Bioresorbable foaming tissue dressing

• US 9,456,860 B2
• Filed: 12/31/2008
• Issued: 10/04/2016
• 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
• Primary Examiner(s): Barham, Bethany
• Assistant Examiner(s): JAVIER, MELISSA L
• Application Number:
  US12/347,791
• Publication Number:
  US 20090157017A1
• Time in Patent Office: 2,834 Days
• Field of Search: None
• US Class Current: 1/1
• 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 dressing for applying reduced-pressure treatment to a tissue site, comprising:

a gas-forming porogen comprising a particle size for developing sufficient porosity for conducting reduced pressure;

a bioresorbable microsphere; and

a bioresorbable gel or a bioresorbable gel-forming solution in a mixture with the gas-forming porogen and the bioresorbable microsphere;

wherein the mixture is flowable, and after delivery to the tissue site, forms a scaffold comprising pores of at least 50 micrometers in diameter for delivering reduced pressure through the scaffold; and

wherein the dressing is bioresorbable.

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 collagen, gelatin, hyaluronic acid, or combinations thereof.

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

7. The dressing of claim 6, wherein the non-gas forming porogen is a salt.

8. The dressing of claim 7, wherein the salt is sodium chloride or potassium chloride.

9. The dressing of claim 6, wherein the non-gas forming porogen is a sugar.

10. The dressing of claim 1, wherein the bioresorbable microsphere comprises polylactide (PLA), polyglycolic acid (PLG), poly(lactide-co-glycolide) (PLGA), polyethylene glycol-PLA, PLA-polycaprolactone (PCL), a polyorthoester, a polyphosphazene, or a polyphosphoester.

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

12. The dressing of claim 11, wherein the compound is calcium sulfate hemihydrate.

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

14. The dressing of claim 13, wherein the bioactive agent is an antibiotic.

15. The dressing of claim 13, wherein the bioactive agent is a growth factor.

16. The dressing of claim 15, 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).

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

18. The dressing of claim 17, 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.

19. The dressing of claim 17, wherein the mammalian cell is a human cell.

20. The dressing of claim 1, wherein the pores of the scaffold are between approximately 50 micrometers and 1,500 micrometers in diameter.

21. The dressing of claim 1, wherein the pores of the scaffold are between approximately 100 micrometers and 500 micrometers in diameter.

22. A tissue dressing for applying reduced-pressure treatment to a tissue site, comprising:

a gas-forming porogen comprising a particle size for developing sufficient porosity for conducting reduced pressure;

a bioresorbable microsphere; and

a gel or gel-forming solution in a mixture with the gas-forming porogen and the bioresorbable microsphere;

wherein the mixture is flowable, and after delivery to the tissue site, forms a scaffold comprising pores of at least 50 micrometers in diameter for delivering reduced pressure through the scaffold.

23. The dressing of claim 22, wherein the porogen is a mixture of an acid and a carbonate salt.

24. The dressing of claim 23, wherein the acid is citric acid.

25. The dressing of claim 23, wherein the carbonate salt is ammonium bicarbonate, sodium bicarbonate or calcium carbonate.

26. The dressing of claim 22, wherein the gel or gel-forming solution comprises a polyacrylate, a poloxamer, a polyethylene glycol, chitosan, collagen, gelatin, hyaluronic acid, or combinations thereof.

27. The dressing of claim 22, wherein the gel or gel-forming solution comprises a combination of polyacrylate and chitosan.

28. The dressing of claim 22, wherein the gel or gel-forming solution is thermoreversible.

29. The dressing of claim 22, further comprising a non-gas forming porogen.

30. The dressing of claim 29, wherein the non-gas forming porogen is a salt.

31. The dressing of claim 30, wherein the salt is sodium chloride or potassium chloride.

32. The dressing of claim 29, wherein the non-gas forming porogen is a sugar.

33. The dressing of claim 22, wherein the bioresorbable microsphere comprises polylactide (PLA), polyglycolic acid (PLG), poly(lactide-co-glycolide) (PLGA), polyethylene glycol-PLA, PLA-polycaprolactone (PCL), a polyorthoester, a polyphosphazene, or a polyphosphoester.

34. The dressing of claim 22, further comprising a compound that adds stiffness to the dressing.

35. The dressing of claim 34, wherein the compound is calcium sulfate hemihydrate.

36. The dressing of claim 22, further comprising a bioactive agent.

37. The dressing of claim 36, wherein the bioactive agent is an antibiotic.

38. The dressing of claim 36, wherein the bioactive agent is a growth factor.

39. The dressing of claim 38, 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).

40. The dressing of claim 22, further comprising a mammalian cell.

41. The dressing of claim 40, 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.

42. The dressing of claim 40, wherein the mammalian cell is a human cell.

43. The tissue dressing of claim 22, wherein the pores of the scaffold are between approximately 100 micrometers and 300 micrometers in diameter.