Delivery assembly

Abstract

The utility model relates to a delivery assembly. A leaflet assembly for a prosthetic heart valve may include a leaflet having a cuspidal valve edge portion and opposing major surfaces. A reinforcing structure may be attached to the leaflet along the cuspid edge portion. The reinforcement structure may include a first reinforcement member and a second reinforcement member disposed on opposing major surfaces of the leaflet. A prosthetic heart valve may include a frame and a valve leaflet assembly. The leaflet assembly may include a leaflet and a reinforcement structure attached to the leaflet along a cuspid edge portion of the leaflet. The cusp edge portion may be coupled to the frame via a reinforcement structure. A method of assembling a prosthetic heart valve may include disposing a leaflet at least partially within a frame, and attaching the leaflet to the frame by extending a suture through reinforcing members attached to opposing major surfaces of the leaflet.

Description

[0001] This application is a divisional application. The application date of the original application is July 21, 2023, the application number is 2023219269508, and the name of the invention is "Valve leaf assembly and prosthetic heart valve".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,156, filed on July 22, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure relates to prosthetic heart valves, and methods and assemblies for forming and mounting leaflet assemblies to the frames of such prosthetic heart valves. Background Art

[0005] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. In various surgeries, percutaneous and minimally invasive surgical methods are used to deliver artificial medical devices to a position in the body that is not easily accessible by surgery or to a position that is desired to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and advance through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site in the heart. Subsequently, for example, by inflating a balloon on which a prosthetic heart valve is mounted, a mechanical actuator that applies an expansion force to the prosthetic heart valve is actuated, or by deploying the prosthetic heart valve from a sheath of a delivery device so that the prosthetic heart valve can self-expand to its functional size, the prosthetic heart valve is expanded to its functional size.

[0006] Most expandable prosthetic heart valves include an annular frame or stent, and prosthetic leaflets mounted within the frame. The leaflets can be attached to the frame along the cusp edge portions of the leaflets and at the commissure tabs of the leaflets. Mechanically expandable prosthetic heart valves (i.e., prosthetic valves that rely on mechanical actuators for expansion), as well as some balloon-expandable valves and self-expandable valves, are axially elongated when radially compressed for delivery to the patient. This can cause excessive stretching of the leaflets in the axial direction, which can deform and / or damage the leaflets. Utility Model Content

[0007] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, delivery devices, and methods can, for example, provide enhanced structural integrity of a prosthetic heart valve. In particular, described herein are leaflets having reinforced cusp edge portions that are tear-resistant when sutured to a frame of a prosthetic heart valve or to a skirt attached to a frame of a prosthetic heart valve. Thus, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery devices.

[0008] A valve leaflet assembly for a prosthetic heart valve may include a valve leaflet having a cusp edge portion and a reinforcement structure attached to the valve leaflet along the cusp edge portion.In addition to these components, the valve leaflet assembly may also include one or more of the components disclosed herein.

[0009] In some examples, a leaflet assembly can include a leaflet having a cusp segment, a first major surface, and a second major surface, wherein the first major surface and the second major surface are separated by a thickness of the leaflet.

[0010] In some examples, the reinforcement structure of the leaflet assembly may be attached to the leaflet along the cusp edge portion.

[0011] In some examples, the reinforcement structure may include a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0012] In some examples, the first and second reinforcement members can be aligned across the thickness of the leaflet.

[0013] In some examples, the reinforcement structure can be attached to the leaflet by sutures that extend through both the first and second reinforcement members and a portion of the leaflet between the first and second reinforcement members.

[0014] In some examples, the first reinforcement member may include a plurality of apertures spaced along the length of the first reinforcement member, the second reinforcement member may include a plurality of apertures spaced along the length of the second reinforcement member, and the sutures may extend through the apertures in the first and second reinforcement members.

[0015] In some examples, the leaflet can include a plurality of apertures that align with a plurality of apertures in the first and second reinforcement members.

[0016] In some examples, the first and second reinforcement members can follow the curvature of the cusp edge portion.

[0017] In some instances, a leaflet assembly for a prosthetic heart valve includes a leaflet and a reinforcement structure. The leaflet includes a cusp edge portion, a first major surface, and a second major surface. The first major surface and the second major surface are separated by a thickness of the leaflet. The reinforcement structure is attached to the leaflet along the cusp edge portion. The reinforcement structure includes a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0018] In some examples, the flap leaf assembly includes one or more of the components described in Examples 1-8 below.

[0019] A prosthetic heart valve may include a frame, and a valve leaflet assembly coupled to the frame.In addition to these components, a prosthetic heart valve may also include one or more of the components disclosed herein.

[0020] In some examples, a leaflet assembly can include at least one leaflet and a reinforcement structure.

[0021] In some examples, the leaflet can include a cusp edge portion, a first major surface, and a second major surface, such that the first major surface and the second major surface are separated by a thickness of the leaflet.

[0022] In some examples, the reinforcement structure may be attached to the leaflet along the cusp edge portion.

[0023] In some examples, the reinforcement structure may include a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0024] In some examples, the cusp edge portions of the leaflets can be coupled to the frame via a reinforcement structure.

[0025] In some examples, the frame can include a plurality of struts, and the cusp edge portion can be coupled to at least one strut of the plurality of struts by at least one suture extending through the reinforcement structure.

[0026] In some instances, the first reinforcement member may include a plurality of apertures spaced apart along the length of the first reinforcement member, the second reinforcement member may include a plurality of apertures spaced apart along the length of the second reinforcement member, and at least one suture may extend through one of the apertures in the first reinforcement member and one of the apertures in the second reinforcement member.

[0027] In some examples, at least one suture can form a loop extending around at least one strut.

[0028] In some examples, the prosthetic heart valve can include an inner skirt extending along an inner surface of the frame, and at least one suture can extend through the inner skirt and couple the cusp edge portion to the inner skirt.

[0029] In some examples, the prosthetic heart valve can include an outer skirt disposed about an outer surface of the frame, and at least one suture can extend through the outer skirt and couple the inner skirt to the outer skirt.

[0030] In some instances, a prosthetic heart valve includes a frame and a leaflet assembly. The frame is configured to be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The leaflet assembly is at least partially located within the frame. The leaflet assembly includes at least one leaflet and a reinforcement structure. At least one leaflet includes a cusp edge portion, a first major surface, and a second major surface. The first major surface and the second major surface are separated by the thickness of the leaflet. The reinforcement structure is attached to the leaflet along the cusp edge portion. The reinforcement structure includes a first reinforcement member arranged on the first major surface and a second reinforcement member arranged on the second major surface. The cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure.

[0031] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 18-39 below.

[0032] A method of assembling a prosthetic heart valve may include positioning the leaflets at least partially within a frame, and attaching the leaflets to the frame. In addition to these steps, the method of assembling a prosthetic heart valve may further include one or more of the steps disclosed herein.

[0033] In some instances, a method of assembling a prosthetic heart valve may include attaching the leaflet to a frame by extending sutures through first and second reinforcing members attached to opposing major surfaces of the leaflet along the cusp edge portions of the leaflet, through an inner skirt disposed on an inner surface of the frame, and around struts of the frame.

[0034] In some examples, the stitching may extend through the inner skirt at two spaced-apart locations.

[0035] In some examples, the stitching may extend through an outer skirt disposed about an outer surface of the frame at two spaced-apart locations, and the stitching may extend over an outer surface of the outer skirt.

[0036] In some examples, the method may include forming a connecting portion between the inner skirt and the outer skirt such that the struts are enclosed in a space formed between the inner skirt, the outer skirt, and the connecting portion.

[0037] In some instances, a method of assembling a prosthetic heart valve includes positioning the leaflet at least partially within a frame, and attaching the leaflet to the frame by extending sutures through first and second reinforcing members attached to opposing major surfaces of the leaflet along a cusp edge portion of the leaflet, through an inner skirt positioned on an inner surface of the frame, and around struts of the frame.

[0038] In some examples, a method of assembling a prosthetic heart valve includes one or more of the steps recited in Examples 40-47 below.

[0039] The various innovations disclosed herein may be used in combination or individually. This summary is provided to introduce some concepts in a simplified form, which are further described in the detailed description below. This summary is not intended to define the principal or basic structure of the subject matter protected by the claims, nor is it intended to limit the scope of the subject matter protected by the claims. The foregoing and other objects, features, and advantages of the present invention will become more apparent from the detailed description below, which is presented with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0041] Figure 2A is a perspective view of a prosthetic heart valve according to another example.

[0042] Figure 2B yes Figure 2A A perspective view of a prosthetic heart valve of FIG. 1 is shown with components on the outside of the frame shown in dashed lines.

[0043] Figure 3A and Figure 3B is a plan view of a flap leaf assembly in a flat configuration according to one embodiment.

[0044] Figure 4 is a plan view of a leaflet assembly in a flat configuration according to one embodiment, wherein the leaflet assembly includes Figures 3A-3B A multiple lobe leaf assembly of the type shown in .

[0045] Figures 5A-5C Suturing a reinforcement structure to a leaflet is shown according to one example.

[0046] Figure 6A Based on an example including Figure 3A and Figure 3B Side elevation view of the leaflet assembly of a prosthetic heart valve.

[0047] Figure 6B yes Figure 6ASide elevation view of a prosthetic heart valve of FIG. 1 , with components behind the outer skirt shown for illustrative purposes.

[0048] Figure 6C yes Figure 6A An enlarged view of a portion of the inner surface of the frame depicting an exemplary valve leaf assembly.

[0049] Figure 6D is similar to Figure 6B 1 is a side elevation view of a prosthetic heart valve illustrating an exemplary location of a connection between an inner skirt and an outer skirt of the prosthetic heart valve.

[0050] Figure 7 yes Figure 6B The prosthetic heart valve Figure 6B 7, which illustrates an exemplary attachment of the cusp edge portion of the valve leaflet assembly to the frame of the prosthetic heart valve via the reinforcement structure of the valve leaflet assembly.

[0051] Figure 8 is similar to Figure 7 , showing another example of attaching the cusp edge portion of the leaflet assembly to the frame.

[0052] Figure 9 is similar to Figure 7 , showing another example of attaching the cusp edge portion of the leaflet assembly to the frame.

[0053] Figure 10 is a side view of an example of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site. DETAILED DESCRIPTION

[0054] General considerations

[0055] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to any problems.

[0056] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may in some cases be rearranged or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by those of ordinary skill in the art.

[0057] 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 "comprising" means "including." Furthermore, the term "coupled" generally refers to a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and, in the absence of specific language to the contrary, does not exclude the presence of intervening elements between the coupled or associated items.

[0058] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction or portion of a device that is further away from the user and further away from the implantation site. Thus, for example, the proximal motion of a device is the motion of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal motion of the device is the motion of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise expressly defined.

[0059] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0060] Introduction to public technology

[0061] Figure 1An exemplary prosthetic valve 100 according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in the native aortic valve annulus, but in other examples, the prosthetic valve may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valves may also be implanted in a blood vessel connected to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0062] In some instances, a prosthetic heart valve can be implanted within a docking or anchoring device that is implanted within a natural heart valve or blood vessel. In one instance, a prosthetic heart valve can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Patent Publication No. 2017 / 0231756, which is incorporated herein by reference. In another instance, a prosthetic heart valve can be implanted within a docking device implanted within or at the natural mitral valve, such as disclosed in International Patent Publication No. WO2020 / 247907, which is incorporated herein by reference. In another instance, a prosthetic heart valve can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0063] In some examples, a leaflet assembly that can be used in a valve structure of a prosthetic heart valve includes a leaflet and a reinforcement structure attached to the leaflet. In some examples, the reinforcement structure includes a pair of reinforcement members attached to opposite sides of the leaflet and adjacent to the cusp edge portion of the leaflet. The reinforcement structure can protect the cusp edge portion from tearing when the cusp edge portion is sutured to the frame of the prosthetic heart valve.

[0064] Examples of Disclosed Technology

[0065] Figure 1An exemplary prosthetic heart valve 100 according to one example is shown. The prosthetic heart valve 100 can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration for delivery into a patient. In the example shown, the prosthetic heart valve 100 includes a frame 102 (or stent) and a valve structure 104 coupled to the frame. The prosthetic heart valve 100 may include an inner skirt 106 disposed on an inner surface of the frame 102 and / or coupled to the inner surface of the frame. The prosthetic heart valve 100 may include an outer skirt 108 (or paravalvular outer sealing member) disposed on an outer surface of the frame 102 and / or coupled to the outer surface of the frame. In the example shown, the outer skirt 108 is attached to the frame 102 by sutures 130, 132.

[0066] Frame 102 can be made of any of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) known in the art. When constructed of plastic expansion materials, frame 102 (and therefore prosthetic heart valve 100) can be curled into a radially compressed state on a delivery catheter, and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed of self-expanding materials, frame 102 (and therefore prosthetic heart valve 100) can be curled into a radially compressed state, and be limited in a compressed state by inserting a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic heart valve can be advanced from the delivery sheath, which allows the prosthetic heart valve to expand to its functional size.

[0067] Suitable plastically expandable materials that can be used to form the frames disclosed herein (e.g., frame 102) include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the frame 102 can comprise stainless steel. In some instances, the frame 102 can comprise a cobalt-chromium alloy. In some instances, the frame 102 can comprise a nickel-cobalt-chromium alloy. In some instances, the frame 102 can comprise a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trade name of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains, by weight, 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum.

[0068] The valve structure 104 is configured to regulate the flow of blood through the prosthetic heart valve 100 from the inflow end 110 of the prosthetic heart valve 100 to the outflow end 113 of the prosthetic heart valve 100. The valve structure 104 may include one or more leaflets. In one example, the valve structure 104 includes three leaflets 114 formed into a leaflet assembly 118 that can be arranged to collapse in a tricuspid valve arrangement. In some examples, the leaflets 114 can be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials as are known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0069] The leaflets 114 can be secured to each other at adjacent sides thereof to form commissures 126 of the valve structure 104. The commissures 126 can be used to couple the valve structure 104 to the frame 102. For example, the frame 102 can have a plurality of circumferentially spaced slots 124 (or commissure windows) adapted to mount the commissures 126 of the valve structure 104 to the frame. In some examples, the lower edge of the valve structure 104 can have a wavy, curved, fan-like shape and can be secured to the inner skirt 106 by sutures (not shown). The inner skirt 106 can be secured to the frame 102 to couple the lower edge of the valve structure 104 to the frame.

[0070] Additional details regarding the prosthetic heart valve 100 and its various components are described in International Patent Publication No. WO 2018 / 222799, which is incorporated herein by reference.

[0071] Figure 2A and 2B An exemplary prosthetic heart valve 200 according to another example is shown. In the example shown, the prosthetic heart valve 200 includes a frame 202 (or stent), a valve structure 204, and a sealing member 206. The valve structure 204 may include three leaflets 208 that together form a leaflet assembly 210 that is arranged to collapse in a tricuspid arrangement. Each leaflet 208 can be coupled to the frame 202 along a cusp edge portion 212 of the leaflet (i.e., the inflow edge or inferior edge of the leaflet in the figure) and at a commissure 214 of the valve structure 204 where adjacent portions of two leaflets 208 are connected to each other. In some examples, a reinforcing element (not shown), such as a fabric strip, can be directly connected to the cusp edge portion of the leaflet 208 and the struts 216 of the frame 202 to couple the cusp edge portion 212 of the leaflet 208 to the frame 202.

[0072] Similar to Figure 1 Frame 102, frame 202 may be made of any of a variety of suitable plastically expandable or self-expanding materials as known in the art and described above. Figure 2A and Figure 2B The frame 202 in the illustrated example includes a plurality of circumferentially extending rows of angled struts 216 that define rows of cells 218 (or openings) of the frame 202. The frame 202 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inflow end 220 to the outflow end 222 of the frame as shown, or the diameter of the frame can vary along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0073] In the example shown, the sealing member 206 is mounted on the outside of the frame 202 and is used to form a seal against the surrounding tissue (e.g., the native leaflets and / or the native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 206 may have an inner layer 224 and an outer layer 226. In the example shown, the inner layer 224 is arranged to contact the outer surface of the frame 202, and the outer layer 226 is arranged radially outside the inner layer 224. The sealing member 206 can be connected to the frame 202 using a suitable technique or mechanism. For example, the sealing member 206 can be sutured to the frame 202 via sutures that can extend around the struts 216 and through the inner layer 224. In other examples, the inner layer 224 can be mounted on the inner surface of the frame 202, and the outer layer 226 is mounted on the outer surface of the frame 202.

[0074] In some examples, the outer layer 226 can be constructed or shaped to extend radially outward from the inner layer 224 and the frame 202 when the prosthetic heart valve 200 is deployed. When the prosthetic heart valve is fully expanded outside the patient's body, the outer layer 226 can expand away from the inner layer 224 to create a space between the two layers. Thus, when implanted in the body, this allows the outer layer 226 to expand to contact surrounding tissue, such as the native annulus.

[0075] Additional details regarding the prosthetic heart valve 200 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0076] Figure 3A and 3B A valve leaflet assembly 500 according to one example is shown. A valve structure for a prosthetic heart valve may include one or more valve leaflet assemblies 500. In the example shown, the valve leaflet assembly 500 includes a valve leaflet 501 and a cusp edge reinforcement structure 502 attached to the valve leaflet 501 to increase the cusp edge portion ( Figure 3A and 3B The cusp edge reinforcement structure 502 can prevent tearing at the cusp edge portion of the leaflet 501 when the cusp edge portion is sutured to the frame of the prosthetic heart valve directly or via the inner skirt attached to the frame.

[0077] The leaflet 501 includes a body 503 having a first major surface 504a (e.g., Figure 3A ) and the second major surface 504b (as depicted in Figure 3B ), a cusp edge portion 508 (which may also be referred to as the inflow edge portion of the leaflet or the lower edge portion of the leaflet), a free edge portion 510 (which may also be referred to as the upper edge portion of the leaflet), and a pair of commissure tabs 512 on opposite side edges of the body 503. Major surfaces 504a, 504b are separated by the thickness of the leaflet 501 (and form opposing major surfaces of the leaflet). The free edge portion 510 can engage with the free edge portion of an adjacent leaflet when the leaflet assembly is in a closed position under pressure from backflow of blood. The commissure tabs 512 of adjacent leaflets can be coupled together to form the leaflet assembly of the valve structure.

[0078] As described with respect to leaflets 104, leaflets 501 can be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0079] The cusp edge reinforcement structure 502 includes a first reinforcement member 514 and a second reinforcement member 516. The first reinforcement member 514 is arranged on the first major surface 504a along the cusp edge portion 508. The second reinforcement member 516 is arranged on the second major surface 504b along the cusp edge portion 508. The first reinforcement member 514 and the second reinforcement member 516 are attached to the leaflet 501, for example, using a suture 515 (or multiple sutures 515). In some examples, the cusp edge portion 508 may have a curved shape. The attachment of the reinforcement members 514, 516 to the leaflet 501 (e.g., via the suture 515) can allow the reinforcement members 514, 516 to follow the curvature of the cusp edge portion 508.

[0080] In some examples, the position of the first reinforcement member 514 on the first major surface 504a corresponds to the position of the second reinforcement member 516 on the second major surface 504b (i.e., the reinforcement members 514, 516 are aligned across the thickness of the leaflet 501) so that the suture 515 can extend through both of the reinforcement members 514, 516 in a direction perpendicular to the major surfaces 504a, 504b. In the example shown, the first reinforcement member 514 is offset from the cusp edge 509 by a margin 517. Similarly, the second reinforcement member 516 is offset from the cusp edge 509 by a margin 519. The margins 517, 519 can be selected so that the suture 515 is offset inwardly from the tip edge 509 (e.g., Figure 3A and 3B depicted in ).

[0081] In some instances, such as Figure 3A and 3B As depicted in FIG, orifices 520, 522 (or suture holes) can be preformed in the reinforcing members 514, 516 to receive a needle (or other tool) carrying a suture for forming a stitch. The spacing between the orifices 520, 522 on each of the reinforcing members 514, 516 can be uniform or non-uniform (e.g., it may be desirable to have the orifices closer together where the radius of curvature of the member is smaller and to have the orifices further apart where the radius of curvature of the member is larger). The leaflet 501 can have preformed holes or orifices that align with the orifices 520, 522 in the reinforcing members 514, 516 (e.g., Figure 5A and 5B 530a, 530b depicted in FIG. ). Apertures 520, 522 may be used when attaching reinforcement members 514, 516 to leaflets 501, and when attaching cusp edge portion 508 to the frame or to the inner skirt of the frame.

[0082] Reinforcement members 514, 516 can be in the form of lines or strips. In a specific instance, reinforcement members 514, 516 can be braided sutures, which can be formed of natural suture material or synthetic suture material (e.g., polyester suture, such as Ethibond suture). In some instances, the suture 515 that attaches reinforcement members 514, 516 to the leaflet 501 can have a smaller diameter than the diameter of any one of reinforcement members 514, 516. In some instances, suture 515 can be a braided suture (e.g., Ethibond suture) with a suture size (gauge) in the range of 3-0 to 5-0, with 4-0 being a specific instance, and reinforcement members 514, 516 can be a braided suture (e.g., Ethibond suture) with a suture size (gauge) in the range of 2-0 to 3-0, with 3-0 being a specific instance. Suture 515 can be made of any suitable suture material. In another example, the reinforcing members 514, 516 can be braided sutures, while the suture 515 can be a monofilament suture. In other examples, the reinforcing members 514, 516 can include a fabric, such as a woven, braided, or knitted fabric, such as PET or UHMW fabric. In other examples, the reinforcing members 514, 516 can include natural tissue (e.g., pericardial tissue) or a non-woven material layer, such as made from any of a variety of polymers (e.g., TPU).

[0083] Two or more leaflet assemblies 500 may be used to form a leaflet assembly. Figure 4An example of three leaflet assemblies 500a, 500b, 500c coupled together to form a leaflet assembly is shown. For example, a commissure 513 can be formed between adjacent commissure tabs 512 of adjacent leaflets. In some examples, the commissure 513 may include an attachment member 517 (e.g., a fabric, flexible polymer, etc.) that is attached to the commissure tabs 512 at opposite ends. The outer commissure tabs 512a, 512c of the leaflet assembly can be coupled together with another attachment member 517 to form a third commissure 513 and form a leaflet assembly having an annular shape. The commissures 513 formed between the leaflet assemblies can be used to couple the leaflet assembly to the frame of a prosthetic heart valve.

[0084] In some examples, cusp edge reinforcement structure 502 can be attached to leaflet 501 before leaflet 501 is attached to the other leaflets to form the leaflet assembly. In other examples, cusp edge reinforcement structure 502 can be attached to leaflet 501 after leaflet 501 is attached to the other leaflets to form the leaflet assembly.

[0085] In some examples, adjacent ends of first reinforcement members 514 on adjacent leaflets of a leaflet assembly may be connected together to form a single reinforcement member that extends continuously along the first major surface of all leaflets in the leaflet (or portions of a single reinforcement member that extends around the first major surface of the leaflet assembly may provide first reinforcement members 514 on the first major surface of the leaflets of the leaflet assembly). Similarly, in some examples, adjacent ends of second reinforcement members 516 on adjacent leaflets of the leaflet assembly may be connected together to form a single reinforcement member that extends continuously along the second major surface of all leaflets in the leaflet (or portions of a single reinforcement member that extends around the second major surface of the leaflet assembly may provide second reinforcement members 516 on the second major surface of the leaflets of the leaflet assembly).

[0086] Figures 5A-5C The attachment of the cusp edge reinforcement structure 502 to the leaflets 501 is shown. In this example, an in-out suture pattern (or flat stitch pattern) is used, but any suture pattern capable of securely securing the cusp edge reinforcement structure 502 to the leaflets 501 may be used in other examples.

[0087] Figure 5A A portion 524a of thread 524 (or suture) is shown extending through the first opening 520a in the first reinforcing member 514, through the opening 530a in the leaflet 501 (i.e., the opening extending from the first major surface 504a to the second major surface 504b), and through the first opening 522a in the second reinforcing member 516 to complete the "in" portion of the first stitch. Figure 5BAnother portion 524b of thread 524 is shown extending through a second aperture 522b in second reinforcement member 516 that is offset from first aperture 522a, through aperture 530b in leaflet 501 that is aligned with second aperture 522b, and through a second aperture 520b in first reinforcement member 514 that is offset from first aperture 520a and aligned with apertures 522b, 530b to complete the "out" portion of the first stitch. This suturing sequence can be repeated at other apertures along reinforcement members 514, 516, and leaflet 501. Figure 5C A completed stitch line 515 is shown extending along the length of the reinforcement structure 502. The ends of the line 524 may be knotted or otherwise secured in place (as depicted at 526, 528).

[0088] Figures 6A-6C An exemplary prosthetic heart valve 300 including a leaflet assembly 500 is shown. The prosthetic heart valve 300 includes a frame 302 and a valve structure 304 arranged within the frame 302. In the example shown, the valve structure 304 includes a leaflet assembly comprised of three leaflet assemblies 500 as described herein. The three leaflet assemblies 500 are arranged to collapse in a tricuspid arrangement. In other examples, the valve structure 304 may have a greater or fewer number of leaflets (e.g., one or more of the leaflet assemblies 500). The leaflet assemblies 500 are secured to each other via commissures 513 and to the frame 302 at the commissures 513.

[0089] In the example shown, the frame 302 includes an inflow end 310 and an outflow end 312. The frame 302 includes a plurality of angled and interconnected struts 308 arranged in a plurality of circumferentially extending rows of angled struts 308 between the inflow end 310 and the outflow end 312. Each row of struts 308 defines a row of cells 314 (or openings) of the frame 302. The struts 308 may intersect at the inflow end 310 and the outflow end 312 to form a plurality of vertices 316 spaced apart along the circumference of the frame 302. The struts 308 may further intersect at locations between the inflow end 310 and the outflow end 312 to form strut joints 318. In the example shown, the frame 302 is similar to Figure 2A and 2B In other examples, the frame 302 may have a different structure, such as Figure 1 The structure shown in .

[0090] The prosthetic heart valve 300 may include an inner skirt 306 that extends along the inner surface of the frame 302 and covers the inner sides of at least some of the struts 308. The inner skirt 306 may cover the inner surfaces of the struts 308 along a fan-shaped line pattern (e.g., Figure 6B). There may be one inner skirt 306 extending continuously along the inner surface of frame 302, or there may be multiple inner skirts 306, with each inner skirt extending along a portion of frame 302 corresponding to the attachment area of ​​cusp edge region 508 of one of leaflets 501. Inner skirt 306 may be made of a suitable tear-resistant material (e.g., an implantable polymer in the form of a woven or non-woven material, such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), or thermoplastic polyurethane (TPU)).

[0091] Prosthetic heart valve 300 can include an outer skirt 305 (or outer paravalvular sealing member) that extends around the outer surface of frame 302 and covers the outside of at least some of struts 308. Outer skirt 305 can be made of a suitable tear-resistant material (e.g., an implantable polymer in the form of a woven or non-woven material, such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), or thermoplastic polyurethane (TPU)).

[0092] Inner skirt and / or outer skirt can be formed wholly or in part by any suitable biomaterial, synthetic material (for example, any one of various polymers) or its combination.In some instances, inner skirt and / or outer skirt may comprise a fabric with interwoven yarn or fiber, for example, in the form of a weaving, braiding or knitted fabric.In some instances, fabric may have plush pile or suede.Exemplary fabrics with plush pile or suede include velvet, velvet, velveteen, corduroy, terry cloth, fleece cloth etc.In some instances, inner skirt and / or outer skirt may comprise a fabric without interwoven yarn or fiber or randomly interwoven yarn or fiber, for example, felt or electrospun fabric.Exemplary materials that can be used to form such fabrics (with or without interwoven yarn or fiber) include but are not limited to polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the inner and / or outer skirt can include a non-woven or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the inner and / or outer skirt can include a sponge material or foam, such as polyurethane foam. In some examples, the inner and / or outer skirt can include natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0093] In some examples, the cusp edge portion 508 of the leaflet 501 can be attached to the frame 302 via stitched sutures 324 that extend through the reinforcement structure 502 of the leaflet assembly 500, through one or both of the inner skirt 306 and the outer skirt 305, and around the struts 308. Figure 6B and 6C , the inner skirt 306 is attached to both the leaflets 501 (via the reinforcement structure 502) and the outer skirt 305. In some examples, the inner skirt 306 can be connected to the outer skirt 305 along the undulating struts 308 of the frame 302 (e.g., following a scalloped pattern). In other examples, the sutures 324 can extend through the cusp edge portions of the leaflets (e.g., through the reinforcement structure 502), through the inner skirt 306, and around selected struts 308 of the frame, but not through the outer skirt 305 (which can be secured to selected struts of the frame 302 with separate sutures).

[0094] In some examples, the sutures 324 may be relatively loose, and the sutures between the outer skirt 305 and the inflow end 310 or outflow end 312 of the frame 302 may be omitted (e.g., Figure 1 ), such that the outer skirt 305 can slide relative to the frame 302 during the transition of the frame 302 between the compressed state and the expanded state without being longitudinally stretched.

[0095] Figure 7 The structure of suture 324 according to one example is shown. In this example, suture 324 extends in a radially outward direction through the orifices of reinforcement structure 502 and leaflet 501 (as depicted at 324a), and passes through the inner skirt 306 and the portion of outer skirt 305 above the strut 308 (as depicted at 324b). Suture 324 forms a loop above the outside of outer skirt 305 (as depicted at 324c). Suture 324 extends back through the outer skirt 305 and the portion of inner skirt 306 below the strut 308 (as depicted at 324d) and passes through the orifice of reinforcement structure 502 (as depicted at 324e). The ends of suture 324 can be tied or otherwise secured together (as depicted at 324f). In this way, suture 324 forms a loop around strut 308. A plurality of spaced-apart sutures 324 (e.g., a plurality of spaced-apart sutures 324) may be formed to loop around respective struts 308 and extend through skirts 305, 306, reinforcement structure 502, and leaflets 501. Figure 6B and 6C ) to couple cusp edge portions 508 of leaflets 501 to frame 302. Sutures 324 can be formed along struts 308 along an undulating path so that cusp edge regions 508 of leaflets 501 are coupled to frame 302 following a scalloped line pattern.

[0096] In some examples, a connecting portion 360 is formed between the inner skirt 306 and the outer skirt 305 and around the skirt suture (formed by suture 324), which encloses the struts 308 in the space 328 between the inner skirt 306 and the outer skirt 305. The connecting portion 360 can provide a relatively smooth and gradual transition between the struts 308 and the outer skirt 305 to facilitate proper flushing and reduce the risk of stagnant flow areas that could otherwise promote thrombus or pannus formation over time. The connecting portion 360 can be formed by being positioned above the suture 324 (e.g., along the Figure 6D 306 is formed by bonding or sewing the inner skirt 306 to the outer skirt 305 along the path 370 shown in FIG. For example, one or both of the skirts 305, 306 may carry an adhesive layer that can be used to bond the skirts together to form a connecting portion. In some examples, the inner skirt 306 may be made of a material (e.g., ePTFE or TPU) that can be bonded or fused to the outer skirt 305 via heat and / or pressure. In some such examples, the inner skirt 306 can be fused to the outer skirt 305 at the connecting portion 306 without any stitches or a separate adhesive layer.

[0097] exist Figure 7 In the illustrated example, the stitching 324 extends through the space 328 and avoids the connecting portion 360 (in other words, the stitching 324 does not extend through the inner and outer skirts along the connecting portion 306). Figure 8 An alternative example is shown in which the stitching 326 may extend through the connection 362 formed between the inner skirt 306 and the outer skirt 305. Figure 8 In the example of FIG. 5 , the suture 326 extends in an outward direction through the orifices of the reinforcement structure 502 and the leaflet 501 (as depicted at 326 a), and through the connecting portion 362 a formed between the inner skirt 306 and the portion of the outer skirt 305 above the struts 308 (as depicted at 326 b). The suture 326 extends over the outside of the outer skirt 305 (as depicted at 326 c). The suture 326 extends back through the connecting portion 362 b formed between the portion of the outer skirt 305 and the portion of the inner skirt 306 below the struts 308 (as depicted at 326 d), and through the orifice of the reinforcement structure 502 (as depicted at 326 e). The ends of the suture 326 can be tied or otherwise secured together (as depicted at 326 f). Figure 8 The example shown in can extend the durability of the attachment of the valve leaflet assembly to the frame by suturing (e.g., by passing sutures 326 through the skirt to reduce the possibility of holes formed in the skirts 305, 306 expanding over time).

[0098] Figure 9 Another example of attaching the flap leaf assembly 510 to the frame is shown. Figure 9 In the example shown in , the inner skirt 306' is looped around the struts 308 of the frame so that the struts 308 are enclosed within the inner skirt. A connecting portion 364 is formed between the inner skirt 306' and the outer skirt 305 to attach the inner skirt 306' to the outer skirt 305. The connecting portion 364 can be formed, for example, by bonding (e.g., fusing) a portion of the inner skirt 306' to a portion of the outer skirt 305. The cusp edge portion 508 of the leaflet 501 can be coupled to the frame 302 by a suture 330. In this example, the suture 330 extends in an outward direction above the enclosed struts 308 through the orifices of the reinforcement structure 502 and the leaflet 501 (as depicted at 330a), and through the outer skirt 305 (as depicted at 330b). The suture 330 extends over the outside of the outer skirt 305 (as depicted at 330c). The suture 330 extends back through the outer skirt 305 (as depicted at 330d) and through the aperture of the reinforcing structure 502 (as depicted at 330e). The ends of the suture 330 may be knotted or otherwise secured together (as depicted at 330f). Figure 9 In some embodiments, sutures 330 do not penetrate inner skirt 306'. In other embodiments, sutures 330 penetrate inner skirt 306'. A plurality of spaced-apart sutures 330 may be formed to loop around struts 308 enclosed within inner skirt 306' and extend through outer skirt 305, reinforcement structure 502, and leaflets 501 to couple cusp edge portions 508 of leaflets 501 to frame 302.

[0099] Figure 10 A delivery device 400 is shown according to one example. The delivery device 400 may be used to implant an expandable heart valve (e.g., Figure 1 Prosthetic heart valve 100, Figures 2A-2B Prosthetic heart valve 200, Figures 6A-6D

[0066] In some examples, the delivery device 400 is particularly suitable for introducing a prosthetic heart valve into the heart.

[0100] In the example shown, the delivery device 400 is a balloon catheter having a handle 402 and a steerable outer shaft 404 extending distally from the handle 402. The delivery device 400 may also include an intermediate shaft 406 (which may also be referred to as a balloon shaft) extending proximally from the handle 402 and extending distally from the handle 402, with the portion extending distally from the handle 402 also extending coaxially through the outer shaft 404. Additionally, the delivery device 400 may also include an inner shaft 408 extending distally from the handle 402 coaxially through the intermediate shaft 406 and an outer shaft 404 extending proximally from the handle 402 coaxially through the intermediate shaft 406.

[0101] The outer shaft 404 and the intermediate shaft 406 can be configured to translate longitudinally relative to each other along a central longitudinal axis 420 of the delivery apparatus 400 to facilitate delivery and positioning of a prosthetic heart valve at an implantation site within a patient.

[0102] The intermediate shaft 406 can include a proximal portion 410 that extends proximally from the proximal end of the handle 402 to an adapter 412. A rotatable knob 414 can be mounted on the proximal portion 410 and can be configured to rotate the intermediate shaft 406 about the central longitudinal axis 420 and relative to the outer shaft 404. The adapter 412 can include a first port 438 configured to receive a guidewire therethrough and a second port 440 configured to receive a fluid (e.g., an inflation fluid) from a fluid source. The second port 440 can be fluidically coupled to the inner lumen of the intermediate shaft 406.

[0103] The intermediate shaft 406 can also include a distal portion that extends distally beyond the distal end of the outer shaft 404 when the distal end of the outer shaft 404 is positioned distally from the inflatable balloon 418 of the delivery device 400. The distal portion of the inner shaft 408 can extend distally beyond the distal portion of the intermediate shaft 406. The balloon 418 can be coupled to the distal portion of the intermediate shaft 406.

[0104] In some examples, the distal end of the balloon 418 can be coupled to the distal end of the delivery device 400, such as to the nose cone 422 (e.g., Figure 10 ), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 400. The middle portion of the balloon 418 can cover the valve mounting portion 424 of the distal portion of the delivery device 400, and the distal portion of the balloon 418 can cover the distal shoulder 426 of the delivery device 400. The valve mounting portion 424 and the middle portion of the balloon 418 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 10 As schematically shown in , a prosthetic heart valve 450 (which may be one of the prosthetic heart valves described herein) may be mounted around a balloon 418 at a valve mounting portion 424 of the delivery device 400 .

[0105] The balloon shoulder assembly, including distal shoulder 426 , is configured to maintain a prosthetic heart valve 450 (or other medical device) in a fixed position on balloon 418 during delivery through the patient's vasculature.

[0106] The outer shaft 404 may include a distal tip portion 428 mounted on its distal end. Figure 4), and during delivery of the prosthetic heart valve to a target implantation site, outer shaft 404 and middle shaft 406 can translate axially relative to each other to position distal tip portion 428 adjacent to the proximal end of valve mounting portion 424. Thus, distal tip portion 428 can be configured to resist proximal movement of prosthetic heart valve 450 relative to balloon 418 in an axial direction when distal tip portion 428 is disposed adjacent to the proximal end of valve mounting portion 424.

[0107] An annular space can be defined between an outer surface of the inner shaft 408 and an inner surface of the intermediate shaft 406 and can be configured to receive fluid from a fluid source via the second port 440 of the adapter 412. The annular space can be fluidly coupled to a fluid passage formed between an outer surface of the distal portion of the inner shaft 408 and an inner surface of the balloon 418. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate and radially expand the balloon 418 and deploy the prosthetic heart valve 450.

[0108] The inner lumen of the inner shaft 408 can be configured to receive a guidewire therethrough for guiding the distal portion of the delivery device 400 to the target implantation site.

[0109] The handle 402 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 400. In the example shown, the handle 402 includes an adjustment member, such as a rotatable knob 460 shown, which is in turn operatively coupled to the proximal portion of the traction wire. The traction wire may extend distally from the handle 402 through the outer shaft 404 and have a distal portion fixed to the outer shaft 404 at or near the distal end of the outer shaft 404. Rotating the knob 460 may increase or decrease the tension of the traction wire, thereby adjusting the curvature of the distal portion of the delivery device 400. Further details about the steering or flexing mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0110] The handle 402 may also include an adjustment mechanism 461 including an adjustment member, such as the illustrated rotatable knob 462, and an associated locking mechanism including another adjustment member configured as a rotatable knob 478. The adjustment mechanism 461 is configured to adjust the axial position of the intermediate shaft 406 relative to the outer shaft 404 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 400 may be found in International Publication No. WO2022 / 046585, which is incorporated herein by reference.

[0111] Delivery Technology

[0112] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal 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 in the natural 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 the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J-sternotomy or a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0113] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0114] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0115] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal 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) for access to any native heart valve. Atrial delivery can also be performed intravascularly, for example from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0116] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0117] Any system, device, equipment etc. herein can be sterilized (for example, with heating / heat, pressure, steam, radiation and / or chemicals etc.) to ensure that they are safe for patient's use, and as one of the step of method, any method herein can comprise the sterilization of associated system, equipment, device etc. The example of heating / thermal sterilization comprises steam sterilization and autoclave. The example of radiation for sterilization includes but is not limited to gamma radiation, ultraviolet radiation and electron beam. The example of chemicals for sterilization includes but is not limited to ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde. For example hydrogen peroxide plasma can be used to complete with hydrogen peroxide sterilization.

[0118] Additional Instances

[0119] In view of the above-mentioned implementation of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of an example adopted in combination, and optionally combined with one or more features of one or more other examples, are additional examples that also fall within the disclosure of the present application.

[0120] Example 1: A leaflet assembly for a prosthetic heart valve includes: a leaflet having a cusp edge portion, a first major surface and a second major surface, wherein the first major surface and the second major surface are separated by the thickness of the leaflet; and a reinforcement structure attached to the leaflet along the cusp edge portion, the reinforcement structure including a first reinforcement member arranged on the first major surface and a second reinforcement member arranged on the second major surface.

[0121] Example 2: The leaflet assembly of any example herein, in particular example 1, wherein the first and second reinforcement members are aligned across the thickness of the leaflet.

[0122] Example 3: A leaflet assembly of any example herein, in particular any of Examples 1-2, wherein the reinforcement structure is attached to the leaflet by sutures extending through both the first reinforcement member and the second reinforcement member and a portion of the leaflet between the first reinforcement member and the second reinforcement member.

[0123] Example 4: The flap leaf assembly of any example herein, in particular Example 3, wherein the first reinforcement member includes a plurality of orifices spaced along the length of the first reinforcement member, and wherein the second reinforcement member includes a plurality of orifices spaced along the length of the second reinforcement member.

[0124] Example 5: The leaflet assembly of any example herein, particularly Example 4, wherein the suture extends through apertures in the first and second reinforcement members.

[0125] Example 6: The leaflet assembly of any example herein, particularly any of examples 4-5, wherein the leaflet comprises a plurality of apertures aligned with a plurality of apertures in the first and second stiffening members.

[0126] Example 7: The valve leaflet assembly of any example herein, particularly any of examples 1-6, wherein the first and second reinforcement members follow the curvature of the cusp edge portion.

[0127] Example 8: The leaflet assembly of any example herein, particularly any of examples 1-7, wherein each of the first and second reinforcement members comprises a braided suture.

[0128] Example 9: A leaflet assembly for a prosthetic heart valve includes a plurality of leaflet assemblies, each of the leaflet assemblies including a leaflet having a cusp edge portion, a first major surface, and a second major surface, wherein the first major surface and the second major surface are separated by the thickness of the leaflet, wherein the leaflet assembly includes a reinforcing structure attached to the leaflet along the cusp edge portion, the reinforcing structure including a first reinforcing member arranged on the first major surface and a second reinforcing member arranged on the second major surface, and wherein the leaflet assembly includes a plurality of commissures connecting the leaflet assemblies together.

[0129] Example 10: The leaflet assembly of any example herein, in particular Example 9, wherein the first and second reinforcement members of each leaflet assembly are aligned across the thickness of the leaflets of the leaflet assembly.

[0130] Example 11: A leaflet assembly of any example herein, in particular any example 9-10, wherein the reinforcement structure of each leaflet assembly is attached to the leaflet of each leaflet assembly by a suture, the suture extending through both the first reinforcement member and the second reinforcement member of the reinforcement structure and a portion of the leaflet between the first reinforcement member and the second reinforcement member of the reinforcement structure.

[0131] Example 12: The leaflet assembly of any example herein, in particular Example 11, wherein the first reinforcement member of each leaflet assembly includes a plurality of orifices spaced along the length of the first reinforcement member, and wherein the second reinforcement member of each leaflet assembly includes a plurality of orifices spaced along the length of the second reinforcement member.

[0132] Example 13: The leaflet assembly of any example herein, particularly Example 12, wherein the sutures of each leaflet assembly extend through apertures in the first and second reinforcement members of the leaflet assembly.

[0133] Example 14: The leaflet assembly of any example herein, in particular any of Examples 12-13, wherein each leaflet of the leaflet assembly includes a plurality of orifices that are aligned with a plurality of orifices in the first and second reinforcement members of the leaflet assembly.

[0134] Example 15: The leaflet assembly of any example herein, in particular any of Examples 9-14, wherein the reinforcement structure of each leaflet assembly follows the curvature of the cusp edge portion of each leaflet assembly.

[0135] Example 16: The leaflet assembly of any example herein, particularly any of Examples 9-15, wherein each of the first and second reinforcement members of each leaflet assembly comprises a braided suture.

[0136] Example 17: A leaflet assembly of any example herein, in particular any example 9-16, wherein each leaflet assembly includes a pair of commissure tabs located on opposite sides of the leaflet of the leaflet assembly, and wherein each commissure is formed between adjacent commissure tabs of adjacent leaflet assemblies.

[0137] Example 18: A prosthetic heart valve includes a frame configured to be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; and a leaflet assembly at least partially located within the frame. The leaflet assembly includes: at least one leaflet having a cusp edge portion, a first major surface, and a second major surface, wherein the first major surface and the second major surface are separated by a thickness of the leaflet; and a reinforcement structure attached to the leaflet along the cusp edge portion, the reinforcement structure including a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure.

[0138] Example 19: The prosthetic heart valve of any example herein, in particular Example 18, wherein the frame comprises a plurality of struts.

[0139] Example 20: The prosthetic heart valve of any example herein, in particular Example 19, wherein the cusp edge portion is coupled to at least one strut of the plurality of struts by at least one suture extending through the reinforcement structure.

[0140] Example 21: The prosthetic heart valve of any example herein, in particular Example 20, wherein the first reinforcement member includes a plurality of orifices spaced along the length of the first reinforcement member, wherein the second reinforcement member includes a plurality of orifices spaced along the length of the second reinforcement member, and wherein the at least one suture extends through one of the orifices in the first reinforcement member and one of the orifices in the second reinforcement member.

[0141] Example 22: The prosthetic heart valve of any example herein, particularly any of Examples 20-21, wherein the at least one suture forms a ring extending around the at least one strut.

[0142] Example 23: The prosthetic heart valve of any example herein, particularly any of Examples 20-22, further comprising an inner skirt extending along the inner surface of the frame, wherein at least one suture extends through the inner skirt and couples the cusp edge portion to the inner skirt.

[0143] Example 24: The prosthetic heart valve of any example herein, in particular Example 23, wherein the at least one suture extends through the inner skirt on opposite sides of the at least one strut.

[0144] Example 25: The prosthetic heart valve of any example herein, particularly any of Examples 23-24, further comprising an outer skirt disposed around an outer surface of the frame, wherein the at least one suture extends through the outer skirt and couples the inner skirt to the outer skirt.

[0145] Example 26: The prosthetic heart valve of any example herein, particularly Example 25, wherein the at least one suture extends through the outer skirt on opposite sides of the at least one strut and over a portion of the outer side of the outer skirt.

[0146] Example 27: A prosthetic heart valve according to any of the examples herein, in particular any of Examples 25-26, wherein a connecting portion is formed between the inner skirt and the outer skirt on opposite sides of the at least one strut, and wherein the at least one strut is enclosed in the space between the inner skirt, the outer skirt and the connecting portion.

[0147] Example 28: The prosthetic heart valve of any example herein, in particular Example 27, wherein the connecting portion comprises a portion of the outer skirt and the inner skirt joined together.

[0148] Example 29: The prosthetic heart valve of any example herein, in particular Example 27, wherein the connecting portion comprises a sewn-together portion of the outer skirt and the inner skirt.

[0149] Example 30: The prosthetic heart valve of any example herein, particularly any of Examples 27-29, wherein the at least one suture extends through the space between the inner skirt and the outer skirt.

[0150] Example 31: The prosthetic heart valve of any example herein, in particular any of Examples 27-29, wherein the at least one suture extends through the connecting portion.

[0151] Example 32: The prosthetic heart valve of any example herein, particularly any of Examples 20-22, further comprising an inner skirt encapsulating the at least one strut.

[0152] Example 33: The prosthetic heart valve of any example herein, particularly Example 32, further comprising an outer skirt disposed around an outer surface of the frame, and a connecting portion formed between the outer skirt and the inner skirt.

[0153] Example 34: The prosthetic heart valve of any example herein, in particular Example 33, wherein the at least one suture extends through the outer skirt and couples the cusp edge portion to the outer skirt.

[0154] Example 35: The prosthetic heart valve of any example herein, particularly any of Examples 19-34, wherein the first and second reinforcement members follow the curvature of the cusp edge portion.

[0155] Example 36: The prosthetic heart valve of any example herein, particularly any of Examples 19-35, wherein each of the first and second reinforcement members comprises a braided suture.

[0156] Example 37: The prosthetic heart valve of any example herein, particularly Example 19, further comprising an inner skirt extending along an inner surface of the frame, wherein the leaflets are sutured to the inner skirt via the reinforcement structure and along at least one of the plurality of struts.

[0157] Example 38: The prosthetic heart valve of any example herein, particularly Example 37, further comprising an outer skirt disposed about an outer surface of the frame, wherein the inner skirt is sewn to the outer skirt along the at least one strut.

[0158] Example 39: The prosthetic heart valve of any example herein, in particular any of Examples 18-38, wherein the leaflet assembly comprises a plurality of leaflets.

[0159] Example 40: A method of assembling a prosthetic heart valve includes: positioning the leaflet at least partially within a frame; and attaching the leaflet to the frame by extending sutures through first and second reinforcing members attached to opposite major surfaces of the leaflet along the cusp edge portions of the leaflet, through an inner skirt positioned on the inner surface of the frame, and around the struts of the frame.

[0160] Example 41: The method of any example herein, in particular example 40, wherein the suture extends through the inner skirt at two spaced-apart locations.

[0161] Example 42: The method of any example herein, particularly any of Examples 40-41, wherein the suture extends through an outer skirt disposed around an outer surface of the frame.

[0162] Example 43: The method of any example herein, in particular Example 42, wherein the suture extends through the outer skirt at two spaced-apart locations.

[0163] Example 44: The method of any example herein, in particular example 42, wherein the stitching extends over the outer surface of the outer skirt.

[0164] Example 45: The method of any example herein, particularly Example 42, further comprises forming a connecting portion between the inner skirt and the outer skirt, wherein the struts are enclosed in a space formed between the inner skirt, the outer skirt, and the connecting portion.

[0165] Example 46: The method of any example herein, in particular example 45, wherein the suture extends through the space.

[0166] Example 47: The method of any example herein, in particular example 45, wherein the suture extends through the connecting portion.

[0167] Example 48: A delivery assembly comprises: a delivery device; and a prosthetic heart valve coupled to the delivery device. The prosthetic heart valve comprises: a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration; and at least one leaflet having a cusp edge portion and opposing major surfaces; and a reinforcement structure attached to the leaflet along the cusp edge portion, the reinforcement structure comprising first and second reinforcement members disposed on the opposing major surfaces of the leaflet, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure.

[0168] Example 49: The delivery assembly of any example herein, in particular example 48, wherein the frame comprises a plurality of struts.

[0169] Example 50: The delivery assembly of any example herein, particularly Example 49, wherein the cusp edge portion is coupled to at least one of the plurality of struts by at least one suture extending through the reinforcement structure and the leaflet.

[0170] Example 51: The delivery assembly of any example herein, particularly any of Examples 48-50, further comprising an inner skirt disposed around the inner surface of the frame, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcing structure and the inner skirt.

[0171] Example 52: The delivery assembly of any example herein, particularly Example 49, further comprising an outer skirt disposed around an outer surface of the frame, wherein the inner skirt is attached to the outer skirt such that the at least one strut is enclosed between the inner skirt and the outer skirt.

[0172] Example 53: The delivery assembly of any example herein, particularly any of Examples 48-52, wherein the first and second reinforcement members follow the curvature of the cusp edge portion.

[0173] Example 54: A delivery assembly comprises: a delivery device; and a prosthetic heart valve coupled to the delivery device. The prosthetic heart valve comprises: a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration; and a plurality of leaflet assemblies coupled to the frame. Each of the leaflet assemblies comprises: a leaflet having a cusp edge portion and opposing major surfaces; and a reinforcement structure attached to the leaflet along the cusp edge portion, the reinforcement structure comprising a first reinforcement member and a second reinforcement member disposed on the opposing major surfaces of the leaflet, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure.

[0174] Example 55: The leaflet assembly, leaflet assembly, prosthetic heart valve, or delivery assembly of any example herein, particularly any of Examples 1-39 and Examples 48-54, wherein the leaflet assembly, leaflet assembly, prosthetic heart valve, or delivery assembly is sterilized.

[0175] Example 56: A method comprising sterilizing the valve leaflet assembly, leaflet assembly, prosthetic heart valve, or delivery assembly of any example herein, particularly any of Examples 1-39 and Examples 48-54.

[0176] Unless otherwise stated, features described herein with respect to any example can be combined with other features described in any one or more of the other examples. For example, any one or more features of one leaflet assembly can be combined with any one or more features of another leaflet assembly. As another example, any one or more features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve.

[0177] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery component, characterized in that include: delivery equipment; as well as A prosthetic heart valve coupled to the delivery device, the prosthetic heart valve comprising a frame radially collapsible and expandable between a collapsed configuration and an expanded configuration; and at least one leaflet having a cusp edge portion and opposing major surfaces; and a reinforcement structure attached to the leaflet along the cusp edge portion, the reinforcement structure comprising a first reinforcement member and a second reinforcement member arranged on opposing major surfaces of the leaflet, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure.

2. The delivery assembly according to claim 1, wherein The frame includes a plurality of pillars.

3. The delivery assembly according to claim 2, characterized in that wherein the cusp edge portion is coupled to at least one of the plurality of struts by at least one suture extending through the reinforcement structure and the leaflet.

4. The delivery assembly according to any one of claims 1 to 3, characterized in that Also included is an inner skirt disposed around an inner surface of the frame, wherein the cusp edge portion of the leaflet is coupled to the frame via the reinforcement structure and the inner skirt.

5. The delivery assembly according to claim 4, characterized in that Also included is an outer skirt disposed about an outer surface of the frame, wherein the inner skirt is attached to the outer skirt such that the at least one strut is enclosed between the inner skirt and the outer skirt.

6. The delivery assembly according to any one of claims 1 to 5, characterized in that The first reinforcement member and the second reinforcement member follow the curvature of the cusp edge portion.

7. The delivery assembly according to any one of claims 1 to 6, characterized in that Wherein the valve leaflet assembly, valve leaflet assembly, prosthetic heart valve or delivery assembly is sterilized.

8. A delivery component, characterized in that include: delivery equipment; as well as a prosthetic heart valve coupled to the delivery device, the prosthetic heart valve comprising a frame radially collapsible and expandable between a collapsed configuration and an expanded configuration; and a plurality of leaflet assemblies coupled to the frame, each of the leaflet assemblies comprising a leaflet having a cusp edge portion and opposing major surfaces; and a reinforcing structure attached to the leaflet along the cusp edge portion, the reinforcing structure comprising a first reinforcing member and a second reinforcing member arranged on opposite major surfaces of the leaflet, wherein the cusp edge portion of the leaflet is connected to the frame via the reinforcing structure.

9. The delivery assembly of claim 8, wherein Wherein the valve leaflet assembly, valve leaflet assembly, prosthetic heart valve or delivery assembly is sterilized.

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