Prosthetic heart valve

Abstract

To provide a prosthetic heart valve.SOLUTION: A prosthetic valve has: a radially expandable and compressible frame including a plurality of interconnected struts; and a valvular structure including a plurality of leaflets configured to regulate a flow of blood through the prosthetic valve. The leaflets can have undulating cusp edge portions. The prosthetic valve further includes at least one connecting skirt having a shape that corresponds to the cusp edge portion of at least one leaflet. The connecting skirt can connect the cusp edge portion of the leaflet to at least one of the struts of the frame. The connecting skirt includes a first set of yams intersecting with a second set of yams. The first and second sets of yarns can extend at oblique angles relative to a longitudinal axis of the at least one strut.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 026,866, filed May 19, 2020, which is incorporated herein by reference.

[0002] The present disclosure relates to embodiments of prosthetic valves for implantation in a body vessel, such as a native heart valve annulus. [Background technology]

[0003] The human heart can suffer from a variety of valvular heart diseases. These valvular heart diseases can result in significant cardiac dysfunction, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are numerous known repair devices (e.g., stents) and prosthetic valves, as well as numerous known methods for implanting these devices and prosthetic valves in humans. Percutaneous, minimally invasive surgical approaches are utilized in various procedures to deliver prosthetic medical devices to internal locations not readily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve may be crimped onto the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, by actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath in the delivery device so that the prosthetic valve can self-expand to its functional size. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Publication No. 2017 / 0231756 [Patent Document 2] International Publication No. 2020 / 247907 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0000615 [Patent Document 4] U.S. Patent No. 6,730,118 [Patent Document 5] U.S. Patent No. 9,155,619 [Patent Document 6] U.S. Patent Application Publication No. 2018 / 0028310 [Patent Document 7] U.S. Patent No. 9,339,384 [Patent Document 8] U.S. Provisional Patent Application No. 63 / 138890 Summary of the Invention [Means for solving the problem]

[0005] Some embodiments of the present disclosure relate to a prosthetic valve. The prosthetic valve may include a radially expandable and compressible frame having a plurality of interconnected struts and a valve structure having a plurality of leaflets configured to regulate blood flow through the prosthetic valve. The leaflets may have wavy leaflet edge portions. At least one connecting skirt may have a shape corresponding to the leaflet edge portion of at least one leaflet. The connecting skirt may connect the leaflet edge portion to at least one of the struts of the frame. The connecting skirt comprises a first set of threads crossed with a second set of threads. The first set of threads and the second set of threads may extend at an oblique angle relative to the longitudinal axis of the at least one strut.

[0006] Some embodiments of the present disclosure also relate to a prosthetic valve including a radially expandable and compressible frame having a plurality of interconnected struts. The frame may have an inflow end and an outflow end. The prosthetic valve may also include a valve structure having a plurality of leaflets configured to regulate blood flow through the prosthetic valve. The leaflets may have wavy leaflet edge portions. The prosthetic valve may further include a connecting skirt having a wavy shape corresponding to the shape of the leaflet edge portions. The connecting skirt may connect the leaflet edge portions of the plurality of leaflets to struts of the frame extending diagonally relative to the inflow and outflow ends of the frame. The connecting skirt may include a first set of threads interwoven with a second set of threads. The first set of threads may extend at an oblique angle relative to the struts connected to the connecting skirt.

[0007] Some embodiments of the present disclosure further relate to a method for mounting a multi-leaflet valve structure to a radially expandable and compressible frame. The method may include coupling at least one leaflet to a connecting skirt and coupling the connecting skirt to struts of the frame that extend diagonally along a line extending from the inflow end of the frame to the outflow end of the frame. The connecting skirt may comprise a first set of yarns interwoven with a second set of yarns. The connecting skirt may be oriented such that the first set of yarns extend at an oblique angle relative to the longitudinal axis of the struts.

[0008] The foregoing and other objects, features, and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1 is a perspective view of a prosthetic heart valve according to one embodiment. [Figure 1B] 1B is a perspective view of the prosthetic heart valve shown in FIG. 1A, with components on the exterior of the frame shown in phantom for illustrative purposes. [Figure 2] FIG. 1 is a perspective view of a partially assembled prosthetic heart valve illustrating attachment of the leaflets using a connecting skirt according to one embodiment. [Figure 3] FIG. 3 is a plan view of the leaflets and connecting skirt used in the prosthetic heart valve of FIG. 2. [Figure 4] FIG. 4 is a perspective view showing the attachment of the connecting skirt and leaflets of FIG. 3. [Figure 4A] FIG. 5 is an enlarged view of the circular portion shown in FIG. [Figure 5] FIG. 10 is a flattened view of the leaflets and the connecting skirt connected to the leaflets. [Figure 6] 4 is a perspective view showing the connection of the connecting skirt of FIG. 3 to the frame of the prosthetic heart valve of FIG. 2. [Figure 6A] FIG. 7 is an enlarged view of the circular portion shown in FIG. [Figure 6B] FIG. 7 is an enlarged view of another circular portion shown in FIG. 6. [Figure 7] 10 is a cross-sectional view illustrating attachment of leaflet edge portions of a leaflet to a connecting skirt according to another embodiment. [Figure 8] 8 is a plan view of one embodiment of the connecting skirt of FIG. 7 shown in a flat, deployed configuration. [Figure 9] FIG. 1 is a side elevational view of a prosthetic heart valve comprising a frame and a valve assembly mounted within the frame according to one embodiment. [Figure 10] FIG. 10 is an enlarged view of a portion of the frame and valve assembly of FIG. [Figure 11] FIG. 11 is a perspective view of the valve cusps of the artificial heart valve of FIGS. 9 and 10. [Figure 12] 12 is a plan view of the leaflet of FIG. 11 with the connecting skirt of FIG. 8 positioned along the leaflet edge portion of the leaflet. [Figure 13] 10A-10C are cross-sectional views illustrating coupling of leaflets to struts of a frame using connecting skirts according to another embodiment. [Figure 14] FIG. 10 is a schematic diagram illustrating an edge portion of a connecting skirt overlapping a portion of an outer surface of a strut according to one embodiment. [Figure 15]FIG. 10 is a schematic diagram illustrating the orientation of yarns in a connecting skirt relative to a connecting strut according to one embodiment. [Figure 16] FIG. 1 is a side view of one embodiment of a delivery device configured for delivering and implanting a radially expandable prosthetic heart valve at an implantation site. [Figure 17] 17 is a side view of the distal end portion of the delivery device of FIG. 16 with a prosthetic heart valve mounted on the valve mounting portion of the delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0010] The prosthetic valves disclosed herein may be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, these prosthetic valves may be crimped onto or held by an implant delivery device in a radially compressed state during delivery, and then expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery devices and may be implanted by a variety of delivery techniques, examples of which are discussed in more detail below.

[0011] While all of the prosthetic valves disclosed herein are adapted for implantation within the native aortic valve annulus, in other examples, they can be adapted for implantation within other native valve annulus of the heart (such as the pulmonary, mitral, and tricuspid valves). Furthermore, the prosthetic valves of the present disclosure can also be implanted within vessels communicating with the heart, including the pulmonary artery (for functional replacement of a diseased pulmonary valve) or the superior or inferior vena cava (for functional replacement of a diseased tricuspid valve), or within various other veins, arteries, and vessels of a patient. Furthermore, the prosthetic valves of the present disclosure can also be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0012] In some examples, the prosthetic valve of the present disclosure may be implanted within a docking or anchoring device that is implanted within a native heart valve or vessel. For example, in one example, the prosthetic valve of the present disclosure may be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as that disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference. In another example, the prosthetic valve of the present disclosure may be implanted within a docking device implanted within or at the location of a native mitral valve, such as that disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference. In another example, the prosthetic valve of the present disclosure may be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, such as that disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference.

[0013] The prosthetic heart valve of the present disclosure is particularly suitable for implantation within a native aortic valve. In the context of a prosthetic aortic valve, the terms "inferior" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively, for convenience. Thus, for example, in the orientation shown in the drawings, the inferior end of the prosthetic valve is the inflow end of the prosthetic valve, and the superior end of the prosthetic valve is the outflow end of the prosthetic valve. However, it should be understood that the prosthetic valve can be implanted in the opposite orientation. For example, when implanted in the mitral position, the superior end of the prosthetic valve is the inflow end, and the inferior end of the valve is the outflow end.

[0014] Figure 1A is a perspective view of a prosthetic heart valve 10 according to one embodiment. This exemplary valve is adapted for implantation within the native aortic valve annulus, although in other embodiments it may be adapted for implantation in other native annulus of the heart or in other locations as described above. Valve 10 may have three main components: a stent or frame 12, a valve structure 14, and a sealing member 16. Figure 1B is a perspective view of prosthetic valve 10, with the components on the exterior of frame 12 (including sealing member 16) shown in phantom for illustrative purposes.

[0015] The valve structure 14 may have three leaflets 20, which collectively form the valve leaflet structure. The leaflets 20 may be configured to collapse in a tricuspid configuration, although other embodiments may have more or fewer leaflets (e.g., one or more leaflets 20). The lower edge of the valve leaflet structure 14 may have a wavy, fan-shaped section, which may be a smooth curve or multiple U-shaped or V-shaped corrugations with a flat lower central section (see, e.g., FIGS. 3, 11, and 12). Forming the leaflets in this fan-shaped geometry may reduce stress on the leaflets, further improving valve durability. Additionally, this fan-shaped configuration may eliminate or at least minimize folds and undulations in the abdomen (the central region of each leaflet), an area that can lead to premature calcification. This fan-shaped geometry also allows for a reduction in the amount of tissue material used to form the leaflet structure, resulting in a smaller, more uniform crimped profile at the inflow end of the prosthetic valve. The leaflets 20 may be formed from pericardial tissue (such as bovine or porcine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Patent No. 6,223,999, which is incorporated herein by reference.

[0016] Each leaflet 20 may be coupled to the frame 12 along its curved inflow edge 30 (also called the lower edge, or "leaflet edge" in the drawings) and at a commissure 32 of the valve structure 14 where adjacent portions of the two leaflets are interconnected.

[0017] Frame 12 may be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol, etc.) as known in the art. If made from a plastically expandable material, frame 12 (and thus prosthetic valve 10) may be crimped into a radially compressed state onto a delivery catheter and then expanded inside the patient by an inflatable balloon or any suitable expansion mechanism. If made from a self-expanding material, frame 12 (and thus prosthetic valve 10) may be crimped into a radially compressed state and held in this compressed state by insertion into a sheath or equivalent mechanism of the delivery catheter. Once inside the body, the prosthetic valve may be advanced from the delivery sheath, allowing the prosthetic valve to expand to its functional size.

[0018] Suitable plastically expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N® / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. The use of MP35N to form the frame 12 has been found to provide superior structural performance over stainless steel. In particular, when MP35N is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Additionally, the reduced material requirement allows for a reduced crimp profile for the frame, thereby enabling a lower profile valve assembly for percutaneous delivery to a treatment location within the body.

[0019] The frame 12 of the illustrated embodiment may include a plurality of rows of circumferentially extending angled struts 22 that define a plurality of rows of cells or openings 24 in the frame. The frame 12 may have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 26 to the outflow end 28 of the frame as shown, or the frame may have a varying diameter along its height as disclosed in U.S. Patent No. 5,623,999, which is incorporated herein by reference.

[0020] The sealing member 16 in the illustrated embodiment is mounted on the exterior of the frame 12 and functions to prevent or at least minimize paravalvular regurgitation by forming a seal against surrounding tissue (e.g., the native valve leaflets and / or annulus). Alternative embodiments of the sealing member, as well as methods of coupling the sealing member 16 to the frame, are described in U.S. Patent Application Publication No. 2007 / 0129994, which is incorporated herein by reference.

[0021] 2-6 illustrate a technique for attaching the inflow edge 30 of the leaflet 20 to the frame 12 according to one embodiment.

[0022] In the illustrated embodiment, a linking skirt 100 is secured to the lower edge portion 102 (also referred to as the leaflet edge portion) of each leaflet. As best shown in FIG. 3, each linking skirt 100 can have an elongated, generally rectangular body 104 formed with a plurality of flaps 106 a, 106 b formed along opposite longitudinal edges of the body 104. The skirt 100 can comprise any suitable synthetic material (e.g., PET) and can be woven with yarn, as described more fully below.

[0023] 3, each leaflet 20 may have opposing tabs 60. Each tab 60 may be secured to an adjacent tab 60 on an adjacent leaflet 20 to form a commissure 32 that is secured to the frame 12. Methods for attaching the commissures to the frame are described in detail in U.S. Patent No. 6,279,999.

[0024] 4 and 4A, to secure the connecting skirt 100 to the leaflet 20, the body 104 may be folded along a central longitudinal crease that bisects the body to form fold portions 110a, 110b. These fold portions 110a, 110b are then placed on either side of the lower edge portion 102 of the leaflet 20, with flap 106a adjacent the outer surface of the leaflet and flap 106b adjacent the inner surface of the leaflet. Sutures may then be used to form stitches 108 that extend longitudinally through both portions 110a, 110b of the body 104 and the lower edge portion 102 of the leaflet, extending longitudinally along the length of the lower edge portion 102. FIG. 5 shows a flattened view of the leaflet 20 with the skirt 100 folded around the lower edge portion 102 of the leaflet and secured thereto by the stitches 108. As shown, the shape of the connecting skirt 100 generally corresponds to the curved leaflet edge portion 102 of the leaflet 20 .

[0025] 6, 6A, and 6B, each pair of flaps 106a, 106b may be folded over a respective strut 22 of the frame and away from the leaflet 20 and secured in place with stitches 112 that extend through the flaps 106a, 106b along a stitching line on the outside of the frame 12. As best shown in FIG. 6B, the connecting skirt 100 may attach the leaflet to the frame 12 such that the lower edge portion 102 extends radially inward at an angle of approximately 90 degrees relative to the frame 12. This effectively shifts the bending axis of the lower edge portion 102 inward, away from the inner surface of the frame, toward the center of the frame.

[0026] As best shown in FIG. 2 , each skirt 100 may be secured to the frame along a diagonal line 116 that extends along the curved surface of the frame defined by rows of diagonally extending struts 22 extending from the inflow end toward the outflow end of the frame. In other words, the longitudinal axis of each strut 22 connecting each skirt 100 extends at an oblique angle relative to the central longitudinal axis of the frame. As such, the lower edge portion 102 of each leaflet may also be positioned along a respective diagonal line 116 defined by each row of diagonally extending struts 22. Advantageously, this may reduce tension and wrinkle formation in the leaflets 20.

[0027] Additionally, attachment along diagonal line 116 can help reduce the crimp profile of the prosthetic valve when it is radially compressed into the delivery configuration. In particular, while struts in a row of struts extending circumferentially around the frame are moved or bent toward one another during the crimping process, struts located along diagonal line 116 substantially maintain their alignment relative to one another along line 116 during the crimping process. As such, linking skirt 100 (typically formed from a non-stretchable material) does not prevent movement or deformation of the struts relative to one another. Additionally, because the leaflet edge portions of the valve leaflets move with the linking skirt during crimping, elongation of the leaflets along the leaflet edge portions is prevented, or at least minimized.

[0028] Furthermore, the linking skirt 100 (and other linking skirts described herein) can facilitate assembly of the prosthetic valve compared to known assembly techniques. For example, the leaflets and skirt can be assembled while the leaflets are in a flat, deployed configuration, prior to forming the tubular (annular) configuration, valve structure 14. Automated or semi-automated techniques can be utilized to suture the skirt to the leaflets. Also, once the valve structure is positioned inside the frame, the lower edge portions 102 of the leaflets can be secured to the frame with stitching located entirely outside the frame 12. This can significantly reduce assembly time because the assembler does not need to thread a needle to form stitches 112 in and out of the frame cells 24. Furthermore, as described below, the woven threads of the linking skirt 100 can be configured to extend at an oblique angle relative to the struts connected to the linking skirt 100 to improve the durability of the linking skirt 100.

[0029] FIG. 9 illustrates another embodiment of a prosthetic valve 180. The prosthetic valve 180 may include leaflets 120 interconnected at their outflow ends to form commissures 170 that are attached to cells at the outflow end of a frame. The commissures 170 may be formed by folding the commissure tabs of the leaflets and securing them to commissure attachment members 172. Each commissure attachment member 172 may be sutured to four struts 22 that define the closed cells 24 of the frame. Methods for forming the commissures 170 and attaching them to the cells 24 via the commissure attachment members 172 are described in detail in U.S. Patent No. 6,277,999. As shown in FIG. 7, the prosthetic valve 180 may further include a sealing member 16 attached to the exterior of the frame 12 (the sealing member is omitted from FIG. 9 for clarity).

[0030] As best shown in FIG. 12 , each leaflet 120 has a lower edge portion or leaflet edge portion 122 that can be attached to the frame 12. In the illustrated embodiment, the leaflet edge portion 122 has a generally U-shaped portion with a flat lower central portion that further has side portions extending upward from the central portion toward lower tabs 158. The lower edge portion 122 can terminate at an upper end at two laterally projecting integral lower tabs 158. Integral upper tabs 160 (also called commissure tabs) project from the upper corners of the leaflet 120. The upper tabs 160 can be spaced from the lower tabs 158 by side edges 159 forming laterally extending gaps or recesses 160 in the leaflet. Each upper tab 160 can be folded along fold lines 162 to form first and second tab layers 160 a, 160 b. The upper tabs 160 , along with the upper tabs 160 of adjacent leaflets, may be secured to the commissure mounting members 172 to form the commissures 170 .

[0031] The inflow or leaflet edge portions 122 of the leaflets 120 can be secured to the frame 12 using multiple linking skirts 130 ( FIG. 8 ), which can be formed from the same materials as those described above for the linking skirts 100 (e.g., PET fiber). In the illustrated embodiment, a single linking skirt 130 is provided for each leaflet edge portion 122 of the leaflet 120. The linking skirts 130 can have a shape that corresponds to the curved leaflet edge portion 122 and can be sized to extend along the entire length of the leaflet edge portion 122 to a position just below the inferior tab 158 of the leaflet 120. FIG. 12 shows the linking skirts 130 positioned along the leaflet edge portions 122 of the leaflets 120 prior to attachment to the leaflets with sutures. The linking skirt 130 may include a central portion 130a sized to extend over the central lower edge portion and two side portions 130b sized to extend over angled side edge portions extending from the lower central portion to the lower tab 158. The linking skirt 130 may be formed with slits 132 partially separating the side portions 130b from the central portion 130a to facilitate alignment of the skirt along the leaflet edge portions, as shown in FIG. 12. In an alternative embodiment, the linking skirt 130 may be curved to match the curvature of the leaflet edges 122 of the valve leaflets.

[0032] In alternative embodiments, multiple connecting skirts may be provided for each leaflet edge portion (e.g., the central portion 130a and the side portions 130b can be separate pieces of fabric). In another embodiment, a single connecting skirt may be used to secure all of the leaflets to the frame, i.e., the single connecting skirt may be sized to extend along the leaflet edge portions of all of the leaflets. For example, a single connecting skirt may include multiple skirt segments, each connecting a corresponding leaflet edge portion of the leaflet to a respective strut (or struts). The leaflet edge portions of the leaflets may form wavy or curved portions. The single connecting skirt may have a wavy shape that corresponds to the curvature of the leaflet edge portions of the leaflets.

[0033] Prior to attaching the leaflets to the frame, a connecting skirt 130 may be attached to the leaflet edge portion of each leaflet. As shown in FIG. 7 , the connecting skirt 130 may be folded lengthwise to form two fold layers 134 a, 134 b and placed against the inflow surface of the leaflet edge portion 122. Optionally, a reinforcing member or cord 136 (e.g., Ethibond suture) may be placed against the outflow surface of the leaflet edge portion on the opposite side of the connecting skirt 130. The reinforcing member 136 and fold layers 134 a, 134 b may be sutured to each other and to the leaflet edge portion 122 with stitches 138, which may be a single suture or multiple sutures extending through one or more layers of material.

[0034] When suturing the reinforcement cord 136 to the leaflet 120, the lower tab 158 may be folded downwardly against the leaflet edge portion 122 (see FIG. 12 ), and the reinforcement cord 136 may be positioned over the folded lower tab 158. The upper end of the connecting skirt 130 may be sized to extend over the folded lower tab 158. Stitches 138 may be used to secure the reinforcement cord 136 in place against the folded lower tab 158. In certain embodiments, the reinforcement cord 136 may extend along the folded lower tab 158 of one leaflet 120, through the space between a pair of adjacent lower tabs 158 and a pair of upper tabs 160 below the commissures 170, and further along the lower tab 158 and the leaflet edge portion of the adjacent leaflet 120. In some embodiments, a single reinforcing cord 136 may extend continuously along the leaflet edge portions 122 of all leaflets and through the space below each commissure 170. In other embodiments, multiple reinforcing cords 136 may be used, with one reinforcing cord secured to the leaflet edge portions of each leaflet. When multiple reinforcing cords 136 are used, the end of each cord may be connected (e.g., by tying or knotting) to the adjacent end of another cord. For example, the adjacent ends of two cords may be connected to each other in the space below the commissures.

[0035] 7, 9, and 10 illustrate the connection of a connecting skirt 130 to a frame 12 according to one embodiment. As shown, the connecting skirt 130 may be sutured to the struts 22 of the frame 12 to form a diagonal line extending from the commissures 170 to the inflow end of the frame. In certain embodiments, one or both layers 134a, 134b of the connecting skirt may be secured to the intersections 128 (formed by the intersections of struts 22) with individual stitches 172 and additionally with overlock stitches 144 formed along the length of the struts 22 between the two intersections 128. Each overlock stitch 144 may extend around the strut 22 through the edge portion 142 and multiple times along the length of the strut. Optionally, the overlock stitches 144 may extend through the leaflet edge portion 122, as shown in FIG. 7. Additionally, as will be described below, the threads of the connecting skirt 130 may be configured to extend at an oblique angle relative to the connecting struts 22 to improve the durability of the connecting skirt 130 .

[0036] As disclosed herein, the folded lower tabs 158 help reinforce the connection between the leaflet edge portion 122 of the leaflet and the frame along the upper section of the leaflet edge portion adjacent the commissure 170. The folded lower tabs 158 can also shift the bending axis of the upper section of the leaflet edge portion inward and away from the inner surface of the frame to prevent or minimize contact between the leaflet and the frame in the area below the commissure. In the illustrated embodiment, each lower tab 158 forms one additional layer of leaflet material on the upper (outflow) surface of the leaflet. In alternative embodiments, each lower tab 158 can be configured to form multiple additional layers of leaflet material, such as two, three, or four layers, on the upper surface of the leaflet to shift the bending axis of the leaflet below the commissure further away from the inner surface of the frame.

[0037] The side edges 159 between the lower tabs 158 and the upper tabs 160 can remain unattached to the frame of the prosthetic valve. This unattached side edge 159 can allow for greater axial elongation or stretching of the leaflets when the prosthetic valve is compressed and greater radial elongation or stretching of the leaflets when the prosthetic valve is expanded. During diastole, adjacent side edges 159 can abut each other to prevent retrograde blood from flowing between the side edges 159. During systole, adjacent side edges 159 can separate from each other to allow antegrade blood to flow between the side edges 159, helping to flush blood away from the area below the commissures 170.

[0038] 13 schematically illustrates the connection of a connecting skirt 130 to an adjacent strut 22 according to another embodiment. As shown, a first longitudinal edge portion 124 of the connecting skirt 130 is bonded to a leaflet edge portion 122 of a leaflet 120. A second longitudinal edge portion 126 of the connecting skirt 130 is bonded to an adjacent strut 22. The second edge portion 126 is located on the opposite side of the first edge portion 124.

[0039] The first edge portion 124 of the linking skirt 130 may extend along the entire length of the leaflet edge portion 122 of the leaflet 120, similar to the embodiment shown in Figure 12. The first edge portion 124 of the linking skirt 130 and the leaflet edge portion 122 of the leaflet 120 may be joined together by one or more stitches 146. Optionally, a reinforcing cord (not shown) may be positioned against the outflow surface of the leaflet edge portion on the opposite side of the first longitudinal edge portion 124 of the linking skirt 130, similar to the example shown in Figure 7. The reinforcing cord may be joined together to the leaflet edge portion 122 and the first edge portion 124 by stitches 146.

[0040] 13, the second edge portion 126 of the connecting skirt 130 may be attached to the frame with one or more sutures 148. Each suture 148 may extend around a connecting strut 22 and through the skirt 130 at one or more locations to form one or more loops around the strut 22. For example, each suture 148 may be used to form multiple overlock stitches that extend around a strut 22 and through the skirt 130.

[0041] The second edge portion 126 of the connecting skirt 130 in the illustrated embodiment is configured to overlap at least a portion of the inner surface of the connecting strut 22. For example, as shown in FIG. 14 , the strut 22 has a quadrilateral cross-section and four sides 50, and the second edge portion 126 of the connecting skirt 130 overlaps only one of these four sides 50. Arrow 52 indicates a direction parallel to the longitudinal axis of the strut 22, and arrow 54 indicates a direction substantially perpendicular or transverse to direction 52. In other embodiments, the cross-section of the strut 22 can have a non-quadrilateral shape, and thus the strut can have any number of sides. In alternative embodiments, the second edge portion 126 of the connecting skirt 130 can overlap at least two of the sides of the strut.

[0042] 13-14 show the connecting skirt 130 connected to the strut 22 as an example, although similar connecting mechanisms can be applied to the connecting skirt 100 described above. For example, the skirt 130 can have multiple flaps that extend at least partially around the strut 22. In certain implementations, the skirt 130 can have multiple flaps 106a and multiple flaps 106b, which can be connected to the strut 22 in the manner shown in FIGS. 2, 6, 6A, and 6B. In another embodiment, the skirt 130 can be folded and attached to the strut 22 in the manner shown in FIG. 7.

[0043] FIG. 15 shows a portion of the yarns of a connecting skirt 130 (or 100) according to one embodiment. As shown, the connecting skirt 130 is comprised of a first set of yarns 152 crossed with a second set of yarns 154. These yarns 152, 154 may be made from natural or synthetic materials. Each yarn 152 or 154 can be a monofilament (e.g., single fiber) or multifilament fiber or strand. The first set of yarns 152 may be oriented perpendicular to the second set of yarns 154. In some embodiments, the first set of yarns 152 are woven together with the second set of yarns 154. In alternative embodiments, the connecting skirt 130 may have a knitted or braided structure rather than a woven structure.

[0044] Similarly, FIG. 15 shows two arrows 52, 54, which respectively indicate the longitudinal and lateral directions of adjacent struts 22 to which connecting skirt 130 is joined. As shown, when connecting skirt 130 is joined to adjacent struts 22, first set of threads 152 may extend at an oblique angle (α) relative to the longitudinal direction (as indicated by arrow 52) of connecting strut 22. Similarly, second set of threads 154 may extend at an oblique angle (β) relative to the lateral direction (as indicated by arrow 54) of connecting strut 22. In certain embodiments, angle α (or β) may range between about 20 and 70 degrees in some instances, more desirably between about 30 and 60 degrees in some instances, and even more desirably between about 40 and 50 degrees in some instances. In one particular embodiment, angle α (or β) is about 45 degrees.

[0045] Traditionally, the interwoven yarns of the connecting skirt are parallel or perpendicular to the longitudinal axis of the connecting struts. These cyclical movements of the leaflets can cause ablation of the connecting skirt relative to the connecting struts. The orientation of the interwoven yarns relative to the connecting struts described above can be advantageous because it can result in a larger overlap or contact area between the yarns and the struts, thereby improving the durability of the connecting skirt over time.

[0046] delivery device 16 and 17 illustrate a delivery apparatus 300 according to one embodiment, which may be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 10 of FIGS. 1A and 1B and / or prosthetic heart valve 180 of FIG. 9) or another type of expandable prosthetic medical device (such as a stent). In some embodiments, delivery apparatus 300 is particularly adapted for use in introducing a prosthetic valve into the heart.

[0047] 16 and 17, the delivery device 300 is a balloon catheter including a handle 302 and a steerable outer shaft 304 extending distally from the handle 302 (FIG. 16). The delivery device 300 can further include an intermediate shaft 306 (also referred to as a balloon shaft) extending proximally and distally from the handle 302 (FIG. 16), the portion extending distally from the handle 302 further extending coaxially through the outer shaft 304. The delivery device 300 can further include an inner shaft 308 extending coaxially distally from the handle 302 through the intermediate shaft 306 and the outer shaft 304 (FIG. 16) and coaxially proximally from the handle 302 through the intermediate shaft 306.

[0048] The outer shaft 304 and the intermediate shaft 306 are configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 320 of the delivery device 300, which may facilitate delivery and positioning of the prosthetic valve at an implantation site within a patient's body.

[0049] The intermediate shaft 306 may include a proximal end portion 310 that extends proximally from the proximal end of the handle 302 to an adapter 312 ( FIG. 16 ). In some embodiments, a rotatable knob 314 may be mounted on the proximal end portion 310 ( FIG. 16 ) and configured to rotate the intermediate shaft 306 about a central longitudinal axis 320 of the delivery device 300 and relative to the outer shaft 304.

[0050] The adapter 312 may include a first port 338 configured to receive a guidewire therethrough and a second port 340 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 340 may be fluidly coupled to the inner lumen of the midshaft 306.

[0051] The midshaft 306 may further include a distal end portion 316 that extends distally beyond the distal end of the outer shaft 304 (FIG. 16) when the distal end of the outer shaft 304 is positioned away from the inflatable balloon 318 of the delivery device. The distal end portion of the inner shaft 308 may extend distally beyond the distal end portion 316 of the midshaft 306 (FIG. 16).

[0052] The balloon 318 may be coupled to the distal end portion 316 of the midshaft 306. For example, in some embodiments, the proximal end portion of the balloon 318 may be coupled to and / or around the distal end of the midshaft 306 (FIG. 16).

[0053] The balloon 318 can have a distal end portion (or distal end section) 332, a proximal end portion (or proximal end section) 333, and an intermediate portion (or intermediate section) 335, which is disposed between the distal end portion 332 and the proximal end portion 333 (FIG. 16).

[0054] In some embodiments, the distal end of the distal end portion 332 of the balloon 318 can be coupled to the distal end of the delivery device 300, such as to a nosecone 322 (as shown in FIGS. 16 and 17 ) or to an alternative component (e.g., a distal shoulder) located at the distal end of the delivery device 300. In some embodiments, the intermediate portion 335 of the balloon 318 can overlap the valve mounting portion 324 of the distal end portion 309 of the delivery device 300, the distal end portion 332 can overlap the distal shoulder 326 of the delivery device 300, and the proximal end portion 333 can surround a portion of the inner shaft 308. The valve mounting portion 324 and the intermediate portion 335 of the balloon 318 can be configured to receive a prosthetic heart valve 370 in a radially compressed state, as shown in FIG. In some embodiments, the prosthetic heart valve 370 shown in FIG. 17 can be one of the valve 10 of FIGS. 1A and 1B or the valve 180 of FIG.

[0055] In some embodiments, rotation of the midshaft 306 can result in rotation of the balloon 318 and the prosthetic valve mounted on the balloon 318 to rotationally position the prosthetic valve relative to the native anatomical structures at the target implantation site.

[0056] The balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device in a fixed position on the balloon 318 during delivery through the patient's vasculature. The balloon shoulder assembly can include a distal shoulder 326 ( FIGS. 16 and 17 ) that is disposed within a distal end portion 332 of the balloon 318 and is coupled to the distal end portion of the inner shaft 308. The distal shoulder 326 can be configured to prevent axial (e.g., along the central longitudinal axis 320) distal movement of a prosthetic valve or other medical device mounted on the valve mounting portion 324 relative to the balloon 318.

[0057] The outer shaft 304 may include a distal tip portion 328 mounted on its distal end ( FIGS. 16 and 17 ). The outer shaft 304 and the intermediate shaft 306 may translate axially relative to one another to position the distal tip portion 328 adjacent the proximal end of the valve mounting portion 324 when the prosthetic valve is mounted in radial compression on the valve mounting portion 324 and during delivery of the prosthetic valve to the target implantation site (as shown in FIG. 17 ). Thus, the distal tip portion 328 may be configured to prevent axial proximal movement of the prosthetic valve relative to the balloon 318 when the distal tip portion 328 is positioned proximal to the valve mounting portion 324 ( FIG. 17 ).

[0058] In some embodiments, the nosecone 322 may be disposed distally of and coupled to the distal shoulder 326. In some embodiments, the nosecone 322 may be coupled to the distal end portion of the inner shaft 308.

[0059] In some embodiments, an annular space may be defined between the outer surface of the inner shaft 308 and the inner surface of the midshaft 306. In some embodiments, the annular space may be referred to as the inner lumen of the midshaft 306. In some embodiments, the annular space may be configured to receive fluid from a fluid source via the second port 340 of the adapter 312 (e.g., the annular space is in fluid communication with the second port 340 of the adapter 312). The annular space may be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 308 and the inner surface of the balloon 318. Fluid from the fluid source may then flow into the balloon 318, thereby inflating the balloon 318 and radially expanding and deploying the prosthetic valve (e.g., the prosthetic valve 370 shown in FIG. 17 ).

[0060] The inner lumen of the inner shaft 308 can be configured to receive a guidewire therethrough for guiding the distal end portion 309 of the delivery device 300 to the target implantation site. As introduced above, the first port 338 of the adapter 312 can be coupled to the inner lumen and configured to receive a guidewire. For example, the distal end portion 309 of the delivery device 300 can be advanced over a guidewire to the target implantation site.

[0061] As shown in FIG. 16 , the handle 302 can include a steering mechanism configured to adjust the curvature of the distal end portion 309 of the delivery device 300. In the illustrated embodiment, for example, the handle 302 includes an adjustment member, such as a rotatable knob 360 as shown, which is further operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 302 through the outer shaft 304 and have a distal end portion fixedly attached to the outer shaft 304 at or near its distal end. Rotating the knob 360 increases or decreases tension in the pull wire, thereby adjusting the curvature of the distal end portion 309 of the delivery device 300. Further details regarding steering or bending mechanisms for delivery devices can be found in U.S. Patent Application Publication No. 2009 / 0129994, which is incorporated herein by reference.

[0062] The handle 302 can include one or more additional adjustment mechanisms. For example, in some embodiments, the handle 302 can include an adjustment mechanism 361 that includes an adjustment member, such as the illustrated rotatable knob 362. The adjustment mechanism 361 can be configured to adjust the axial position of the midshaft 306 relative to the outer shaft 304. In some embodiments, the handle 302 can further include a locking mechanism, which can include a rotatable knob 379, that is configured to maintain (e.g., lock) the position of the midshaft 306 relative to the handle 302 and allow for fine positioning of the prosthetic valve 370 at the implantation site.

[0063] Further details regarding the delivery device 300 are disclosed in U.S. Patent Application Publication No. 202001022329, filed January 19, 2021, which provisional patent application is incorporated herein by reference.

[0064] delivery technology To implant a prosthetic valve (e.g., valve 10 or 180) within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device (e.g., delivery device 300). The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from a sheath to allow it to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (located on the distal end portion of the delivery device) is introduced through a surgical opening in the chest and the apex of the heart into the left ventricle and positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (located on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as via a partial J-sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0065] To implant a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein, advanced into and through the inferior vena cava into the right atrium, across the atrial septum (through a perforation created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, in which the prosthetic valve (located on the distal end portion of the delivery device) is introduced through a surgical opening in the chest and the apex of the heart into the left ventricle and positioned within the native mitral valve.

[0066] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / artery.

[0067] Another delivery approach is the transatrial approach, in which the prosthetic valve (located on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, for example, through a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (located on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision made through the right ventricular wall (typically located at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0068] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery techniques and delivery devices known in the art.

[0069] General matters It should be appreciated that embodiments of the present disclosure may be adapted to deliver and implant prosthetic devices in any native annulus of the heart (e.g., aortic, pulmonary, mitral, and tricuspid annulus, etc.) and may be used with any of a variety of delivery devices for delivering prosthetic valves using any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0070] For purposes of description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, devices, and systems of the present disclosure should not be construed as limiting in any respect. Rather, the present disclosure is directed to all novel and unobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations. These methods, devices, and systems are not limited to any particular aspect or feature thereof, or combination thereof, and embodiments of the present disclosure do not require that any particular advantage or problem be present or solved. The technology based on any example can be combined with the technology described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the technology of the present disclosure can be applied, it should be understood that the illustrated embodiments are merely preferred examples and should not be construed as limiting the scope of the technology of the present disclosure.

[0071] Although some operations of the embodiments of the present disclosure are described in a particular sequential order for convenience of presentation, it should be understood that this description encompasses reordering unless a particular order is required by specific language set forth herein. For example, a series of operations described sequentially may in some cases be reordered or performed simultaneously. Moreover, for simplicity's sake, the accompanying drawings may not depict the various ways in which the methods of the present disclosure may be utilized in combination with other methods. Furthermore, at times, the description uses terms such as "implement" or "achieve" to describe the methods of the present disclosure. These terms are highly abstract representations of actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0072] In this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, the term "include" means "comprise." Furthermore, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items unless specifically stated to the contrary.

[0073] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate explanation of the figures and principles herein, but are not intended as limitations. For example, terms such as "inner," "outer," "top," "lower," "inner," and "external" may be used. Such terms are used, where applicable, to provide some clarity to the description, particularly when addressing relative relationships with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" portion can become a "lower" portion simply by flipping the object. However, the portions are still the same portion, and the object remains the same object. As used herein, "and / or" means "and" or "or" and "and" and "or."

[0074] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), and distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0075] Further examples of the techniques of the present disclosure In view of the above-described implementations of the subject matter of the present disclosure, the present application discloses the following additional examples: A single feature of an example, as well as a combination of two or more features of that example, and optionally a combination with one or more features of one or more other examples, are additional examples that are also within the scope of the present disclosure.

[0076] Example 1: A prosthetic valve comprising: a radially expandable and compressible frame comprising a plurality of interconnected struts; a valve structure comprising a plurality of leaflets configured to regulate blood flow through the prosthetic valve, the leaflets having wavy leaflet edge portions; and at least one linking skirt having a shape corresponding to the leaflet edge portion of at least one leaflet, the linking skirt connecting the leaflet edge portion to at least one of the struts of the frame, the linking skirt comprising a first set of threads crossed with a second set of threads, the first and second sets of threads extending at an oblique angle relative to the longitudinal axis of the at least one strut.

[0077] Example 2 The prosthetic valve of any of the examples in this section, particularly Example 1, wherein the first set of threads are perpendicular to the second set of threads.

[0078] [Example 3] The prosthetic valve of any example of this section, particularly any one of Examples 1-2, wherein the first set of threads is woven together with the second set of threads.

[0079] [Example 4] The prosthetic valve of any example of this chapter, particularly any one of Examples 1 to 3, wherein the first set of threads extend at an angle of between about 40 and 50 degrees relative to the longitudinal axis of at least one strut.

[0080] [Example 5] The artificial valve of any of the examples of this chapter, particularly Example 4, wherein said angle is 45 degrees.

[0081] [Example 6] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 1 to 5, wherein a first longitudinal edge portion of the connecting skirt is bonded to a leaflet edge portion of the valve leaflet, and a second longitudinal edge portion of the connecting skirt is bonded to at least one strut, the second edge portion being located on the opposite side of the first edge portion.

[0082] Example 7 The prosthetic valve of any example of this chapter, particularly Example 6, wherein the second edge portion of the connecting skirt is sutured to at least one strut.

[0083] [Example 8] An artificial valve according to any example of this chapter, particularly any one of Examples 6 to 7, wherein the second edge portion of the connecting skirt is configured to overlap at least a portion of the inner surface of at least one strut.

[0084] [Example 9] The prosthetic valve of any example of this chapter, particularly Example 8, wherein the second edge portion of the connecting skirt has a plurality of flaps extending at least partially around at least one strut.

[0085] [Example 10] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 6 to 9, wherein the first edge portion of the connecting skirt extends along the entire length of the leaflet edge portion of the valve leaflet.

[0086] [Example 11] An artificial valve according to any of the examples in this chapter, particularly any one of Examples 6 to 10, wherein the first edge portion of the connecting skirt, the leaflet edge portion of the valve leaflet, and the reinforcing cord extending along the leaflet edge portion of the valve leaflet are joined together by one or more stitches.

[0087] [Example 12] An artificial valve according to any of the examples in this chapter, particularly any one of Examples 1 to 11, wherein the connecting skirt is one of a plurality of connecting skirts, each connecting skirt connecting a corresponding valve leaflet to each adjacent strut.

[0088] [Example 13] An artificial valve according to any of the examples in this chapter, particularly any one of Examples 1 to 12, wherein the longitudinal axis of at least one strut extends at an oblique angle relative to the central longitudinal axis of the frame.

[0089] Example 14: A prosthetic valve comprising: a radially expandable and compressible frame with a plurality of interconnected struts, the frame having an inflow end and an outflow end; a valve structure with a plurality of leaflets configured to regulate blood flow through the prosthetic valve, the leaflets having wavy leaflet edge portions; and a connecting skirt having a wavy shape corresponding to the leaflet edge portions, the connecting skirt connecting the leaflet edge portions of the plurality of leaflets to struts of the frame extending diagonally relative to the inflow and outflow ends of the frame, the connecting skirt being comprised of a first set of threads interwoven with a second set of threads, the first set of threads extending at an oblique angle relative to the struts connected to the connecting skirt.

[0090] [Example 15] An artificial valve according to any of the examples of this chapter, particularly Example 14, wherein the connecting skirt is made up of multiple skirt segments, each skirt segment connecting a corresponding leaflet edge portion of the leaflet to a respective strut.

[0091] [Example 16] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 14 to 15, wherein the first set of threads are perpendicular to the second set of threads.

[0092] [Example 17] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 14 to 16, wherein the oblique angle is between about 40 and about 50 degrees.

[0093] [Example 18] The artificial valve of any of the examples of this chapter, particularly Example 17, wherein the oblique angle is about 45 degrees.

[0094] [Example 19] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 14 to 18, wherein a first longitudinal edge portion of the connecting skirt is bonded to a leaflet edge portion of the valve leaflet, and a second longitudinal edge portion of the connecting skirt is bonded to a strut, the second edge portion being located on the opposite side of the first edge portion.

[0095] [Example 20] The prosthetic valve of any example of this chapter, particularly Example 19, wherein the second edge portion of the connecting skirt is sutured to the strut.

[0096] [Example 21] An artificial valve according to any of the examples of this chapter, particularly any one of Examples 19 to 20, wherein the second edge portion of the connecting skirt is configured to overlap at least a portion of the inner surface of the strut. [Example 22]

[0097] The prosthetic valve of any of the examples of this section, particularly any one of Examples 19-21, wherein the first edge portion of the connecting skirt extends along the entire length of the leaflet edge portion of the valve leaflet.

[0098] [Example 23] An artificial valve according to any of the examples in this chapter, particularly any one of Examples 19 to 22, wherein the first edge portion of the connecting skirt, the leaflet edge portion of the valve leaflet, and one or more reinforcing cords extending along the leaflet edge portion of the valve leaflet are joined together by one or more stitches.

[0099] Example 24: A method for mounting a valve structure having multiple leaflets to a radially expandable and compressible frame, comprising: coupling at least one leaflet to a connecting skirt; and coupling the connecting skirt to struts of the frame that extend diagonally along a line extending from the inflow end of the frame to the outflow end of the frame, the connecting skirt comprising a first set of yarns interwoven with a second set of yarns, the connecting skirt oriented such that the first set of yarns extend at an oblique angle relative to the longitudinal axis of the struts.

[0100] The method of any example of this chapter, particularly Example 24, further comprising coupling a plurality of leaflets to a plurality of linking skirts and coupling the plurality of linking skirts to respective struts of the frame, wherein the leaflets have wavy leaflet edge portions, and the linking skirts form wavy sections corresponding to the wavy leaflet edge portions of the leaflets.

[0101] [Example 26] The method of any example in this chapter, particularly any one of Examples 24 to 25, wherein the first set of yarns is perpendicular to the second set of yarns.

[0102] [Example 27] A method according to any of the examples in this chapter, particularly any one of Examples 24 to 26, wherein the oblique angle is between about 40 and 50 degrees.

[0103] Example 28. The method of any of the examples of this chapter, particularly Example 27, wherein the oblique angle is about 45 degrees.

[0104] [Example 29] A method of any example of this chapter, particularly any one of Examples 24 to 28, wherein joining the leaflet to the strut includes joining a first longitudinal edge portion of the connecting skirt to a leaflet edge portion of the leaflet, and joining a second longitudinal edge portion of the connecting skirt to the strut, the second edge portion being located on the opposite side of the first edge portion.

[0105] [Example 30] The method of any example of this chapter, particularly Example 29, wherein the second edge portion of the connecting skirt is sewn to the strut.

[0106] [Example 31] A method of any example in this chapter, particularly any one of Examples 29 to 30, wherein the second edge portion of the connecting skirt is configured to overlap at least a portion of the inner surface of the strut.

[0107] [Example 32] A method of any example of this chapter, particularly any one of Examples 29 to 31, wherein the second edge portion of the connecting skirt comprises a plurality of flaps, each flap connecting a segment of the leaflet edge portion to a respective strut adjacent to that segment of the leaflet edge portion.

[0108] [Example 33] A method of any example in this chapter, particularly any one of Examples 29 to 32, wherein the first edge portion of the connecting skirt extends along the entire length of the leaflet edge portion of the valve leaflet.

[0109] [Example 34] A method of any example of this chapter, particularly any one of Examples 29 to 33, wherein joining the leaflet to the strut includes joining together a first edge portion of the connecting skirt, a leaflet edge portion of the leaflet, and a reinforcing cord extending along the leaflet edge portion of the leaflet with one or more stitches.

[0110] In view of the many possible embodiments to which the inventive principles of this disclosure may be applied, it should be understood that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the disclosure, which is rather defined by the appended claims. [Explanation of symbols]

[0111] 10. Artificial Heart Valves 12 frames 14 Valve structure, valve leaflet structure 16 Sealing member 20 leaflets 22 Angled struts, connecting struts 24 cells, opening 26 Inlet end 28 Outflow end 30 incoming edges 32 Commissure 60 tabs 100 linked skirt 102 Lower edge part 104 Main Unit 106a Flap 106b Flap 108 stitches 110a Folded part 110b Folded part 112 stitches 116 Diagonal Lines 120 Leaflets 122 Valve cusp edge, lower edge 124 first longitudinal edge portion 126 second longitudinal edge portion 128 Intersection 130 linked skirt 130a central part 130b side portion 132 Slit 134a Folded layer 134b Folded layer 136 Reinforcing members, reinforcing cords 138 stitches 142 Edge 144 Overlock Stitch 146 stitches 148 Sutures 152 Thread 154 Thread 158 Lower Tab 159 Side Edge 160 Upper tab, gap, recess 160a First Tab Layer 160b Second Tab Layer 162 crease line 170 Commissure 172 Commissure attachment member, stitch 180 Artificial Heart Valves 300 Delivery Device 302 Handle 304 Outer shaft 306 Intermediate shaft 308 Inner Shaft 309 Distal end portion 310 proximal end portion 312 adapter 314 Rotatable Knob 316 Distal end portion 318 Inflatable Balloon 320 central longitudinal axis 322 Nosecone 324 Valve mounting part 326 Distal Shoulder 328 Distal tip 332 distal end portion, distal end section 333 proximal end portion, proximal end section 335 Middle part, middle section 338 First Port 340 Secondary Port 360° rotatable knob 361 Adjustment mechanism 362 Rotatable Knob 370 Artificial Heart Valves 379 Rotatable Knob

Claims

1. An artificial valve, a radially expandable and compressible frame comprising a plurality of interconnected struts; a valve structure including a plurality of leaflets configured to regulate blood flow through the prosthetic valve, the leaflets having wavy leaflet edge portions; at least one connecting skirt having a shape corresponding to a leaflet edge portion of at least one leaflet; the connecting skirt connecting the leaflet edge portion of the leaflet to at least one of the struts of the frame; the connecting skirt includes a first set of threads that intersect with a second set of threads, the first set of threads and the second set of threads extending at an oblique angle relative to a longitudinal axis of at least one of the struts.

2. The prosthetic valve of claim 1 , wherein the first set of threads are perpendicular to the second set of threads.

3. 3. The prosthetic valve of claim 1, wherein the first set of threads is woven together with the second set of threads.

4. The prosthetic valve of any one of claims 1 to 3, wherein the first set of threads extend at an angle of between about 40 and 50 degrees relative to the longitudinal axis of at least one of the struts.

5. The prosthetic valve of claim 4 , wherein the angle is approximately 45 degrees.

6. 6. The prosthetic valve of claim 1, wherein a first longitudinal edge portion of the connector skirt is bonded to the leaflet edge portion of the leaflet and a second longitudinal edge portion of the connector skirt is bonded to at least one of the struts, the second edge portion being on an opposite side of the first edge portion.

7. The prosthetic valve of claim 6 , wherein the second edge portion of the connecting skirt is sutured to at least one of the struts.

8. 8. The prosthetic valve of claim 6 or 7, wherein the second edge portion of the connecting skirt is configured to overlap at least a portion of an inner surface of at least one of the struts.

9. The prosthetic valve of claim 8 , wherein the second edge portion of the connecting skirt includes a plurality of flaps extending at least partially around at least one of the struts.

10. 10. The prosthetic valve of claim 6, wherein the first edge portion of the connecting skirt extends along the entire length of the leaflet edge portion of the leaflet.

11. 11. The prosthetic valve of claim 6, wherein the first edge portion of the connecting skirt, the leaflet edge portion of the leaflet, and the reinforcing cord extending along the leaflet edge portion of the leaflet are joined together by one or more stitches.

12. 12. The prosthetic valve of claim 1, wherein the connecting skirt is one of a plurality of connecting skirts, each connecting skirt connecting a corresponding leaflet to a respective adjacent strut.

13. 13. The prosthetic valve of claim 1, wherein the longitudinal axis of at least one strut extends at an oblique angle relative to a central longitudinal axis of the frame.

14. An artificial valve, a radially expandable and compressible frame comprising a plurality of interconnected struts, said frame having an inflow end and an outflow end; a valve structure including a plurality of leaflets configured to regulate blood flow through the prosthetic valve, the leaflets having wavy leaflet edge portions; a connecting skirt having a wave shape corresponding to the shape of the leaflet edge portion; Equipped with the connecting skirt connects leaflet edge portions of the plurality of leaflets to struts of the frame that extend diagonally relative to the inflow and outflow ends of the frame; the connecting skirt includes a first set of yarns interwoven with a second set of yarns, the first set of yarns extending at an oblique angle to the struts connected to the connecting skirt.

15. The prosthetic valve of claim 14 , wherein the connecting skirt comprises a plurality of skirt segments, each connecting a corresponding leaflet edge portion to each strut.

16. 1. A method for mounting a multi-leaflet valve structure to a radially expandable and compressible frame, comprising: coupling at least one leaflet to a connecting skirt; coupling the connecting skirt to a strut of the frame that extends diagonally along a line extending from the inflow end of the frame to the outflow end of the frame; wherein the connecting skirt comprises a first set of yarns interwoven with a second set of yarns, the connecting skirt being oriented such that the first set of yarns extend at an oblique angle relative to a longitudinal axis of the strut.

17. 17. The method of claim 16, further comprising coupling the plurality of leaflets to a plurality of link skirts and coupling the plurality of link skirts to respective struts of the frame, the leaflets having wavy leaflet edge portions, the link skirts forming wavy sections corresponding to the wavy leaflet edge portions of the leaflets.

18. 18. The method of claim 16 or 17, wherein coupling the leaflet to the strut comprises coupling a first longitudinal edge portion of the connector skirt to a leaflet edge portion of the leaflet and coupling a second longitudinal edge portion of the connector skirt to the strut, the second edge portion being on an opposite side of the first edge portion.

19. 20. The method of claim 18, wherein the second edge portion of the connecting skirt comprises a plurality of flaps, each flap connecting a segment of the leaflet edge portion to a respective strut adjacent the segment of the leaflet edge portion.

20. 20. The method of claim 18 or 19, wherein coupling the leaflet to the strut comprises coupling together the first edge portion of the connecting skirt, the leaflet edge portion of the leaflet, and a reinforcing cord extending along the leaflet edge portion of the leaflet with one or more stitches.

Images