Prosthetic heart valve formation

• US 10,433,955 B2
• Filed: 10/30/2017
• Issued: 10/08/2019
• Est. Priority Date: 07/02/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Edelman, Peter G., Fisher, Scott, Wang, Huisun, Gunderson, Richard Charles, Lin, Horng-Ban, Lindquist, Jeffrey S.
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US15/797,394
• Publication Number:
  US 20180049869A1
• Time in Patent Office: 708 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: B05B 12/1454 separate units comprising both a material container and a spray device permanently connected thereto being removably attached to a part of the spray apparatus, e.g. to a robot arm
• CPC Class Codes: B05B 13/0207 the work being an elongated body, e.g. wire or pipe B05B13/0436, B05B13/0463 take precedence
• CPC Class Codes: B05B 13/0627 Arrangements of nozzles or spray heads specially adapted for treating the inside of hollow bodies B05B13/0645 takes precedence
• CPC Class Codes: B05B 7/0408 with arrangements for mixing two or more liquids
• CPC Class Codes: B05B 7/0416 with arrangements for mixing one gas and one liquid
• CPC Class Codes: B05B 7/0433 with one inner conduit of gas surrounded by an external conduit of liquid upstream the mixing chamber
• CPC Class Codes: B05B 7/0466 with means for deflecting the central liquid flow towards the peripheral gas flow
• CPC Class Codes: B05D 1/02 performed by spraying
• CPC Class Codes: B05D 2254/02 : Applying the material on the exterior of the tube
• CPC Class Codes: B05D 7/222 : of pipes
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: Y10T 29/49405 : Valve or choke making

Abstract

A prosthetic heart valve includes a base and a plurality of polymeric leaflets. Each leaflet has a root portion coupled to the base, and each leaflet has an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets. Each leaflet includes) at least two polymers along at least one portion of the leaflet, and each leaflet has a composition gradient of each of the at least two polymers along at least one portion of the leaflet.

Claims

1. A method of forming a prosthetic heart valve, the method comprising:

forming a base defining a cylindrical passage therethrough;

forming a plurality of leaflets, each leaflet having a root portion and an edge portion opposite the root portion, each leaflet comprising at least two polymers and having a uniform thickness;

coupling the root portion of each of the plurality of leaflets to the base such that each edge portion is movable relative to the root portion to coapt with the edge portion of at least one of the other leaflets of the plurality of leaflets;

wherein a first polymer of the at least two polymers is in the form of a plurality of fibers at least partially embedded in a second polymer of the at least two polymers and extending from the root portion to the edge portion within each leaflet; and

wherein the fibers are arranged such that a fiber concentration gradient is formed from the root portion to the edge portion within each leaflet such that there is a decreasing concentration of fibers in a direction from the root portion to the edge portion within each leaflet.

2. The method of claim 1, wherein forming the plurality of leaflets comprises a dip-coating process.

3. The method of claim 1, wherein forming the plurality of leaflets comprises dip-coating a mold into a polymer solution comprising the second polymer of the at least two polymers.

4. The method of claim 3, wherein dip-coating the mold is repeated multiple times.

5. The method of claim 3, further comprising dip-coating the mold into a polymer solution comprising a third polymer that is different than the second polymer of the at least two polymers.

6. The method of claim 3, further comprising disposing the fibers on the mold.

7. The method of claim 6, further comprising disposing the fibers in a groove defined by the mold.

8. The method of claim 3, further comprising positioning a leaflet form and a divider having surfaces extending above the mold to form the individual plurality of leaflets.

9. The method of claim 1, wherein forming the base comprises a dip-coating process.

10. The method of claim 1, wherein forming the base comprises dip-coating a mold.

11. The method of claim 1, wherein forming the base comprises dip-coating a mold and a frame.

12. The method of claim 1, wherein coupling the root portion of each of the plurality of leaflets to the base includes integrally forming the root portion with the base in a dip-coating process.

13. The method of claim 1, wherein the base and the plurality of leaflets are formed in separate dip-coating processes.

14. The method of claim 1, wherein forming the plurality of leaflets comprises a spray-coating process.

15. The method of claim 14, wherein forming the plurality of leaflets comprises spraying a solution comprising the second polymer of the at least two polymers from a first spray head.

16. The method of claim 15, wherein forming the plurality of leaflets comprises spraying a solution comprising the second polymer from a first spray head and spraying a solution comprising a third polymer from a second spray head to form multiple layers.

17. The method of claim 16, further comprising controlling a ratio of the volume of the solution comprising the second polymer from the first spray head to the volume of the third polymer solution from the second spray head to create a composition gradient of the second polymer along the leaflets.

18. A method of forming a prosthetic heart valve, the method comprising:

forming a base defining a cylindrical passage therethrough;

forming a plurality of leaflets, each leaflet having a root portion and an edge portion opposite the root portion, each leaflet comprising at least two polymers and having a uniform thickness;

wherein the base and each of the plurality of leaflets are integrally formed such that the root portion each of the plurality of leaflets is integral with the base, and wherein each edge portion is movable relative to each root portion to coapt with the edge portion of at least one of the other leaflets of the plurality of leaflets;

wherein a first polymer of the at least two polymers is in the form of a plurality of fibers at least partially embedded in a second polymer of the at least two polymers and extending from the root portion to the edge portion within each leaflet; and

wherein the fibers are arranged such that a fiber concentration gradient is formed from the root portion to the edge portion within each leaflet such that there is a decreasing concentration of fibers in a direction from the root portion to the edge portion within each leaflet.