Methods of conditioning sheet bioprosthetic tissue

Patent metadata

Field	Value
Publication number	US-11213385-B2
Application number	US-201816154353-A
Country	US
Kind code	B2
Filing date	Oct 8, 2018
Priority date	Mar 23, 2010
Publication date	Jan 4, 2022
Grant date	Jan 4, 2022

Abstract

Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

First claim

What is claimed is:

1. A method for preparing a bioprosthetic tissue membrane material, comprising:
subjecting a collagenous tissue membrane to a glycerin-based treatment solution; and
removing at least a portion of material from a surface of the collagenous tissue membrane by ablating the collagenous tissue membrane with a laser, the surface of the collagenous tissue membrane having a smoothness;
wherein the removing increases the smoothness of the surface of the collagenous tissue membrane.

2. The method of claim 1 , wherein the collagenous tissue membrane is bovine pericardial tissue.

3. The method of claim 2 , wherein the bovine pericardial tissue has a fibrous side and a smooth side.

4. The method of claim 3 , wherein the surface of the collagenous tissue membrane is the fibrous side.

5. The method of claim 1 , further comprising cross-linking the collagenous tissue membrane before the subjecting.

6. The method of claim 1 , wherein the collagenous tissue membrane has opposite sides and a non-uniform thickness.

7. The method of claim 6 , further comprising topographically mapping the collagenous tissue membrane before the removing.

8. The method of claim 7 , wherein the removing is performed to produce a collagenous tissue membrane of substantially uniform thickness.

9. The method of claim 7 , wherein the removing is performed to selectively thin the collagenous tissue membrane to obtain regions of different thicknesses.

10. The method of claim 1 , further comprising cutting one or more heart valve leaflets from the collagenous tissue membrane before the removing.

11. The method of claim 10 , wherein the one or more heart valve leaflets have a shape having:
an arcuate cusp edge,
a generally straight free edge opposite the arcuate cusp edge; and
a pair of oppositely directed tabs at ends of the free edge.

12. The method of claim 11 , wherein the removing is performed to produce a peripheral region of the one or more heart valve leaflets that is thicker than a remaining region of the one or more heart valve leaflets.

13. The method of claim 12 , wherein the peripheral region comprises the entire cusp edge and at least a portion of the pair of oppositely directed tabs.

14. The method of claim 13 , wherein the peripheral region further comprises the generally straight free edge.

15. The method of claim 1 , wherein the laser is a very short pulse duration laser.

16. The method of claim 15 , wherein the laser is characterized as having:
a pulse width of approximately 650 fs; and
a wavelength of approximately 1550 nm.

17. The method of claim 1 , wherein the laser is a short pulse duration laser.

18. The method of claim 1 , wherein the laser is an ultra-short-pulsed laser in the Femtosecond range.

19. The method of claim 1 , wherein the laser has an approximately 1550 nm wavelength.

20. A method for preparing a bioprosthetic tissue membrane material, comprising:
at least partially drying a collagenous tissue membrane; and
removing at least a portion of material from the collagenous tissue membrane with a laser after the at least partially drying.

21. The method of claim 20 , wherein the at least partially drying is performed by subjecting the collagenous tissue membrane to a glycerin-based treatment solution.

22. The method of claim 20 , further comprising cross-linking the collagenous tissue membrane before the at least partially drying.

23. The method of claim 20 , further comprising treating the collagenous tissue membrane with one or both of a capping agent and a reducing agent to mitigate calcification of the collagenous tissue membrane after implantation.

24. The method of claim 23 , wherein the capping agent is ethanolamine.

25. The method of claim 23 , wherein the reducing agent is a borohydride.

26. The method of claim 20 , further comprising topographically mapping the collagenous tissue membrane before the removing.

27. The method of claim 26 , wherein the removing is performed to produce a collagenous tissue membrane of substantially uniform thickness.

28. The method of claim 27 , wherein the removing is performed to selectively thin the collagenous tissue membrane to obtain regions of different thicknesses.

29. The method of claim 20 , further comprising cutting one or more heart valve leaflets from the collagenous tissue membrane before the removing.

30. The method of claim 29 , wherein the one or more heart valve leaflets have a shape having:
an arcuate cusp edge,
a generally straight free edge opposite the arcuate cusp edge; and
a pair of oppositely directed tabs at ends of the free edge.

31. The method of claim 30 , wherein the removing is performed to produce a peripheral region of the one or more heart valve leaflets that is thicker than a remaining region of the one or more heart valve leaflets.

32. The method of claim 31 , wherein the peripheral region comprises the entire cusp edge and at least a portion of the pair of oppositely directed tabs.

33. The method of claim 32 , wherein the peripheral region further comprises the generally straight free edge.

34. The method of claim 20 , wherein the laser is a very short pulse duration laser.

35. The method of claim 20 , wherein the laser is a short pulse duration laser.

36. The method of claim 20 , wherein the laser is an ultra-short-pulsed laser in the Femtosecond range.

37. The method of claim 20 , wherein the laser has an approximately 1550 nm wavelength.

38. The method of claim 20 , wherein the laser is characterized as having:
a pulse width of approximately 650 fs; and
a wavelength of approximately 1550 nm.

Assignees

• Edwards Lifesciences Corp

Inventors

• Dove Jeffrey S
• Tian Bin
• Schneider Ralph
• Cohen Jeffrey S
• Jankovic Ivan
• Migliazza John F
• Wright Gregory A
• Young James M
• Campbell Louis A

Classifications

• A61F2/02

  Prostheses implantable into the body · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61L27/3691

  characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation · CPC title

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• A61F2250/0036

  differing in thickness · CPC title