Reduced pressure treatment system

• US 8,062,273 B2
• Filed: 12/06/2010
• Issued: 11/22/2011
• Est. Priority Date: 09/03/2002
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott
• Primary Examiner(s): Anderson; Lynne
• Application Number:
  US12/961,295
• Publication Number:
  US 20110077604A1
• Time in Patent Office: 351 Days
• Field of Search: 604/313, 604/315, 604/316, 604/327, 604/541, 602 48- 56
• US Class Current: 604/313
• CPC Class Codes: A61F 13/00059 provided with visual effects, e.g. printed or colored
• 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 15/008 Appliances for wound protecting, e.g. avoiding contact between wound and bandage corn plasters A61F13/063
• CPC Class Codes: A61F 2013/00153 coloured or with decoration pattern or printing
• CPC Class Codes: A61F 2013/0028 applying of mechanical pressure; passive massage
• CPC Class Codes: A61M 1/732 Visual indicating means for vacuum pressure
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site

Abstract

A wound treatment apparatus is provided for treating tissue damage, which comprises a fluid impermeable wound cover sealed over a site for purposes of applying a reduced pressure to the site. The apparatus also includes a cover with protrusions on its surface for purposes of monitoring pressure at the site. An absorbable matrix may be placed in the site of a wound to encourage tissue growth into the matrix. Temperature of the site may be monitored using a layer of temperature sensitive material and temperature sensors connected to an alarm and recording device. A vacuum pump supplies suction within the wound cover over the treatment site. A portable version of the wound treatment apparatus is also provided. Finally, a method for treating wounds using reduced pressure is provided.

Claims

1. A method of treating a wound, comprising:

positioning a cover over the wound, the cover being at least liquid impermeable;

applying a reduced pressure to a space between the cover and the wound; and

monitoring the reduced pressure in the space between the cover and the wound by visually observing a pressure monitoring element supported by the cover;

wherein;

the pressure monitoring element comprises at least one surface that is in communication with the space between the cover and the wound; and

at least one surface of the pressure monitoring element is configured to move relative to a portion of the cover surrounding the pressure monitoring element that is also exposed to the reduced pressure in response to a change in reduced pressure within the space between the cover and the wound.

2. The method of claim 1, wherein the reduced pressure is from about 2 in. Hg below atmospheric pressure to about 7 in. Hg below atmospheric pressure.

3. The method of claim 1, wherein the reduced pressure is applied in a cyclic nature.

4. The method of claim 1, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a portable vacuum source that is supportable by the cover or spaced apart from the cover.

5. The method of claim 1, further comprising collecting wound exudate in a container, wherein the container is supportable by the cover or spaced apart from the cover.

6. The method of claim 5, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing in communication with the cover and the container.

7. The method of claim 5, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing having one end in communication with a collection container and another end connected to a port supported by the cover.

8. The method of claim 1, wherein foam, porous polymer material, gauze, soft flexible padding, an absorbable matrix, or other material is positioned between the wound and the cover.

9. The method of claim 1, further comprising monitoring an alarm, the alarm being in communication with the cover and being configured to alert a user when a threshold value is reached within the cover.

10. The method of claim 1, comprising sealing or adhering the cover to at least tissue surrounding the wound so as to create a generally fluid-tight or gas-tight seal between the cover and the tissue surrounding the wound.

11. The method of claim 1, further comprising positioning an adhesive strip over at least a portion of the cover to seal the cover.

12. The method of claim 1, wherein the cover is formed from or comprises a sheet of flexible polymer material.

13. The method of claim 1, wherein monitoring the reduced pressure in the space between the cover and the wound by visually observing the pressure monitoring element supported by the cover comprises monitoring whether a predetermined level of reduced pressure has been achieved in the space between the cover and the wound.

14. The method of claim 1, wherein the pressure monitoring element produces an audible sound when moving from a first position to a second position relative to the portion of the cover surrounding the pressure monitoring element.

15. The method of claim 1, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a battery powered vacuum source.

16. The method of claim 1, wherein monitoring the reduced pressure in the space between the cover and the wound comprises determining whether at least a threshold level of reduced pressure has been achieved under the cover.

17. The method of claim 1, wherein the pressure monitoring element comprises a pliable material.

18. The method of claim 1, wherein the at least one surface of the pressure monitoring element is a collapsible wall.

19. The method of claim 1, further comprising monitoring a condition under the cover using an electronic sensor.

20. The method of claim 1, wherein positioning the cover over the wound comprises positioning the cover over an incisional wound.

21. The method of claim 20, wherein the incisional wound is a dehisced incisional wound.

22. The method of claim 1, wherein positioning the cover over the wound comprises positioning the cover over an open wound.

23. The method of claim 1, further comprising positioning a sealing ring around the wound to seal the cover to tissue surrounding the wound.

24. A method of treating a wound, comprising:

positioning a cover over the wound, the cover being at least liquid impermeable;

applying a reduced pressure to a space between the cover and the wound; and

monitoring the reduced pressure in the space between the cover and the wound by visually observing a pressure monitoring element supported by the cover;

wherein monitoring the reduced pressure in the space between the cover and the wound comprises monitoring a displacement of one or more protrusions supported by or integrally formed on the cover.

25. The method of claim 24, wherein each of the one or more protrusions is configured to displace toward the wound as the reduced pressure between the cover and the wound increases such that the amount of inward displacement of the protrusion increases as the reduced pressure between the cover and the wound increases.

26. The method of claim 24, wherein at least one protrusion has the shape of a hill, a bump, or a bellows.

27. The method of claim 24, wherein at least a portion of the pressure monitoring element has a color different from the color of the remaining surface of the cover, or a different shade of the same color as the shade of the color on the remaining surface of the cover, and wherein the color or the shade of the color of the pressure monitoring element changes as the pressure monitoring element is displaced away from the remaining surface of the cover.

28. The method of claim 24, wherein monitoring a displacement of one or more protrusions supported by or integrally formed on the cover comprises monitoring a displacement or collapse of at least one wall portion of one or more protrusions supported by or integrally formed on the cover.

29. The method of claim 24, wherein at least one of the one or more protrusions comprises a curved surface.

30. The method of claim 24, wherein at least one of the one or more protrusions comprises a closed end portion and an open end portion.

31. The method of claim 24, wherein the one or more protrusions are configured to collapse toward the cover so as to be approximately level with the cover.

32. The method of claim 24, wherein the one or more protrusions are made from a material that is different from that of the cover.

33. The method of claim 24, wherein positioning the cover over the wound comprises positioning the cover over an incisional wound.

34. The method of claim 33, wherein the incisional wound is a dehisced incisional wound.

35. The method of claim 24, wherein positioning the cover over the wound comprises positioning the cover over an open wound.

36. A method of treating a wound, comprising:

positioning a cover over the wound, the cover being at least liquid impermeable;

applying a reduced pressure to a space between the cover and the wound; and

monitoring the reduced pressure in the space between the cover and the wound by visually observing a pressure monitoring element supported by the cover;

wherein monitoring the reduced pressure in the space between the cover and the wound comprises monitoring one or more protrusions supported by the cover, each protrusion being configured to move between at least an expanded state and a compressed state, and wherein each of the one or more protrusions is configured to move toward the compressed state as the level of reduced pressure between the cover and the wound increases.

37. The method of claim 36, wherein the one or more protrusions are configured to move from an expanded state to a compressed state when a predetermined level of reduced pressure has been achieved in the space between the cover and the wound.

38. The method of claim 36, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a portable vacuum source that is supportable by the cover or spaced apart from the cover.

39. The method of claim 36, further comprising collecting wound exudate in a container, wherein the container is supportable by the cover or spaced apart from the cover.

40. The method of claim 39, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing in communication with the cover and the container.

41. The method of claim 39, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing having one end in communication with a collection container and another end connected to a port supported by the cover.

42. The method of claim 36, wherein foam, porous polymer material, gauze, soft flexible padding, an absorbable matrix, or other material is positioned between the wound and the cover.

43. The method of claim 36, further comprising sealing or adhering the cover to at least tissue surrounding the wound so as to create a generally fluid-tight or gas-tight seal between the cover and the tissue surrounding the wound.

44. The method of claim 36, wherein the cover is formed from or comprises a sheet of flexible polymer material.

45. The method of claim 36, further comprising positioning a sealing ring around the wound to seal the cover to tissue surrounding the wound.

46. A method of treating a wound, comprising:

positioning a cover over the wound, the cover being at least liquid impermeable;

applying a reduced pressure to a space between the cover and the wound through a conduit, the conduit being in communication with the cover and a vacuum source; and

monitoring the existence of or an amount of reduced pressure in the space between the cover and the wound by visually observing a pressure monitor comprising a protrusion protruding away from a surface of the cover, the protrusion configured to displace downwardly in response to a level of reduced pressure between the cover and the wound.

47. The method of claim 46, wherein the conduit is connected to a port supported by the cover.

48. The method of claim 46, comprising sealing or adhering at least a periphery of the cover to tissue surrounding the wound.

49. The method of claim 46, further comprising positioning foam, porous polymer material, gauze, soft flexible padding, an absorbable matrix, or other packing material beneath the cover.

50. The method of claim 46, wherein the reduced pressure is applied in a cyclic nature.

51. The method of claim 46, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a portable vacuum source that is supportable by the cover or spaced apart from the cover.

52. The method of claim 46, further comprising collecting wound exudate in a container, wherein the container is supportable by the cover or spaced apart from the cover.

53. The method of claim 52, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing in communication with the cover and the collection container.

54. The method of claim 46, further comprising monitoring an alarm, the alarm being in communication with the cover and being configured to alert a user when a threshold value is reached within the cover.

55. The method of claim 46, further comprising positioning an adhesive strip over at least a portion of the cover to seal the cover.

56. The method of claim 46, wherein the protrusion has the shape of a hill, a bump, or a bellows.

57. The method of claim 46, wherein the cover is formed from or comprises a sheet of flexible polymer material.

58. The method of claim 46, further comprising producing an audible sound associated with movement of the pressure monitor from a first position to a second position.

59. The method of claim 46, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a battery powered vacuum source.

60. The method of claim 46, wherein monitoring the existence of or an amount of reduced pressure in the space between the cover and the wound comprises determining whether at least a threshold level of reduced pressure has been achieved under the cover.

61. The method of claim 46, wherein the pressure monitor comprises a pliable material.

62. The method of claim 46, wherein the pressure monitor comprises a collapsible wall.

63. The method of claim 46, wherein the pressure monitor comprises at least one curved surface.

64. The method of claim 46, further comprising positioning a soft, flexible padding material in contact with the skin under the cover.

65. The method of claim 46, further comprising monitoring a condition under the cover using an electronic sensor.

66. The method of claim 46, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a battery powered vacuum source.

67. The method of claim 46, wherein positioning the cover over the wound comprises positioning the cover over an incisional wound.

68. The method of claim 67, wherein the incisional wound is a dehisced incisional wound.

69. The method of claim 46, wherein positioning the cover over the wound comprises positioning the cover over an open wound.

70. A method of treating a wound, comprising:

positioning an occlusive or semi-occlusive dressing over the wound, the dressing comprising one or more expandable areas that expand relative to the surrounding portions of the dressing in the presence of atmospheric pressure; and

applying sub-atmospheric pressure to the dressing;

wherein the one or more expandable areas contract toward the dressing relative to the surrounding portions of the dressing that are also exposed to the sub-atmospheric pressure when the dressing is under sub-atmospheric pressure.

71. The method of claim 70, wherein the one or more expandable areas contract toward the dressing at a sub-atmospheric pressure of 5 mmHg to 50 mmHg.

72. The method of claim 70, wherein the one or more expandable areas comprise one or more mountains having a pyramidal, cylindrical, square or other three-dimensional shape.

73. The method of claim 70, comprising applying the sub-atmospheric pressure with a suction pump.

74. The method of claim 73, wherein the sub-atmospheric pressure is applied via tubing.

75. The method of claim 74, wherein the sub-atmospheric pressure is in communication with a canister.

76. The method of claim 73, further comprising distributing the sub-atmospheric pressure across the wound through a matrix material of gauze or foam.

77. The method of claim 75, wherein the sub-atmospheric pressure is further in communication with an overflow/bacterial filter.

78. A method of treating a wound, comprising:

positioning a wound dressing apparatus over the wound, comprising positioning an at least liquid impermeable cover over the wound so as to create a substantially sealed space between the cover and the wound;

applying reduced pressure to the space between the cover and the wound; and

monitoring the reduced pressure in the space between the cover and the wound by visually observing a pressure indicator device supported by the wound dressing apparatus, the pressure indicator device comprising at least one surface that is configured to move relative to a portion of the wound dressing apparatus surrounding the pressure indicator device that is also exposed to the reduced pressure in response to a change in reduced pressure within the space.

79. The method of claim 78, wherein the at least one surface is configured to move toward the wound when the level of reduced pressure in the space increases to a greater reduced pressure value, and to move away from the wound when the level of reduced pressure in the space decreases.

80. The method of claim 78, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a portable vacuum source that is supportable by the cover or spaced apart from the cover.

81. The method of claim 78, further comprising collecting wound exudate in a container, wherein the container is supportable by the cover or spaced apart from the cover.

82. The method of claim 81, wherein collecting wound exudate in a container comprises drawing wound exudate through a length of tubing having one end in communication with a collection container and another end connected to a port supported by the cover.

83. The method of claim 78, wherein foam, porous polymer material, gauze, an absorbable matrix, soft flexible padding, or other material is positioned between the wound and the cover.

84. The method of claim 78, further comprising monitoring an alarm, the alarm being in communication with the cover and being configured to alert a user when a threshold value is reached within the cover.

85. The method of claim 78, further comprising sealing or adhering the cover to at least the tissue surrounding the wound so as to create a generally fluid-tight or gas-tight seal between the cover and the tissue surrounding the wound.

86. The method of claim 78, further comprising positioning an adhesive strip over at least a portion of the cover to seal the cover.

87. The method of claim 78, further comprising producing an audible sound associated with movement of the pressure monitoring element from a first position to a second position.

88. The method of claim 78, wherein applying a reduced pressure to a space between the cover and the wound comprises supplying reduced pressure from a battery powered vacuum source.

89. The method of claim 78, wherein monitoring the reduced pressure in the space between the cover and the wound comprises determining whether at least a threshold level of reduced pressure has been achieved under the cover.

90. The method of claim 78, wherein the pressure monitoring element comprises a pliable material.

91. The method of claim 78, wherein the at least one surface of the pressure monitoring element is a collapsible wall.

92. The method of claim 78, further comprising monitoring a condition under the cover using an electronic sensor.

93. The method of claim 78, wherein positioning the wound dressing apparatus over the wound comprises positioning the wound dressing apparatus over an incisional wound.

94. The method of claim 93, wherein the incisional wound is a dehisced incisional wound.

95. The method of claim 78, wherein positioning the wound dressing apparatus over the wound comprises positioning the wound dressing apparatus over an open wound.

96. The method of claim 78, further comprising positioning a sealing ring around the wound to seal the cover to tissue surrounding the wound.