Prosthetic heart valve formation

• US 9,814,572 B2
• Filed: 03/12/2015
• Issued: 11/14/2017
• 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., Lin, Horng-Ban, Fisher, Scott, Lindquist, Jeffrey S., Wang, Huisun, Gunderson, Richard C.
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US14/656,044
• Publication Number:
  US 20150182332A1
• Time in Patent Office: 978 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 prosthetic heart valve comprising:

a base;

a plurality of polymeric leaflets, each leaflet having a root portion coupled to the base, each leaflet having an edge portion 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 comprising at least two polymers;

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

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 continuously decreasing concentration of fibers in a direction from the root portion to the edge portion within each leaflet; and

wherein each leaflet has a uniform thickness.

2. The prosthetic heart valve of claim 1, wherein each leaflet has a stiffness gradient along at least one portion of the leaflet corresponding to the fiber concentration gradient.

3. The prosthetic heart valve of claim 2, wherein each leaflet has the fiber concentration gradient and the stiffness gradient in the direction extending from the root portion to the edge portion.

4. The prosthetic heart valve of claim 2, wherein each leaflet has the fiber concentration gradient and the stiffness gradient in a direction extending along the thickness of the leaflet.

5. The prosthetic heart valve of claim 2, wherein each leaflet has a maximum thickness of 100 μ

m or less.

6. The prosthetic heart valve of claim 1, wherein at least one of the at least two polymers has hard segments and soft segments.

7. The prosthetic heart valve of claim 6, wherein at least one of the at least two polymers is a block polymer, wherein the soft segments of the block polymer are a copolymer of a first monomer and a second monomer and a comonomer ratio of the first monomer to the second monomer is varied in combination with a hard segment to soft segment ratio, wherein the first monomer is dimethyl siloxane and the second monomer is hexamethylene carbonate.

8. The prosthetic heart valve of claim 1, wherein at least one of the at least two polymers is a polyurethane block polymer and/or a polyurethane urea block polymer.

9. The prosthetic heart valve of claim 1, wherein at least one of the at least two polymers is one or more of the following:

polycarbonate urethane;

poly(dimethylsiloxane urethane); and

poly(isobutylene urethane).

10. The prosthetic heart valve of claim 1, further comprising a skirt disposed about the base, the base defining a concentric passage therethrough, and the skirt eccentrically arranged relative to the concentric passage of the base.

11. The prosthetic heart valve of claim 1, wherein the base comprises one or more of the at least two polymers.

12. The prosthetic heart valve of claim 1, wherein the fibers extend in a direction perpendicular to the direction extending from the root portion to the edge portion of each leaflet.

13. The prosthetic heart valve of claim 1, wherein the fibers are arranged in a cross-hatch pattern.

14. The prosthetic heart valve of claim 1, the fibers including a plurality of radial fibers extending in a direction parallel to the direction extending from the root portion to the edge portion of each leaflet, and a plurality of circumferential fibers extending in a direction perpendicular to the direction extending from the root portion to the edge portion of each leaflet.

15. A prosthetic heart valve comprising:

a base;

a plurality of polymeric leaflets, each leaflet having a root portion coupled to the base, each leaflet having an edge portion 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 comprising at least two polymers;

wherein one of the at least two polymers is in the form of a plurality of fibers at least partially embedded in the other polymer of each leaflet, wherein the plurality of fibers are arranged along an axis from the root portion to the edge portion of each leaflet, and

wherein the plurality of fibers arranged along the axis varies such that the number of fibers decreases continuously along the axis in a direction from the root portion to the edge portion of each leaflet to form a fiber concentration gradient; and

wherein each leaflet has a uniform thickness.

16. The prosthetic heart valve of claim 15, wherein the fiber concentration gradient along the axis in the direction from the root portion to the edge portion of each leaflet imparts one or more anisotropic mechanical properties to the leaflets.