ABSORBABLE ADHESIVES AND THEIR FORMULATION FOR USE IN MEDICAL APPLICATIONS

• US 20090092651A1
• Filed: 09/24/2008
• Published: 04/09/2009
• Est. Priority Date: 10/05/2007
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Shah, Bhavin, Hall, Paul J.
• Granted Patent: US 10,500,309 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61L 24/104 Gelatin
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

Described are medical products including an adhesive containing a polypeptide component such as gelatin and a tackiness-providing polyhydroxy compound, such as at least one compound selected from the group consisting of glycerin and fructose. Such medical products can find use as a bolster material for use in conjunction with a surgical fastening device such as a stapler. Other medical applications utilizing a medical product of the invention include tissue repair and pharmaceutical delivery to a desired location. Related methods of manufacture and use are also described.

Claims

1. A medical product, comprising:

a medical graft material; and

a dried, reversible adhesive coating on at least a portion of a surface of said material, wherein said adhesive comprises gelatin and at least one of glycerin and fructose.

2. The medical product of claim 1, wherein said medical material is comprised of a synthetic or a biological material.

3. The medical product of claim 2, wherein said medical material is comprised of a biological material.

4. The medical product of claim 3, wherein said medical material is remodelable.

5. The medical product of claim 4, wherein said medical material comprises an extracellular matrix (ECM) material.

6. The medical product of claim 5, wherein said ECM comprises submucosa.

7. The medical product of claim 6, wherein said submucosa is intestinal, urinary bladder or stomach submucosa.

8. The medical product of claim 7, wherein said submucosa is small intestinal submucosa (SIS).

9. The medical product of claim 1, wherein said medical product is useful as a bolster material.

10. The medical product of claim 9, wherein said bolster material is configured for application to an arm of a surgical fastening device

11. The medical product of claim 1, wherein said medical product is useful as a hernia repair graft.

12. The medical product of claim 1, wherein said adhesive is dried to form a porous open-cell foam.

13. The medical product of claim 1, wherein said adhesive further comprises a bioactive component and/or pharmaceutical agent.

14. The medical product of claim 1, wherein said adhesive is coated onto a substantial portion of the medical material.

15. The medical product of claim 1, wherein said adhesive is air dried.

16. The medical product of claim 1, wherein said adhesive is vacuum dried.

17. A medical product comprising:

a layer of dried, collagenous extracellular matrix material; and

a dried, reversible adhesive coating on at least a portion of a surface of said layer, wherein said adhesive comprises gelatin and a compound selected from the group consisting of glycerin and fructose.

18. The medical product of claim 17, wherein said layer and said coating are lyophilized.

19. The medical product of claim 17, wherein said layer comprises submucosa of a warm-blooded vertebrate.

20. The medical product of claim 19, wherein said layer comprises small intestinal submucosa.

21. The medical product of claim 17, wherein said adhesive is air dried.

22. The medical product of claim 17, wherein said adhesive is vacuum dried.

23. A method for preparing a medical product, comprising:

providing a medical material as a first layer;

applying an adhesive including gelatin and a compound selected from the group consisting of glycerin and fructose to at least a portion of a surface of the medical material to form an adhesive coating on said material;

drying said medical material including said adhesive so as to form the medical product.

24. The method of claim 23, wherein said medical material is comprised of a synthetic or a biological material.

25. The method of claim 24, wherein said medical material is comprised of a biological material.

26. The method of claim 25, wherein said medical material is remodelable.

27. The method of claim 26, wherein said medical material comprises an extracellular matrix (ECM) material.

28. The method of claim 27, wherein said ECM comprises submucosa.

29. The method of claim 28, wherein said submucosa is intestinal, urinary bladder or stomach submucosa.

30. The method of claim 29, wherein said submucosa is small intestinal submucosa (SIS).

31. The method of claim 23, wherein said medical product is useful as a bolster material.

32. The method of claim 31, wherein said bolster material is configured for application to an arm of a surgical fastening device

33. The method of claim 23, wherein said medical product is useful as a hernia repair graft.

34. The method of claim 23, wherein said medical material and said adhesive are dried by lyophilization.

35. The method of claim 34, wherein said, medical material and said adhesive are air dried.

36. The method of claim 34, wherein said, medical material and said adhesive are vacuum dried.

37. The method of claim 23, wherein said adhesive further comprises a bioactive component and/or pharmaceutical agent.

38. The method of claim 23, wherein said adhesive is coated onto a substantial portion of the medical material.

39. The method of claim 38, wherein said method further comprises applying a non-stick, releasable liner to the coated surface of the medical product.

40. A bolster material, comprising:

bolster material configured for application to an arm of a surgical fastening device; and

a dried, reversible adhesive coating on at least a portion of a surface of said bolster material, wherein said adhesive comprises a polypeptide and a polyhydroxy compound.

49. The device of claim 40, wherein said polypeptide exhibits thermally reversible self crosslinking.

41. A medical device comprising:

a layer of dried, collagenous extracellular matrix material; and

a dried, reversible adhesive coating on at least a portion of a surface of said collagenous extracellular matrix material, wherein said adhesive comprises a polypeptide and a polyhydroxy compound on said layer.

42. The medical device of claim 41, wherein said sheet and said coating are lyophilized.

43. The medical device of claim 42 wherein said sheet comprises submucosa of a warm-blooded vertebrate.

44. The medical device of claim 43, wherein said sheet comprises porcine small intestinal submucosa.

50. The device of claim 41, wherein said polypeptide exhibits thermally reversible self crosslinking.

45. A medical device, comprising:

bolster material configured for application to a working surface of a surgical fastening device; and

an adhesive coating on at least a portion of a surface of said bolster material, the adhesive coating comprising a polypeptide and a polyhydroxy compound.

46. The device of claim 45, wherein the bolster material is remodelable.

47. The device of claim 45, wherein the bolster material comprises an extracellular matrix material.

48. The device of claim 47, wherein the extracellular matrix material comprises submucosa.

51. The device of claim 45, wherein said polypeptide exhibits thermally reversible self crosslinking.

52. The device of claim 45, also comprising an applicator element, said bolster material supported on said applicator element.

53. The device of claim 52, wherein said applicator element is formed with a compressible foam material.

54. A method for loading a bolster material on a surgical fastening device, comprising:

providing a bolster material configured for application to a working surface of the surgical fastening device, the bolster material having an adhesive coating on at least a portion of a surface of said bolster material, the adhesive coating comprising at least one matrix-forming polypeptide and at least one polyhydroxy compound; and

contacting said adhesive material against the working surface of the surgical fastening device so as to adhere the bolster material to the working surface.

55. The method of claim 54, wherein said at lest one polypeptide comprises gelatin and said at least one polyhydroxy compound comprises fructose.