Surgical incise drape

• US 5,979,450 A
• Filed: 04/09/1998
• Issued: 11/09/1999
• Est. Priority Date: 05/16/1997
• Status: Expired due to Term

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Scholz, Matthew T., Eull, Patricia A., Bruno, John E., Schlei, Dietmar, Baker, Dennis L.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/057,835
• Time in Patent Office: 579 Days
• Field of Search: 128/849-856
• US Class Current: 128/849
• CPC Class Codes: A61B 2046/205 Adhesive drapes
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61F 2013/00817 handles or handling tabs
• CPC Class Codes: A61F 2013/15073 as drapes

Abstract

A surgical incise drape including a flexible film having a leading edge and a trailing edge, and a film handle applied at the leading edge of the flexible film. A liner substantially covers the major portion of the flexible film, which is coated with an adhesive. The liner may include a liner handle at the leading edge, and one of the liner handle and film handle are of a size for wrapping about at least a portion of the drape when the drape is in a folded configuration. A tensioning strip may be applied to the liner at a position away from the leading edge of the liner to hold at least a portion of the flexible film lying between the film handle and the tensioning strip in a wrinkle-free state when the liner is being removed from the major portion of the flexible film. Further, the liner may be stiff relative to the flexible film such that the liner and the film handle hold the flexible film in a wrinkle-free state when the liner is being removed from the major portion of the flexible film. Methods for using these surgical incise drapes, tear lines, and connecting or reinforcement strips are also described.

Claims

1. A surgical incise drape comprising:

a flexible film having a major portion coated with an adhesive, the flexible film having a leading edge and a trailing edge;

a film handle at the leading edge of the flexible film, the film handle being stiffer than the flexible film; and

a liner having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film, the liner including a liner handle at the leading edge thereof, the liner substantially covering the major portion of the flexible film coated with the adhesive;

one of the liner handle and film handle being of a size for wrapping about at least a portion of the drape when the drape is in a folded configuration.

2. The drape according to claim 1, wherein the one of the liner handle and film handle is of a size for wrapping about the entire periphery of the drape when the drape is in the folded configuration.

3. The drape according to claim 1, further comprising a closure element.

4. The drape according to claim 3, wherein the closure element is attached to the one of the liner handle and the film handle and extending for attachment to another portion of the drape when the drape is in the folded configuration.

5. The drape according to claim 1, wherein the drape in the folded configuration is flattened such that the liner includes creases at respective opposing regions thereof.

6. The drape according to claim 5, wherein the liner is a polyolefin liner.

7. The drape according to claim 6, wherein the liner is a polyethylene liner.

8. The drape according to claim 1, wherein the liner is relatively stiff compared to the flexible film such that the liner and the film handle hold the flexible film in a wrinkle-free state when the liner is being removed from the major portion of the flexible film.

9. The drape according to claim 8 wherein the liner is capable of forming creases to hold the drape in a folded configuration.

10. The drape according to claim 8, wherein the liner is a polyolefin liner having a thickness of at least about 50 microns.

11. The drape according to claim 10, wherein the liner is a polyolefin liner having a thickness of at least about 75 microns.

12. The drape according to claim 10, wherein the liner is a polyethylene liner.

13. The drape according to claim 8, wherein the liner includes one or more tensioning strips applied to the liner at a position away from the leading edge of the liner so as to hold at least a portion of the flexible film lying between the film handle and the one or more tensioning strips in a wrinkle-free state when the liner is being removed from the major portion of the flexible film.

14. The drape according to claim 1, wherein the liner includes one or more tensioning strips applied to the liner at a position away from the leading edge of the liner so as to hold at least a portion of the flexible film lying between the film handle and the one or more tensioning strips in a wrinkle-free state when the liner is being removed from the major portion of the flexible film.

15. The drape according to claim 14, wherein the liner includes a tensioning strip applied at the trailing edge of the liner.

16. The drape according to claim 14, wherein the liner includes a tensioning strip applied at a position between the leading edge and trailing edge of the liner.

17. The drape according to claim 1, wherein the liner handle is stiffer than the flexible film.

18. The drape according to claim 1, wherein the adhesive coating the major portion of the flexible film includes a first adhesive region proximate the leading edge of the flexible film and a second adhesive region at or near the trailing edge of the flexible film, a greater force being required to remove the liner from the second adhesive region relative to removing the liner from the first adhesive region.

19. The drape according to claim 18, wherein the flexible film or liner includes a removal marking to indicate a stop point when a user is removing the liner from the flexible film.

20. The drape according to claim 1, wherein at least one of the film handle and the liner handle includes printed information thereon.

21. The drape according to claim 1, wherein the film handle is removably applied to the leading edge of the flexible film.

22. The drape according to claim 21, wherein the film handle is removably applied to the leading edge of the flexible film using at least one of a releasable adhesive coated on the film handle, a low adhesive backsize coated on a portion of the flexible film, perforation of the film handle, perforation of the flexible film, or a perforation in a reinforcement tape connecting the film handle to the flexible film.

23. The drape according to claim 21 wherein the flexible film is formed of elastomeric material and further includes:

opposite side edges extending between the leading and trailing edges of the flexible film; and

a tear line in the elastomeric film extending generally adjacent, and generally parallel with, the leading edge for facilitating propagating tearing of the film along the tear line to separate the handle from the elastomeric film, the tear line having opposite ends spaced from the opposite side edges of the film.

24. The drape according to claim 23 wherein the tear line comprises a line of perforations.

25. The drape according to claim 23 wherein the opposite ends of the tear line are spaced from the opposite side edges of the flexible film by at least 0.5 cm.

26. The drape according to claim 25 wherein the opposite ends of the tear line are spaced from the opposite side edges of the flexible film by at least 1 cm.

27. The drape according to claim 26 wherein the opposite ends of the tear line are spaced from the opposite side edges of the flexible film by at least 2 cm.

28. The drape according to claim 27 wherein the opposite ends of the tear line are spaced from the opposite side edges of the flexible film by no less than 2.5 cm.

29. The surgical incise drape according to claim 25 wherein the flexible film has a thickness no greater than 75 microns.

30. The surgical incise drape according to claim 29 wherein the flexible film has a thickness no greater than 52 microns.

31. The drape according to claim 1, wherein the liner handle is removable to expose at least one adhesive portion that allows the liner after complete removal from the flexible film to be attached to other locations.

32. The drape according to claim 1, wherein a substantial portion of the liner includes a substantially transparent film.

33. The drape according to claim 1, wherein the liner handle and the film handle include at least one differentiating characteristic such that the liner handle can be easily differentiated from the film handle.

34. The drape according to claim 1, wherein the flexible film includes at least two additional edges extending between the leading and trailing edges of the flexible film, and further wherein at least one region along one of the additional edges of the flexible film lacks adhesive such that after application to a patient the flexible film can be easily removed by pulling on the at least one adhesive lacking region.

35. The drape according to claim 1, wherein the one of the liner handle and the film handle includes an adhesive region for attaching the handle to a portion of the drape when in the folded configuration.

36. A method of applying the surgical incise drape of claim 1 to a patient, the method comprising the steps of:

grasping the film handle;

pulling upon the liner handle to remove at least a portion of the liner and exposing at least a portion of the adhesive coating the major portion of the flexible film;

holding the surgical incise drape such that at least a portion of the adhesive is contacting the patient; and

removing a remainder of the liner from the trailing edge of the flexible film after the flexible film is smoothed down upon the patient.

37. The drape according to claim 36, wherein the adhesive coating the major portion of the flexible film includes a first adhesive region proximate the leading edge of the flexible film and a second adhesive region at or near the trailing edge of the flexible film, a greater force being required to remove the liner from the second adhesive region relative to removing the liner from the first adhesive region.

38. The drape according to claim 37, wherein the flexible film includes a removal marking to indicate a stop point when a user is removing the liner from the flexible film.

46. A method of applying the surgical incise drape of claim 37 to a patient, the method comprising the steps of:

grasping the film handle;

pulling upon the liner to remove at least a portion of the liner and exposing at least a portion of the adhesive coating the major portion of the flexible film;

holding the surgical incise drape such that the flexible film attains a substantially U-shaped configuration with the adhesive at a lower portion of the substantially U-shaped configuration contacting the patient; and

removing a remainder of the liner including the tensioning strip from the trailing edge of the flexible film after regions of adhesive on opposing sides of the lower portion of the substantially U-shaped configuration are smoothed down upon the patient.

39. A surgical incise drape comprising:

a flexible film having a major portion coated with an adhesive, the flexible film having a leading edge and a trailing edge;

a film handle at the leading edge of the flexible film; and

a liner having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film, the liner substantially covering the major portion of the flexible film coated with the adhesive, the liner including one or more tensioning strips applied to the liner at a position away from the leading edge of the liner so as to hold at least a portion of the flexible film lying between the film handle and the tensioning strip in a wrinkle-free state when the liner is being removed from the major portion of the flexible film, the tensioning strip being stiffer than the flexible film.

40. The drape according to claim 39, wherein the film handle is stiffer than the flexible film.

41. The drape according to claim 39, wherein the one or more tensioning strips include a tensioning strip applied at a position between the leading edge and trailing edge of the liner.

42. The drape according to claim 39, wherein the one or more tensioning strips include an additional tensioning strip applied at the trailing edge of the liner.

43. The drape according to claim 39, wherein the liner includes a liner handle at the leading edge of the liner, the liner handle being stiffer than the flexible film.

44. The drape according to claim 39, wherein the film handle is removably applied at the leading edge of the flexible film.

45. The drape according to claim 39, wherein the film handle is removably connected to the leading edge of the flexible film using at least one of:

a releasable adhesive coated on the film handle and a low adhesive backsize coated on at least a portion of the flexible film;

perforation of the film handle or the flexible film;

a perforated reinforcement tape.

47. A method for use with a surgical incise drape, the method comprising the steps of:

providing a substantially flat surgical incise drape, the drape including a flexible film having a major portion covered with an adhesive, the flexible film having a leading edge and a trailing edge with a film handle applied at the leading edge of the flexible film, and the drape including a liner having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film, the liner substantially covering the major portion of the flexible film covered with the adhesive;

folding the drape from the trailing edge to the leading edge; and

wrapping one of the film handle and the liner handle about at least a portion of the folded drape.

48. The method according to claim 47, further comprising the step of flattening the folded drape to create creases at respective opposing regions of the folded drape.

49. The method according to claim 47, wherein the wrapping step includes the step of wrapping one of the film handle and the liner handle around the entire periphery of the folded drape, the method further comprising the step of applying a closure element associated with the one of the film handle and liner handle to another portion of the drape to prevent the folded drape from unfolding.

50. The method according to claim 47 wherein the drape further includes opposite side edges extending between the leading and trailing edges of the flexible film, the method further comprising the step of selectively melting portions of the edges of the folded drape to releasably hold the drape in its folded configuration.

51. The method according to claim 47 further comprising the step of applying a releasable adhesive to the drape to releasably attach one portion of the drape to another to releasably hold the drape in its folded configuration.

52. A surgical incise drape comprising:

a flexible film having a major portion coated with an adhesive, the flexible film having a leading edge and a trailing edge;

a film handle at the leading edge of the flexible film, the film handle being stiffer than the flexible film; and

a liner having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film, the liner substantially covering the major portion of the flexible film coated with the adhesive, and the liner being a laminate film comprising two or more polymer layers.

53. The drape according to claim 52, wherein the laminate film includes at least one low melting point polymer layer and at least one high melting point polymer layer.

54. The drape according to claim 53, wherein the at least one low melting point polymer layer has a melt temperature less than about 175°

C.

55. The drape according to claim 54, wherein the at least one low melting point polymer layer is a polyolefin layer.

56. The drape according to claim 53, wherein the at least one high melting point polymer layer has a melt temperature greater than about 175°

C.

57. The drape according to claim 56, wherein the at least one high melting point polymer layer is a polyester or cellulose acetate layer.

59. The drape according to claim 52, wherein the liner is relatively stiff compared to the flexible film such that the liner and the film handle hold the flexible film in a wrinkle-free state when the liner is being removed from the major portion of the flexible film.

60. The drape according to claim 52, wherein the liner includes one or more tensioning strips applied to the liner at a position away from the leading edge of the liner so as to hold at least a portion of the flexible film lying between the film handle and the one or more tensioning strips in a wrinkle-free state when the liner is being removed from the major portion of the flexible film.

61. The drape according to claim 60, wherein the liner includes a tensioning strip applied at the trailing edge of the liner.

62. The drape according to claim 60, wherein the liner includes a tensioning strip applied at a position between the leading edge and trailing edge of the liner.

63. The drape according to claim 52, wherein the liner includes a liner handle, the liner handle being stiffer than the liner.

64. The drape according to claim 52, wherein the film handle is removably applied to the leading edge of the flexible film.

58. The drape according to clam 56, wherein the at least one high melting point polymer layer is a polyamide layer.

65. A surgical incise drape comprising:

an elastomeric film having a major portion coated with an adhesive, the flexible film having a leading edge, a trailing edge and opposite side edges; and

a handle at the leading edge of the flexible film, the handle being formed of sheet material that is stiffer than the elastomeric film;

a tear line in the elastomeric film extending generally adjacent, and generally parallel with, the leading edge for facilitating propagating tearing of the film along the tear line to separate the handle from the elastomeric film, the tear line having opposite ends spaced from the opposite side edges of the film.

66. The surgical incise drape according to claim 65 wherein the tear line comprises a line of perforations.

67. The surgical incise drape according to claim 66 wherein the opposite ends of the tear line are spaced from the opposite side edges of the elastomeric film by at least 0.5 cm.

68. The surgical incise drape according to claim 67 wherein the opposite ends of the tear line are spaced from the opposite side edges of the elastomeric film by at least 1 cm.

69. The surgical incise drape according to claim 68 wherein the opposite ends of the tear line are spaced from the opposite side edges of the elastomeric film by at least 2 cm.

70. The surgical incise drape according to claim 69 wherein the opposite ends of the tear line are spaced from the opposite side edges of the elastomeric film by no less than 2.5 cm.

71. The surgical incise drape according to claim 66 wherein the elastomeric film has a thickness no greater than 75 microns.

72. The surgical incise drape according to claim 71 wherein the elastomeric film has a thickness no greater than 52 microns.

73. The surgical incise drape according to claim 65 wherein the tear line comprises the elastomeric film being scored or otherwise made thinner along the tear line than along the elastomeric film generally to facilitate propagating tearing along the tear line.

74. A surgical incise drape comprising:

an elastomeric film having a major portion coated with an adhesive, the flexible film having a leading edge, a trailing edge and opposite side edges; and

a handle adjacent the leading edge of the flexible film;

an elongate strip connecting the film and handle along the leading edge of the film, the strip being stiffer than the elastomeric film and handle, the strip having a tear line for facilitating propagating tearing of the strip along the tear line to separate the handle from the elastomeric film.

75. The surgical incise drape according to claim 74 wherein the tear line comprises a line of perforations.

76. The surgical incise drape according to claim 75 wherein the handle is formed of sheet material that is stiffer than the elastomeric film.

77. The surgical incise drape according to claim 76 wherein the elongate strip comprises reinforcement tape that is more resistant to tearing than the film or handle other than along the tear line.

78. The surgical incise drape according to claim 77 wherein the reinforcement tape is a film tape having one surface coated with an adhesive.

79. The surgical incise drape according to claim 78 wherein the adhesive comprises a pressure sensitive adhesive.

80. The surgical incise drape according to claim 79 wherein the film tape comprises a low-density polyethylene film tape, and the adhesive comprises an acrylate adhesive.