Normothermic heater wound covering

• US 5,986,163 A
• Filed: 01/21/1997
• Issued: 11/16/1999
• Est. Priority Date: 06/19/1992
• Status: Expired due to Fees

• 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:
  US08/785,794
• Time in Patent Office: 1,029 Days
• Field of Search: 602/2, 602/41, 602/42, 602/46, 602/48, 602/56, 602/57, 128/887-889, 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 13/00051 Accessories for dressings
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 13/0233 characterised by the oclusive layer skin contacting layer
• CPC Class Codes: A61F 13/0236 characterised by the application/handling support layer
• CPC Class Codes: A61F 15/008 Appliances for wound protecting, e.g. avoiding contact between wound and bandage corn plasters A61F13/063
• CPC Class Codes: A61F 2007/0001 Body part
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• 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 2007/0226 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 controllable heater wound covering and method 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 the selected treatment area;

a flexible attachment member for attaching the heater in a non-contact position proximate the selected treatment 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 maintaining the temperature of the heater in a temperature range from above ambient 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 wound 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, polyvinyl-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 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. 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 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 across 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 they wound area; and

a controller connected to the heater layer, for maintaining the temperature of the heater layer in a temperature range from above ambient temperature to about 38°

C.

18. The wound covering of claim 17 in which the heater layer is for uniformly heating the selected wound area.

19. The wound covering of claim 17 in which the heater layer is for non-uniformly heating the selected wound area.

20. The wound covering of claim 17 in which the sealing ring defines an open cavity and seals around the selected treatment area.

21. The wound covering of claim 20 in which the sealing ring comprises a conformal polymeric ring.

22. The wound covering of claim 21 in which the conformal polymeric ring includes a polymeric foam.

23. The wound covering of claim 17 in which the heater layer spans the one or more supports to maintain a treatment volume over the selected wound area.

24. The wound covering of claim 23 in which the layer includes sealing to the one or more supports as a barrier.

25. The wound covering of claim 17 in which the layer comprises a flexible sheet material.

26. The wound covering of claim 25 in which the flexible sheet material comprises a polymeric film.

27. The wound covering of claim 26 in which the polymeric film is selected from a group of polymers consisting of:

cellulose, cellulose acetate, polyethylene, polyvinyl-chloride, polyurethane, and polypropylene.

28. The wound covering of claim 25 in which the layer includes a gas permeable material.

29. The wound covering of claim 17 in which the one or more supports includes a pocket on the layer for releasable attachment of the heater layer.

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

a heater for providing heat to the selected treatment area;

a flexible attachment member for attaching the heater in a non-contact position proximate the selected treatment 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 maintaining the average temperature of the heater in a temperature range from above ambient room temperature to about 38°

C.

31. The wound covering of claim 30 in which the heater is for uniformly heating the selected treatment area.

32. The wound covering of claim 30 in which the heater is for non-uniformly heating the selected treatment area.

33. The wound covering of claim 30 in which the controller includes selectable pre-set average temperature settings.

34. The wound covering of claim 30 in which the controller is programmable to provide heat at the average temperature over a therapy cycle.

35. The wound covering of claim 30 in which the controller is programmable to provide heat at the average temperature over a therapeutic sequence.

36. The wound covering of claim 30 in which the controller is pre-programmed to provide heat at the average temperature over a therapy cycle.

37. The wound covering of claim 30 in which the controller is pre-programmed to provide heat at the average temperature over a therapeutic sequence.

38. 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 the wound;

providing a heater;

providing a controller 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 the heater over at least a portion of the selected wound treatment area; and

controlling the heater so as to maintain a temperature in a range from above ambient temperature to about 38°

C.

39. The method of claim 38 further comprising the step of programming the controller to control the temperature of the heater over a duty cycle.

40. The method of claim 38 further comprising the step of programming the controller to control the temperature of the heater over a therapy cycle.

41. The method of claim 38 further comprising the step of programming the heater to control the temperature over a therapeutic sequence.

42. The method of claim 38 in which controlling the heater includes controlling the heater temperature at an average heater temperature.

43. The method of claim 42 further comprising the step of programming the controller to control the average temperature of the heater over a therapy cycle.

44. The method of claim 42 further comprising the step of programming the controller to control the average temperature of the heater over a therapeutic sequence.

45. The method of claim 38 further comprising the step of inputting a temperature to the controller in a temperature range above ambient temperature to about 38°

C.

46. The method of claim 38 further comprising the step of inputting an average temperature to the controller in an temperature range from above ambient temperature to about 38°

C.

47. 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 sealing member to a person in order to place the volume over a wound such that the sealing member and the heater are out of contact with the wound; and

a controller connected to the heater for causing the heater to maintain a temperature in a temperature range from above ambient temperature to about 38°

C.

48. The wound covering of claim 47, wherein the flexible sealing member includes a sealing ring.

49. The wound covering of claim 48, wherein the sealing ring is formed from polymeric foam.

50. The wound covering of claim 47, wherein the heater is supported against the upper surface by a barrier layer over the volume.

51. The wound covering of claim 50, further including a pocket in the barrier layer in which the heater is received.

52. The wound covering of claim 47, the controller including programmable means for causing the heater to operate according to a therapy cycle in which the temperature is an average temperature.