Sealing member for prosthetic heart valve

Abstract

To provide a radially collapsible and expandable prosthetic valve that includes improved sealing members for reducing perivalvular leakage.SOLUTION: An implantable prosthetic valve can include a radially expandable and collapsible annular frame having an inflow end and an outflow end. A valvular structure can be positioned within the frame. A plurality of sealing members can be positioned around an outer surface of the frame, where the sealing members are configured to transform from an unfurled configuration extending along the outer surface of the frame when the frame is in the radially collapsed configuration to a coiled configuration when the frame is radially expanded to the radially expanded configuration.SELECTED DRAWING: Figure 24

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 824,904, filed March 27, 2019, which is incorporated herein by reference.

[0002] The present disclosure relates to implantable, expandable prosthetic devices, such as prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can result in significant dysfunction of the heart, which may ultimately require replacement of the natural valve with an artificial valve. There are many known artificial valves and many known methods of implanting these artificial valves in humans. Due to the drawbacks associated with traditional open-chest surgery, percutaneous minimally invasive surgical approaches have attracted great attention. In one technique, artificial valves are configured to be implanted in a much less invasive procedure by catheterization. For example, collapsible transcatheter artificial heart valves can be crimped in a compressed state, introduced percutaneously in a compressed state on a catheter, and expanded to a functional size at the desired location by balloon inflation or by the use of a self-expanding frame or stent.

[0004] Prosthetic valves for use in such procedures may include a radially contractible and expandable frame to which the leaflets of the prosthetic valve may be coupled. For example, U.S. Patent No. 6,730,118, U.S. Patent No. 7,393,360, U.S. Patent No. 7,510,575, and U.S. Patent No. 7,993,394 (incorporated herein by reference) describe examples of contractible transcatheter prosthetic heart valves.

[0005] Prosthetic valves for use in such procedures can include a radially contractible and expandable frame to which the leaflets of the prosthetic valve can be attached, which can be percutaneously introduced in a contracted configuration on a catheter and expanded at the desired location by balloon inflation or by the use of a self-expanding frame or stent. A difficulty with catheter-implanted prosthetic valves is the control of paravalvular leakage around the valve, which can occur over a period of time after initial implantation. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] U.S. Patent No. 7,393,360 [Patent Document 3] U.S. Patent No. 7,510,575 [Patent Document 4] U.S. Patent No. 7,993,394 [Patent Document 5] U.S. Patent Application Serial No. 14 / 704,861 [Patent Document 6] US Patent Application Publication No. 2012 / 0123529 [Patent Document 7] US Patent Application Publication No. 2013 / 0030519 [Patent Document 8] US Patent Application Publication No. 2017 / 0231756 [Patent Document 9] US Patent Application Publication No. 2018 / 0055628 [Patent Document 10] US Patent Application Publication No. 2018 / 0000615 Summary of the Invention [Means for solving the problem]

[0007] Disclosed herein are embodiments of radially contractible and expandable prosthetic valves with improved sealing members for mitigating paravalvular leakage. In some embodiments, the disclosed prosthetic valves are configured as replacement heart valves for implantation within a subject.

[0008] In one exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end and radially contractible and expandable between radially contracted and radially expanded configurations, a valve structure positioned within the frame, and a plurality of sealing members positioned about an outer surface of the frame, the sealing members configured to transform from an unrolled configuration extending along the outer surface of the frame when the frame is in the radially contracted configuration to a coiled configuration when the frame is radially expanded to the radially expanded configuration.

[0009] In some embodiments, the prosthetic valve further comprises a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion.

[0010] In some embodiments, the tether is configured to apply an axial force to the sealing member that transforms the sealing member from the coiled configuration to the uncoiled configuration when the frame is radially contracted to the radially contracted configuration.

[0011] In some embodiments, the tethers are configured to be placed in tension when the frame is radially contracted to the radially contracted configuration.

[0012] In some embodiments, the tether comprises a suture.

[0013] In some embodiments, each sealing member has an inflow end portion held in a fixed position relative to the frame and an outflow end portion connected to the first end portion of each tether.

[0014] In some embodiments, the second end portion of the tether is fixed relative to the frame.

[0015] In some embodiments, the second end portion of the tether is secured to a strut of the frame at the outflow end of the frame.

[0016] In some embodiments, the tether is looped around a strut at the outflow end of the frame and extends into the interior of the frame toward the inflow end of the frame, with a second end portion of the tether secured to a strut of the frame spaced from the outflow end of the frame.

[0017] In some embodiments, the second end portion of the tether is secured to a strut at the inflow end of the frame.

[0018] In some embodiments, the sealing member is secured relative to the frame at spaced apart discrete locations.

[0019] In some embodiments, each sealing member comprises a fiber that is shape-set into a coiled configuration.

[0020] In some embodiments, the sealing member comprises a Nitinol wire that is shape-set into a coiled configuration.

[0021] In some embodiments, the sealing member lies flat along an outer surface of the frame when in the unrolled configuration.

[0022] In another exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end and radially contractible and expandable between radially contracted and radially expanded configurations, a valve structure positioned within the frame, and a plurality of sealing members positioned about an outer surface of the frame. Each sealing member has an inflow end portion and an outflow end portion, the inflow end portion being held in a fixed position relative to the frame and the outflow end portion being movable relative to the frame. The sealing members are configured to transform from an unrolled configuration extending along the outer surface of the frame when the frame is in the radially contracted configuration to a coiled configuration when the frame is expanded to the radially expanded configuration. When the sealing members are in the unrolled configuration, the outflow end portions are located at respective first positions relative to the outflow end of the frame, and when the sealing members are in the coiled configuration, the outflow end portions are located at respective second positions closer to the inflow end of the frame than the first positions.

[0023] In some embodiments, the prosthetic valve further comprises a plurality of tethers, each of the tethers having a first end portion coupled to the outflow end portion of a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion.

[0024] In some embodiments, the tether is configured to apply an axial force to the sealing member that transforms the sealing member from the coiled configuration to the uncoiled configuration when the frame is radially contracted to the radially contracted configuration.

[0025] In some embodiments, the inflow end portion of the sealing member is secured at the inflow end of the frame.

[0026] In some embodiments, the tethers are configured to be placed in tension when the frame is radially contracted to the radially contracted configuration.

[0027] In some embodiments, the tether comprises a suture.

[0028] In some embodiments, the second end portion of the tether is fixed relative to the frame.

[0029] In some embodiments, the second end portion of the tether is secured to a strut of the frame at the outflow end of the frame.

[0030] In some embodiments, the tether is looped around a strut at the outflow end of the frame and extends into the interior of the frame toward the inflow end of the frame, with a second end portion of the tether secured to a strut of the frame spaced from the outflow end of the frame.

[0031] In some embodiments, the second end portion of the tether is secured to a strut at the inflow end of the frame.

[0032] In some embodiments, the sealing member is secured relative to the frame at spaced apart discrete locations.

[0033] In some embodiments, each sealing member comprises a fiber that is shape-set into a coiled configuration.

[0034] In some embodiments, the sealing member comprises a Nitinol wire that is shape-set into a coiled configuration.

[0035] In some embodiments, the sealing member lies flat along an outer surface of the frame when in the unrolled configuration.

[0036] In some embodiments, the prosthetic valve further comprises an inner skirt secured against an inner surface of the frame, the second end portion of the tether being secured against the inner skirt.

[0037] In another representative embodiment, a method of implanting a prosthetic heart valve includes inserting into a patient a distal end portion of a delivery device and a prosthetic heart valve in a radially compressed configuration and coupled to the distal end portion of the delivery device. The prosthetic valve includes an annular frame, a valve structure positioned within the frame, and a plurality of sealing members positioned about an outer surface of the frame, the sealing members being in an unrolled configuration extending along the outer surface of the frame when the prosthetic heart valve is in the radially compressed configuration. The method further includes positioning the prosthetic heart valve adjacent a native valve of the patient's heart and radially expanding the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration. Expanding the prosthetic heart valve transforms the sealing members from the unrolled configuration to a coiled configuration that engages surrounding tissue of the native valve.

[0038] In some embodiments, the prosthetic heart valve further comprises a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion. When the prosthetic heart valve is in the radially compressed configuration, the tethers are held in tension, and the step of holding the sealing member in the unrolled configuration and expanding the prosthetic heart valve relieves the tension on the tethers, allowing the sealing member to transform into the coiled configuration.

[0039] In some embodiments, when the prosthetic heart valve is radially expanded and the sealing members transform from the unrolled configuration to the coiled configuration, the free ends of the sealing members move from respective first positions to respective second positions that are closer to the inflow end of the frame than the first positions.

[0040] In some embodiments, the sealing member is shape-set into a coiled configuration.

[0041] In some embodiments, the tether comprises a suture.

[0042] In some embodiments, each sealing member has an inflow end portion held in a fixed position relative to the frame and an outflow end portion connected to the first end portion of each tether.

[0043] In some embodiments, the second end portion of the tether is fixed relative to the frame.

[0044] In some embodiments, the second end portion of the tether is secured to a strut of the frame at the outflow end of the frame.

[0045] In some embodiments, the tether is looped around a strut at the outflow end of the frame and extends into the interior of the frame toward the inflow end of the frame, with a second end portion of the tether secured to a strut of the frame spaced from the outflow end of the frame.

[0046] In some embodiments, the second end portion of the tether is secured to a strut at the inflow end of the frame.

[0047] In some embodiments, the sealing member is secured relative to the frame at spaced apart discrete locations.

[0048] In some embodiments, each sealing member comprises a fiber that is shape-set into a coiled configuration.

[0049] In some embodiments, the sealing member comprises a Nitinol wire that is shape-set into a coiled configuration.

[0050] In some embodiments, the sealing member lies flat along an outer surface of the frame when in the unrolled configuration.

[0051] In another exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end and radially contractible and expandable between a radially contracted configuration and a radially expanded configuration, a valve structure positioned within the frame, a plurality of sealing members positioned about an outer surface of the frame, and a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending about a location on the prosthetic valve axially spaced from the first end portion, when the frame is radially contracted from the radially expanded configuration to the radially contracted configuration, each tether applies an axial force to a respective sealing member that transforms the sealing member from a coiled configuration to an unrolled configuration, and when the frame is radially expanded from the radially contracted configuration to the radially expanded configuration, each tether relieves the axial force applied to the respective sealing member, thereby allowing the sealing member to transform from the unrolled configuration to the coiled configuration.

[0052] In some embodiments, the second end portion of the tether is secured to a strut of the frame at the outflow end of the frame.

[0053] In some embodiments, the tether is looped around a strut at the outflow end of the frame and extends into the interior of the frame toward the inflow end of the frame, with a second end portion of the tether secured to a strut of the frame spaced from the outflow end of the frame.

[0054] In some embodiments, the second end portion of the tether is secured to a strut at the inflow end of the frame.

[0055] In some embodiments, the prosthetic valve further comprises an inner skirt secured against an inner surface of the frame, the second end portion of the tether being secured against the inner skirt.

[0056] In some embodiments, each sealing member comprises a fiber that is shape-set into a coiled configuration.

[0057] In some embodiments, the sealing member comprises a Nitinol wire that is shape-set into a coiled configuration.

[0058] In some embodiments, the sealing member lies flat along an outer surface of the frame when in the unrolled configuration.

[0059] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0060] [Figure 1] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Diagram 2] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Diagram 3] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Figure 4] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Diagram 5] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 6] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 7] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 8] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 9] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 10] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 11] FIG. 2 shows an example of an inner skirt of the prosthetic heart valve of FIG. 1. [Figure 12] FIG. 2 shows an example of an inner skirt of the prosthetic heart valve of FIG. 1. [Figure 13] 13A-13C show another embodiment of a prosthetic heart valve with a modified frame. [Figure 14]FIG. 2 illustrates the prosthetic heart valve of FIG. 1 in a contracted configuration and mounted on an example balloon catheter. [Figure 15] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 16] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 17] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 18] 1A-1D illustrate an example leaflet structure assembly. [Figure 19] 1A-1D illustrate an example leaflet structure assembly. [Figure 20] 13A-13D show assembly of the commissure portions of the leaflet structure with the window frame portion of the frame. [Figure 21] FIG. 13 illustrates assembly of the leaflet structure with an inner skirt along the lower edge of the leaflet. [Figure 22] FIG. 13 illustrates assembly of the leaflet structure with an inner skirt along the lower edge of the leaflet. [Diagram 23] FIG. 2 is a flat view of an example outer skirt. [Figure 24] FIG. 1 is a perspective view of a prosthetic heart valve having multiple coiled sealing members according to one embodiment. [Diagram 25] 25 is a cross-sectional view of a portion of the frame and one of the sealing members of the prosthetic valve of FIG. 24, the sealing member being shown in a coiled configuration. [Figure 26] 25 is a cross-sectional view of a portion of the frame and one of the sealing members of the prosthetic valve of FIG. 24, the sealing member being shown in an unrolled configuration. [Figure 27] FIG. 25 shows the prosthetic heart valve of FIG. 24 implanted within a patient's native aortic valve. [Figure 28] FIG. 25 shows the prosthetic heart valve and docking device of FIG. 24 implanted in the pulmonary artery of a patient. [Figure 29] FIG. 25 shows the prosthetic heart valve and docking device of FIG. 24 implanted within a patient's native mitral valve. [Diagram 30]1A-1C show alternative embodiments of a docking device for a prosthetic valve. [Diagram 31] 1A-1C show alternative embodiments of a docking device for a prosthetic valve. [Diagram 32] FIG. 32 shows the prosthetic heart valve of FIG. 24 and the docking device of FIGS. 30-31 implanted in the inferior vena cava of a patient. [Diagram 33] 25 is a cross-sectional view of a portion of the frame and one of the sealing members of FIG. 24 showing an alternative method of connecting the tether to the frame. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] 1-3 show various views of a prosthetic heart valve 10 according to one embodiment. The illustrated prosthetic valve is configured to be implanted within the native aortic valve annulus, but in other embodiments, it may be configured to be implanted within other native valve annuluses of the heart, such as the pulmonary, mitral, and tricuspid valves. It may also be configured to be implanted within other tubular organs or passageways within the body. The prosthetic valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular sealing means or member. The prosthetic valve 10 may have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. In the illustrated embodiment, the perivalvular sealing means includes an outer skirt 18.

[0062] The valve structure 14 can include three leaflets 41 that collectively form a leaflet structure. The leaflets 41 can be configured to fold in a tricuspid configuration as best shown in FIG. 2. Desirably, the lower edge of the leaflet structure 14 has a wavy curved fan shape (the suture line 154 shown in FIG. 22 follows the fan shape of the leaflet structure). Forming the leaflets in this fan shape geometry reduces stress on the leaflets, which in turn improves the durability of the prosthesis. Additionally, the fan shape can eliminate or at least minimize folds and undulations in the abdomen (the central region of each leaflet) of each leaflet that can lead to premature calcification. Additionally, the fan shape geometry reduces the amount of tissue material used to form the leaflet structure, which results in a smaller, more uniform crimped profile at the inflow end of the prosthesis. The leaflets 41 may be formed from pericardial tissue (such as bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0063] The bare frame 12 is shown in FIG. 4. The frame 12 may be formed with a plurality (three in the illustrated embodiment) of circumferentially spaced slots or commissure windows 20. These commissure windows 20 are configured for mounting the commissures of the valve structure 14 to the frame as described in more detail below. The frame 12 may be made from any of a variety of suitable plastically expandable materials (such as stainless steel) or self-expanding materials (such as nickel-titanium alloys (NiTi) such as Nitinol) as known in the art. If made from a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially contracted configuration on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. If made from a self-expanding material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially contracted configuration and held in this contracted configuration by insertion into a sheath or equivalent mechanism of the delivery catheter. Once inside the body, the prosthetic valve can be advanced out of the delivery sheath, thereby allowing the prosthetic valve to expand to its functional size.

[0064] Suitable plastically expandable materials that may be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular embodiment, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® / UNS R30035 alloy includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. The use of MP35N® alloy to form the frame 12 has been found to provide superior structural results over stainless steel. In particular, when MP35N® alloy is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Furthermore, because less material is required, the crimp profile of the frame can be reduced, thereby enabling a lower profile prosthetic valve assembly for percutaneous delivery to a treatment location within the body.

[0065] 4 and 5, the frame 12 of the illustrated embodiment comprises a first lower row I of end-to-end connected circumferentially extending angled struts 22 at the inflow end of the frame, a second row II of circumferentially extending angled struts 24, a third row III of circumferentially extending angled struts 26, a fourth row IV of circumferentially extending angled struts 28, and a fifth row V of circumferentially extending angled struts 32 located at the outflow end of the frame. A plurality of substantially straight axially extending struts 34 may be used to interconnect the struts 24 of the second row II with the struts 22 of the first row I. The angled struts 32 of the fifth row V are connected to the angled struts 28 of the fourth row IV by a plurality of axially extending window frame portions 30 (defining the commissure windows 20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30 extends from a position defined by the convergence of the lower ends of two angled struts 32 to another position defined by the convergence of the upper ends of two angled struts 28. Figures 6, 7, 8, 9, and 10 are enlarged views of the portions of frame 12 designated by the letters A, B, C, D, and E, respectively, in Figure 5.

[0066] Each commissure window frame portion 30 mounts a respective commissure of the leaflet structure 14. As will be appreciated, each frame portion 30 is secured at its upper and lower ends to adjacent rows of struts to provide a robust configuration that improves fatigue resistance under cyclic loading of the prosthetic valve as compared to known cantilever struts for supporting the commissures of the leaflet structure. This configuration allows for a reduced frame wall thickness, thereby enabling a smaller crimp diameter of the prosthetic valve. In certain embodiments, the thickness T (FIG. 4) of the frame 12, measured between the inner diameter and the outer diameter, is about 0.48 mm or less.

[0067] The struts and frame portions of the frame collectively define a plurality of open cells of the frame. At the inflow end of frame 12, struts 22, 24, and 34 define a lower row of cells that define an opening 36. The second row of struts 24, the third row of struts 26, and the fourth row of struts 28 define two middle rows of cells that define an opening 38. The fourth row of struts 28 and the fifth row of struts 32, together with frame portions 30 and struts 31, define an upper row of cells that define an opening 40. The opening 40 is relatively large and sized to allow a portion of the leaflet structure 14 to protrude or bulge into and / or through the opening 40 when the frame 12 is crimped to minimize the crimp profile.

[0068] As best shown in FIG. 7, the lower end of strut 31 is connected to two struts 28 at node or junction 44, and the upper end of strut 31 is connected to two struts 32 at node or junction 46. Strut 31 may have a thickness S1 that is less than the thickness S2 of junctions 44, 46. Junctions 44, 46, along with junction 64, prevent complete closure of opening 40. FIG. 14 shows prosthetic valve 10 crimped onto a balloon catheter. As can be seen, the geometry of struts 31 and junctions 44, 46, and 64 helps provide enough space in the contracted configuration for opening 40 to allow a portion of the prosthetic leaflet to protrude or bulge outwardly through the opening. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if the entire leaflet material was constrained within the crimped frame.

[0069] The frame 12 is configured to reduce, eliminate, or minimize the possibility of overexpansion of the prosthetic valve at a given balloon pressure, particularly at the outflow end portion of the frame that supports the leaflet structures 14. In one aspect, the frame is configured with relatively large angles 42a, 42b, 42c, 42d, 42e between the struts as shown in FIG. 5. The larger the angle, the greater the force required to open (expand) the frame. Thus, the angles between the struts of the frame can be selected to limit the radial expansion of the frame at a given opening pressure (e.g., balloon inflation pressure). In certain embodiments, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more particularly, these angles are up to about 120 degrees when the frame is expanded to its functional size.

[0070] Additionally, the inflow and outflow ends of the frame generally have a tendency to overexpand more than the middle portion of the frame due to the "dogbone" effect of the balloon used to expand the prosthetic valve. To prevent overexpansion of the leaflet structure 14, the leaflet structure is desirably fixed relative to the frame 12 below the upper row of struts 32, as best shown in FIG. 1. Thus, if the outflow end of the frame becomes overexpanded, the leaflet structure is positioned at a lower height than where overexpansion would otherwise occur, thereby preventing overexpansion of the leaflet structure.

[0071] In known prosthetic valve structures, if the leaflets are attached too close to the distal end of the frame, a portion of the leaflets may protrude longitudinally beyond the outflow end of the frame when the prosthetic valve is crimped. If the delivery catheter onto which the crimped prosthetic valve is attached includes a push mechanism or stop member that presses against or abuts the outflow end of the prosthetic valve (e.g., to maintain the position of the crimped prosthetic valve on the delivery catheter), the push or stop member may damage the exposed portion of the leaflets that extends beyond the outflow end of the frame. Another advantage of attaching the leaflets at a location spaced from the outflow end of the frame is that the outflow end of the frame 12, rather than the leaflets 41, becomes the most proximal component of the prosthetic valve 10 when the prosthetic valve is crimped onto the delivery catheter. As a result, if the delivery catheter includes a push mechanism or stop member that presses against or abuts the outflow end of the prosthetic valve, the push mechanism or stop member will contact the outflow end of the frame rather than the valve leaflets 41, thereby avoiding damage to the valve leaflets.

[0072] Also, as can be seen in FIG. 5, the openings 36 in the bottom row of openings of the frame are relatively larger than the openings 38 in the two middle rows of openings. This allows the frame, when crimped, to assume a generally tapered shape, tapering from a maximum diameter at the outflow end of the prosthesis to a minimum diameter at the inflow end of the prosthesis. When crimped, the frame 12 has a reduced diameter region extending along a portion of the frame adjacent the inflow end of the frame, which region approximately corresponds to the area of ​​the frame covered by the outer skirt 18. In some embodiments, the reduced diameter region is reduced relative to the diameter of the upper portion of the frame (portion not covered by the outer skirt) such that the outer skirt 18 does not increase the overall crimp profile of the prosthesis. When the prosthesis is deployed, the frame is allowed to expand to a generally cylindrical shape as shown in FIG. 4. In one example, the frame of a 26 mm prosthetic valve when crimped had a first diameter of 14 French at the outflow end of the prosthetic valve and a second diameter of 12 French at the inflow end of the prosthetic valve.

[0073] The primary function of the inner skirt 16 is to help secure the valve structure 14 to the frame 12 and to help form a good seal between the prosthetic valve and the native annulus by preventing blood flow through the open cells of the frame 12 that are located below the lower edge of the leaflets. The inner skirt 16 preferably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), although various other synthetic or natural materials (e.g., pericardial tissue) can be used. Desirably, the skirt has a thickness of less than about 6 mils (0.15 mm), desirably less than about 4 mils (0.1 mm), and even more desirably about 2 mils (0.05 mm). In certain embodiments, the skirt 16 can have a non-constant thickness, for example, the skirt can be thicker at at least one of its edges than at the center. In one implementation, the skirt 16 can include a PET skirt having a thickness of about 0.07 mm at the edges and about 0.06 mm at the center. A thinner skirt may provide better crimp performance while still achieving a good perivalvular seal.

[0074] The skirt 16 may be secured to the interior of the frame 12 via sutures 70 as shown in FIG. 22. The valve structure 14 may be attached to the skirt via one or more reinforcing sealing members 72 (which may collectively form a sleeve), such as a thin PET reinforcing sealing member discussed below, which allows for secure suturing and protects the pericardial tissue of the leaflet structure from tearing. The valve structure 14 may be sandwiched between the skirt 16 and the thin PET sealing member 72 as shown in FIG. 21. The sutures 154 that secure the PET strip and leaflet structure 14 to the skirt 16 may be any suitable suture, such as Ethibond Excel® PET suture (Johnson & Johnson, New Brunswick, New Jersey). Desirably, the sutures 154 follow the curvature of the bottom edge of the leaflet structure 14 as described in more detail below.

[0075] Known textile skirts may include a woven arrangement of warp and weft fibers extending perpendicular to one another, one set of fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which the textile skirt is fixed is radially compressed, the overall axial length of the frame is stretched. Unfortunately, the textile skirt, which has limited elasticity, is unable to stretch with the frame and thus tends to deform the struts of the frame and prevent uniform crimping.

[0076] 12, in contrast to known textile skirts, the skirt 16 is desirably woven from a first set of fibers, threads, or strands 78 and a second set of fibers, threads, or strands 80, both of which are not perpendicular to the upper and lower edges 82, 84 of the skirt. In certain embodiments, the first set of fibers 78 and the second set of fibers 80 extend at an angle of about 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the upper and lower edges 82, 84. For example, the skirt 16 may be formed by weaving the fibers at an angle of 45 degrees relative to the upper and lower edges of the fibers. Alternatively, the skirt 16 can be diagonally cut (bias cut) from vertically woven fibers (fibers extending perpendicular to the material edges) that extend at a 45 degree angle relative to the cut upper and lower edges of the skirt. As further shown in FIG. 12, the opposing short edges 86, 88 of the skirt are desirably non-perpendicular to the upper and lower edges 82, 84. For example, the short edges 86, 88 desirably extend at approximately a 45 degree angle relative to the upper and lower edges and are therefore aligned with the first set of fibers 78. The skirt's general overall shape is therefore that of a rhomboid or parallelogram.

[0077] 13 shows an example of a crimped prosthetic valve having a skirt with fibers that run perpendicular to and / or longitudinally between the upper and lower edges of the skirt. During crimping, this fiber orientation can cause the struts to deform non-uniformly. Furthermore, when crimped, the fibers tend to pucker or bulge in excess material in some places, which limits the minimum crimp profile and prevents uniform crimping.

[0078] 15 and 16 show the inner skirt 16 after the opposing short edge portions 90, 92 have been sewn together to form the annular shape of the skirt. As shown, the edge portion 90 may be placed in overlapping relationship with the opposing edge portion 92, and the two edge portions may be sewn together using a diagonally extending stitching line 94 that is parallel to the short edges 86, 88. The upper edge portion of the inner skirt 16 may be formed with a plurality of projections 96 that define a wavy portion that generally follows the shape or contour of the fourth row of struts 28 immediately adjacent the lower end of the axial strut 31. In this manner, the upper edge of the inner skirt 16 may be tightly secured to the struts 28 by the sutures 70, as best shown in FIG. 17. The inner skirt 16 may also be formed with slits 98 to facilitate attachment of the skirt to the frame. The slits 98 are sized to allow the upper edge portion of the inner skirt 16 to be wrapped partially around the struts 28 to relieve stress on the skirt during the installation procedure. For example, in the illustrated embodiment, the inner skirt 16 is placed on the inside of the frame 12 and the upper edge portion of the skirt is wrapped around the upper surfaces of the struts 28 and secured in place with sutures 70. Wrapping the upper edge portion of the inner skirt 16 around the struts 28 in this manner allows for a stronger and more durable attachment of the skirt to the frame. Additionally, the inner skirt 16 may be secured to the first row of struts 22, the second row of struts 24, and / or the third row of struts 26 with sutures 70.

[0079] Referring again to FIG. 12, the angled orientation of the fibers relative to the upper and lower edges allows the skirt to undergo greater elongation in the axial direction (ie, in the direction from upper edge 82 to lower edge 84).

[0080] Thus, when the metal frame 12 is crimped (as shown in FIG. 14), the inner skirt 16 may stretch axially with the frame, thus achieving a more uniform and predictable crimp profile. Each cell of the metal frame in the illustrated embodiment includes at least four angled struts that rotate axially upon crimping (e.g., the angled struts become more aligned relative to the length of the frame). The angled struts of each cell act as a mechanism for rotating the fibers of the skirt in the same direction as the struts, thereby allowing the skirt to stretch along the length of the struts. This allows for greater stretching of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.

[0081] Additionally, the spacing between the interwoven fibers or yarns can be increased to aid in axial elongation of the skirt. For example, for a PET inner skirt 16 formed from 20 denier yarns, the yarn density can be about 15% to about 30% lower than for a typical PET skirt. In some examples, the yarn spacing of the inner skirt 16 can be about 60 yarns / cm (about 155 yarns / inch) to about 70 yarns / cm (about 180 yarns / inch), such as about 63 yarns / cm (about 160 yarns / inch), while for a typical PET skirt, the yarn spacing can be about 85 yarns / cm (about 217 yarns / inch) to about 97 yarns / cm (about 247 yarns / inch). The beveled edges 86, 88 promote uniform and even distribution of the fiber material along the inner circumference of the frame during crimping, which reduces or minimizes fiber crimping and facilitates uniform crimping to the smallest possible diameter. Additionally, cutting the diagonal sutures perpendicularly may leave raw edges along the cut edges. The beveled edges 86, 88 are effective in minimizing this occurrence. As noted above, FIG. 13 illustrates a crimped prosthetic valve having a typical skirt with fibers that extend perpendicular to the upper and lower edges of the skirt. Compared to the configuration of a typical skirt (e.g., FIG. 13), the configuration of the inner skirt 16 (e.g., FIG. 14) avoids undesirable deformation of the frame struts and allows for a more uniform crimp of the frame.

[0082] In alternative embodiments, the skirt may be formed from woven elastic fibers that are axially stretchable during crimping of the prosthetic valve. The warp and weft fibers may extend vertically and horizontally relative to the upper and lower edges of the skirt, or alternatively, may extend at an angle between 0 and 90 degrees relative to the upper and lower edges of the skirt, as described above.

[0083] The inner skirt 16 can be sewn to the frame 12 at a location away from the suture line 154, allowing the skirt to have more flexibility in that area. This configuration avoids stress concentrations at the suture line 154 which attaches the lower edge of the leaflet to the inner skirt 16.

[0084] As noted above, the leaflet structure 14 in the illustrated embodiment includes three flexible leaflets 41 (although more or fewer leaflets may be used). Further information regarding these leaflets, as well as skirt materials, may be found, for example, in U.S. Patent Application No. 14 / 704,861, filed May 5, 2015, which is incorporated herein by reference in its entirety.

[0085] The leaflets 41 are secured together at adjacent sides to form the leaflet structure's commissures 122. A number of flexible connectors 124 (one of which is shown in FIG. 18) may be used to interconnect adjacent side pairs of the leaflets and attach them to the commissure window frame portion 30 (FIG. 5).

[0086] Figure 18 shows adjacent sides of two leaflets 41 interconnected by flexible connectors 124. As shown in Figure 19, three leaflets 41 may be secured together side-to-side using three flexible connectors 124. Further information regarding interconnecting leaflets and connecting leaflets to a frame can be found, for example, in U.S. Patent Application Publication No. 2012 / 0123529, which is incorporated herein by reference in its entirety.

[0087] As mentioned above, the inner skirt 16 may be used to assist in suturing the leaflet structure 14 to the frame. The inner skirt 16 may have wavy temporary marking sutures to guide the attachment of the lower edge of each leaflet 41. The inner skirt 16 itself may be sewn to the struts of the frame 12 using sutures 70 as described above prior to securing the leaflet structure 14 to the skirt 16. Desirably, those sutures that cross the marking sutures are not attached to the inner skirt 16. This allows the inner skirt 16 to have more versatility in the areas that are not secured to the frame and minimizes stress concentrations along the suture lines that secure the lower edges of the leaflets to the skirt. As mentioned above, when the skirt is secured to the frame, the fibers 78, 80 (see FIG. 12) of the skirt are generally aligned with the angled struts of the frame to promote uniform crimping and expansion of the frame.

[0088] FIG. 20 illustrates one specific approach for securing the commissure portions 122 of the leaflet structure 14 to the commissure window frame portion 30 of the frame. The flexible connectors 124 (FIG. 19) securing the two adjacent sides of the two leaflets together are folded widthwise and the upper tab portions 112 are folded downwardly against the flexible connectors. Each upper tab portion 112 is creased lengthwise (vertically) to form an L-shape with an inner portion 142 folded against the inner surface of the leaflet and an outer portion 144 folded against the connector 124. The outer portion 144 may then be sutured to the connector 124 along suture line 146. The commissure tab assemblies may then be inserted through the commissure windows 20 of the corresponding window frame portion 30 and the outer fold of the window frame portion 30 may be sutured to the portion 144.

[0089] 20 also illustrates that the folded upper tab portion 112 may form a double layer of leaflet material at the commissures. The inner portion 142 of the upper tab portion 112 is positioned flush against two layers of leaflet 41 to form the commissures, such that each commissure comprises four layers of leaflet material immediately within the window frame 30. This four-layer portion of the commissure may have a higher resistance to bending or articulation than the portion of the leaflet 41 located radially inward from the four-layer portion, which has a relatively higher stiffness. This allows the leaflets 41 to articulate primarily at the inner edge 143 of the folded inner portion 142 in response to blood flowing through the prosthetic valve during operation in vivo, as opposed to articulating about or proximal to the axial struts of the window frame 30. By articulating the leaflets at a location spaced radially inward from the window frame 30, the leaflets avoid contact with the frame, which may be avoided. However, under high forces, the four-layered portions of the commissures may spread apart about the longitudinal axis adjacent the window frame 30, with each inner portion 142 folding back on its respective outer portion 144. For example, this may occur when the prosthetic valve 10 is compressed and mounted onto a delivery shaft, allowing for a smaller crimp diameter. The four-layered portions of the commissures may also spread apart about the longitudinal axis when the balloon catheter is inflated during expansion of the prosthetic valve, which may partially relieve pressure on the commissures caused by the balloon and reduce the possibility of damage to the commissures during expansion.

[0090] After the three commissure tab assemblies are secured to their respective window frame portions 30, the lower edges of the leaflets 41 between the commissure tab assemblies may be sutured to the inner skirt 16. As shown, for example, in FIG. 21, each leaflet 41 may be sutured to the inner skirt 16 along suture lines 154 using, for example, Ethibond Excel® PET thread. These sutures may be in-and-out sutures that extend through each leaflet 41, the inner skirt 16, and each reinforcing strip 72. Each leaflet 41 and each reinforcing strip 72 may be individually sewn to the inner skirt 16. In this manner, the lower edges of the leaflets are secured to the frame 12 via the inner skirt 16. As shown in FIG. 21, the leaflets may be further secured to the skirt with blanket stitches 156 that loop around the reinforcing sealing member 72 and the edge of the leaflet 41 and extend through each reinforcing strip 72, the leaflet 41, and the inner skirt 16. The blanket stitches 156 may be formed from a PTFE suture material. Figure 22 shows a side view of the frame 12, the leaflet structure 14, and the inner skirt 16 after securing the leaflet structure 14 and the inner skirt 16 to the frame 12, and securing the leaflet structure 14 to the inner skirt 16.

[0091] 23 shows a flat view of the outer skirt 18 prior to attachment to the frame 12. The outer skirt 18 may be laser cut or otherwise formed from a tough, durable material, such as PET or various other suitable synthetic or natural materials, configured to restrict and / or impede blood flow therethrough. The outer skirt 18 may include a substantially straight lower edge 160 and an upper edge portion 162 defining a plurality of alternating protrusions 164 and notches 166 or castellations. The outer skirt 18 may also include a plurality of openings 167 (e.g., twelve in the illustrated embodiment) disposed on a middle portion 169 of the outer skirt 18 (i.e., the portion between the lower edge 160 and the upper edge portion 162). The openings 167 are spaced from the lower edge 160 and the upper edge portion 162 such that the material of the outer skirt 18 spaces the openings 167 from the lower edge 160 and the upper edge portion 162.

[0092] 3, a lower edge portion 174 of the outer skirt 18 is wrapped around the inflow end 15 of the frame 12, and a lower edge 160 of the outer skirt 18 may be attached to the lower edge 84 of the inner skirt 16 and / or the frame 12 at the inflow end of the prosthetic valve 10. In some embodiments, the outer skirt 18 may be attached to the inner skirt 16, such as by sutures or a suitable adhesive.

[0093] Instead of or in addition to sutures, the outer skirt 18 may be attached to the inner skirt 16 by, for example, ultrasonic welding. Ultrasonic welding may provide several significant advantages. For example, ultrasonic welding may provide improved strength while being relatively quick and inexpensive compared to sewing.

[0094] 1, each projection 164 of the outer skirt 18 may be attached to a strut 26 (FIG. 5) of the third row III of the frame 12. These projections 164 may, for example, overlap a respective strut 26 of row III and be secured with sutures 168.

[0095] As can be seen in Figures 1-3, the outer skirt 18 is secured to the frame 12 such that when the frame is in an expanded configuration (e.g., deployed within a subject), there is excess material between the lower edge 160 and the upper edge portion 162 that is not flush against the outer surface of the frame 12. The outer skirt 18 may be secured directly to the frame 12 and / or indirectly to the frame 12, such as by securing the outer skirt 18 to an inner skirt 16 that is secured directly to the frame 12. In the expanded configuration of the prosthetic valve, the distance between the upper and lower attachment points of the outer skirt 18 is reduced (shortened), resulting in radial expansion of the outer skirt 18. Additionally, the excess material located between the lower and upper edges of the outer skirt 18 allows the frame 12 to stretch axially without resistance from the outer skirt 18 when crimped.

[0096] The outer skirt 18 has an axial length or height H s where H s is the height of the outer skirt 18 excluding the lower edge portion 174 that wraps around the inflow end 15 of the frame 12, as best shown in Figures 1, 3, and 23. In some embodiments, the height H s may be substantially the same as the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. In such an embodiment, the outer skirt 18 may lie flush against the outer surface of the frame 12 when the frame 12 is fully crimped. In other embodiments, the height H of the outer skirt 18 may be substantially the same as the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. s may exceed the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. In such an embodiment, the outer skirt 18 may include multiple folds 170 (e.g., twelve in the illustrated embodiment).

[0097] As best shown in FIG. 3, the folds 170 may extend axially from the lower edge 160 of the outer skirt 18 toward the middle portion 169. The folds 170 are circumferentially aligned with the respective projections 164, and the outer skirt 18 may be oriented with respect to the frame 12 such that the folds 170 are circumferentially aligned between each pair of apices 22a (FIG. 5) formed by the struts 22 at the inflow end 15 of the frame 12. For example, the folds 170 may be circumferentially aligned along each vertical line 172 (FIGS. 2 and 5) that is parallel to the longitudinal axis of the frame 12 and bisects the frame 12 equidistant from each tip 22a of each pair of apices 22a. In this manner, the folds 170 may retract excess material of the outer skirt 18 radially inward between the apices 22a into the inflow end 15 of the frame 12 when the prosthetic valve 10 is crimped from the expanded configuration. As best shown in FIG. 2, each fold 170 may be circumferentially aligned with a respective opening 167 and protrusion 164 along a respective line 172 .

[0098] In lieu of or in addition to fold 170 (FIG. 1), outer skirt 18 may be attached and / or positioned relative to frame 12 such that a lower edge 160 of outer skirt 18 contacts inflow end 15 of frame 12 at a location (e.g., tip 22a) that is offset from a location (e.g., junction 64) where an upper edge portion 162 of outer skirt 18 contacts outflow end 19 of frame 12. By configuring outer skirt 18 and frame 12 in this manner, excess material of outer skirt 18 may be retracted inwardly between tips 22a of frame 12 when prosthetic valve 10 is crimped from an expanded to a contracted configuration.

[0099] This configuration also allows the deformed fibers of the contracted outer skirt 18 to spread over a relatively large distance, resulting in a smaller amount of outer skirt material per cross-sectional area, flattening the outer skirt 18 around the crimped frame 12, and thus reducing the crimp profile of the prosthetic heart valve 10. The reduced crimp profile of the prosthetic heart valve 10 may reduce the pushing force required to move the prosthetic heart valve 10 relative to the patient's vessel or the delivery cylinder of the delivery device. This may also reduce the compressive force applied to the leaflets 41 to achieve a particular crimp profile, thereby reducing and / or eliminating damage caused to the leaflets 41 by overly compressing the leaflets 41 during crimping and / or delivery of the prosthetic heart valve 10 to the implantation location.

[0100] Advantageously, the retraction of excess material into the frame 12 beneath the leaflets 41 when the prosthetic valve 10 is crimped allows the prosthetic valve 10 to have a relatively large outer skirt 18, which significantly reduces paravalvular leakage and minimizes the radial crimp profile of the prosthetic valve 10. For example, the height H of the outer skirt 18 may be 0.1 mm or less than 0.1 mm. s The height H of the frame 12 in the radially expanded state can be about 9 mm to about 25 mm, or about 13 mm to about 20 mm, and a specific example is about 19 mm. f The outer skirt 18 has a ratio H of about 12 mm to about 27 mm, or about 15 mm to about 23 mm, and a specific example is about 20 mm. s :H f (Here, H s (Fig. 23) is the height of the outer skirt 18, H f (FIG. 5) is the height of frame 12 in an expanded state) can be between about 0.75 and about 0.95. In some embodiments, this ratio H s :H f can be between about 0.80 and about 0.90, or between about 0.84 and about 0.87. In certain embodiments, the ratio H s :Hf can be 0.86.

[0101] By providing a relatively larger outer skirt 18, the prosthetic valve 10 may be positioned at a greater variety of positions relative to the native annulus while still providing an adequate perivalvular seal. This improved range may make the prosthetic valve 10 easier to position during the implantation procedure, and it may allow the prosthetic valve to conform to a greater variety of native annular anatomies.

[0102] Additionally, the folds 170 may aid in the contraction of the outer skirt 18 in a predetermined and uniform manner when the prosthetic valve 10 is crimped. This uniformity prevents the outer skirt 18 from plicating or clumping during crimping and / or loading of the prosthetic valve 10 within a delivery device, which in turn allows the outer skirt 18 to expand more quickly and consistently to a functional state when the prosthetic valve 10 is deployed, as described further below.

[0103] Each fold 170 may be formed, for example, by overlapping and securing together adjacent portions of the outer skirt 18. The folds may then be secured in the overlapping state, for example, by sutures, ultrasonic welding, and / or adhesives. The folds 170 may also be referred to as permanent folds because they are maintained when the prosthetic valve 10 is in both radially compressed and radially expanded states.

[0104] As best seen in FIG. 23, the openings 167 may be spaced laterally (circumferentially in FIGS. 1-3) from adjacent openings 167 and aligned laterally (circumferentially in FIGS. 1-3) with respective projections 164. Also, as best shown in FIGS. 1 and 3, the openings 167 may be circumferentially aligned with respective folds 170. For example, as best shown in FIG. 2, the projections 164, openings 167, and folds 170 may be aligned along respective vertical lines 172. Aligning the openings 167 and folds 170 may allow for rapid ingress of blood into, and thus rapid expansion of, the overlapping portions of the outer skirt 18 with blood, for example, when the prosthetic valve is initially deployed, as described further below.

[0105] Also, openings 167 advantageously allow backflowing blood (e.g., retrograde blood) to enter outer skirt 18 from a different angle or direction than notches 166, thus improving rapid initial expansion of outer skirt 18 and improving perivalvular sealing. Openings 167 may be provided as an alternative or in addition to notches 166.

[0106] The opening 167 can have a variety of shapes. For example, the opening 167 can have a teardrop shape as shown in the illustrated embodiment. In other embodiments, the opening can be circular, oval, rectangular, etc.

[0107] The prosthetic valve 10 may be configured for and mounted on a delivery device suitable for implantation within a subject. Although several catheter-based delivery devices are known, non-limiting examples of suitable catheter-based delivery devices include those disclosed in U.S. Patent Application Publication No. 2013 / 0030519, which is incorporated herein by reference in its entirety, and U.S. Patent Application Publication No. 2012 / 0123529.

[0108] As best shown in FIG. 14 , for implantation of the plastically expandable prosthetic valve 10 in a patient, the prosthetic valve 10 with the outer skirt 18 can be crimped onto an elongate shaft 180 of a delivery device. The prosthetic valve together with the delivery device can form a delivery assembly for implanting the prosthetic valve 10 in the patient's body. The shaft 180 includes an inflatable balloon 182 for expanding the prosthetic valve in the body. Once the balloon 182 is deflated, the prosthetic valve 10 can then be delivered percutaneously to a desired implantation location (e.g., in the area of ​​the native aortic valve). Once the prosthetic valve 10 is delivered to the implantation site in the body (e.g., in the area of ​​the native aortic valve), the prosthetic valve 10 can be radially expanded to its functional state by inflating the balloon 182.

[0109] As the prosthetic valve 10 expands, the notches 166 and openings 167 allow blood to flow between the outer skirt 18 and the inner skirt 16. This blood flow causes the excess fiber of the outer skirt 18 to bulge further radially away from the inner skirt 16.

[0110] The expanded outer skirt 18 may fill the gap between the frame 12 and the surrounding native annulus to aid in forming a good fluid-tight seal between the prosthetic valve 10 and the native annulus. Thus, the outer skirt 18 cooperates with the inner skirt 16 to avoid paravalvular leakage after implantation of the prosthetic valve 10. In some embodiments, a prosthetic valve 10 with an outer skirt 18 that expands radially outward may reduce paravalvular leakage when implanted in a subject when compared to a similar prosthetic valve having a smaller outer skirt or no outer skirt 18.

[0111] Alternatively, a self-expanding prosthetic valve 10 may be crimped into a radially contracted configuration and held in this contracted configuration by inserting the prosthetic valve 10 with the outer skirt 18 into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve 10 may then be delivered percutaneously to a desired implantation location. Once in place within the body, the prosthetic valve 10 may be advanced out of the delivery sheath, thereby allowing the prosthetic valve to expand to its functional state.

[0112] When the outer skirt 18 is exposed from the delivery sheath, the notches 166 and openings 167 allow blood to flow between the outer skirt 18 and the inner skirt 16. This blood flow causes the excess fiber of the outer skirt 18 to further radially expand, away from the inner skirt 16.

[0113] FIG. 24 illustrates an embodiment of a prosthetic heart valve 10 in which a plurality of sealing members 250 are positioned around the outer surface of the frame. In this embodiment, the prosthetic heart valve 10 may include any of the features described above in connection with FIGS. 1-23 and will not be repeated here for brevity. As discussed in detail below, the sealing members 250 are capable of moving or transforming between an unrolled (desirably flat) configuration extending along the exterior of the frame when the prosthetic valve 10 is radially compressed for delivery (FIG. 26) and a coiled functional configuration when the prosthetic valve 10 is radially expanded (FIGS. 24-25). The prosthetic valve 10 may include any number of sealing members 250, such as two, three, four, or more. In certain embodiments, the prosthetic valve 10 includes 24 sealing members. In other embodiments, the prosthetic valve 10 may include a single sealing member 250.

[0114] The sealing member 250 may be coupled to the frame 12 and / or inner skirt 16 of the prosthetic valve. The sealing member 250 may be directly secured to the frame 12 and / or indirectly secured to the frame 12, such as by securing the sealing member 250 to the inner skirt 16 that is secured directly to the frame 12 as described above. For example, the sealing member 250 may be attached to the frame 12 and / or inner skirt 16 of the prosthetic heart valve 10 by sutures and / or ultrasonic welding. In some embodiments, as shown in FIG. 24, the prosthetic valve 10 may have multiple sealing members 250 positioned around the outer surface of the annular frame 12 near the inflow end 15 of the annular frame 12.

[0115] In the embodiment of FIG. 24, the sealing member 250 is replaced by the outer skirt 18. However, in alternative embodiments, the prosthetic valve 10 may include one or more sealing members 250 and an outer skirt, such as the outer skirt 18. For example, the outer skirt may be positioned as shown in FIG. 1, and the one or more sealing members 250 may be positioned above the outer skirt along the outflow end portion of the frame or along the outer surface of the outer skirt to at least partially overlap the outer skirt. In some embodiments, the one or more sealing members 250 may be located between the outer skirt 18 and the annular frame 12. In some embodiments, the outer skirt 18 may have some features similar to the sealing member 250, such as being able to assume a coiled configuration when the valve 10 is in a radially expanded configuration.

[0116] In the illustrated embodiment, the inflow edge portion (or inflow end portion) 252 of each sealing member 250 may be secured to or near the inflow end 15 of the annular frame 12, such as by a suture that forms a stitch that passes through the sealing member and extends around adjacent struts of the frame. For example, the inflow edge portion 252 of the sealing member 250 may be secured to or near the tip 22a, strut 22, or substantially straight axially extending strut 34, such as by one or more sutures.

[0117] Also, in some embodiments, the inflow edge portion 252 of the sealing member 250 may be secured to the inner skirt 16 instead of or in addition to the frame. For example, the inflow edge portion 252 of the sealing member 250 may be secured to an outer surface of the inner skirt 16 that faces away from the longitudinal axis of the valve 10, such as by a suture that extends through the sealing member 250 and the inner skirt 16, and optionally around a strut of the frame.

[0118] In some embodiments, the inflow edge portion of the inner skirt is wrapped around the inflow end 15 of the frame 12 and extends at least partially along the outer surface of the frame 12, and the inflow edge portion is secured to the frame 12. The sealing member 250 may be secured to the inflow edge portion of the inner skirt 16 by sutures or the like at a location on the inflow edge portion of the inner skirt 16 that extends along the outer surface of the frame 12.

[0119] All of the sealing members 250 may be disposed at the same height along the length of the frame. For example, in the illustrated embodiment, all of the sealing members are fixed relative to the inflow end of the frame 12 and have the same overall length when in the unrolled configuration (FIG. 26). In alternative embodiments, the sealing members 250 may be fixed relative to the frame 12 and / or inner skirt 16 at staggered or non-constant heights. For example, half of the sealing members 250 may be fixed relative to the angled struts 22 of the lower row I and the other half may be fixed relative to the circumferentially extending angled struts 24 of the second row II. In another example, the sealing members 250 may alternate in terms of mounting position relative to the frame such that one set of sealing members is mounted at one height and another set of sealing members is mounted at another height, with each sealing member of the first set positioned between two sealing members of the second set. Additionally, in alternative embodiments, the overall length of the sealing members 250 in the unrolled configuration may vary from one sealing member to its adjacent sealing members.

[0120] As shown in FIGS. 24-25, in certain embodiments, the sealing members 250 may be configured to assume a coiled shape in a fully deployed configuration similar to that of a snail shell or a helical planar coil. As shown in FIG. 25, in the deployed (coiled) configuration, the outflow edge portion (or outflow end portion) 256 of each sealing member 250 may be located at the innermost of such a helical shape, and the sealing members 250 may form a coiled shape by curving or wrapping on themselves. This coiled shape may be configured to bulge away from the frame 12 as shown in FIG. 24. As best shown in FIG. 25, the sealing members may be configured to coil inwardly toward the frame, i.e., the outermost winding or layer of the coil first begins at a location where it is coupled to the inflow edge portion 252, curves radially away from the frame 12 and toward the outflow end of the frame, and then curves radially (counterclockwise in FIG. 25) back toward the frame to form a helical planar coil.

[0121] In an alternative embodiment, the sealing member can be configured to coil outwardly from the frame, i.e., the outermost winding or layer of the coil originates at a location where it is connected to the inflow edge portion 252, extends along the outer surface of the frame, curves away from the frame 12 and toward the inflow end of the frame, and then curves back toward the frame toward the outflow end of the frame (in a clockwise direction in FIG. 25 ) to form a helical planar coil.

[0122] In the illustrated embodiment, each sealing member 250 may be positioned around the exterior of the frame 12 such that both longitudinal side edges 258 of each sealing member 250 are configured to face the side edges 258 of an adjacent sealing member 250. In the illustrated embodiment, the sealing members 250 are positioned relative to one another such that they are circumferentially spaced from one another around the outer surface of the frame 12 when the prosthetic valve is in a radially expanded configuration. As shown, the sealing members 250 are uniformly spaced at equal intervals along the circumference of the annular frame 12. In other embodiments, the spacing between adjacent sealing members 250 may be non-constant around the circumference of the frame.

[0123] The spacing between adjacent sealing members 250 is reduced when the prosthetic valve is in the radially compressed configuration. In some embodiments, the side edges 258 are in contact with or adjacent to the side edges 258 of adjacent sealing members 250 when the prosthetic valve is in the radially compressed configuration.

[0124] In alternative embodiments, the sealing members 250 may be configured such that the side edges 258 of adjacent sealing members 250 contact or are otherwise very close to one another when the prosthetic valve 10 is in the radially expanded configuration. In other embodiments, the sealing members 250 may partially overlap one another when the prosthetic valve is in the radially expanded configuration. For example, the sealing members may be sized and positioned relative to one another such that each sealing member partially overlaps an adjacent sealing member in the circumferential direction when the prosthetic valve is in the radially expanded configuration.

[0125] 24, the sealing member 250 may be positioned on the frame 12 in a configuration such that one coiled strip is positioned over and circumferentially centered on each vertical line 172 or 173 (see FIG. 2). In another embodiment, the sealing member 250 may be circumferentially centered at each location between the vertical lines 172, 173. In other embodiments, the sealing member 250 may be sized to extend over two or more respective vertical lines 172 or 173 simultaneously.

[0126] The sealing members 250 may extend axially from near the inflow end portion 15 of the valve 10 toward the outflow end portion 19 of the valve. Each of the plurality of sealing members 250 may be circumferentially aligned between respective pairs of tips 22a (FIG. 5) formed by the struts 22 at the inflow end 15 of the frame 12. For example, the sealing members 250 may be circumferentially aligned along respective vertical lines 172 (FIGS. 2 and 5) that are parallel to the longitudinal axis of the frame 12 and intersect the frame 12 equidistantly from each pair of tips 22a.

[0127] The sealing member 250 may be formed from any of a variety of suitable materials as discussed above in connection with the inner and outer skirts 16, 18, including, but not limited to, a variety of fibrous and non-fibrous materials made from PET, PTFE, ePTFE, polyurethane, polyester, and / or other suitable materials configured to restrict and / or prevent the passage of blood therethrough. In a particular embodiment, the sealing member 250 is made from PET fibers.

[0128] The sealing member 250 may have any of a variety of shapes. In the illustrated embodiment, the sealing member 250 has a rectangular shape when in a flattened configuration and has a constant or substantially constant width along the length of the sealing member (as measured between the side edges 258). In other embodiments, the sealing member 250 can be wider near its inflow edge portion 252 and narrower near its outflow edge portion 256. In other embodiments, the sealing member 250 can be narrower near the inflow edge portion 252 and wider near the outflow edge portion 256.

[0129] The coil shape of the sealing member may be formed utilizing a variety of techniques or mechanisms. In some embodiments, the sealing member 250 may be formed by weaving fibers into a coil shape. In other embodiments, the sealing member 250 may first be formed in a flat configuration, such as by cutting pieces of fiber, and then shape-setting the material into the desired configuration (e.g., the coil shape shown in FIG. 24). As an alternative or in addition to these techniques, the sealing member 250 may include wires or threads formed from a shape memory metal or alloy (e.g., Nitinol) that are primed to assume a coil shape when the prosthetic valve is radially expanded. For example, the sealing member 250 may include one or more shape memory wires or threads that extend along the length of the sealing member and may be woven into the fibers that form the sealing member.

[0130] In the illustrated embodiment, when each sealing member 250 is in the coiled configuration, the inflow end portion 252 may remain straight or flat while the coiled portion is located at a position between the struts of the first and second rows of the frame. As shown in FIG. 24, some coiled portions of the sealing member are aligned with the center of the cell formed from strut I of the first row and strut II of the second row of the frame, and other portions are aligned with strut 34. In alternative embodiments, the sealing members 250 may be sized and shaped such that the coiled portion is located at other positions along the length of the frame, such as between strut II of the second row and strut III of the third row or between strut III of the third row and strut IV of the fourth row.

[0131] In some embodiments, the location of the coiled portion of the sealing member along the height of the frame can vary from sealing member to sealing member. For example, in one embodiment, all sealing members 250 may have the same overall length in the unrolled configuration (FIG. 26) and the inflow end portion 252 may be coupled to the same location on the frame (e.g., the inflow end of the frame), but the portion of each sealing member that forms the coil can vary from sealing member to sealing member. For example, some sealing members may form coils that are located closer to the inflow end of the frame, while some sealing members may form coils that are located closer to the outflow end of the frame.

[0132] In certain embodiments, the prosthetic valve 10 may further comprise a plurality of tethers 260 to facilitate unwinding of the sealing members when the prosthetic valve is radially compressed. Each tether 260 has a first end portion 262 (in the illustrated embodiment, the inflow end portion of the tether) coupled to a respective sealing member 250 and a second end portion 266 (in the illustrated embodiment, the outflow end portion of the tether) coupled to the frame 12 or to another component of the prosthetic valve at a location axially spaced from the sealing member. In this manner, each tether 260 is configured to apply an axial force to a respective sealing member 250 upon radial compression of the prosthetic valve by axial extension of the frame 12. The axial force applied to the sealing members facilitates unwinding of the sealing members into an unwinding configuration ( FIG. 26 ), as described further below.

[0133] 24 and 25, a first end portion 262 of each tether 260 may be secured to each sealing member 250 at or near an outflow edge portion 256 of the sealing member 250. Alternatively, the first end portion 262 of each tether 260 may be secured to each sealing member 250 at an intermediate portion 254 of the sealing member 250. The second end portion 266 of the tether 260 may be secured to the frame 12 (or another component of the prosthetic valve) at any convenient location axially spaced from the outflow edge portion 256 of the sealing member 250 when the sealing member is in the unrolled configuration (FIG. 26). For example, instead of being fixed to the frame, the second end portion 266 may be connected to the inner skirt 16 at a position axially spaced from the outflow edge portion 256 of the sealing member 250 when the sealing member is in the unrolled configuration (in which case the inner skirt 16 extends closer to the outflow end of the frame 12 than the outflow end of the sealing member in the unrolled configuration).

[0134] In certain embodiments, the second end portion 266 of each tether 260 may be anchored at or near the outflow end 19 of the annular frame 12. For example, in the embodiment shown, the second end portion 266 of the tether 260 is anchored at or near the tip 270 of the frame located at the outflow end (the convergence of the upper ends of the two angled struts 32). Alternatively, the second end portion 266 of the tether 260 may be anchored at or near the convergence of the lower ends of the two angled struts 32. The convergence of the lower ends of the two angled struts 32 may be located either at or near a node or junction 46 or at or near an axially extending window frame portion 30.

[0135] In the illustrated embodiment, one tether 260 is secured to each sealing member. In alternative embodiments, more than one tether 260, e.g., two, three, or more tethers, may be secured to each sealing member 250, each tether having a first end 262 secured to the same sealing member and a second end portion 266 secured to the frame or another component of the prosthetic valve. In some embodiments, more than one sealing member 250 may be secured to each tether 260.

[0136] The tether 260 can be formed from any of a variety of suitable materials, such as PET, PTFE, ePTFE, polyurethane, polyester, and / or other suitable materials. In certain embodiments, the tether 260 can be a suture (e.g., a single filament suture, or a multifilament suture, e.g., a multifilament, braided suture, etc.). In other embodiments, the tether (or a portion thereof) can be formed from a less flexible material. For example, the tether 260 (or a portion thereof) can be formed from a polymer, a metal, a metal alloy, or a combination thereof. For example, the tether can be in the form of a wire made from such materials. In some embodiments, a portion of the tether 260, such as the second end portion 266 or the intermediate portion 264, can include a less flexible material, such as a polymer, a metal, or a metal alloy (e.g., stainless steel).

[0137] In alternative embodiments, the tether 260 may be elastic so as to stretch longitudinally when the prosthetic valve is radially compressed and contract longitudinally when the prosthetic valve is radially expanded. For example, the tether may be made from any of a variety of elastomers and may take the form of an elastomeric cord or band.

[0138] The first and second ends of the tether 260 may be secured to the sealing member 250 or to the frame using a variety of techniques and / or mechanisms. For example, in one implementation, the tether 260 includes a suture, where each suture is sewn to a respective sealing member 250 at one end and knotted around a strut of the frame 12 at the other end of the suture. If the second end (upper end) of the suture is secured to the inner skirt 16 (rather than secured to the frame), the upper end of the suture may be sewn to the inner skirt. In other embodiments, the tether 260 may be secured at the first and second end portions using mechanical connectors, welding, adhesives, or a combination thereof.

[0139] As discussed above, the sealing members 250 are capable of moving or deforming between an unrolled configuration (preferably a flat or straight configuration) when the prosthesis is radially compressed for delivery, and a coiled functional configuration when the prosthesis is radially expanded. When the prosthesis 10 is radially compressed and the frame 12 is axially stretched, each tether 260 applies a tensile force to each sealing member 250, causing the sealing members to unroll along the outer surface of the frame. Desirably, the tethers have a length selected such that when the frame is radially compressed, they are under tension effective to hold the sealing members in a flat or substantially flat configuration against the frame until the prosthesis is expanded. Also, in the unrolled configuration, desirably the sealing members are straight or substantially straight along their length, but may be curved in their width to conform to the outer surface of the frame.

[0140] Once the prosthetic valve 10 is radially expanded at a desired implantation location within the body (e.g., within a native aortic valve), tension on the tether 260 is reduced and the sealing member 250 may return to a coiled shape. As discussed above, the sealing member may be shape-set so that it "self-expands" or "moves" into a coiled shape due to its own elasticity even in the absence of tension from the tether. In some embodiments, as discussed above, the sealing member 250 may include Nitinol threads or wires (or threads or wires made from other types of shape memory alloys or materials) to facilitate the sealing member's movement into the coiled configuration. As the sealing member moves into the coiled configuration, it extends radially outward from the frame in contact with the surrounding tissue. In this way, the sealing member 250 may reduce and / or eliminate paravalvular leakage between the frame of the prosthetic heart valve 10 and the native annulus. As a result, the sealing member 250 may improve the functionality of the prosthetic heart valve 10 and therefore the functionality of the patient's heart.

[0141] FIG. 33 illustrates an alternative method of connecting a tether 260 to the frame 12. In this embodiment, a first end portion 262 of the tether is connected to each sealing member 250 similar to the embodiment of FIG. 25. Instead of being fixed to the outflow end of the frame, the tether 260 is wrapped or looped around the outflow end of the frame and extends along the inner surface of the frame to the inflow end of the frame where a second end portion 266 of the tether 260 is fixed to the frame, such as by ligating the second end portion 266 to one or more struts of the frame. Upon radial compression and corresponding shortening of the frame 12, the tether 260 is allowed to slide against the outflow end of the frame by the tether pulling the sealing member 250 toward the outflow end of the frame, which causes the sealing member to unwind as previously described. Because the tether 260 traverses a greater number of struts of the frame compared to FIG. 25, a greater tensile force can be applied to the sealing member. Alternatively, the second end portion 266 of the tether 260 may be secured to another component of the prosthetic valve, such as to the inner skirt 16 of the prosthetic valve. For example, the second end portion 266 may be sewn to the inner skirt 16 or ligated around a portion of the inner skirt.

[0142] In another representative embodiment, an assembly for implanting a prosthetic heart valve 10 within a patient's body is provided. The assembly may include a delivery device including an elongate shaft and the prosthetic heart valve 10 mounted on the shaft in a radially contracted configuration for delivery within the body. In a particular embodiment, the delivery device may be the delivery device shown in FIG. 14, which includes a balloon catheter having a balloon 182 for deploying the prosthetic valve.

[0143] In another representative embodiment, a method of implanting the prosthetic heart valve 10 of Fig. 24 in a patient's body is provided. The method may include coupling the prosthetic heart valve 10 to a distal end of a delivery device (e.g., by crimping the prosthetic valve onto a balloon 182), inserting the distal end portion of the delivery device and the prosthetic heart valve 10 into the patient's body, positioning the prosthetic heart valve 10 adjacent to a native valve (e.g., a native aortic valve) of the patient's heart, and radially expanding the prosthetic heart valve 10 such that the prosthetic heart valve 10 engages the native valve. Once the prosthetic heart valve is radially expanded, the sealing member 250 returns to a coiled configuration to assist in sealing the prosthetic valve within the native valve annulus by engaging the surrounding tissue.

[0144] In the embodiment described above, sealing member 250 is fixed at its inflow end portion and the outflow end portion is free to roll up to form a sealing coil upon expansion of the prosthetic valve. However, in alternative embodiments, sealing member 250 can be fixed at its outflow end portion 256 to the frame (e.g., sutured to the frame, such as to a strut located at the outflow end of the frame) and inflow end portion 252 is free to roll up to form a sealing coil upon expansion of the prosthetic valve. In such embodiments, each tether 260 can have a first end portion fixed to the frame (e.g., at the inflow end of the frame) and a second end portion fixed to the inflow end portion 252 of each sealing member.

[0145] Figures 27-32 show various implantation locations for the prosthetic heart valve 10 of Figure 24. Figure 27 shows the prosthetic heart valve 10 of Figure 24 implanted within a patient's native aortic valve.

[0146] FIG. 28 shows the prosthetic heart valve 10 of FIG. 24 implanted in a patient's pulmonary artery to replace or improve the function of a diseased pulmonary valve. Due to the variety of sizes and shapes of the native pulmonary valve and pulmonary artery, the prosthetic valve 10 may be implanted in a radially expandable outer docking device 600. The docking device 600 includes a radially expandable and compressible annular stent 602 and a sealing member 604 that may cover all or a portion of the stent and extend across the inner and / or outer surfaces of the stent. The docking device 600 is configured to engage the inner wall of the pulmonary artery and may accommodate the variety of patient anatomies. The docking device 600 may also compensate for the case where the expanded prosthetic heart valve 10 is much smaller than the vessel in which it is placed. The docking device 600 may also be used to support the prosthetic valve in other regions of the patient's anatomy, such as the inferior vena cava, superior vena cava, or aorta. Further details of the docking device 600 and methods for implanting a docking device and a prosthetic valve are disclosed in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference.

[0147] 29 shows the prosthetic heart valve 10 of FIG. 24 implanted in a patient's native mitral valve using a docking device in the form of a helical anchor 700. The helical anchor 700 may include one or more coils 702 deployed in the left atrium and one or more coils 704 deployed in the left ventricle and radially outside the native mitral valve leaflets 706. When the prosthetic valve 10 is deployed in the native valve, the native valve leaflets are compressed or pinched between the prosthetic valve 10 and the anchor 700, thereby holding the prosthetic valve in place. Further details of the helical anchor 700 and methods for implanting the anchor and prosthetic valve are disclosed in U.S. Patent Application Publication No. 2018 / 0055628, which is incorporated herein by reference.

[0148] 30 and 31 show a docking device 800 for a prosthetic heart valve according to another embodiment. The docking device 800 comprises a radially expandable and compressible frame 802 having an outer portion 804, an inner portion 806 coaxially disposed within one end portion of the outer portion 804, and a curved transition portion 808 extending between and connecting the inner portion 806 and the outer portion 804. The docking device 800 can further comprise a sealing member 810 that extends over an inner surface of the inner portion 806, a portion of an outer surface of the outer portion 804 adjacent the inner portion 806, and the transition portion 808.

[0149] FIG. 32 shows the docking device 800 implanted in a blood vessel 820, which can be, for example, the inferior vena cava, the superior vena cava, or the ascending aorta. As shown, the prosthetic valve 10 of FIG. 24 can be deployed in the inner portion 806 of the docking device 800. As with the docking device 600, the docking device 800 can compensate for the case where the expanded prosthetic heart valve 10 is much smaller than the blood vessel in which it is placed. The docking device 800 is particularly suitable for implanting a prosthetic valve in the inferior vena cava to replace or improve the function of a native tricuspid valve. Further details of the docking device 800 and methods for implanting the docking device and prosthetic valve are disclosed in U.S. Patent Application Publication No. 2018 / 0000615, which is incorporated herein by reference.

[0150] General matters It should be appreciated that embodiments of the present disclosure may be configured to deliver and implant prosthetic devices in any of the native annulus of the heart (e.g., aortic, pulmonary, mitral, and tricuspid annuli, etc.) and may be used with any of a variety of approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). Embodiments of the present disclosure may also be used to implant prostheses in other cavities of the body. Furthermore, in addition to prosthetic valves, embodiments of the delivery assemblies described herein may be configured to deliver and implant a variety of other prosthetic devices, such as stents and / or other prosthetic repair devices.

[0151] For the purpose of this description, some aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The methods, devices, and systems of the present disclosure should not be interpreted as limiting in any respect. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various embodiments disclosed, both alone and in various combinations and subcombinations. These methods, devices, and systems are not limited to any particular aspect or feature thereof or combinations thereof, and the embodiments of the present disclosure do not require that any one or more particular advantages exist or problems are solved.

[0152] Although some operations of the embodiments of the present disclosure are described in a certain sequential order for convenience of presentation, it should be understood that this description style encompasses reordering unless a specific order is required by specific wording below. For example, a series of operations described sequentially may in some cases be reordered or performed simultaneously. Furthermore, for simplicity reasons, the accompanying drawings may not depict the various ways in which the method of the present disclosure may be utilized in combination with other methods. Furthermore, at times, the description uses terms such as "realize" or "achieve" to describe the method of the present disclosure. These terms are highly abstract representations of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are readily recognizable to those skilled in the art.

[0153] In this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "include" means "comprise." Additionally, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0154] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user and distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0155] As used herein, the terms "integrally formed" and "unitary structure" refer to a structure that does not include any welds, fasteners, or other means for fastening separately formed pieces of material together.

[0156] As used herein, the term "coupled" means physically joined or linked and does not exclude the presence of intermediate elements between the coupled items, unless specifically stated to the contrary.

[0157] As used herein, operations that are performed "simultaneously" or "concurrently" are generally performed at the same time relative to one another, but delays in the performance of one operation relative to another due to, for example, spacing, play, or backlash between components, such as threads, gears, and the like, of a mechanical linkage are expressly included within the scope of the term unless specifically stated to the contrary.

[0158] In view of the many possible embodiments to which the inventive principles of this disclosure may be applied, it is to be understood that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Accordingly, everything that comes within the scope and spirit of the claims is claimed as the invention. [Explanation of symbols]

[0159] 10 Artificial Heart Valves 12 Stents, frames 14 Valve structure, valve cusp structure 15 Inflow end section, inflow end section 16 Inner Skirt 17 Middle part 18 Outer Skirt 19 Outflow end section, Outflow end section 20 Commissure window 22 Angled strut 22a Tip 24 Angled strut 26 Angled strut 28 Angled strut 30 Window frame part, commissure window frame part 31 Axial strut 32 Angled strut 34 Axially extending strut 36 Aperture 38 Aperture 40 aperture 41 Valve leaflet 44 nodes, junctions 46 nodes, junctions 64 Junction 70 Sutures 72 Reinforcement sealing member, reinforcement strip 78 First set of fibers, threads, or strands 80 Second set of fibers, threads, or strands 82 Upper Edge 84 Lower Edge 86 Short Edge, Beveled Edge 88 Short Edge, Beveled Edge 90 Short edge part 92 Short edge part 94 Suture Line 96 Protrusion 98 Slit 112 Upper tab part 122 Commissure, commissure part 124 Flexible Connector 142 Inner part 143 Inner Edge 144 Outer part 146 Suture Line 154 Suture line, suture thread 156 Blanket Stitch 160 Lower Edge 162 Upper edge part 164 Protrusion 166 Notch 167 Aperture 168 Sutures 169 Middle part 170 creases 172 Vertical Line 173 Vertical Line 174 Lower edge part 180 Thin Shaft 182 Inflatable Balloon 250 Sealing member 252 Inlet edge portion, inlet end portion 254 Middle part 256 Outflow edge, outflow end 258 Longitudinal Side Edge 260 Tether 262 First end portion 264 Middle part 266 Second End Portion 600 Docking Device 602 Circular stent 604 Sealing member 700 Helical Anchor 702 Coil 704 Coil 706 Native mitral valve leaflet 800 Docking Devices 802 Frames 804 Outer part 806 Inner part 808 Transition section, curved transition section 810 Sealing member 820 Blood vessels

Claims

1. 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a valve structure positioned within the annular frame; a plurality of sealing members positioned about an outer surface of the annular frame; Equipped with the sealing member is configured to transform from an unrolled configuration extending along the outer surface of the annular frame when the annular frame is in the radially contracted configuration to a coiled configuration when the annular frame is radially expanded to the radially expanded configuration.

2. 13. The prosthetic valve of claim 1, further comprising a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion.

3. 3. The prosthetic valve of claim 2, wherein the tether is configured to apply an axial force to the sealing member that transforms the sealing member from the coiled configuration to the unrolled configuration when the annular frame is radially contracted to the radially contracted configuration.

4. 4. The prosthetic valve of claim 3, wherein the tether is configured to be placed in tension when the annular frame is radially contracted to the radially contracted configuration.

5. The prosthetic valve of claim 2 , wherein the tether comprises a suture.

6. 6. The prosthetic valve of claim 2, wherein each sealing member has an inflow end portion held in a fixed position relative to the annular frame and an outflow end portion connected to the first end portion of each tether.

7. 7. The prosthetic valve of claim 2, wherein the second end portion of the tether is fixed to the annular frame.

8. 8. The prosthetic valve of claim 7, wherein the second end portion of the tether is secured to a strut of the annular frame at the outflow end of the annular frame.

9. 8. The prosthetic valve of claim 7, wherein the tether is looped around a strut at the outflow end of the annular frame and extends inside the annular frame toward the inflow end of the annular frame, and the second end portion of the tether is secured to a strut of the annular frame spaced from the outflow end of the annular frame.

10. 10. The prosthetic valve of claim 9, wherein the second end portion of the tether is secured to a strut at the inflow end of the annular frame.

11. 11. The prosthetic valve of claim 1, wherein the sealing members are secured to the annular frame at spaced apart discrete locations.

12. 12. The prosthetic valve of claim 1, wherein each sealing member comprises fibers that are shape-set into the coiled configuration.

13. 13. The prosthetic valve of claim 1, wherein the sealing member comprises a Nitinol wire shape-set into the coiled configuration.

14. 14. The prosthetic valve of claim 1, wherein the sealing member lies flat along the outer surface of the annular frame when in the unrolled configuration.

15. 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a valve structure positioned within the annular frame; a plurality of sealing members positioned about an outer surface of the annular frame, each sealing member having an inlet end portion and an outlet end portion, the inlet end portion being held in a fixed position relative to the annular frame and the outlet end portion being movable relative to the annular frame; Equipped with the sealing member is configured to transform from an unrolled configuration extending along the outer surface of the annular frame when the annular frame is in the radially contracted configuration to a coiled configuration when the annular frame is expanded to the radially expanded configuration; when the sealing members are in the unrolled configuration, the outflow end portions are located at respective first positions relative to the outflow end of the annular frame, and when the sealing members are in the coiled configuration, the outflow end portions are located at respective second positions closer to the inflow end of the annular frame than the first positions.

16. 16. The prosthetic valve of claim 15, further comprising a plurality of tethers, each of the tethers having a first end portion coupled to the outflow end portion of a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion.

17. 17. The prosthetic valve of claim 16, wherein the tether is configured to apply an axial force to the sealing member that transforms the sealing member from the coiled configuration to the unrolled configuration when the annular frame is radially contracted to the radially contracted configuration.

18. 18. The prosthetic valve of any one of claims 15 to 17, wherein the inflow end portion of the sealing member is secured at the inflow end of the annular frame.

19. 19. The prosthetic valve of any one of claims 16 to 18, wherein the tether is configured to be placed in tension when the annular frame is radially contracted to the radially contracted configuration.

20. 20. The prosthetic valve of any one of claims 16 to 19, wherein the tether comprises a suture.

21. 21. The prosthetic valve of any one of claims 16 to 20, wherein the second end portion of the tether is fixed relative to the annular frame.

22. 22. The prosthetic valve of claim 21, wherein the second end portion of the tether is secured to a strut of the annular frame at the outflow end of the annular frame.

23. 22. The prosthetic valve of claim 21, wherein the tether is looped around a strut at the outflow end of the annular frame and extends into the interior of the annular frame toward the inflow end of the annular frame, and the second end portion of the tether is secured to a strut of the annular frame spaced from the outflow end of the annular frame.

24. 24. The prosthetic valve of claim 23, wherein the second end portion of the tether is secured to a strut at the inflow end of the annular frame.

25. 25. The prosthetic valve of any one of claims 15 to 24, wherein the sealing members are secured to the annular frame at spaced apart discrete locations.

26. 26. The prosthetic valve of any one of claims 15 to 25, wherein each sealing member comprises fibers shape-set into the coiled configuration.

27. 27. The prosthetic valve of any one of claims 15 to 26, wherein the sealing member comprises a Nitinol wire shape-set into the coiled configuration.

28. 28. The prosthetic valve of any one of claims 15 to 27, wherein the sealing member lies flat along the outer surface of the annular frame when in the unrolled configuration.

29. 29. The prosthetic valve of any one of claims 16 to 20 and claims 25 to 28, further comprising an inner skirt secured to an inner surface of the annular frame, the second end portion of the tether being secured to the inner skirt.

30. 1. A method of implanting a prosthetic heart valve, comprising: inserting into a patient a distal end portion of a delivery device and a prosthetic heart valve in a radially compressed configuration and coupled to the distal end portion of the delivery device, the prosthetic heart valve comprising an annular frame, a valve structure positioned within the annular frame, and a plurality of sealing members positioned about an outer surface of the annular frame, the sealing members being in an unrolled configuration extending along an outer surface of the annular frame when the prosthetic heart valve is in the radially compressed configuration; positioning the prosthetic heart valve adjacent to a native valve in the patient's heart; radially expanding the prosthetic heart valve from the radially compressed configuration to a radially expanded configuration; Including, The method, wherein expanding the prosthetic heart valve causes the sealing member to transform from the unrolled configuration to a coiled configuration that engages surrounding tissue of the native valve.

31. The prosthetic heart valve further comprises a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic heart valve axially spaced from the first end portion; the tether is held in tension when the prosthetic heart valve is in the radially compressed configuration, retaining the sealing member in the unrolled configuration; 31. The method of claim 30, wherein expanding the prosthetic heart valve relieves tension on the tether, thereby allowing the sealing member to transform into the coiled configuration.

32. 32. The method of claim 30 or 31, wherein when the prosthetic heart valve is radially expanded and the sealing members transform from the unrolled configuration to the coiled configuration, the free ends of the sealing members move from respective first positions to respective second positions that are closer to the inflow end of the annular frame than the first positions.

33. 33. The method of any one of claims 30 to 32, wherein the sealing member is shape-set into the coiled configuration.

34. 34. The method of any one of claims 30 to 33, wherein the tether comprises a suture.

35. 35. The method of any one of claims 30 to 34, wherein each sealing member has an inflow end portion held in a fixed position relative to the annular frame and an outflow end portion connected to the first end portion of each tether.

36. 36. The method of any one of claims 30 to 35, wherein the second end portion of the tether is fixed relative to the annular frame.

37. 37. The method of claim 36, wherein the second end portion of the tether is secured to a strut of the annular frame at the outflow end of the annular frame.

38. 37. The method of claim 36, wherein the tether is looped around a strut at the outflow end of the annular frame and extends into the interior of the annular frame toward the inflow end of the annular frame, and the second end portion of the tether is secured to a strut of the annular frame spaced from the outflow end of the annular frame.

39. 39. The method of claim 38, wherein the second end portion of the tether is secured to a strut at the inflow end of the annular frame.

40. 40. A method according to any one of claims 30 to 39, wherein the sealing member is secured relative to the annular frame at spaced apart discrete locations.

41. 41. The method of any one of claims 30 to 40, wherein each sealing member comprises a fiber shape-set into the coiled configuration.

42. 42. The method of any one of claims 30 to 41, wherein the sealing member comprises a Nitinol wire shape-set into the coiled configuration.

43. 43. A method according to any one of claims 30 to 42, wherein the sealing member lies flat along the outer surface of the annular frame when in the unrolled configuration.

44. 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a valve structure positioned within the annular frame; a plurality of sealing members positioned about an outer surface of the annular frame; a plurality of tethers, each of the tethers having a first end portion coupled to a respective sealing member and a second end portion coupled to or extending around a location on the prosthetic valve axially spaced from the first end portion; Equipped with when the annular frame is radially contracted from the radially expanded configuration to the radially contracted configuration, each tether applies an axial force to a respective sealing member causing the sealing member to transform from a coiled configuration to an unrolled configuration, and when the annular frame is radially expanded from the radially contracted configuration to the radially expanded configuration, each tether relieves the axial force applied to the respective sealing member, thereby allowing the sealing member to transform from the unrolled configuration to the coiled configuration.

45. 45. The prosthetic valve of claim 44, wherein the second end portion of the tether is secured to a strut of the annular frame at the outflow end of the annular frame.

46. 45. The prosthetic valve of claim 44, wherein the tether is looped around a strut at the outflow end of the annular frame and extends into the interior of the annular frame toward the inflow end of the annular frame, and the second end portion of the tether is secured to a strut of the annular frame spaced from the outflow end of the annular frame.

47. 47. The prosthetic valve of claim 46, wherein the second end portion of the tether is secured to a strut at the inflow end of the annular frame.

48. 45. The prosthetic valve of claim 44, further comprising an inner skirt secured against an inner surface of the annular frame, the second end portion of the tether being secured against the inner skirt.

49. 49. The prosthetic valve of any one of claims 44 to 48, wherein each sealing member comprises fibers shape-set into the coiled configuration.

50. 50. The prosthetic valve of any one of claims 44 to 49, wherein the sealing member comprises a Nitinol wire shape-set into the coiled configuration.

51. 51. The prosthetic valve of any one of claims 44 to 50, wherein the sealing member lies flat along the outer surface of the annular frame when in the unrolled configuration.

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