Method of treating tissue damage and apparatus for same

• US 5,645,081 A
• Filed: 11/14/1991
• Issued: 07/08/1997
• Est. Priority Date: 11/14/1991
• Status: Expired due to Term

• Current Assignee: Wake Forest University Health Sciences
• Original Assignee: Wake Forest University
• Inventors: Morykwas, Michael J., Argenta, Louis C.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US07/792,001
• Time in Patent Office: 2,063 Days
• Field of Search: 128/897-8, 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 2090/401 using air flow
• 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 13/05 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 2013/00174 possibility of applying pressure
• 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 2013/00919 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 1/78 Means for preventing overflow or contamination of the pumping systems combined with drainage containers A61M1/60
• 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 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• 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

The invention disclosed is a method of treating tissue damage comprising 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. Configurations of apparatus for carrying out the method are also disclosed.

Claims

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

vacuum means for creating a negative pressure between about 0.1 and 0.99 atmospheres on the area of skin including and surrounding the wound;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound; and

screen means for positioning at the wound within the sealing means for preventing the overgrowth of tissue in the wound.

2. An apparatus according to claim 1, in which said screen means comprises an open-cell polymer foam.

3. An apparatus according to claim 1, in which said screen means comprises a flat, porous, semi-rigid member.

4. An apparatus according to claim 1, in which said sealing means includes a flexible sealing rim in contact with said skin surrounding said wound.

5. An apparatus according to claim 1, in which said sealing means includes a flexible polymer sheet overlying said screen means, said polymer sheet having adhesive on at least a surface facing the wound to attach and seal said polymer sheet to said surrounding skin.

6. An apparatus according to claim 1, in which said sealing means includes a sealing cuff in contact with said skin surrounding the wound.

7. An apparatus according to claim 6, in which said sealing cuff is inflatable.

8. An apparatus according to claim 1, in which said vacuum means includes pump means for providing at least 0.1 pounds suction.

9. An apparatus according to claim 1, in which said vacuum means includes a pump means for providing at least 3 pounds suction.

10. An apparatus according to claim 1, in which said vacuum means includes a pump means for providing at least 14 pounds suction.

11. An apparatus according to claim 1, in which said vacuum means operates continuously.

12. An apparatus according to claim 1, in which said vacuum means operates cyclically to provide periods of application and non-application of suction.

13. An apparatus according to claim 1 wherein said vacuum means supplies a negative pressure between about 0.3 and 0.99 atmospheres to the wound.

14. An apparatus according to claim 1 wherein said vacuum means supplies a negative pressure between about 0.5 and 0.99 atmospheres to the wound.

15. An apparatus according to claim 1 wherein said vacuum means supplies a negative pressure between about 0.5 and 0.8 atmospheres to the wound.

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

vacuum means for creating a negative pressure on the area of skin including and surrounding the wound;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound, wherein said sealing means includes a semi-rigid cup configured to protect said wound from external contact; and

screen means for positioning at the wound within the sealing means for preventing the overgrowth of tissue in the wound.

17. An apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal comprising:

an open cell polymer foam section for positioning beneath said seal configured to overlie the wound such that said negative pressure is maintained within said foam and applied to the wound; and

a flexible tube having an inlet end inserted into said open cell polymer foam section and an outlet end for extending from beneath said seal and for supplying said negative pressure; and

wherein said apparatus is in an aseptic package.

18. An apparatus for treating a wound, comprising:

an open-cell foam section configured to overlie the wound;

a fluid-impermeable cover overlying said foam section, said cover adapted to form a seal with skin surrounding the wound for maintaining negative pressure beneath said cover; and

a single tubular member having a first end inserted beneath at least a portion of the foam section and having a second end extending from beneath said cover to a location external to said cover for supplying negative pressure beneath the cover.

19. The apparatus of claim 18 wherein said open-cell foam section is configured to overlie only a region of said wound within the margin of said wound.

20. The apparatus of claim 18 wherein said first end of the tubular member is embedded within the foam section.

21. An apparatus according to claim 18 wherein said vacuum source supplies a negative pressure between about 0.3 and 0.99 atmospheres to the wound.

22. An apparatus according to claim 18 wherein said vacuum source supplies a negative pressure between about 0.5 and 0.99 atmospheres to the wound.

23. An apparatus according to claim 18 wherein said vacuum source supplies a negative pressure between about 0.5 and 0.8 atmospheres to the wound.

30. An apparatus according to claim 23, in which said screen means comprises an open-cell polymer foam.

24. An apparatus for treating a wound, comprising:

a semi-rigid, fluid-impermeable cup for positioning over the wound and for maintaining a negative pressure upon said wound, said cup having only a single external fluid communication port;

sealing means for sealing said cup about the wound, said sealing means including a cuff for inflating and conforming to the surrounding skin to seal said cup in place by said negative pressure;

tubular means extending from said fluid communication port of said cup for supplying said negative pressure; and

screen means for positioning beneath the cup at the wound for preventing overgrowth of the wound.

25. The apparatus of claim 24 wherein said screen means is a porous sheet.

26. The apparatus of claim 24 wherein said screen means is an open-cell foam.

31. An apparatus according to claim 24, in which said screen means comprises a flat, porous, semi-rigid member.

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

vacuum means for creating a negative pressure on the area of skin including and surrounding the wound, wherein said vacuum means operates cyclically to provide periods of application and non-application of suction with the ratio of duration of application period to non-application period between about 1;

10 and 10;

1;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound; and

screen means for positioning at the wound within the sealing means for preventing the overgrowth of tissue in the wound.

28. An apparatus according to claim 27 in which the duration of said application period is about 5 minutes.

29. An apparatus according to claim 28 in which the duration of said non-application period is about 5 minutes.

32. An apparatus according to claim 27, in which said sealing means includes a flexible sealing rim in contact with said skin surrounding said wound.

33. An apparatus according to claim 27, in which said sealing means includes a flexible polymer sheet overlying said screen means, said polymer sheet having adhesive on at least a surface facing the wound to attach and seal said polymer sheet to said surrounding skin.

34. An apparatus according to claim 27, in which said sealing means includes a sealing cuff in contact with said skin surrounding the wound.

35. An apparatus according to claim 34, in which said sealing cuff is inflatable.

36. An apparatus according to claim 27, in which said vacuum means includes pump means for providing at least 0.1 pounds suction.

37. An apparatus according to claim 27, in which said vacuum means includes a pump means for providing at least 3 pounds suction.

38. An apparatus according to claim 27, in which said vacuum means includes a pump means for providing at least 14 pounds suction.

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

vacuum means for creating a negative pressure on the area of skin including and surrounding the wound;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound, wherein said sealing means comprises a fluid-impermeable cover; and

screen means for positioning at the wound within the sealing means for preventing the overgrowth of tissue in the wound.

40. An apparatus according to claim 39, in which said screen means comprises an open-cell polymer foam.

41. An apparatus according to claim 39, in which said screen means comprises a flat, porous, semi-rigid member.

42. An apparatus according to claim 39, in which said sealing means includes a flexible sealing rim in contact with said skin surrounding said wound.

43. An apparatus according to claim 39, in which said cover includes a flexible polymer sheet overlying said screen means, said polymer sheet having adhesive on at least a surface facing the wound to attach and seal said polymer sheet to said surrounding skin.

44. An apparatus according to claim 39, in which said sealing means includes a sealing cuff in contact with said skin surrounding the wound.

45. An apparatus according to claim 44, in which said sealing cuff is inflatable.

46. An apparatus according to claim 39, in which said vacuum means includes pump means for providing at least 0.1 pounds suction.

47. An apparatus according to claim 39, in which said vacuum means includes a pump means for providing at least 3 pounds suction.

48. An apparatus according to claim 39, in which said vacuum means includes a pump means for providing at least 14 pounds suction.

49. An apparatus according to claim 39, in which said vacuum means operates continuously.

50. An apparatus according to claim 39, in which said vacuum means operates cyclically to provide periods of application and non-application of suction.

51. An apparatus according to claim 50 in which said vacuum means provides periods of application and non-application of suction with the ratio of duration of application period to non-application period between about 1:

10 and 10;

1.

52. An apparatus according to claim 51 in which the duration of said application period is about 5 minutes.

53. An apparatus according to claim 52 in which the duration of said non-application period is about 5 minutes.

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

vacuum means for creating a negative pressure on the area of skin including and surrounding the wound;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound; and

screen means for positioning at the wound within the sealing means, said screen means having a pore size sufficiently large to prevent the overgrowth of tissue in the wound.

55. An apparatus according to claim 54, in which said screen means comprises an open-cell polymer foam.

56. An apparatus according to claim 54, in which said screen means comprises a flat, porous, semi-rigid member.

57. An apparatus according to claim 54, in which said sealing means includes a flexible sealing rim in contact with said skin surrounding said wound.

58. An apparatus according to claim 54, in which said cover includes a flexible polymer sheet overlying said screen means, said polymer sheet having adhesive on at least a surface facing the wound to attach and seal said polymer sheet to said surrounding skin.

59. An apparatus according to claim 54, in which said sealing means includes a sealing cuff in contact with said skin surrounding the wound.

60. An apparatus according to claim 59, in which said sealing cuff is inflatable.

61. An apparatus according to claim 54, in which said vacuum means includes pump means for providing at least 0.1 pounds suction.

62. An apparatus according to claim 54, in which said vacuum means includes a pump means for providing at least 3 pounds suction.

63. An apparatus according to claim 54, in which said vacuum means includes a pump means for providing at least 14 pounds suction.

64. An apparatus according to claim 54, in which said vacuum means operates continuously.

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

66. An apparatus according to claim 65, in which said vacuum means operates cyclically to provide periods of application and non-application of suction with the ratio of duration of application period to non-application period between about 1:

10 and 10;

1.

67. An apparatus according to claim 66 in which the duration of said application period is about 5 minutes.

68. An apparatus according to claim 67 in which the duration of said non-application period is about 5 minutes.

69. An apparatus for treating a wound comprising:

an open-cell foam section configured to overlie the wound;

a cover overlying said foam section, said cover adapted to form a seal with skin surrounding the wound for maintaining a negative pressure beneath said cover;

a single tubular member having a first end inserted beneath at least a portion of the foam section and having a second end extending from beneath said cover to a location external to said cover; and

a vacuum source connected with the second end of the tubular member for supplying said negative pressure between about 0.1 and 0.99 atmospheres to the wound.

70. An apparatus according to claim 69 wherein said vacuum source supplies a negative pressure between about 0.3 and 0.99 atmospheres to the wound.

71. An apparatus according to claim 69 wherein said vacuum source supplies a negative pressure between about 0.5 and 0.99 atmospheres to the wound.

72. An apparatus according to claim 69 wherein said vacuum source supplies a negative pressure between about 0.5 and 0.8 atmospheres to the wound.

73. An apparatus according to claim 69 wherein said open-cell foam section is configured to overlie only a region of said wound within the margin of said wound.

74. An apparatus according to claim 69 wherein said first end of the tubular member is embedded within the foam section.

75. An apparatus for treating a wound comprising:

an open-cell foam section configured to overlie the wound, said foam section having a pore size sufficiently large to prevent overgrowth of the wound;

a cover overlying said foam section, said cover adapted to form a seal with skin surrounding the wound for maintaining a negative pressure beneath said cover; and

a single tubular member having a first end inserted beneath at least a portion of the foam section and having a second end extending from beneath said cover to a location external to said cover for supplying said negative pressure beneath the cover.

76. An apparatus according to claim 75 wherein said open-cell foam section is configured to overlie only a region of said wound within the margin of said wound.

77. An apparatus according to claim 75 wherein said first end of the tubular member is embedded within the foam section.

78. An apparatus for treating a wound comprising:

an open-cell foam section configured to overlie the wound;

a cover overlying said foam section, said cover adapted to form a seal with skin surrounding the wound for maintaining a negative pressure beneath said cover;

a single tubular member having a first end inserted beneath at least a portion of the foam section and having a second end extending from beneath said cover to a location external to said cover; and

a vacuum source for supplying a negative pressure on the area of skin including and surrounding the wound, wherein said vacuum source operates cyclically to provide periods of application and non-application of suction with the ratio of duration of application period to non-application period between about 1;

10 and 10;

1.

79. An apparatus according to claim 78 in which the duration of said application period is about 5 minutes.

80. An apparatus according to claim 79 in which the duration of said non-application period is about 5 minutes.

81. An apparatus according to claim 78 wherein said open-cell foam section is configured to overlie only a region of said wound within the margin of said wound.

82. An apparatus according to claim 78 wherein said first end of the tubular member is embedded within the foam section.