Methods of using expandable foam-like biomaterials

• US 8,071,124 B2
• Filed: 01/26/2005
• Issued: 12/06/2011
• Est. Priority Date: 11/07/2000
• Status: Active Grant

• Current Assignee: Cryolife Incorporated
• Original Assignee: Cryolife Incorporated
• Inventors: Yuksel, K. Umit, Bird, Ana T., Black, Kirby S.
• Primary Examiner(s): Woodward, Cherie M
• Assistant Examiner(s): Kassa, Tigabu
• Application Number:
  US11/042,180
• Publication Number:
  US 20050163819A1
• Time in Patent Office: 2,505 Days
• Field of Search: None
• US Class Current: 424/444
• 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 method of treating a tissue site comprising:

applying to the tissue site a proteinaceous pre-polymeric liquid material and a cross linker solution;

combining the proteinaceous pre-polymeric liquid material and the cross linker solution to produce a mixture;

introducing or producing a gaseous blowing agent into the proteinaceous pre-polymeric liquid material or the mixture; and

allowing the mixture to solidify at the tissue site to thereby form a biopolymeric material having a cellular foam structure, to treat the tissue site.

2. The method of claim 1, wherein the proteinaceous pre-polymeric liquid material comprises an aqueous solution of human or animal-derived protein material, and the cross-linker solution comprises an aqueous solution of a di- or polyaldehyde material.

3. The method of claim 2, wherein the aqueous solution of human or animal-derived protein material includes a bicarbonate, and the aqueous solution of di- or polyaldehyde includes an acidic titrant.

4. The method of claim 2 or 3, wherein the biopolymeric material has a volume which is greater than combined volumes of the aqueous solutions.

5. The method of claim 2, wherein the aqueous solution of human or animal-derived protein material is neutral or alkaline.

6. The method of claim 2, wherein the aqueous solution of a di- or polyaldehyde material is acidic.

7. The method of claim 2, wherein the aqueous solutions are introduced as a mixture onto the tissue site.

8. The method of claim 1 or 2, further comprising incorporating into the mixture a biocompatible fibrous or particulate matter.

9. The method of claim 2, wherein the tissue site is in need of repair and wherein the method comprises applying the proteinaceous pre-polymeric liquid to the tissue site in sufficient quantity to repair the tissue site.

16. The method of claim 1, further comprising expelling the proteinaceous pre-polymeric liquid material from a first chamber and expelling the cross linker solution from a second chamber, and passing the expelled materials into a mixing tip comprising static mixing elements that cause the proteinaceous pre-polymeric liquid material and the cross linker solution to combine to form the mixture.

17. The method of claim 16, wherein the proteinaceous pre-polymeric liquid material comprises a serum albumin.

18. The method of claim 16, wherein the crosslinker solution comprises glutaraldehyde.

19. The method of claim 1, wherein the biopolymeric material adheres to the tissue site.

10. A method of treating a tissue site comprising:

applying to the tissue site a two-part mixture which comprises a Part A and a Part B, wherein the Part A includes an aqueous solution of a human- or animal-derived protein material and a bicarbonate compound, and the Part B includes an aqueous solution of a di- or polyaldehyde and a titrant, and wherein the bicarbonate compound and the titrant react to produce a gas into the mixture;

allowing the two-part mixture to react and solidify at the tissue site, thereby forming a biopolymeric material having a cellular foam structure, to treat the tissue site.

11. The method of claim 10, wherein the bicarbonate compound is sodium bicarbonate, potassium bicarbonate, or ammonium bicarbonate.

12. The method of claim 10, wherein the titrant is phosphoric acid, sulfuric acid, hydrochloric acid, citric acid, or acetic acid.

13. The method of claim 10, wherein the human- or animal-derived protein material comprises a serum albumin.

14. The method of claim 10, wherein the di- or polyaldehyde comprises a glutaraldehyde.

15. The method of claim 10, wherein the biopolymeric material adheres to the tissue site.