Occlusive wound dressing and applicator with same flexibility

• US 5,713,842 A
• Filed: 02/14/1994
• Issued: 02/03/1998
• Est. Priority Date: 11/06/1991
• Status: Expired due to Fees

• Current Assignee: BioDerm Inc.
• Original Assignee: BioDerm Inc.
• Inventors: Kay, Dennis
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/195,063
• Time in Patent Office: 1,450 Days
• Field of Search: 602/41, 602/42, 602/52, 602/55, 602/57, 602/58, 604/307, 206/440, 206/441, 424/445
• US Class Current: 602/57
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 2013/00578 conformable; soft or flexible, e.g. elastomeric
• CPC Class Codes: A61F 2013/0071 containing active agent
• CPC Class Codes: A61F 2013/0077 arranged in lines
• CPC Class Codes: A61F 2013/00774 arranged in discrete dots
• CPC Class Codes: A61F 2013/00817 handles or handling tabs
• 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 2013/00906 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 2013/00914 with deodorising or perfuming means
• CPC Class Codes: A61F 2013/00919 for physical therapy, e.g. cold or magnetic
• CPC Class Codes: A61F 2013/00927 with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors

Abstract

A thin film wound dressing that is particularly easy to position accurately and apply smoothly to form an occlusive seal comprises three layers: a first wound covering layer being permeable to gases and water vapor while being impermeable to microbes and liquids; a second adhesive layer intimately disposed on the first layer for use in occlusively attaching the invention to skin or wound surfaces; and a third release backing layer disposed on the second adhesive layer. The release backing layer has a functionally contiguous or integral pull-tab attached in a manner that creates a substantially U-shaped release backing/pull-tab assembly. The release backing and pull-tab portions of the assembly are highly flexible while also being highly resistant to elongation to facilitate the smooth and wrinkle-free application of the first and second layers to skin or wound surfaces and formation of an occlusive, microbe and liquid impermeable barrier. The various layers of the invention are preferably transparent to light and may be impregnated or coated with antiseptics, antimicrobials or other medically active substances. The wound dressing is provided in non-polygonal shapes that eliminate redundant surface area and increase the effective adhesion to anatomic surfaces.

Claims

1. A wound dressing comprising:

a highly flexible thin film layer having a transverse axis;

an adhesive layer provided on said flexible thin film layer; and

a highly flexible release backing film layer releasably attached directly to said adhesive layer, said release backing layer being divided into at least two backing pieces, said backing pieces having substantially the same flexibility as said flexible thin film layer and attached directly to said adhesive layer, a first of said backing pieces releasably attached to said adhesive layer on one side of said transverse axis of said flexible thin film layer and a second of said backing pieces releasably attached to said adhesive layer on another side of said transverse axis of said flexible thin film layer, each of said backing pieces having a pull-tab attached thereto, each said pull-tab flexible film material having substantially the same flexibility as said flexible thin film layer, each said pull-tab extending away from said transverse axis of said flexible thin film layer.

7. A wound dressing as defined in claim 1, wherein said adhesive layer is disposed only on a periphery of said flexible thin film layer.

8. A wound dressing as defined in claim 1, wherein said flexible thin film layer comprises one or more materials selected from the group consisting of polyurethane, polyethylene, and silicone.

9. A wound dressing as defined in claim 1, wherein said flexible thin film layer comprises polyurethane.

10. A wound dressing as defined in claim 1, wherein said flexible thin film layer is from 0.5 to 2.0 mils thick.

11. A wound dressing as defined in claim 1, wherein said flexible thin film layer is from 0.4 to 0.6 mils thick.

12. A wound dressing as defined in claim 1, wherein said flexible thin film layer is from 0.6 to 1.1 mils thick.

13. A wound dressing as defined in claim 1, wherein said adhesive layer comprises a medical grade acrylic adhesive compound.

14. A wound dressing as defined in claim 1, wherein said flexible thin film layer and said adhesive layer are transparent to light.

15. A wound dressing as defined in claim 14 wherein said backing pieces and each said pull-tab are transparent to light.

16. A wound dressing as defined in claim 1 wherein said adhesive layer is impregnated with an antiseptic.

17. A wound dressing as defined in claim 16, wherein said antiseptic comprises povidone iodine.

18. A wound dressing as defined in claim 1 wherein said adhesive layer is impregnated with an antimicrobial substance.

19. A wound dressing as defined in claim 18 wherein said antimicrobial substance comprises polymyxin B sulfate-bacitracin zinc-neomycin sulfate antibiotic.

20. A wound dressing as defined in claim 1 wherein said adhesive layer is provided discontinuously in a pattern.

21. A wound dressing as defined in claim 1 wherein said adhesive layer is provided continuously.

22. A wound dressing as defined in claim 20, wherein (i) said pattern defines a regular grid of adhesive material and (ii) a medically active substance is provided on said flexible thin film layer in the interstices of said grid.

23. A wound dressing as defined in claim 22, wherein said medically active substance comprises one or more substances selected from the group consisting of antimicrobials and antiseptics.

24. A wound dressing as defined in claim 22 wherein said medically active substance comprises one or more substances selected from the group consisting of povidone iodine and polymyxin B sulfate-bacitracin zinc-neomycin sulfate antibiotic.

25. A wound dressing as defined in claim 22 wherein said medically active substance improves healing.

26. A wound dressing as defined in claim 22 wherein said medically active substance is epidermal growth factor.

27. A wound dressing as defined in claim 1 wherein a perimeter of said wound dressing is shaped to fit anatomical surfaces.

28. A wound dressing as defined in claim 27, wherein said perimeter of said wound dressing has an absence of corners.

29. A wound dressing as defined in claim 27 wherein said wound dressing is substantially elliptical in shape.

30. A wound dressing as defined in claim 27 wherein said wound dressing is substantially circular in shape.

31. A wound dressing as defined in claim 1, wherein each of said backing pieces is continuous with its said pull-tab.

34. A wound dressing as defined in claim 1, wherein each said pull-tab extends beyond a periphery of said flexible thin film layer.

35. A wound dressing as defined in claim 1, wherein said transverse axis lies across a center of said flexible thin film layer.

36. A wound dressing as defined in claim 1, wherein:

said flexible thin film layer comprises a material impermeable to liquids and microbes but permeable to gasses and water vapor;

said adhesive layer comprises a material permeable to gasses and water vapor; and

said backing pieces and each said pull-tab are resistant to elongation so that, when force is applied to said pull-tab to detach an associated one of said backing pieces from said adhesive layer, said associated one of said backing pieces detaches along a line of separation substantially transverse to said flexible thin film layer to apply said flexible thin film layer to one of a skin and a wound surface to form a wrinkle-free, microbe-impermeable, physical barrier.

38. A wound dressing as defined in claim 1, wherein said flexible thin film layer comprises polyurethane and said flexible release backing layer comprises at least one film material that (A) has substantially the same flexibility as said polyurethane of said flexible thin film layer and (B) is selected from the group consisting of polyurethane, low density polyethylene, polypropylene, polybutylene, and silicone.

39. A wound dressing as defined in claim 1, wherein said flexible thin film layer and said flexible release backing layer both comprise a polyurethane film material.

40. A wound dressing as defined in claim 1, wherein said adhesive layer has uniform adhesive strength between said flexible thin film layer and said flexible release backing layer.

41. A wound dressing as defined in claim 1, wherein each of said backing pieces and its said pull-tab are substantially parallel.

2. A wound dressing comprising:

a highly flexible thin film layer having a bonding surface and an external surface;

an adhesive layer provided on said bonding surface of said flexible thin film layer;

a highly flexible release backing film layer releasably attached directly to said adhesive layer, said release backing layer having a single backing piece and a pull-tab, said single backing piece and said pull-tab having substantially the same flexibility as said flexible thin film layer, said single backing piece being releasably attached to said adhesive layer, said pull-tab being attached to one end of said backing piece; and

an affixation tab disposed on said external surface of said flexible thin film layer.

32. A wound dressing as defined in claim 2 wherein said affixation tab is removable.

33. A wound dressing as defined in claim 2, wherein said single backing piece and said pull-tab are contiguous.

37. A wound dressing as defined in claim 2, wherein:

said flexible thin film layer comprises a material impermeable to liquids and microbes but permeable to gasses and water vapor;

said adhesive layer comprises a material permeable to gasses and water vapor; and

said backing piece and said pull-tab are resistant to elongation so that application of force to said pull-tab detaches said backing piece from said adhesive layer along a line of separation substantially transverse to said flexible thin film layer to apply said flexible thin film layer to one of a skin and a wound surface to form a wrinkle-free, microbe-impermeable, physical barrier.

42. A wound dressing as defined in claim 2, wherein said flexible thin film layer comprises polyurethane and said flexible release backing layer comprises one or more film materials having substantially the same flexibility as said polyurethane of said flexible thin film layer, said one or more film materials selected from the group consisting of polyurethane, low density polyethylene, polypropylene, polybutylene, and silicone.

43. A wound dressing as defined in claim 2, wherein said flexible thin film layer and said flexible release backing layer comprise a polyurethane film material.

44. A wound dressing as defined in claim 2, wherein said adhesive layer has uniform adhesive strength between said flexible thin film layer and said flexible release backing layer.

45. A wound dressing as defined in claim 2, wherein said single backing piece and said pull-tab are substantially parallel.

46. A wound dressing as defined in claim 2, wherein said single backing piece has a surface area greater than a surface area of said flexible thin film layer.

47. A wound dressing as defined in claim 2, wherein said pull-tab has a length greater than a length of said flexible thin film layer.

3. A wound dressing comprising:

a flexible thin film layer;

an adhesive layer provided on said flexible thin film layer; and

a highly flexible release backing film layer releasably attached directly to said adhesive layer, and having substantially the same flexibility as said flexible thin film layer, said flexible release backing layer having at least one backing piece releasably attached to said adhesive layer and a pull-tab attached to said at least one backing piece.

48. A wound dressing as defined in claim 3, wherein said flexible thin film layer comprises polyurethane and said flexible release backing layer comprises one or more film materials having substantially the same flexibility as said polyurethane of said flexible thin film layer, said one or more film materials selected from the group consisting of polyurethane, low density polyethylene, polypropylene, polybutylene, and silicone.

49. A wound dressing as defined in claim 3, wherein said flexible thin film layer and said flexible release backing layer both comprise a polyurethane film material.

4. A wound dressing comprising:

a highly flexible thin film layer;

an adhesive layer provided on said flexible thin film layer; and

a highly flexible release backing film layer releasably attached directly to said adhesive layer, and having substantially the same flexibility as said flexible thin film layer.

50. A wound dressing as defined in claim 4, wherein said flexible thin film layer and said flexible release backing layer both comprise a polyurethane film material.

51. A wound dressing as defined in claim 4, wherein said release backing layer is divided into at least two backing pieces, a first of said backing pieces releasably attached to said adhesive layer on one side of a transverse axis of said flexible thin film layer and a second of said backing pieces releasably attached to said adhesive layer on another side of said transverse axis of said flexible thin film layer, each of said backing pieces having a pull-tab attached thereto, each said pull-tab extending away from said transverse axis of said flexible thin film layer.

5. A wound dressing consisting essentially of:

a highly flexible thin film layer;

an adhesive layer provided on said flexible thin film layer; and

a highly flexible release backing film layer releasably attached directly to said adhesive layer and having substantially the same flexibility as said flexible thin film layer.

52. A wound dressing as defined in claim 5, wherein said flexible thin film layer and said flexible release backing layer both comprise a polyurethane film material.

6. A wound dressing comprising:

a highly flexible thin film layer made of polyurethane;

an adhesive layer provided on said flexible thin film layer; and

a highly flexible release backing layer releasably attached directly to said adhesive layer, said flexible release backing layer made of polyurethane and having substantially the same flexibility as said flexible thin film layer.