Stented prosthetic heart valve with wrapping portion

Abstract

Systems and methods for delivering and deploying a stented prosthetic heart valve (10) having a wrap portion (40) that automatically deploys to prevent or mitigate paravalvular leakage. In various embodiments, during transcatheter delivery of the stented prosthetic heart valve, the wrap portion extends beyond the stent frame (14) of the stented prosthetic heart valve so that the profile of the stented prosthetic heart valve does not increase during delivery. The disclosed embodiments are configured and constructed such that upon expansion of the stent frame of the stented prosthetic heart valve, a plurality of elongated members (54) automatically pull the wrap portion distally into a deployed arrangement.

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2017 / 022784, international application date March 16, 2017, application number 201780018550.8 entering the Chinese national phase, and name “Prosthetic heart valve with stent having a wrapping portion”. Background Art

[0002] The present invention generally relates to systems and methods for delivering and deploying a stented prosthetic heart valve having a wrap for preventing and / or mitigating paravalvular leak.

[0003] The human heart includes four heart valves that determine the path of blood flow through the heart: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. The mitral valve and tricuspid valve are atrioventricular valves located between the atria and ventricles, while the aortic valve and pulmonary valve are semilunar valves located in the arteries leaving the heart. Ideally, the natural leaflets of the heart valve move away from each other when the valve is in the open position and touch or "close" when the valve is in the closed position. Problems that may arise with the valve include: stenosis, when the valve does not open properly; and / or insufficiency or regurgitation, when the valve does not close properly. Stenosis and insufficiency may occur simultaneously in the same valve. The effects of valve dysfunction vary, and regurgitation or backflow usually has relatively serious physiological consequences for the patient.

[0004] Recently, flexible prosthetic valves for cardiac and venous valve replacement have been developed, which are supported by a stent structure and can be delivered percutaneously using a catheter-based delivery system. These prosthetic valves may include a self-expanding or balloon-expandable stent structure, and the leaflets are attached to the interior of the stent structure. The diameter of the prosthetic valve can be reduced by being pressed onto a balloon catheter or by being contained in a sheath component of a delivery catheter, so that the prosthetic valve can be advanced through the venous or arterial vasculature. Once the prosthetic valve is positioned at the treatment site, such as in an insufficient natural valve, the stent structure can be expanded to hold the prosthetic valve fixedly in place. An example of a stented prosthetic valve is disclosed in U.S. Patent No. 5,957,949, entitled "Percutaneous Placement Valve Stent" by Leonhardt et al. Another example of a stented prosthetic valve for use in percutaneous pulmonary valve replacement procedures is described in US Patent Application Publication No. 2003 / 0199971 Al and US Patent Application Publication No. 2003 / 0199963 Al, both filed by Tower et al.

[0005] Although transcatheter delivery methods have provided a safer and more minimally invasive method for replacing defective natural heart valves, a recurring problem is leakage between the implanted prosthetic valve and the surrounding natural tissue. Leakage sometimes occurs due to the fact that the most minimally invasive and percutaneous heart valve replacements generally do not involve the actual physical removal of the diseased or injured heart valve. Instead, the prosthetic valve with a stent for replacement is delivered to the valve site under compression, where the prosthetic valve expands to its operating state within the natural valve. The calcified or diseased natural valve leaflets are pressed to the sidewalls of the natural valve by the radial force of the stent frame of the prosthetic valve. These calcified leaflets do not allow complete compliance of the stent frame with the natural valve and become the source of paravalvular leakage (PVL). The significant pressure gradient on the valve causes leakage of blood through the gap between the implanted prosthetic valve and the calcified anatomical structure.

[0006] Embodiments of the present application are directed to systems and methods for transcatheter delivery and deployment of a stented prosthetic heart valve having a wrap for preventing and / or mitigating paravalvular leak. Summary of the invention

[0007] The present application relates to systems and methods for delivering and deploying a stented prosthetic heart valve having a wrap that automatically deploys to alleviate or assist in preventing paravalvular leakage. In various embodiments, during transcatheter delivery of a stented prosthetic heart valve, the wrap is either before or after (i.e., distally or proximally to) a stent frame of the stented prosthetic heart valve. The disclosed embodiments are configured and constructed such that a plurality of elongated members spaced apart around the stent frame automatically pull the wrap proximally over and around the stent frame as the stent frame expands from a compressed delivery arrangement. In other embodiments, the wrap is pulled upward, causing it to flip over on itself in the process.

[0008] The embodiments disclosed herein can reliably deploy the wrap and effectively reduce stasis without adding additional steps to the delivery process that need to be performed by the clinician. Other embodiments are also beneficial because they do not increase the profile of the stented prosthetic heart valve during delivery compared to similar stented prosthetic heart valves with fixed wraps, which is particularly important for catheter-only delivery procedures. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A Shown is an exemplary delivery device for delivering and deploying a stented prosthetic heart valve (not shown) having an inner shaft assembly and an optional outer sheath assembly.

[0010] Figure 1B yes Figure 1ASchematic illustration of a delivery device is shown wherein a stented prosthetic heart valve has a paravalvular leak prevention wrap loaded therein, the stented prosthetic heart valve and wrap secured to an inner shaft assembly (outer sheath assembly not shown) in a delivery arrangement.

[0011] Figure 1C yes Figure 1A-1B A schematic illustration of a delivery device is shown with a stented prosthetic heart valve and a wrapping portion in an expanded arrangement prior to release from the delivery device.

[0012] Figure 1D yes Figure 1B A side view of a delivery arrangement of a stented prosthetic heart valve and wrap is shown (for clarity, the multiple elongated members interconnecting the wrap to the stent frame of the stented prosthetic heart valve are not shown).

[0013] Figure 1E yes Figure 1C A side view of a wrap and deployed arrangement of a stented prosthetic heart valve is shown.

[0014] Figure 2A is similar to Figure 1D-1E A front view of a stented prosthetic heart valve is shown secured in a compressed arrangement to a delivery device for delivery wherein the stented prosthetic heart valve extends beyond the stent frame (for clarity, the delivery device is only partially shown and the valve leaflets are not shown).

[0015] Figure 2B is in a compressed delivery arrangement Figure 2A A partial schematic illustration of a stented prosthetic heart valve and wrapping is shown.

[0016] Figure 2C yes Figure 2A-2B A partial schematic illustration of a stented prosthetic heart valve is shown illustrating representative elongated members interconnecting a wrap portion to a stent frame.

[0017] Figure 2D Is in a partially expanded configuration Figure 2A-2C A stented prosthetic heart valve is shown in front view; wherein the stent frame is partially expanded and the elongated member attached thereto has begun to pull the wrap over the stent frame and onto the stent frame.

[0018] Figure 2E It is in the deployment Figure 2A-2D A three-dimensional view of a stented prosthetic heart valve is shown; wherein the stented prosthetic heart valve is released from a delivery device and the wrapping portion is secured to the stent frame.

[0019] Figure 2FIt is in the deployment Figure 2A-2E A partial schematic illustration of a stented prosthetic heart valve and wrapping is shown.

[0020] Figure 2G It is in the deployment Figure 2A-2F A partial schematic illustration of a stented prosthetic heart valve is shown (only one elongate member is shown for clarity).

[0021] Figure 3A is a perspective view of a stented prosthetic heart valve having a stent frame with a wrap secured to a delivery device in an expanded deployed arrangement (for clarity, the delivery device is only partially shown and the valve leaflets are not shown).

[0022] Figure 3B Is in delivery arrangement Figure 3A A schematic illustration of a wrapping portion of a stented prosthetic heart valve is shown, illustrating how a representative elongated member is secured to two cells of a stent frame in an offset manner.

[0023] Figure 3C When Figure 3A A stented prosthetic heart valve is shown in an expanded configuration. Figure 3A-3B A schematic illustration of the wrapping portion is shown.

[0024] Figure 4A is a front view of a stented prosthetic heart valve having a prosthetic frame secured to a delivery device (for clarity, the delivery device is only partially shown and the valve leaflets are not shown); the stented prosthetic heart valve has a wrap portion extending beyond the stent frame in a delivery arrangement.

[0025] Figure 4B is in an expanded, deployed configuration prior to release of a stented prosthetic heart valve from a delivery device Figure 4A A perspective view of a prosthetic heart valve with a stent is shown.

[0026] Figure 4C yes Figure 4A-4B A schematic illustration of a stented prosthetic heart valve is shown, illustrating how a representative elongated member may be secured to one of a plurality of cells of a stent frame.

[0027] Figure 5A is a perspective view of a partially assembled stented prosthetic heart valve having a wrap portion; the stented prosthetic heart valve also has a stent frame secured to a delivery device (for clarity, the delivery device is only partially shown and the valve leaflets are not shown).

[0028] Figure 5B yes Figure 5AA schematic illustration of a stented prosthetic heart valve is shown showing how a representative elongated member is secured to one of a plurality of cells of a stent frame.

[0029] Figure 5C yes Figure 5A-Figure 5B A schematic illustration of a stented prosthetic heart valve is shown with the stented prosthetic heart valve and a packaging portion loaded onto a delivery device (only a portion of the delivery device is shown).

[0030] Figure 5D yes Figure 5A-5C A schematic illustration of a stented prosthetic heart valve is shown, wherein the stented prosthetic heart valve is in an expanded, deployed configuration, which automatically positions the encasement over and onto the stent frame.

[0031] Figure 5E yes Figure 5A-5D A perspective view of a stented prosthetic heart valve is shown, showing the stented prosthetic heart valve in an expanded, deployed configuration; wherein the wrap is folded over itself onto the stent frame.

[0032] Fig. 6A A partially schematic illustration of another embodiment of a stented prosthetic heart valve having a wrapping portion secured to a stent frame by a plurality of elongated members, the stented prosthetic heart valve being in a compressed delivery arrangement with the wrapping portion extending beyond the stent frame (for clarity, the valve leaflets of the stented prosthetic heart valve are not shown).

[0033] Figure 6B is in a transitional position between a compressed delivery configuration and an expanded deployment configuration Fig. 6A A partial schematic illustration of a stented prosthetic heart valve is shown.

[0034] Figure 6C is in an expanded deployment configuration Figure 6A-6B A partial schematic illustration of a prosthetic heart valve with a stent is shown, wherein the wrapping portion is positioned above the stent frame.

[0035] Fig. 7A A partially schematic illustration of another embodiment of a stented prosthetic heart valve having a wrapping portion secured to a stent frame by a plurality of elongated members, the stented prosthetic heart valve being in a compressed delivery arrangement with the wrapping portion extending beyond the stent frame (for clarity, the valve leaflets of the stented prosthetic heart valve are not shown).

[0036] Figure 7B is in an expanded deployment configuration Fig. 7A A partial schematic illustration of a prosthetic heart valve with a stent is shown; wherein the wrapping portion is positioned above the stent frame.

[0037] Fig. 8A A partially schematic illustration of another embodiment of a stented prosthetic heart valve having a wrapping portion secured to a stent frame by a plurality of elongated members, the stented prosthetic heart valve being in a compressed delivery arrangement with the wrapping portion extending beyond the stent frame (for clarity, the valve leaflets of the stented prosthetic heart valve are not shown).

[0038] Figure 8B is in an expanded deployment configuration Fig. 8A A partial schematic illustration of a prosthetic heart valve with a stent is shown; wherein the wrapping portion is positioned above the stent frame. DETAILED DESCRIPTION

[0039] Specific embodiments of the present invention are now described with reference to the accompanying drawings, wherein similar reference numerals indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description with respect to the position or direction of the treating clinician. "Distal" or "distalwardly" is a position away from the clinician or in a direction away from the clinician. "Proximal" and "proximalwardly" are a position close to the clinician or in a direction toward the clinician. Although the application has been described with reference to preferred embodiments, it will be appreciated by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the application.

[0040] As background information, Figure 1A-1E , the overall components of a non-limiting example of a delivery device 1 useful for various aspects of the present application are shown. The delivery device 1 is configured and constructed for percutaneous delivery of a stented prosthetic heart valve 10 (hereinafter referred to as a "prosthetic valve") to a defective heart valve of a patient. The delivery device 1 includes an optional outer sheath assembly 2, an inner shaft assembly 4, and a handle assembly 6. One or more sutures 12 are provided, and the one or more sutures may be considered as part of the delivery device 1 in some embodiments and as part of the prosthetic valve 10 in other embodiments. The delivery device 1 provides a loading delivery arrangement ( Figure 1B ), in which a prosthetic heart valve 10 is loaded onto an inner shaft assembly 4 and is held compressively on a core shaft 8 or the like by sutures 12. Figure 1B-Figure 1C As schematically shown in FIG. 1 , the pressure on the prosthetic valve 10 can be adjusted by means of one or more sutures 12. Once loaded and compressed, the prosthetic valve 10 is located at the target site and the tension in the sutures 12 is reduced to allow the prosthetic valve 10 to self-expand, partially release and eventually fully deploy the prosthetic valve 10 from the inner shaft assembly 4 (see FIG. 1 ). Figure 1BIn the illustrated embodiment, where provided, the outer sheath assembly 2 includes a balloon 9 that is selectively disposed over the prosthetic valve 10, which assists in restraining the prosthetic valve 10 in a loaded or compressed arrangement and can be retracted by the handle assembly 6 to expose the prosthetic heart valve 10.

[0041] As mentioned herein, the stented prosthetic heart valves or "prosthetic valves" used in and / or as part of the various delivery systems and methods of the present application can take on numerous different configurations, such as bio-stented prosthetic heart valves with tissue leaflets or synthetic heart valves with polymeric, metallic, or tissue-engineered leaflets, and can be specifically constructed to replace any heart valve. Thus, the prosthetic valves used in the systems and methods of the present application can be generally used for replacement of a native aortic, mitral, pulmonary, or tricuspid valve, used as a venous valve, or for replacement of a failed bioprosthesis, such as a bioprosthesis in the region of the aortic or mitral valve.

[0042] In general, the prosthetic valve of the present application includes a stent or stent frame that maintains the valve structure (tissue or synthetic), and the stent frame has a conventional expanded configuration and can be collapsed into a compressed configuration for loading into a delivery device. The stent frame is conventionally configured to self-deploy or self-expand when released from the delivery device. For example, the prosthetic valve used in the present application can be a stent or stent frame available from Medtronic CoreValve, LLC under the trade name Prosthetic valves for sale. Other non-limiting examples of transcatheter heart valve prostheses for the systems and methods of the present application are described in U.S. Notices No. 2006 / 0265056, No. 2007 / 0239266 and No. 2007 / 0239269, and the teachings of each document are incorporated herein by reference. Each stent or stent frame is a supporting structure that includes a plurality of struts or wire parts that are arranged relative to each other to provide the desired compressibility and strength for the prosthetic valve. In general, the stent or stent frame of the present application is generally a tubular supporting structure with an inner region, and the valve structure leaflets will be fixed in this inner region. The leaflets can be formed by various materials, such as autologous tissue, xenotransplantation materials or synthetics as known in the art. The leaflets can be provided as homologous biological valve structures, such as valves of pigs, cattle or horses. Alternatively, the leaflets may be provided independently of one another (e.g., bovine, porcine, or equine pericardial leaflets) and subsequently assembled to the support structure of the stent frame. In another alternative, the stent frame and leaflets may be manufactured simultaneously, such as may be accomplished using, for example, high-strength nanofabricated NiTi films produced at Advance BioProsthetic Surfaces (ABPS). The stent frame support structure is generally configured to accommodate at least two (typically three) leaflets; however, a replacement prosthetic valve of the type described herein may include more or less than three leaflets.

[0043] Some embodiments of the stent frame can be a series of wires or wire segments arranged so that they can self-transition from a compressed or collapsed arrangement to a conventional radially expanded arrangement. In some configurations, many individual wires comprising the stent frame support structure may be made of metal or other materials. These wires are arranged so that the stent frame support structure allows folding or compression or folding to a compressed arrangement in which the inner diameter is smaller than the inner diameter in a conventional expanded arrangement. In a compressed arrangement, such a stent frame support structure with attached leaflets can be mounted on a delivery device. The stent frame support structures are configured so that they can change to their conventional expanded arrangements when desired, such as by relative movement of one or more sheaths relative to the length of the stent frame.

[0044] The stent frame support structure in each embodiment of the present application can be made of nickel-titanium alloy (e.g., Nitinol TM) shape memory material. With the help of this material, the support structure can self-expand from a compressed arrangement to a conventional expanded arrangement, such as by applying heat, energy, etc. or by removing an external force (for example, a compressive force). This stent frame support structure can also be compressed and re-expanded multiple times without damaging the structure of the stent frame. In addition, the stent frame support structure of some embodiments can be laser cut from a single piece of material or assembled from many different parts. For these types of stent frame structures, an example of a delivery device that can be used includes a catheter with a retractable sheath that covers the stent frame until it is deployed, at which time the sheath can be retracted to allow the stent frame to self-expand. Other details of these embodiments are discussed below.

[0045] Figure 1D-1E A non-limiting prosthetic valve 10 for use with the systems and methods of the present application is shown in FIG. As a reference point, the prosthetic valve 10 has a Figure 1D 9 (eg, when held compressively on the inner shaft assembly 4 and perhaps within the capsule 9). The prosthetic valve 10 also has a compressed delivery configuration as shown in FIG. Figure 1E The prosthetic valve 10 includes a stent or stent frame 14, a valve structure 16, and a wrap 40 interconnected to the stent frame by a plurality of elongated members 54 (such as sutures, strings, wires, bands, etc.). The stent frame 14 can take any of the above-described forms and is generally configured so that it can be moved from a compressed arrangement ( Figure 1D ) from expansion to conventional expansion delivery arrangement ( Figure 1E ). In other embodiments, the stent frame 14 can be expanded to an expanded configuration by a separate device (e.g., a balloon located inside the stent frame 14). The stent frame 14 is at least partially formed by a plurality of cells 18, which are defined by a plurality of segments 20 adjacent at nodes 22. The valve structure 16 is assembled to the stent frame 14 and provides two or more (typically three) leaflets 24. The valve structure 16 can take any of the forms described above and can be assembled to the stent frame 14 in a variety of ways, such as by sewing the valve structure 16 to one or more segments 20 defined by the stent frame 42.

[0046] Figure 1D-1EThe prosthetic valve 10 shown is configured to replace an aortic valve (not shown). Alternatively, other shapes can also be envisioned that are adapted to the specific anatomical structure of the valve to be replaced (e.g., a prosthetic valve according to the present application can alternatively be shaped and / or dimensioned to replace a natural mitral valve, pulmonary valve, or tricuspid valve). In any case, the valve structure 16 can be configured to extend less than the entire length of the stent frame 14. Specifically, the valve structure 16 can be assembled to and extend along the first end 26 of the prosthetic valve 10, while the second end 28 can be free of the material of the valve structure 16. A variety of other configurations are also acceptable and within the scope of the present application. For example, the valve structure 16 can be dimensioned and shaped to extend along the entire length or nearly the entire length of the stent frame 14.

[0047] In certain embodiments, the expansion and contraction of the stent frame 14 is controlled as described above by means of one or more sutures 12 actuated by the braking device 1. The sutures 12 may be wrapped around the periphery of the stent frame 14. For example, at the first and second ends 26, 28, the compression sutures 12 may be wrapped through a plurality of eyelets 30, 32 disposed in the stent frame 14 to provide compression and release of the compressive tension placed on the stent frame 14 by means of the delivery device 1. In addition, the one or more sutures 12 may be positioned around the stent frame 14 between the first and second ends 26, 28 to provide uniform compression of the stent frame 14.

[0048] The prosthetic valves disclosed herein include paravalvular leak mitigation and wrap-around prevention features, such as Figure 1B-Figure 1E Wrap 40 is shown. In some embodiments, for example, during transcatheter, transfemoral, or subclavian delivery of prosthetic valve 10, wrap 40 is positioned in front of (i.e., distal to) stent frame 14. In the case of transapical delivery, wrap 40 is positioned behind (i.e., proximal to) stent frame 14. Regardless of whether wrap 40 is positioned proximally or distally relative to stent frame 14, a plurality of elongated members 54 interconnecting wrap 40 to stent frame 14 are arranged and constructed such that, when stent frame 14 is moved from Figure 1B and Figure 1D The compressed delivery arrangement shown expands to Figure 1C and Figure 1E In the expanded arrangement shown, elongated member 54 automatically pulls wrap 40 proximally over and around stent frame 14. In some embodiments, during delivery of prosthetic valve 10, wrap 40 is positioned to at least partially surround stent frame 14, and elongated member 54 pulls the remaining portion of wrap 40 over and around stent frame 14. In some embodiments, during delivery of prosthetic valve 10, wrap 40 is positioned completely around stent frame 14, and elongated member 54 changes the configuration of wrap 40 from the delivery configuration to the deployed configuration.

[0049] In some embodiments discussed further below, the wrap is pulled upward, flipping itself in the process. In some embodiments disclosed herein, the wrap generally comprises a cylindrical body material having a fixed end and a free end. In some embodiments, the wrap comprises a portion of a cylindrical body material or a non-cylindrical body material having a fixed end and a free end. The wrap material may be made of a flexible material such as, for example, polyester fabric, velvet, and tissue. The wrap may have a diameter that is substantially the same as the diameter of the expanded stent frame. The wrap may also include an edge on one or more of the free end and the fixed end. If the edge is provided on the fixed end, it can be used to connect the wrap to an inner skirt (not shown, if provided) provided within the stent frame.

[0050] As in Figure 2A-2G As seen in FIG. 1 , the prosthetic valve 110 can be provided with respect to Figure 1A-1E The prosthetic valve 110 is delivered and deployed in the manner schematically shown and described with the aid of a delivery device 1. Figure 1B - Figure 1E The prosthetic valve 110 includes a wrap portion 140 that generally includes a cylindrical body material 142 of a material having a fixed end 144 and a free end 146. The fixed end 144 of the wrap portion 140 can be fixed to the stent frame 114 by one or more attachment sutures 152 that pass through the eyelet 130 of the stent frame 114. Figure 2A A prosthetic valve 110 is shown retained on a shaft assembly 4 (partially shown) of a delivery device 1 in a compressed delivery arrangement by at least one compression suture 112. In this compressed or delivery arrangement, a wrap 140 extends from or beyond (i.e., distally of) a stent frame 114 such that the profile or perimeter of the prosthetic valve 110 is not increased during delivery by the addition of the wrap 140. It is highly desirable that the profile of the prosthetic valve 110 be as small as possible to facilitate transcatheter delivery of the prosthetic valve 110.

[0051] like Figure 2C and Figure 2FAs best shown in FIG, in order to fully deploy the wrap portion 140, a plurality of elongated members 154 are provided that are configured to automatically pull the wrap portion 140 into place as the prosthetic valve 110 expands during deployment. The elongated members 154 may be sutures, strings, wires, bands, or the like. In the illustrated embodiment, the wrap portion 140 is actuated by means of six elongated members 154 that are equally spaced about the stent frame 114 and attached proximate the free end 146 of the wrap portion 140 (not all of the elongated members 154 are visible, and more or fewer elongated members may be utilized alternatively). The wrap portion 140 may optionally include an opening 148, in which the attachments and elongated members 154 are secured or pass through, as will be discussed further below. Figure 2C and Figure 2F 14 and 15. As generally shown in FIG. 14 (only one exemplary elongated member 154 is shown), each elongated member 154 extends from a free end 146 and wraps around and proximate to a pivot node of the stent frame 114, and then the elongated member 154 is threaded through two cells 118a of the stent frame 114 to a second node 122b to which the corresponding elongated member 154 is attached. This "two-cell" threading arrangement provides sufficient slack in the corresponding elongated member 154 to allow the wrapping portion 140 to be positioned proximate to the stent frame 114 when the stent frame 114 is in a compressed delivery configuration, such as Figure 2A . It will be appreciated that the number of cells 118a spanned by the elongated members 154 may vary based on the design of the stent frame 114. The elongated members 154 are threaded and configured to provide the travel length required to pull the wrap 140 from the delivery configuration to the deployed configuration. When the frame 114 is allowed to expand by releasing the tension in the compression sutures 112 or otherwise, each elongated member 154 is pulled through the expanded periphery of the stent frame 114, thereby also pulling the wrap 140 proximally over the stent frame 114 into place, as shown in FIG. Figure 2B-Figure 3B In other words, as the stent frame 114 expands, the elongated member 154 pulls the free end 146 of the wrap portion 140 until the free end 146 is rolled over the fixed end 144 and the free end 146 is proximal to the fixed end 144 in an expanded arrangement. By increasing or decreasing the tension in the compression suture(s) 112 with the aid of the delivery device 1, the expansion of the stent frame 114 and, therefore, the corresponding expansion of the wrap portion 140 can be controlled and regulated as desired.

[0052] Figure 3A-3C The alternative prosthetic valve 110' generally shown in FIG. Figure 2A-2GThe prosthetic valve shown is the same, except that each elongated member 154 is threaded to be offset to provide a greater suture length, and a wider wrap portion configuration may be required, which requires that the second end or the first end 146 of the wrap 140 be removed from the delivery arrangement ( Figure 3B ) is pulled over a longer distance to the deployed layout ( Figure 3A and Figure 3C ). Threading the elongated members 154 in such a way that they are offset also results in corrugations and ridges 143 in the body material 142 of the wrapper, which is believed to help fill in gaps around the stent frame 114 to further prevent any potential paravalvular leaks. As shown, each elongated member 154 extends from the free end 146 of the wrapper 140 and extends to an adjacent node 122c, which is in a direction opposite to the node 122d and away from the two cells 118b, and the elongated member 154 is ultimately attached to the node 122d. Figure 3B-Figure 3C 122c, and then return counterclockwise across the width of two or more cells 118b to the next node 122d to which the elongated member 154 is secured by tethering or the like. As will be appreciated, although not shown, each elongated member 154 may alternatively extend counterclockwise to an adjacent pivot node and be wrapped around it, and then return clockwise across the width of two or more cells to the next node to which the elongated member is secured. As with previously disclosed embodiments, the valve structure of the prosthetic valve 110' is not shown in the drawings for clarity.

[0053] Figure 4A-4C Another prosthetic valve 210 is shown in FIG. 1. In this embodiment, which is substantially similar to the above-described embodiments, there are a plurality (e.g., six) of elongated members 254 equally spaced about and secured to the free end 246 of the wrap portion 240 (not all of the elongated members are visible). Rather than having an elongated member 254 extend across two or more cells 218 of the stent frame 214 as in the previous embodiments, each of the elongated members 254 is wrapped around (i.e., "a cell" passes through) a corresponding cell 218. As shown in FIG. 1 , the elongated members 254 are each wrapped around (i.e., "a cell" passes through) a corresponding cell 218. Figure 4CAs best shown in FIG. 1 , each elongated member 254 extends from a first node 222a to which the elongated member 254 is attached. The corresponding elongated member 254 then passes through the adjacent unit 218 to the second node 222b, around which the corresponding elongated member 254 is wound. The corresponding elongated member 254 is then guided toward the free end 246 of the wrapping portion 240, which includes a first hole 248a through which the elongated member 254 passes. The corresponding elongated member 254 then passes back along the direction of the first node 222a to the second hole 24b in the free end 246, and then reaches the adjacent first node 222a upward and around the first node. The elongated member 254 then passes back across the unit 218 to the second node 222b, to which the corresponding elongated member 254 is fixed by tethering or similarly. The remaining five elongated members 254 (not all of which are visible) can be passed through in a similar manner. Similar to the previous embodiment, when the stent frame 214 is allowed to expand by releasing the tension in one or more compression sutures 212 or otherwise, each elongated member 254 will be pulled over the periphery of the stent frame 214, thereby also pulling the wrap portion 240 from the stent frame 214. Figure 4A The delivery arrangement shown is pulled to Figure 4B-4C As with the previously disclosed embodiments, the elongate member 254 may be of the type described above, with the valve structure not shown in the drawings for clarity.

[0054] Another prosthetic valve 310 is Figure 5A-5E In this embodiment, the prosthetic valve 310 includes a wrap portion 340 and a plurality of elongated members 354a equally spaced around the periphery of the wrap portion 340 and threaded approximately at the midpoint of the width W of the wrap portion 340 . Figure 5A and Figure 5B is a pre-assembly view showing the attachment of the elongated member 354b and the placement of the wrap adjacent to the stent frame 314 of the prosthetic valve 310 for delivery (see also Figure 5C-5E ) before the prosthetic valve 310. To complete the assembly of the wrapping portion 340, the second elongated member 354b is passed through the fixed end 326 of the stent frame 314 and the free end 346 of the wrapping portion 340 and tied to form a closed loop (see, e.g. Figure 5E ). When the stent frame 314 expands, the wrapping portion 340 Figure 5C The delivery arrangement shown transitions to Figure 5D and Figure 5EAs the stent frame 314 expands due to the release of the compressive tension provided by the compression suture 312 actuated by the delivery device 1, the wrap portion 340 is pulled so that the wrap portion folds onto the stent frame 314 and folds onto itself at the elongated member 354a so that the free end 346 and the fixed end 344 of the wrap portion 340 are approximately aligned with each other at the first end 326 of the stent frame 314, as shown in FIG. Figure 5E 340 once deployed, but without increasing the profile of the prosthetic valve 310 during delivery. It is believed that the thicker wrap 340 in the deployed arrangement provides additional sealing capability to prevent paravalvular leakage compared to the embodiments disclosed above. In this embodiment, there are two layers of wrap body material 342 wrapped around the first end 326 of the stent frame 314, wherein the fixed end 344 is generally flush with the free end 346 in the deployed arrangement. Figure 5B As best shown in FIG. 1 , each elongated member 354a is tied to a first node 322a and passes through a cell 318 to a second node 322b around which the elongated member 354a is wrapped. The elongated member 354 then extends downward through a hole 348a approximately halfway through the wrap portion 340. The elongated member 354 then extends upward to a second hole 348b in the wrap portion 340 and then extends toward the first node 322a. Except as clearly stated, the wrap portion 340 and the elongated members 354 can be of the type described with reference to the embodiments above. As with the previously disclosed embodiments, the valve structure is not shown in the drawings for clarity.

[0055] Figure 6A-6C Schematically depicting a portion of yet another prosthetic valve 410 (partially shown) having an inverted wrap portion 440 secured to a stent frame 414 (also partially shown). Figure 1D and Figure 1E The valve leaflets are not shown for clarity. Figure 6A-6C . The wrap portion 440 has a proximal end 446, a distal end 444, and a midsection 447 therebetween. In this embodiment, the proximal end 446 is the most proximal relative to the stent frame 414, and the proximal end is fixed to the stent frame 414 by means of attachment sutures (not visible) or the like. The distal end 444 is positioned distally relative to the proximal end 446. The wrap portion 440 is also secured to the stent frame 414 by means of a plurality of elongated members at two points 448a, 448b within the midsection 447. Figure 6A-6C454a, 454b) are fixed to the support frame 414. Each elongated member pair includes two elongated members 454a, 454b, which can be threaded around the support frame 414 in any manner disclosed herein. Various embodiments may include multiple (e.g., six) elongated members 454a, 454b that similarly pass through the support frame 414 and are equally spaced around the support frame. The elongated members 454a, 454b can be of the type disclosed with the previous embodiments.

[0056] exist Figure 6A-6C In one exemplary method of passing a pair of elongated members 454a, 454b, shown in FIG. 1 , a first elongated member 454a may be tethered or otherwise secured to a pivot node 422a in a midsection 447 of a wrap portion 440, and the first elongated member 454a may be passed through or around the stent. The first elongated member 454a then passes through the stent frame 414 to a second point 422b where it leaves the two cells 418. The first elongated member 454a is tethered or otherwise secured to the stent frame 414 at a second point 422b, which may be a needle eye 430. The second elongated member 454b is attached at point 448 in the midsection 477 of the wrap portion 440 and extends proximally to a pivot node 422c in the stent frame 414, around which the second elongated member 454b passes and leads to a second node 422d of the stent frame 414, which is separated from the two cells 418 and at which the second elongated member 454b is secured by a tether or the like. In one embodiment, the approximate distance from the pivot node 422c to the pivot node 422a away from the proximal end 446 is approximately one-third of the width of the wrap portion 440. In another embodiment, point 448b is approximately the same distance from 448a and from the proximal end 446, which is one-third of the width of the wrap portion 440. As with the previously disclosed embodiments, when the stent frame 414 is moved from the delivery arrangement ( Fig. 6A ) expands to the expanded layout ( Figure 6C ), the expansion of the stent frame 414 correspondingly pulls the elongated members 454a, 454b, thereby pulling the middle section 447 of the wrapping portion 440 toward the proximal end 446 of the wrapping portion 440, so that the wrapping portion 440 becomes flipped and has a triple thickness along at least a portion of the wrapping portion 440 (see Figure 6C ). This embodiment is also particularly useful in preventing the "parachute effect" observed in previously disclosed embodiments where the wrap is drawn upward and over the stent frame, which can collect blood and make it difficult to flip the wrap from the delivery configuration to the deployed configuration.

[0057] As in Figure 7A-7BAs generally shown in FIG. 1 , the prosthetic valve 510 (partially shown) is substantially the same as the prosthetic valve 10 and can be used as described with reference to FIG. Figure 1A-1E The prosthetic valve 510 is delivered and deployed by means of the delivery device 1 in the manner schematically shown and described. The prosthetic valve 510 includes a wrapping portion 540, which generally includes a cylindrical body material having a fixed end 544 and a free end 546. The fixed end 544 of the wrapping portion 540 is fixed to the stent frame 514. Fig. 7A The prosthetic valve 510 is generally shown being held in a compressed delivery arrangement. In order to fully deploy the wrap 540, a plurality of elongated members 554 are provided that are configured to automatically pull the wrap 540 into place as the prosthetic valve 510 expands during deployment (only one illustrative elongated member 554 is shown for ease of illustration). The plurality of elongated members 554 may be equally spaced about the stent frame 514 and attached proximate the free end 546 of the wrap 540. Each elongated member 554 extends from the free end 546, through an aperture 528 in the wrap and to the stent frame 514, where it wraps around a pivot node 522a of the stent frame 514, and then the elongated member 554 is threaded across two adjacent cells 518 of the stent frame 514 to a second node 522b to which the respective elongated member 554 is attached. This "two-unit" through arrangement provides sufficient slack in the respective elongated members 554 to allow the wrapping portion 540 to be positioned sufficiently close to the stent frame 514 when the stent frame 514 is in the compressed delivery configuration, such as Fig. 7A . It will be appreciated that the number of cells 518 through which the elongated members 554 span may vary based on the design of the stent frame 514. The elongated members 554 are threaded and configured to provide the travel length required to pull the wrap portion 540 from the delivery configuration to the deployed configuration. When the stent frame 514 is expanded for deployment, each elongated member 554 is pulled across the expanded periphery of the stent frame 514, thereby pulling the free end 546 of the wrap portion 540 proximally into position over the stent frame 514, as shown in FIG. Figure 7B as shown in .

[0058] Similarly, Figure 8A-8B The prosthetic valve 610 (partially shown) is generally the same as the prosthetic valve 10 and can be used as described with reference to FIG. Figure 1A-1E The prosthetic valve 610 is delivered and deployed by means of the delivery device 1 in the manner schematically shown and described. The prosthetic valve 610 includes a wrapping portion 640, which generally includes a cylindrical body material having a fixed end 644 and a free end 646. The fixed end 644 of the wrapping portion 640 can be fixed to the stent frame 614. Fig. 8AThe prosthetic valve 610 is generally shown being held in a compressed delivery arrangement. To deploy the wrap 640, a plurality of elongated members 654 are provided that are configured to automatically pull the wrap 640 into place as the prosthetic valve 610 expands during deployment (only one illustrative elongated member 654 is shown for ease of illustration). The plurality of elongated members 654 may be equally spaced about the stent frame 614 and attached proximate the free end 646 of the wrap 640. Each elongated member 654 extends from the free end 646 and to the stent frame 614 where it wraps around a pivot node 622a of the stent frame 614, and then the elongated member 654 is threaded across two adjacent cells 618 of the stent frame 614 to a second node 622b to which the respective elongated member 654 is attached. This "two-unit" through arrangement provides sufficient slack in the respective elongated members 654 to allow the wrapping portion 640 to be positioned sufficiently close to the stent frame 614 when the stent frame 614 is in the compressed delivery configuration, such as Fig. 8A . It will be appreciated that the number of cells 618 through which the elongated members 654 span may vary based on the design of the stent frame 614. The elongated members 654 are threaded and configured to provide the travel length required to pull the wrap portion 640 from the delivery configuration to the deployed configuration. When the stent frame 614 is expanded for deployment, each elongated member 654 is pulled across the expanded periphery of the stent frame 614, thereby pulling the free end 646 of the wrap portion 640 proximally into position over the stent frame 614, as shown. Figure 8B as shown in .

[0059] In view of the present application, it will be appreciated that there are many methods by which the elongated members can be passed through and disposed around the stent frame to provide such a configuration in which the elongated members do not cross or contact each other, while still providing multiple elongated members to actuate the transition of the wrap portion from the delivery arrangement to the deployed arrangement. These embodiments provide many attachment points to facilitate the actuation or flipping of the wrap portion, which is generally resisted by the patient's tissue. It will also be appreciated that the direction in which the elongated members are wrapped around the stent frame can be clockwise, counterclockwise, or a combination thereof, in view of the teachings herein. Additional configurations implementing this concept are within the scope of the present application.

[0060] The various sutures disclosed herein may be of many types commonly used to compress a stented prosthetic heart valve during delivery. In various embodiments, the elongated member may be elastic such that the wrap reaches (achieves) its fully expanded configuration before the stent frame is in its fully expanded deployed configuration.

[0061] Although the present application has been described with reference to preferred embodiments, workers skilled in the art will recognize that various changes in form and details may be made without departing from the spirit and scope of the present application.

Claims

1. A prosthetic heart valve with a stent, comprising: Bracket frame; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as A wrapping portion, wherein the wrapping portion is connected to the support frame by means of a slender member, the wrapping portion includes a first end and a second end, the slender member includes a first end and a second end, wherein the first end of the slender member is fixed to the support frame, wherein the first end of the wrapping portion is fixed to the support frame, wherein the second end of the wrapping portion is connected to the slender member so that the second end of the wrapping portion is movably connected to the support frame, wherein the slender member passes through the wrapping portion at least once, and the second end of the slender member is attached to the wrapping portion, wherein the wrapping portion has a delivery structure and an expansion structure, and the expansion structure is actuated by the expansion of the support frame, wherein when the support frame expands, the slender member is pulled to pass through the expanded periphery of the support frame, thereby pulling the wrapping portion into place proximally above the support frame.

2. The prosthetic heart valve according to claim 1, wherein: The stent frame includes a plurality of cells formed by segments adjoining at a plurality of nodes, wherein the elongated member extends from the wrap portion in a first direction, wraps around a corresponding node, and then extends in a second direction different from the first direction.

3. The prosthetic heart valve according to claim 1, wherein: The stent frame defines a length, and the wrap portion covers a greater portion of the length of the stent frame in the deployed configuration than in the delivery configuration.

4. The prosthetic heart valve according to claim 1, wherein: The stent frame includes a first end and a second end, wherein in the delivery configuration, the second end of the wrap portion extends beyond the first end of the stent frame, and in the deployed configuration, the second end of the wrap portion extends above the stent frame.

5. The prosthetic heart valve according to claim 1, wherein: Also included are a plurality of elongated members connecting the stent frame and the wrapping portion, wherein each of the elongated members passes through the wrapping portion at least once.

6. The prosthetic heart valve according to claim 5, characterized in that The plurality of elongated members are arranged and constructed such that they do not intersect each other.

7. The prosthetic heart valve according to claim 5, characterized in that The plurality of elongated members are arranged and configured to be offset such that in the deployed configuration, a plurality of ridges are formed in the outwardly facing surface of the wrap portion.

8. The prosthetic heart valve according to claim 1, wherein: The stent frame includes a plurality of cells formed by segments adjoined at a plurality of nodes, wherein the elongated member passes around a respective individual one of the plurality of cells.

9. The prosthetic heart valve according to claim 1, wherein: The stent frame includes a plurality of cells formed by segments adjoined at a plurality of nodes, wherein the elongated member passes around two corresponding cells of the plurality of cells.

10. The prosthetic heart valve according to claim 9, wherein: It also includes a plurality of slender members connecting the support frame with the wrapping portion, wherein each of the plurality of slender members passes around two corresponding units among the plurality of units, and wherein each of the plurality of slender members passes through without surrounding any corresponding unit surrounded and passed by another slender member among the plurality of slender members.

11. The prosthetic heart valve according to claim 1, characterized in that: The wrapping portion is folded at least once in the delivery configuration.

12. The prosthetic heart valve according to claim 1, wherein: The elongated structure passes through the wrapping portion multiple times.

13. A prosthetic heart valve with a stent, comprising: a support frame comprising a plurality of cells formed by segments adjoined at a plurality of nodes; The support frame also includes a first frame end and a second frame end; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as A wrapping portion, the wrapping portion is connected to the stent frame by means of at least one slender member, each of the slender members having two ends, wherein at least one of the ends of the slender members is fixed to the stent frame and the other end of the slender member is attached to the wrapping portion; wherein the wrapping portion has a delivery arrangement and an expansion arrangement, the expansion arrangement is actuated by the expansion of the stent frame, wherein each of the slender members extends from the wrapping portion in a first direction, wraps around a corresponding node, and then extends in a second direction different from the first direction, wherein when the stent frame expands, the slender members are pulled through the expanded periphery of the stent frame, thereby pulling the wrapping portion into place proximally above the stent frame.

14. The stented prosthetic heart valve according to claim 13, wherein: The stent frame defines a length, and the wrapping portion covers a greater portion of the length of the stent frame in the deployed arrangement than in the delivery arrangement.

15. The stented prosthetic heart valve according to claim 13, wherein: The wrap portion has a first end and a second end; wherein, in the delivery arrangement, the second end of the wrap portion extends beyond the first frame end, and in the deployed arrangement, the second end of the wrap portion extends above the stent frame.

16. The stented prosthetic heart valve according to claim 15, wherein: In the delivery arrangement, the first end of the wrap portion extends beyond the first frame end, and in the deployed arrangement, the first end of the wrap portion extends above the stent frame.

17. The stented prosthetic heart valve according to claim 13, wherein: Also included are a plurality of elongated members connecting the support frame and the wrapping portion.

18. The stented prosthetic heart valve according to claim 17, wherein: The plurality of elongated members are arranged and constructed such that they do not intersect each other.

19. The stented prosthetic heart valve according to claim 17, wherein: The wrap portion has a first end and a second end; wherein six or more individual elongated members connect one of the first end and the second end to the stent frame.

20. The stented prosthetic heart valve of claim 17, wherein: The plurality of elongated members are arranged and configured to be offset such that in the deployed arrangement a plurality of ridges are formed in the outwardly facing surface of the wrap portion.

21. The stented prosthetic heart valve of claim 17, wherein: Each of the elongated members passes around a respective one of the plurality of cells.

22. The stented prosthetic heart valve of claim 13, wherein: Both ends of the elongated member are connected to the support frame.

23. The stented prosthetic heart valve of claim 13, wherein: Also included is a plurality of eyelets at the first frame end, wherein at least one of the plurality of elongated members passes through one of the eyelets.

24. The stented prosthetic heart valve of claim 14, wherein: The wrapping portion is folded onto itself in the delivery arrangement.

25. The stented prosthetic heart valve of claim 24, wherein: The wrapping portion is not folded onto itself in the unfolded arrangement.

26. The stented prosthetic heart valve of claim 13, wherein: In the deployed arrangement, each elongate member is oriented tangentially to the stent frame.

27. The stented prosthetic heart valve of claim 13, wherein: The longitudinal position of the wrapping portion relative to the stent frame is different in the delivery arrangement compared to the deployed arrangement.

28. A prosthetic heart valve with a stent, comprising: a support frame comprising a plurality of cells formed by segments adjoined at a plurality of nodes; The support frame also includes a first frame end and a second frame end; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as a wrapping portion, the wrapping portion being connected to the support frame by means of a plurality of elongated members; Each of the elongated members has two ends; wherein at least one end of the elongated member is fixed to the support frame, and the other end of the elongated member is attached to the wrapping portion; wherein the wrapping portion has a delivery frame; wherein each of the elongated members passes around two corresponding units of the plurality of units; Each of the plurality of elongated members does not surround but passes through any corresponding unit surrounded and passed through by another of the plurality of elongated members, and wherein, when the stent frame expands, the elongated members are pulled through the expanded periphery of the stent frame, thereby pulling the wrapping portion into place proximally above the stent frame.

29. A prosthetic heart valve with a stent, comprising: a support frame comprising a plurality of cells formed by segments adjoined at a plurality of nodes; The support frame also includes a first frame end and a second frame end; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as a wrapping portion, the wrapping portion being connected to the support frame by means of a plurality of elongated members; The slender members are sutures or chords, and each of the slender members has two ends; wherein at least one end of the slender members is fixed to the stent frame; wherein the wrapping portion has a delivery arrangement and an expansion arrangement, and the expansion arrangement is actuated by the expansion of the stent frame; wherein the wrapping portion has a first end and a second end; wherein the first end of the wrapping portion is fixed to the stent frame, and the second end of the wrapping portion is movably connected to the stent frame by means of the multiple slender members; wherein each of the multiple slender members passes through the wrapping portion approximately halfway between the first end and the second end of the wrapping portion, wherein when the stent frame expands, the slender members are pulled through the expanded periphery of the stent frame, thereby pulling the wrapping portion into place proximally above the stent frame.

30. The stented prosthetic heart valve of claim 29, wherein: In the deployed arrangement, the first end and the second end are adjacent to each other.

31. A prosthetic heart valve with a stent, comprising: a support frame comprising a plurality of cells formed by segments adjoined at a plurality of nodes; The support frame also includes a first frame end and a second frame end; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as a wrapping portion, the wrapping portion being connected to the support frame by means of a plurality of elongated members; The slender members are sutures or chords, and each of the slender members has two ends; wherein at least one of the ends of the slender members is fixed to the stent frame; wherein the wrapping portion has a delivery arrangement and an expansion arrangement, and the expansion arrangement is actuated by the expansion of the stent frame; wherein at least one slender member extends twice between two adjacent nodes, wherein when the stent frame expands, the slender member is pulled through the expanded periphery of the stent frame, thereby pulling the wrapping portion into place proximally above the stent frame.

32. A prosthetic heart valve with a stent, comprising: a support frame comprising a plurality of cells formed by segments adjoined at a plurality of nodes; The support frame also includes a first frame end and a second frame end; a plurality of valve leaflets, the valve leaflets being positioned within the stent frame; as well as a wrapping portion connected to the support frame by means of at least one elongated member; The elongated members are sutures or strings, and each of the elongated members has two ends; wherein at least one of the ends of the elongated members is fixed to the stent frame; wherein the wrapping portion has a delivery arrangement and a deployment arrangement, the deployment arrangement being actuated by expansion of the stent frame; wherein the wrapping portion has a first end and a second end; wherein the wrap portion has a midsection between the first end of the wrap portion and the second end of the wrap portion; wherein in the unfolded arrangement, the wrap portion is folded at the midsection When the stent frame is expanded, the slender member is pulled to pass through the expanded periphery of the stent frame, thereby pulling the wrapping portion into place proximally above the stent frame.

33. The stented prosthetic heart valve of claim 32, wherein: In the deployed arrangement, the midsection of the wrap is closer to the first frame end than in the delivery arrangement.

34. The stented prosthetic heart valve of claim 32, wherein: The middle section of the wrapping portion is connected to the stent frame so that each of the elongated members can be slidably wrapped around a node and then horizontally span the width of at least one unit.

Images