阅读说明：本技术 具有可变直径的心脏瓣膜密封裙部 (Heart valve sealing skirt with variable diameter ) 是由 斯特凡·德拉洛耶 于 2019-03-06 设计创作，主要内容包括：实施例包括人工瓣膜和相关方法。在实施例中,包括了一种具有框架的植入式瓣膜,所述框架包括多个框架支柱。所述框架能够限定中心内腔。外裙部能够布置在所述框架的远腔侧表面上。所述外裙部能够包括翼部,所述翼部具有第一末端和第二末端。所述翼部的第一末端能够固定至所述框架的远腔侧表面,而所述第二末端能够背离所述框架的远腔侧表面自由移动。本文还包括另一些实施例。(Embodiments include prosthetic valves and related methods. In an embodiment, an implantable valve having a frame comprising a plurality of frame struts is included. The frame can define a central lumen. An outer skirt can be disposed on a distal surface of the frame. The outer skirt can include a wing having a first end and a second end. The first end of the wing can be fixed to the distal surface of the frame, while the second end can be freely movable away from the distal surface of the frame. Still other embodiments are included herein.)

1. An implantable valve, comprising:

a frame including a plurality of frame struts, the frame defining a central lumen; and

an outer skirt disposed on a distal surface of the frame;

wherein the outer skirt comprises a wing comprising a first end and a second end, the first end being fixed to the distal surface of the frame and the second end being free to move away from the distal surface of the frame.

2. The implantable valve of any one of claims 1 and 3-9, wherein the wings are annular wings extending around the frame.

3. The implantable valve of any one of claims 1-2 and 4-9, further comprising at least one leaflet disposed within the central lumen.

4. The implantable valve of any one of claims 1-3 and 5-9, wherein the inner diameter of the central lumen is at least 15mm but not more than 40 mm.

5. The implantable valve of any one of claims 1-4 and 6-9, wherein the outer skirt comprises a second wing, the second wing comprising a first tip and a second tip, the first tip adhered to the distal surface of the frame and the second tip free to move away from the distal surface of the frame.

6. The implantable valve of any one of claims 1-5 and 7-9, wherein the wing and the second wing are aligned in the same direction such that a first end of the wing and a first end of the second wing are closer to the inlet of the central lumen and a second end of the wing and a second end of the second wing are closer to the outlet of the central lumen.

7. The implantable valve of any one of claims 1-6 and 8-9, wherein a portion of the outer skirt is disposed between the frame distal side surface and the wings.

8. The implantable valve of any one of claims 1-7 and 9, wherein the first end of the flap is closer to the inlet of the central lumen and the second end of the flap is closer to the outlet of the central lumen.

9. The implantable valve of any one of claims 1-8, further comprising: an inner skirt disposed on a cavity surface of the frame.

10. A method of manufacturing an implantable valve, the method comprising:

obtaining a frame defining a central lumen;

forming an outer skirt on a distal surface of the frame;

positioning a spacer on an outer surface of the outer skirt;

forming a wing including a first end and a second end, the first end adhered to the distal luminal side surface of the frame and the second end free to move away from the distal luminal side surface of the frame, wherein the spacer is disposed between the second end of the wing and the distal luminal side surface of the frame; and

the spacers are removed.

11. The method of manufacturing an implantable valve of any one of claims 10 and 12-13, further comprising:

an inner skirt is formed on a cavity surface of the frame.

12. The method of manufacturing an implantable valve of any one of claims 10-11 and 13, wherein "forming" comprises molding a thermoplastic polymer.

13. The method of manufacturing an implantable valve of any one of claims 10-12, further comprising:

positioning a second spacer on an outer portion of the outer skirt;

forming a second wing comprising a first end and a second end, the first end adhered to the distal surface of the frame and the second end free to move away from the distal surface of the frame, wherein the spacer is disposed between the second end of the wing and the distal surface of the frame; and

removing the second spacers.

14. A method of manufacturing an implantable valve, the method comprising:

obtaining a frame defining a central lumen;

positioning a spacer on a distal surface of the frame;

forming an outer skirt and wings, wherein the outer skirt is disposed on the distal luminal side surface and the wings comprise a first tip and a second tip, the first tip being adhered to the distal luminal side surface and the second tip being free to move away from the distal luminal side surface, wherein the spacer is disposed between the second tip of the wings and the distal luminal side surface; and

The spacers are removed.

15. The method of manufacturing an implantable valve of claim 14, further comprising:

positioning a second spacer on the distal luminal side surface;

forming a second wing comprising a first end and a second end, the first end adhered to the distal surface and the second end free to move away from the distal surface, wherein the second spacer is disposed between the second end of the wing and the distal surface; and

removing the second spacers.

Technical Field

The present application relates to prosthetic valves and related methods.

Background

When the heart valve fails to function properly, heart function may be significantly impaired. Potential causes of heart valve dysfunction include expansion of the peri-valve annulus, ventricular expansion, and valve leaflet prolapse or malformation. When a heart valve fails to close properly, blood within the heart chamber may regurgitate or leak back through the valve.

Valve regurgitation may be treated by replacing or repairing a diseased valve, such as the aortic valve. Surgical valve replacement is one method of treating diseased valves. Minimally invasive treatment methods, such as Transcatheter Aortic Valve Replacement (TAVR), generally involve the use of delivery catheters that are delivered into the heart through arterial access or other anatomical routes to replace a diseased valve with an implanted prosthetic heart valve. The leaflets of such valves are formed from a variety of materials, including synthetic materials and animal tissue. The valve is typically designed to allow flow in one direction and prevent flow in the opposite direction. Due to the systolic and diastolic pressures acting in opposite directions, blood may attempt to flow in both directions. Thus, the valve may be designed with a particular intent to prevent blood flow in a direction opposite to that desired.

Disclosure of Invention

In a first aspect, an implantable valve is included. The implantable valve can include a frame and an outer skirt. The frame may include a plurality of frame struts. The frame can define a central lumen. The outer skirt may be disposed on a distal (luminal) surface of the frame. The outer skirt may include a flap. The wing portion may include a first end and a second end. The first end may be fixed to a distal surface of the frame and the second end may be free to move away from the distal surface of the frame.

In a second aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the wings may be annular wings extending around the frame.

In a third aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the implantable valve may further comprise at least one leaflet disposed within the central lumen.

In a fourth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a portion of the leaflet can have a thickness that is greater than a thickness of the wing.

In a fifth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the leaflets can comprise the same polymer as the outer skirt and wings.

In a sixth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the inner diameter of the central lumen may be at least 15mm but not more than 40 mm.

In a seventh aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the outer skirt may include a second wing. The second wing can include a first end and a second end. The first end may be adhered to the distal surface of the frame and the second end may be free to move away from the distal surface of the frame.

In an eighth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the wing and the second wing can be aligned in a same direction such that the first end of the wing and the first end of the second wing can be closer to the inlet of the central lumen and the second end of the wing and the second end of the second wing can be closer to the outlet of the central lumen.

In a ninth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a portion of the outer skirt may be disposed between the distal luminal side surface of the frame and the wings.

In a tenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the outer skirt may comprise a thermoplastic polymer.

In an eleventh aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the first end of the wing can be closer to the inlet of the central lumen and the second end of the wing can be closer to the outlet of the central lumen.

In a twelfth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the implantable valve can further comprise an inner skirt disposed on a luminal surface of the frame.

In a thirteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the second end of the wing may not be fixed to the distal luminal side surface.

In a fourteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a method of manufacturing an implantable valve is included. The method may include obtaining a frame defining a central lumen. The method may include forming an outer skirt on a distal surface of the frame. The method may include positioning a spacer on an outer surface of the outer skirt. The method may include forming a wing portion. The wing portion may include a first end and a second end. The first end may be adhered to the distal surface of the frame and the second end may be free to move away from the distal surface of the frame. The spacer may be disposed between the second end of the wing and the distal surface of the frame. The method may further comprise removing the spacer.

In a fifteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a method of manufacturing an implantable valve can include forming an inner skirt on a luminal surface of a frame.

In a sixteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the "forming" can include molding the thermoplastic polymer.

In a seventeenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the spacers may be rectangular stripes.

In an eighteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a method of manufacturing an implantable valve can include positioning a second spacer on an exterior portion of an outer skirt. The method can include forming a second wing. The second wing can include a first end and a second end. The first end may be adhered to the distal surface of the frame and the second end may be free to move away from the distal surface of the frame. The spacer may be disposed between the second end of the wing and the distal surface of the frame. The method may further include removing the second spacer.

In a nineteenth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, a method of making an implantable valve is included. The method may include obtaining a frame defining a central lumen. The method may include positioning a spacer on a distal surface of the frame. The method may include forming an outer skirt and a wing. The outer skirt may be disposed on the distal luminal side surface. The wing portion may include a first end and a second end. The first end may be adhered to the distal surface and the second end may be free to move away from the distal surface. The spacer may be disposed between the second end of the wing and the distal side surface. The method may include removing the spacer.

In a twentieth aspect, in addition to or in lieu of one or more of the preceding or subsequent aspects, the claimed method of manufacturing an implantable valve may further comprise positioning a second spacer on the distal luminal side surface. The method can include forming a second wing portion including a first end and a second end. The first end may be adhered to the distal surface and the second end may be free to move away from the distal surface. A second spacer may be disposed between the second end of the wing and the distal luminal side surface. The method may include removing the second spacer.

This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details can be found in the detailed description and the appended claims. Other aspects will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not in a limiting sense. The scope of the present application is defined by the following claims and their legal equivalents.

Drawings

The present technology may be more fully understood in conjunction with the following drawings, in which:

fig. 1 is a schematic perspective view of a valve closed in a portion of an environment in which the closed valve may be used, according to various embodiments.

Fig. 2 is a schematic end view of a valve closed in a portion of an environment in which the closed valve may be used, according to various embodiments.

Fig. 3 is a schematic diagram of an implantable valve according to various embodiments.

Fig. 4 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 5 is a flow diagram depicting a method of manufacturing an implantable valve, in accordance with various embodiments.

Fig. 6 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 7 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 8 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 9 is a flow diagram depicting a method of manufacturing an implantable valve, in accordance with various embodiments.

Fig. 10 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 11 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 12 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 13 is a schematic cross-sectional view of a portion of an implantable valve according to various embodiments.

Fig. 14 is a view of a spacer according to various embodiments.

Fig. 15 is a view of a spacer according to various embodiments.

While the technology is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings and will be described in detail. It should be understood, however, that the intention is not to limit the application to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the present technology.

Detailed Description

The human body has four heart valves: pulmonary, tricuspid, aortic, and mitral valves. The purpose of heart valves is to allow blood to flow in a particular direction through the heart and from the heart into the major blood vessels connected to the heart, such as the aorta and the pulmonary arteries. Prosthetic valves designed to replace valves in the human body typically include two or more leaflets (typically three) attached to a frame. The prosthetic valve can be configured to allow one-way flow through the valve, such as by separating the leaflets from each other to open the valve or by joining the leaflets together (coaptation of the valve leaflets) to close the valve.

In many scenarios, the prosthetic valve is configured to allow flow through the valve in one direction, e.g., at systolic pressure, and prevent flow in the opposite direction, e.g., at diastolic pressure. The performance of the valve may be highly dependent on the fit of the valve within the vessel. Various embodiments of variable diameter sealing skirts and related methods are disclosed herein.

In some embodiments, the sealing skirt or wings can be at least partially secured to the distal luminal side surface of the valve frame. The sealing skirt may have a variable diameter to accommodate differences in size of the valve and the vessel in which the valve is located. The variable diameter may also allow the valve to conform to the shape of a blood vessel. The skirt may be configured to prevent flow in an undesired direction, such as at diastolic pressure. The flow of blood at diastolic pressure may reverse direction compared to the flow at systolic pressure. The sealing skirt may include wings having free edges that may be spaced from the distal luminal side surface of the valve frame to define a cavity or pocket. The cavity or pocket may block fluid attempting to flow in an undesired direction. The wings may provide a seal between the distal surface of the frame and the surrounding blood vessel, thereby preventing backflow.

Fig. 1 shows a schematic view of a closed valve 100 in a vessel 114, according to various embodiments. Fig. 2 shows an end view of the closed valve 100. It should be understood that the valve 100 may be any type of heart valve (e.g., mitral valve, aortic valve, etc.). In use, the valve 100 can be implanted (e.g., surgically or by transcatheter delivery) into a mammalian heart.

The valve 100 can be configured to allow one-way flow through the valve 100, such as depicted by arrow 112. In an embodiment, arrow 112 represents blood flow during systolic pressure, such as when valve 100 is an aortic valve. In other embodiments, such as when valve 100 is a mitral valve, the arrows represent blood flow during diastolic pressure. Flow in a direction opposite to arrow 112 between the distal surface of frame 102 and blood vessel 114 may be prevented by the various embodiments disclosed herein. Valve 100 can include an inlet 136 and an outlet 138. The inlet 136 may refer to an upstream portion of the valve 100 through which blood enters the valve 100 during flow induced by systolic pressure. The outlet 138 may be a downstream portion of the valve 100 from which blood exits the valve 100 during flow induced by systolic pressure.

The valve 100 can include a frame 102 that defines a central lumen 216 (see fig. 2), which can be substantially cylindrical in some embodiments. The side of the frame 102 and other components facing the central internal cavity 216 may be referred to as the cavity surface 230 or cavity side. The opposite side of the frame 102 and other components (e.g., facing away from the central lumen 216) may be referred to as a distal surface 232 or a distal side. In various embodiments, the frame 102 may have a substantially circular cross-section. In other embodiments, the frame 102 may have a non-circular cross-section such as a D-shape. In some embodiments, the non-circular frame 102 may be used to repair a mitral valve or another non-circular valve in the body. The frame 102 (including at least some components of the frame) may be formed from a variety of materials including, but not limited to, metals and metal alloys (e.g., corrosion resistant metals and metal alloys), composites, ceramics, polymers, and the like. In some embodiments, the frame 102 may be formed at least in part from nitinol.

The valve 100 can include a plurality of valve leaflets 104 disposed within the central lumen 216. Each leaflet 104 can include a respective root edge 106 coupled to the frame 102 and a respective free or coaptation edge 108 that is movable relative to the root edge 106 to coapt with the coaptation edge 108 of the other polymeric leaflet 104 along a coaptation region 110. In some embodiments, the plurality of leaflets 104 can be integrally formed with one another such that the leaflets 104 are formed as a single unit. In some embodiments, for example, where the leaflets 104 are formed on the frame 102, the "root edge" can be a contoured edge. However, in other embodiments, the valve leaflets 104 can be integrally formed with other structures, such as an integral skirt, base structure, liner, leaflets, and so forth, and thus in those cases the "root edges" are not actually cut or otherwise separated edges, but are instead where the valve leaflets integrally meet those other structures as opposed to coaptation edges.

The coaptation edges 108 of the leaflets 104 move into coaptation with one another in the closed position (fig. 1 and 2) to substantially restrict fluid flow through the valve 100 in the closed position. The leaflets 104 can coapt to fill or close the central lumen 216 of the valve 100, thereby impeding fluid flow opposite the arrows 112.

Fig. 3 illustrates a view of an implantable valve 300 according to various embodiments. Valve 300 may include one or more of the following: a frame 302, one or more leaflets 304, an inner skirt 318, and an outer skirt 320. Frame 302 may include a plurality of frame struts 322. Frame 302 may define a central lumen 216. Valve leaflets 304 can include coaptation edges. Valve leaflets 304 can be coupled to frame 302.

In various embodiments, the implantable valve 300 can include an inner skirt 318. An inner skirt 318 may be disposed on the cavity surface 230 of the frame 302. The cavity surface 230 of the frame 302 may be the surface of the frame 302 that defines the central internal cavity 216. The inner skirt 318 can direct blood flow through the valve 300. The inner skirt 318 can ensure that blood flows through the central lumen 216 of the valve 300 and does not flow around the leaflets 304 in the closed configuration during diastolic pressure, such as when the valve is configured as an aortic valve.

In various embodiments, implantable valve 300 can include an outer skirt 320. Outer skirt 320 may be disposed on distal luminal side surface 232 of frame 302. Distal surface 232 of frame 302 may be the surface of frame 302 outside of central lumen 216. When the valve is implanted (e.g., as shown in fig. 1 and 2), outer skirt 320 may be disposed between frame 302 and the vessel wall so as to prevent blood from flowing around valve 300. Outer skirt 320 can ensure that blood flows through valve 300 and does not flow around valve 300, so as to ensure that leaflets 304 in the closed position during diastolic pressure can prevent the flow of blood.

In various embodiments, the outer skirt 320 may include wings 324. The wings 324 may include a first end 326 and a second end 328. First end 326 may be secured, attached, or coupled, directly or indirectly, to distal surface 232 of frame 302. The second end 328 is free to move away from the distal surface 232 of the frame 302. In some embodiments, the second end 328 is not attached or secured to the distal luminal side surface 232 such that the second end 328 can freely move away from or toward the distal luminal side surface 232. In some embodiments, wings 324 may be annular wings such that wings 324 extend around frame 302. In some embodiments, second end 328 may be attached to distal surface 232 of frame 302 at one or more discrete locations circumferentially around frame 302 such that some portions of second end 328 remain free to move away from distal surface 232 while other portions are attached thereto, forming a pocket.

In some embodiments, the leaflets 304 can be formed of a material that includes a thermoplastic polymer. In some embodiments, inner skirt 318 may be formed from a material including a thermoplastic polymer. In some embodiments, outer skirt 320 and/or wings 324 may be formed from materials including thermoplastic polymers. In some embodiments, one or more of the leaflets 304, inner skirt 318, outer skirt 320, and wings 324 can be formed from the same material, including the same thermoplastic polymer. In some embodiments, the thermoplastic polymer may comprise polyurethane. In some embodiments, one or more of leaflets 304, inner skirt 318, outer skirt 320, and/or wings 324 can be formed from a biological material such as bovine pericardium, equine pericardium, or porcine pericardium.

The second end 328 of the wing 324 may be bent away from the distal luminal side surface 232 to form a pocket or cavity 434. The cavity 434 may be configured to capture or block blood flowing in an undesired direction (e.g., flowing during diastolic pressure). The cavity 434 can be seen in the schematic cross-sectional view shown in fig. 4 (it being understood that fig. 4, as well as some other figures herein, are schematic representations in which certain aspects are simplified for purposes of illustration and clarity). The opening of the cavity may face the outlet end of the valve. In some embodiments, the first end 326 of the wings 324 can be disposed closer to the inlet 436 of the valve 300 than the second end 328 of the wings 324. Likewise, the second end 328 of the wing 324 may be disposed closer to the outlet 438 than the first end 326 of the wing 324.

In some embodiments, a portion 446 of outer skirt 320 may be disposed between distal lumen side surface 232 and wings 324, such as shown in fig. 4. In other embodiments, no portion of outer skirt 320 is disposed between distal lumen side surface 232 and wings 324, such as shown in fig. 12.

In some embodiments, at least a portion of the leaflets 304 have a thickness greater than a thickness of the wings 324. In some embodiments, the thickness of the leaflet 304 is greater than or equal to the thickness of the wings 324.

In various embodiments, the inner diameter 440 of the central lumen 216 may be at least 10mm but not more than 50 mm. In various embodiments, the inner diameter 440 of the central lumen 216 may be at least 15mm but not more than 40 mm. In various embodiments, the inner diameter 440 of the central lumen 216 may be at least 20mm but not more than 35 mm.

In some embodiments, the inner diameter of wing 442 (e.g., the inner portion of wing 324) or the diameter of cavity 434 may be at least 105% of the size of inner diameter 440 but not more than 130% of the size of inner diameter 440. In some embodiments, the outer diameter of the wing 324 may be at least 110% of the size of the inner diameter 440 but not more than 125% of the size of the inner diameter 440. In some embodiments, the outer diameter of the wing 324 may be at least 110% of the size of the inner diameter 440 but not more than 120% of the size of the inner diameter 440.

In some embodiments, height 444 of wing portion 324 may be at least 5% of the size of inner diameter 440 but no more than 50% of the size of inner diameter 440. In some embodiments, height 444 of wing portion 324 may be at least 10% of the size of inner diameter 440 but no more than 40% of the size of inner diameter 440. In some embodiments, the height 444 of the wing 324 may be at least 10% of the size of the inner diameter 440 but no more than 30% of the size of the inner diameter 440.

Fig. 5 shows a flow diagram depicting a method 548 of manufacturing an implantable valve, in accordance with an embodiment. The method 548 may include obtaining 550 a framework. As discussed above, the frame 302 may define the central lumen 216.

The method 548 may include forming 552 an outer skirt on the frame. The outer skirt may be formed on a distal surface of the frame, such as shown in fig. 6. The method may further include forming an inner skirt on the cavity surface of the frame. In some embodiments, "forming" may include depositing, molding, or otherwise placing the polymer in place. Fig. 6 shows a cross-section of frame 302 with outer skirt 320 disposed on distal luminal side surface 232 and inner skirt 318 disposed on luminal surface 230 of frame 302 due to forming 552 the outer skirt on the frame before, after, or simultaneously with forming 552 the inner skirt 318 on the frame.

In some embodiments, method 548 may further include positioning 554 the spacer, such as positioning the spacer on outer skirt 320. Fig. 7 illustrates an embodiment of a cross-section of a spacer 760 disposed on outer skirt 320. Spacers 760 may be temporarily disposed on outer skirt 320, for example, only during formation of the wings or during the manufacturing process. The spacer can be configured to define a gap or spacing between the wings and a portion of the distal luminal side surface 232 or the outer skirt 320.

In various embodiments, method 548 can also include forming 556 wings. The wing portion may include a first end and a second end. The first end may be adhered to the distal surface of the frame and the second end may be free to move away from the distal surface. The spacer 760 may be disposed between the second end 328 of the wing 324 and the distal luminal side surface 232, as shown in fig. 8. Fig. 8 shows a cross-section of frame 302 with spacer 760 disposed between wing 324 and a portion of outer skirt 320. In some embodiments, forming 556 wings can include depositing or molding a thermoplastic polymer. In some embodiments, wings 556 may be integrally molded with outer skirt 320 or portions thereof.

In various embodiments, the method 548 may further include removing the spacers 760. In some embodiments, spacer 760 may be formed of a material that does not adhere to or separate readily from the polymeric material used to form the wings. In some embodiments, spacer 760 may be formed from PTFE (i.e., polytetrafluoroethylene), silicone, polyethylene, or polypropylene. Removing spacer 760 may define a cavity or space between wings 324 and distal side surface 232 of frame 302, such as shown in fig. 4.

In some embodiments, the method 548 may further include positioning a second spacer on, for example, the outer skirt. The method 962 can include forming a second wing portion including a first end and a second end. The first end may be adhered to the distal surface or the outer skirt, while the second end may be free to move away from the distal surface. A second spacer may be disposed between the second end of the wing and the outer skirt. The method 548 can also include removing the second spacer.

Fig. 9 shows a flow diagram depicting a method 962 of manufacturing an implantable valve in accordance with various embodiments. The method 962 can include obtaining 964 the framework. As discussed above, the frame 302 may define the central lumen 216.

In some embodiments, method 962 may further include positioning 966 the spacer, such as positioning spacer 760 on distal surface 232 of frame 302. Fig. 10 illustrates an embodiment of a cross-section of a spacer 760 disposed on the distal luminal side surface 232 of the frame 302. Spacers 760 may be temporarily disposed on distal side surface 232, for example, only during formation of the wings or during the manufacturing process. Spacer 760 may be configured to define a gap or space between the wings and distal luminal side surface 232.

In various embodiments, the method 962 can include forming 968 an outer skirt and wings. The outer skirt may be formed on the abluminal surface of the frame, such as shown in fig. 11. The method may further include forming an inner skirt on the cavity surface of the frame. In some embodiments, "forming" may include depositing or molding a thermoplastic polymer. Fig. 11 shows a cross-section of frame 302 with outer skirt 320 disposed on distal luminal side surface 232 and wings 324 disposed on spacers 760. Fig. 11 further illustrates an inner skirt 318 disposed on the cavity surface 230 of the frame 302.

As discussed above, the wing portion may include a first end and a second end. The first end may be adhered to the distal surface of the frame and the second end may be free to move away from the distal surface. The spacer 760 may be disposed between the second end 328 of the wing 324 and the distal luminal side surface 232. In some embodiments, forming 968 the outer skirt and wings can include depositing or molding a thermoplastic polymer.

In various embodiments, the method 962 can also include removing 970 the spacer. Removing 970 the spacer may define a cavity between the wings 324 and the distal luminal side surface 232 of the frame 302, such as shown in fig. 12.

In some embodiments, the method 962 can further include positioning a second spacer on the distal luminal side surface. The method 962 can include forming a second wing portion including a first end and a second end. The first end may be adhered to the distal surface and the second end may be free to move away from the distal surface. A second spacer may be disposed between the second end of the wing and the distal luminal side surface. The method 962 can also include removing the second spacer.

In some embodiments, the outer skirt 320 may include a second wing 1324. Fig. 13 illustrates a cross-sectional view of a portion of an implantable valve 300 having a second wing 1324, in accordance with various embodiments. The second wing 1324 can include a first end 1326 and a second end 1328. Similar to the wings 324, the first end 1326 can be adhered or secured to the distal surface 232 of the frame 302, while the second end 1328 can be free to move away from the distal surface 232 of the frame 302.

The wing 324 and the second wing 1324 can be aligned in the same direction such that the first end 326 of the wing 324 and the first end 1326 of the second wing 1324 are closer to the inlet 336 of the central lumen 216 and the second end 328 of the wing 324 and the second end 1328 of the second wing 1324 are closer to the outlet 338 of the central lumen 216. It should be understood that all of the description relating to the wing portion 324 is also applicable to the second wing portion 1324. Likewise, a second spacer can be used to define the second wing 1324 in the method described in fig. 5-12.

Fig. 14 and 15 illustrate a spacer according to various embodiments. In some embodiments, the spacers 1460 may be rectangular bars, such as shown in fig. 14. The rectangular strip may have a rectangular cross-section. In some embodiments, the spacer 1560 may be a wedge, such as shown in fig. 15. The wedge may have a greater thickness at one end than at the other end to form a cavity or pocket.

Polymer and method of making same

Different polymers may be used to form the components herein, e.g., leaflets, inner skirt, outer skirt, wing(s), etc. In some embodiments, the exemplary polymer is a synthetic polymer. However, in some embodiments, non-synthetic polymers may also be used. In some embodiments, the polymer may begin in the form of a flowable and/or moldable composition. In some embodiments, the flowable state may be achieved by heating the polymer to a temperature above its melting temperature. After the polymer composition is placed in place, the polymer composition may be allowed to cool and/or solidify. In some examples, the polymer may be a thermoplastic polymer. In some embodiments, the fluid state may be present prior to crosslinking, curing, solvent evaporation, and/or polymerization steps that may be performed thereafter. In some examples, the final form of the polymer may be a thermoset polymer.

In some embodiments, the polymers herein may comprise one or more polymers selected from the group consisting of: poly (ethylene oxide), polyethylene, polyester, polyisobutylene Polyurethane (PIBU), poly (styrene-block-isobutylene-block-styrene (SIBS)), polypropylene, polystyrene, polyvinyl chloride, Polyisobutylene (PIB), poly (styrene) polyurethane, polyvinylidene fluoride, poly (methyl methacrylate), polyethylene glycol, polyaniline, polypyrrole, polythiophene, polyphenol, polyacetylene, polyphenylene, polyacrylonitrile, polylactic acid, polycaprolactone, polyglycolide, polyvinyl acetate, polyethylene terephthalate (PET), cellulose acetate, chitosan, proteins, carbohydrates, and copolymers including one or more of these. In some embodiments, different portions of the valve may be formed from different polymers or polymer alloys, but in other embodiments the same polymer or polymer alloy may be used.

The embodiments of the present technology described herein are not intended to be exhaustive or to limit the present technology to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may understand and appreciate the principles and practices of the present technology.

All publications and patents mentioned herein are incorporated herein by reference. The disclosures and patents disclosed herein are provided solely for their disclosure. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any publication and/or patent, including any publication and/or patent cited herein.

It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

It should also be noted that, as used in this specification and the appended claims, the phrase "configured to" describes a system, apparatus, or other structure that is constructed or arranged to perform a particular task or take a particular configuration. The phrase "configured" may be used interchangeably with other similar phrases such as "arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this technology pertains. All publications and patent applications herein are incorporated by reference in their entirety as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

The present technology has been described with reference to a number of different specific and preferred embodiments and techniques. It should be understood, however, that many variations and modifications may be made without departing from the spirit and scope of the present technology.