Adjustable overlay reduced pressure wound treatment system

• US 20050222527A1
• Filed: 03/31/2005
• Published: 10/06/2005
• 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
• Granted Patent: US 7,776,028 B2
• Time in Patent Office: Days
• US Class Current: 602/1
• 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:

(a) an overlay comprised of;

(i) a top cup member, wherein the top cup member is comprised of a top membrane portion and a top frame portion and the top frame portion is adjacent to and circumscribes the top membrane portion; and

(ii) a secondary cup member, wherein the secondary cup member is comprised of a secondary membrane portion and a secondary frame portion, wherein the secondary membrane portion circumscribes and is attached to the top frame portion and the secondary frame portion is adjacent to and circumscribes the secondary membrane portion;

(iii) 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;

(b) sealing means 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; and

(c) reduced pressure supply means 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.

2. The appliance of claim 1, 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.

3. The appliance of claim 2, wherein the overlay is further comprised of 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.

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

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

6. The appliance of claim 1, wherein the overlay is further comprised of 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.

7. The appliance of claim 6, wherein the sealing means is comprised of 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.

8. The appliance of claim 1, wherein the top cup member and the secondary cup member are comprised of 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 member and the secondary frame member.

9. The appliance of claim 1, wherein:

(a) the top frame portion and the secondary frame portion are each comprised of materials from the group consisting of semi-rigid materials, rigid materials, and combinations of such materials; and

(b) the top membrane portion and the secondary membrane portion are each comprised of materials from the group consisting of semi-flexible materials, flexible materials, and combinations of such materials.

10. The appliance of claim 1, wherein the sealing means is comprised of 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.

11. The appliance of claim 1, wherein the sealing means is comprised of 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.

12. The appliance of claim 1, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the overlay at the site of the wound; and

(b) suction drain connecting means to operably connect the reduced pressure supply means to the suction drain so that the suction drain is in fluid communication with the reduced pressure supply means and reduced pressure is supplied by means of the suction drain to the volume under the overlay at the site of the wound.

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

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

(a) an overlay comprised of;

(i) a top cup member, wherein the top cup member is comprised of a top membrane portion and a top frame portion and the top frame portion is adjacent to and circumscribes the top membrane portion; and

(ii) at least two additional cup members, wherein;

(A) each of the at least two additional cup members is comprised of an additional membrane portion and an additional frame portion;

(B) the additional membrane portion of one of the at least two additional cup members circumscribes and is attached to the top frame portion, and the additional frame portion of the one additional cup member is adjacent to and circumscribes the additional membrane portion of the one additional cup member; and

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

(iii) 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;

(b) a seal 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

(c) reduced pressure supply means 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.

15. The appliance of claim 14, 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.

16. The appliance of claim 15, wherein the overlay is further comprised of 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.

17. The appliance of claim 14, wherein the top cup member and each additional cup member are comprised of 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 member and each additional frame member.

18. The appliance of claim 14, wherein:

(a) the top frame portion and each additional frame portion are comprised of materials from the group consisting of semi-rigid materials, rigid materials, and combinations of such materials; and

(b) the top membrane portion and each additional membrane portion are comprised of materials from the group consisting of semi-flexible materials, flexible materials, and combinations of such materials.

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

(a) an overlay comprised of;

(i) a top cup member, wherein the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(ii) a secondary cup member, wherein the secondary cup member is comprised of an interior secondary membrane portion, a secondary frame portion, and an exterior secondary membrane portion, and the interior secondary membrane portion is adjacent to a portion of and circumscribes the exterior top membrane portion, and the secondary frame portion is adjacent to and circumscribes the interior secondary membrane portion, and the exterior secondary membrane portion is adjacent to and circumscribes the secondary frame portion; and

(iii) cup connecting means to removably connect the top cup member to the secondary cup member;

(iv) 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;

(b) a seal 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

(c) reduced pressure supply means 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.

20. The appliance of claim 19, wherein:

(a) the top frame portion has a vertical displacement so that the interior top membrane portion and the exterior top membrane portion do not lie within the same plane; and

(b) the secondary frame portion has a vertical displacement so that the interior secondary membrane portion and the exterior secondary membrane portion do not lie within the same plane.

21. The appliance of claim 20, wherein:

(a) the top cup member is further comprised of at least one vertical frame member extending along the contour of the surface of the top cup member from the outside perimeter of the top cup member to the outside perimeter of the interior top membrane portion; and

(b) the secondary cup member is further comprised of at least one vertical frame member extending along the contour of the surface of the secondary cup member from the outside perimeter of the secondary cup member to the inside perimeter of the secondary cup member.

22. The appliance of claim 19, wherein the cup connecting means are comprised of an adhesive.

23. The appliance of claim 19, wherein the cup connecting means are comprised of snap connectors.

24. The appliance of claim 19, wherein the overlay is approximately rectangular in shape.

25. The appliance of claim 19, wherein the overlay is approximately elliptical in shape.

26. The appliance of claim 19, wherein the top cup member and the secondary cup member are comprised of a semi-rigid material and the interior and exterior top membrane portions and the interior and exterior secondary membrane portions each have a thickness less than the thickness of the top frame member and the secondary frame member.

27. The appliance of claim 19, wherein:

(a) the top frame portion and the secondary frame portion are each comprised of materials from the group consisting of semi-rigid materials, rigid materials, and combinations of such materials; and

(b) the interior and exterior top membrane portions and the interior and exterior secondary membrane portions are each comprised of materials from the group consisting of semi-flexible materials, flexible materials, and combinations of such materials.

28. The appliance of claim 19, wherein the overlay further comprises a pressure venting valve operably disposed on the overlay.

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

(a) an overlay comprised of;

(i) a top cup member, wherein the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion; and

(ii) at least two additional cup members, wherein;

(A) each of the at least two additional cup members is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(B) the interior additional membrane portion of one of the at least two additional cup members circumscribes and is adjacent and removably attached to a portion of the exterior top membrane portion, and the additional frame portion of the one at least two additional cup members is adjacent to and circumscribes the interior additional membrane portion of the one at least two additional cup member, and the exterior additional membrane portion of the one at least two additional cup member is adjacent to and circumscribes the additional frame portion of the one at least two additional cup member; and

(C) the interior additional membrane portion of each additional at least two cup members circumscribes and is adjacent and removably attached to a portion of the exterior membrane portion of the previous at least two additional cup member, and the additional frame portion of each additional at least two cup member is adjacent to and circumscribes the interior additional membrane portion of said at least two additional cup member, and the exterior additional membrane portion of said at least two additional cup member is adjacent to and circumscribes the additional frame portion of said at least two additional cup member;

(iii) 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;

(b) sealing means 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

(c) reduced pressure supply means 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.

30. The appliance of claim 29, wherein:

(a) the top frame portion has a vertical displacement so that the interior top membrane portion and the exterior top membrane portion do not lie within the same plane; and

(b) the additional frame portion of each of the at least two additional cup members has a vertical displacement so that the interior additional membrane portion and the exterior additional membrane portion of each of the at least two additional cup members do not lie within the same plane.

31. The appliance of claim 30, wherein:

(a) the top cup member is further comprised of at least one vertical frame member extending along the contour of the surface of the top cup member from the outside perimeter of the top cup member to the outside perimeter of the interior top membrane portion; and

(b) each of the at least two additional cup members is further comprised of at least one vertical frame member extending along the contour of the surface of each of the at least two additional cup members from the outside perimeter of each of the at least two additional cup members to the inside perimeter of each of the at least two additional cup members.

32. The appliance of claim 29, wherein the top cup member and each of the at least two additional cup members are comprised of a semi-rigid material and the interior and exterior top membrane portions and the interior and exterior additional membrane portions of each of the at least two additional cup members have a thickness less than the thickness of the top frame member and each of the additional frame members.

33. The appliance of claim 29, wherein:

(a) the top frame portion and the additional frame portion of each of the at least two additional cup members are comprised of materials from the group consisting of semi-rigid materials, rigid materials, and combinations of such materials; and

(b) the interior and exterior top membrane portions and the interior and exterior additional membrane portions are each comprised of materials from the group consisting of semi-flexible materials, flexible materials, and combinations of such materials.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay further comprised of a top cup member and at least one additional cup member, wherein;

(A) the top cup member is comprised of a top membrane portion and a top frame portion and the top frame portion is adjacent to and circumscribes the top membrane portion;

(B) the at least one additional cup member is comprised of an additional membrane portion and an additional frame portion;

(C) the additional membrane portion of the first at least one additional cup member circumscribes and is attached to the top frame portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the additional membrane portion of the first at least one additional cup member; and

(D) the additional membrane portion of each additional at least one cup member, if any, circumscribes and is attached to the frame portion of the previous at least one additional cup member, and the additional frame portion of said additional at least one additional cup member is adjacent to and circumscribes the additional membrane portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

(i) a reduced pressure supply source that provides a supply of reduced pressure; and

(ii) reduced pressure supply means 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.

35. The appliance of claim 34, wherein the reduced pressure supply source is comprised of a vacuum pump.

36. The appliance of claim 35, 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.

37. The appliance of claim 35, wherein:

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

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

38. The appliance of claim 35, wherein the vacuum pump is comprised of a portable vacuum pump.

39. The appliance of claim 34, wherein the reduced pressure supply means is comprised of flexible tubing.

40. The appliance of claim 34, wherein the reduced pressure supply means is comprised of a collection system that is operably positioned between the overlay and the reduced pressure supply source and the collection system comprises a container to receive and hold fluid aspirated from the wound.

41. The appliance of claim 40, wherein the collection system is further comprised of pressure halting means to halt the application of reduced pressure to the wound when the fluid in the container exceeds a predetermined amount.

42. The appliance of claim 34, 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.

43. The appliance of claim 34, wherein the reduced pressure is applied in a cyclic nature, the cyclic nature providing alternating time periods of application of reduced pressure and without application of reduced pressure.

44. The appliance of claim 34, wherein the treatment appliance is further comprised of a pressure venting valve operably disposed on the overlay.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay further comprised of a top cup member and at least one additional cup member, wherein;

(A) the top cup member is comprised of a top membrane portion and a top frame portion and the top frame portion is adjacent to and circumscribes the top membrane portion;

(B) the at least one additional cup member is comprised of an additional membrane portion and an additional frame portion;

(C) the additional membrane portion of the first at least one additional cup member circumscribes and is attached to the top frame portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the additional membrane portion of the first at least one additional cup member; and

(D) the additional membrane portion of each additional at least one cup member, if any, circumscribes and is attached to the frame portion of the previous at least one additional cup member, and the additional frame portion of said additional at least one additional cup member is adjacent to and circumscribes the additional membrane portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

(i) a reduced pressure supply source that provides a supply of reduced pressure; and

(ii) reduced pressure supply means to operably connect the enclosure 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

(c) wound packing means, wherein the wound packing means is positioned between the overlay and the wound to be treated.

46. The appliance of claim 45, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the enclosure in the area of the wound; and

(b) suction drain connecting means to operably connect the reduced pressure supply means to the suction drain so that the suction drain is in fluid communication with the reduced pressure supply means and reduced pressure is supplied to the volume under the overlay in the area of the wound by means of the suction drain.

47. The appliance of claim 46, wherein the suction drain is further comprised of a distal end portion and the distal end portion has at least one perforation in the surface thereof.

48. The appliance of claim 47, wherein the distal end portion of the suction drain is positioned within the interior volume of the wound packing means.

49. The appliance of claim 45, wherein the wound packing means is comprised of the group consisting of absorbent dressings, antiseptic dressings, nonadherent dressings, water dressings, or combinations of such dressings.

50. The appliance of claim 49, wherein the wound packing means is comprised of the group consisting of gauze, cotton and combinations of gauze and cotton.

51. The appliance of claim 45, wherein the wound packing means is comprised of an absorbable matrix adapted to encourage growth of the tissue in the area of the wound into the matrix.

52. The appliance of claim 51, wherein the absorbable matrix is comprised of a collagen material.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay further comprised of a top cup member and at least one additional cup member, wherein;

(A) the top cup member is comprised of a top membrane portion and a top frame portion and the top frame portion is adjacent to and circumscribes the top membrane portion;

(B) the at least one additional cup member is comprised of an additional membrane portion and an additional frame portion;

(C) the additional membrane portion of the first at least one additional cup member circumscribes and is attached to the top frame portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the additional membrane portion of the first at least one additional cup member; and

(D) the additional membrane portion of each additional at least one cup member, if any, circumscribes and is attached to the frame portion of the previous at least one additional cup member, and the additional frame portion of said additional at least one additional cup member is adjacent to and circumscribes the additional membrane portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

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

(ii) reduced pressure supply means 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.

54. The appliance of claim 53, wherein:

(a) the suction bulb is further comprised of an inlet port and an outlet port, wherein the inlet port is operably connected to the reduced pressure supply means; and

(b) the vacuum system further comprises an exhaust tubing member operably connected to the outlet port.

55. The appliance of claim 54, wherein the vacuum system further comprises an exhaust control valve operably connected to the exhaust tubing member.

56. The appliance of claim 54, wherein the vacuum system is further comprised of a filter operably connected to the exhaust tubing member, wherein the filter prevents the venting of micro-organisms or fluids or both aspirated from the wound.

57. The appliance of claim 54, wherein the vacuum system is further comprised of a supplemental vacuum system that is operably connected to the exhaust tubing member.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay comprised of a top cup member, at least one additional cup member, and cup connecting means to removably connect the top cup member and the at least one additional cup member together, wherein;

(A) the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(B) the at least one additional cup member is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(C) the interior additional membrane portion of the first at least one additional cup member circumscribes and is adjacent to a portion of the exterior top membrane portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of the first at least one additional cup member, and the exterior additional membrane portion of the first at least one additional cup member is adjacent to and circumscribes the additional frame portion of the first at least one additional cup member; and

(D) the interior additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is adjacent to a portion of the exterior membrane portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of said additional at least one additional cup member, and the exterior additional membrane portion of said additional at least one additional cup member is adjacent to and circumscribes the additional frame portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

(i) a reduced pressure supply source that provides a supply of reduced pressure; and

(ii) reduced pressure supply means 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.

59. The appliance of claim 58, wherein the reduced pressure supply source is comprised of a vacuum pump.

60. The appliance of claim 59, 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.

61. The appliance of claim 59, wherein:

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

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

62. The appliance of claim 59, wherein the vacuum pump is comprised of a portable vacuum pump.

63. The appliance of claim 58, wherein the reduced pressure supply means is comprised of flexible tubing.

64. The appliance of claim 58, wherein the reduced pressure supply means is comprised of a collection system that is operably positioned between the overlay and the reduced pressure supply source and the collection system comprises a container to receive and hold fluid aspirated from the wound.

65. The appliance of claim 64, wherein the collection system is further comprised of pressure halting means to halt the application of reduced pressure to the wound when the fluid in the container exceeds a predetermined amount.

66. The appliance of claim 58, 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.

67. The appliance of claim 58, wherein the reduced pressure is applied in a cyclic nature, the cyclic nature providing alternating time periods of application of reduced pressure and without application of reduced pressure.

68. The appliance of claim 58, wherein the treatment appliance is further comprised of a pressure venting valve operably disposed on the overlay.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay comprised of a top cup member, at least one additional cup member, and cup connecting means to removably connect the top cup member and the at least one additional cup member together, wherein;

(A) the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(B) the at least one additional cup member is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(C) the interior additional membrane portion of the first at least one additional cup member circumscribes and is adjacent to a portion of the exterior top membrane portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of the first at least one additional cup member, and the exterior additional membrane portion of the first at least one additional cup member is adjacent to and circumscribes the additional frame portion of the first at least one additional cup member; and

(D) the interior additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is adjacent to a portion of the exterior membrane portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of said additional at least one additional cup member, and the exterior additional membrane portion of said additional at least one additional cup member is adjacent to and circumscribes the additional frame portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

(i) a reduced pressure supply source that provides a supply of reduced pressure; and

(ii) reduced pressure supply means to operably connect the enclosure 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

(c) wound packing means, wherein the wound packing means is positioned between the overlay and the wound to be treated.

70. The appliance of claim 69, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the overlay in the area of the wound; and

(b) suction drain connecting means to operably connect the reduced pressure supply means to the suction drain so that the suction drain is in fluid communication with the reduced pressure supply means and reduced pressure is supplied to the volume under the overlay in the area of the wound by means of the suction drain.

71. The appliance of claim 70, wherein the suction drain is further comprised of a distal end portion and the distal end portion has at least one perforation in the surface thereof.

72. The appliance of claim 71, wherein the distal end portion of the suction drain is positioned within the interior volume of the wound packing means.

73. The appliance of claim 69, wherein the wound packing means is comprised of the group consisting of absorbent dressings, antiseptic dressings, nonadherent dressings, water dressings, or combinations of such dressings.

74. The appliance of claim 73, wherein the wound packing means is comprised of the group consisting of gauze, cotton and combinations of gauze and cotton.

75. The appliance of claim 69, wherein the wound packing means is comprised of an absorbable matrix adapted to encourage growth of the tissue in the area of the wound into the matrix.

76. The appliance of claim 75, wherein the absorbable matrix is comprised of a collagen material.

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

(a) a treatment device, wherein the treatment device is further comprised of;

(i) an overlay comprised of a top cup member, at least one additional cup member, and cup connecting means to removably connect the top cup member and the at least one additional cup member together, wherein;

(A) the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(B) the at least one additional cup member is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(C) the interior additional membrane portion of the first at least one additional cup member circumscribes and is adjacent to a portion of the exterior top membrane portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of the first at least one additional cup member, and the exterior additional membrane portion of the first at least one additional cup member is adjacent to and circumscribes the additional frame portion of the first at least one additional cup member; and

(D) the interior additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is adjacent to a portion of the exterior membrane portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of said additional at least one additional cup member, and the exterior additional membrane portion of said additional at least one additional cup member is adjacent to and circumscribes the additional frame portion of said additional at least one additional cup member; and

(ii) sealing means 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

(b) a vacuum system, wherein the vacuum system is comprised of;

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

(ii) reduced pressure supply means 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.

78. The appliance of claim 77, wherein:

(a) the suction bulb is further comprised of an inlet port and an outlet port, wherein the inlet port is operably connected to the reduced pressure supply means; and

(b) the vacuum system further comprises an exhaust tubing member operably connected to the outlet port.

79. The appliance of claim 78, wherein the vacuum system further comprises an exhaust control valve operably connected to the exhaust tubing member.

80. The appliance of claim 78, wherein the vacuum system is further comprised of a filter operably connected to the exhaust tubing member, wherein the filter prevents the venting of micro-organisms or fluids or both aspirated from the portion of the body to be treated.

81. The appliance of claim 78, wherein the vacuum system is further comprised of a supplemental vacuum system that is operably connected to the exhaust tubing member.

82. A method of treating a wound on a body, such method comprising the steps of:

(a) positioning an overlay on the body over the wound, wherein;

(i) the overlay is sized to be placed over and enclose the wound and is adapted to maintain reduced pressure at the site of the wound; and

(ii) the overlay is further comprised of a top cup member, at least one additional cup member, and cup connecting means to removably connect the top cup member and the at least one additional cup member together, wherein;

(A) the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(B) the at least one additional cup member is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(C) the interior additional membrane portion of the first at least one additional cup member circumscribes and is adjacent to a portion of the exterior top membrane portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of the first at least one additional cup member, and the exterior additional membrane portion of the first at least one additional cup member is adjacent to and circumscribes the additional frame portion of the first at least one additional cup member; and

(D) the interior additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is adjacent to a portion of the exterior membrane portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of said additional at least one additional cup member, and the exterior additional membrane portion of said additional at least one additional cup member is adjacent to and circumscribes the additional frame portion of said additional at least one additional cup member;

(b) sealing the overlay to the portion of the body surrounding the wound, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound;

(c) operably connecting the overlay with a vacuum system for producing reduced pressure in the volume under the overlay at the site of the wound; and

(d) maintaining the reduced pressure until the wound has progressed toward a selected stage of healing.

83. The method of claim 82, further comprising the step of detaching at least one additional cup member of the overlay so that the overlay is sized to cover a smaller area of the body surrounding the wound, such step being performed prior to positioning the overlay on the body over the wound.

84. The method of claim 82, wherein the vacuum system is comprised of a suction bulb and the step of operably connecting the overlay with the vacuum system further comprises the step of squeezing the suction bulb to reduce its volume and then releasing the suction bulb, so that reduced pressure is produced in the volume under the overlay at the site of the wound.

85. The method of claim 82, wherein the reduced pressure under the overlay at the site 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.

86. The method of claim 82, wherein the reduced pressure is applied in a cyclic nature, the cyclic nature providing alternating time periods of application of reduced pressure and without application of reduced pressure.

87. The method of claim 82, further comprising the step of placing wound packing means between the wound and the overlay, such step being performed prior to positioning the overlay on the body over the wound.

88. A method of treating a wound on a body, the method comprising the steps of:

(a) operably connecting an overlay with a vacuum system, wherein;

(i) the overlay is sized to be placed over and enclose the wound;

(ii) the overlay is adapted to maintain reduced pressure at the site of the wound;

(iii) the vacuum system produces reduced pressure for the volume under the overlay at the site of the wound; and

(iv) the overlay is comprised of a top cup member, at least one additional cup member, and cup connecting means to removably connect the top cup member and the at least one additional cup member together, wherein;

(A) the top cup member is comprised of an interior top membrane portion, a top frame portion, and an exterior top membrane portion, and the top frame portion is adjacent to and circumscribes the interior top membrane portion, and the exterior top membrane portion is adjacent to and circumscribes the top frame portion;

(B) the at least one additional cup member is comprised of an interior additional membrane portion, an additional frame portion, and an exterior additional membrane portion;

(C) the interior additional membrane portion of the first at least one additional cup member circumscribes and is adjacent to a portion of the exterior top membrane portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of the first at least one additional cup member, and the exterior additional membrane portion of the first at least one additional cup member is adjacent to and circumscribes the additional frame portion of the first at least one additional cup member; and

(D) the interior additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is adjacent to a portion of the exterior membrane portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the interior additional membrane portion of said additional at least one additional cup member, and the exterior additional membrane portion of said additional at least one additional cup member is adjacent to and circumscribes the additional frame portion of said additional at least one additional cup member;

(b) positioning the overlay on the body over the wound;

(c) sealing the overlay to the portion of the body surrounding the wound, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound; and

(d) maintaining the reduced pressure until the wound has progressed toward a selected stage of healing.

89. A method of treating a wound on a body, such method comprising the steps of:

(a) positioning an overlay on the body over the wound, wherein;

(i) the overlay is sized to be placed over and enclose the wound and is adapted to maintain reduced pressure at the site of the wound; and

(ii) the overlay is further comprised of a top cup member and at least one additional cup member, wherein;

(A) the top cup member is comprised of a top membrane portion and a top frame portion, and the top frame portion is adjacent to and circumscribes the top membrane portion;

(B) the at least one additional cup member is comprised of an additional membrane portion and an additional frame portion;

(C) the additional membrane portion of the first at least one additional cup member circumscribes and is attached to the top frame portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the additional membrane portion of the first at least one additional cup member; and

(D) the additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is attached to the additional frame portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the additional membrane portion of said additional at least one additional cup member;

(b) sealing the overlay to the portion of the body surrounding the wound, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound;

(c) operably connecting the overlay with a vacuum system for producing reduced pressure in the volume under the overlay at the site of the wound; and

(d) maintaining the reduced pressure until the wound has progressed toward a selected stage of healing.

90. The method of claim 89, further comprising the step of cutting away a portion of the overlay so that the overlay is sized to cover a smaller area of the body surrounding the wound, such step being performed prior to positioning the overlay on the body over the wound.

91. The method of claim 89, wherein the vacuum system is comprised of a suction bulb and the step of operably connecting the overlay with the vacuum system further comprises the step of squeezing the suction bulb to reduce its volume and then releasing the suction bulb, so that reduced pressure is produced in the volume under the overlay at the site of the wound.

92. The method of claim 89, wherein the reduced pressure under the overlay at the site 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.

93. The method of claim 89, wherein the reduced pressure is applied in a cyclic nature, the cyclic nature providing alternating time periods of application of reduced pressure and without application of reduced pressure.

94. The method of claim 89, further comprising the step of placing wound packing means between the wound and the overlay, such step being performed prior to positioning the overlay on the body over the wound.

95. A method of treating a wound on a body, such method comprising the steps of:

(a) positioning an overlay on the body over the wound, wherein;

(i) the overlay is sized to be placed over and enclose the wound and is adapted to maintain reduced pressure at the site of the wound; and

(ii) the overlay is further comprised of a top cup member and at least one additional cup member, wherein;

(A) the top cup member is comprised of a top membrane portion and a top frame portion, and the top frame portion is adjacent to and circumscribes the top membrane portion;

(B) the at least one additional cup member is comprised of an additional membrane portion and an additional frame portion;

(C) the additional membrane portion of the first at least one additional cup member circumscribes and is attached to the top frame portion, and the additional frame portion of the first at least one additional cup member is adjacent to and circumscribes the additional membrane portion of the first at least one additional cup member; and

(D) the additional membrane portion of each additional at least one additional cup member, if any, circumscribes and is attached to the additional frame portion of the previous at least one additional cup member, and the additional frame portion of each additional at least one additional cup member is adjacent to and circumscribes the additional membrane portion of said additional at least one additional cup member;

(b) operably connecting the overlay with a vacuum system for producing reduced pressure in the volume under the overlay at the site of the wound;

(c) sealing the overlay to the portion of the body surrounding the wound, so that reduced pressure may be maintained in the volume under the overlay at the site of the wound; and

(d) maintaining the reduced pressure until the wound has progressed toward a selected stage of healing.