Adjustable overlay reduced pressure wound treatment system

• US 7,776,028 B2
• Filed: 03/31/2005
• Issued: 08/17/2010
• Est. Priority Date: 04/05/2004
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott, Johnson, Timothy Robert, Miller, Michael Seth
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Craig; Paula L
• Application Number:
  US11/095,859
• Publication Number:
  US 20050222527A1
• Time in Patent Office: 1,965 Days
• Field of Search: 604/75, 604/313, 604/541, 604/27, 604/76, 604/305, 604/543, 602/1
• US Class Current: 604/543
• 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 2013/00089 Wound bandages A61F2013/00361 takes precedence;
• CPC Class Codes: A61F 2013/00217 not adhering to the wound with wax A61F2013/00161
• CPC Class Codes: A61M 1/60 Containers for suction drainage, adapted to be used with an external suction source containers not adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/82 Membrane pumps, e.g. bulbs
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/964 having venting means on or near the dressing
• CPC Class Codes: A61M 1/982 with means for detecting level of collected exudate
• 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 reduced pressure treatment appliance is provided for treating a wound on the body of a patient. In some embodiments, the appliance comprises an overlay, which is further comprised of cup members that may be detached or cut away from the overlay so that the overlay can be adjusted in size and shape. Also, in some embodiments, the overlay is further comprised of a pressure venting valve to maintain a predetermined level of reduced pressure at the site of the wound. In other embodiments, the wound treatment appliance also includes a vacuum system to supply reduced pressure to the site of the wound in the volume under the overlay. In yet other embodiments, the treatment appliance also includes wound packing means to prevent overgrowth of the wound or to encourage growth of wound tissue into an absorbable matrix comprising the wound packing means. In still other embodiments, a suction bulb may be used to provide a source of reduced pressure to an overlay that covers the wound. Finally, methods are provided for using various embodiments of the treatment appliance.

Claims

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

an overlay comprising;

a top cup member comprising a top membrane portion and a top frame portion adjacent to the top membrane portion; and

a secondary cup member comprising a secondary membrane portion and a secondary frame portion adjacent to the secondary membrane portion; and

a seal configured to seal the overlay to the body, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound;

wherein;

the entire top frame portion circumscribes an outer periphery of the top membrane portion;

the secondary membrane portion is directly attached to the top frame portion;

the entire secondary membrane portion circumscribes an outer periphery of the top frame portion;

the entire secondary frame portion circumscribes an outer periphery of the secondary membrane portion;

the secondary frame portion is larger than and has substantially the same shape as the top frame portion; and

the overlay is sized to be placed over and enclose the wound and adapted to maintain reduced pressure in the volume under the overlay at the site of the wound;

means for supplying reduced pressure,

configured to operably connect the overlay to a reduced pressure supply source that provides a supply of reduced pressure to the overlay, so that the volume under the overlay at the site of the wound is supplied with reduced pressure by the reduced pressure supply source;

wherein the top frame portion has a vertical displacement so that the secondary membrane portion and the top membrane portion do not lie within the same plane.

2. The appliance of claim 1, wherein the overlay further comprises at least one vertical frame member extending along the contour of the surface of the overlay from the outside perimeter of the overlay to the outside perimeter of the top membrane portion.

3. The appliance of claim 1, wherein the overlay is approximately rectangular in shape.

4. The appliance of claim 1, wherein the overlay is approximately elliptical in shape.

5. The appliance of claim 1, wherein the overlay further comprises a flexible lower membrane member that circumscribes and is attached to the secondary frame portion and the secondary frame portion has a vertical displacement so that the secondary membrane portion and the lower membrane member do not lie within the same plane.

6. The appliance of claim 5, wherein the seal comprises the suction of the lower membrane member against the body, such suction being produced by the presence of reduced pressure in the volume under the overlay at the site of the wound.

7. The appliance of claim 1, wherein the top cup member and the secondary cup member comprises a semi-rigid material and the top membrane portion and the secondary membrane portion each have a thickness less than the thickness of the top frame portion and the secondary frame portion.

8. The appliance of claim 1, wherein:

the top frame portion and the secondary frame portion comprise materials from the group consisting of semi-rigid materials, rigid materials, and combinations of such materials.

9. The appliance of claim 1, wherein the seal comprises an adhesive that is disposed between a portion of the outside perimeter of the overlay and the portion of the body adjacent to said portion of the outside perimeter of the overlay.

10. The appliance of claim 1, wherein the seal comprises an adhesive tape that is disposed over a portion of the overlay and the portion of the body adjacent to said portion of the overlay.

11. The appliance of claim 1, further comprising:

a suction drain extending from the means for supplying reduced pressure into the volume under the overlay at the site of the wound; and

a means for suction drain connecting configured to operably connect the means for supplying reduced pressure to the suction drain so that the suction drain is in fluid communication with the cup members is directly attached and reduced pressure is supplied by means of the suction drain to the volume under the overlay at the site of the wound.

12. The appliance of claim 1, wherein the overlay further comprises a pressure venting valve operably disposed on the overlay.

96. The appliance of claim 1, wherein the overlay is approximately circular in shape.

97. The appliance of claim 1, wherein the overlay is configured such that at least a portion of the overlay is shaped to approximately match the surface shape of at least a portion of the body covered by the overlay.

98. The appliance of claim 1, wherein the overlay is configured such that the size or shape of the overlay can be modified by cutting the overlay with a cutting tool.

99. The appliance of claim 1, wherein the seal comprises lanolin that is disposed over a portion of the overlay and a portion of the body adjacent to said portion of the overlay.

100. The appliance of claim 1, further comprising a fluid collection system in communication with the overlay to collect exudate aspirated from the wound.

101. The appliance of claim 100, wherein the fluid collection system is configured to inhibit the supply of reduced pressure to the overlay when the amount of fluid in the fluid collection system exceeds a predetermined quantity.

13. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

an overlay comprising;

a top cup member comprising a top membrane portion and a top frame portion;

at least two additional cup members; and

a seal configured to operably seal the overlay to the body, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound;

wherein;

the top frame portion is adjacent to the top membrane portion and is configured to entirely circumscribe an outer periphery of the top membrane portion;

each of the at least two additional cup members comprises an additional membrane portion and an additional frame portion;

the additional membrane portion of one of the at least two additional cup members is directly attached to the top frame portion;

the additional membrane portion of one of the at least two additional cup members entirely circumscribes an outer periphery of the top frame portion, and the additional frame portion of the one additional cup member is adjacent to and entirely circumscribes an outer periphery of the additional membrane portion of the one additional cup member;

the additional membrane portion of each at least two additional cup members circumscribes and is directly attached to the frame portion of the previous at least two additional cup members, and the additional frame portion of each at least two additional cup members is adjacent to and circumscribes the additional membrane portion of said at least two additional cup members; and

the overlay is sized to be placed over and enclose the wound and adapted to maintain reduced pressure in the volume under the overlay at the site of the wound;

means for supplying reduced pressure configured to operably connect the overlay to a reduced pressure supply source that provides a supply of reduced pressure to the overlay, so that the volume under the overlay at the site of the wound is supplied with reduced pressure by the reduced pressure supply source;

wherein the top frame portion and each additional frame portion has a vertical displacement so that each additional membrane portion and the top membrane portion do not lie within the same plane.

14. The appliance of claim 13, wherein the overlay comprises at least one vertical frame member extending along the contour of the surface of the overlay from the outside perimeter of the overlay to the outside perimeter of the top membrane portion.

15. The appliance of claim 13, wherein the top cup member and each additional cup member comprises a semi-rigid material and the top membrane portion and each additional membrane portion have a thickness less than the thickness of the top frame portion and each additional frame portion.

16. The appliance of claim 13, wherein

the top membrane portion and each additional membrane portion comprise materials from the group consisting of semi-flexible materials, flexible materials, and combinations of such materials.

17. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

a treatment device comprising;

an overlay comprising a top cup member and an additional cup member, wherein;

the top cup member comprises a top membrane portion and a top frame portion and the top frame portion is adjacent to the top membrane portion;

the entire top frame portion circumscribes an outer periphery of the top membrane portion;

the additional cup member comprises an additional membrane portion and an additional frame portion; and

the additional membrane portion is attached to the top frame portion, and the additional frame portion is adjacent to the additional membrane portion;

the entire additional membrane portion circumscribes an outer periphery of the top frame portion;

the entire additional frame portion circumscribes an outer periphery of the additional membrane portion; and

the additional frame portion is larger than and has substantially the same shape as the top frame portion; and

a seal configured to operably seal the overlay to the body, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound; and

a vacuum system comprising;

a reduced pressure supply source that provides a supply of reduced pressure; and

means for supplying reduced pressure configured to operably connect the overlay to the reduced pressure supply source, so that the volume under the overlay at the site of the wound is supplied with reduced pressure by the reduced pressure supply source;

wherein the top frame portion and each additional frame portion has a vertical displacement so that each additional membrane portion and the top membrane portion do not lie within the same plane.

18. The appliance of claim 17, wherein the reduced pressure supply source comprises a vacuum pump.

19. The appliance of claim 18, wherein the reduced pressure supply source further comprises a control system for the vacuum pump, wherein the control system controls the operation of the vacuum pump.

20. The appliance of claim 18, wherein:

the reduced pressure supply source further comprises a filter operably positioned between the vacuum pump and the means for supplying reduced pressure; and

the filter prevents the venting of and contamination of the vacuum pump by micro-organisms or fluids or both aspirated from the wound.

21. The appliance of claim 18, wherein the vacuum pump comprises a portable vacuum pump.

22. The appliance of claim 17, wherein the means for supplying reduced pressure comprises flexible tubing.

23. The appliance of claim 17, wherein the means for supplying reduced pressure comprises a collection system that is operably positioned between the overlay and the reduced pressure supply source and the collection system comprises a container configured at least to receive and hold fluid aspirated from the wound.

24. The appliance of claim 23, wherein the collection system further comprises a means for halting pressure configured to halt the application of reduced pressure to the wound when the fluid in the container exceeds a predetermined amount.

25. The appliance of claim 17, wherein the reduced pressure under the overlay in the area of the wound is in the range from approximately 20 mm of Hg below atmospheric pressure to approximately 125 mm of Hg below atmospheric pressure.

26. The appliance of claim 17, wherein the reduced pressure supply source is configured to apply reduced pressure in a cyclic nature, the cyclic nature providing alternating time periods of application of reduced pressure and without application of reduced pressure.

27. The appliance of claim 17, wherein the treatment appliance further comprises a pressure venting valve operably disposed on the overlay.

28. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

a treatment device comprising;

an overlay comprising a first cup member and an additional cup member; and

a seal configured to operably seal the overlay to the body, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound;

a vacuum system comprising a reduced pressure supply source that is configured to provide a supply of reduced pressure and means for supplying reduced pressure configured to operably connect the overlay to the reduced pressure supply source so that the volume under the overlay at the portion of the body to be treated is supplied with reduced pressure by the reduced pressure supply source; and

means for wound packing positioned between the overlay and the wound to be treated;

wherein;

the first cup member comprises a first membrane portion and a first frame portion and the first frame portion is adjacent to and circumscribes the entirety of the first membrane portion, the first membrane portion being approximately flat and generally defining a plane in a relaxed state;

the additional cup member comprises an additional membrane portion and an additional frame portion;

the additional membrane portion circumscribes the entirety of the first frame portion and extends from the first frame portion, and the additional frame portion is adjacent to and circumscribes the additional membrane portion, the additional membrane portion being approximately flat and generally defining a plane in a relaxed state; and

the additional frame portion is larger than and has substantially the same shape as the first frame portion;

wherein the first frame portion and each additional frame portion have a vertical displacement so that each additional membrane portion and the first membrane portion do not lie within the same plane; and

the first cup member is located at a top of the appliance, and is configured for positioning farther from the wound than the additional cup member.

29. The appliance of claim 28, further comprising:

a suction drain extending from the means for supplying reduced pressure into the volume under the overlay in the area of the wound; and

means for suction drain connecting configured to operably connect the means for supplying reduced pressure to the suction drain so that the suction drain is in fluid communication with the means for supplying reduced pressure and reduced pressure is supplied to the volume under the overlay in the area of the wound by means of the suction drain.

30. The appliance of claim 29, wherein the suction drain further comprises a distal end portion and the distal end portion has at least one perforation in the surface thereof

31. The appliance of claim 30, wherein the distal end portion of the suction drain is configured to be positioned within the interior volume of the means for wound packing.

32. The appliance of claim 28, wherein the means for wound packing comprises the group consisting of absorbent dressings, antiseptic dressings, nonadherent dressings, water dressings, or combinations of such dressings.

33. The appliance of claim 32, wherein the means for wound packing comprises the group consisting of gauze, cotton and combinations of gauze and cotton.

34. The appliance of claim 28, wherein the means for wound packing comprises an absorbable matrix adapted to encourage growth of tissue in the area of the wound into the matrix.

35. The appliance of claim 34, wherein the absorbable matrix comprises a collagen material.

36. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

a treatment device comprising;

an overlay comprising a top cup member and at least one additional cup member, wherein;

the top cup member comprises a top membrane portion and a top frame portion and the top frame portion is adjacent to the top membrane portion;

the entire top frame portion circumscribes an outer periphery of the top membrane portion;

the at least one additional cup member comprises an additional membrane portion and an additional frame portion; and

the additional membrane portion is attached to the top frame portion, and the additional frame portion is adjacent to the additional membrane portion;

the entire additional membrane portion circumscribes an outer periphery of the top frame portion;

the entire additional frame portion circumscribes an outer periphery of the additional membrane portion; and

the additional frame portion is larger than and has substantially the same shape as the top frame portion; and

a seal configured to operably seal the overlay to the body, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound; and

a vacuum system comprising;

a suction bulb, wherein the suction bulb may provide a source of reduced pressure; and

means for supplying reduced pressure configured to operably connect the overlay to the suction bulb, so that the volume under the overlay at the site of the wound may be supplied with reduced pressure by the suction bulb;

wherein the top frame portion and each additional frame portion has a vertical displacement so that each additional membrane portion and the top membrane portion do not lie within the same plane.

37. The appliance of claim 36, wherein:

the suction bulb further comprises an inlet port and an outlet port, wherein the inlet port is configured to be operably connected to the means for supplying reduced pressure; and

the vacuum system further comprises an exhaust tubing member configured to be operably connected to the outlet port.

38. The appliance of claim 37, wherein the vacuum system further comprises an exhaust control valve operably connected to the exhaust tubing member.

39. The appliance of claim 37, wherein the vacuum system further comprises a filter configured to be operably connected to the exhaust tubing member, wherein the filter is configured to prevent the venting of micro-organisms or fluids or both aspirated from the wound.

40. The appliance of claim 37, wherein the vacuum system further comprises a supplemental vacuum system that is configured to be operably connected to the exhaust tubing member.

41. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

an overlay comprising;

a first cup member, wherein the first cup member comprises a first membrane portion and a first frame portion and the first frame portion is adjacent to and circumscribes the first membrane portion, the first membrane portion being approximately flat and generally defining a plane in its natural shape prior to being applied to a patient for treatment of the wound, the first frame portion extending downward from the first membrane portion to circumscribe a portion of an interior volume defined at least in part by a lower surface of the first membrane portion and an inner surface of the first frame portion, wherein the inner surface of the first frame portion along its entire length circumscribes an area at least as large as an area circumscribed by an outer periphery of the lower surface of the first membrane portion; and

a second cup member, wherein the second cup member comprises a second membrane portion and a second frame portion, wherein the second membrane portion circumscribes the first frame portion and extends outward from the first frame portion and the second frame portion is adjacent to and circumscribes the second membrane portion, the second membrane portion being approximately flat and generally defining a plane in its natural shape prior to being applied to a patient for treatment of the wound, the second frame portion extending downward from the second membrane portion to circumscribe a portion of the interior volume defined at least in part by a lower surface of the second membrane portion and an inner surface of the second frame portion, wherein the inner surface of the second frame portion along its entire length circumscribes an area at least as large as an area circumscribed by an outer periphery of the lower surface of the second membrane portion;

wherein the overlay is sized to be placed over and enclose the wound and adapted to maintain reduced pressure in the volume under the overlay at the site of the wound; and

a port provided on the overlay configured to connect the overlay to a source of reduced pressure;

wherein the first membrane portion and the second membrane portion do not lie within the same plane; and

the first cup member is located at a top of the appliance, and is configured for positioning farther from the wound than the second cup member.

42. The appliance of claim 41, further comprising a seal to operably seal the overlay to the body.

43. The appliance of claim 41, wherein the overlay further comprises a third cup member, wherein:

the third cup member comprises a third membrane portion and a third frame portion, wherein the third membrane portion circumscribes the second frame portion and extends outward from the second frame portion and the third frame portion is adjacent to and circumscribes the third membrane portion, the third membrane portion being approximately flat and generally defining a plane in its natural shape prior to being applied to a patient for treatment of the wound, the third frame portion extending downward from the third membrane portion to circumscribe a portion of the interior volume defined at least in part by a lower surface of the third membrane portion and an inner surface of the third frame portion, wherein the inner surface of the third frame portion along its entire length circumscribes an area at least as large as an area circumscribed by an outer periphery of the lower surface of the third membrane portion.

44. The appliance of claim 43, wherein the overlay further comprises a fourth cup member, wherein:

the fourth cup member comprises a fourth membrane portion and a fourth frame portion, wherein the fourth membrane portion circumscribes the third frame portion and extends outward from the third frame portion and the fourth frame portion is adjacent to and circumscribes the fourth membrane portion;

the fourth membrane portion being approximately flat and generally defining a plane in its natural shape prior to being applied to a patient for treatment of the wound, the fourth frame portion extending downward from the fourth membrane portion to circumscribe a portion of the interior volume defined at least in part by a lower surface of the fourth membrane portion and an inner surface of the fourth frame portion, wherein the inner surface of the fourth frame portion along its entire length circumscribes an area at least as large as an area circumscribed by an outer periphery of the lower surface of the fourth membrane portion.

45. The appliance of claim 44, wherein the overlay further comprises a fifth membrane portion that circumscribes and extends outward from the fourth frame portion.

46. The appliance of claim 45, wherein the first cup member, the second cup member, the third cup member, the fourth cup member, the fifth membrane portion, are integrally formed.

47. The appliance of claim 45, wherein the appliance further comprises adhesive, snaps, or other similar materials or fasteners configured to connect the first cup member to the second cup member, the second cup member to the third cup member, the third cup member to the fourth cup member, and the fifth membrane portion to the fourth cup member.

48. The appliance of claim 41, further comprising a reduced pressure supply source that provides a supply of reduced pressure to the overlay through the port.

49. The appliance of claim 48, further comprising a flexible tubing member connecting said port to said reduced pressure supply source.

50. The appliance of claim 48, further comprising a collection system that is configured to be operably positioned between the overlay and the reduced pressure supply source, wherein the collection system comprises a container to receive and hold fluid aspirated from the wound.

51. The appliance of claim 41, wherein the appliance further comprises at least one dressing selected from the group consisting of absorbent dressings, antiseptic dressings, non-adherent dressings, water dressings, or combinations of such dressings, wherein said at least one dressing is positioned between the overlay and the wound to be treated.

52. The appliance of claim 41, wherein the appliance further comprises at least one material selected from the group consisting of gauze, cotton, and combinations of gauze and cotton, wherein said at least one material is positioned between the overlay and the wound to be treated.

53. The appliance of claim 41, wherein the appliance further comprises an absorbable matrix adapted to encourage growth of a tissue in the area of the wound into the matrix.

54. The appliance of claim 53, wherein the absorbable matrix comprises a collagen material.

55. The appliance of claim 42, wherein the seal comprises adhesive, adhesive tape, or lanolin.

56. The appliance of claim 41, wherein the overlay is approximately circular in shape.

57. The appliance of claim 41, wherein the overlay is approximately rectangular in shape.

58. The appliance of claim 41, wherein the overlay is approximately elliptical in shape.

59. The appliance of claim 41, wherein the overlay is configured such that at least a portion of the overlay is shaped to approximately match the surface shape of at least a portion of the body covered by the overlay.

60. The appliance of claim 41, further comprising a fluid collection system in communication with the overlay and configured to collect exudate aspirated from the wound.

61. The appliance of claim 60, wherein the fluid collection system is configured to inhibit the supply of reduced pressure to the overlay when an amount of fluid in the fluid collection system exceeds a predetermined quantity.

62. The appliance of claim 41, further comprising a wound packing material positioned within the overlay.

63. The appliance of claim 62, wherein the wound packing material comprises cotton, gauze, or other absorbent dressing material.

64. The appliance of claim 41, wherein the overlay further comprises a pressure venting valve configured to allow air into the overlay when the reduced pressure within the overlay exceeds a predetermined value.

65. The appliance of claim 41, wherein the overlay is configured such that the size or shape of the overlay can be modified by cutting the overlay.

66. The appliance of claim 41, wherein the first cup member and second cup member are integrally formed.

67. The appliance of claim 43, wherein the first cup member, second cup member, and third cup member are integrally formed.

68. The appliance of claim 44, wherein the first cup member, second cup member, third cup member, and fourth cup member are integrally formed.

69. The appliance of claim 45, wherein the first cup member, second cup member, third cup member, fourth cup member, and fifth membrane portion are integrally formed.

70. The appliance of claim 41, wherein the second membrane portion is directly attached to the first frame portion.

71. The appliance of claim 43, wherein the third membrane portion is directly attached to the second frame portion.

72. The appliance of claim 44, wherein the fourth membrane portion is directly attached to the third frame portion.

73. The appliance of claim 45, wherein the fifth membrane portion is directly attached to the fourth frame portion.

74. The appliance of claim 41, wherein the first cup member further comprises a first support portion configured to support the second cup member.

75. The appliance of claim 74, wherein the second cup member is attached to the first support portion.

76. The appliance of claim 74, wherein the second cup member is attached to the first support portion by adhesive.

77. The appliance of claim 74, wherein the second cup member is attached to the first support portion with a bead and groove locking system.

78. The appliance of claim 74, wherein the second cup member is attached to the first support portion with one or more mechanical fasteners.

79. The appliance of claim 43, wherein the second cup member further comprises a second support portion configured to support the third cup member.

80. The appliance of claim 79, wherein the third cup member is attached to the second support portion.

81. The appliance of claim 79, wherein the third cup member is attached to the second support portion by adhesive.

82. The appliance of claim 79, wherein the third cup member is attached to the second support portion with a bead and groove locking system.

83. The appliance of claim 79, wherein the third cup member is attached to the second support portion with one or more mechanical fasteners.

84. The appliance of claim 44, wherein the third cup member further comprises a third support portion configured support the fourth cup member.

85. The appliance of claim 84, wherein the fourth cup member is attached to the third support portion.

86. The appliance of claim 84, wherein the fourth cup member is attached to the third support portion by adhesive.

87. The appliance of claim 84, wherein the fourth cup member is attached to the third support portion with a bead and groove locking system.

88. The appliance of claim 84, wherein the fourth cup member is attached to the third support portion with one or more mechanical fasteners.

89. The appliance of claim 45, wherein the fourth cup member further comprises a fourth support portion configured to support the fifth membrane portion.

90. The appliance of claim 89, wherein the fifth membrane portion is attached to the fourth support portion.

91. The appliance of claim 89, wherein the fifth membrane portion is attached to the fourth support portion by adhesive.

92. The appliance of claim 89, wherein the fifth membrane portion is attached to the fourth support portion with a bead and groove locking system.

93. The appliance of claim 89, wherein the fifth membrane portion is attached to the fourth support portion with one or more mechanical fasteners.

94. The appliance of claim 48, wherein the reduced pressure supply source comprises a pump.

95. The appliance of claim 48, wherein the reduced pressure supply source comprises a suction bulb.

102. The appliance of claim 41, wherein the second frame portion is larger than and has substantially the same shape as the first frame portion.