Hemostatic sponge

Patent metadata

Field	Value
Publication number	US-9517287-B2
Application number	US-201414320064-A
Country	US
Kind code	B2
Filing date	Jun 30, 2014
Priority date	Dec 16, 2009
Publication date	Dec 13, 2016
Grant date	Dec 13, 2016

Abstract

The present invention provides a hemostatic composite sponge comprising a porous matrix of a biomaterial and a material enhancing the adherence of said sponge to the applied tissue stably associated with at least one surface of said sponge, a method of producing these sponges and their use in hemostasis.

First claim

What is claimed is:

1. A hemostatic composite sponge comprising a porous sponge of a matrix of a biomaterial and a material enhancing the adherence of said porous sponge to an applied tissue stably associated with at least one surface of said porous sponge, wherein said adherence-enhancing material is essentially free of a hydrogel forming component, and wherein the adherence-enhancing material is present in a grid pattern on the porous sponge.

2. The sponge according to claim 1 , wherein said biomaterial is selected from the group consisting of collagen, gelatin, fibrin, a polysaccharide, and a derivative thereof.

3. The sponge according to claim 2 , wherein the polysaccharide comprises chitosan.

4. The sponge according to claim 2 , wherein said adherence-enhancing material is a mixture of two pre-polymers comprising a first cross-linkable component and a second cross-linkable component that cross-links with the first cross-linkable component under reaction enabling conditions.

5. The sponge according to claim 4 , wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

6. The sponge according to claim 2 , wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

7. The sponge according to claim 1 , wherein said adherence-enhancing material is a mixture of two pre-polymers comprising a first cross-linkable component and a second cross-linkable component that cross-links with the first cross-linkable component under reaction enabling conditions.

8. The sponge according to claim 7 , wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

9. The sponge according to claim 1 , wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

10. The sponge according to claim 1 , wherein said adherence-enhancing material forms a continuous or discontinuous layer on at least one surface of said porous sponge.

11. The sponge according to claim 1 having an overall thickness of about 1 mm to about 2.5 mm.

12. The sponge according to claim 1 for use in minimal invasive surgery.

13. The sponge according to claim 12 , wherein the minimal invasive surgery comprises a laparoscopic application.

14. The sponge according to claim 1 wherein the adherence-enhancing material is present in a concentration of 5 to 500 mg per cm 2 of biomaterial.

15. The sponge according to claim 14 , wherein the adherence-enhancing material is present in a concentration of between 5 to 100 mg per cm 2 .

16. A method of treating a wound, a hemorrhage, damaged tissue and/or bleeding tissue comprising administering the hemostatic composite sponge of claim 1 .

17. The method of claim 16 , further comprising sterilizing the composite sponge.

18. The sponge according to claim 1 , wherein the adherence-enhancing material forms a discontinuous layer on at least one surface of the porous sponge.

19. The sponge according to claim 1 , wherein the adherence-enhancing material forms a continuous layer on at least one surface of the porous sponge.

20. The sponge according to claim 1 , wherein the adherence-enhancing material is distributed throughout the porous sponge.

21. A method of manufacturing a hemostatic composite sponge comprising
providing a porous sponge of a matrix of a biomaterial;
providing a material enhancing the adherence of said porous sponge to the applied tissue in the form of a suspension, a solution or powder, wherein said adherence-enhancing material is essentially free of a hydrogel forming component; and
contacting the porous sponge and the adherence-enhancing material so that the adherence-enhancing material is stably associated with at least one surface of said porous sponge so that the hemostatic composite sponge is obtained,
wherein the step of contacting the porous sponge and the adherence-enhancing material comprises first placing a grid onto the porous sponge and then distributing the adherence-enhancing material onto the porous sponge, such that the sponge is partially shielded from the adherence-enhancing material.

22. The method of claim 21 , further comprising drying the composite sponge.

23. The method of claim 21 , further comprising sterilizing the composite sponge.

24. The method according to claim 21 , wherein the adherence-enhancing material is provided in the form of the suspension.

25. The method according to claim 21 , wherein the adherence-enhancing material is provided in the form of the solution.

26. The method according to claim 21 , wherein the adherence-enhancing material is provided in the form of the powder.

27. The method according to claim 21 , wherein the adherence-enhancing material is present in an aqueous acidic solution, and the step of contacting the porous sponge and the adherence-enhancing material comprises allowing the porous sponge to absorb the aqueous acidic solution.

28. The method according to claim 27 , wherein the adherence-enhancing material is present in the aqueous acidic solution at a concentration selected from the group consisting of 10 mg/cm 3 , 35 mg/cm 3 , 70 mg/cm 3 , and 100 mg/cm 3 .

29. The method according to claim 21 , wherein the adherence-enhancing material is present in an ethanol solution, and the step of contacting the porous sponge and the adherence-enhancing material comprises allowing the porous sponge to absorb the ethanol solution.

30. The method according to claim 29 , wherein the adherence-enhancing material is present in the ethanol solution at a concentration selected from the group consisting of 10 mg/cm 3 , 35 mg/cm 3 , 70 mg/cm 3 , and 100 mg/cm 3 .

Assignees

• Baxter Int
• Baxter Healthcare Sa
• Baxter Int
• Baxter Healthcare Sa

Inventors

• Hedrich Hans Christian
• Hoefinghoff Joris
• Rhee Woonza M
• Osawa Atsushi Edward

Classifications

• A61F2013/00468

  applying local pressure · CPC title

• C09J171/02

  Polyalkylene oxides · CPC title

• A61F13/15577

  Apparatus or processes for manufacturing · CPC title

• A61L15/425 Primary

  Porous materials, e.g. foams or sponges · CPC title

• A61F2013/00463

  haemostatic · CPC title