BIORESORBABLE FOAMING TISSUE DRESSING

• US 20090157017A1
• Filed: 12/31/2008
• Published: 06/18/2009
• Est. Priority Date: 03/14/2006
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Ambrosio, Archel
• Granted Patent: US 9,456,860 B2
• Time in Patent Office: Days
• US Class Current: 604/313
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/01017 synthetic, e.g. polymer based
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3611 Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: A61F 2002/368 with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft
• CPC Class Codes: A61F 2002/3694 with longitudinal bores
• CPC Class Codes: A61F 2013/00157 for burns or skin transplants A61F2013/00187 takes precedence; not adhering to the wound A61F2013/00217
• CPC Class Codes: A61F 2013/00174 possibility of applying pressure
• CPC Class Codes: A61F 2013/00221 biodegradable, non-irritating
• CPC Class Codes: A61F 2013/00255 with pores
• CPC Class Codes: A61F 2013/00519 : for treating burn bandages for burns or skin transplants A61F2013/00157
• CPC Class Codes: A61F 2013/0054 : for deep wounds
• CPC Class Codes: A61F 2013/0074 : containing foams
• CPC Class Codes: A61F 2013/00863 : with pores
• CPC Class Codes: A61F 2013/00927 : with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00928 : Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
• CPC Class Codes: A61L 15/20 : containing organic materials
• CPC Class Codes: A61L 15/425 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 15/54 : Radio-opaque materials
• CPC Class Codes: A61L 15/60 : Liquid-swellable gel-forming materials, e.g. super-absorbents
• CPC Class Codes: A61L 15/64 : specially adapted to be resorbable inside the body
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/64 : Animal cells
• CPC Class Codes: A61L 26/0066 : Medicaments; Biocides
• CPC Class Codes: A61L 26/008 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 26/0085 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 26/009 : Materials resorbable by the body
• CPC Class Codes: A61M 1/915 : Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 35/006 : using sponges, foams, absorbent pads or swabs as spreading means
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 41/00 : Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

Provided is a flowable bioresorbable tissue dressing comprising a gas-forming porogen and a gel or gel-forming solution. Also provided is kits for preparing the above-described tissue dressing. Further provided are methods of treating a tissue site of a mammal with the above dressing. Also provided is a reduced pressure delivery system for applying a reduced pressure tissue treatment to a tissue site.

Claims

1. A flowable bioresorbable tissue dressing comprising a gas-forming porogen and a gel or gel-forming solution.

2. The dressing of claim 1, wherein the porogen is a mixture of an acid and a carbonate salt.

3. The dressing of claim 2, wherein the acid is citric acid.

4. The dressing of claim 2, wherein the carbonate salt is ammonium bicarbonate, sodium bicarbonate or calcium carbonate.

5. The dressing of claim 1, wherein the gel or gel-forming solution comprises Pluronic®

F127, a polyacrylate, a poloxamer, a polyethylene glycol, chitosan, collagen, gelatin, hyaluronic acid, or combinations thereof.

6. The dressing of claim 1, wherein the gel or gel-forming solution comprises a combination of polyacrylate and chitosan.

7. The dressing of claim 1, wherein the gel or gel-forming solution is thermoreversible.

8. The dressing of claim 1, further comprising a non-gas forming porogen.

9. The dressing of claim 8, wherein the non-gas forming porogen is a salt.

10. The dressing of claim 9, wherein the salt is sodium chloride or potassium chloride.

11. The dressing of claim 8, wherein the non-gas forming porogen is a sugar.

12. The dressing of claim 1, further comprising a structure that adds mechanical strength to the dressing.

13. The dressing of claim 12, wherein the structure is a microsphere or a fiber.

14. The dressing of claim 12, wherein the structure comprises polylactide (PLA), polyglycolic acid (PLG), poly(lactide-co-glycolide) (PLGA), polyethylene glycol-PLA, PLA-polycaprolactone (PCL), a polyorthoester, a polyphosphazene, or a polyphosphoester.

15. The dressing of claim 1, further comprising a compound that adds stiffness to the dressing.

16. The dressing of claim 15, wherein the compound is calcium sulfate hemihydrate.

17. The dressing of claim 1, further comprising a bioactive agent.

18. The dressing of claim 17, wherein the bioactive agent is an antibiotic.

19. The dressing of claim 17, wherein the bioactive agent is a growth factor.

20. The dressing of claim 19, wherein the growth factor is growth hormone (GH), a bone morphogenetic protein (BMP), transforming growth factor-α

(TGF-α

), a TGF-β

, a fibroblast growth factor (FGF), granulocyte-colony stimulating factor (G-CSF), granulocyte/macrophage colony stimulating factor (GMCSF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), insulin-like growth factor (IGF), vascular endothelial growth factor (VEGF), hepatocyte growth factor/scatter factor (HGF/SF), an interleukin, tumor necrosis factor-α

(TNF-α

) or nerve growth factor (NGF).

21. The dressing of claim 1, further comprising a mammalian cell.

22. The dressing of claim 21, wherein the mammalian cell is an embryonic stem cell, an adult stem cell, an induced pluripotent stem cell, an epithelial cell, an endothelial cell, a mesenchymal cell, a muscle cell, a fibroblast, a chondrocyte, an adipocyte, or an osteocyte.

23. The dressing of claim 21, wherein the mammalian cell is a human cell.

24. A kit for preparing the tissue dressing of claim 1, the kit comprising a gas-forming porogen mixture in a first container and a gel or gel-forming solution or dehydrated ingredients for a gel or gel-forming solution in a second container.

25. The kit of claim 24, wherein the porogen is a mixture of an acid and a carbonate salt.

26. The kit of claim 25, wherein the acid is citric acid.

27. The kit of claim 25, wherein the carbonate salt is ammonium bicarbonate, sodium bicarbonate or calcium carbonate.

28. The kit of claim 24, wherein the gel or gel-forming solution comprises Pluronic®

F127, a polyacrylate, a poloxamer, a polyethylene glycol, chitosan, collagen, gelatin, hyaluronic acid, or combinations thereof.

29. The kit of claim 24, wherein the second container further comprises a structure that adds mechanical strength to the dressing.

30. The kit of claim 29, wherein the structure is a microsphere or a fiber.

31. The kit of claim 24, further comprising a bioactive agent.

32. The kit of claim 31, wherein the bioactive agent is an antibiotic.

33. The kit of claim 31, wherein the bioactive agent is a growth factor.

34. The kit of claim 28, further comprising a mammalian cell.

35. A method of treating a tissue site of a mammal with the dressing of claim 1, the method comprising mixing the gas-forming porogen with the gel or gel-forming solution to create a flowable foaming mixture, then delivering the foaming mixture onto the tissue site while the mixture is foaming.

36. The method of claim 35, wherein the foaming mixture is delivered to the tissue site by pouring or injecting the mixture onto the tissue site.

37. The method of claim 35, wherein the foaming mixture is delivered to the tissue site by delivery through a manifold delivery tube of a reduced pressure delivery system.

38. The method of claim 35, wherein the gel or gel-forming solution is thermoreversible.

39. The method of claim 35, wherein the gas-forming porogen further comprises a structure that adds mechanical strength to the dressing.

40. The method of claim 39, wherein the structure is a microsphere or a fiber.

41. The method of claim 35, wherein the tissue site comprises an exposed wound on the mammal.

42. The method of claim 41, wherein the exposed wound is an acute surgical wound, a pressure ulcer, a trauma wound, a diabetic wound, a skin graft, an open abdominal wound, or a burn.

43. The method of claim 35, wherein the tissue site is an internal site and the foaming mixture is delivered to the tissue site percutaneously.

44. The method of claim 43, wherein the tissue site is on a bone.

45. The method of claim 35, wherein the dressing comprises open pores that create a plurality of flow channels after the mixture stops foaming.

46. The method of claim 34, further comprising covering the dressing with a drape and applying a reduced pressure to the wound site through the dressing.

47. The method of claim 46, wherein the reduced pressure is delivered to the wound site through a manifold,

the manifold comprising a reduced pressure delivery tube, wherein the reduced pressure tube comprises a proximal end, a distal end, and a lumen extending through the tube,

wherein the proximal end is in fluid communication with a reduced pressure source and the distal end is in fluid communication with the dressing.

48. The method of claim 47, wherein the foaming mixture is delivered to the tissue site through the reduced pressure delivery tube.

49. The method of claim 47, wherein the manifold further comprises a second tube, wherein the foaming mixture is delivered to the tissue site through the second tube.

50. The method of claim 35, wherein the mammal is a human.

51. A reduced pressure delivery system for applying a reduced pressure tissue treatment to a tissue site, the system comprising

the kit of claim 24,

a reduced pressure source, and

a manifold, the manifold comprising a reduced pressure delivery tube,

wherein the reduced pressure tube comprises a proximal end, a distal end, and a lumen extending through the tube, wherein the proximal end is in fluid communication with the reduced pressure source and the distal end is in fluid communication with the dressing.

52. The reduced pressure delivery system of claim 51, wherein the manifold further comprises a second tube suitable for delivery of the dressing of claim 1 to a tissue site.