Methods for producing elastin, and tropoelastin products for repairing and or replacing tissue

• US 6,667,051 B1
• Filed: 11/28/2001
• Issued: 12/23/2003
• Est. Priority Date: 05/28/1999
• Status: Expired due to Fees

• Current Assignee: Biomedical Research Services, Inc., Kenton W. Gregory
• Original Assignee: Kenton W. Gregory, Providence Health System - Oregon
• Inventors: Gregory, Kenton W.
• Primary Examiner(s): Aftergut, Jeff H.
• Application Number:
  US09/979,868
• Time in Patent Office: 755 Days
• Field of Search: 156/331.2, 156/94.FOR, 526/248, 523/118, 530/353, 428/63, 428/478.2, 424/443, 264/345, 606/8, 128/898
• US Class Current: 424/443
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: B32B 2307/5825 Tear resistant
• CPC Class Codes: B32B 2307/7265 Non-permeable
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 2556/00 Patches, e.g. medical patches, repair patches
• CPC Class Codes: B32B 9/02 comprising animal or vegetable substances , e.g. cork, bamboo, starch
• CPC Class Codes: C08L 35/04 Homopolymers or copolymers of nitriles C08L35/06, C08L35/08 take precedence

Abstract

The invention is directed to a method including the steps of providing at least one layer of unlaminated elastin or unlaminated elastin-based materials or unlaminated tropoelastin materials. Then, the unlaminated elastin or unlaminated elastin-based materials or unlaminated tropoelastin materials is subjected to heating and pressing steps. The pressing step of the present invention is preferably conducted in the presence of steam. The laminated elastin or laminated elastin-based materials or laminated tropoelastin materials preferably comprises a multi-layer composite material. Typically, the step of adhering with an adhesive material the laminated elastin or laminated elastin-based materials or laminated tropoelastin materials is employed in order to achieve a water-tight engagement with the tissue substrate. A biogradable cyanacrylate glue is generally used in order to achieve quick and easy way to secure the patch in place and provide watertight fusion instantly. Preferably, the adhesive material comprises an alkoxy alkyl cyanoacrylate material.

Claims

1. A method for joining at least one layer of pressed biomaterial to a tissue substrate, comprising:

providing the pressed biomaterial consisting essentially of elastin or tropoelastin materials;

applying a biodegradable cyanoacrylate adhesive to either one of the material and the tissue; and

adhering the pressed biomaterial to the tissue and forming a substantially water-tight engagement therebetween.

2. The method of claim 1, wherein pressing is conducted at a pressure of at least about 40 psi.

3. The method of claim 1, wherein pressing is conducted a temperature of at least about 50 degrees C.

4. The method of claim 1, wherein a suture can be effected without substantial tearing of the biomaterial.

5. The method of claim 1, wherein the cyanoacrylate adhesive comprises an alkoxy alkyl cyanoacrylate adhesive material.

6. The method of claim 1, wherein the tissue substrate comprises human tissue.

17. The product of claim 1, which comprises a pressed and steamed biomaterial.

7. A method for producing a pressed biomaterial, comprising:

providing at least one layer of an unpressed biomaterial consisting essentially of elastin or tropoelastin; and

heating and pressing the unpressed biomaterial to form the pressed biomaterial which is capable of being attached to a tissue substrate for repair or replacement thereof.

8. The method of claim 7, wherein the pressed biomaterial comprises a multi-layer composite material.

9. The method of claim 7, wherein a suture can be effected without substantial tearing of the pressed biomaterial.

10. The method of claim 7, which further includes the step of adhering with an adhesive material the pressed biomaterial in water-tight engagement with the tissue substrate.

11. The method of claim 10, wherein the adhesive material comprises a cyanoacrylate material.

12. The method of claim 11, wherein the cyanoacrylate material comprises an alkoxy alkyl cyanoacrylate material.

13. The method of claim 7, wherein the tissue substrate comprises human or animal tissue.

14. The method of claim 7, wherein the pressed biomaterial is a bilaminar pressed biomaterial.

15. The method of claim 7, which further includes the step of suturing the pressed biomaterial to the tissue substrate.

16. The method of claim 7, wherein the pressing step is conducted in the presence of steam.

18. The method of claim 7, wherein pressing is conducted at a pressure of at least about 40 psi.

19. The method of claim 7, wherein pressing is conducted at a temperature of at least about 50 degrees C.

20. A biomaterial product which comprises at least one layer of a pressed biomaterial consisting essentially of elastin or tropoelastin biomaterial which is capable of being attached to a tissue substrate for repair or replacement thereof.

21. The product of claim 20, wherein the pressed biomaterial comprises a multi-layer composite material.

22. The product of claim 20, which can receive a suture without substantial tearing of the pressed biomaterial.

23. The product of claim 20, which can be adhered with an adhesive material, the adhered biomaterial being in water-tight engagement with the tissue substrate.

24. The product of claim 23, wherein the adhesive material comprises a cyanoacrylate material.

25. The product of claim 24, wherein the cyanoacrylate material comprises an alkoxy alkyl cyanoacrylate material.

26. The product of claim 20, wherein the tissue substrate comprises human tissue.

27. The product of claim 20, wherein the pressed biomaterial is a bilaminar pressed biomaterial.