BIOCOMPATIBLE WOUND DRESSING

• US 20100249688A1
• Filed: 04/12/2010
• Published: 09/30/2010
• Est. Priority Date: 02/16/2001
• Status: Active Grant

• Current Assignee: KCI Licensing Incorporated (3M Company)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: JOHNSON, ROYCE W., AMBROSIO, ARCHEL
• Granted Patent: US 8,163,974 B2
• Time in Patent Office: Days
• US Class Current: 602/43
• CPC Class Codes: A61F 13/01012 being made of natural material, e.g. cellulose-, protein-, collagen-based
• CPC Class Codes: A61F 13/01029 made of multiple layers
• CPC Class Codes: A61F 13/0206 with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
• CPC Class Codes: A61F 13/0209 comprising superabsorbent material
• 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: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/918 for multiple suction locations
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like

Abstract

A multi-layer reduced pressure delivery apparatus is provided for applying reduced pressure tissue treatment to a tissue site. The multi-layer apparatus includes a tissue contact layer, a release layer, and a manifold layer. The tissue contact layer includes a scaffold adapted to contact the tissue site, the release layer includes a water-soluble polymer and a plurality of flow channels, and the manifold layer includes a distribution manifold. The release layer is positioned between the tissue contact layer and the manifold layer to allow easy release of the manifold layer from the tissue contact layer following the administration of reduced pressure tissue treatment.

Claims

1. A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site comprising:

a multi-layer reduced pressure delivery apparatus having a tissue contact layer, a release layer, and a manifold layer, the tissue contact layer including a scaffold adapted to contact the tissue site, the release layer including a water-soluble polymer and a plurality of flow channels, the manifold layer including a distribution manifold, the release layer being positioned between the tissue contact layer and the manifold layer, the water-soluble polymer of the release layer binding to at least one of the tissue contact layer and the manifold layer; and

a reduced-pressure delivery tube fluidly connected to the manifold layer to deliver a reduced pressure to the tissue site.

2. The reduced pressure delivery system according to claim 1, wherein the water-soluble polymer is positioned between the scaffold and the distribution manifold to substantially prevent contact between the scaffold and the distribution manifold in areas where the water-soluble polymer is disposed.

3. The reduced pressure delivery system according to claim 2, wherein the distribution manifold contacts the scaffold in areas in which the water-soluble polymer is not disposed during application of the reduced pressure.

4. The reduced pressure delivery system according to claim 1, wherein the tissue contact layer is from about 1 mm to about 4 mm in thickness.

5. The reduced pressure delivery system according to claim 1, wherein the thickness of the release layer is less than the thickness of the tissue contact layer.

6. The reduced pressure delivery system according to claim 1, wherein the plurality of flow channels of the release layer are provided by pores disposed in a sheet of the water-soluble polymer.

7. The reduced pressure delivery system according to claim 6, wherein the pore sizes of the pores in the release layer are less than the pore sizes of the pores in the scaffold.

8. The reduced pressure delivery system according to claim 1, wherein:

the water-soluble polymer is arranged in a grid pattern such that strands of the water-soluble polymer are aligned in rows and columns; and

the plurality of flow channels are formed by voids disposed between the rows and columns of the water-soluble polymer.

9. The reduced pressure delivery system according to claim 1, wherein:

the water-soluble polymer is provided as a plurality of individual beads, each bead being spaced apart from adjacent beads by a void; and

the plurality of flow channels are formed by the voids disposed between the beads of the water-soluble polymer.

10. The reduced pressure delivery system according to claim 9, wherein the porosity provided by the voids is less than the porosity provided by the scaffold.

11. The reduced pressure delivery system according to claim 1, wherein the distribution manifold is an open-cell, reticulated polyurethane foam.

12. The reduced pressure delivery system according to claim 1, wherein the water-soluble polymer is a barrier to tissue penetration.

13. The reduced pressure delivery system according to claim 1, wherein the scaffold is comprised of at least one material selected from the group of polylactic acid polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyorthoesthers, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, chitosan, hydroxyapatite, coralline apatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, allografts, and autografts.

14. The reduced pressure delivery system according to claim 1, wherein the water-soluble polymer is comprised of at least one material selected from the group of uncrosslinked polyethylene glycol, hydrophilic polyethers, polyvinyl alcohol, polyvinyl acetate, polyacrylates, polysulfonates, polyphosphazenes, collagen, hyaluronic acid, glucosaminoglycans, chitosan, and deoxyribonucleic acid (DNA).

15. The reduced pressure delivery system according to claim 1, wherein the distribution manifold is comprised of at least one material selected from the group of polyurethane foam, polyvinyl alcohol foam, polyethylene foam, expanded polytetrafluoroethylene, silicone foam, loofa sponge, sea sponge, gauze, and felted mats.

16. The reduced pressure delivery system according to claim 1 further comprising:

a reduced pressure source fluidly connected to a proximal end of the reduced-pressure delivery tube.

17. A multi-layer reduced pressure delivery apparatus for applying reduced pressure tissue treatment to a tissue site comprising:

a first layer having a scaffold adapted to contact a tissue site;

a second layer having a water-soluble polymer and a plurality of flow channels, the water-soluble polymer contacting the scaffold; and

a third layer having a distribution manifold contacting the water-soluble polymer.

18. The reduced pressure delivery apparatus according to claim 17, wherein the water-soluble polymer is positioned between the first layer and the third layer and is connected to at least one of the scaffold and the distribution manifold.

19. The reduced pressure delivery apparatus according to claim 17 further comprising:

a reduced-pressure delivery tube fluidly connected to the third layer to deliver a reduced pressure to the tissue site.

20. The reduced pressure delivery apparatus according to claim 17, wherein the water-soluble polymer is positioned between the scaffold and the distribution manifold to substantially prevent contact between the scaffold and the distribution manifold in areas where the water-soluble polymer is disposed.

21. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold contacts the scaffold in areas in which the water-soluble polymer is not disposed during application of a reduced pressure.

22. The reduced pressure delivery apparatus according to claim 17, wherein a reduced pressure is delivered to the tissue site through the distribution manifold, the plurality of flow channels, and the scaffold.

23. The reduced pressure delivery apparatus according to claim 17, wherein the flow channels are capable of transmitting a fluid from the scaffold to the distribution manifold during the application of a reduced pressure.

24. The reduced pressure delivery apparatus according to claim 23, wherein the fluid is a wound exudate from the tissue site.

25. The reduced pressure delivery apparatus according to claim 17, wherein the first layer is from about 1 mm to about 4 mm in thickness.

26. The reduced pressure delivery apparatus according to claim 17, wherein the thickness of the second layer in a dehydrated state is less than the thickness of the first layer.

27. The reduced pressure delivery apparatus according to claim 17, wherein the scaffold includes pores having pore sizes ranging from about 50 microns to about 500 microns in diameter.

28. The reduced pressure delivery apparatus according to claim 17, wherein the scaffold includes pores having pore sizes ranging from about 100 microns to about 400 microns in diameter.

29. The reduced pressure delivery apparatus according to claim 17, wherein the plurality of flow channels of the second layer are provided by pores disposed in a sheet of the water-soluble polymer.

30. The reduced pressure delivery apparatus according to claim 29, wherein the pore sizes of the pores in the second layer are less than the pore sizes of the pores in the scaffold.

31. The reduced pressure delivery apparatus according to claim 17, wherein:

the water-soluble polymer is arranged in a grid pattern such that strands of the water-soluble polymer are aligned in rows and columns; and

the plurality of flow channels are formed by voids disposed between the rows an columns of the water-soluble polymer.

32. The reduced pressure delivery apparatus according to claim 17, wherein:

the water-soluble polymer is provided as a plurality of individual beads, each bead being spaced apart from adjacent beads by a void; and

the plurality of flow channels are formed by the voids disposed between the beads of the water-soluble polymer.

33. The reduced pressure delivery apparatus according to claim 32, wherein the porosity provided by the voids is less than the porosity provided by the scaffold.

34. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold is a cellular foam.

35. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold is an open-cell, reticulated polyurethane foam.

36. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold includes pore sizes ranging from about 400 to about 600 microns in diameter.

37. The reduced pressure delivery apparatus according to claim 17, wherein the third layer includes an antimicrobial agent.

38. The reduced pressure delivery apparatus according to claim 17, wherein the water-soluble polymer is bioabsorbable.

39. The reduced pressure delivery apparatus according to claim 17, wherein the water-soluble polymer is a barrier to tissue penetration.

40. The reduced pressure delivery apparatus according to claim 17, wherein the tissue site is comprised of tissue selected from the group of adipose tissue, bone tissue, cartilage, connective tissue, dermal tissue, ligaments, muscle tissue, tendons, and vascular tissue.

41. The reduced pressure delivery apparatus according to claim 17, wherein the scaffold is comprised of at least one material selected from the group of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyorthoesthers, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, chitosan, hydroxyapatite, coralline apatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, allografts, and autografts.

42. The reduced pressure delivery apparatus according to claim 17, wherein the water-soluble polymer is comprised of at least one material selected from the group of uncrosslinked polyethylene glycol, hydrophilic polyethers, polyvinyl alcohol, polyvinyl acetate, polyacrylates, polysulfonates, polyphosphazenes, collagen, hyaluronic acid, glucosaminoglycans, chitosan, and deoxyribonucleic acid (DNA).

43. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold is comprised of at least one material selected from the group of polyurethane foam, polyvinyl alcohol foam, polyethylene foam, expanded polytetrafluoroethylene, silicone foam, loofa sponge, sea sponge, gauze, and felted mats.

44. The reduced pressure delivery apparatus according to claim 17, wherein the distribution manifold is chosen from the group of a woven porous pad, a non-woven porous pad, a loofa sponge, and a sea sponge.

45. A multi-layer reduced pressure delivery apparatus for applying reduced pressure tissue treatment to a tissue site comprising:

a tissue contact layer having a scaffold adapted to contact the tissue site to receive in-growth of new tissue from the tissue site, the tissue contact layer further having a first plurality of flow channels;

a manifold layer having a cellular material to distribute a reduced pressure to the tissue site, the manifold layer further having a third plurality of flow channels; and

a release layer positioned between the tissue contact layer and the manifold layer, the release layer including a water-soluble polymer connected to at least one of the tissue contact layer and the manifold layer, the water-soluble polymer adapted to dissolve following hydration by a fluid to release the at least one of the tissue contact layer and the manifold layer, the release layer further having a second plurality of flow channels in fluid communication with the first and third plurality of flow channels.

46. The reduced pressure delivery apparatus according to claim 45 further comprising a reduced-pressure delivery tube fluidly connected to the manifold layer to deliver the reduced pressure to the tissue site through the third plurality of flow channels, the second plurality of flow channels, and the first plurality of flow channels.

47. The reduced pressure delivery apparatus according to claim 45, wherein:

the water-soluble polymer substantially prevents contact between the scaffold and the cellular material in areas where the water-soluble polymer is disposed; and

the cellular material contacts the scaffold in areas in which the water-soluble polymer is not disposed during application of the reduced pressure.

48. The reduced pressure delivery apparatus according to claim 45, wherein the tissue contact layer is from about 1 mm to about 4 mm in thickness.

49. The reduced pressure delivery apparatus according to claim 45, wherein the thickness of the release layer is less than the thickness of the tissue contact layer.

50. The reduced pressure delivery apparatus according to claim 45, wherein the scaffold includes pores having pore sizes ranging from about 50 microns to about 500 microns in diameter.

51. The reduced pressure delivery apparatus according to claim 45, wherein the second plurality of flow channels of the release layer are provided by pores disposed in a sheet of the water-soluble polymer.

52. The reduced pressure delivery apparatus according to claim 51, wherein the pore sizes of the pores in the release layer are less than the pore sizes of the pores in the scaffold.

53. The reduced pressure delivery apparatus according to claim 45, wherein:

the water-soluble polymer is arranged in a grid pattern such that strands of the water-soluble polymer are aligned in rows and columns; and

the second plurality of flow channels are formed by voids disposed between the rows and columns of the water-soluble polymer.

54. The reduced pressure delivery apparatus according to claim 45, wherein:

the water-soluble polymer is provided as a plurality of individual beads, each bead being spaced apart from adjacent beads by a void; and

the second plurality of flow channels are formed by the voids disposed between the beads of the water-soluble polymer.

55. The reduced pressure delivery apparatus according to claim 54, wherein the porosity provided by the voids is less than the porosity provided by the scaffold.

56. The reduced pressure delivery apparatus according to claim 45, wherein the cellular material is an open-cell, reticulated polyurethane foam.

57. The reduced pressure delivery apparatus according to claim 45, wherein the water-soluble polymer is a barrier to tissue penetration.

58. The reduced pressure delivery apparatus according to claim 45, wherein the scaffold is comprised of at least one material selected from the group of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyorthoesthers, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, chitosan, hydroxyapatite, coralline apatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, allografts, and autografts.

59. The reduced pressure delivery apparatus according to claim 45, wherein the water-soluble polymer is comprised of at least one material selected from the group of uncrosslinked polyethylene glycol, hydrophilic polyethers, polyvinyl alcohol, polyvinyl acetate, polyacrylates, polysulfonates, polyphosphazenes, collagen, hyaluronic acid, glucosaminoglycans, chitosan, and deoxyribonucleic acid (DNA).

60. The reduced pressure delivery apparatus according to claim 45, wherein the cellular material is comprised of at least one material selected from the group of polyurethane foam, polyvinyl alcohol foam, polyethylene foam, expanded polytetrafluoroethylene, silicone foam, loofa sponge, sea sponge, gauze, and felted mats.

61. A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site comprising:

a reduced pressure delivery apparatus having a distribution manifold to distribute a reduced pressure and a scaffold to encourage in-growth of new tissue from the tissue site, the distribution manifold and scaffold being bound together by a water-soluble polymer positioned between the distribution manifold and the scaffold; and

a reduced-pressure delivery tube having a distal end fluidly connected to the distribution manifold to deliver the reduced pressure through the distribution manifold and scaffold to the tissue site.

62. The reduced pressure delivery system according to claim 61, wherein the water-soluble polymer substantially prevents contact between the scaffold and the distribution manifold in areas where the water-soluble polymer is disposed.

63. The reduced pressure delivery system according to claim 61, wherein the distribution manifold contacts the scaffold in areas in which the water-soluble polymer is not disposed during application of the reduced pressure.

64. The reduced pressure delivery system according to claim 61 further comprising:

a plurality of flow channels disposed between the scaffold and distribution manifold to allow fluid communication between the scaffold and distribution manifold.

65. The reduced pressure delivery system according to claim 61, wherein the scaffold is from about 1 mm to about 4 mm in thickness.

66. The reduced pressure delivery system according to claim 61, wherein the thickness of the water-soluble polymer is less than the thickness of the scaffold.

67. The reduced pressure delivery system according to claim 61 further comprising:

a plurality of flow channels disposed between the scaffold and distribution manifold to allow fluid communication between the scaffold and distribution manifold; and

wherein the plurality of flow channels are provided by pores disposed in a sheet of the water-soluble polymer.

68. The reduced pressure delivery system according to claim 67, wherein the pore sizes of the pores in the sheet of the water-soluble polymer are less than the pore sizes of pores in the scaffold.

69. The reduced pressure delivery system according to claim 61 further comprising:

a plurality of flow channels disposed between the scaffold and distribution manifold to allow fluid communication between the scaffold and distribution manifold;

wherein the water-soluble polymer is arranged in a grid pattern such that strands of the water-soluble polymer are aligned in rows and columns; and

wherein the plurality of flow channels are formed by voids disposed between the rows and columns of the water-soluble polymer.

70. The reduced pressure delivery system according to claim 61 further comprising:

a plurality of flow channels disposed between the scaffold and distribution manifold to allow fluid communication between the scaffold and distribution manifold;

the water-soluble polymer is provided as a plurality of individual beads, each bead being spaced apart from adjacent beads by a void; and

the plurality of flow channels are formed by the voids disposed between the beads of the water-soluble polymer.

71. The reduced pressure delivery system according to claim 70, wherein the porosity provided by the voids is less than the porosity provided by the scaffold.

72. The reduced pressure delivery system according to claim 61, wherein the distribution manifold is an open-cell, reticulated polyurethane foam.

73. The reduced pressure delivery system according to claim 61, wherein the water-soluble polymer is a barrier to tissue penetration.

74. The reduced pressure delivery system according to claim 61, wherein the scaffold is comprised of at least one material selected from the group of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyorthoesthers, polyphosphazenes, polyurethanes, collagen, hyaluronic acid, chitosan, hydroxyapatite, coralline apatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, allografts, and autografts.

75. The reduced pressure delivery system according to claim 61, wherein the water-soluble polymer is comprised of at least one material selected from the group of uncrosslinked polyethylene glycol, hydrophilic polyethers, polyvinyl alcohol, polyvinyl acetate, polyacrylates, polysulfonates, polyphosphazenes, collagen, hyaluronic acid, glucosaminoglycans, chitosan, and deoxyribonucleic acid (DNA).

76. The reduced pressure delivery system according to claim 61, wherein the distribution manifold is comprised of at least one material selected from the group of polyurethane foam, polyvinyl alcohol foam, polyethylene foam, expanded polytetrafluoroethylene, silicone foam, loofa sponge, sea sponge, gauze, and felted mats.

77. The reduced pressure delivery system according to claim 61 further comprising:

a reduced pressure source fluidly connected to a proximal end of the reduced-pressure delivery tube.