Device for Promotion of Hemostasis and/or Wound Healing

• US 20110021964A1
• Filed: 02/27/2009
• Published: 01/27/2011
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Ferrosan Medical Devices A/S
• Original Assignee: Ferrosan Medical Devices A/S
• Inventors: Sabra, Mads, Larsen, Kristian
• Granted Patent: US 8,642,831 B2
• Time in Patent Office: Days
• US Class Current: 602/47
• CPC Class Codes: A61L 2300/254 Enzymes, proenzymes
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/102 Collagen
• CPC Class Codes: A61L 24/104 Gelatin
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 26/0085 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Abstract

The present invention relates to a matrix material comprising a pharmaceutical composition such as a matrix material with a pharmaceutical composition printed on the surface. In one embodiment the pharmaceutical composition comprises thrombin. The invention further describes a method for making the matrix material with a pharmaceutical composition printed on the surface. In one specific embodiment the invention also relates to the use of said matrix material for promotion of hemostasis and/or wound healing. The invention also relates to a kit-of-parts comprising a matrix with a pharmaceutical composition and a container with a peelable lid.

Claims

1. A matrix material comprising a surface and a plurality of open and interconnected cells, said matrix material comprising gelatine or collagen, wherein the surface of said matrix comprises at least one pharmaceutical composition printed onto said surface in individual and discrete locations.

4. The matrix material according to claim 1, wherein the surface of the matrix contains less than 100 IU/cm² of the pharmaceutical composition.

5. The matrix material according to claim 1, wherein the matrix material is a sponge.

6. The matrix material according to claim 5, wherein the sponge is a gelatin or collagen sponge.

7. The matrix material according to claim 1, wherein the matrix material is sterile and contained in a sterile, pre-packaged, ready-to-use container.

8. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s).

9. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) that stimulates hemostasis.

10. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) that stimulates wound healing.

11. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) that stimulates wound healing by inhibition of one or more infections of the wound.

12. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) which comprises one or more anti-fibrinolytic agents.

13. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) which comprises one or more pro-coagulants.

14. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more bioactive agent(s) that stimulates one or more coagulation factors.

15. The matrix material according to claim 1, wherein the pharmaceutical composition comprises thrombin.

16. The matrix material according to claim 15, wherein the matrix contains less than 300 IU thrombin per square cm (cm²) surface area.

17. The matrix material according to claim 1, wherein the pharmaceutical composition is printed onto the surface of the matrix material by deposition of an amount of liquid per position of less than 100 nL.

18. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one or more adhesive agents.

19. The matrix material according to claim 1, wherein the pharmaceutical composition comprises a solvent component and/or a fluid component.

20. The matrix material according to claim 19, wherein the solvent component and/or fluid component is an aqueous medium.

21. The matrix material according to claim 1, wherein the pharmaceutical composition has a viscosity in the range of 0.1-20 cps.

22. The matrix material according to claim 1, wherein the pharmaceutical composition has a surface tension in the range of 0.020 to 0.050 N/m.

23. The matrix material according to claim 1, wherein the pharmaceutical composition comprises one bioactive agent.

24. The matrix material according to claim 1, wherein the pharmaceutical composition comprises two or more agents or bioactive agents.

25. The matrix material according to claim 1, wherein the surface of the matrix material comprises two or more different pharmaceutical compositions each comprising one or more agents or bioactive agents.

26. A matrix according to claim 1, said matrix being obtained by a method comprising the steps of providing a matrix material and printing said at least one pharmaceutical composition onto the surface of said matrix material at individual and discrete locations.

27. The matrix according to claim 26, wherein said method essentially does not alter the physical characteristics of the surface of said matrix.

28. The matrix according to claim 26, wherein said method essentially does not cause any swelling of the matrix.

29. The matrix according to claim 26, wherein said method essentially does not cause any swelling of the surface of said matrix.

30. The matrix according to claim 26, wherein said method essentially does not alter the initial absorption rate of the matrix.

31. The matrix according to claim 26, wherein printing of the pharmaceutical composition occurs essentially perpendicular to the surface of said matrix material.

32. A device comprising the matrix material printed with a pharmaceutical composition according to claim 1.

33. A kit of parts comprising the device according to claim 32 and at least one additional component.

34. A method for making the device according to claim 32 comprising the steps of

a. providing a matrix material, and

b. printing a pharmaceutical composition onto the surface of said matrix material at individual and discrete locations.

35. Use of the device according to claim 32 to promote wound healing in an individual in need thereof.

36. Use of the device according to claim 32 to promote hemostasis in an individual in need thereof.

39. A container for storage and/or preparation of a matrix material according to claim 1 comprising

i) a bottom,

ii) one or more sidewall(s) continuously surrounding said bottom,

iii) a sealing surface for a lid, and

iv) a lid,

wherein the one or more sidewall(s) and the bottom defines an inner cavity suitable for storage and/or preparation of a matrix material

wherein said inner cavity comprises one or more matrix materials according to claim 1.

43. A kit of parts comprising a matrix material according to claim 1 and at least one additional component.

2. (canceled)

3. (canceled)

37. (canceled)

38. (canceled)

40. (canceled)

41. (canceled)

42. (canceled)

44. (canceled)