Expandable foam-like biomaterials and methods

• US 7,226,615 B2
• Filed: 11/07/2001
• Issued: 06/05/2007
• Est. Priority Date: 11/07/2000
• Status: Expired due to Fees

• Current Assignee: Cryolife Incorporated
• Original Assignee: Cryolife Incorporated
• Inventors: Black, Kirby S., Bird, Ana T., Yuksel, K. U
• Primary Examiner(s): Webman; Edward J.
• Application Number:
  US09/986,124
• Publication Number:
  US 20020059001A1
• Time in Patent Office: 2,036 Days
• Field of Search: 424/484, 424/400, 424/426, 424/428, 521/69, 521/68, 521/82, 521/841, 521/85, 521/87, 521 97- 98, 521/186, 521/84.1, 521/65
• US Class Current: 424/484
• CPC Class Codes: A61L 27/22 Polypeptides or derivatives thereof , e.g. degradation products
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges

Abstract

Liquid, injectable, aqueous solutions are transformed in situ to an expandable foam-like, space filling, and adherent biomaterial. Preferably, the foam-like biomaterial is the reaction product of a two-part liquid system to achieve the in situ formation thereof. The liquid system is generally comprised of a protein solution and a cross linker solution which may either be premixed and then applied to a site in need of the biomaterial, or simultaneously mixed and delivered through an in-line mixing/dispensing tip directly to the site. In especially preferred embodiments, an expandable foam-like biomaterial includes the reaction product of human or animal-derived protein material and a di- or polyaldehyde in the presence of a bicarbonate and an acidic titrant amounts sufficient to impart a cellular foam structure to the material.

Claims

1. A kit for forming a solid cellular foam proteinaceous biopolymeric material comprising separate reactable aliquot portions consisting of a first aqueous solution containing a proteinaceous material, and a second aqueous solution which is reactable with, the proteinaceous component of the first aqueous solution to form a solid proteinaceous biopolymeric material in response to mixing of said first and second aqueous solutions, wherein the first aqueous solution includes a blowing agent, and wherein said second aqueous solution includes an acidic titrant reactable on contact with the blowing agent sufficient to evolve a gas to impart a cellular foam structure to the proteinaceous biopolymeric material concurrently while said proteinaceous material of said first aqueous solution reacts with said second aqueous solution to form said solid proteinaceous biopolymeric material.

2. The kit of claim 1, wherein the first aqueous solution comprises human or animal-derived protein material and wherein the second aqueous solution comprises a di- or polyaldehyde.

3. The kit of claim 2, wherein the protein is bovine or human serum albumin.

4. The kit of claim 2, wherein the aldehyde is glutaraldehyde.

5. The kit of any one of claims 1, 2, 3, 4, wherein the blowing agent is a bicarbonate.

6. The kit of claim 5, wherein the bicarbonate is at least one selected from the group consisting of bicarbonates of sodium, potassium, aluminum and iron.

7. The kit of claim 1, wherein the blowing agent is an organic bicarbonate.

8. The kit of claim 1, wherein the blowing agent is ammonium bicarbonate.

9. The kit of claim 1, wherein the acidic titrant is at least one acid selected from the group consisting of phosphoric acid, sulfuric acid, hydrochloric acid, acetic acid and citric acid.

10. The kit of claim 1, wherein at least one of the first and second aqueous solutions includes biocompatible fibrous and/or particulate materials.

11. The kit of claim 1, wherein the first and second aqueous solutions are sterilized.

13. The kit of claim 2, wherein the aldehyde is glutaraldehyde.

12. A kit for forming a solid cellular foam proteinaceous biopolymeric material comprising separate reactable aliquot portions consisting of a first aqueous solution containing bovine or human serum albumin, and a second aqueous solution containing a di- or polyaldehyde which is reactable with the bovine or human serum albumin of the first aqueous solution to form a solid proteinaceous biopolymeric material in response to mixing of said first and second aqueous solutions, wherein one of the first and second aqueous solutions includes a blowing agent, and wherein the other of said first and second aqueous solutions includes an acidic titrant reactable on contact with the blowing agent sufficient to evolve a gas to impart a cellular foam structure to the proteinaceous biopolymeric material concurrently while said bovine or human serum albumin of said first aqueous solution reacts with said di- or polyaldehyde of said second aqueous solution to form said solid proteinaceous biopolymeric material.

14. The kit of claim 12 or 13, wherein the blowing agent is a bicarbonate.

15. The kit of claim 14, wherein the bicarbonate is at least one selected from the group consisting of bicarbonates of sodium, potassium, aluminum and iron.

16. The kit of claim 12, wherein the blowing agent is an organic bicarbonate.

17. The kit of claim 12, wherein the blowing agent is ammonium bicarbonate.

18. The kit of claim 12, wherein the acidic titrant is at least one acid selected from the group consisting of phosphoric acid, sulfuric acid, hydrochloric acid, acetic acid and citric acid.

19. The kit of claim 12, wherein at least one of the first and second aqueous solutions includes biocompatible fibrous and/or particulate materials.

20. The kit of claim 12, wherein the first and second aqueous solutions are sterilized.