Flexible reduced pressure treatment appliance

• US 20050261642A1
• Filed: 02/24/2005
• Published: 11/24/2005
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott
• Granted Patent: US 8,062,272 B2
• Time in Patent Office: Days
• US Class Current: 604/313
• 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: 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 1/682 bulb-type, e.g. nasal mucus aspirators
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/98 Containers specifically adapted for negative pressure wound therapy
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24

Abstract

A wound treatment appliance is provided for treating all or a portion of a wound. In some embodiments, the appliance comprises an impermeable flexible overlay that covers all or a portion of the wound for purposes of applying a reduced pressure to the covered portion of the wound. In other embodiments, the wound treatment appliance also includes a vacuum system to supply reduced pressure to the wound in the area under the flexible overlay. In yet other embodiments, the wound treatment appliance also includes wound packing means to prevent overgrowth of the wound or to encourage growth of the wound tissue into an absorbable matrix comprising the wound packing means. In still other embodiments, the appliance may include a suction drain. In other embodiments, the appliance may include a collection chamber to collect and store exudate from the wound. In yet other embodiments, a suction bulb may be used to provide a source of reduced pressure to an impermeable overlay that covers all or a portion of the wound. Finally, methods are provided for using various embodiments of the wound treatment appliance.

Claims

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

(a) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound; and

(b) reduced pressure supply means to operably connect the impermeable flexible overlay to a reduced pressure supply source that provides a supply of reduced pressure to the impermeable flexible overlay, so that the volume under the impermeable flexible overlay in the area of the wound to be treated is supplied with reduced pressure by the reduced pressure supply source;

(c) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area of the wound.

2. The appliance of claim 1, wherein the impermeable flexible overlay is further comprised of an interior surface facing the area of the wound to be treated and the surface area of the interior surface is greater than the surface area of the portion of the body to be enclosed by the impermeable flexible overlay.

3. The appliance of claim 1, wherein:

(a) the impermeable flexible overlay is further comprised of a bottom portion having an approximately elongated conical shape with an approximately elliptically-shaped open end at the base of the elongated conical bottom portion; and

(b) the approximately elliptically-shaped open end at the base is sized to be placed over and enclose the area of the wound to be treated.

4. The appliance of claim 1, wherein the impermeable flexible overlay has an approximately elongated conical shape with an approximately elliptically-shaped open end at the base of the elongated conical shape, wherein the approximately elliptically-shaped open end at the base is sized to be placed over and enclose the area of the wound to be treated.

5. The appliance of claim 4, wherein the impermeable flexible overlay is further comprised of a port located approximately at the apex of the approximately elongated conical shape and the reduced pressure supply means is operably connected to the port.

6. The appliance of claim 1, wherein:

(a) the impermeable flexible overlay is comprised of at least three cover portions, each of such cover portions being approximately triangular in shape; and

(b) one point of each of the at least three triangular-shaped cover portions are joined to form an apex of the impermeable flexible overlay and one side of each at least three triangular-shaped cover portions adjacent to the apex is joined to an adjacent side of another of such at least three triangular-shaped cover portions so that the bases of the at least three triangular-shaped cover portions form an opening sized to be placed over and enclose the area of the wound to be treated.

7. The appliance of claim 6, wherein the impermeable flexible overlay is further comprised of a port located approximately at the apex of the impermeable flexible overlay and the reduced pressure supply means is operably connected to the port.

8. The appliance of claim 1, wherein:

(a) at least one fold forms in the surface of the impermeable flexible overlay when the impermeable flexible overlay collapses; and

(b) fluids aspirated by the wound flow along the at least one fold to the reduced pressure supply means and are removed from the impermeable flexible overlay by means of the reduced pressure supply means cooperating with the reduced pressure supply source.

9. The appliance of claim 1, further comprising supplemental sealing means to form a seal between the impermeable flexible overlay and the body in the area of the wound.

10. The appliance of claim 1, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the impermeable flexible 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 impermeable flexible overlay in the area of the wound by means of the suction drain.

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

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

(i) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the area of the wound to be treated;

(ii) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area 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 impermeable flexible overlay to the reduced pressure supply source, so that the volume under the impermeable flexible overlay in the area of the wound is supplied with reduced pressure by the reduced pressure supply source.

12. The appliance of claim 11, wherein the reduced pressure supply source is comprised of a vacuum pump.

13. The appliance of claim 12, 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.

14. The appliance of claim 12, 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 aspirated from the wound or fluids aspirated from the wound or both.

15. The appliance of claim 12, wherein the vacuum pump is comprised of a portable vacuum pump.

16. The appliance of claim 11, wherein the reduced pressure supply means is comprised of flexible tubing.

17. The appliance of claim 11, wherein the reduced pressure supply means is comprised of a collection system that is operably positioned between the impermeable flexible overlay and the reduced pressure supply source and the collection system comprises a container to receive and hold fluid aspirated from the wound.

18. The appliance of claim 17, 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.

19. The appliance of claim 11, wherein the reduced pressure under the impermeable 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.

20. The appliance of claim 11, 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.

21. The appliance of claim 11, further comprising tissue protection means operably positioned between the body and the portion of the impermeable flexible overlay adjacent to the body at the wound site, the tissue protection means being to protect and strengthen the tissue of the body adjacent to the impermeable flexible overlay at the wound site.

22. The appliance of claim 21, wherein the tissue protection means is comprised of a hydrocolloid material.

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

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

(i) an impermeable overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the area of the wound to be treated;

(ii) a seal between the impermeable flexible overlay and the body in the area of the wound, wherein reduced pressure is maintained in the volume under the impermeable overlay in the area of the wound to be treated; 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 impermeable overlay to the suction bulb, so that the volume under the impermeable overlay in the area of the wound may be supplied with reduced pressure by the suction bulb.

24. The appliance of claim 23, wherein the impermeable overlay is comprised of a rigid or semi-rigid wound cover.

25. The appliance of claim 23, wherein the impermeable overlay is comprised of a flexible wound cover.

26. The appliance of claim 25, wherein the flexible wound cover is comprised of a flexible overlay that collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, and the seal between the flexible overlay and the body in the area of the wound is an approximately hermetic seal that is formed as a result of such collapse.

27. The appliance of claim 23, 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.

28. The appliance of claim 27, wherein the vacuum system further comprises an exhaust control valve operably connected to the exhaust tubing member.

29. The appliance of claim 27, 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 aspirated from the wound or fluids aspirated from the wound, or both.

30. The appliance of claim 27, wherein the vacuum system is further comprised of a supplemental vacuum system that is operably connected to the exhaust tubing member.

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

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

(i) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the area of the wound to be treated;

(ii) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area 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 impermeable flexible overlay to the reduced pressure supply source, so that the volume under the impermeable flexible overlay in the area of the wound 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 wound treatment device and the portion of the wound to be treated.

32. The appliance of claim 31, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the impermeable flexible 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 impermeable flexible overlay in the area of the wound by means of the suction drain.

33. The appliance of claim 32, 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.

34. The appliance of claim 33, wherein the distal end portion of the suction drain is positioned within the interior volume of the wound packing means.

35. The appliance of claim 31, 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.

36. The appliance of claim 35, wherein the wound packing means is comprised of the group consisting of gauze or cotton or combinations of gauze and cotton.

37. The appliance of claim 31, 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.

38. The appliance of claim 37, wherein the absorbable matrix is comprised of a collagen material.

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

(a) positioning an impermeable flexible overlay on the body over the area of the wound to be treated, wherein the impermeable flexible overlay is sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the area of the wound to be treated;

(b) operably connecting the impermeable flexible overlay with a vacuum system for producing reduced pressure in the volume under the impermeable flexible overlay in the area of the wound to be treated;

(c) collapsing the impermeable flexible overlay in the approximate direction of the wound when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound so that an approximately hermetic seal is formed between the impermeable flexible overlay and the body in the area of the wound; and

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

40. The method of claim 39, further comprising the step of placing tissue protection means on the tissue of the body that is to be approximately adjacent to the impermeable flexible overlay, such tissue protection means being to protect and strengthen the tissue of the body adjacent to the flexible overlay at the wound site, such step being performed prior to positioning the impermeable flexible overlay over the area of the wound to be treated.

41. The method of claim 39, further comprising the step of placing wound packing means between the wound and the impermeable flexible overlay in the area of the wound to be treated, such step being performed prior to positioning the impermeable flexible overlay over the area of the wound to be treated.

42. The method of claim 39, wherein the vacuum system is comprised of a suction bulb and the step of operably connecting the impermeable flexible 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 impermeable flexible overlay in the area of the wound.

43. The method of claim 39, wherein the reduced pressure under the impermeable 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.

44. The method of claim 39, 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.

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

(a) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound;

(b) a collection chamber to receive and hold fluid aspirated from the wound;

(c) collection chamber attachment means to operably attach the collection chamber to the impermeable flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the impermeable flexible overlay; and

(d) reduced pressure supply means to operably connect the collection chamber to a reduced pressure supply source that provides a supply of reduced pressure to the collection chamber, so that the volume within the collection chamber and under the impermeable overlay in the area of the wound to be treated are supplied with reduced pressure by the reduced pressure supply source;

(e) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area of the wound.

46. The appliance of claim 45, wherein the collection chamber is positioned approximately adjacent to the impermeable flexible overlay on the side of the impermeable flexible overlay opposite the wound and the collection chamber attachment means is a rigid or semi-rigid connecting member between the collection chamber and the impermeable flexible overlay, such connection having a port therein that extends between the collection chamber and the impermeable flexible overlay.

47. The appliance of claim 46, wherein

(a) the impermeable flexible overlay has an approximately conical or elongated conical shape with an approximately circularly or elliptically-shaped open end at the base of the conical or elongated conical shape wherein the approximately circularly or elliptically-shaped open end at the base is sized to be placed over and enclose the area of the wound to be treated;

and

(b) the collection chamber and the collection chamber attachment means are positioned approximately at the apex of the conical or elongated conically shaped impermeable flexible overlay on the side of the impermeable flexible overlay opposite the wound.

48. The appliance of claim 47, wherein the collection chamber is approximately cylindrical in shape.

49. The appliance of claim 46, wherein the collection chamber attachment means is further comprised of flow control means operably positioned between the collection chamber and the impermeable flexible overlay, wherein the flow control means permits the fluid to flow from the volume under the impermeable flexible overlay in the area of the wound to the collection chamber, but not in the opposite direction.

50. The appliance of claim 49, wherein the flow control means is comprised of a valve.

51. The appliance of claim 50, wherein the valve is comprised of a flapper-type valve.

52. The appliance of claim 45, wherein:

(a) the collection chamber is positioned approximately adjacent to the impermeable flexible overlay on the side of the impermeable flexible overlay opposite the wound; and

(b) the collection chamber attachment means is comprised of a membrane, wherein;

(i) the membrane acts as a barrier separating the collection chamber and the impermeable flexible overlay, so that the membrane acts as a portion of the surface of the collection chamber and a portion of the surface of the impermeable flexible overlay; and

(ii) the membrane has at least one port therein so that the volume within the collection chamber is in fluid communication with the volume under the impermeable flexible overlay in the area of the wound.

53. The appliance of claim 52, wherein:

(a) the impermeable flexible overlay has an approximately conical shape or approximately elongated conical shape and has;

(i) a base end opening having an either approximately circular shape or approximately elliptical shape, wherein the approximately circularly shaped or approximately elliptically-shaped base end opening is sized to be placed over and enclose the area of the wound to be treated; and

(ii) a top end opening opposite the base end opening, wherein the top end opening has either an approximately circular shape or approximately elliptical shape; and

(b) the membrane is sized to be of the same shape and size as the top end opening and the membrane is positioned so that it is attached to the entire perimeter of the top end opening and covers the entire top end opening.

54. The appliance of claim 53, wherein the collection chamber has an approximately conical shape or approximately elongated conical shape and is further comprised of:

(a) a chamber bottom end opening having an either approximately circular shape or approximately elliptical shape, wherein the approximately circularly shaped or approximately elliptically-shaped chamber bottom end opening is adapted to be of approximately the same size and shape as the top end opening of the impermeable flexible overlay; and

(b) a reduced pressure supply port positioned at the apex of the collection chamber opposite the chamber bottom end opening, wherein the reduced pressure supply port operably connects the reduced pressure supply means to the collection chamber.

55. The appliance of claim 54, further comprising a micropore filter, a hydrophobic filter, or both, operably connected to the reduced pressure supply port.

56. The appliance of claim 52, wherein the collection chamber attachment means is further comprised of flow control means operably connected with the at least one port, wherein the flow control means permits the fluid to flow from the volume under the impermeable flexible overlay in the area of the wound through the at least one port to the collection chamber, but not in the opposite direction.

57. The appliance of claim 56, wherein the flow control means is comprised of a flapper-type valve.

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

(a) a wound treatment device, further comprised of;

(i) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound;

(ii) a collection chamber to receive and hold fluid aspirated from the wound;

(iii) collection chamber attachment means to operably attach the collection chamber to the impermeable flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the impermeable flexible overlay;

(iv) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area 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 collection chamber to the reduced pressure supply source, so that the volume within the collection chamber and under the impermeable overlay in the area of the wound to be treated are 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 aspirated from the wound or fluids aspirated from the wound or both.

62. The appliance of claim 59, wherein the vacuum pump is 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 under the impermeable 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.

65. 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.

66. The appliance of claim 58, further comprising tissue protection means operably positioned approximately between the body and the portion of the impermeable flexible overlay adjacent to the body at the wound site, the tissue protection means being to protect and strengthen the tissue of the body adjacent to the impermeable flexible overlay at the wound site.

67. The appliance of claim 58, further comprising wound packing means, wherein the wound packing means is positioned between the wound treatment device and the portion of the wound to be treated.

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

(a) positioning a wound treatment device on the body over the area of the wound to be treated, wherein the wound treatment device is comprised of;

(i) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound to be treated; and

(ii) a collection chamber to receive and hold fluid aspirated from the wound and collection chamber attachment means to operably attach the collection chamber to the impermeable flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the impermeable flexible overlay;

(b) operably connecting the collection chamber with a vacuum system for producing reduced pressure in the volume within the collection chamber and under the impermeable flexible overlay in the area of the wound to be treated;

(c) collapsing the impermeable flexible overlay in the approximate direction of the wound when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound so that an approximately hermetic seal is formed between the impermeable flexible overlay and the body in the area of the wound; and

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

69. The method of claim 68, further comprising the step of placing tissue protection means on the tissue of the body that is to be approximately adjacent to the impermeable flexible overlay, such tissue protection means being to protect and strengthen the tissue of the body adjacent to the flexible overlay at the wound site, such step being performed prior to positioning the impermeable flexible overlay over the area of the wound to be treated.

70. The method of claim 68, further comprising the step of placing wound packing means in the area of the wound to be treated between the wound and the impermeable flexible overlay, such step being performed prior to positioning the impermeable flexible overlay over the area of the wound to be treated.

71. The method of claim 68, wherein the reduced pressure under the impermeable 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.

72. The method of claim 68, 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.

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

(a) an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound;

(b) a seal to operably seal the impermeable flexible overlay to the body in the area of the wound to be treated, so that reduced pressure is maintained in the volume under the impermeable flexible overlay in the area of the wound; and

(c) reduced pressure supply means to operably connect the impermeable flexible overlay to a reduced pressure supply source that provides a supply of reduced pressure to the impermeable flexible overlay, so that the volume under the impermeable flexible overlay in the area of the wound to be treated is supplied with reduced pressure by the reduced pressure supply source;

(d) wherein the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound.

74. The appliance of claim 73, wherein the impermeable flexible overlay is further comprised of an interior surface facing the area of the wound to be treated and the surface area of the interior surface is greater than the surface area of the portion of the body to be enclosed by the impermeable flexible overlay.

75. The appliance of claim 73, wherein the impermeable flexible overlay is further comprised of a port and the reduced pressure supply means is operably connected to the port.

76. The appliance of claim 73, wherein:

(a) at least one fold forms in the surface of the impermeable flexible overlay when the impermeable flexible overlay collapses; and

(b) fluids aspirated by the wound flow along the at least one fold to the reduced pressure supply means and are removed from the impermeable flexible overlay by means of the reduced pressure supply means cooperating with the reduced pressure supply source.

77. The appliance of claim 73, further comprising:

(a) a suction drain extending from the reduced pressure supply means into the volume under the impermeable flexible 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 impermeable flexible overlay in the area of the wound by means of the suction drain.

78. The appliance of claim 73, further comprising a reduced pressure supply source operably connected to the reduced pressure supply means, wherein the reduced pressure supply source provides a supply of reduced pressure so that the volume under the impermeable flexible overlay in the area of the wound is supplied with reduced pressure by the reduced pressure supply source.

79. The appliance of claim 73, further comprising

(a) a collection chamber to receive and hold fluid aspirated from the wound;

and

(b) collection chamber attachment means to operably attach the collection chamber to the impermeable flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the volume of the impermeable flexible overlay in the area of the wound.