METHOD FOR DETOXIFYING A BIOLOGICAL TISSUE

• US 20140256035A1
• Filed: 05/19/2014
• Published: 09/11/2014
• Est. Priority Date: 06/09/2010
• Status: Abandoned Application

• Current Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Strasly, Marina, Cassolaro, Vincenzo
• Application Number:
  US14/280,804
• Publication Number:
  US 20140256035A1
• Time in Patent Office: Days
• US Class Current: 435/325
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• 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 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: C12N 5/0652 Cells of skeletal and connective tissues; Mesenchyme

Abstract

Biological tissues may be prepared for use in biological prostheses. The biological tissue may be fixated with glutaraldehyde and may be subjected to successive treatment of the tissue with a solution containing taurine to neutralize excess aldehyde groups that remain free after fixation.

Claims

1. A method of treating a biological tissue for use in a biological prosthesis, the method comprising the steps:

treating the biological tissue with a detoxification solution comprising taurine at a concentration within the range from 0.10% w/v to saturation at a temperature between 25°

C. and 45°

C.; and

storing a treated biological tissue in a phosphate buffer;

wherein treating the biological tissue with the detoxification solution at a temperature range between 25°

C. and 45°

C. reduces calcification of the biological tissue when compared to treating a biological tissue at 20°

C.

2. The method according to claim 1, further comprising immersing the biological tissue in a fixation solution comprising glutaraldehyde.

3. The method according to claim 1, wherein the detoxification solution comprises the taurine at a concentration within the range of 0.20% w/v to 1.00% w/v.

4. The method according to claim 1, wherein the detoxification solution comprises the taurine at a concentration of about 0.70% w/v.

5. The method according to claim 1, wherein the detoxification solution comprises a buffer selected from a phosphate, citrate, acetate, HEPES or borate.

6. The method according to claim 1, wherein the detoxification solution comprises a phosphate buffer.

7. The method according to claim 1, wherein the detoxification solution has a pH in the range of 4 to 9.

8. The method according to claim 1, wherein the detoxification solution has a pH in the range of 5 to 8.

9. The method according to claim 1, wherein the detoxification solution has a pH of about 7.

10. The method according to claim 1, wherein the treatment step is carried out at a temperature of 40°

C.

11. The method according to claim 1, wherein the treatment step is carried out for a period of 12 to 48 hours.

12. A method of treating a biological tissue for use in a biological prosthesis, the method comprising the steps:

treating the biological tissue with a detoxification solution at a temperature between 20°

C. and 50°

C., the detoxification solution comprising taurine at a concentration within the range of 0.10% w/v to saturation; and

storing the biological tissue in a phosphate buffer;

wherein treatment of the biological tissue with the detoxification solution reduces calcification of the biological tissue when compared to treatment of a biological tissue using a detoxification solution comprising homocysteic acid.

13. The method according to claim 12, further comprising immersing the biological tissue in a fixation solution comprising glutaraldehyde.

14. The method according to claim 12, wherein the fixing solution comprises glutaraldehyde at a concentration of about 0.5% v/v.

15. The method according to claim 12, further comprising immersing the biological tissue in a fixation solution comprising glutaraldehyde.

16. The method according to claim 12, wherein the detoxification solution comprises the taurine at a concentration within the range of 0.20% w/v to 1.00% w/v.

17. The method according to claim 12, wherein the detoxification solution comprises the taurine at a concentration of about 0.70% w/v.

18. The method according to claim 12, wherein the detoxification step is carried out at a temperature of 20°

C.

19. The method according to claim 12, wherein the detoxification step is carried out at a temperature of 40°

C.

20. The method according to claim 13, wherein the detoxification step is carried out at a temperature of 50°

C.