Wound treatment employing reduced pressure

• US 7,216,651 B2
• Filed: 05/23/2001
• Issued: 05/15/2007
• Est. Priority Date: 11/14/1991
• Status: Expired due to Fees

• Current Assignee: Wake Forest University Health Sciences
• Original Assignee: Wake Forest University Health Sciences
• Inventors: Morykwas, Michael J., Argenta, Louis C.
• Primary Examiner(s): Lacyk; John P.
• Application Number:
  US09/863,234
• Publication Number:
  US 20010029956A1
• Time in Patent Office: 2,183 Days
• Field of Search: 128897-898, 602 42- 53
• US Class Current: 128/897
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• 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 2013/00919 for physical therapy, e.g. cold or magnetic
• CPC Class Codes: A61M 1/08 Cupping glasses , i.e. for enhancing blood circulation
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/782 using valves with freely moving parts, e.g. float valves
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 1/91 Suction aspects of the dressing
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 27/00 : Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

A method of treating tissue damage comprises applying a negative pressure to a wound sufficient in time and magnitude to promote tissue migration and thus facilitate closure of the wound. The method is applicable to wounds, burns, infected wounds, and live tissue attachments. A wound treatment apparatus is provided in which a fluid impermeable wound cover is sealed over a wound site. A screen in the form of an open-cell foam screen or a rigid porous screen is placed beneath the wound cover over the wound. A vacuum pump supplies suction within the wound cover over the treatment site.

Claims

1. An appliance for administering a reduced pressure treatment to a wound, comprising:

(a) a one-piece flexible adhesive cover configured to cover and enclose the wound and adapted to maintain reduced pressure at the site of the wound;

(b) reduced pressure supply means for connection to a source of suction, said reduced pressure supply means cooperating with said cover to supply at least 0.11 atm of reduced pressure; and

a fluid trap interconnected between said reduced pressure supply means and said cover for collection of wound exudate.

2. The appliance as recited in claim 1 wherein said cover includes an adhesive material adapted to secure said cover to the tissue surrounding the wound.

3. The appliance according to claim 1, comprising a porous material comprising a synthetic polymer disposed within the cover and adapted to promote the formation of granulation tissue in the wound.

4. The appliance as recited in claim 3 wherein said screen comprises a porous sheet.

5. The appliance as recited in claim 3 wherein said porous material comprises a foam screen.

6. The appliance according to claim 1, wherein the reduced pressure supply means is adapted to supply at least 0.136 atm of reduced pressure.

7. The appliance according to claim 6, comprising a porous material comprising a synthetic polymer disposed within the cover and adapted to promote the formation of granulation tissue in the wound.

16. The apparatus according to claim 5, wherein the reduced pressure supply means is adapted to maintain at least 0.136 atm of reduced pressure.

17. The apparatus according to claim 16, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

80. The apparatus according to any one of claims 1 and 3–

6, wherein the reduced pressure supply means comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

91. The appliance according to claim 1, comprising a porous material comprising a synthetic polymer for placement under the cover at the wound.

8. An appliance for administering a reduced pressure treatment to a wound comprising:

(a) a flexible cover adapted to cover and enclose the wound and adapted to maintain reduced pressure at the site of the wound;

(b) a continuous, uninterrupted adhesive seal provided on said cover adapted to seal and adhere said cover to tissue surrounding the wound;

(c) a source of suction, cooperating with said cover to supply at least 0.11 atm of reduced pressure; and

(d) a fluid trap interconnected between said cover and said source of suction, said trap adapted to capture wound exudate.

9. The appliance according to claim 8, wherein the suction source is adapted to supply at least 0.136 atm of reduced pressure.

10. The appliance according to claim 9, comprising a porous material comprising a synthetic polymer disposed within the cover and adapted to promote the formation of granulation tissue in the wound.

11. The appliance according to claim 8, comprising a porous material comprising a synthetic polymer disposed within the cover and adapted to promote the formation of granulation tissue in the wound.

81. The method according to any one of claims 8 and 9–

11, wherein the suction source comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and and non-production of reduced pressure.

92. The appliance according to claim 8, comprising a porous material comprising a synthetic polymer for placement under the cover at the wound.

12. An apparatus for treating a wound comprising:

(a) a vacuum system adapted to produce a reduced pressure, wherein said vacuum system includes a collection device for collecting fluid aspirated from the wound; and

(b) a reduced pressure appliance operably connected with said vacuum system adapted to apply said reduced pressure to the wound, the appliance including;

a flexible cover adapted to cover and enclose the wound and adapted to maintain reduced pressure at the site of the wound;

a porous material comprising a synthetic polymer for placement under said cover at the wound;

an adhesive seal provided on said cover and adapted to seal and adhere said cover to tissue surrounding the wound; and

reduced pressure supply means for connection with the vacuum system adapted to supply said reduced pressure within said cover to the wound.

13. The apparatus of claim 12 wherein said reduced pressure supply means comprises a length of tubing, said collection device comprises an aspirating container connected along said length of tubing between said vacuum system and cover, and said collection device comprises a flotation valve within said aspirating container for blocking said tubing when a predetermined amount of fluid is collected within said container.

14. The apparatus of claim 12 wherein said collection device comprises an expandable chamber and a sensing means for sensing expansion of said expandable chamber, said sensing means operatively connected with said vacuum system so that said reduced pressure is halted when a predetermined expansion of said expandable chamber is sensed by said sensing means.

15. The apparatus of claim 12 wherein said reduced pressure supply means comprises a length of tubing and a filter along said tubing, said filter having pores that block the supply of reduced pressure via said tubing when said pores are filled with said fluid.

18. The apparatus according to claim 12, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

19. The apparatus according to claim 12, wherein the reduced pressure supply means is adapted to maintain at least 0.11 atm of reduced pressure.

82. The appliance according to any one of claims 12 and 16–

18, wherein the reduced pressure supply means comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

98. The apparatus according to any one of claims 12, 35, 54, and 71, wherein the porous material comprises foam.

99. The apparatus according to any one of claims 12, 35, 54, and 71, wherein the porous material comprises a honeycombed sheet.

100. The apparatus according to any one of claims 12, 35, 54, and 71, wherein the porous material comprises a mesh.

101. The apparatus according to any one of claims 12, 35, 54, and 71, wherein the porous material comprises a porous sheet.

102. The apparatus according to any one of claims 12, 35, 54, and 71, wherein the porous material comprises polyethylene, polyester, or combinations thereof.

20. A method for treating a wound, comprising:

i. locating a flexible adhesive cover over the wound to provide a chamber between the cover and the wound, said cover adapted for maintaining reduced pressure at the wound;

ii. adhesively sealing and adhering the periphery of said cover to tissue surrounding the wound;

iii. operably connecting a vacuum system with said chamber at said seal for producing said reduced pressure;

iv. interposing a fluid trap between said cover and said vacuum system; and

v. maintaining reduced pressure to promote the formation of granulation tissue at the wound until the wound has progressed toward a selected stage of healing.

21. The method according to claim 20, comprising maintaining reduced pressure of at least 0.136 atm at the wound to promote the formation of granulation tissue until the wound has progressed toward a selected stage of healing.

22. The method according to claim 21, comprising locating a porous material comprising a synthetic polymer under the cover, the porous material adapted to promote the formation of granulation tissue in the wound.

23. The method according to claim 20, comprising locating a porous material comprising a synthetic polymer under the cover, the porous material adapted to promote the formation of granulation tissue in the wound.

83. The method according to any one of claims 20 and 21–

23, wherein the reduced pressure is applied in alternating intervals of application and non-application.

108. The method according to claim 20, comprising locating a porous material comprising a synthetic polymer under the cover at the wound.

109. The method according to claim 42 or 108, wherein the porous material comprises foam.

110. The method according to claim 42 or 108, wherein the porous material comprises a honeycombed sheet.

111. The method according to claim 42 or 108, wherein the porous material comprises a mesh.

112. The method according to claim 42 or 108, wherein the porous material comprises a porous sheet.

113. The method according to claim 42 or 108, wherein the porous material comprises polyethylene, polyester, or combinations thereof.

114. The method according claim 20, 42, or 108, wherein the wound consists of epithelial and subcutaneous tissue.

115. The method according claim 20, 42, or 108, wherein the wound comprises epithelial and subcutaneous tissue.

116. The method according claim 20, 42, or 108, wherein the wound comprises a pressure sore.

117. The method according claim 20, 42, or 108, wherein the wound comprises an ischemic wound.

118. The method according to claim 20, 42, or 108, wherein the selected stage of healing comprises substantial closure of the wound.

119. The method according to claim 20, 42, or 108, wherein the selected stage of healing comprises substantially filling the wound with granulation tissue.

120. The method according claim 20, 42, or 108, wherein the selected stage of healing comprises migration of epithelial and subcutaneous tissue toward the wound.

121. The method according claim 20, 42, or 108, wherein the selected stage of healing comprises re-epithelialization of at least a portion of the wound.

122. The method according claim 20, 42, or 108, wherein the selected stage of healing is a reduction in the volume of the wound by a predetermined amount.

123. The method according claim 20, 42, or 108, wherein the selected stage of healing is a reduction in the diameter of the wound by a predetermined amount.

124. The method according claim 20, 42, or 108, wherein said selected stage of healing is a reduction in the depth of the wound by a predetermined amount.

125. The method according to claim 20, 42, or 108, wherein the step of maintaining reduced pressure comprises uniformly applying reduced pressure across at the wound bed.

24. An appliance for administering a reduced pressure treatment to a wound comprising:

(a) a one-piece flexible sheet adapted to cover and enclose the wound and adapted to maintain reduced pressure at the site of the wound;

(b) a porous material comprising a synthetic polymer for placement under the sheet at the wound;

(c) an adhesive seal provided on said sheet adapted to seal and adhere said sheet to tissue surrounding the wound;

(d) a source of suction cooperating with said sheet and said seal to supply reduced pressure beneath said sheet; and

(e) a fluid trap interposed between said sheet and said source of suction, said fluid trap including a shut off for halting the application of reduced pressure when a predetermined amount of fluid is collected within said trap.

25. The appliance according to claim 24, wherein the suction source is adapted to supply at least 0.136 atm of reduced pressure.

26. The appliance according to claim 25, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

27. The appliance according to claim 24, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

28. The appliance according to claim 24, wherein the suction source is adapted to supply at least 0.11 atm of reduced pressure.

84. The appliance according to any one of claims 24 and 25–

27, wherein the suction source comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

93. The appliance according to any one of claims 24, 91, and 92, wherein the porous material comprises foam.

94. The appliance according to any one of claims 24, 91, and 92, wherein the porous material comprises a honeycombed sheet.

95. The appliance according to any one of claims 24, 91, and 92, wherein the porous material comprises a mesh.

96. The appliance according to any one of claims 24, 91, and 92, wherein the porous material comprises a porous sheet.

97. The appliance according to any one of claims 24, 91, and 92, wherein the porous material comprises polyethylene, polyester, or combinations thereof.

29. An appliance for administering a reduced pressure treatment to a wound comprising:

(a) a one-piece flexible cover adapted to cover and enclose the wound and to provide a vacuum chamber about the wound to maintain reduced pressure at the site of the wound;

(b) an adhesive seal provided on said cover adapted to seal and adhere said cover to tissue surrounding the wound;

(c) reduced pressure supply means for connection to a source of suction, said reduced pressure supply means cooperating with said vacuum chamber to supply said reduced pressure of at least 0.11 atm beneath said vacuum chamber, wherein said reduced pressure supply means comprises a suction port on said vacuum chamber; and

(d) a screen adapted to promote the formation of granulation tissue at the wound for placement at a location within said vacuum chamber and secured in said location by the periphery of said vacuum chamber.

30. The appliance of claim 29 wherein said screen comprises a flexible, sheet-like mesh.

31. The appliance of claim 29 wherein said seal includes a seal member at least partially overlying said cover.

32. The appliance according to claim 29, wherein the reduced pressure supply means is adapted to supply at least 0.136 atm of reduced pressure.

33. The appliance according to claim 32, wherein the seal comprises a liquid impervious seal.

34. The appliance according to claim 29, wherein the seal comprises a liquid impervious seal.

85. The appliance according to any one of claims 29 and 32–

34, wherein the reduced pressure supply means comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

35. An apparatus for treating a wound comprising:

(a) a vacuum system adapted to produce a reduced pressure, wherein said vacuum system comprises;

i. a vacuum pump adapted to supply at least 0.11 atm of reduced pressure; and

ii. a filter for preventing said pump from venting micro-organisms aspirated from the wound; and

(b) a reduced pressure appliance operably connected with said vacuum system adapted to apply said reduced pressure to the wound, the appliance including;

a flexible cover adapted to cover and enclose the wound and adapted to maintain reduced pressure at the site of the wound;

a porous material comprising a synthetic polymer for placement under the cover at the wound;

an adhesive seal disposed about the periphery of said cover and adapted to seal and adhere said cover to tissue surrounding the wound;

reduced pressure supply means for connection with the vacuum system, wherein said reduced pressure supply means comprises a length of tubing connected between said vacuum system and said cover; and

a fluid trap interposed between said cover and said reduced pressure supply means.

36. The apparatus of claim 35 wherein said filter is connected along said tubing between said pump and said fluid trap for preventing contamination of said pump.

37. The apparatus of claim 35, wherein said vacuum system comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

38. The apparatus according to claim 35, wherein the pump is adapted to supply at least 0.136 atm of reduced pressure.

39. The apparatus according to claim 38, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

40. The apparatus according to claim 35, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

41. The apparatus according to claim 35, wherein the pump is adapted to supply at least 0.11 atm of reduced pressure.

86. The apparatus according to any one of claims 35 and 38–

40, wherein the pump comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

42. A method of treating a wound comprising the steps of:

i. providing a vacuum source capable of providing at least 0.11 atm of reduced pressure;

ii. locating a flexible adhesive cover over the wound, said cover having a suction port;

iii. Locating a porous material comprising a synthetic polymer under said cover at the wound;

iv. adhesively sealing and adhering the periphery of said cover to tissue surrounding the wound to form a continuous seal;

v. operably connecting said suction port with said vacuum system for producing said reduced pressure;

v. interposing a fluid trap between said suction port and said vacuum source; and

vi. maintaining reduced pressure of at least 0.11 atm at the wound until the wound had progressed toward a selected stage of healing.

43. The method of claim 42, wherein said selected stage of healing is a reduction in bacterial density in the wound by at least 50%.

44. The method according to claim 42, comprising providing a vacuum source capable of providing at least 0.136 atm of reduced pressure.

45. The method according to claim 44, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

46. The method according to claim 42, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

87. The appliance according to any one of claims 42 and 44–

46, wherein said reduced pressure is applied in alternating periods of application and non-application.

47. A device for promoting closure of a wound comprising:

(a) a deformable cover adapted to be placed over the wound;

(b) a porous material comprising a synthetic polymer disposed under said cover for placement at the wound;

(c) an adhesive layer on the cover adapted to form a liquid impermeable seal between said cover and tissue surrounding the wound; and

(d) reduced pressure supply means for supplying reduced pressure and adapted to maintain at least 0.11 atm of reduced pressure therein to said enclosed volume and for deforming said cover so as to exert tension upon the tissue surrounding the wound; and

(e) a fluid trap interposed between said cover and said supply means.

48. The device according to claim 47, wherein the reduced pressure supply means is adapted to supply at least 0.136 atm of reduced pressure.

49. The device according to claim 48, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

50. The device according to claim 47, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

88. The device according to any one of claims 47 and 48–

50, wherein the reduced pressure supply means comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

103. The device according to claim 47, wherein the porous material comprises foam.

104. The device according to claim 47, wherein the porous material comprises a honeycombed sheet.

105. The device according to claim 47, wherein the porous material comprises a mesh.

106. The device according to claim 47, wherein the porous material comprises a porous sheet.

107. The device according to claim 47, wherein the porous material comprises polyethylene, polyester, or combinations thereof.

51. A method of promoting attachment of a skin graft onto a wound, comprising the steps of:

(a) attaching the graft to the wound; and

(b) applying reduced pressure to the graft to promote blood circulation within the graft, wherein said applying step comprises the steps of;

i. placing a porous screen over the graft on the wound;

ii. locating a cover over the graft on the wound, said cover adapted for maintaining said reduced pressure at the wound, said cover having a suction port;

iii. sealing the periphery of said cover to tissue surrounding the wound;

iv. operably connecting said suction port with a vacuum system for producing said reduced pressure; and

v. interposing a fluid trap between said suction port and said vacuum source.

52. The method of claim 51 wherein the graft is a skin flap, the method comprising the steps of:

(a) applying reduced pressure to a region of skin adjacent to the wound, and

(b) forming the flap by detaching skin from said region prior to said attaching step.

53. The method of claim 51 comprising the steps of:

(a) applying reduced pressure to a region of skin for use as the skin graft; and

(b) forming the graft by detaching skin from said region.

54. An apparatus for facilitating the healing of wounds, comprising:

a flexible cover adapted to cover and enclose a wound and adapted to maintain reduced pressure at the site of the wound;

a porous material comprising a synthetic polymer disposed under said cover for placement at the wound;

a suction pump for creating a reduced pressure of at least 0.11 atm on the area of tissue including and surrounding the wound; and

a liquid impermeable adhesive seal provided on said cover adapted to seal and adhere said cover to tissue surrounding the wound reduced pressure at said wound.

55. The apparatus according to claim 54, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

56. The apparatus according to claim 54 in which said porous material comprises an open-cell polymer foam.

57. The apparatus according to claim 54 in which said porous material comprises a porous, elastic, semi-rigid member.

58. The apparatus according to claim 54, in which said seal includes a flexible sealing rim in contact with said tissue surrounding said wound.

59. The apparatus according to claim 54, in which said cover includes a flexible polymer sheet overlying said porous material, said polymer sheet having an adhesive on at least a surface facing the wound to attach and seal said polymer sheet to said surrounding tissue.

60. The apparatus according to claim 54, in which said seal includes a sealing cuff in contact with said tissue surrounding the wound.

61. The apparatus according to claim 54, in which said pump provides at least 0.11 atm of suction.

62. The apparatus according to claim 54, in which said pump provides at least 0.136 atm of suction.

63. The apparatus according to claim 54, in which said pump provides at least 14 pounds per square inch suction.

64. An apparatus according to claim 54, in which said pump operates cyclically to provide periods of application and non-application of suction.

65. An apparatus according to claim 54, in which said pump operates continuously.

66. An apparatus according to claim 54, in which said pump supplies a reduced pressure between about 0.5 and 0.99 atmospheres to the wound.

67. An apparatus according to claim 54, wherein said pump supplies a reduced pressure between about 0.3 and 0.99 atmospheres to the wound.

68. An apparatus according to claim 54, wherein said pump supplies a reduced pressure between about 0.5 and 0.8 atmospheres to the wound.

69. The apparatus according to claim 54, wherein the suction pump is adapted to maintain at least 0.136 atm of reduced pressure.

70. The apparatus according to claim 69, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

89. The apparatus according to any one of claims 54 and 69, 70, 55 wherein the pump comprises control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.

71. An apparatus for treating a wound, comprising:

a flexible adhesive cover adapted to cover and enclose a wound and adapted to maintain reduced pressure at the site of the wound;

a porous material comprising a synthetic polymer for placement under the cover at the wound;

a liquid impermeable adhesive seal provided on said cover adapted to seal and adhere said cover to tissue surrounding the wound;

a tubular member having an end extending from beneath the seal edge to a location external to said cover for supplying reduced pressure beneath the cover; and

a fluid trap in fluid communication with said tubular member, said fluid trap including a shut off for halting the application of reduced pressure when a predetermined amount of fluid is collected within said trap.

72. The apparatus of claim 71 wherein the porous material comprises a foam section configured to overlay the wound, and wherein said first end of said tubular member is embedded within the foam section.

73. The apparatus of claim 71 including a vacuum source that supplies a reduced pressure between about 0.3 and 0.99 atmospheres to the wound.

74. The apparatus of claim 71 including a vacuum source that supplies a reduced pressure between about 0.5 and 0.99 atmospheres to the wound.

75. The apparatus of claim 71 including a vacuum source that supplies a reduced pressure between about 0.5 and 0.8 atmospheres to the wound.

76. The apparatus according to claim 71, comprising a source of suction cooperating with said cover and seal to supply reduced pressure of at least 0.11 atm beneath said cover.

77. The apparatus according to claim 76, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

78. The apparatus according to claim 71, wherein the porous material is adapted to promote the formation of granulation tissue in the wound.

79. The apparatus according to claim 71, comprising a source of suction cooperating with said cover and seal to supply reduced pressure of at least 0.136 atm beneath said cover.

90. The apparatus according to any one of claims 71 and 76–

78, comprising a reduced pressure supply means cooperating with the cover, the supply means comprising a control means for cyclically controlling said production of reduced pressure in alternating periods of production and non-production of reduced pressure.