Process for biological tissue

• US 20070020248A1
• Filed: 03/01/2006
• Published: 01/25/2007
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Frank Everaerts, Frans Everaerts, Mark Torrianni, Paul Trescony, Wilfred Hartog
• Original Assignee: Frank Everaerts, Frans Everaerts, Mark Torrianni, Paul Trescony, Wilfred Hartog
• Inventors: Trescony, Paul, Everaerts, Frans, Everaerts, Frank, Hartog, Wilfred, Torrianni, Mark
• Granted Patent: US 8,445,278 B2
• Time in Patent Office: Days
• US Class Current: 424/93.210
• CPC Class Codes: A61K 35/34 Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes vascular smooth muscle A61K35/44
• 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 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment

Abstract

The present invention provides an electrophoretic system, apparatus, and method of use thereof for the preparation of a tissue-derived bioprosthesis.

Claims

1. A method for preparing a tissue-derived bioprosthesis comprising subjecting tissue to an electrophoretic field to extract at least one electrically charged substance from the tissue to provide a tissue-derived bioprosthesis.

2. The method of claim 1, wherein the electrically charged substance comprises a decellularization agent, a cellular component of the tissue, or any combination thereof.

3. The method of claim 1, further comprising contacting the tissue with a decellularization solution for up to about 170 hours.

4. The method of claim 2, wherein the cellular component comprises a cell membrane protein, an intracellular protein, a non-structural extracellular matrix protein, a nucleic acid, a glycoprotein, a fragment thereof, a portion thereof, a derivative thereof or any combination thereof.

5. The method of claim 1, wherein the tissue is mammalian tissue.

6. The method of claim 5, wherein the mammalian tissue is aortic tissue, pericardial tissue, venous tissue, arterial tissue, a component thereof or any combination thereof.

7. The method of claim 6, wherein the aortic tissue component comprises collagen, elastin, hyaluronic acid, or any combination thereof.

8. The method of claim 5, wherein the mammalian tissue is human, porcine, bovine, marsupial, ovine, or canine tissue.

9. The method of claim 8, wherein the mammalian tissue is porcine tissue or bovine tissue.

10. The method of claim 1, wherein the tissue comprises fresh tissue, cadaveric tissue, fixed tissue or unfixed tissue.

11. The method of claim 2, wherein the decellularizing agent comprises a negatively charged molecule.

12. The method of claim 2, wherein the decellularization agent comprises an ionic detergent.

13. The method of claim 12, wherein the ionic detergent is an anionic detergent.

14. The method of claim 13, wherein the anionic detergent is sodium dodecyl sulphate or a derivative thereof.

15. The method of claim 14, wherein the bioprosthesis is substantially free of SDS.

16. The method of claim 1, wherein the tissue is subjected to the electrophoretic field for less than 600 hours.

17. The method of claim 1, further comprising washing the tissue to remove tissue debris, blood, fluid, fat, or any combination thereof prior to subjecting the tissue to the electrophoretic field.

18. The method of claim 1, further comprising rinsing the tissue with a rinse solution.

19. The method of claim 1, further comprising subjecting the tissue to pulsatile flow.

20. A method for preparing a tissue-derived bioprosthesis comprising contacting tissue with at least one electrically charged substance and subjecting the tissue an electrophoretic field so as to cause the electrically charged substance to be electrophoretically transported into and/or out of the tissue to provide the tissue-derived bioprosthesis.

21. The method of claim 20, wherein the electrically charged substance comprises a fixative agent, a decellularization agent, a recellularization agent, a bioactive agent, or any combination thereof.

22. The method of claim 21, wherein the contacting is simultaneous, separate or sequential.

23. The method of claim 20, wherein the electrically charged substance is electrophoretically transported into the tissue.

24. The method of claim 20, wherein the electrically charged substance is electrophoretically transported out of the tissue.