitching, without pre-formed (e.g., laser drilled) holes. The first portion may include reinforcement cloth skirt bands 1248A adapted to facilitate attachment of the skirt assembly to the prosthetic leaflet. The skirt assembly may also include a main portion 1248B adapted to facilitate attachment to a frame structure. In some embodiments, a first portion of the skirt assembly (e.g., the reinforcing cloth skirt band 1248A) that is sewn to the prosthetic leaflet 1108A may be folded over itself (outward or inward) to cover the first row of exposed sutures 1109A, thereby preventing the leaflet 1108A from contacting potentially worn skirt edges formed by cutting the reinforcing cloth skirt band 1248A and also preventing any portion of the sutures 1109A, 1109B from contacting the leaflet 1108A, which contact may also result in wear over time. Figures 15D-4 and 15D-5 show examples of different portions of the reinforcement cloth skirt band 1248A of the skirt assembly that is folded over on itself to prevent the sutures 1109 from exposing or contacting the leaflets 1108A.

For example, a method of assembling the leaflets 1108A to a double-frame valve structure includes securing at least one component or portion of a skirt assembly (e.g., skirt assembly 1238) to an inner frame with a first suture 1109A using a reinforcement band (e.g., reinforcement band 1248A); the leaflet 1108A is secured to the reinforcement band 1248A by a primary or first suture 1109A; the reinforcement band 1248A is folded over the first suture 1109A to cover the first suture, and then the folded portion of the reinforcement band 1248A of the skirt assembly is sutured with a second suture (e.g., a second suture) 1109B parallel to and spaced apart from the first suture 1109A, which also does not contact any portion of the leaflet 1108A. The primary suture 1109A and the secondary suture 1109B create more than one suture 1108D (e.g., a double suture or two sutures). Also, the assembly method may be applied to single frame valve structures in addition to double frame valve structures.

15E-1 through 15E-4, the method of assembling the leaflet 1108A to a double frame valve structure (e.g., implant 30, 1230) may alternatively or additionally include inwardly folding the cusp edge portions or tabs 1108C of the leaflet 1108A and applying sutures 1109 to secure the folded cusp edge portions or tabs 1108C to the reinforcing struts 1237A of the skirt assembly. In this embodiment, neither the suture 1109 nor the skirt assembly (e.g., reinforcing tape 1237A) is in contact with the abdomen of the leaflet 1108A. Also, this assembly method can be applied to single frame valve structures.

In some embodiments, the double suture 1108D may include a second suture at the cusp edge portion 1108C of each prosthetic leaflet 1108A where it is attached to other components of the double frame valve prosthesis in order to increase the retention strength of the suture and more evenly distribute the stress during valve opening and closing while adding minimal additional volume. Folded cusp edge portions or tabs 1108C positioned between the cloth of the skirt assembly and the exposed suture portions advantageously act as a barrier to prevent wear to the leaflet belly as the prosthetic valve opens and closes over time. The leaflets 1108 can be formed from bovine or porcine pericardial tissue (e.gBovine pericardial tissue). The restiia bovine pericardial tissue may advantageously resist calcification.

Fig. 16A shows a configuration of an inner frame 1232 coupled to a prosthetic valve assembly 1231 that includes a plurality of prosthetic valve leaflets (not shown). Fig. 16B illustrates a configuration of the external frame 1234. The inner frame 1232 may be similar in configuration to the inner frame 32 and the outer frame 1234 may be similar in configuration to the outer frame 34 shown and described with respect to fig. 2-2K-2. Reference numerals of the same or substantially the same features may share the same last two digits.

Fig. 17A-17D illustrate the configuration of the skirt assembly 1238. The skirt assembly 1238 may comprise cloth. For example, the skirt assembly 1238 may comprise a single piece, unitary cloth, or multiple pieces of cloth coupled together. The skirt assembly 1238 may include a proximal or inflow portion 1238A, a middle or intermediate portion 1238B, and a distal or outflow portion 1238C.

As shown in fig. 17B, the skirt assembly 1238 may include different diameters. For example, the skirt assembly 1238 may include a plurality of diameters D1, D2, D3, D4, D5, D6, D7. In some configurations, the third diameter D3 may be the largest diameter. In some configurations, the seventh diameter D7 may be a minimum diameter. The first, second, fourth, fifth and sixth diameters D2, D3, D4, D5, D6 may be between the third diameter D3 and the seventh diameter D7. The plurality of diameters D1, D2, D3, D4, D5, D6, D7 may be the same diameter or each diameter may be different. According to several embodiments, the skirt assembly 1238 technique described herein advantageously facilitates transitioning between different diameters within a piece of cloth without having to cut the cloth into multiple components. Advantageously, by having the skirt assembly 1238 as an integral component having different diameters D1, D2, D3, D4, D5, D6, D7, the amount of cloth used may be reduced and the thickness of the skirt assembly 1238 may be reduced. By reducing the thickness of the skirt assembly 1238, the loading and retrieving forces exerted on the implant 1230 during delivery and retrieval can be reduced.

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 a body portion 1240B, the inflow portion 1238A may include a plurality of proximal portions or extensions 1240A extending from the body portion 1240B, and the outflow portion 1238C may include a plurality of distal portions or extensions 1240C extending from the body portion 1240B. The proximal extension 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 fig. 16B), and the proximal extension 1240A may be received by the plurality of openings 1234D such that the proximal extension 1240A may be positioned between the inner frame 1232 and the outer frame 1234. When the implant 1230 is assembled, the body portion 1240B may be configured to be positioned outside of the outer frame 1234. 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, distal extension 1240C may be inserted through a space distal of the distal edge of outer frame 1234 such that distal extension 1240C may be positioned between inner frame 1232 and outer frame 1234 on the outflow side of implant 1230.

In the illustrated configuration, the skirt assembly 1238 has a plurality of trapezoidal portions 1240A, 1240C. In other configurations, the skirt assembly 1238 can include portions 1240A, 1240C having a square, triangular, circular, or any other suitable shape. The plurality of proximal extensions 1240A may comprise 18 proximal extensions 1240A. In other configurations, the plurality of proximal extensions 1240A may include any number of proximal extensions (e.g., less than or more than 18 proximal extensions). The plurality of distal extensions 1240C may comprise 9 distal extensions. In other configurations, the plurality of distal extensions 1240C may include any number of distal extensions (e.g., less or more than 9 distal extensions).

As shown in fig. 17C, the skirt assembly 1238 may include a plurality of features 1242A, 1242B, 1242C, 1242D, 1242E, 1242F, 1242G, 1242H configured to facilitate assembly of the skirt assembly 1238 and the implant 1230. For example, the plurality of features may include a plurality of tabs 1242A, which may extend from one or more proximal extensions 1240A. Tab 1242A may be configured to be positioned between inner frame 1232 and aperture 1235 of outer frame 1234. Advantageously, tab 1242A may prevent corrosion of eyelet 1235. In the illustrated configuration, the plurality of tabs 1242A may include 9 tabs 1242A on alternating proximal extensions 1240A. In some configurations, a plurality of tabs 1242A may be located on each proximal extension 1240A or on less than half of the proximal extensions 1240A.

In some configurations, the plurality of features may include keying feature 1242B. Keying feature 1242B may be positioned on one side of one or more proximal extensions 1240A. When the skirt assembly 1238 is folded and sewn into a folded configuration, the keying feature 1242B can indicate which side of the proximal extension 1240A should be positioned on top of an adjacent proximal extension 1240A, as further described below with reference to fig. 17D.

In some configurations, the plurality of features may include a plurality of holes 1242C in the distal extension 1240C. For example, each distal extension 1240C may contain one or more holes 1242C. In the illustrated configuration, each distal extension 1240C has a single hole 1242C. The plurality of apertures 1242C may allow blood to flow into the enclosed volume of the implant 1230 (e.g., the volume between the inner frame 1232 and the prosthetic valve assembly 1231, and the volume between the outer frame 1234 and the skirt assembly 1238). The plurality of holes 1242C may be sized such that blood may flow into the implant 1230 through the holes 1242C, but blood flow out of the implant 1230 is prevented or limited. When the implant 1230 is assembled, the holes 1242C can be positioned between the anchors 1237 of the inner frame 1232 (as shown in fig. 16A) such that the anchors 1237 do not restrict blood flow through the holes 1242C. Further, by ensuring that the apertures 1242C are positioned between the anchors 1237, the apertures 1242C can assist the manufacturer in properly attaching the skirt assembly 1238 to the inner and outer frames 1232, 1234.

In some configurations, the plurality of features may include at least one tapered section 1242D. At least one tapered section 1242D may be positioned on the exterior of the outer frame 1234. In some configurations, at least one tapered section 1242D can comprise two tapered sections 1242D that can be stitched together when the implant 1230 is assembled.

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

The second alignment feature 1242F may be positioned on at least one distal extension 1240C. In the illustrated configuration, each distal extension 1240C includes a second alignment feature 1242F along an 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 relative to 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.

Fig. 17D shows skirt assembly 1238 in a folded configuration, with distal extension 1240C stitched together and tapered section 1242D stitched together. When the skirt assembly 1238 is folded, adjacent proximal extensions 1240A may overlap and/or adjacent distal extensions 1240C may overlap such that adjacent proximal extensions 1240A and/or adjacent distal extensions 1240C may be stitched together.

In some embodiments, the cloth of the skirt assembly may be treated to soften the edges, which may become roughened when laser cutting is applied. Figures 17E-1 and 17E-2 illustrate the softened edges of the cloth for the skirt assembly of figures 17A through 17D. The roughened edge may be softened by applying a soldering iron with heat within a threshold temperature to the edge of the monolith. For example, a soldering iron may be used to melt the fibers of the cloth into a smooth melted edge 1238D. Alternatively, the z-axis characteristics of the laser may be applied to defocus the laser to produce a thicker melted cloth region that is smooth along the edges.

Fig. 17F illustrates the process of applying interlocking stitches to the cloth for the skirt assembly of fig. 17A-17D to eliminate knots. In current methods, transcatheter heart valves are typically manually sutured using sutures, and therefore knots are often present as a deceleration strip for the delivery system when the valve is crimped. In some embodiments, interlocking stitching techniques may be applied to eliminate knots. Interlocking stitches can use the braided structure of the stitch itself to pierce and interlock within its own strand and can secure the stitch without creating a large knot. In some embodiments, referring to fig. 17F, the needle tip may be pierced within the center of the braided structure of the suture to form an interlocking structure, which may create a safe starting or ending point for the suture. The interlocking method may comprise tensioning the suture (2) with a force fiber suture needle (1), passing again with the force fiber suture needle to create an interlocking stitch (3) on the opposite side, and finally tensioning again the suture (4) to complete the interlocking stitch.

Additional tether retention assembly configuration

Fig. 18A-18F illustrate the configuration of the distal subassembly 1303. The distal subassembly 1303 may be similar in configuration to the distal subassembly 703 shown and described with respect to fig. 7A-7E. Reference numerals of the same or substantially the same features may share the same last two digits.

As shown in fig. 18A-18C, the distal tether retention assembly 1307 may be configured to retain a tether or suture 710. Tether or suture 710 may contain a plurality of distal loops 1320. The distal tether retention assembly 1307 may be spaced apart from the proximal tether retention assembly 1306. For example, the distal subassembly 1303 may include an intermediate component 1312 positioned between the proximal tether retention component 1306 and the distal tether retention component 1307. In some configurations, the intermediate component 1312 may comprise a tube. The intermediate assembly 1312 may be made of a metallic material such as stainless steel. In some configurations, the proximal tether retention assembly 1306 may have a diameter that is greater than the diameter of the intermediate assembly 1312 and/or the manifold cable 705. In some configurations, the diameter of the distal tether retention assembly 1307 may be greater than the diameter of the intermediate assembly 1312 and/or the manifold cable 705.

As shown in fig. 18A, the distal tether retention assembly 1307 may include a plurality of slots 1318 extending radially of the distal tether retention assembly 1307 beyond portions of the intermediate assembly 1312 and/or the manifold cable 705. The plurality of slots 1318 may include a length extending along the longitudinal axis of the distal subassembly 1303. The illustrated configuration has nine slots 1318 in the distal tether retention assembly 1307. Other numbers of slots 1318 (e.g., two, four, five, six, seven, eight) may also be used in other configurations. The slot 1318 may be configured to receive portions of the tether or suture 710 and prevent the tether or suture 710 from being removed or uncoupled from the distal tether retention assembly 1307.

As shown in fig. 18B and 18C, the proximal tether retention assembly 1306 may include a plurality of slots 1314 extending radially of the proximal tether retention assembly 1306 beyond portions of the intermediate assembly 1312 and/or the manifold cable 705. The plurality of slots 1314 may include a length that extends along a longitudinal axis of the distal subassembly 1303. The number of slots 1314 of the proximal tether retention assembly 1306 may correspond to the number of slots 1318 of the distal tether retention assembly 1307. The illustrated configuration has nine slots 1314 in the proximal tether retention assembly 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 slots 1314 may be configured to receive a distal loop 1320 of a tether or suture 710. In other configurations, one or more slots 1314 may be configured to receive two or more distal loops 1320 of a tether or suture 710. In some configurations, the slot 1314 of the proximal tether retention assembly 1306 may be aligned with the slot 1318 of the distal tether retention assembly 1307. In other configurations, the slot 1314 of the proximal tether retention assembly 1306 may be offset from the slot 1318 of the distal tether retention assembly 1307.

Fig. 18D shows a tether or suture 710 secured to the distal subassembly 1303. As previously described, the slot 1314 may receive a distal loop 1320 of the tether or suture 710. A release (or locking) tether/suture 1322 may extend through the distal loop 1320, preventing the implant 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 secure the tether or suture 710 to the implant 30, 1230.

Fig. 18E and 18F illustrate the removal of tether or suture 710 from distal subassembly 1303. The release tether/suture 1322 may be withdrawn such that the free end 1324 of the release tether/suture 1322 may pass through the distal loop 1320, thereby releasing the implant 30, 1230 from tethered attachment with the distal subassembly 1303. In some embodiments, multiple release (or locking) tethers/sutures 1322 may be used (e.g., one for each distal ring 1320 or one for multiple distal rings 1320).

Fig. 19A and 19B illustrate another configuration of a proximal tether retention assembly 1406 and an intermediate assembly 1412 that is similar to the embodiments of the proximal tether retention assemblies 706, 1306 and the intermediate assembly 1312 illustrated and described with respect to fig. 7A-7E and 18A-18F. Reference numerals of the same or substantially the same features may share the same last two digits.

The plurality of slots 1414 of the proximal tether retention assembly 1406 may include three slots 1414. Each slot 1414 may be configured to receive one or more distal loops 1320 of a tether or suture 710 (not shown). In some configurations, as shown in fig. 19A, a shaft extending between the intermediate assembly 1412 and the manifold cable 705 may include a plurality of holes 1426. The holes 1426 may be circumferentially spaced apart. As shown, the aperture 1426 may be aligned with the slot 1414. In some configurations, the aperture 1426 may be at least partially offset from the slot 1414.

Timing or implant orientation control

Fig. 20A-20C illustrate a configuration of a handle 1514 similar to the embodiment of handle 14 illustrated and described with respect to fig. 1 and 11. The handle 1514 may be configured to rotate the implant 30, 1230 during delivery. For example, the implant 30, 1230 may be rotated to avoid certain anatomical structures, to enhance the sealing of the implant 30, 1230, and/or to avoid erosion of certain anatomical regions (e.g., aortic root in the atrium).

As shown, the handle 1514 may include a capsule knob 1505 (similar to the capsule knob 905 shown and described with respect to fig. 9A and 9B), an orientation mechanism 1516 configured to rotate the implant 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 one side of the handle 1514 that may be rotated about a 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 may also be rotated. In some configurations, the rotation mechanism 1518 may include a worm gear 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 1520 may be coupled to the linear guide 1524 such that when the orientation knob 1516 is rotated, the worm gear 1520 may rotate the linear guide 1524. The adapter 1522 may be coupled to the linear guide 1524 such that when the linear guide 1524 is rotated, the linear guide 1524 may rotate the adapter 1522. The adapter 1522 may be coupled to the outer proximal shaft 302 (not shown) of the capsule assembly 306. As the linear guide 1524 rotates the adapter 1522, the adapter 1522 may rotate the outer proximal shaft 302. In some configurations, the adapter 1522 may be configured to control the linear movement of the outer proximal shaft 302 when the capsule knob 1505 is rotated.

In some configurations, the orientation knob 1516 may rotate the outer proximal shaft 302 of the capsule assembly 306. During delivery of the implant 30, 1230, the orientation knob 1516 may be actuated to rotate the outer proximal shaft 302 of the capsule subassembly 306 and the implant 30, 1230 within the capsule subassembly 306 for positioning the implant 30, 1230 within the patient.

In some configurations, the orientation knob 1516 may include a plurality of indicators located on an outer surface of the orientation knob 1516. An indicator on the orientation knob 1516 may be associated with rotation of the implant 30, 1230. For example, the indicator may show that the implant 30, 1230 has rotated a certain number of degrees. In some configurations, the orientation knob 1516 may be directly coupled to the outer proximal shaft 302 of the capsule assembly 306 such that rotating the orientation knob 1516 may directly rotate the outer proximal shaft 302. In some configurations, the orientation mechanism 1516 may be a lever configured to be pushed and/or pulled to rotate the implant 30, 1230 during delivery.

Fig. 20D, 20E, 20F, and 20G further illustrate an embodiment of the orientation mechanism of fig. 20C coupled to an outer lumen 20A within which an implant (e.g., implant 30, 1230) may be rotated. The detailed gear mechanism is described above in connection with fig. 20B and 20C, and thus, a detailed description of the gear mechanism of the orientation mechanism is omitted here. By rotating the orientation mechanism or knob 1516, as shown in fig. 20F-20G, the implant 30, 1230 (not shown) can be rotated by a gear mechanism during implantation to position the implant with a desired rotational orientation (e.g., to avoid the possibility of conductive interference caused by a portion of the implant coming into contact with certain tissue). As previously discussed, the gear mechanism may include a worm gear mechanism 1520 and a capsule 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 1520 may be coupled to the linear guide 1524 such that when the orientation knob 1516 is rotated, the worm gear 1520 may rotate the linear guide 1524 (and thus the outer sheath subassembly 20 and capsule subassembly 306 and the implant positioned therein). Because of the operative coupling to the outer sheath subassembly 20, rotation of the outer sheath subassembly 20 can passively cause rotation of other subassemblies and implants, but cannot be directly rotated by rotating the orientation knob 1516.

The implant (e.g., a double-frame valve prosthesis or a replacement heart valve) may be preloaded in a desired orientation based on a pre-operative plan. For example, a predicted location of the bundle of his may be identified, and a predicted amount of secondary deflection deemed necessary to implant the implant into the heart valve location may be determined. Based on the determination, the orientation of the implant may be set during loading to avoid contact of the anchor or other implant portion with the his bundle. Additionally, or alternatively, real-time timing may be performed by the orientation mechanism 1516 based on direct or indirect fluoroscopic markers. Referring to fig. 20H-20I, which illustrate a virtual representation of the implant 30, 1230 superimposed on an image (e.g., a fluoroscopic image) of the patient's body (e.g., heart anatomy) taken prior to performing a rotation, the implant 30, 1230 may be positioned by rotating the orientation knob 1516 to avoid contact of one or more anchors 37 or other portions of the implant 30, 1230 with the patient's his bundle, as represented by marker 3000, for example. Rotation (orientation) of the implant 30, 1230 may be performed in the process (e.g., by rotating from fig. 20H to fig. 20I) prior to deploying the implant to prevent (or reduce the likelihood of) the anchors 37 from contacting the his bundle or other undesirable tissue contacting location based on the location of the markers 3000. That is, the orientation mechanism 1516 may be used not only during implantation as described with reference to fig. 23A-23C, but also prior to implant delivery by marking points 3000 to be avoided, such as the patient's his bundle, on images taken prior to performing implant delivery. With respect to indirect visualization, the relationship (e.g., angular offset Θ) between the anchor-free region on the implant and the fluorescent indicator can be determined. Then, a marker 3000 identifying a location on the his bundle may be marked, and the angular offset Θ may be plotted on a pre-operative image (e.g., CT scan) of the patient's heart. The implant view may then be arranged to place the fluoroscopic plane orthogonal to the fluoroscopic indicator. The implant may then be loaded at the determined angular offset Θ. The clinician may then bring the fluoroscopic indicator to the center of view in the fluoroscopic image to place the implant in the desired orientation without flipping to a direct fluoroscopic view. The fluoroscopic indicator may be an existing feature of the implant, rather than a separate indicator. In this case, the loading step may not be necessary.

Fig. 21 illustrates another configuration of a handle 1614 similar to the embodiment of the handle 14, 1514 shown and described with respect to fig. 1, 11, and 20A-20C. Reference numerals of the same or substantially the same features may share the same last two digits. The handle 1614 may be configured to rotate the implant 30, 1230 during delivery. The orientation knob 1616 may extend along a longitudinal axis of the handle 1614 and be configured to rotate about the longitudinal axis of the handle 1614. The orientation knob 1616 may be configured to rotate the outer proximal shaft 302 and the implants 30, 1230 when the orientation knob 1616 is rotated.

Fig. 22-23C illustrate implant 30 delivered to the heart. As shown, the heart may contain a hotspot 2000. The hot spot 2000 may be located within the ventricular septum near the aortic valve, containing conductive fibers (e.g., the right branch and/or the left branch of the bundle of his). When implant 30 is delivered to the tricuspid valve of the heart, anchors 37 of implant 30 may contact the conductive fibers within hot spot 2000. If anchors 37 of implant 30 contact the conductive fibers, this may result in atrioventricular block ("AV block") within the tricuspid valve. Advantageously, any of the orientation knobs 1516, 1616 described herein may be used to rotate or synchronize the implant 30 during delivery such that the anchors 37 of the implant 30 do not contact the conductive fibers. For example, synchronization of the implant may advantageously keep the anchors 37 away from the primary fiber bundle extending along the right ventricular septum near the aortic valve. In addition, the synchronization function may facilitate the use of an asymmetric implant design, which may provide additional benefits such as enhanced sealing capability or avoidance of erosion of critical areas such as the aortic root in the atrium. Although implant 30 is shown and described, other implants (e.g., implant 1230 or other implants described herein) may also be delivered or "synchronized" as described herein.

Additional statements and terms

From the foregoing description, it can be appreciated that inventive products and methods for an implant delivery system are disclosed. Although several components, techniques and aspects have been described with a certain degree of particularity, it is apparent that many changes may be made in the specific designs, constructions and methods described above without departing from the spirit and scope of the disclosure.

The section headings used herein are provided only for enhanced readability and are not intended to limit the scope of the embodiments disclosed in a particular section to the features or elements disclosed in that section. Certain features that are described in this disclosure in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in certain combinations, one or more features from a claimed combination can in some cases be excised from the combination, and the combination may be directed to a subcombination or variation of a subcombination. In some embodiments, the delivery system or delivery device includes individual features in the form of a single feature (as opposed to multiple features). For example, in one embodiment, the delivery system comprises a single delivery device having a single implant. In alternative embodiments, a plurality of features or components are provided.

Furthermore, although methods may be depicted in the drawings or described in the specification in a particular order, such methods are not required to be performed in the particular order shown or in an order that does not require performance of all methods to achieve desirable results. Other methods not depicted or described may be incorporated into the example methods and processes. For example, one or more additional methods may be performed before, after, concurrently with, or between any of the described methods. Further, in other embodiments, the methods may be rearranged or reordered. Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. In addition, other embodiments are within the scope of the present disclosure.

Conditional language such as "may/capable/likelihood" is generally intended to convey that certain embodiments include or exclude certain features, elements and/or steps unless specifically stated otherwise or otherwise understood in the context of use. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

Spatially relative terms, such as "proximal," "distal," "below," "lower," "upper," and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or elements or features as illustrated in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "below" may encompass both an orientation of "above" and "below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms unless otherwise indicated by the context. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and, similarly, a second feature/element discussed below could be termed a first feature/element, without departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" will be understood to mean various components (e.g. compositions and apparatus comprising devices and methods) which may be employed together in the methods and articles of manufacture. For example, the term "comprising" will be understood to imply the inclusion of any stated element or step but not the exclusion of any other element or step.

Connection language such as the phrase "at least one of X, Y and Z" is understood along with the context in which the term, etc., may be X, Y or Z, as commonly used in the expression, unless specifically stated otherwise. Thus, such connection language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of z.

The terms "about," "generally," and "substantially" as used herein mean a value, quantity, or characteristic that is near the value, quantity, or characteristic that still performs the desired function or achieves the desired result. For example, the terms "about," "generally," and "substantially" may refer to amounts that are less than or equal to 10%, less than or equal to 5%, less than or equal to 1%, less than or equal to 0.1%, and less than or equal to 0.01% of the stated amount. If the amount is 0 (e.g., none), the above range may be a particular range and not within a particular% of the value. For example, the amount is within less than or equal to 10wt./vol.%, less than or equal to 5wt./vol.%, less than or equal to 1wt./vol.%, less than or equal to 0.1wt./vol.% and less than or equal to 0.01 wt./vol.%.

Some embodiments have been described in conjunction with the accompanying drawings. The drawings are to scale, but such scale should not be limiting, as dimensions and proportions other than those shown are also contemplated and are within the scope of the disclosed invention. The distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual size and layout of the device shown. Components may be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. associated with various embodiments may be used in all other embodiments set forth herein. Additionally, it will be appreciated that any of the methods described herein may be implemented using any device suitable for performing the steps described.

In some configurations, the delivery system includes one or more of the following: means for introducing a delivery device, means for stabilizing a delivery device, means for manipulating a delivery device, means for releasing an implant from a delivery device, and the like.

Although various embodiments and variations thereof have been described in detail, other modifications and methods of using these embodiments will be apparent to those skilled in the art. It should therefore be understood that various applications, modifications, materials and substitutions may be made without departing from the scope of the unique and inventive disclosure or claims herein.

Claims (40)

1. A valve prosthesis adapted for non-uniform compression during loading into a capsule, the valve prosthesis comprising:

a self-expanding frame configured to transition between a compressed configuration and an expanded configuration, the frame comprising at least one row of cells forming a ring; and

a plurality of prosthetic valve leaflets coupled to the frame,

wherein the frame comprises a plurality of pre-curved axial connection portions, each extending between a top end and a bottom end of one of the at least one row of cells, wherein each axial connection portion is adapted to curve in a predetermined manner to accommodate variations in cell height during uneven compression of the valve prosthesis.

2. The valve prosthesis of claim 1, wherein the axial connection portion is curved in a circumferential direction.

3. The valve prosthesis of claim 1 or 2, wherein the axial connection portion has an asymmetric shape.

4. Valve prosthesis according to any of the preceding claims, wherein the axial connection allows the unit to shorten during loading.

5. The valve prosthesis of any one of the preceding claims, wherein each axial connection portion comprises a single curved axial strut.

6. The valve prosthesis of any one of claims 1-4, wherein each axial connection portion includes a pair of axial struts forming a slot therebetween, and wherein each of the pair of axial struts is curved in opposite directions.

7. The valve prosthesis of any one of the preceding claims, further comprising a conformable outer frame for engaging tissue of a native heart valve.

8. The valve prosthesis of any one of the preceding claims, wherein each cell of the at least one row of cells has a chevron shape.

9. The valve prosthesis of any one of claims 1 to 7, wherein each cell of the at least one row of cells has a diamond shape.

10. A dual frame valve prosthesis, comprising:

a self-expanding outer frame configured to transition back and forth between a compressed configuration and an expanded configuration; and

a self-expanding inner frame positioned within the self-expanding outer frame, the self-expanding inner frame configured to transition back and forth between a compressed configuration and an expanded configuration,

wherein the inner frame comprises a plurality of strut assemblies biased in a particular configuration or shape so as to bend or deform in a desired direction during transition of the self-expanding inner frame between the expanded configuration and the compressed configuration or between the compressed configuration and the expanded configuration.

11. The valve prosthesis of claim 10, wherein the frame comprises a plurality of rows of cells formed by struts.

12. The valve prosthesis of claim 11, wherein at least a plurality of cells in a distal-most row of the plurality of rows of cells includes the plurality of strut assemblies.

13. The valve prosthesis of claim 12, wherein the plurality of strut assemblies comprise axial struts connecting a distal apex of each cell of the plurality of cells with a distal apex of an adjacent cell in a row directly above the distal-most row.

14. Valve prosthesis according to claim 13, wherein the axial struts are adapted to prevent cell ovality during transition of the self-expanding inner frame between the expanded configuration and the compressed configuration, and/or vice versa.

15. The valve prosthesis of claim 10, wherein the plurality of strut assemblies comprise a double bow spring structure comprising two axial strut sections connected at their proximal and distal ends but separated along their lengths.

16. The valve prosthesis of claim 11, wherein the cells comprise chevron cells.

17. The valve prosthesis of claim 16, wherein the plurality of strut assemblies comprise a single bow spring structure adapted to prevent cell ovality of the chevron cells during the transition between the compressed configuration and the expanded configuration and/or between the expanded configuration and the compressed configuration.

18. The valve prosthesis of claim 17, wherein the bow spring structure is asymmetric.

19. The valve prosthesis of claim 17, wherein the bow spring structure is symmetrical.

20. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and a middle portion extending between the inflow portion and the outflow portion, wherein the inflow end of the inner frame includes a plurality of inflow struts; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the inflow end of the outer frame includes a plurality of inflow struts,

Wherein each of the inflow struts of the outer frame is attached to a respective inflow strut of the inner frame, and

wherein the inflow struts of the outer frame each comprise a bendable tab that is unattached to the inflow struts of the outer frame along at least a portion of the bendable tab such that the bendable tab is bendable along a plane independent of the respective inflow struts of the inner frame.

21. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion,

wherein the inflow end of the outer frame and the inflow end of the inner frame are mechanically attached together such that there is an angle between the inflow end of the outer frame and the inflow end of the inner frame adjacent to the attachment point.

22. The valve prosthesis of claim 21, wherein the inflow end of the outer frame and the inflow end of the inner frame are mechanically attached by a dovetail joint configuration or a "puzzle piece" mating configuration.

23. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and a middle portion extending between the inflow portion and the outflow portion, wherein the inflow end of the inner frame includes a plurality of axial inflow struts; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the inflow end of the outer frame includes a plurality of axial inflow struts,

wherein the axial inflow support post of the inflow end portion of the outer frame and the axial inflow support post of the inflow end portion of the inner frame are attached together, and

Wherein the proximal-most ends of at least two of the axial inflow struts are configured to be positioned at a distance offset from each other.

24. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the outflow end of the inner frame includes a plurality of anchors; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion,

wherein at least some of the plurality of anchors include an attachable anchor damper that does not include foam.

25. The valve prosthesis of claim 24, wherein the attachable anchor damper is configured to have a first portion configured to engage a native heart valve leaflet that is more rigid than a second portion configured to contact a diaphragm wall or annulus of a heart, wherein the second portion is configured to provide a cushioned contact surface.

26. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the outflow end of the inner frame includes a plurality of anchors; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion,

wherein at least some of the plurality of anchors include a metallic cushioned anchor tip configured to distribute and attenuate loads exerted on natural tissue in contact with the anchor tip.

27. The valve prosthesis of claim 26, wherein the metallic buffer anchor tip comprises nitinol.

28. The valve prosthesis of claim 26, wherein the metallic buffer anchor tip comprises a stirrer configuration comprising a plurality of wire loops.

29. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the outflow end of the inner frame includes a plurality of anchors; and

an outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion,

wherein at least some of the plurality of anchors include anchor tips configured to provide a cushioning effect in a radially outward direction to reduce the likelihood of conductive interference caused by contact of the anchors with a septal wall of the heart and to provide rigidity in a radially inward direction to facilitate capture of a native heart valve leaflet.

30. A dual frame valve prosthesis comprising common tissue features to facilitate alignment and registration during compression and expansion of the dual frames of the dual frame valve prosthesis, the valve prosthesis comprising:

An inner frame; and

an outer frame comprising one or more common tissue features configured to facilitate alignment and registration during compression and expansion of the inner and outer frames.

31. The valve prosthesis of claim 30, wherein the inner frame comprises one or more common tissue features that are complementary to the one or more common tissue features of the outer frame.

32. The valve prosthesis of claim 30 or 31, wherein the one or more common tissue characteristics of the outer frame include one or more of:

a C-shaped or U-shaped joint sized and shaped to span a corresponding axial strut of the inner frame;

designing a hammer head near side eyelet;

a distal apex at the outflow end of the inner frame and the outflow end of the outer frame is circumferentially offset.

33. A dual frame valve prosthesis, the valve prosthesis comprising:

an internal frame, the internal frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion;

An outer frame, the outer frame comprising: an inflow portion including an inflow end; an outflow portion including an outflow end; and an intermediate portion extending between the inflow portion and the outflow portion, wherein the inflow end of the outer frame includes a plurality of axial inflow struts including a plurality of apertures, wherein at least one aperture of the plurality of apertures of each of the plurality of axial inflow struts of the outer frame is configured to engage with at least one aperture of the plurality of apertures of the plurality of axial inflow struts of the inner frame; and

a skirt assembly positioned between the inner frame and the outer frame, wherein the skirt assembly comprises:

a unitary sheet of material having different diameters, the unitary sheet of material comprising a body portion, a plurality of proximal extensions extending from the body portion, and a plurality of distal extensions extending from the body portion, wherein the plurality of proximal extensions are positioned between the inflow portion of the inner frame and the inflow portion of the outer frame, wherein the body portion of the skirt assembly is positioned outside the intermediate portion of the outer frame, wherein the plurality of distal extensions are positioned between the outflow portion of the inner frame and the outflow portion of the outer frame.

34. The valve prosthesis of claim 33, wherein one or more of the plurality of proximal extensions comprises a tab configured to be positioned between one or more of a plurality of inflow struts at the inflow end of the inner frame and one or more of the plurality of axial inflow struts of the outer frame.

35. The valve prosthesis of claim 33 or 34, wherein one or more of the plurality of distal extensions comprises a hole configured to allow blood to flow into a volume between the inner frame and the outer frame.

36. The valve prosthesis of any one of claims 33-35, wherein the plurality of proximal extensions and/or the plurality of distal extensions comprise a trapezoidal shape.

37. The valve prosthesis of any one of claims 33 to 36, wherein the plurality of proximal extensions are stitched together by one or more sutures when the valve prosthesis is assembled; and/or wherein the plurality of distal extensions are stitched together by one or more sutures when the valve prosthesis is assembled.

38. The valve prosthesis of claim 37, wherein the one or more sutures comprise at least one interlocking stitch.

39. The valve prosthesis of any one of claims 33 to 38, wherein at least one edge of the cloth of the skirt assembly is melted so as to provide a smooth edge surface.

40. The valve prosthesis of any one of claims 33-39, further comprising a valve assembly positioned within the internal frame, the valve assembly comprising a plurality of prosthetic leaflets, wherein a cusp of each prosthetic leaflet of the plurality of prosthetic leaflets is sutured to the skirt assembly using two different sutures.