Sterilization wraps and methods for sterilizing articles

• US 20050163654A1
• Filed: 10/13/2004
• Published: 07/28/2005
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Allegiance Corporation (Cardinal Health, Inc.)
• Original Assignee: Allegiance Corporation (Cardinal Health, Inc.)
• Inventors: Whitaker, James F., Schotz, Debra, Puentes, Alejandro, Stecklein, Greg, Duski, Michael, Blankenship, Barbara Anne
• Granted Patent: US 7,560,082 B2
• Time in Patent Office: Days
• US Class Current: 422/28
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61B 50/31 Carrying cases or bags, e.g. doctors' bags
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: B32B 2250/03 3 layers
• CPC Class Codes: B32B 2250/242 All polymers belonging to those covered by group B32B27/32
• CPC Class Codes: B32B 2439/02 Open containers
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 7/05 the layers not being connected over the whole surface, e.g. discontinuous connection or patterned connection using interposed adhesives or bonding materials applied in spaced arrangements B32B7/14
• CPC Class Codes: B65D 75/08 with the ends of the tube closed by folding
• CPC Class Codes: Y10T 428/19 Sheets or webs edge spliced or joined
• CPC Class Codes: Y10T 428/24942 including components having same physical characteristic in differing degree
• CPC Class Codes: Y10T 428/31913 Monoolefin polymer

Abstract

There is provided an improved sterilization wrap and a method for using the improved sterilization wrap to sterilize an article. The wrap is made of at least a first panel of sterilization material and includes an additional panel of material. The first panel is multi-layered and includes at least one pathogen filtration layer. The first panel is rectangular and has an outer periphery and a central portion. The outer periphery includes first, second, third and fourth edges. The additional panel of material is bonded to the first panel, approximately at a forty-five degree angle to the first panel, with a substantial portion of the additional panel being adjacent to the central portion of the first panel. The perimeter of the additional panel is smaller than the perimeter of the first panel. Portions of the additional panel are bonded to the first panel along the first, second, third and fourth edges of the first panel. The article to be sterilized is placed on the additional panel, is wrapped, and sterilant is applied to the wrapped article. A chemical visual indicator is provided to indicate whether or not the article has been exposed to adequate sterilization conditions.

Claims

1. A sterilization wrap for wrapping an article to be sterilized comprising:

a first panel of sterilization material;

said first panel being rectangular and having an outer periphery and a central portion;

said outer periphery including first, second, third and fourth edges; and

an additional panel of material;

said additional panel being bonded to said first panel;

a substantial portion of said additional panel being adjacent to the central portion of said first panel;

the perimeter of said additional panel being smaller than the perimeter of said first panel;

a portion of said additional panel is bonded to said first panel along said first edge.

2. A sterilization wrap as set forth in claim 1 wherein said additional panel is rectangular;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

3. A sterilization wrap as set forth in claim 1, further including a second panel of sterilization material;

said second panel adjacent to and in register with said first panel.

4. A sterilization wrap as set forth in claim 3 wherein said second panel is bonded to said first panel.

5. A sterilization wrap as set forth in claim 4 wherein said second panel has an outer periphery, including first, second, third and fourth edges;

said first, second, third and fourth edges of said second panel bonded respectively to said first, second, third and fourth edges of said first panel.

6. A sterilization wrap as set forth in claim 3 wherein said first and second panels are formed by a single folded sheet of sterilization material.

7. A sterilization wrap as set forth in claim 1 wherein said additional panel is rectangular;

said additional panel being oriented approximately forty-five degrees with respect to said first panel.

8. A sterilization wrap as set forth in claim 1 wherein said additional panel is made of spun bond polypropylene.

9. A sterilization wrap as set forth in claim 1 wherein said first panel is made of SMS.

10. A sterilization wrap as set forth in claim 3 wherein said second panel is made of SMS.

11. A sterilization wrap as set forth in claim 1 wherein said additional panel has a lower basis weight than said first panel.

12. A sterilization wrap as set forth in claim 11 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

13. A sterilization wrap as set forth in claim 1 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

14. A sterilization wrap as set forth in claim 2 wherein at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

15. A sterilization wrap as set forth in claim 1, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

16. A sterilization wrap as set forth in claim 15 wherein said chemical visual indicator is a color change indicator.

17. A sterilization wrap as set forth in claim 15 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

18. A sterilization wrap as set forth in claim 15 wherein said chemical visual indicator is attached to said additional panel.

19. A sterilization wrap for wrapping an article to be sterilized comprising:

a first panel of sterilization material; and

an additional panel material;

said additional panel attached to said first panel;

said first panel being multi-layered and including at least one pathogen filtration layer;

said additional panel not including a pathogen filtration layer.

20. A sterilization wrap as set forth in claim 19 wherein said first panel has an outer periphery and a central portion;

said outer periphery including first, second, third and fourth edges;

a substantial portion of said additional panel being adjacent to the central portion of said first panel.

21. A sterilization wrap as set forth in claim 20 wherein said additional panel is rectangular;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

22. A sterilization wrap as set forth in claim 19, further including a second panel of sterilization material;

said second panel adjacent to and in register with said first panel.

23. A sterilization wrap as set forth in claim 22 wherein said second panel is bonded to said first panel.

24. A sterilization wrap as set forth in claim 23 wherein said first panel has an outer periphery and a central portion;

said outer periphery including first, second, third and fourth edges;

said second panel having an outer periphery, including first, second, third and fourth edges;

said first, second, third and fourth edges of said second panel bonded respectively to said first, second, third and fourth edges of said first panel.

25. A sterilization wrap as set forth in claim 22 wherein said first and second panels are formed by a single folded sheet of sterilization material.

26. A sterilization wrap as set forth in claim 19 wherein said first panel is rectangular;

said additional panel is rectangular;

said additional panel being oriented approximately forty-five degrees with respect to said first panel.

27. A sterilization wrap as set forth in claim 19 wherein said additional panel is made of spun bond polypropylene.

28. A sterilization wrap as set forth in claim 19 wherein said first panel is made of SMS.

29. A sterilization wrap as set forth in claim 22 wherein said second panel is made of SMS.

30. A sterilization wrap as set forth in claim 19 wherein said additional panel has a lower basis weight than said first panel.

31. A sterilization wrap as set forth in claim 30 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

32. A sterilization wrap as set forth in claim 19 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

33. A sterilization wrap as set forth in claim 21 wherein said first panel is rectangular;

at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

34. A sterilization wrap as set forth in claim 19, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

35. A sterilization wrap as set forth in claim 34 wherein said chemical visual indicator is a color change indicator.

36. A sterilization wrap as set forth in claim 34 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

37. A sterilization wrap as set forth in claim 34 wherein said chemical visual indicator is attached to said additional panel.

38. A sterilization wrap for wrapping an article to be sterilized comprising:

a first panel of sterilization material;

said first panel being rectangular;

an additional panel;

said additional panel being rectangular;

said additional panel being bonded to said first panel;

said additional panel being oriented on said first panel so as to form a diamond shape with respect to said first panel.

39. A sterilization wrap as set forth in claim 38 wherein said first panel includes first, second, third and fourth edges;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

40. A sterilization wrap as set forth in claim 38, further including a second panel of sterilization material;

said second panel adjacent to and in register with said first panel.

41. A sterilization wrap as set forth in claim 40 wherein said second panel of sterilization material is bonded to said first panel of sterilization material.

42. A sterilization wrap as set forth in claim 40 wherein said first and second panels are formed by a single folded sheet of sterilization material.

43. A sterilization wrap as set forth in °

claim 38 wherein said additional panel is oriented approximately forty-five degrees with respect to said first panel.

44. A sterilization wrap as set forth in claim 38 wherein said additional panel is made of spun bond polypropylene.

45. A sterilization wrap as set forth in claim 38 wherein said first panel is made of SMS.

46. A sterilization wrap as set forth in claim 40 wherein said second panel is made of SMS.

47. A sterilization wrap as set forth in claim 38 wherein said additional panel has a lower basis weight than said first panel.

48. A sterilization wrap as set forth in claim 47 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

49. A sterilization wrap as set forth in claim 38 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

50. A sterilization wrap as set forth in claim 39 wherein at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

51. A sterilization wrap as set forth in claim 38, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

52. A sterilization wrap as set forth in claim 51 wherein said chemical visual indicator is a color change indicator.

53. A sterilization wrap as set forth in claim 51 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

54. A sterilization wrap as set forth in claim 51 wherein said chemical visual indicator is attached to said additional panel.

55. A method for sterilizing an article comprising the steps of:

providing an article to be sterilized;

providing sterilization wrap which comprises;

a first panel of sterilization material;

said first panel being rectangular and having an outer periphery and a central portion;

said outer periphery including first, second, third and fourth edges; and

an additional panel of material;

said additional panel being bonded to said first panel;

a substantial portion of said additional panel being adjacent to the central portion of said first panel;

the perimeter of said additional panel being smaller than the perimeter of said first panel;

a portion of said additional panel is bonded to said first panel along said first edge;

placing said article to be sterilized on said additional panel;

wrapping said article to be sterilized with said sterilization wrap; and

applying sterilant to the wrapped article.

56. A method as set forth in claim 55 wherein said additional panel is rectangular;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

57. A method as set forth in claim 55, further including a second panel of sterilization material;

said second panel adjacent to and in register with said first panel.

58. A method as set forth in claim 57 wherein said second panel is bonded to said first panel.

59. A method as set forth in claim 58 wherein said second panel has an outer periphery, including first, second, third and fourth edges;

said first, second, third and fourth edges of said second panel bonded respectively to said first, second, third and fourth edges of said first panel.

60. A method as set forth in claim 57 wherein said first and second panels are formed from a single folded sheet of sterilization material.

61. A method as set forth in claim 55 wherein said additional panel is rectangular;

said additional panel being oriented approximately forty-five degrees with respect to said first panel.

62. A method as set forth in claim 61, further including the step of orienting said article to be sterilized approximately at a forty-five degree angle with respect to said first panel.

63. A method as set forth in claim 55 wherein said additional panel is made of spun bond polypropylene.

64. A method as set forth in claim 55 wherein said first panel is made of SMS.

65. A method as set forth in claim 55 wherein said additional panel has a lower basis weight than said first panel.

66. A method as set forth in claim 65 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

67. A method as set forth in claim 55 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

68. A method as set forth in claim 56 wherein at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

69. A method as set forth in claim 55, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

70. A method as set forth in claim 69 wherein said chemical visual indicator is a color change indicator.

71. A method as set forth in claim 69 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

72. A method as set forth in claim 69 wherein said chemical visual indicator is attached to said additional panel.

73. A method for sterilizing an article comprising the steps of:

providing an article to be sterilized;

providing sterilization wrap which comprises;

a first panel of sterilization material; and

an additional panel material;

said additional panel attached to said first panel;

said first panel being multi-layered and including at least one pathogen filtration layer;

said additional panel not including a pathogen filtration layer;

placing said article to be sterilized on said additional panel;

wrapping said article to be sterilized with said sterilization wrap; and

applying sterilant to the wrapped article.

74. A method as set forth in claim 73 wherein said first panel has an outer periphery and a central portion;

said outer periphery including first, second, third and fourth edges;

a substantial portion of said additional panel being adjacent to the central portion of said first panel.

75. A method as set forth in claim 74 wherein said additional panel is rectangular;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

76. A method as set forth in claim 74, further including a second panel of sterilization material;

said second panel adjacent to an in register with said first panel.

77. A method as set forth in claim 76 wherein said second panel is bonded to said first panel.

78. A method as set forth in claim 77 wherein said second panel has an outer periphery, including first, second, third and fourth edges;

said first, second, third and fourth edges of said second panel bonded respectively to said first, second, third and fourth edges of said first panel.

79. A method as set forth in claim 76 wherein said first and second panels are formed from a single folded sheet of steirlization material.

80. A method as set forth in claim 74 wherein said first panel is rectangular;

said additional panel is rectangular;

said additional panel being oriented approximately forty-five degrees with respect to said first panel.

81. A method as set forth in claim 80, further including the step of orienting said article to be sterilized approximately at a forty-five degree angle with respect to said first panel.

82. A method as set forth in claim 74 wherein said additional panel is made of spun bond polypropylene.

83. A method as set forth in claim 74 wherein said first panel is made of SMS.

84. A method as set forth in claim 76 wherein said second panel is made of SMS.

85. A method as set forth in claim 74 wherein said additional panel has a lower basis weight than said first panel.

86. A method as set forth in claim 85 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

87. A method as set forth in claim 74 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

88. A method as set forth in claim 75 wherein said first panel is rectangular;

at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

89. A method as set forth in claim 74, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

90. A method as set forth in claim 89 wherein said chemical visual indicator is a color change indicator.

91. A method as set forth in claim 89 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

92. A method as set forth in claim 89 wherein said chemical visual indicator is attached to said additional panel.

93. A method for sterilizing an article comprising the steps of:

providing an article to be sterilized;

providing sterilization wrap which comprises;

a first panel of sterilization material;

said first panel being rectangular; and

an additional panel;

said addition panel being rectangular;

said additional panel being bonded to said first panel;

said additional panel being oriented on said first panel so as to form a diamond shape with respect to said first panel;

placing said article to be sterilized on said additional panel;

wrapping said article to be sterilized with said sterilization wrap; and

applying sterilant to the wrapped article.

94. A method as set forth in claim 93 wherein said first panel includes first, second, third and fourth edges;

said additional panel having first, second, third and fourth corners;

said first corner of said additional panel bonded to said first edge of said first panel;

said second corner of said additional panel bonded to said second edge of said first panel;

said third corner of said additional panel bonded to said third edge of said first panel.

95. A method as set forth in claim 93, further including a second panel of sterilization material adjacent to and in register with said first panel.

96. A method as set forth in claim 94 wherein said second panel of sterilization material is bonded to said first panel of sterilization material.

97. A method as set forth in claim 94 wherein said first and second panels are formed from a single sheet of sterilization material.

98. A method as set forth in claim 93 wherein said additional panel is oriented forty-five degrees with respect to said first panel.

99. A method as set forth in claim 98, further including the step of orienting said article to be sterilized approximately at a forty-five degree angle with respect to said first panel.

100. A method as set forth in claim 93 wherein said additional panel is made of spun bond polypropylene.

101. A method as set forth in claim 93 wherein said first panel is made of SMS.

102. A method as set forth in claim 93 wherein said additional panel has a lower basis weight than said first panel.

103. A method as set forth in claim 102 wherein the basis weight of said additional panel is in the range of 0.5 osy to 3.0 osy and the basis weight of said first panel is in the range of 0.75 osy to 2.9 osy.

104. A method as set forth in claim 93 wherein the grab tensile to basis weight ratio of said additional panel is equal to or greater than the grab tensile to basis weight ratio of said first panel.

105. A method as set forth in claim 94 wherein at least three corners of said additional panel are bonded to respective edges of said first panel approximately at the mid-point of said edges.

106. A method as set forth in claim 93, further including a chemical visual indicator;

said chemical visual indicator being in one state prior to exposure to sterilant and being in another state after exposure to sterilant;

said chemical visual indicator being attached to said wrap so as to indicate whether or not the article has been exposed to adequate sterilization conditions.

107. A method as set forth in claim 106 wherein said chemical visual indicator is a color change indicator.

108. A method as set forth in claim 106 wherein said chemical visual indicator meets the requirements of ISO 11140-1.

109. A method as set forth in claim 106 wherein said chemical visual indicator is attached to said additional panel.