Covered prosthetic heart valve

Abstract

The present application relates to a covered prosthetic heart valve. The prosthetic heart valve includes a frame having a plurality of strut members, an inflow end, and an outflow end. The prosthetic heart valve also includes a leaflet structure at least partially located within the frame and a cover disposed around the frame. The cover has a first layer and a second layer, wherein the second layer has a plush surface. The first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along the longitudinal axis of the prosthetic heart valve.

Description

[0001] This application is a divisional application of Chinese patent application 2018800062517 (PCT / US2018 / 014918) entitled “Covered Prosthetic Heart Valve” filed on January 23, 2018. Technical Field

[0002] The present disclosure relates to prosthetic heart valves, and in particular to prosthetic heart valves that include a covering that cushions tissue of a native heart valve in contact with the prosthetic heart valve. Background Art

[0003] In the procedure of implanting a transcatheter prosthetic heart valve, the prosthetic heart valve is typically positioned in the annulus of a natural heart valve and expanded or allowed to expand to its functional size. In order to keep the prosthetic heart valve in a desired position, the prosthetic heart valve may be larger than the diameter of the natural valve annulus so that it applies force to the surrounding tissue to prevent the prosthetic heart valve from falling off. In other configurations, the prosthetic heart valve may expand within a support structure located within the natural annulus and be configured to maintain the prosthetic heart valve at a selected position relative to the annulus. Over time, relative movement of the prosthetic heart valve and tissue of the natural heart valve in contact with the prosthetic heart valve (e.g., natural valve leaflets, chordae tendineae, etc.) may result in damage to the tissue. Therefore, there is a need to improve the prosthetic heart valve. Summary of the invention

[0004] Certain disclosed embodiments relate to covers for prosthetic heart valves and methods of making and using the same. In a representative embodiment, the prosthetic heart valve includes a frame comprising a plurality of strut members and having an inflow end and an outflow end. The prosthetic heart valve also includes a leaflet structure at least partially located within the frame and a cover disposed around the frame. The cover includes a first layer and a second layer, wherein the second layer has a plush surface. The first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along the longitudinal axis of the prosthetic heart valve.

[0005] In some embodiments, the protecting portion is a first protecting portion positioned adjacent to the inflow end of the frame, and the cover further comprises a second protecting portion positioned adjacent to the outflow end of the frame.

[0006] In some embodiments, the first layer extends along the inner surface of the second layer from the inflow end of the frame to the outflow end of the frame, and is folded over the circumferential edge of the second layer at the outflow end of the frame to form the second protective portion.

[0007] In some embodiments, the first layer of the first protective portion is configured as a strip member that is folded over a circumferential edge portion of the second layer at the inflow end of the frame.

[0008] In some embodiments, the first layer of the second protective portion is configured as a strip member that is folded over a circumferential edge portion of the second layer at the outflow end of the frame.

[0009] In some embodiments, the strip members of the first protecting portion encapsulate the vertices of the strut members at the inflow end of the frame, and the strip members of the second protecting portion encapsulate the vertices of the strut members at the outflow end of the frame.

[0010] In some embodiments, the second layer includes a fabric having a woven layer and a plush pile layer including a plurality of pile yarns.

[0011] In some embodiments, the pile yarns are arranged to form a looped pile, or are cut to form a cut pile.

[0012] In some embodiments, the first layer comprises a tissue layer.

[0013] In another representative embodiment, a method includes securing a first layer to a first surface of a second layer such that a longitudinal edge portion of the first layer extends beyond a longitudinal edge portion of the second layer, the first surface of the second layer being a plush second surface. The method also includes securing the attached first and second layers into a cylindrical shape to form a cover, and positioning the cover around a frame of a prosthetic heart valve, the frame comprising a plurality of strut members. The method also includes folding the longitudinal edge portion of the first layer over the longitudinal edge portion of the second layer to form a protective portion such that the protective portion extends beyond the apex of the strut member in a direction along the longitudinal axis of the valve.

[0014] In some embodiments, positioning the cover about the frame further comprises positioning the cover about the frame such that the plush first surface of the second layer is oriented radially outward.

[0015] In some embodiments, the protection portion is an inflow protection portion adjacent to the inflow end of the frame, the first layer of the inflow protection portion is configured as a first strip member, and the method also includes folding a longitudinal edge portion of a second strip member over a longitudinal edge portion of the second layer to form an outflow protection portion adjacent to the outflow end of the frame.

[0016] In some embodiments, folding the longitudinal edge portion of the first strip member also includes folding the longitudinal edge portion of the first strip member so that the inflow protection portion encapsulates the respective vertices of the pillar member at the inflow end of the frame, and folding the longitudinal edge portion of the second strip member also includes folding the longitudinal edge portion of the second strip member so that the outflow protection portion encapsulates the respective vertices of the pillar member at the outflow end of the frame.

[0017] In some embodiments, the second layer includes a fabric having a woven layer and a plush pile layer including a plurality of pile yarns forming the second surface.

[0018] In another representative embodiment, a method includes positioning a prosthetic heart valve in the annulus of a natural heart valve. The prosthetic heart valve is in a radially compressed state and has a frame that includes a plurality of strut members and has an inflow end and an outflow end. The prosthetic heart valve also includes a leaflet structure at least partially located within the frame and a covering disposed around the frame. The covering includes a first layer and a second layer. The second layer has a plush surface, and the first layer is folded over a circumferential edge portion of the second layer to form a protective portion that extends beyond the strut members in a direction along the longitudinal axis of the prosthetic heart valve. The method also includes expanding the prosthetic heart valve in the annulus of the natural heart valve so that the leaflet structure of the prosthetic heart valve regulates blood flow through the annulus.

[0019] In some embodiments, expanding the prosthetic heart valve further comprises expanding the prosthetic heart valve such that the guard portion prevents native heart tissue in contact with the guard portion from contacting the apices of the strut members.

[0020] In some embodiments, expanding the prosthetic heart valve further comprises expanding the prosthetic heart valve such that leaflets of the native heart valve are captured between the plush surface of the second layer and an anchoring device positioned in the heart.

[0021] In some embodiments, the protecting portion is a first protecting portion positioned adjacent to the inflow end of the frame, and the cover further comprises a second protecting portion positioned adjacent to the outflow end of the frame.

[0022] In some embodiments, the second layer includes a fabric having a woven layer and a plush pile layer including a plurality of pile yarns forming a plush surface.

[0023] In some embodiments, the first layer is folded over a circumferential edge portion of the second layer such that the protective portion encapsulates each apex of the strut member.

[0024] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A schematic cross-sectional view of a human heart is shown.

[0026] Figure 2 A schematic top view of the mitral valve annulus of a heart is shown.

[0027] Figure 3 is a perspective view of an embodiment of a prosthetic heart valve.

[0028] Figure 4A is a cross-sectional side view of an annular anchor deployed in the mitral valve location of a heart with an implanted valve prosthesis according to one embodiment.

[0029] Figure 4B A cross-sectional side view of a coil anchor deployed in the mitral valve location of a heart with an implanted valve prosthesis is shown according to another embodiment.

[0030] Figure 4C is a perspective view of a representative embodiment of a helical anchor.

[0031] Figure 5 is a perspective view of a prosthetic heart valve including a representative embodiment of a covering.

[0032] Figure 6 yes Figure 5 Side view of a prosthetic heart valve.

[0033] Figure 7 yes Figure 5 A top plan view of a prosthetic heart valve.

[0034] Figure 8 yes Figure 5 Cross-sectional side elevation view of a prosthetic heart valve.

[0035] Fig. 9 is a perspective view of a representative embodiment of a cushioning layer including plush pile.

[0036] Fig.10 It is deployed in the mitral valve of the heart. Figure 5 Cross-sectional side view of a prosthetic heart valve.

[0037] Fig.11 is a side elevation view of a prosthetic heart valve including another embodiment of a covering.

[0038] Fig.12 is a perspective view of a backing layer, a template for making the backing layer, and a buffer layer before the backing layer and the buffer layer are secured together.

[0039] Fig.13is a cross-sectional side elevation view of a prosthetic heart valve including another embodiment of a covering.

[0040] Fig.14 yes Fig.13 Detailed view of the inflow protection portion of the covering.

[0041] Fig.15 is a side elevation view of a prosthetic heart valve including another embodiment of a cover comprising a spacer fabric.

[0042] Fig.16 is a perspective view of a representative embodiment of a spacer fabric including terry yarns.

[0043] Fig.17 yes Fig.16 Side elevation view of a spacer fabric.

[0044] Fig.18 is a top plan view of an embodiment of a backing layer after being cut using a parallelogram stencil.

[0045] Fig.19 is a perspective view of a prosthetic heart valve including another embodiment of a covering.

[0046] Fig. 20 yes Fig.19 Side elevation view of a prosthetic heart valve.

[0047] Fig.21 yes Fig.19 A plan view of the outflow end of a prosthetic heart valve.

[0048] Fig. 22 yes Fig.19 Cross-sectional side elevation view of a prosthetic heart valve.

[0049] Fig.23 Is in the expanded configuration Fig.19 A top plan view of the covering.

[0050] Fig.24 It is shown that after the cover is formed into a cylindrical shape, Fig.19 Perspective view of a prosthetic heart valve being placed into a covering.

[0051] Fig.25 yes Fig.19 A perspective view of the inflow end of a prosthetic heart valve showing the strut members attaching the cover to the valve frame.

[0052] Fig.26 yes Fig.19 A perspective view of the inflow end of a prosthetic heart valve showing the strap members folded over the strut members of the valve frame to form a cover for the inflow protection portion.

[0053] Fig. 27 is a perspective view of a frame for a prosthetic heart valve including another embodiment of a covering.

[0054] Fig.28 yes Fig. 27 A cross-sectional side elevation view of the frame and covering.

[0055] Figure 29-31A It shows the manufacturing Fig. 27 A perspective view of a representative approach to covering.

[0056] Fig.31B yes Fig.31A Detailed view of the electrospun layer covering the inflow end portion of the cover.

[0057] Fig.32 is a perspective view of a prosthetic heart valve including a primary cover and a secondary cover extending over an apex of a frame.

[0058] Fig.33 yes Fig.32 Side view of a prosthetic heart valve.

[0059] Fig.34 Is in a flat configuration Fig.32 A plan view of a portion of the frame of a prosthetic valve.

[0060] Fig.35 There is no main exterior covering Fig.32 Perspective view of a prosthetic heart valve.

[0061] Fig.36 yes Fig.32 A perspective view of a prosthetic heart valve showing how the second cover is wrapped around the apex of the frame.

[0062] Fig.37 is a diagram showing a second covering crimped onto the shaft of a delivery device. Fig.32 Perspective view of the frame of a prosthetic valve.

[0063] Fig.38A According to another embodiment, the outer covering Fig.19 Side elevation view of a prosthetic valve.

[0064] Fig.38B yes Fig.38A Detailed view of the fabric of the exterior covering.

[0065] Fig.39A is a diagram showing a coiled portion of the delivery device. Fig.38A Plan view of a prosthetic heart valve.

[0066] Fig.39B yes Fig.39A Detailed view of the outer covering of a prosthetic heart valve in.

[0067] Fig.40A is in a relaxed state Fig.38A A cross-sectional side elevation view of the fabric of the outer covering.

[0068] Fig.40B It is in tension Fig.38A A cross-sectional side elevation view of the fabric of the outer covering.

[0069] Fig.41A is a plan view of another embodiment of a fabric outer covering for a prosthetic valve in a lay-flat configuration and including an outer surface defined by a pile layer.

[0070] Fig.41B yes Fig.41A A magnified view of the exterior covering.

[0071] Fig.42A yes Fig.41A Plan view of the base layer of the external covering.

[0072] Fig.42B yes Fig.42A A magnified view of the base layer. DETAILED DESCRIPTION

[0073] The present disclosure relates to embodiments of implantable prosthetic heart valves and methods of making and using such devices. In one aspect, the prosthetic heart valve includes an outer covering having a backing layer and a main buffer layer disposed on the backing layer, such that the buffer layer is oriented radially outward around the circumference of the valve. The buffer layer can be soft and compliant so as to reduce damage to the natural tissue of the heart valve and / or the surrounding anatomical structures at the implantation site due to relative movement or friction between the prosthetic valve and the tissue, for example, when the heart expands and contracts. The covering may also include an inflow protection portion and an outflow protection portion to cushion the surrounding anatomical structures and prevent the natural tissue of the heart valve from contacting the apex of the strut members of the frame, thereby protecting the surrounding tissue. In another embodiment, the covering may include an inflow strip member and an outflow strip member, which are fixed to the buffer layer and folded over the apex of the strut member to form the inflow protection portion and the outflow protection portion.

[0074] Embodiments of the disclosed technology may be used in conjunction with various prosthetic heart valves configured for implantation at various locations within the heart. A representative example is a prosthetic heart valve used to replace the function of the native mitral valve. Figure 1 and Figure 2The mitral valve of a human heart is shown. The mitral valve controls the flow of blood between the left atrium and the left ventricle. After the left atrium receives oxygenated blood from the lungs through the pulmonary veins, the mitral valve allows the oxygenated blood to flow from the left atrium into the left ventricle. When the left ventricle contracts, the oxygenated blood held in the left ventricle is delivered to the rest of the body through the aortic valve and the aorta. At the same time, the mitral valve closes during ventricular contraction to prevent any blood from flowing back into the left atrium.

[0075] When the left ventricle contracts, the blood pressure inside the left ventricle rises greatly, which causes the mitral valve to close. Since the pressure difference between the left ventricle and the left atrium is large during this period, the possibility of the leaflets of the mitral valve prolapping or everting back into the atrium arises. Therefore, a series of chordae tendineae connect the leaflets of the mitral valve to the papillary muscles located on the wall of the left ventricle, wherein during ventricular contraction, both the chordae tendineae and the papillary muscles are tensioned to hold the leaflets in the closed position and prevent them from extending back toward the left atrium. This normally prevents the backflow of oxygenated blood into the left atrium. Figure 1 Heart cross section and Figure 2 A top view of the mitral valve schematically illustrates the chordae tendineae.

[0076] Figure 2 The general shape of the mitral valve and its leaflets as viewed from the left atrium is shown in . Various complications of the mitral valve can lead to fatal heart failure. One form of valvular heart disease is mitral valve leakage or mitral regurgitation, which is characterized by abnormal leakage of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused by, for example, dilation of the left ventricle, which can cause incomplete coaptation of the native mitral valve leaflets, resulting in leakage through the valve. Mitral regurgitation can also be caused by damage to the native leaflets. In these cases, it may be necessary to repair the mitral valve, or replace the function of the mitral valve with that of a prosthetic heart valve, such as a transcatheter heart valve.

[0077] Some transcatheter heart valves are designed to be radially crimped or compressed to facilitate intravascular delivery to an implantation site at a patient's heart. Once positioned at the native valve annulus, the replacement valve is then inflated, for example, by an inflatable balloon, to an operative state such that the leaflet structure of the prosthetic heart valve regulates blood flow through the native valve annulus. In other cases, when released from a delivery sheath, the prosthetic valve can mechanically expand or radially self-expand from a compressed delivery state to an operative state under its own elasticity. One embodiment of a prosthetic heart valve is Figure 3 As shown in. Figure 3 The transcatheter heart valve with the valve profile of the prosthetic valve shown is the Edwards Lifesciences SAPIEN XT TM valve. Figure 3The prosthetic valve 1 in FIG. 1 has an inflow end 2 and an outflow end 3, and includes a frame or stent 10 and a leaflet structure 20 supported inside the frame 10. In some embodiments, a skirt 30 may be attached to the inner surface of the frame 10 to form a more suitable attachment surface for the valve leaflets of the leaflet structure 20.

[0078] The frame 10 may be made of any body compatible expandable material that allows for crimping to a radially collapsed state and expansion back to a radially collapsed state. Figure 3 The expanded functional state shown. For example, in embodiments where the prosthetic valve is a self-expanding prosthetic valve that expands to its functional size under its own elasticity, the frame 10 can be made of nitinol or another self-expanding material. In other embodiments, the prosthetic valve can be a plastic expandable valve that is expanded to its functional size by a balloon or other expansion device, in which case the frame can be made of a plastic expandable material (such as stainless steel or cobalt chromium alloy). Other suitable materials can also be used.

[0079] The frame 10 may include an annular structure having a plurality of vertically extending commissural attachment posts 11 to which the leaflet structure 20 is attached and to which it helps to form. Additional vertical posts or strut members 12 along with circumferentially extending strut members 13 help to form the remainder of the frame 10. The strut members 13 of the frame 10 are zigzag shaped at the inflow end 2 and outflow end 3 of the valve 1 and form a crown portion or apex 14 with an edge. In addition, the attachment posts 11 may also form an edge at one or both ends of the frame 10.

[0080] In the prosthetic valve 1, the skirt 30 is attached to the inner surface of the valve frame 10 via one or more threads 40, which generally wrap around the exterior of each strut 11, 12, 13 of the frame 10, as desired. The skirt 30 provides a more substantial attachment surface for the portion of the leaflet structure 20 located closer to the inflow end 2 of the valve 1.

[0081] Figure 4A and Figure 4B A side cross-sectional view of an embodiment of a different anchor that can be used to facilitate implantation of the valve 1 at the mitral valve location of a patient's heart is shown. Figure 4A and Figure 4B As shown, the left side of the heart 80 includes a left atrium 82, a left ventricle 84, and a mitral valve 86 connecting the left atrium 82 and the left ventricle 84. The mitral valve 86 includes an anterior leaflet 88 and a posterior leaflet 89 connected to the inner wall of the left ventricle 84 via chordae tendineae 90 and papillary muscles 92.

[0082] exist Figure 4AIn the embodiment, the first anchoring device includes a flexible ring or halo 60 surrounding the natural leaflets 88 and / or chordae tendineae 90 of the mitral valve 86. In order to more effectively implant the prosthetic valve 1, the ring 60 clamps or pushes portions of the leaflets inwardly to form a more circular opening at the mitral valve location. The valve prosthesis 1 is retained in the natural mitral valve annulus 86 by the annular anchor 60 and can be delivered to the position shown, for example, by positioning the valve 1 in the mitral valve annulus 86 while the valve 1 is crimped, and then once the valve 1 is as shown, Figure 4A Once the valve 1 is positioned as shown, the valve 1 is expanded. Once expanded, the valve 1 pushes the annular anchor 60 outward to fix the position of the valve 1 and the annular anchor 60. In some embodiments, an undersized annular anchor 60 having an inner diameter slightly smaller than the diameter of the prosthetic valve 1 in its expanded state may be used to provide greater friction between these parts, resulting in a more secure attachment. Figure 4A As shown, at least a portion of the native mitral valve leaflets 88 and / or a portion of the chordae tendineae 90 are clamped or sandwiched between the valve 1 and the annular anchor 60 to secure the components to the native anatomy.

[0083] Figure 4B Similar to Figure 4A , except that in place of the annular anchor 60, a helical anchor 70 is utilized instead. The helical anchor 70 may include more coils or turns than the annular anchor 60, and may extend both upstream and downstream of the mitral valve annulus 86. In some cases, the helical anchor 70 may provide a larger and more secure attachment area against which the valve 1 may rest. Similar to Figure 4A The annular anchor 60 in the embodiment of the present invention, at least a portion of the native mitral valve leaflets 88 and / or chordae tendineae 90 is clamped between the valve 1 and the helical anchor 70. Methods and devices for implanting helical anchors and prosthetic valves are described in U.S. Application No. 15 / 682,287 filed on August 21, 2017 and U.S. Application No. 15 / 684,836 filed on August 23, 2017.

[0084] Figure 4CAnother representative embodiment of a spiral anchor 300 that can be used in conjunction with any of the prosthetic valves described herein is shown. The anchor 300 can be configured as a coil having a central region 302, a lower region 304, and an upper region 306. The lower region 304 includes one or more turns arranged in a spiral, which can be configured to surround or capture the chordae tendineae and / or leaflets of the mitral valve. The central region 302 includes a plurality of turns configured to retain the prosthetic valve in the native annulus. The upper region 306 includes one or more turns and can be configured to prevent the anchor from falling off the valve annulus prior to implantation of the prosthetic valve. In some embodiments, the upper region 306 can be positioned above the floor of the left atrium and can be configured to retain the turns of the central region 302 that is positioned higher within the mitral valve device.

[0085] The anchor 300 also includes an extension portion 308 positioned between the central region 302 and the upper region 306. In other embodiments, for example, the extension portion 308 may alternatively be positioned entirely in the central region 302 (e.g., at an upper portion of the central region) or entirely in the upper region 306. The extension portion 308 includes a portion of a coil that extends substantially parallel to the central axis of the anchor. In other embodiments, the extension portion 308 may be angled relative to the central axis of the anchor. The extension portion 308 may be used to space the central region 302 and the upper region 306 apart from each other in a direction along the central axis such that a gap is formed between the atrial side and the ventricular side of the anchor.

[0086] The extension 308 of the anchor is intended to be positioned through or near the native valve annulus so as to reduce the number of anchors that pass through, push against or abut against the native annulus and / or native leaflets when the anchor is implanted. This can reduce the force applied by the anchor on the native mitral valve and reduce wear of the native leaflets. In one arrangement, the extension 308 is positioned at one of the commissures of the native mitral valve and passes through one of the commissures of the native mitral valve. In this way, the extension 308 can separate the upper region 306 from the natural leaflets of the mitral valve to prevent the upper region 306 from interacting with the natural leaflets from the atrial side. The extension 308 also raises the upper region 306 so that the upper region contacts the atrial wall above the native valve, which can reduce stress on and around the natural valve and provide better retention of the anchor.

[0087] In the illustrated embodiment, the anchor 300 may also include one or more openings configured as through holes 310 at or near one or both of the proximal and distal ends of the anchor. The through holes 310 may be used, for example, as suture holes for attaching a cover layer over the coil of the anchor, or as attachment sites for delivery tools (such as pull wires) for pushers or other propulsion devices. In some embodiments, the width or thickness of the coil of the anchor 300 may also vary along the length of the anchor. For example, the center portion of the anchor may be made thinner than the end portions of the anchor. This may allow the center portion to exhibit greater flexibility while the end portions may be stronger or more robust. In some examples, making the end portions of the coil relatively thick may also provide a larger surface area for suturing or otherwise attaching the cover layer to the coil of the anchor.

[0088] In certain embodiments, the helical anchor 300 can be configured for insertion through the native valve annulus in a counterclockwise direction. For example, the anchor can be advanced through commissures A3P3, commissures A1P1, or through another portion of the native mitral valve. The counterclockwise direction of the coil of the anchor 300 can also allow the distal end of the delivery catheter to be bent in a similar counterclockwise direction, which is easier to accomplish than bending the delivery catheter in a clockwise direction. However, it should be understood that the anchor can be configured for insertion through the valve either clockwise or counterclockwise, as desired.

[0089] Back to Figure 3 The prosthetic valve 1 generally includes a metal frame 10 that forms a plurality of edges. In addition, many frames 10 are configured to have a crown or apex 14 with edges and a protruding commissure attachment post 11, as well as threads 40 that may be exposed along the outer surface of the frame 10. For example, these features may cause damage to native mitral valve tissue (such as tissue located between the prosthetic valve 1 and the anchors 60, 70) through movement or friction between the native tissue and the various abrasive surfaces of the prosthetic valve 1. In addition, other native tissues (such as chordae tendineae) near the prosthetic valve 1 may also be damaged.

[0090] Figures 5 to 7 An Edwards Lifesciences SAPIEN similar to that described in detail in U.S. Pat. No. 9,393,110 is shown. TM1. A representative embodiment of a prosthetic heart valve 100 with a 3-valve structure. The prosthetic valve 100 includes a frame 102 formed by a plurality of angled strut members 104 and having an inflow end 106 and an outflow end 108. The prosthetic valve 100 also includes a leaflet structure including three leaflets 110 that are at least partially located within the frame 102 and are configured to collapse in a tricuspid arrangement similar to an aortic valve, but the prosthetic valve may also include two leaflets configured to collapse in a bicuspid arrangement in a bicuspid manner, or more than three leaflets as desired. The strut members 104 may form a plurality of vertices 124 arranged around the inflow end and the outflow end of the frame.

[0091] The prosthetic heart valve may include an outer covering 112 configured to cushion (protect) natural tissue in contact with the prosthetic valve after implantation and to reduce damage to the tissue due to movement or friction between the tissue and the valve surface. The covering 112 may also reduce paravalvular leakage. Figure 5 In the embodiment of the present invention, the cover 112 includes a backing layer 114 configured as a backing layer (see, for example Figure 8 ) and a second layer configured as a cushioning layer 116. The cushioning layer 116 can be disposed on the backing layer 114 and can include a soft plush surface 118 oriented radially outward to protect tissue or objects in contact with the cushioning layer. In the illustrated configuration, the cover 112 also includes an atraumatic inflow protection portion 120 extending circumferentially around the inflow end 106 of the frame and an atraumatic outflow protection portion 122 extending circumferentially around the outflow end 108 of the frame. The portion of the cushioning layer 116 between the inflow protection portion 120 and the outflow protection portion 122 can define a main cushioning portion 136.

[0092] Figure 8 1 is a schematic cross-sectional view of a prosthetic valve 100 with the leaflet structure removed for illustration purposes. Cover 112 extends around the exterior of frame 102 such that the interior surface of backing layer 114 is adjacent to or abuts the exterior surface of strut member 104. Figure 8As shown, the length of the buffer layer 116 can be greater than the length of the frame when measured along the longitudinal axis 126 of the frame. Thus, the covering 112 can be positioned so that the buffer layer 116 extends distally (e.g., in an upstream direction) beyond the apex 124 of the strut member at the inflow end 106 of the frame, wherein the portion of the buffer layer extending beyond the apex is referred to herein as the distal end portion 128. At the opposite end of the valve, the buffer layer 116 can extend proximally (e.g., in a downstream direction) beyond the apex 124 of the strut member, wherein the portion located beyond the apex is referred to as the proximal end portion 130. The distances that the proximal end portion 128 and the distal end portion 130 of the buffer layer 116 extend beyond the apex at the respective ends of the valve can be the same or different, depending on, for example, the size of the valve, the specific application, and the like.

[0093] The backing layer 114 may have sufficient length in the axial direction so that the proximal end portion or flap 132 of the backing layer 114 can be folded over the proximal end portion 130 of the buffer layer 116 in a cuff manner to form the outflow protection portion 122. At the same time, the distal end portion or flap 134 of the backing layer 114 can be folded over the distal end portion 128 of the buffer layer 116 to form the inflow protection portion 120. The proximal flap 132 and the distal flap 134 of the backing layer 116 can be fixed to the lower section of the backing layer by, for example, sutures 136. In this way, the inflow protection portion 120 and the outflow protection portion 122 are configured so that the proximal end portion 130 and the distal end portion 128 of the buffer layer 116 are at least partially surrounded by the flaps 132, 134 of the backing layer 116. This configuration provides sufficient strength and resistance to bending to the inflow protection portion 120 and the outflow protection portion 122 so that they extend along the longitudinal axis 126 of the valve without bending or otherwise protruding into the inner diameter of the valve (e.g., by bending under their own weight, by blood flow, or by blood pressure). In this way, the inflow protection portion 120 and the outflow protection portion 122 minimally affect the flow through the prosthetic valve and avoid interfering with the prosthetic valve leaflets, thereby reducing flow disturbances and thrombotic risks.

[0094] In the illustrated configuration, the inflow protection portion 120 may extend beyond the apex 124 of the strut member at the inflow end of the frame by a distance d1, and the outflow protection portion 122 may extend beyond the apex 124 of the strut member at the outflow end of the frame by a distance d2. The distances d1 and d2 may be the same or different, depending on the type of prosthetic valve, the treatment location, etc. For example, for a 29 mm prosthetic valve, the distances d1 and d2 may be from about 0.5 mm to about 3 mm. In a representative embodiment, the distances d1 and d2 may be from about 1 mm to about 2 mm. Because the inflow protection portion 120 and the outflow protection portion 122 extend beyond the apex 124 of the respective ends of the frame, the inflow protection portion and the outflow protection portion may protect adjacent tissues adjacent to the prosthetic valve and / or another implant from contacting the apex 124 of the frame.

[0095] For example, similar to the above Figure 4A and Figure 4B , Fig.10 A prosthetic valve 100 is shown implanted within a helical anchor 70 in a native mitral valve 86. In the example shown, the inflow end portion of the prosthetic valve is positioned above the upper surface of the native mitral valve annulus and spaced apart from the surrounding tissue. However, in other embodiments, depending on the axial positioning of the prosthetic valve, the inflow protection portion 120 may contact the native leaflets 88 and prevent them from directly contacting the apex 124 at the inflow end of the frame. Depending on the diameter of the prosthetic valve at the inflow end, the inflow protection portion 120 may be used to prevent the atrial wall from directly contacting the apex 124 at the inflow end of the frame.

[0096] like Fig.10 As shown, the anchor 70 may also be placed against the compliant inflow protection portion 120. At the same time, the portion of the native leaflet 88 captured between the anchor 70 and the prosthetic valve 100 may be cushioned by the plush surface 118 of the main cushioning portion 136. In certain embodiments, the soft, compliant nature and texture of the cushioning layer 116 may increase the friction between the native leaflet and the prosthetic valve. This may reduce the relative movement of the native leaflet and the prosthetic valve as the left ventricle expands and contracts, thereby reducing the possibility of damaging the native leaflet and surrounding tissue. The cushioning layer 116 may also provide increased retention between the anchor 70 and the prosthetic valve 100. The plush, compressible nature of the cushioning layer 116 may also reduce the penetration of the covering 112 through the opening in the frame 102 by applying pressure to the covering, thereby reducing interference with the hemodynamics of the valve. Additionally, the outflow relief portions 122 may protect the chords 90 from contacting the strut members of the frame, particularly the apexes 124 at the outflow end of the frame, thereby reducing the risk of chord damage or rupture.

[0097] The backing layer 114 may include, for example, any of a variety of woven fabrics, such as gauze, polyethylene terephthalate (PET) fabrics (e.g., Dacron), polyester fabrics, polyamide fabrics, or any of a variety of non-woven fabrics, such as felt. In certain embodiments, the backing layer 114 may also include a film comprising any of a variety of crystalline or semi-crystalline polymer materials, such as polytetrafluoroethylene (PTFE), PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc. In this way, the backing layer 114 can be relatively thin and strong enough to allow the cover 112 to be sutured to the frame and allow the prosthetic valve to be crimped without tearing.

[0098] As described above, cushioning layer 116 may include at least one soft, plush surface 118. In some examples, cushioning layer 116 may be made of any of a variety of woven or knitted fabrics, where surface 116 is the surface of a plush pile or pile of the fabric. Exemplary fabrics having pile include velvet, velvet, velveteen, corduroy, terry cloth, wool, etc. Fig. 9 A representative embodiment of the buffer layer 116 is shown in more detail. Fig. 9 In an embodiment of the present invention, the buffer layer 116 may have a base layer 162 (first layer) from which a pile 158 (second layer) extends. The base layer 162 may include warp yarns and weft yarns woven or knitted into a mesh structure. For example, in a representative configuration, the yarns of the base layer 162 may be flat yarns with a denier range of about 7 dtex to about 100 dtex, and may be knitted at a density of about 20 Weirs / inch to about 100 Weirs / inch and about 30 wefts / inch to about 110 wefts / inch. The yarns may be made of, for example, biocompatible thermoplastic polymers (such as PET, nylon, ePTFE, etc.), other suitable natural or synthetic fibers, or soft monolithic materials.

[0099] The pile 158 may include a pile yarn 164 woven or knitted into loops. In some configurations, the pile yarn 164 may be a warp or weft yarn of a base layer 162 woven or knitted to form loops. Depending on the specific features required, the pile yarn 164 may also be a separate yarn incorporated into the base layer. In some embodiments, the loops may be cut so that the pile 158 is a cut pile, for example, in the form of a velvet fabric. Figure 5-8 A representative embodiment of cushioning layer 116 configured as a velvet fabric is shown. In other embodiments, the loops may remain intact, forming a terry loop in the form of, for example, terry cloth. Fig. 9 A representative embodiment of the cushioning layer 116 is shown in which pile yarns 164 are knitted to form loops 166 . Fig.11 Shows the combination Fig. 9 An embodiment of a cover 112 of a buffer layer 116 .

[0100] In some configurations, the pile yarn 164 can be a textured yarn having an increased surface area due to, for example, a wavy or undulating structure. Fig.11 In the configuration of the loop embodiment, the loop structure and increased surface area provided by the textured yarn of loop 166 can allow the loop to act as a scaffold for tissue growing into and around the loop. Encouraging tissue growth into pile 158 can increase retention of the valve at the implant site and contribute to the long-term stability of the valve.

[0101] The cushioning layer embodiments described herein may also contribute to the improved compressibility and shape memory properties of the covering 112 over known valve coverings and skirts. For example, the pile 158 may be compliant so that it compresses under load (e.g., when in contact with tissue, implants, etc.) and returns to its original size and shape when the load is relieved. This may help improve the seal between the cushioning layer 116 and, for example, a support structure or other device (such as a spiral anchor 70 in which a prosthetic valve is deployed) or between the cushioning layer and the wall of the natural ring. The compressibility provided by the pile 158 of the cushioning layer 116 also helps to reduce the curling profile of the prosthetic valve. In addition, when the prosthetic valve is curled, the covering 112 may prevent the leaflet 110 or a portion thereof from extending through the space between the pillar members 104, thereby reducing damage to the prosthetic leaflet due to the leaflet being clamped between the pillars.

[0102] In alternative embodiments, the cushioning layer 116 is made of a nonwoven fabric such as felt or fibers such as nonwoven cotton fibers. The cushioning layer 116 may also be made of a porous or sponge material such as, for example, any of a variety of compliant polymer foam materials or woven or knitted fabrics (such as woven or knitted PET). In further alternative embodiments, Fig.11 The proximal and distal end portions of the buffer layer 116 of the embodiment may not have the ring 166, and the inflow protection portion 120 and the outflow protection portion 122 may be formed by folding the base layer 162 back on itself to form a cuff at the inflow end and the outflow end of the valve.

[0103] exist Fig.12 In the representative example shown, the backing layer 114 can be manufactured by cutting a fabric material (e.g., PET fabric) with a template 138 to form the backing layer 114. Figure 5-8 The cover 112 of the present invention. In the embodiment shown, the template 138 is shaped as a parallelogram, but other configurations are possible. The angles of the corners of the template 138 can be shaped so that the fabric material is cut at an angle of about 45 degrees relative to the direction of the fibers of the fabric. This can improve the curl of the resulting backing layer 114 by, for example, allowing the backing layer to stretch in the diagonal direction of the warp and weft yarns. Fig.18 A plan view of a representative example of backing layer 114 after cutting using parallelogram stencil 138 is shown.

[0104] The cushioning layer 116 may be attached to the backing layer 114 (e.g., by sutures, adhesives, etc.). Fig.12 , the locations of the proximal and distal ends of the frame 102 when the covering is attached to the frame are indicated on the backing layer 114 as dashed lines 140, 141. Meanwhile, dashed lines 142, 144 indicate the locations of the proximal and distal edges of the cushioning layer 116 once the cushioning layer is secured to the backing layer. For example, the cushioning layer 116 may be sewn to the backing layer 114 along the proximal and distal edges at or near the lines 142, 144. Fig.12 As shown, the line 142 representing the proximal edge of the buffer layer 116 can be offset from the proximal edge 146 of the backing layer 114 by a distance d3 to form the proximal winglet 132. At the same time, the line 144 representing the distal edge of the buffer layer 116 can be offset from the distal edge 148 of the backing layer 114 by a distance d4 to form the distal winglet 134. The distances d3 and d4 can be the same or different as desired. For example, depending on the size of the valve and the size of the inflow buffer portion and the outflow buffer portion, the distances d3 and d4 can be, for example, about 3-5 mm. In some embodiments, the distances d3 and d4 can be about 3.5 mm.

[0105] Once the cushioning layer 116 is secured to the backing layer 114, the resulting sample can be folded and sewn into a cylindrical shape. The flaps 132, 134 of the backing layer 114 can be folded over the edges of the cushioning layer 116 and sewn to form the inflow protection portion 120 and the outflow protection portion 122. The resulting covering 112 can then be secured to the frame 102 by, for example, sewing it to the strut members 104.

[0106] Fig.13 and Fig.14 Another embodiment of the covering 112 is shown, in which the inflow protection portion 120 and the outflow protection portion 122 are formed by separate pieces of material that surround the ends of the cushioning layer 116 at the inflow end and the outflow end of the valve. For example, the proximal end portion 130 of the cushioning layer 116 can be covered by a member configured as a strip of material 150 that wraps around the cushioning layer from the interior surface 170 of the cushioning layer 116 (e.g., a surface adjacent to the frame), over the circumferential edge of the proximal end portion 130, and onto the exterior surface 118 of the cushioning layer to form the outflow protection portion 122. Similarly, the material strip member 152 can extend from the interior surface 170 of the cushioning layer, over the circumferential edge of the distal end portion 128 and onto the exterior surface of the cushioning layer to form the inflow protection portion 120. The strip members 150, 152 can be sutured to the cushioning layer 116 along the proximal edge portion 130 and the distal edge portion 128 of the cushioning layer at suture lines 154, 156, respectively.

[0107] In certain configurations, the strap members 150, 152 can be made from any of a variety of natural materials and / or tissues, such as pericardial tissue (e.g., bovine pericardial tissue). The strap members 150, 152 can also be made from any of a variety of synthetic materials, such as PET and / or expanded polytetrafluoroethylene (ePTFE). In some configurations, making the strap members 150, 152 from natural tissue, such as pericardial tissue, can provide desirable properties, such as strength, durability, fatigue resistance, and compliance, as well as cushioning and reduced friction with materials or tissue surrounding the implant.

[0108] Fig.15 A prosthetic valve 200 is shown that includes another embodiment of an outer covering 202 having a cushioning layer 204 made of a spacer fabric. In the illustrated embodiment, the outer covering 202 is shown without an inflow protection portion and an outflow protection portion, but with a cushioning layer 204 that extends along the entire length of the frame from the inflow end of the valve to the outflow end of the valve. However, the outer covering 202 may also include an inflow protection portion and / or an outflow protection portion as described elsewhere herein.

[0109] refer to Fig.16 and Fig.17 , the spacer fabric cushioning layer may include a first layer 206, a second layer 208, and a spacer layer 210 extending between the first layer and the second layer to form a three-dimensional fabric. The first layer 206 and the second layer 208 may be a woven fabric or a mesh layer. In certain configurations, one or more of the first layer 206 and the second layer 208 may be woven so that they define a plurality of openings 212. In some examples, openings such as openings 212 may promote tissue growth into the covering 202. In other embodiments, the layers 206, 208 need not define openings, but may be porous as desired.

[0110] The spacer layer 210 may include a plurality of pile yarns 214. The pile yarns 214 may be, for example, monofilament yarns arranged to form a scaffolding-like structure between the first layer 206 and the second layer 208. For example, Fig.16 and Fig.17 An embodiment is shown in which the pile yarns 214 extend between the first layer 206 and the second layer 208 in a sinusoidal or cyclical manner.

[0111] In some examples, the pile yarns 214 may have a stiffness greater than the stiffness of the fabric of the first layer 206 and the second layer 208, such that the pile yarns 214 may extend between the first layer 206 and the second layer 208 without collapsing under the weight of the second layer 208. The pile yarns 214 may also have sufficient elasticity such that the pile yarns may flex or give when subjected to a load, thereby allowing the fabric to compress, and return to their undeflected state when the load is removed.

[0112] As required, the spacer fabric can be warp knitted or weft knitted. Some configurations of the spacer fabric can be manufactured on a double-sided bar knitting machine. In a representative example, the yarn of the first layer 206 and the second layer 208 can have a denier range of about 10dtex to about 70dtex, and the yarn of the monofilament pile yarn 214 can have a denier range of about 2 mils to about 10 mils. The pile yarn 214 can have a knitting density of about 20 Will / inch to about 100 Will / inch and about 30 wefts / inch to about 110 wefts / inch. In addition, in some configurations (e.g., warp knitted spacer fabrics), materials with different flexibility properties can be incorporated into the spacer fabric to improve the overall flexibility of the spacer fabric.

[0113] Figure 19-21 Another embodiment of a prosthetic heart valve 400 is shown, which includes an outer cover having an inflow protection portion and an outflow protection portion that encapsulates the apex of the strut member. For example, the prosthetic valve may include a apex 420 ( Fig. 22 and Fig.24 ) and may have an inflow end 406 and an outflow end 408. A plurality of leaflets 410 may be at least partially located within the frame 402.

[0114] The prosthetic valve may include an outer covering 412 positioned around the frame 402. The outer covering 412 may include a primary cushioning layer 414 that is disposed adjacent to the outer covering 412. Fig.13 The cushioning layer 116 of the valve similarly includes a plush outer surface 432 (e.g., a first surface). The covering 412 may also include an inflow protection portion 416 extending circumferentially around the inflow end 406 of the valve, and an outflow protection portion 418 extending circumferentially around the outflow end 408 of the valve. The inflow protection portion 416 and the outflow protection portion 418 may be formed with separate pieces of material that are folded around the circumferential ends of the cushioning layer 414 at the inflow end and the outflow end of the valve so that the protection portion encapsulates the apex 420 of the strut member.

[0115] For example, refer to Fig. 22, the inflow protection portion 416 may include a member configured as a strip 424 of material including a first circumferential edge portion 426 and a second circumferential edge portion 428. The strip member 424 of material may be folded such that the first circumferential edge portion 426 is adjacent to (e.g., in contact with) an inner skirt 430 disposed within the frame 402. The first circumferential edge portion 426 thereby forms a first or inner layer of the inflow protection portion 416. The strip member 424 may extend above the apex 420 of the strut member and over the inflow end portion 422 of the buffer layer 414 such that the second circumferential edge portion 428 is disposed on an outer surface 432 of the buffer layer 414. In this manner, the inflow end portion 422 of the buffer layer 414 may form a second layer of the inflow protection portion 414, and the second circumferential edge portion 428 may form a third or outer layer of the inflow protection portion. The first circumferential edge portion 426 and the second circumferential edge portion 428 of the strip member 424 may be secured to the strut member 404 (e.g., the crosspiece of the strut closest to the inflow end 406) with sutures 434, 435. Thus, the strip member 424 may encapsulate the apex 420 with the inflow end portion 422 of the cushioning layer 414 between the first circumferential edge portion 426 and the second circumferential edge portion 428.

[0116] In the illustrated configuration, similar to the above-described embodiments, the inflow protection portion 416 can extend beyond the apex 420 of the frame. Specifically, the inflow end portion 422 of the cushioning layer 414 can extend beyond the apex 420 of the frame and into the inflow protection portion 416 within the folded strip 424. In this manner, the inflow end portion 422 of the cushioning layer 414 together with the strip member 424 can impart a resilient cushioning quality to the inflow protection portion 416. This can also allow the inflow protection portion 416 to elastically deform to adapt to and protect, for example, natural tissue, other implants, etc. that are in contact with the inflow protection portion.

[0117] In the illustrated embodiment, the inflow end portion 422 can extend beyond the apex 420 by a distance d1. The distance d1 can be configured such that when the inflow protection portion 416 contacts the natural tissue at, for example, the treatment site, the inflow end portion 422 can extend above the apex 420, or cover the apex 420. The strip member 424 can also form a dome over the edge of the inflow end portion 422, such that the edge of the inflow end portion 422 is spaced apart from the dome portion of the strip member 424. In other embodiments, similar to Fig.13 In an embodiment, the strip member 424 may be folded such that it contacts the edge of the inflow edge portion 422 .

[0118] The outflow protection portion 418 may include a member configured as a strip 436 of material that is folded such that a first circumferential edge portion 438 is adjacent (e.g., in contact) to the inner surface 440 of the strut member, and similar to the inflow protection portion 416, a second circumferential edge portion 442 is disposed on the outer surface 432 of the cushioning layer 414. The outflow end portion 444 of the cushioning layer 414 may extend beyond the vertex 420 by a distance d2, and may be enclosed between the first circumferential edge portion 438 and the second circumferential edge portion 442 by the strip member 436 along with the vertex 420. Distance d2 may be the same as or different from distance d1 as desired. The strip member 436 may be secured to the strut member 404 with sutures 446, 447. The strip member 436 may also be formed into a dome shape similar to the strip member 424.

[0119] In some configurations, as described above, the cushioning layer 414 can be a fabric including a plush pile, such as a velvet fabric or any other type of plush knitted, woven or nonwoven material. In some embodiments, the cushioning layer 414 can also include a relatively low thickness woven fabric without a plush pile. In some configurations, the strip members 424, 436 can be made of an elastic natural tissue material such as pericardium. Alternatively, the strip members can also be made of a fabric or a polymer material (such as PTFE or ePTFE).

[0120] Figure 23-26 A representative method of manufacturing outer covering 412 and attaching the covering to prosthetic valve 400 to form inflow protection portion 416 and outflow protection portion 418 is shown. Fig.23 The outer cover 412 is shown in an expanded configuration prior to securing the cover to the frame 402. Fig.23 As shown, the second circumferential edge portion 428 of the strip member 424 can be sewn to the plush surface 432 (e.g., the first surface) of the cushioning layer 414 at the inflow end portion 422 of the cushioning layer. The second circumferential edge portion 442 of the strip member 436 can be sewn to the plush surface 432 of the cushioning layer 414 at the outflow end portion 444 of the cushioning layer.

[0121] In the illustrated configuration, the cushioning layer 414 and the strap members 424, 436 can have a length dimension L corresponding to the circumference of the frame 402. In a representative example, the length dimension L can be approximately 93 mm. The strap members 424, 436 can also have corresponding width dimensions W1, W2. For purposes of illustration, with reference to the width dimension W1, the width dimension W1 can be configured such that the strap member 424 extends from the interior of the valve to the exterior of the valve without contacting the apex 420 of the strut member, as shown. Fig. 22For example, the width dimension W1 can be configured such that the strip member 424 extends from near the crosspiece of the strut member 404 at the inflow end 406 of the frame to the outside of the valve adjacent to the same crosspiece of the strut member and forms a dome shape above the apex 420. In some configurations, the width dimension W1 can be about 6 mm. The width dimension W2 can be the same or different from W1 as desired.

[0122] refer to Fig.24 , the outer covering 412 can be folded and sewn into a cylindrical shape. The outer covering 412 can then be positioned around the frame 402 so that the second surface or inner surface 454 of the cushioning layer 414 is oriented toward the frame. In some configurations, the frame 402 may already include the inner skirt 430 and the leaflet structure 410, such as Fig.24 shown.

[0123] refer to Fig.25 and Fig.26 , the outer covering 412 may then be sewn to the frame. Fig.25 4. As shown, the strip member 424 can be aligned with an adjacent crosspiece of the strut member 404 (e.g., the crosspiece of the strut member closest to the inflow end of the frame). The cushioning layer 414 and / or the strip member 424 can then be sewn to the strut member 404 at the stitching line 434. The strip member 424 can then be folded over the apex 420 at the inflow end of the frame, and the first circumferential edge portion 426 and the second circumferential edge portion 428 can be sewn to each other at the stitching line 435 to form the inflow protection portion 416. In other embodiments, the strip member 424 can be folded and sewn to form the inflow protection portion 416 before sewing the outer covering 412 to the frame.

[0124] The outflow protection portion 418 can be formed in a similar manner. For example, the strip member 426 can be aligned with the crosspiece of the strut member 404 near the outflow end 408 of the frame, and the strip member 426 and / or the cushioning layer 414 can be sewn to the strut member. The strip member 436 can then be folded over the apex 420 and the cushioning layer 414 at the outflow end of the frame, and the first circumferential edge portion 438 and the second circumferential edge portion 442 can be sewn together and to the crosspiece of the strut member 404 adjacent the outflow end of the frame to form the outflow protection portion 418. Fig. 22 As shown, the cover 412 may also be stitched to the frame at one or more additional locations, such as at stitches 448 and 450 .

[0125] Fig. 27 and Fig.28 Another embodiment of a prosthetic heart valve 500 is shown, which includes a frame 502 formed by a plurality of strut members 504 defining an apex 506 ( Fig.28), similar to frame 102 described above and in US Pat. No. 9,393,110. Prosthetic valve 500 can have an inflow end 508 and an outflow end 510, and can include a leaflet structure (not shown) at least partially positioned within the frame.

[0126] The prosthetic valve may include an outer covering 514 positioned around the frame 502. The outer covering 514 may include a main cushioning layer 516 (also referred to as a main layer) having a cylindrical shape and made of a woven, knitted or braided fabric (e.g., a PET fabric, an ultra-high molecular weight polyethylene (UHMWPE) fabric, a PTFE fabric, etc.). In some embodiments, the fabric of the main cushioning layer 516 may include a plush pile. In some embodiments, the fabric of the main cushioning layer 516 may include a textured yarn, wherein the constituent fibers of the yarn have been expanded by, for example, twisting, heat setting, and untwisting, so that the fibers maintain their deformed twisted shape and form a bulky fabric. The volume caused by the textured yarn can improve the cushioning properties of the covering and increase the friction between the fabric and the surrounding anatomical structure and / or the anchoring device in which the valve is deployed.

[0127] The outer cover 514 may include an inflow protection portion 518 extending circumferentially around the inflow end 508 of the frame, and an outflow protection portion 520 extending circumferentially around the outflow end 510 of the frame. In certain embodiments, the inflow protection portion 518 and the outflow protection portion 520 may be formed on the fabric of the main cushioning layer 516 so that the outer cover 514 is a unitary, unitary construction, as further described below.

[0128] refer to Fig.28 , the main buffer layer 516 may include a first circumferential edge portion 522 (also referred to as an inflow edge portion) positioned adjacent to the inflow end 508 of the valve, which may form a portion of the inflow protection portion 518. The buffer layer 516 may also include a second circumferential edge portion 524 (also referred to as an outflow edge portion) positioned adjacent to the outflow end 510 of the valve, and which may form a portion of the outflow protection portion 520. Still referring to Fig.28 , the first circumferential edge portion 522 may include an edge 526, and the second circumferential edge portion 524 may include an edge 528. The first circumferential edge portion 522 may be folded or wrapped over the apex 506 of the strut member 504 such that the edge 526 is disposed on the inside of the frame 502. The second circumferential edge portion 524 may be folded around the apex 506 at the outflow end 510 of the frame in a similar manner such that the edge 528 is also disposed on the inside of the frame opposite the edge 522.

[0129] In the illustrated configuration, the inflow protection portion 518 may include a second layer or outer layer configured as a lubricity layer 530 of material disposed on the outer surface 532 of the primary buffer layer 516. The outflow protection portion 520 may also include a second layer or outer lubricity layer 534 of material disposed on the outer surface 532 of the primary buffer layer 516. In some embodiments, the layers 530 and 534 may be a smooth, low-thickness coating comprising a low-friction or lubricating material. For example, in certain configurations, one or both of the layers 530, 534 may comprise PTFE or ePTFE.

[0130] In the illustrated configuration, the lubricating layer 530 may have a first circumferential edge 536 ( Fig. 27 ) and the second circumferential edge 538 ( Fig.28 ). Lubricating layer 530 may extend from outer surface 532 of primary buffer layer 516 and over apex 506 such that first circumferential edge 536 is disposed on the outside of the frame and second circumferential edge 538 is disposed on the inside of the frame. Lubricating layer 534 may be similarly configured such that first circumferential edge 540 ( Fig. 27 ) is disposed outside the frame, layer 534 extends above the apex 506 of the outflow end 510 of the frame, and a second circumferential edge 542 ( Fig.28 ) is disposed on the inside of the frame. Once the natural heart valve is implanted, the protection portions 518 and 520 can prevent direct contact between the apex 506 and the surrounding anatomical structures, and the lubricating material of layers 530 and 534 can also reduce friction of tissue (e.g., chordae) of the natural valve in contact with the inflow and outflow ends of the prosthetic valve, thereby preventing damage to the tissue. In other embodiments, the entire outer surface 532 of the main buffer layer 516 or a portion thereof (except for the inflow protection portion 518 and the outflow protection portion 520) can be covered with a lubricating coating such as ePTFE, so that the lubricating coating extends axially from the inflow end of the coating to the outflow end of the coating. In yet other embodiments, the main buffer layer 516 can be formed of woven, knitted, braided or electrospun fibers of a lubricating material (such as PTFE, ePTFE, etc.), and can form an inflow protection portion and an outflow protection portion.

[0131] Figure 29-31B A representative method of making cover 514 is shown. Fig.29 The primary buffer layer 516 is shown formed as a cylindrical tubular body. Fig.30 , the first circumferential edge portion 522 of the buffer layer 516 can then be folded in the direction of arrow 544 (e.g., inwardly toward the interior surface of the tubular body) so that the lower edge 526 is inside the tubular body and is disposed against the interior surface of the tubular body. The edge portion 524 can be folded in a manner similar to that shown by arrow 546 so that the top edge 528 is inside the tubular body and is disposed against the interior surface.

[0132] refer to Fig.31A and Fig.31B , lubrication layers 530, 534 can then be applied to the main layer 516 to form the inflow protection portion 518 and the outflow protection portion 520. In certain embodiments, the lubrication layers 530, 534 can be formed by electrospinning a low friction material (e.g., PTFE, ePTFE, etc.) onto the first circumferential edge portion 522 and the second circumferential edge portion 524. In certain embodiments, forming the layers 530 and 534 by electrospinning can provide a smooth, uniform surface and keep the thickness of the layers within strictly specified specifications.

[0133] For example, layers 530 and 534 can be made relatively thin, which can reduce the overall curling profile of the valve. In certain embodiments, the thickness of layers 530 and 534 can be from about 10 μm to about 500 μm, from about 100 μm to about 500 μm, from about 200 μm to about 300 μm, about 200 μm or about 300 μm. In other embodiments, layers 530 and / or 534 can be manufactured by dipping, spraying or any other suitable method for applying a thin layer of lubricating material to the main buffer layer 516. The finished outer covering 514 can then be positioned around the frame 502 and secured to the frame 502 using, for example, sutures, ultrasonic welding or any other suitable attachment method. In other embodiments, the main buffer layer 516 can be positioned around the frame 502 before the edges are folded and / or before the lubricating layers 530 and 534 are applied. In still other embodiments, one or both of the lubricating layers 530 and / or 534 can be omitted from the first circumferential edge portion 522 and the second circumferential edge portion 524. In still other embodiments, one or both of the first circumferential edge portion 522 and the second circumferential edge portion 524 need not be folded into the inside of the frame, but can extend to the corresponding inflow end or outflow end of the frame as needed, or beyond the end of the frame frame on the outside of the frame.

[0134] In addition to covering the frame 502 and the apex 506, the outer covering 514 can also provide many other significant advantages. For example, the covering 514 can be relatively thin, thereby allowing the prosthetic valve to achieve a low crimp profile (e.g., 23 Fr or less). The integral, unitary configuration of the outer covering 514 and the protective portions 518 and 520 can also significantly reduce the time required to produce the covering and secure it to the frame, and can improve production yields.

[0135] In some embodiments, one or both of the inflow protection portion and the outflow protection portion may be configured as a separate cover that is spaced apart from the main outer cover and may or may not be coupled to the main outer cover. Figure 32-36Another embodiment of a prosthetic heart valve 600 is shown that includes a frame 602 formed of a plurality of strut members 604 defining an apex 606, similar to the frame 102 described above and in U.S. Patent No. 9,393, 110. The prosthetic valve 600 may have an inflow end 608 and an outflow end 610, and may include a plurality of leaflets 612 at least partially within the frame.

[0136] For illustration purposes, Fig.34 602 in a flat configuration. The strut members 604 can be arranged end-to-end to form a plurality of rows or rungs of strut members extending circumferentially around the frame 602. For example, referring to Fig.34 , the frame 602 can include a first or lower row I of angled strut members forming an inflow end 608 of the frame; a second row II of strut members above the first row; a third row III of strut members above the second row; a fourth row IV of strut members above the third row; and a fifth row V of strut members above the fourth row and forming an outflow end 610 of the frame. At the outflow end 610 of the frame, the strut members 604 of the fifth row V can be arranged at alternating angles in a zigzag pattern. The strut members 604 of the fifth row V can be joined together at their distal ends (relative to the implantation direction in the mitral valve) to form an apex 606, and at their proximal ends at a joint 630, which can form a portion of a commissure window 638. Additional structures and features of rows I through V of strut members 604 are described in more detail in U.S. Patent No. 9,393,110.

[0137] Back to Fig.32 and Fig.33 , the prosthetic valve may include a first cover 614 (also referred to as a primary cover) positioned around the frame 602. The valve may also include an outflow protection portion configured as a second cover 616 disposed around the strut members 604 and the apex 606 of the fifth row V of the strut members at the outflow end 610 of the frame. Fig.33, the first cover 614 may include a woven or knitted fabric made of, for example, PET, UHMWPE, PTFE, etc. The first cover 614 may include an inflow end portion 618 located at the inflow end 608 of the valve and an outflow end portion 620 located at the outflow end 610 of the valve. In the illustrated embodiment, the outflow end portion 620 of the first cover 614 may be offset from the fifth row V of the strut members 604 toward the inflow end of the frame (e.g., in an upstream direction). In other words, the strut members 604 of the fifth row V may extend beyond the uppermost circumferential edge 622 of the first cover 614 (e.g., distally beyond the edge 622 when the prosthetic valve is implanted in the mitral valve). The lowest circumferential edge 624 of the main cover 614 may be disposed adjacent to the first row I of the strut members 604 at the inflow end 608 of the valve. In some embodiments, the first cover 614 may extend over and cover the vertex 606 at the inflow end 608 of the frame.

[0138] Fig.35 The frame 602 including the second cover 616 and the inner skirt 640 is shown without the first cover 614 for illustrative purposes. In some embodiments, the second cover 616 can be configured as a wrap extending around the circumference of the frame 602 and around the fifth row V of the strut members 604. For example, referring to Fig.36 , the covering 616 can be configured as one or more bands or strips 626 of material that are spirally wrapped around the struts 604 and the apex 606 of the fifth row of strut members at the outflow end 610 of the frame in a direction indicated by, for example, arrow 632. In some configurations, the second covering 616 can be made of a lubricating or low-friction polymer material such as PTFE, ePTFE, UHMWPE, polyurethane, etc. In this way, the second covering 616 can reduce friction between the second covering and the native tissue in contact with the outflow end 610 of the valve. The covering 616 can also prevent damage to the native tissue by preventing it from directly contacting the apex 606.

[0139] In some embodiments, the strip 626 may be relatively thick to improve the cushioning properties of the second covering 616. For example, in some embodiments, the strip 626 may be a PTFE strip having a thickness of about 0.1 mm to about 0.5 mm and a width of about 3 mm to about 10 mm. In a representative embodiment, the strip 626 may have a thickness of about 0.25 mm and a width of about 6 mm. The second covering 616 may also include one or more layers. For example, the second covering 616 may include a single layer (e.g., a single strip 626) wrapped around a row of struts of the frame. The second covering may also include two layers, three layers, or more layers of strips wrapped around a row of struts of the frame. In some embodiments, the second covering 616 may include multiple layers made of different materials. In certain configurations, the second covering 616 may also be porous and may have a pore size and pore density configured to promote tissue ingrowth into the material of the second covering.

[0140] In some embodiments, the first cover 614 and / or the second cover 616 can be secured to the frame by, for example, sewing. In some embodiments, the first cover 614 and the second cover 616 can also be secured to each other. Fig.32 and Fig.33 , the first covering 614 may include one or more sutures 628 extending circumferentially around the outflow end portion 620 of the first covering, for example in a running stitch. At or near the junction 630 of the fifth row V of the strut members 604 ( Fig.34 ), the suture 628 may extend out of the stitch line (e.g., from the radially outward surface of the covering 614) and loop / loop over the second covering 616. The suture 628 may then re-enter the covering 614 (e.g., on the radially inward surface of the covering 614) and restart the flat stitch. In the illustrated embodiment, the suture 628 may loop over the second covering 616 at the junction 630. The loop of suture 628 is thus placed in the "valley" between the apexes 606 and can be used to hold the second covering 616 in place on the strut members 602. The suture 628 may also hold the first covering 614 in place when the valve is crimped.

[0141] Still reference Fig.32 and Fig.33, the circumferential edge 622 of the first cover 614 can be relatively straight, while the second cover 616 can conform to the angled or zigzag pattern of the fifth row V of the strut members 604. In this manner, the first cover 614 and the second cover 616 can define a plurality of gaps or openings 634 through the frame 602 between the first cover and the second cover. In the illustrated embodiment, the openings 634 have a triangular shape, wherein the base of the triangle is defined by the edge 622 of the first cover 614 and the sides are defined by the second cover 616. The openings 634 can be configured such that after the valve 600 is implanted, blood can flow into and / or out of the frame 602 through the openings. In this manner, during operation of the prosthetic valve, the space between the interior of the frame 602 and the ventricular surface 638 of the leaflet 612 can be flushed or washed by blood flowing into and out of the openings 634. This can reduce the risk of thrombosis and left ventricular outflow tract obstruction.

[0142] Fig.37 The frame 602 including the second cover 616 is shown in a radially collapsed or curled delivery configuration on the shaft 636 of the delivery device. Fig.37 As shown, the second cover 616 can conform to the tightly packed serpentine shape of the strut member 604 when the strut member 604 moves to the radially collapsed configuration. In some configurations, the second cover 616 can closely mimic the shape and orientation of the strut member 604 without bulging, pleating, creasing or bunching to maintain a low curl profile. In other embodiments, the inflow end of the frame can also include a separate cover similar to the cover 616.

[0143] Fig.38A , Fig.38B , Fig.39A and Fig.39B A device including an outer cover 700 according to another embodiment is shown. Figure 19-26 The outer covering 700 may include a main cushioning layer 702 having a plush outer surface 704. The covering 700 may also include an inflow protection portion 706 extending circumferentially around the inflow end 406 of the valve, and an outflow protection portion 708 extending circumferentially around the outflow end 408 of the valve. Figure 19-26As in the embodiment of the present invention, the inflow protection portion 706 and the outflow protection portion 708 can be formed with separate sheets of material that are folded around the circumferential ends of the main layer 702 so that the cushioning portions encapsulate the apex 420 of the strut members at the inflow and outflow ends of the valve. For example, the inflow protection portion 706 and the outflow protection portion 708 can be formed from a strip of folded material (e.g., a polymer material such as PTFE, ePTFE, etc., or a natural tissue such as pericardium, etc.) so that one circumferential edge of the strip is placed against the interior of the frame 402 (or the inner skirt within the frame) and the other circumferential edge is placed against the outer surface of the main layer 702. The outer covering 700 can be secured to the frame 402 using, for example, sutures, ultrasonic welding, or any other suitable attachment method.

[0144] The main layer 702 of the outer cover 700 may include a woven or knitted fabric. The fabric of the main layer 702 may be in a first, natural or relaxed configuration ( Fig.38A and Fig.38B ) and second, slender or tensioned configuration ( Fig.39A and Fig.39B ) are elastically stretched between the two ends. When disposed on the frame 402, the relaxed configuration may correspond to the radially expanded functional configuration of the prosthetic valve, and the elongated configuration may correspond to the radially collapsed delivery configuration of the valve. Fig.38A , the outer covering 700 can have a first length L1 when the prosthetic valve is in the expanded configuration, and can have a second length L2 (longer than L1) when the valve is crimped to the delivery configuration. Fig.39A ), as described in more detail below.

[0145] The fabric can include a plurality of circumferentially extending warp yarns 712 and a plurality of axially extending weft yarns 714. In some embodiments, the warp yarns 712 can have a denier of from about 1D to about 300D, from about 10D to about 200D, or from about 10D to about 100D. In some embodiments, the warp yarns 712 can have a thickness t1 (mm) of from about 0.01 mm to about 0.5 mm, from about 0.02 mm to about 0.3 mm, or from about 0.03 mm to about 0.1 mm. Fig.40A In some embodiments, the warp yarns 712 can have a thickness t1 of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.09 mm, or about 0.1 mm. In an exemplary embodiment, the warp yarns 712 can have a thickness of about 0.06 mm.

[0146] Weft yarn 714 can be a deformed yarn including a plurality of deformed filaments 716. For example, the filament 716 of weft yarn 714 can be bulky, wherein for example filament 716 is twisted, heat-set and untwisted, so that the filament keeps its deformed twisted shape in a relaxed non-stretched configuration. The filament 716 can also be materialized by curling, winding, etc. When weft yarn 714 is in a relaxed non-tensioned state, the filament 716 can be loosely filled and can provide compressible volume or volume to fabric and plush surface. In some embodiments, weft yarn 714 can have a denier from about 1D to about 500D, a denier from about 10D to about 400D, a denier from about 20D to about 350D, a denier from about 20D to about 300D, or a denier from about 40D to about 200D. In certain embodiments, weft yarn 714 can have a denier of about 150D. In some embodiments, the filament count of the weft yarn 714 can range from 2 filaments per weft yarn to 200 filaments per weft yarn, from 10 filaments per weft yarn to 100 filaments per weft yarn, from 20 filaments per weft yarn to 80 filaments per weft yarn, or from 30 filaments per weft yarn to 60 filaments per weft yarn. In addition, although the axially extending textured yarn 714 can be referred to as a weft yarn in the illustrated configuration, the fabric can also be manufactured such that the axially extending textured yarn 714 is a warp yarn and the circumferentially extending yarn is a weft yarn.

[0147] Fig.40A and Fig.40B The diagram illustrates a cross-sectional view of a primary layer 702 with a weft yarn 712 extending into the plane of the page. Fig.40A , when in a relaxed state, the fabric of the main layer 702 may have a thickness t2 of about 0.1 mm to about 10 mm, about 1 mm to about 8 mm, about 1 mm to about 5 mm, about 1 mm to about 3 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or about 3 mm and is secured to the frame. In some embodiments, the main layer 702 has a thickness of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, or about 0.5 mm measured in a relaxed state using a weighted drop gauge with a pressure foot. In a representative example, the main layer 702 may have a thickness of about 1.5 mm when secured to the prosthetic valve frame in a relaxed state. This may allow the fabric of the main layer 702 to cushion the valve body and the leaflets between the anchors or rings of the implanted valve and occupy gaps or spaces in the anatomical structure. The deformed loose-fill filaments 716 of the weft yarns 714 in a relaxed state may also promote tissue growth into the main layer 702 .

[0148] When the fabric is in a relaxed state, the deformed filaments 716 of the weft yarns 714 can be widely dispersed, making it difficult to distinguish the individual weft yarns, such as Fig.38A and Fig.38B When tensioned, the filaments 716 of the weft yarns 714 can be pulled together as the weft yarns stretch, and kinks, twists, etc. of the filaments are straightened, so that the fabric is stretched and the thickness is reduced. In some embodiments, when sufficient tension is applied to the fabric in the axial (e.g., weft) direction, such as when a prosthetic valve is crimped onto a delivery shaft, the deformed fibers 716 can be pulled together so that the individual weft yarns 714 become discernible, as shown. Fig.39B and Fig.40B Best shown in .

[0149] Thus, for example, when fully stretched, the primary layer 702 may have a Fig.40B A second thickness t3 is shown that is less than thickness t2. In some embodiments, the thickness of the tensioned weft yarns 714 can be the same or nearly the same as the thickness t1 of the warp yarns 712. Therefore, in some embodiments, when stretched, the fabric can have a thickness t3 that is the same or nearly the same as three times the thickness t1 of the warp yarns 712, which depends, for example, on the amount of flattening of the weft yarns 714. Therefore, in the above example, the warp yarns 712 have a thickness of about 0.06 mm, and the thickness of the main layer 702 can vary between about 0.2 mm and about 1.5 mm as the fabric stretches and relaxes. In other words, the thickness of the fabric can vary by 750% or more as the fabric stretches and relaxes.

[0150] Additionally, if Fig.40A As shown, when the outer cover is in a relaxed state, the warp yarns 712 may be spaced apart from each other by a distance y1 in the fabric. Fig.39B and Fig.40B As shown, when tension is applied to the fabric in a direction perpendicular to the warp yarns 712 and parallel to the weft yarns 714, the distance between the warp yarns 712 can increase as the weft yarns 714 are lengthened. Fig.40B In the example shown, where the fabric has been stretched such that weft yarns 714 have lengthened and narrowed to approximately the diameter of warp yarns 712, the distance between warp yarns 712 may increase to a new distance y2 that is greater than distance y1.

[0151] In some embodiments, the distance y1 can be, for example, about 1 mm to about 10 mm, about 2 mm to about 8 mm, or about 3 mm to about 5 mm. In a representative example, the distance y1 can be about 3 mm. In some embodiments, when the fabric is as Fig.39B and Fig.40BWhen stretched as shown, the distance y2 can be about 6 mm to about 10 mm. Thus, in certain embodiments, the length of the outer covering 700 can vary by 100% or more between the relaxed length L1 and the fully stretched length (e.g., L2). The ability of the fabric to be lengthened in this manner can allow the prosthetic valve to be curled to a diameter of, for example, 23 Fr without being limited by the stretchability of the outer covering. Thus, the outer covering 700 is soft and voluminous when the prosthetic valve is expanded to its functional size, and is relatively thin when the prosthetic valve is curled to minimize the overall curling profile of the prosthetic valve.

[0152] Fig.41A , Fig.41B , Fig.42A and Fig.42B An outer sealing member or covering 800 of a prosthetic heart valve (eg, such as prosthetic heart valve 400) according to another embodiment is shown. Sealing member 800 can be a double layer fabric including a base layer 802 and a fleece layer 804. Fig.41A The outer surface of the sealing member 800 is shown defined by the pile layer 804. Fig.42A The inner surface of the sealing member 800 is shown as being defined by a base layer 802. The base layer 802 in the illustrated configuration comprises a mesh weave having circumferentially extending rows or stripes 806 of higher density mesh portions interspersed with rows or stripes 808 of lower density mesh portions.

[0153] In certain embodiments, in the circumferential direction (edge ​​to edge or in Fig.42A and Fig.42B The yarn count of the yarns extending in the circumferential direction (horizontally in the middle) is greater in the higher density row 806 than in the lower density row 808. In other embodiments, the yarn count of the yarns extending in the circumferential direction and the yarn count of the yarns extending in the axial direction (in the middle) are greater in the higher density row 806 than in the lower density row 808. Fig.42A and Fig.42B The yarn count of the yarn extending vertically in the row 806 is greater than that in the row 808 of lower density.

[0154] The pile layer 804 can be formed from yarns woven into the base layer 802. For example, the pile layer 804 can include a velvet knit formed from yarns incorporated into the base layer 802. Fig.41B, the pile layer 804 can include circumferentially extending rows or stripes 810 of pile formed at axially spaced locations along the height of the sealing member 800, such that there are axially extending gaps between adjacent rows 810. In this way, the density of the pile layer varies along the height of the sealing member. In an alternative embodiment, the pile layer 804 can be formed without gaps between adjacent rows of pile, but the pile layer can include circumferentially extending rows or stripes of higher density pile interspersed with rows or stripes of lower density pile.

[0155] In an alternative embodiment, the base layer 802 can include a uniform mesh weave (the density of the weave pattern is uniform) and the pile layer 804 has a varying density.

[0156] In alternative embodiments, the density of the sealing member 800 can vary along the circumference of the sealing member. For example, the pile layer 804 can include multiple axially extending circumferentially spaced rows of pile yarns, or alternatively, alternating axially extending rows of higher density pile interspersed with axially extending rows of lower density pile. Similarly, the base layer 802 can include multiple axially extending rows of higher density mesh interspersed with rows of lower density mesh.

[0157] In other embodiments, the sealing member 800 can include a base layer 802 and / or a pile layer 804 having a density that varies along the circumference of the sealing member and along the height of the sealing member.

[0158] An advantage of varying the density of pile layer 804 and / or base layer 802 along the height and / or circumference of sealing member 800 is that it reduces the bulk of the sealing member in the radially collapsed state and, therefore, reduces the overall crimp profile of the prosthetic heart valve.

[0159] In some embodiments, the outer cover 800 can include an inflow protection portion and an outflow protection portion similar to the protection portions 416 and 418 above. However, in other embodiments, the outer cover 800 need not include a protection portion, but can extend between the top and bottom rows of the frame's leg members, or between the middle rows of leg members, depending on the specific application.

[0160] Although the prosthetic valve covering embodiments described herein are presented in the context of mitral valve repair, it should be understood that the disclosed coverings may be used in conjunction with any of a variety of prosthetic heart valves for implantation at any valve in the heart. For example, the prosthetic valve coverings described herein may be used in conjunction with transcatheter heart valves, surgical heart valves, minimally invasive heart valves, and the like. Covering embodiments may be used in valves intended for implantation at any native annulus of the heart (e.g., aortic, pulmonary, mitral, and tricuspid annuli), and include valves intended for implantation within existing prosthetic valves (so-called "valve-in-valve" procedures). Covering embodiments may also be used in conjunction with other types of devices implantable in other body cavities outside the heart, or heart valves implantable in the heart at various locations other than native valves (such as transatrial or transventricular septal valves).

[0161] General Notes

[0162] For the purpose of illustration, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be construed as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments (alone and in various combinations and sub-combinations with each other). The methods, devices and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or solutions to problems.

[0163] Although for ease of presentation, the operations of some of the disclosed embodiments are described in a particular sequential order, it should be understood that unless the specific language set forth below requires a specific ordering, this manner of description includes rearrangement. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are high-level summaries of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and can be easily recognized by those of ordinary skill in the art.

[0164] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "including" means "comprising". Furthermore, the terms "coupled" and "associated" generally mean electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) coupling or connection, and do not exclude the presence of intervening elements between coupled or associated items absent specific language to the contrary.

[0165] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of the valve is its outflow end.

[0166] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closer to a user and further from an implantation site. As used herein, the term "distal" refers to a position, direction or portion of a device that is further from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of the device toward the user, while the distal motion of the device is the motion of the device away from the user. Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions.

[0167] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. On the contrary, the scope of the disclosure is at least as broad as the appended claims.

Claims

1. A prosthetic heart valve, comprising: a frame including a plurality of strut members and having an inflow end and an outflow end; a leaflet structure located at least partially within the frame; as well as a covering disposed around the exterior of the frame, the covering comprising: Buffer layer; a first strip member folded over an inflow circumferential edge portion of the buffer layer to form a first protective portion; and a second strip member folded over an outflow circumferential edge portion of the buffer layer to form a second protective portion; Wherein the first strap member and the second strap member are spaced apart from one another along a longitudinal axis of the prosthetic heart valve.

2. A prosthetic heart valve according to claim 1, wherein the cushioning layer forms an outer surface of the covering.

3. The prosthetic heart valve of claim 1 , wherein: The buffer layer includes a first material; and The first strip member includes a second material different from the first material.

4. The prosthetic heart valve of claim 3, wherein the first material is a woven fabric and the second material is a polymer material or a tissue material.

5. The prosthetic heart valve of claim 4, wherein the woven fabric of the cushioning layer comprises textured yarns that provide compressible volume to the woven fabric.

6. The prosthetic heart valve of claim 5, wherein the woven fabric of the cushioning layer is stretchable between a first configuration corresponding to a radially expanded configuration of the prosthetic heart valve and a second configuration corresponding to a radially collapsed configuration of the prosthetic heart valve.

7. The prosthetic heart valve of claim 6, wherein the woven fabric of the cushioning layer has a thickness when the prosthetic heart valve is in the expanded configuration that is greater than a thickness when the prosthetic heart valve is in the collapsed configuration.

8. The prosthetic heart valve of claim 4, wherein the first material of the cushioning layer comprises woven polyethylene terephthalate fabric (PET fabric) and the second material of the first strip member comprises expanded polytetrafluoroethylene (ePTFE).

9. The prosthetic heart valve of claim 1 wherein the first strap member extends around a circumference of the inflow end of the frame and the second strap member extends around a circumference of the outflow end of the frame.

10. The prosthetic heart valve of claim 1 wherein the first strap member extends over an inflow apex of the frame and the second strap member extends over an outflow apex of the frame.

11. The prosthetic heart valve of claim 1 , wherein: The first strip member includes a first circumferential edge portion and a second circumferential edge portion; and The first circumferential edge portion is disposed on an outer side of the frame, and the second circumferential edge portion is disposed on an inner side of the frame.

12. The prosthetic heart valve of claim 11, wherein the first circumferential edge portion and the second circumferential edge portion of the first strip member are sewn together by the buffer layer to form the first protective portion.

13. The prosthetic heart valve of claim 12, wherein: The prosthetic heart valve further includes an inner skirt disposed within the frame; and The first strap member is sewn to the inner skirt.

14. A prosthetic heart valve, comprising: a frame including a plurality of strut members and having an inflow end and an outflow end; a leaflet structure located at least partially within the frame; as well as a covering disposed around the exterior of the frame, the covering comprising: a buffer layer comprising a first material, the buffer layer forming an outer surface of the covering; and a first protective portion at the inflow end of the frame, the first protective portion comprising a second material different from the first material; and a second protective portion at the outflow end of the frame, the second protective portion comprising the second material, The first protection portion includes a first strip member, the first strip member includes the second material, and the first strip member is folded over an inflow circumferential edge portion of the buffer layer to form the first protection portion.

15. The prosthetic heart valve of claim 14, wherein the cushioning layer comprises a woven fabric including textured yarns that provide a compressible volume to the woven fabric.

16. The prosthetic heart valve of claim 15, wherein the cushioning layer comprises polyethylene terephthalate (PET).

17. The prosthetic heart valve of claim 14, wherein the second material comprises expanded polytetrafluoroethylene (ePTFE).

18. The prosthetic heart valve of claim 14, wherein the first protection portion and the second protection portion are spaced apart from one another along a longitudinal axis of the prosthetic heart valve.

19. A prosthetic heart valve, comprising: a frame including a plurality of strut members and having an inflow end and an outflow end; a leaflet structure located at least partially within the frame; as well as a covering disposed around the exterior of the frame, the covering comprising: A cushioning layer comprising a woven fabric; a first strip member folded over an inflow circumferential edge portion of the buffer layer to form a first protective portion, the first strip member comprising expanded polytetrafluoroethylene (ePTFE); and a second strip member folded over an outflow circumferential edge portion of the cushioning layer to form a second protective portion, the second strip member comprising ePTFE; Wherein the first strap member and the second strap member are spaced apart from one another along a longitudinal axis of the prosthetic heart valve.

20. A prosthetic heart valve, comprising: a frame including a plurality of strut members and having an inflow end and an outflow end; a leaflet structure located at least partially within the frame; as well as a covering disposed about the frame, the covering comprising a first protective portion positioned adjacent the inflow end of the frame, the first protective portion comprising a first layer and a second layer, the first layer being configured as a first strip member, the second layer having a plush surface and extending between the inflow end and the outflow end of the frame, the first strip member being folded over an inflow circumferential edge portion of the second layer to form the first protective portion, the first protective portion extending beyond the strut members in a direction along a longitudinal axis of the prosthetic heart valve; the covering also includes a second protective portion positioned adjacent the outflow end of the frame, the second protective portion including a second strip member that is discontinuous with the first strip member and axially spaced apart from the first strip member along the longitudinal axis of the prosthetic heart valve, the second strip member being folded over an outflow circumferential edge portion of the second layer to form the second protective portion, Wherein the second layer extends beyond the support member at the inflow end and the outflow end of the frame.

21. The prosthetic heart valve of claim 20, wherein the plush surface of the second layer is exposed between the first and second protective portions and forms an outer surface of the covering.

22. A method of making and using a covering for a prosthetic heart valve comprising: securing a first layer configured as a first strip member to a first surface of a second layer such that a longitudinal edge portion of the first strip member extends beyond a first longitudinal edge portion of the second layer, the first surface of the second layer being a plush surface; fixing the attached first and second layers into a cylindrical shape to form a covering; positioning the cover around a frame of a prosthetic heart valve such that the second layer extends between an inflow end and an outflow end of the frame, the frame comprising a plurality of strut members and a leaflet structure at least partially positioned within the frame; folding the longitudinal edge portion of the first strap member over the first longitudinal edge portion of the second layer to form a first protection portion adjacent the inflow end of the frame such that the first protection portion extends beyond an apex of the strut member in a direction along the longitudinal axis of the prosthetic heart valve; and A longitudinal edge portion of a second strip member is folded over a second longitudinal edge portion of the second layer to form a second protective portion positioned adjacent the outflow end of the frame, the second strip member being discontinuous with the first strip member and axially spaced apart from the first strip member along the longitudinal axis of the prosthetic heart valve.

23. The method of claim 22, wherein positioning the covering about the frame further comprises positioning the covering about the frame such that the plush first surface of the second layer is oriented radially outward.

24. The method of claim 22, wherein: Folding the longitudinal edge portions of the first strip members further comprises folding the longitudinal edge portions of the first strip members so that the first protective portion encapsulates respective vertices of the strut members at the inflow end of the frame; and Folding the longitudinal edge portions of the second strip members further includes folding the longitudinal edge portions of the second strip members such that the second protective portions encapsulate respective vertices of the strut members at the outflow end of the frame.

25. The method of claim 22, wherein the second layer comprises a fabric having a woven layer and a plush pile layer including a plurality of pile yarns forming the plush first surface.

26. A prosthetic heart valve comprising: a frame including a plurality of strut members and having an inflow end and an outflow end; a leaflet structure located at least partially within the frame; as well as a covering disposed about the frame, the covering comprising a first layer and a second layer, the second layer having a plush surface, the first layer being folded over a circumferential edge portion of the second layer to form a protective portion, the protective portion extending beyond the strut members in a direction along a longitudinal axis of the prosthetic heart valve, the first layer comprising a first circumferential edge portion and a second circumferential edge portion, and the first circumferential edge portion and the second circumferential edge portion being sewn together to form the protective portion; wherein the first layer comprises a tissue layer; and wherein the second layer extends beyond the support members at the inflow end and the outflow end of the frame, in: The protection portion is a first protection portion located adjacent the inflow end of the frame; and The cover also includes a second protective portion positioned adjacent the outflow end of the frame, and Wherein the first layer of the first protective portion is configured as a strip member, the strip member of the first protective portion is folded over the circumferential edge portion of the second layer at the inflow end of the frame.

27. The prosthetic heart valve of claim 26, wherein the first layer of the second protective portion is configured as a strip member, the strip member of the second protective portion being folded over a circumferential edge portion of the second layer at the outflow end of the frame.

28. The prosthetic heart valve of claim 27, wherein: The strip member of the first protective portion encapsulates each vertex of the strut member at the inflow end of the frame; and The strip members of the second protective portion encapsulate respective vertices of the strut members at the outflow end of the frame.

29. The prosthetic heart valve of claim 26, wherein the second layer comprises a fabric having a woven layer and a plush pile layer including a plurality of pile yarns.

30. The prosthetic heart valve of claim 29, wherein the pile yarns are arranged to form loops, or are cut to form cut pile.

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