Flexible reduced pressure treatment appliance

• US 7,909,805 B2
• Filed: 04/04/2005
• Issued: 03/22/2011
• 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
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US11/098,265
• Publication Number:
  US 20050222544A1
• Time in Patent Office: 2,178 Days
• Field of Search: 604/305, 604/313, 604/314, 604/543, 602/42, 602/45
• 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 1/68 Containers incorporating a flexible member creating suction
• CPC Class Codes: A61M 1/682 bulb-type, e.g. nasal mucus aspirators
• CPC Class Codes: A61M 1/782 using valves with freely moving parts, e.g. float valves
• CPC Class Codes: A61M 1/784 by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/98 Containers specifically adapted for negative pressure wound therapy
• CPC Class Codes: A61M 2205/075 Bulb type

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 impermeable flexible overlay comprises suction assistance means, such as channels, which assist in the application of reduced pressure to the area of the wound and removal of exudate from 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 liquid impermeable flexible overlay having an opening sized to be placed over and enclose the area of the wound to be treated, the overlay adapted to maintain reduced pressure in the volume under the flexible overlay in the area of the wound; and

reduced pressure supply means supported at a top portion of the overlay to operably connect the flexible overlay to a reduced pressure supply source that provides a supply of reduced pressure to the flexible overlay, so that the volume under the flexible overlay in the area of the wound to be treated is supplied with reduced pressure by the reduced pressure supply source;

wherein;

the overlay comprises a plurality of preformed channels formed in or affixed to the overlay extending from the reduced pressure supply means toward the opening to assist in the application of reduced pressure to the area of the wound and removal of exudate from the wound, wherein each of the plurality of preformed channels are joined together near the center of the flexible overlay; and

the 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 flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the flexible overlay and the body in the area of the wound.

2. The appliance of claim 1, wherein the flexible overlay comprises 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 flexible overlay.

3. The appliance of claim 1, wherein:

the flexible overlay comprises a bottom portion having an approximately elongated conical shape, and the opening is formed at the base of the bottom portion and has an approximately elliptical shape.

4. The appliance of claim 1, wherein the flexible overlay has an approximately elongated conical shape, and the opening is formed at the base of the bottom portion and has an approximately elliptical shape.

5. The appliance of claim 4, wherein the flexible overlay comprises 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:

the flexible overlay comprises at least three cover portions, each of such cover portions being approximately triangular in shape;

one point of each of the at least three triangular-shaped cover portions are joined to form an apex of the 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 the opening.

7. The appliance of claim 1, wherein the flexible overlay is approximately cup-shaped, and the flexible overlay comprises a port located approximately at the apex of the flexible overlay, and the reduced pressure supply means is operably connected to the port.

8. The appliance of claim 1, wherein:

at least one fold forms in the surface of the flexible overlay when the flexible overlay collapses; and

fluids aspirated by the wound flow along the at least one fold to the reduced pressure supply means and are removed from the 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 flexible overlay and the body in the area of the wound.

10. The appliance of claim 1, further comprising:

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

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 flexible overlay in the area of the wound by means of the suction drain.

11. The appliance of claim 1, wherein the suction assist means comprises at least one channel supported by flexible overlay.

12. The appliance of claim 1, wherein the flexible overlay comprises a port, and the reduced pressure supply means is operably connected to one side of the port, and the plurality of preformed channels are operably connected to the other side of the port.

13. The appliance of claim 1, wherein the plurality of preformed channels comprise at least one raised portion disposed on the surface of the flexible overlay.

46. The method of claim 1, wherein the flexible overlay comprises a port, and the reduced pressure supply means is operably connected to one side of the port, and the plurality of channels are operably connected to the other side of the port.

61. The appliance of claim 1, further comprising one or more perforations formed in at least one of the plurality of preformed channels.

62. The appliance of claim 1, further comprising foam configured to be positioned over the wound under the flexible overlay.

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

a wound treatment device, wherein the wound treatment device comprises a liquid impermeable flexible overlay having a bottom opening 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, wherein the flexible overlay comprises at least one channel formed in or affixed to the overlay and extending between a port in a top portion of the overlay and the bottom opening to assist in the application of reduced pressure to the area of the wound and removal of exudate from the wound; and

the 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 flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the flexible overlay and the body in the area of the wound; and

a vacuum system, wherein the vacuum system comprises a reduced pressure supply source that provides a supply of reduced pressure; and

reduced pressure supply means to operably connect the flexible overlay to the reduced pressure supply source, so that the volume under the flexible overlay in the area of the wound is supplied with reduced pressure by the reduced pressure supply source.

15. The appliance of claim 14, wherein the reduced pressure supply source comprises a vacuum pump.

16. The appliance of claim 15, 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.

17. The appliance of claim 15, wherein:

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

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.

18. The appliance of claim 15, wherein the vacuum pump comprises a portable vacuum pump.

19. The appliance of claim 14, wherein the reduced pressure supply means comprises flexible tubing.

20. The appliance of claim 14, wherein the reduced pressure supply means comprises a collection system that is operably positioned between the flexible overlay and the reduced pressure supply source and the collection system comprises a container to receive and hold fluid aspirated from the wound.

21. The appliance of claim 20, wherein the collection system comprises pressure halting means to halt the application of reduced pressure to the wound when the fluid in the container exceeds a predetermined amount.

22. The appliance of claim 14, 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.

23. The appliance of claim 14, 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.

24. The appliance of claim 14, further comprising tissue protection means operably positioned between the body and the portion of the impermeable 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 flexible overlay at the wound site.

25. The appliance of claim 14, wherein the at least one channel comprises at least one raised portion disposed on the surface of the flexible overlay.

31. The appliance of claim 14, further comprising a wound packing means, wherein the wound packing means is positioned between the wound treatment device and a portion of the wound to be treated.

32. The appliance of claim 14, further comprising:

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

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 flexible overlay in the area of the wound by means of the suction drain.

33. The appliance of claim 32, wherein the suction drain comprises 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 selected from the group consisting of absorbent dressings, antiseptic dressings, nonadherent dressings, water dressings, and combinations of such dressings.

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

37. The appliance of claim 31, wherein the wound packing means comprises 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 comprises a collagen material.

63. The appliance of claim 14, further comprising one or more perforations formed in the at least one channel.

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

a wound treatment device, wherein the wound treatment device comprises a 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 and a plurality of channels to assist in the application of reduced pressure to the area of the wound and removal of exudate from the wound, the plurality of channels each having a tubular structure;

wherein the 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 flexible overlay in the area of the wound and is configured to be sealed to the body in the area of the wound to maintain reduced pressure in the volume under the flexible overlay in the area of the wound to be treated.

27. The appliance of claim 26, further comprising:

a vacuum system, wherein the vacuum system comprises a suction bulb configured to provide a source of reduced pressure; and

reduced pressure supply means to operably connect the flexible overlay to the suction bulb, so that the volume under the flexible overlay in the area of the wound may be supplied with reduced pressure by the suction bulb;

wherein the suction bulb comprises an inlet port and an outlet port, wherein the inlet port is operably connected to the reduced pressure supply means; and

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 comprises a filter operably connected to the exhaust tubing member, wherein the filter prevents the venting of micro-organisms aspirated from the wound or exudate aspirated from the wound, or both.

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

57. The appliance of claim 26, wherein at least one channel comprises an elongate and raised structure on the surface of the flexible overlay.

58. The appliance of claim 26, wherein each of the plurality of channels comprises stiffening members that make each of the plurality of channels stiffer than the other portions of the flexible overlay.

59. The appliance of claim 26, further comprising reduced pressure supply means to operably connect the flexible overlay to a source of reduced pressure.

60. The appliance of claim 26, further comprising a source of reduced pressure operably connected to the flexible overlay.

64. The appliance of claim 26, wherein the overlay is liquid impermeable.

65. The appliance of claim 26, wherein the plurality of channels extend generally from a first opening formed at the apex the overlay toward a peripheral edge of the overlay.

66. The appliance of claim 26, wherein the tubular structure has one or more perforations formed therein.

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

positioning a flexible overlay on the body over the area of the wound to be treated, wherein the flexible overlay has an apex and an open-ended base and 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; and

the flexible overlay comprises preformed suction assist means extending generally from the apex toward a peripheral edge of the base to assist in the application of reduced pressure to the area of the wound and removal of exudate from the wound;

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

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

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 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 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 flexible overlay in the area of the wound to be treated, such step being performed prior to positioning the flexible overlay over the area of the wound to be treated.

42. The method of claim 39, wherein the vacuum system comprises a suction bulb and the step of operably connecting the 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 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. The method of claim 39, wherein the suction assist means comprises at least one channel disposed on the surface of the flexible overlay.

47. The method of claim 39, wherein the suction assist means comprises at least one raised portion disposed on the surface of the flexible overlay.

67. The method of claim 45, wherein the at least one channel comprises one or more perforations formed therein.

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

a liquid impermeable flexible overlay that maintains shape upon the application of reduced pressure, the overlay having an opening sized to be placed over and enclose the area of the wound to be treated, and being adapted to maintain reduced pressure in the volume under the flexible overlay in the area of the wound;

a seal to operably seal the 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 flexible overlay in the area of the wound; and

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

wherein;

the 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 flexible overlay in the area of the wound and the portions of the flexible overlay adjacent to the opening form a substantially perpendicular angle with the body in the area of the wound adjacent to the opening of the flexible overlay; and

the overlay comprises at least one channel disposed on the surface of the overlay extending from the reduced pressure supply means at the apex of the overlay toward the opening to assist in the application of reduced pressure to the area of the wound and removal of exudate from the wound.

49. The appliance of claim 48, wherein the flexible overlay comprises 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 flexible overlay.

50. The appliance of claim 48, wherein the flexible overlay comprises a port and the reduced pressure supply means is operably connected to the port.

51. The appliance of claim 48, wherein:

at least one fold forms in the surface of the flexible overlay when the flexible overlay collapses; and

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

52. The appliance of claim 48, further comprising:

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

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 flexible overlay in the area of the Wound by means of the suction drain.

53. The appliance of claim 48, 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 flexible overlay in the area of the wound is supplied with reduced pressure by the reduced pressure supply source.

54. The appliance of claim 48, further comprising 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 flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the volume of the flexible overlay in the area of the wound.

55. The appliance of claim 48, wherein the flexible overlay comprises a port, and the reduced pressure supply means is operably connected to one side of the port, and the at least one channel is operably connected to the other side of the port.

56. The appliance of claim 48, wherein the at least one channel comprises at least one raised portion disposed on the surface of the flexible overlay.