Cultured cell leaflet material

Patent metadata

Field	Value
Publication number	US-10405975-B2
Application number	US-201615272747-A
Country	US
Kind code	B2
Filing date	Sep 22, 2016
Priority date	Oct 7, 2015
Publication date	Sep 10, 2019
Grant date	Sep 10, 2019

Abstract

A prosthetic heart valve provided herein can include a cultured cell tissue leaflet. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member. The cultured cell tissue can be obtained by culturing fibroblast cells, smooth muscle cells, or a combination thereof to form a sheet of cultured cells and chemically cross-linking the fibroblast cells while under tension. In some cases, the cultured cell tissue can be radially tensioned. In some cases, the cultured cell tissue can be bi-axially tensioned.

First claim

What is claimed is:

1. A prosthetic heart valve comprising
a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue;
wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and
wherein the cultured cell tissue leaflets have a percentage of elongation at 500 kPa of between 6.5% and 8.5%.

2. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue is cultured from fibroblast cells.

3. The prosthetic heart valve of claim 2 , wherein the fibroblast cells are dermal fibroblast cells.

4. The prosthetic heart valve of claim 3 , wherein the dermal fibroblast cells are bovine dermal fibroblast cells.

5. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue is cultured from cells including smooth muscle cells.

6. The prosthetic heart valve of claim 5 , wherein the smooth muscle cells are bovine smooth muscle cells.

7. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue is cultured from a mixture of fibroblasts and smooth muscle cells.

8. The prosthetic heart valve of claim 7 , wherein the fibroblast cells and smooth muscle cells are in a ratio of between 20:80 and 80:20.

9. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue is cross-linked with glutaraldehyde.

10. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue is cultured for at least 3 weeks.

11. The prosthetic heart valve of claim 10 , wherein cultured cell tissue is cultured for at least 5 weeks.

12. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue has a thickness of between 50 micrometers and 300 micrometers.

13. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue leaflets have a percentage of elongation at 1 MPa of between 10.5% and 13.5%.

14. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue leaflets have an ultimate tensile strength of between 4 MPa and 6.5 MPa.

15. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue leaflets have a moisture content of between 80% and 88%.

16. The prosthetic heart valve of claim 1 , wherein the cultured cell tissue leaflets consist of radially or biaxially oriented and fixed cultured cell tissue.

17. A prosthetic heart valve comprising
a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue;
wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and
wherein the cultured cell tissue leaflets have a shrinkage temperature of between 83.8° C. and 84.6° C.

18. A prosthetic heart valve comprising
a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue;
wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and
the leaflets comprising tissue-only cultured cell tissue excluding exogenous biomaterial scaffolds.

Assignees

• Boston Scient Scimed Inc

Inventors

• Anderson-Cunanan Crystal Marie
• Fazackerley Katherine Cora
• Eppihimer Michael
• Kenwood Shannon Smith
• Sushkova Natalia P
• Lavery Karen Suzanne

Classifications

• C12M21/08

  for producing artificial tissue or for ex-vivo cultivation of tissue (prostheses A61F2/00, grafts A61L27/00) · CPC title

• A61L27/507

  for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062) · CPC title

• A61L27/3895

  using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions · CPC title

• A61L27/3826

  Muscle cells, e.g. smooth muscle cells · CPC title

• A61L27/3804

  characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells · CPC title