Method for fixing tissue

• US 20050119728A1
• Filed: 01/05/2005
• Published: 06/02/2005
• Est. Priority Date: 07/19/2001
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sarac, Timur Paul
• Granted Patent: US 7,559,953 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

Abstract

A method of preparing a fixed biological tissue includes, shaping the biological tissue, cross-linking the biological tissue, sterilizing the biological tissue, and inactivating prions in the biological tissue.

Claims

1. A method of preparing a fixed biological tissue, the method comprising:

harvesting at least one layer of biological tissue;

shaping the biological tissue;

at least partially cross-linking the biological tissue;

sterilizing the biological tissue; and

inactivating prions in the biological tissue.

2. The method of claim 1, the biological tissue being selected from the group consisting essentially of pericardial tissue, peritoneal tissue, and pleural tissue.

3. The method of claim 1, the step of shaping the biological tissue comprising cutting the harvested layer of biological tissue to a desired size and suturing the cut biological tissue to a member.

4. The method of claim 1, the biological tissue being at least partially cross-linked by contacting the biological tissue with a solution containing at least one cross-linking agent.

5. The method of claim 4, the cross-linking agent being selected from the group consisting essentially of glutaraldehyde, formaldehyde, glyceraldehyde, paraformaldehyde, dialdehyde starch, and combinations thereof.

6. The method of claim 1, the biological tissue being sterilized by contacting the biological tissue with a solution containing an alcohol.

7. The method of claim 6, the alcohol being selected from the group consisting essentially of ethanol, methanol, propanol, isopropanol, and combinations thereof and being present in the solution at a concentration of about 10% to about 90% by volume.

8. The method of claim 1, the prions in the biological tissue being inactivated by contacting the biological tissue with a basic solution.

9. The method of claim 8, the basic solution having a molar concentration of about 0.5 M to about 4.0 M.

10. The method of claim 1, further comprising contacting the biological tissue with at least one solution that causes lysis of cells of the biological tissue.

11. The method of claim 10, the solution that causes cell lysis being a hypertonic solution that has a salt concentration of about 2% to about 8% by weight.

12. The method of claim 1, further comprising applying at least one pharmacological agent to the biological tissue.

13. A method of preparing a fixed biological tissue, the method comprising:

harvesting at least one layer of biological tissue;

shaping the layer of harvested biological tissue;

at least partially cross-linking the shaped biological tissue;

sterilizing the at least partially cross-linked biological tissue; and

inactivating prions in the sterilized biological tissue.

14. The method of claim 13 further comprising applying at least one pharmacological agent to the fixed biological tissue, the pharmacological agent comprising at least one of an anti-inflammatory agent, an anti-proliferative agent, an anti-coagulation agent, or an anti-platelet aggregation agent.

15. The method of claim 13, further comprising contacting the shaped biological tissue with a cell lysis solution prior to cross-linking the biological tissue.

16. The method of claim 13, the biological tissue being at least partially cross-linked by contacting the biological tissue with a solution containing at least one cross-linking agent, the cross-linking agent being selected from the group consisting essentially of glutaraldehyde, formaldehyde, glyceraldehyde, paraformaldehyde, dialdehyde starch, and combinations thereof.

17. The method of claim 13, the biological tissue being sterilized by contacting the biological tissue with a solution containing an alcohol, the alcohol being selected from the group consisting essentially of ethanol, methanol, propanol, isopropanol, and combinations thereof and being present in the solution at a concentration of about 10% to about 90% by volume.

18. The method of claim 13, the prions being inactivated by contacting the biological tissue with a basic solution, the basic solution having a molar concentration of about 0.5 M to about 4.0 M.

19. A method of preparing a fixed biological tissue, the method comprising:

harvesting at least one layer of biological tissue, the layer of biological tissue comprising a plurality of cells;

contacting the shaped layer with at one solution that causes lysis of the cells;

at least partially cross-linking the biological tissue;

sterilizing the at least partially cross-linked biological tissue; and

inactivating prions in the sterilized biological tissue.

20. The method of claim 19, further comprising shaping the biological tissue.

21. The method of claim 19, further comprising applying at least one pharmacological agent to the fixed tissue.