Normothermic tissue heating wound covering

• US 5,964,723 A
• Filed: 01/21/1997
• Issued: 10/12/1999
• Est. Priority Date: 06/19/1992
• Status: Expired due to Term

• Current Assignee: Arizant Technologies LLC
• Original Assignee: Augustine Medical, Inc. (3M Company)
• Inventors: Augustine, Scott D.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): LEWIS, KIM M
• Application Number:
  US08/786,713
• Time in Patent Office: 994 Days
• Field of Search: 602/2, 602/41, 602/42, 602/46, 602/48, 602/56, 602/57, 128/888, 128/889, 128/887, 607/96, 607/99, 607/108, 607/109, 607/111, 607/112, 607/152, 604/113, 604/114
• US Class Current: 602/42
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 2007/0001 Body part
• CPC Class Codes: A61F 2007/006 of gas
• CPC Class Codes: A61F 2007/0062 the gas being steam or water vapour
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0091 inflatable
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0226 adhesive, self-sticking
• CPC Class Codes: A61F 2007/0255 with a reflective layer
• CPC Class Codes: A61F 2007/0295 for heating or cooling or use at more than one temperature
• CPC Class Codes: A61F 2013/0017 possibility of applying fluid
• CPC Class Codes: A61F 2013/00174 possibility of applying pressure
• CPC Class Codes: A61F 2013/00187 insulating; warmth or cold applying
• CPC Class Codes: A61F 2013/00195 electric warmer
• CPC Class Codes: A61F 2013/002 with temperature control
• CPC Class Codes: A61F 2013/00212 infrared absorbing or reflecting
• CPC Class Codes: A61F 2013/0057 with openable cover
• CPC Class Codes: A61F 2013/00825 protection of wound surround protecting the body against ulcers A61F2013/15024; protection in contaminated, e.g. NBC or industrial toxic ambience A61F2013/15065; prophylaxis A61F2013/15081; protection of the body or articulation A61F2013/00272; safety barrier for protection of the operator A61F2013/00297; skin protection A61F2013/00387; for protection of suture stitches A61F2013/00455
• CPC Class Codes: A61F 2013/00834 as a frame
• CPC Class Codes: A61F 2013/00846 with transparent or translucent part
• CPC Class Codes: A61F 2013/00851 : with grid or reference marks
• CPC Class Codes: A61F 2013/00868 : thin film
• CPC Class Codes: A61F 2013/00872 : with controlled oxygen permeability
• CPC Class Codes: A61F 2013/00906 : for transcutaneous or transdermal drugs application
• CPC Class Codes: A61F 2013/0091 : with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 2013/00919 : for physical therapy, e.g. cold or magnetic
• CPC Class Codes: A61F 2013/00944 : humidity; moisture
• CPC Class Codes: A61F 2013/00953 : temperature
• CPC Class Codes: A61F 7/007 : characterised by electric heating
• CPC Class Codes: A61F 7/02 : Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61F 7/03 : thermophore, i.e. self-heating, e.g. using a chemical reaction
• CPC Class Codes: A61M 1/85 : with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 3/0283 : with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 35/00 : Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15

Abstract

A non-contact heated wound covering preferably having a peripheral sealing ring covered by a layer to which is attached a heater and this assembly is attached to the skin with an adhesive so that the heater is held proximate the wound area in a non-contact position. The layer and peripheral sealing ring together define a treatment volume proximate the wound. The wound covering includes a programmable active heater control and the sealing ring may dispense water to control the humidity of the treatment volume. One form of active heat is an electrical resistive filament in variable geometric shapes providing versatility in application of heat to different types of wounds and wound area geometries. Another form of active heat is the transfer of a heated gas to the wound covering.

Claims

1. A wound covering for application to a selected treatment area of a person'"'"'s body, the selected treatment area including a wound area, said wound covering comprising:

a heater for providing heat to at least a portion of the selected treatment area;

a flexible attachment member for attaching the heater in a non-contact position proximate the selected treatnent area, said flexible attachment member including a peripheral sealing ring having an upper surface and a lower surface, said upper surface having a substantially continuous layer extending thereacross for support of the heater, said lower surface having an adhesive layer thereon for attaching the member around the selected treatment area, wherein neither the heater nor the member contacts the wound area; and

a controller connected to the heater, for controlling the output of the heater to raise the temperature of the selected treatment area fom a pretreatment temperature to about 38°

C.

2. The wound covering of claim 1 in which the heater includes an electrically resistive filament.

3. The wound covering of claim 1 in which the heater comprises a source of heat selected from the group consisting of:

warm water pads, exothermic chemical heating pads, and phase-change salt pads.

4. The wound covering of claim 1 in which the heater is for uniformly heating the selected treatment area.

5. The would covering of claim 1 in which the heater is for non-uniform heating of the selected treatment area.

6. The wound covering of claim 1 in which the sealing ring defines an open cavity and seals around the selected treatment area.

7. The wound covering of claim 6 in which the sealing ring comprises a conformal polymeric ring.

8. The wound covering of claim 7 in which the conformal polymeric ring includes a polymeric foam.

9. The wound covering of claim 1, the layer maintaining a treatment volume proximate the selected wound area.

10. The wound covering of claim 9 in which the layer comprises a flexible sheet material.

11. The wound covering of claim 10 in which the flexible sheet material comprises a polymeric film.

12. The wound covering of claim 11 in which the polymeric film is selected from a group of polymers consisting of:

cellulose, cellulose acetate, polyethylene, poly-vinyl-chloride, polyurethane, and polypropylene.

13. The wound covering of claim 9 in which the layer comprises a gas permeable material.

14. The wound covering of claim 9 in which the layer is sealed to the flexible attachment member as a barrier layer.

15. The wound covering of claim 1 in which the flexible attachment member includes a pocket on the layer suitable for releasable attachment of the heater.

16. The wound covering of claim 1 further comprising a pressure response switch to turn off the heater when pressure is applied to the wound covering.

17. The wound covering of claim 1 further including a tissue temperature sensor connected to the controller and input means for inputting at least one operator selectable target tissue temperature to the controller.

18. The wound covering of claim 17 in which the tissue temperature sensor senses the temperature of a tissue chosen from a group of tissue types consisting of:

wound surface, wound tissue below the wound surface, periwound surface, and tissue below the periwound surface.

19. The wound covering of claim 1 in which the controller includes input means for providing at least one parameter in a programmable treatment paradigm.

20. The wound covering of claim 19 in which the at least one parameter is chosen from a group of parameters consisting of:

thermodynamics characteristic of tissue, heat conduction rate of tissue types, wound location, wound type, wound stage, wound blood flow, tissue surface area involved in the selected treatment area, tissue volume involved in the selected treatment area, heater geometry, heater output, heater surface area, and ambient temperature.

21. A wound covering for application to a selected treatment area of a person'"'"'s body, the selected treatment area including a wound area, said wound covering comprising:

a heater layer for providing heat to at least a portion of the selected treatment area;

one or more supports to support the heater layer in a non-contact position proximate the selected treatment area, said one or more supports including a peripheral sealing ring having an upper surface and a lower surface, said upper surface having a substantially continuous layer extending thereacross for support of the heater layer, said lower surface having an adhesive layer thereon for attaching the one or more supports around the selected treatment area, wherein neither the heater layer nor the one or more supports contacts the wound area;

a controller operably connected to the heater layer, for controlling the temperature of the heater layer; and

an input interface operably connected to the controller, for inputting to the controller a tissue treatment regimen for the portion of selected treatment area receiving heat so as to reach a target tissue temperature in a range from a pretreatment temperature to about 38°

C.

22. The wound covering of claim 21 in which the heater layer is for uniformly heating the selected wound area.

23. The wound covering of claim 21 in which the heater layer is for non-uniform heating of the selected wound area.

24. The wound covering of claim 21 in which the sealing ring defines an open cavity and seals around the selected treatment area.

25. The wound covering of claim 24 in which the sealing ring comprises a conformal polymeric ring.

26. The wound covering of claim 25 in which the conformal polymeric ring includes a polymeric foam.

27. The wound covering of claim 21 in which the layer maintains a treatment volume over the selected wound area.

28. The wound covering of claim 27 in which the layer includes sealing to the one or more supports as a barrier.

29. The wound covering of claim 21 in which the layer comprises a flexible sheet material.

30. The wound covering of claim 29 in which the flexible sheet material comprises a polymeric film.

31. The wound covering of claim 30 in which the polymeric film is selected from a group of polymers consisting of:

cellulose, cellulose acetate, polyethylene, poly-vinyl-chloride, polyurethane, and polypropylene.

32. The wound covering of claim 29 in which the layer includes a gas permeable material.

33. The wound covering of claim 21 in which the attachment means includes a pocket on the layer for releasable attachment of the heater layer.

34. The wound covering of claim 21 in which the controller includes a tissue temperature sensor and the input interface provides for inputting at least one operator selectable target tissue temperature.

35. The wound covering of claim 34 in which the tissue temperature sensor senses the temperature of a tissue chosen from a group of tissue types consisting of:

wound surface, wound tissue below the wound surface, periwound surface, and tissue below the periwound surface.

36. The wound covering of claim 21 in which the input interface includes at least one parameter in a programmable treatment paradigm.

37. The wound covering of claim 36 in which the at least one parameter is chosen from a group of parameters consisting of:

thermodynamics characteristic of tissue, heat conduction rate of tissue types, wound location, wound type, wound stage, wound blood flow, tissue surface area involved in the selected treatment area, tissue volume involved in the selected treatment area, heater geometry, heater output, heater surface area, and ambient temperature.

38. A wound covering for application to a selected treatment area of a person'"'"'s body, the selected treatment area including a wound area, said wound covering comprising:

a heater for providing heat to at least a portion of the selected treatment area;

a support for attaching the heater in a non-contact position proximate the selected treatment area, said support including a peripheral sealing ring having an upper surface and a lower surface, said upper surface having a substantially continuous layer extending thereacross for support of the heater, said lower surface having an adhesive layer thereon for attaching the support around the selected treatment area, wherein neither the heater nor the support contacts the wound area;

a controller, operably connected to the heater, for controlling the temperature of the heater; and

an interface, operably connected to the controller, for inputting to the controller a tissue treatment regimen for the portion of selected treatment area receiving heat so as to reach an average target tissue temperature in a range from above a pretreatment temperature to about 38°

C.

39. The wound covering of claim 38 in which the heater includes an electrically resistive filament.

40. The wound covering of claim 38 in which the heater comprises a source of heat selected from the group consisting of:

warm water pads, exothermic chemical heating pads, and phase-change salt pads.

41. The wound covering of claim 38 in which the heater is for uniformly heating the selected treatment area.

42. The wound covering of claim 38 in which the heater is for non-uniform heating of the selected treatment area.

43. The wound covering of claim 38 in which the sealing ring defines an open cavity and seals around the selected treatment area.

44. The wound covering of claim 43 in which the sealing ring comprises a conformal polymeric ring.

45. The wound covering of claim 44 in which the conformal polymeric ring includes a polymeric foam.

46. The wound covering of claim 38 wherein the layer maintains a treatment volume proximate the selected wound area.

47. The wound covering of claim 46 in which the layer comprises a flexible sheet material.

48. The wound covering of claim 47 in which the flexible sheet material comprises a polymeric film.

49. The wound covering of claim 48 in which the polymeric film is selected from a group of polymers consisting of:

cellulose, cellulose acetate, polyethylene, poly-vinyl-chloride, polyurethane, and polypropylene.

50. The wound covering of claim 46 in which the layer comprises a gas permeable material.

51. The wound covering of claim 46 in which the layer is sealed to the support as a barrier layer.

52. The wound covering of claim 38 in which the support includes a pocket on the layer suitable for releasable attachment of the heater.

53. The wound covering of claim 38 further comprising a pressure response switch to turn off the heater when pressure is applied to the wound covering.

54. The wound covering of claim 38 in which the controller includes a tissue temperature sensor and the interface provides for inputting at least one operator selectable target tissue temperature.

55. The wound covering of claim 54 in which the tissue temperature sensor senses the temperature of a tissue chosen from a group of tissue types consisting of:

wound surface, wound tissue below the wound surface, periwound surface, and tissue below the periwound surface.

56. The wound covering of claim 38 in which the interface includes at least one parameter in a programmable treatment paradigm.

57. The wound covering of claim 56 in which the at least one parameter is chosen from a group of parameters consisting of:

thermodynamics characteristic of tissue, heat conduction rate of tissue types, wound location, wound type, wound stage, wound blood flow, tissue surface area involved in the selected treatment area, tissue volume involved in the selected treatment area, heater geometry, heater output, heater surface area, and ambient temperature.

58. A wound covering for treating a selected treatment area of a person'"'"'s body, said wound covering comprising:

a heater;

a support to hold the heater in a non-contact position proximate a wound in the selected treatment are, said support including a peripheral sealing ring having an upper surface and a lower surface, said upper surface having a substantially continuous layer extending thereacross for support of the heater, said lower surface having an adhesive layer thereon for attaching the support around the selected treatment area, wherein neither the heater nor the support contacts the wound area;

a programmable temperature controller connected to the heater; and

programming for causing the controller to operate the heater according to a tissue treatment regimen for raising the temperature of the tissue in a portion of the selected treatment area to an average target tissue temperature in a range from above a pretreatment temperature to about 38°

C.

59. The wound covering of claim 58 in which the heater is for uniformly heating the selected treatment area.

60. The wound covering of claim 58 in which the heater is for non-uniform heating of the selected treatment area.

61. The wound covering of claim 58 in which the sealing ring defines an open cavity and seals around the selected treatment area.

62. The wound covering of claim 61 in which the sealing ring comprises a conformal polymeric ring.

63. The wound covering of claim 62 in which the conformal polymeric ring includes a polymeric foam.

64. The wound covering of claim 58 in which the heater includes spanning the support for maintaining a treatment volume proximate the selected treatment area.

65. The wound covering of claim 58 in which the heater comprises a flexible sheet material.

66. The wound covering of claim 65 in which the heater includes a gas permeable material.

67. The wound covering of claim 65 in which the flexible sheet material comprises a polymeric film.

68. The wound covering of claim 67 in which the polymeric film is selected from a group of polymers consisting of:

cellulose, cellulose acetate, polyethylene, poly-vinyl-chloride, polyurethane, and polypropylene.

69. The wound covering of claim 58 in which the support includes a pocket suitable for releasable attachment of the heater layer.

70. The wound covering of claim 58 in which the controller includes a tissue temperature sensor and the programming provides for inputting at least one operator selectable target tissue temperature.

71. The wound covering of claim 70 in which the tissue temperature sensor senses the temperature of a tissue chosen from a group of tissue types consisting of:

wound surface, wound tissue below the wound surface, periwound surface, and tissue below the periwound surface.

72. The wound covering of claim 58 in which the programing includes at least one parameter in a programmable treatment paradigm.

73. The wound covering of claim 72 in which the at least one parameter is chosen from a group of parameters consisting of:

thermodynamics characteristic of tissue, heat conduction rate of tissue types, wound location, wound type, wound stage, wound blood flow, tissue surface area involved in the selected treatment area, tissue volume involved in the selected treatment area, heater geometry, heater output, heater surface area, and ambient temperature.

74. A method for treating a wound of a person, the method comprising the steps of:

selecting a wound treatment area of the person'"'"'s skin including a target tissue near a wound;

providing a heater;

providing a controller operably connected to the heater;

forming a wound treatment volume over the wound by placing an enclosure over the wound treatment area, out of contact with the wound, said enclosure including a peripheral sealing ring having an upper surface and a lower surface, said upper surface having a substantially continuous layer extending thereacross for support of the heater, said lower surface having an adhesive layer thereon for attaching the enclosure around the selected treatment area;

attaching the heater to the enclosure, out of contact with the wound;

heating at least the target tissue; and

causing the controller to operate the heater according to a tissue treatment regimen in which the target tissue receives heat;

the tissue treatment regime including operating the heater so as to heat at least the target tissue to a temperature in a range from a pretreatment temperature to about 38°

C.

75. The method of claim 74 further comprising the step of programming the controller to operate the heater over a therapy cycle.

76. The method of claim 74 further comprising the step of programming the controller to operate the heater over a therapeutic sequence.

77. The method of claim 74 in which the tissue treatment regime includes controlling the temperature of at least the target tissue at an average temperature.

78. The method of claim 77 further comprising the step of programming the controller to operate the heater by maintaining an average temperature of the target tissue over a therapy cycle.

79. The method of claim 77 further comprising the step of programming the controller to operate the heater by maintaining an average temperature of the target tissue over a therapeutic sequence.

80. The method of claim 74 further comprising the step of inputting a target tissue temperature value to the controller in a temperature range a pretreatment temperature to about 38°

C.

81. The method of claim 74 further comprising the step of inputting an average target tissue temperature value to the controller in an temperature range from a pretreatment temperature to about 38°

C.

82. A wound covering, comprising:

a flexible sealing member defining a volume and including an upper surface and a lower surface;

a substantially continuous layer extending across the upper surface;

a heater supported against the upper surface by the layer;

an adhesive supported against the lower surface for attaching the flexible sealing member to a person in order to place the volume over a wound such that the member and the heater are out of contact with the wound; and

a controller connected to the heater for causing the heater to raise a temperature of a selected temperature area including a wound from a pretreatment temperature to about 38°

C.

83. The wound covering of claim 82, wherein the flexible sealing member includes a sealing ring.

84. The wound covering of claim 83, wherein the sealing ring is formed from polymeric foam.

85. The wound covering of claim 82, wherein the layer is a barrier layer.

86. The wound covering of claim 85, further including a pocket in the barrier layer in which the heater is received.

87. The wound covering of claim 82, the controller including programmable means for causing the heater to operate according to a therapy cycle in which the temperature of the selected treatment area is an average temperature.