Enclosure-based reduced pressure treatment system

• US 8,100,887 B2
• Filed: 03/08/2005
• Issued: 01/24/2012
• Est. Priority Date: 03/09/2004
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott, Johnson, Timothy Robert, Miller, Michael Seth
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): CRAIG, PAULA L
• Application Number:
  US11/075,020
• Publication Number:
  US 20050203452A1
• Time in Patent Office: 2,513 Days
• Field of Search: 604/313, 604/315, 604/317, 604319-320, 604/541, 604/543
• US Class Current: 604/543
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/00574 shaped as a body part A61F2013/00187 take precedence; use of plasters A61F2013/00365; containing means for different purposes A61F2013/00902
• CPC Class Codes: A61H 2205/065 Hands
• CPC Class Codes: A61H 2205/106 for the lower legs
• CPC Class Codes: A61H 2205/12 Feet
• CPC Class Codes: A61H 9/0057 Suction suction kneading A61H7/008
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/917 specially adapted for covering whole body parts
• 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 1/982 with means for detecting level of collected exudate

Abstract

A reduced pressure treatment appliance is provided for enclosing and providing reduced pressure treatment to a portion of a body of a patient. The reduced pressure treatment appliance may be used to treat wounds and other conditions, such as lymphedema, varicose veins, venous insufficiency and stasis, and other infirmities. In some embodiments, the appliance includes an enclosure that encloses the portion of the body to be treated for purposes of applying a reduced pressure to the enclosed portion of the body. In other embodiments, the wound treatment appliance also includes a vacuum system to supply reduced pressure to the portion of the body to be treated in the volume under the enclosure. 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 an extremital body portion, the appliance comprising:

a one-piece enclosure comprising a flexible material and having an opening and an enclosed volume opposite the opening, wherein the enclosure is sized to be placed over and completely enclose an extremital body portion to be treated and adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein at least a portion of the enclosure is configured to deform to substantially conform to a majority of the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion to be treated is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels via which fluid from the portion of the body to be treated is removed;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue, wherein the wound contacting material is separate from the enclosure;

sealing means to seal the opening to the extremital body portion, wherein the sealing means is configured to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated; and

reduced pressure supply means to operably connect the enclosure to a reduced pressure supply source that provides a supply of reduced pressure to the enclosure, so that the volume under the enclosure at the extremital body portion to be treated is supplied with reduced pressure by the reduced pressure supply source, the reduced pressure supply means configured to supply reduced pressure to the enclosure in an amount sufficient to treat the wound.

2. The appliance of claim 1, wherein the enclosure has approximately the same shape as the extremital body portion to be enclosed by the enclosure and the enclosure is of a size adapted to enclose such extremital body portion.

3. The appliance of claim 2, wherein the enclosure comprises a portion approximately in the shape of a human hand.

4. The appliance of claim 2, wherein the enclosure comprises a portion approximately in the shape of a human foot.

5. The appliance of claim 1, wherein the enclosure comprises a portion approximately in the shape of a mitten.

6. The appliance of claim 1, wherein the enclosure comprises a portion approximately in the shape of a bootee.

7. The appliance of claim 1, wherein the channels are recessed from a surface of the enclosure that faces the body.

8. The appliance of claim 1, wherein:

at least one fold forms in the surface of the enclosure when reduced pressure is present under the enclosure; and

wherein the at least one fold is configured such that fluids aspirated from the extremital body portion flow along the at least one fold to the reduced pressure supply means and are removed from the enclosure by means of the reduced pressure supply means cooperating with the reduced pressure supply source.

9. The appliance of claim 1, wherein the sealing means comprises the suction of the area adjacent to the opening against the body, such suction being produced by the presence of reduced pressure in the volume under the enclosure at the extremital body portion to be treated.

10. The appliance of claim 1, wherein the sealing means comprises an adhesive or adhesive tape that is disposed between the area of the enclosure adjacent to the opening and the extremital body portion adjacent to such area of the enclosure.

11. The appliance of claim 1, wherein the sealing means comprises a material that is positioned approximately around the perimeter of the enclosure on the area of the enclosure adjacent to the opening, and the material holds such area against the extremital body portion adjacent to such area.

12. The appliance of claim 1, further comprising:

a suction drain extending from the reduced pressure supply means into the volume under the enclosure at the extremital body portion to be treated; 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 by means of the suction drain to the volume under the enclosure at the extremital body portion to be treated.

13. The appliance of claim 1, wherein the preformed channels are disposed within the volume of the enclosure.

14. The appliance of claim 1, wherein the preformed channels are recessed into the surface of the enclosure.

15. The appliance of claim 1, wherein the preformed channels extend along substantially the entire length of the enclosure.

16. An appliance for administering reduced pressure treatment to a wound on an extremital body portion of a patient'"'"'s body, the appliance comprising:

an enclosure comprising a flexible material and having an opening and an enclosed volume opposite the opening, wherein the enclosure is sized to be placed over and completely enclose the extremital body portion to be treated and adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein at least a portion of the enclosure is configured to deform to substantially conform to substantially all of the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels configured to provide a conduit through which fluid from the portion of the body to be treated is removed;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue, wherein the wound contacting material is separate from the enclosure;

a seal to operably seal the opening to the body, wherein the seal is configured to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated; and

tubing to operably connect the enclosure to a reduced pressure supply source configured to supply reduced pressure to the enclosure for substantially the entire time that the enclosure is disposed over the extremital body portion to be treated, so that the volume under the enclosure at the extremital body portion to be treated is supplied with reduced pressure by the reduced pressure supply source.

17. The appliance of claim 16, wherein the enclosure comprises one or more materials selected from the group consisting of rubber, silicone, polyurethane, and any combination of such materials.

18. The appliance of claim 16, wherein a portion of the enclosure has a greater thickness than the remaining portion of the enclosure, and wherein the portion with the greater thickness is positioned approximately adjacent to an area of the body requiring a reduced level of pressure.

19. The appliance of claim 16, wherein the enclosure comprises at least one rod-like portion constructed of a rigid or semi-rigid material.

20. The appliance of claim 19, wherein the at least one portion of the enclosure constructed of a rigid or semi-rigid material is positioned approximately adjacent to an area of the body requiring a reduced level of pressure.

21. The appliance of claim 19, wherein the at least one portion constructed of a rigid or semi-rigid material is constructed of materials selected from the group consisting of metals, wood, ceramics, plastics and other polymers, and combinations of all such materials.

22. The appliance of claim 16, wherein:

the enclosure comprises at least one elongated panel disposed thereon; and

the at least one panel is shaped to conform to the shape of at least a part of the extremital body portion to be treated so that the at least one panel supports or immobilizes such part.

23. The appliance of claim 22, wherein the at least one elongated panel comprises a rigid or semi-rigid material or both.

24. The appliance of claim 16, wherein the preformed channels are recessed into the inner surface of the enclosure.

25. An appliance for administering reduced pressure treatment to a wound on an extremital body portion, the appliance comprising:

an enclosure comprising a flexible material and a port, wherein the enclosure has an opening and an enclosed volume opposite the opening and the enclosure is sized to be placed over and completely enclose the extremital body portion to be treated and the enclosure is adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein at least a portion of the enclosure is configured to deform to substantially conform to substantially all of the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels on an inner surface of the enclosure that faces the body, the channels configured to facilitate the flow of fluid from the portion of the body to be treated;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue, wherein the wound contacting material is separate from the enclosure;

a seal to operably seal the enclosure to the extremital body portion about the opening, wherein the seal is configured to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated; and

wherein the port is configured to be operably connected to a reduced pressure supply source to provide a supply of reduced pressure to the enclosure, the reduced pressure supply source configured to supply reduced pressure to the enclosure in an amount sufficient to draw out wound exudate from the wound.

26. The appliance of claim 25, wherein:

the enclosure comprises flow control means;

the flow control means is operably connected to the port; and

the flow control means permits fluids to flow from the volume under the enclosure at the extremital body portion to be treated through the port to a volume outside the enclosure, but not in the opposite direction.

27. The appliance of claim 26, wherein the flow control means is a one-way valve.

28. The appliance of claim 25, wherein the port is located approximately adjacent to the opening of the enclosure.

29. The appliance of claim 25, wherein the port is located approximately at the end of the enclosure that is distal from the opening of the enclosure.

30. An appliance for administering reduced pressure treatment to a wound on an extremital body portion of a patient'"'"'s body, the appliance comprising:

a treatment device, wherein the treatment device comprises;

an enclosure comprising a flexible material and having an opening and an enclosed volume opposite the opening, wherein the enclosure is sized to be placed over and completely enclose the extremital body portion to be treated and adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein at least a portion of the enclosure is configured to deform to substantially conform to substantially all of the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels through which fluid from the portion of the body to be treated is aspirated;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue, wherein the wound contacting material is separate from the enclosure;

sealing means to operably seal the opening to the body, wherein the sealing means are configured to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated; 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 enclosure to the reduced pressure supply source, so that the volume under the enclosure at the extremital body portion to be treated is supplied with reduced pressure by the reduced pressure supply source, the reduced pressure supply means configured to supply reduced pressure to the enclosure in an amount sufficient to treat the wound.

31. The appliance of claim 30, wherein the reduced pressure supply source comprises a vacuum pump.

32. The appliance of claim 31, 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.

33. The appliance of claim 31, 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 or fluids or both aspirated from the extremital body portion to be treated.

34. The appliance of claim 31, wherein the vacuum pump comprises a portable vacuum pump.

35. The appliance of claim 30, wherein the reduced pressure supply means comprises flexible tubing.

36. The appliance of claim 30, wherein the reduced pressure supply means comprises a collection system that is operably positioned between the enclosure and the reduced pressure supply source and the collection system comprises a container to receive and hold fluid aspirated from the extremital body portion to be treated.

37. The appliance of claim 36, wherein the collection system comprises pressure halting means to halt the application of reduced pressure to the body when the fluid in the container exceeds a predetermined amount.

38. The appliance of claim 30, wherein the reduced pressure under the enclosure 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.

39. The appliance of claim 30, 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.

40. The appliance of claim 30, wherein the treatment appliance comprises a liner disposed between the extremital body portion to be treated and the enclosure.

41. The appliance of claim 30, further comprising:

a suction drain extending from the reduced pressure supply means into the volume under the enclosure 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 enclosure in the area of the wound by means of the suction drain.

42. The appliance of claim 41, wherein the suction drain comprises a distal end portion and the distal end portion has at least one perforation in the surface thereof.

43. The appliance of claim 42, wherein the distal end portion of the suction drain is positioned within the interior volume of the wound contacting material.

44. The appliance of claim 30, wherein the wound contacting material is selected from the group consisting of absorbent dressings, antiseptic dressings, nonadherent dressings, water dressings, and combinations of such dressings.

45. The appliance of claim 44, wherein the wound contacting material is selected from the group consisting of gauze, cotton and combinations of gauze and cotton.

46. The appliance of claim 30, wherein the wound contacting material comprises an absorbable matrix adapted to encourage growth of the tissue in the area of the wound into the matrix.

47. The appliance of claim 46, wherein the absorbable matrix comprises a collagen material.

48. The appliance of claim 30, wherein some or all of the wound contacting material is placed within the wound.

49. The appliance of claim 30, further comprising a liner disposed between the wound contacting material and the enclosure.

50. The appliance of claim 30, wherein the preformed channels are recessed into the surface of the enclosure.

51. The appliance of claim 30, wherein the preformed channels extend along substantially the entire length of the enclosure.

52. An appliance for administering reduced pressure treatment to a wound on an extremital body portion, the appliance comprising:

a treatment device, wherein the treatment device comprises;

an enclosure comprising a flexible material and having an opening and an enclosed volume opposite the opening, wherein the enclosure is sized to be placed over and completely enclose the extremital body portion to be treated and adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein the enclosure is adapted to be sealed to the extremital body portion about the opening, wherein the enclosure is configured to deform to substantially conform to substantially all of the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels configured to facilitate the removal of fluid from the portion of the body to be treated;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue, wherein the wound contacting material is separate from the enclosure; and

a vacuum system, wherein the vacuum system comprises;

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

tubing to operably connect the enclosure to the reduced pressure supply source, to supply the volume under the enclosure at the extremital body portion, the reduced pressure supply source configured to supply reduced pressure to the enclosure in an amount sufficient to treat the extremital body portion.

53. The appliance of claim 52, wherein the reduced pressure supply source is a suction bulb.

54. The appliance of claim 53, wherein:

the suction bulb comprises an inlet port and an outlet port, wherein the inlet port is operably connected to the tubing; and

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 comprises 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 extremital body portion to be treated.

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

58. The appliance of claim 52, wherein the preformed channels are recessed into the surface of the enclosure.

59. An appliance for administering reduced pressure treatment to a wound on an extremital body portion of a patient'"'"'s body, the appliance comprising:

an enclosure comprising a flexible material and having an opening and an enclosed volume opposite the opening, wherein the enclosure is sized to be placed over and completely enclose the extremital body portion to be treated and adapted to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated, wherein the enclosure has a shape that substantially conforms with the extremital body portion, wherein at least a portion of the enclosure is configured to deform to substantially conform to the contours of the extremital body portion to be treated when reduced pressure is present under the enclosure, wherein the extremital body portion is selected from the group consisting of a hand, a foot, a finger and a toe, and wherein the enclosure comprises a plurality of preformed channels through which at least a portion of fluid from the portion of the body to be treated is removed;

wound contacting material configured to be positioned primarily at the wound within the enclosure to provide a desired effect on wound tissue;

a seal to operably seal the opening to the body, wherein the seal is configured to maintain reduced pressure in the volume under the enclosure at the extremital body portion to be treated; and

tubing to operably connect the enclosure to a reduced pressure supply source that provides a supply of reduced pressure to the enclosure, so that the volume under the enclosure at the extremital body portion to be treated is supplied with reduced pressure by the reduced pressure supply source, the reduced pressure supply source configured to supply reduced pressure to the enclosure in an amount sufficient to treat the wound;

wherein at least one fold forms in the surface of the enclosure when reduced pressure is present under the enclosure and wherein the at least one fold is configured such that fluids aspirated from the extremital body portion flow along the at least one fold to the reduced pressure supply means and are removed from the enclosure by means of the reduced pressure supply means cooperating with the reduced pressure supply source;

wherein

the enclosure conforms to substantially all of the contours of the extremital body portion to be treated; and

the wound contacting material is separate from the enclosure.

60. The appliance of claim 59, wherein the preformed channels are disposed within the volume of the enclosure.

61. The appliance of claim 59, wherein the preformed channels are recessed into the inner surface of the enclosure.

62. The appliance of claim 60, wherein the channels are in the form of tubes positioned within the volume of the enclosure and comprising one or more perforations so as to be in fluid communication with the enclosed volume of the enclosure.