Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage

• US 10,722,316 B2
• Filed: 10/24/2017
• Issued: 07/28/2020
• Est. Priority Date: 11/06/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Zeng, Qinggang, Limsakoune, Chacphet, Ko, Diana E., Aguila, Christina M.
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/792,441
• Publication Number:
  US 20180042690A1
• Time in Patent Office: 1,008 Days
• CPC Class Codes: A61B 2050/002 having adhesive means, e.g. an adhesive strip
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2250/0069 Sealing means

Abstract

A packaged bioprosthetic heart valve comprising a bioprosthetic heart valve, an adaptive seal and a package. The bioprosthetic heart valve comprises an at least partially dehydrated biological tissue leaflet structure coupled to a supporting frame. The bioprosthetic heart valve has a periphery, an inflow portion, and an outflow portion. The adaptive seal is coupled to the bioprosthetic heart valve around at least a portion of the periphery. The adaptive seal comprises an expandable material that expands after exposure to an initiating condition. The bioprosthetic heart valve and the adaptive seal is stored and contained within the package, which does not contain a liquid storage solution in contact with the bioprosthetic heart valve and the adaptive seal.

Claims

1. A bioprosthetic heart valve, comprising:

a dry biological tissue leaflet structure comprising an inflow portion and an outflow portion;

an expandable supporting frame coupled to the dry biological tissue leaflet structure; and

an adaptive seal coupled to the expandable supporting frame, the adaptive seal comprising an expandable material configured to expand after exposure to an initiating condition;

wherein the expandable material is a substantially dehydrated hydrogel that has been crosslinked with a biodegradable crosslinker;

wherein the dry biological tissue leaflet structure, the expandable supporting frame, and the adaptive seal are configured for joint storage in a sealed package that does not contain a liquid storage solution.

2. The bioprosthetic heart valve of claim 1, wherein the adaptive seal surrounds a periphery of the expandable supporting frame, and is coupled thereto at a spaced distance from the inflow portion and the outflow portion of the dry biological tissue leaflet structure.

3. The bioprosthetic heart valve of claim 1, wherein the expandable material is configured to expand in an outward radial direction away from the dry biological tissue leaflet structure.

4. The bioprosthetic heart valve of claim 1, wherein the expandable material is configured to expand in a longitudinal direction toward the inflow portion and the outflow portion of the dry bioprosthetic tissue leaflet structure.

5. The bioprosthetic heart valve of claim 1, wherein the expandable material is configured to expand in both an outward radial direction and a longitudinal direction relative to the dry biological tissue leaflet structure.

6. The bioprosthetic heart valve of claim 1, wherein the initiating condition is selected from:

a change in temperature, a change in an electrical field, a change in a magnetic field, a change in a chemical environment, a change in pH, contact with a liquid, and combinations thereof.

7. The bioprosthetic heart valve of claim 1, wherein the adaptive seal further comprises a substrate, and wherein the expandable material is disposed on one or more portions of the substrate.

8. The bioprosthetic heart valve of claim 7, wherein the substrate is located between the expandable material and the expandable supporting frame.

9. The bioprosthetic heart valve of claim 7, wherein the substrate is configured to prevent expansion of the expandable material in an inward radial direction toward the dry biological tissue leaflet structure.

10. The bioprosthetic heart valve of claim 7, wherein the substrate is configured to radially expand upon expansion of the expandable supporting frame.

11. The bioprosthetic heart valve of claim 1, wherein the expandable supporting frame is a stent comprising a plurality of struts and open cells.

12. The bioprosthetic heart valve of claim 11, wherein the adaptive seal further comprises one or more discrete patches disposed within the open cells of the stent, wherein each of the one or more discrete patches comprises the expandable material.

13. The bioprosthetic heart valve of claim 1, wherein one or more portions of the expandable supporting frame are coated with the expandable material.

14. A sealed package comprising the bioprosthetic heart valve of claim 1, wherein the sealed package does not contain a liquid storage solution.