U.S. patent application number 10/685545 was filed with the patent office on 2005-04-14 for sterilization wraps and methods for sterilizing articles.
This patent application is currently assigned to Allegiance Corporation. Invention is credited to Cannady, Clay, Duski, Michael, Hoge, Brian G., Stecklein, Greg, Whitaker, James F..
Application Number | 20050079093 10/685545 |
Document ID | / |
Family ID | 34423178 |
Filed Date | 2005-04-14 |
United States Patent
Application |
20050079093 |
Kind Code |
A1 |
Cannady, Clay ; et
al. |
April 14, 2005 |
Sterilization wraps and methods for sterilizing articles
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 one sheet, and preferably two sheets,
of sterilization material and in some embodiments, includes an
additional sheet which may be made of an absorbent material. The
sheet of absorbent material may have a smaller perimeter than at
least one sheet of sterilization material. One side of at least one
sheet of sterilization material includes a central portion. The
absorbent material may be attached to the central portion of at
least one sheet of sterilization material. The article to be
sterilized is placed on the sterilization wrap and is then wrapped.
The absorbent material provides sterility protection for the
article in addition to the at least one sheet of sterilization
material and also wicks moisture away from the article after
sterilization has taken place. A visual indicator may be provided
to indicate whether or not the article has been exposed to adequate
sterilization conditions.
Inventors: |
Cannady, Clay; (Highland
Park, IL) ; Duski, Michael; (Buffalo Grove, IL)
; Hoge, Brian G.; (Fletcher, NC) ; Stecklein,
Greg; (Lake Villa, IL) ; Whitaker, James F.;
(Alexander, NC) |
Correspondence
Address: |
DAVID M. CARTER
CARTER SCHNEDLER & MONTEITH, P.A.
56 CENTRAL AVENUE, SUITE 101
P.O. BOX 2985
ASHVILLE
NC
28802
US
|
Assignee: |
Allegiance Corporation
McGaw Park
IL
60085
|
Family ID: |
34423178 |
Appl. No.: |
10/685545 |
Filed: |
October 14, 2003 |
Current U.S.
Class: |
422/1 ; 422/119;
422/26; 422/28; 422/297; 422/300; 422/40 |
Current CPC
Class: |
Y10T 428/19 20150115;
A61B 2050/314 20160201; A61L 2202/24 20130101; B32B 2439/02
20130101; B65D 75/08 20130101; A61L 2/26 20130101; B32B 2250/242
20130101; Y10T 428/31913 20150401; A61L 2/07 20130101; B32B 2250/03
20130101; A61L 2202/181 20130101; A61B 50/3001 20160201; B32B 7/05
20190101; A61L 2/28 20130101; B32B 27/08 20130101; A61B 50/31
20160201; B32B 27/32 20130101; A61L 2/206 20130101; Y10T 428/24942
20150115 |
Class at
Publication: |
422/001 ;
422/026; 422/028; 422/040; 422/119; 422/297; 422/300 |
International
Class: |
A01N 001/00; A61L
002/00 |
Claims
1. A sterilization wrap for wrapping an article to be sterilized
comprising: at least a first sheet of sterilization material; and a
sheet of absorbent material bonded to said first sheet of
sterilization material; said sheet of absorbent material adapted to
receive the article to be sterilized thereon; said sheet of
absorbent material (a) providing sterility protection for the
article in addition to said first sheet of sterilization material,
and (b) wicking moisture away from the article after sterilization
has taken place.
2. A sterilization wrap as set forth in claim 1 further including a
second sheet of sterilization material; said second sheet of
sterilization material bonded to said first sheet of sterilization
material.
3. A sterilization wrap as set forth in claim 2 wherein each of
said first and second sheets of sterilization material includes
four edges about their peripheries; said four edges of said first
sheet of sterilization material being bonded to said four edges of
said second sheet of sterilization material.
4. A sterilization wrap as set forth in claim 2, wherein said sheet
of absorbent material is made of cellulose.
5. A sterilization wrap as set forth in claim 2, wherein said sheet
of absorbent material is made of an absorbent synthetic.
6. A sterilization wrap as set forth in claim 5, wherein said
absorbent synthetic is taken from the group consisting of
hydrophilic spunmelt polyolefins, polyester, and nylon, and
polyrayons and bicomponent fibers.
7. A sterilization wrap as set forth in claim 2, wherein the
perimeter of said sheet of absorbent material is smaller than the
perimeter of said first sheet of sterilization material.
8. A sterilization wrap as set forth in claim 7, wherein the
perimeter of said sheet of absorbent material is at least 25% less
than the perimeter of said first sheet of sterilization
material.
9. A sterilization wrap as set forth in claim 7, wherein said first
sheet of sterilization material has two sides; one side of said
first sheet of sterilization material having a central portion;
said sheet of absorbent material bonded to said first sheet of
sterilization material at said central portion.
10. A sterilization wrap as set forth in claim 2, wherein said
first and second sheets of sterilization material are made of
SMS.
11. A sterilization wrap as set forth in claim 2, wherein said
sheet of absorbent material is bonded to said first sheet of
sterilization material by glue.
12. A sterilization wrap as set forth in claim 2, wherein said
sheet of absorbent material is bonded to said first sheet of
sterilization material by heat and pressure.
13. A sterilization wrap as set forth in claim 2, wherein the color
of said first sheet of sterilization material is different from the
color of said sheet of absorbent material so that a sterile field
may be readily identified.
14. A sterilization wrap as set forth in claim 2, further including
a chemical visual indicator; said chemical visual indicator being
in one visual state prior to exposure to sterilant and being in
another visual 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.
15. A sterilization wrap as set forth in claim 14, wherein said
chemical visual indicator is attached to said absorbent
material.
16. A sterilization wrap as set forth in claim 14, wherein said
chemical visual indicator changes color after having been exposed
to steam.
17. A sterilization wrap as set forth in claim 14, wherein said
chemical visual indicator meets the requirements of ISO
11140-1.
18. A sterilization wrap as set forth in claim 1 further including
a chemical visual indicator; said visual indicator being in one
visual state prior to exposure to sterilant and being in another
visual state after exposure to sterilant; said visual indicator
being attached to said sterilization wrap to indicate whether or
not the article has been exposed to adequate sterilization
conditions.
19. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping the article to be
sterilized with a sterilization wrap which comprises: at least a
first sheet of sterilization material; and a sheet of absorbent
material bonded to said first sheet of sterilization material; said
sheet of absorbent material adapted to receive the article to be
sterilized thereon; said sheet of absorbent material (a) providing
sterility protection for the article in addition to said sheet of
sterilization material, and (b) wicking moisture away from the
article after sterilization has taken place; and applying sterilant
to the wrapped article.
20. A method for sterilizing an article as set forth in claim 19
further including a second sheet of sterilization material; said
second sheet of sterilization material bonded to said first sheet
of sterilization material.
21. A method for sterilizing an article as set forth in claim 20,
wherein each of said first and second sheets of sterilization
material includes four edges about their peripheries; said four
edges of said first sheet of sterilization material being bonded to
said four edges of said second sheet of sterilization material.
22. A method as set forth in claim 20, wherein said sheet of
absorbent material is made of cellulose.
23. A method as set forth in claim 20, wherein said sheet of
absorbent material is made of an absorbent synthetic.
24. A method as set forth in claim 23, wherein said absorbent
synthetic is taken from the group consisting of hydrophillic
spunmelt polyolefins, polyester, and nylon, and polyrayons and
bicomponent fibers.
25. A method as set forth in claim 20, wherein the perimeter of
said sheet of absorbent material is smaller than the perimeter of
said first sheet of sterilization material.
26. A method as set forth in claim 25, wherein the perimeter of
said sheet of absorbent material is at least 25% less than the
perimeter of said first sheet of sterilization material.
27. A method as set forth in claim 25, wherein said first sheet of
sterilization material has two sides; one side of said first sheet
of sterilization material having a central portion; said sheet of
absorbent material bonded to said first sheet of sterilization
material at said central portion.
28. A method as set forth in claim 20, wherein said first and
second sheets of sterilization material are made of SMS.
29. A method as set forth in claim 20, wherein said sheet of
absorbent material is bonded to said first sheet of sterilization
material by heat and pressure.
30. A method as set forth in claim 20, wherein the color of said
first sheet of sterilization material is different from the color
of said first sheet of absorbent material so that a sterile field
may be readily identified.
31. A method as set forth in claim 20, further including a chemical
visual indicator; said chemical visual indicator being in one
visual state prior to exposure to sterilant and being in another
visual 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.
32. A method as set forth in claim 31 further including an
additional sheet attached to said first sheet of sterilization
material and to said sheet of absorbent material.
33. A method as set forth in claim 31, wherein said chemical visual
indicator is attached to said sheet of absorbent material.
34. A method as set forth in claim 31, wherein said chemical visual
indicator changes color after having been exposed to steam.
35. A method as set forth in claim 31, wherein said chemical visual
indicator meets the requirements of ISO 11140-1.
36. A method as set forth in claim 20, further including a chemical
visual indicator, said chemical visual indicator being in one
visual state prior to exposure to sterilant and being in another
visual state after exposure to sterilant; said chemical visual
indicator being attached to said sterilization wrap to indicate
whether or not the article has been exposed to adequate
sterilization conditions.
37. A sterilization wrap for wrapping an article to be sterilized,
comprising: at least a first sheet of sterilization material; said
first sheet having an outer periphery and a central portion; and an
additional sheet of material being bonded to the central portion of
said first sheet; the perimeter of said additional sheet being
smaller than the perimeter of said first sheet.
38. A sterilization wrap as set forth in claim 37 further including
a second sheet of sterilization material; said second sheet of
sterilization material bonded to said first sheet of sterilization
material.
39. A sterilization wrap as set forth in claim 38, wherein the
second sheet of sterilization material includes an outer periphery;
said outer periphery of said first sheet of sterilization material
being bonded to the outer periphery of said second sheet of
sterilization material.
40. A sterilization wrap as set forth in claim 39 further including
a chemical visual indicator, said chemical visual indicator being
in one visual state prior to exposure to sterilant and being in
another visual 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.
41. A sterilization wrap as set forth in claim 37 further including
a chemical visual indicator, said chemical visual indicator being
in one visual state prior to exposure to sterilant and being in
another visual 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.
42. A sterilization wrap as set forth in claim 41 further including
an absorbent sheet attached to said additional sheet.
43. A sterilization wrap as set forth in claim 40, wherein said
chemical visual indicator is a color change indicator.
44. A sterilization wrap as set forth in claim 40, wherein said
chemical visual indicator meets the requirements of ISO
11140-1.
45. A sterilization wrap as set forth in claim 40, wherein said
chemical visual indicator is attached to said additional sheet.
46. A sterilization wrap as set forth in claim 39, wherein said
first and second sheets of sterilization material and said
additional sheet are made of SMS.
47. A sterilization wrap as set forth in claim 40, wherein the
basis weight of said additional sheet is equal to or greater than
the basis weight of said first sheet of sterilization material.
48. A sterilization wrap as set forth in claim 47, wherein the
basis weight of said first sheet is in the range from 0.75 osy to
2.9 osy and the basis weight of said absorbent sheet is in the
range from 1.0 osy to 3.0 osy.
49. A sterilization wrap as set forth in claim 39, wherein said
additional sheet is SMS.
50. A sterilization wrap as set forth in claim 49 further including
an absorbent sheet attached to said additional sheet.
51. A sterilization wrap as set forth in claim 50 further including
a chemical visual indicator; said chemical visual indicator being
in one visual state prior to exposure to sterilant and being in
another visual 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 37 further including
an absorbent sheet attached to said additional sheet.
53. A sterilization wrap as set forth in claim 50, wherein the
perimeter of said absorbent sheet is smaller than the perimeter of
said additional sheet.
54. A sterilization wrap for wrapping an article to be sterilized
comprising: at least one sheet of sterilization material; and a
sheet of absorbent material attached to said sheet of sterilization
material; said sheet of absorbent material adapted to contact the
article to be sterilized; said sheet of absorbent material enabled
to wick moisture away from the article after sterilization has
taken place.
55. A sterilization wrap as set forth in claim 54 further including
a chemical visual indicator responsive to the presence of sterilant
so as to indicate whether or not the article has been exposed to
adequate sterilization conditions.
56. A sterilization wrap for wrapping an article to be sterilized
comprising: at least one sheet of sterilization material having a
central portion; and a panel attached to said central portion of
said sheet of sterilization material; the basis weight of said
panel being higher than the basis weight of said sheet of
sterilization material.
57. A sterilization wrap as set forth in claim 56 further including
a sheet of absorbent material attached to said panel; said sheet of
absorbent material enabled to wick moisture away from the article
after sterilization has taken place.
58. A sterilization wrap as set forth in claim 57 further including
a chemical visual indicator responsive to the presence of sterilant
so as to indicate whether or not the article has been exposed to
adequate sterilization conditions.
59. A sterilization wrap as set forth in claim 56 further including
a chemical visual indicator responsive to the presence of sterilant
so as to indicate whether or not the article has been exposed to
adequate sterilization conditions.
60. A sterilization wrap as set forth in claim 56, wherein said
panel is absorbent; said panel enabled to wick moisture away from
the article after sterilization has taken place.
61. A sterilization wrap as set forth in claim 60 further including
a chemical visual indicator responsive to the presence of sterilant
so as to indicate whether or not the article has been exposed to
adequate sterilization conditions.
62. A sterilization wrap for wrapping an article to be sterilized
comprising: at least one sheet of sterilization material; and a
chemical visual indicator responsive to the presence of sterilant
so as to indicate whether or not the article has been exposed to
adequate sterilization conditions.
63. A sterilization wrap as set forth in claim 62 further including
a second sheet of sterilization material; said second sheet of
sterilization material bonded to said first sheet.
64. A sterilization wrap as set forth in claim 63, wherein said
chemical visual indicator is attached to said second sheet.
65. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping the article to be
sterilized with a sterilization wrap which comprises: at least a
first sheet of sterilization material; said first sheet having an
outer periphery and a central portion; and an additional sheet of
material being bonded to the central portion of said first sheet;
the perimeter of said additional sheet being smaller than the
perimeter of said first sheet; and applying sterilant to the
wrapped article.
66. A method for sterilizing an article as set forth in claim 65
further including a second sheet of sterilization material; said
second sheet of sterilization material bonded to said first sheet
of sterilization material.
67. A method for sterilizing an article as set forth in claim 6E,
wherein the second sheet of sterilization material includes an
outer periphery; said outer periphery of said first sheet of
sterilization material being bonded to the outer periphery of said
second sheet of sterilization material.
68. A method for sterilizing an article as set forth in claim 67
further including a chemical visual indicator, said chemical visual
indicator being in one visual state prior to exposure to sterilant
and being in another visual 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.
69. A method for sterilizing an article as set forth in claim 65
further including a chemical visual indicator, said chemical visual
indicator being in one visual state prior to exposure to sterilant
and being in another visual 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 for sterilizing an article as set forth in claim 68,
wherein said chemical visual indicator meets the requirements of
ISO 11140-1.
71. A method for sterilizing an article as set forth in claim 68,
wherein said chemical visual indicator is attached to said first
shoat of sterilization material.
72. A method for sterilizing an article as set forth in claim 68,
wherein said chemical visual indicator is attached to said
additional sheet.
73. A method for sterilizing an article as set forth in claim 67,
wherein said first and second sheets of sterilization material and
said additional sheet are made of SMS.
74. A method for sterilizing an article as set forth in claim 73,
wherein the basis weight of said additional sheet is equal to or
greater than the basis weight of said first sheet of sterilization
material.
75. A method for sterilizing an article as set forth in claim 74,
wherein the basis weight of said first sheet is in the range from
0.75 osy to 2.9 osy and the basis weight of said absorbent sheet is
in the range from 1.0 osy to 3.0 osy.
76. A method for sterilizing an article as set forth in claim 67,
wherein said additional sheet is SMS.
77. A method for sterilizing an article as set forth in claim 76
further including an absorbent sheet attached to said additional
sheet.
78. A method for sterilizing an article as set forth in claim 65
further including an absorbent sheet attached to said additional
sheet.
79. A method for sterilizing an article as set forth in claim 78
further including a chemical visual indicator responsive to the
presence of sterilant so as to indicate whether or not the article
has been exposed to adequate sterilization conditions.
80. A method for sterilizing an article as set forth in claim 78,
wherein the perimeter of said absorbent sheet is smaller than the
perimeter of said additional sheet.
81. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping the article to be
sterilized with sterilization wrap which comprises: at least one
sheet of sterilization material; and a sheet of absorbent material
attached to said sheet of sterilization material; said sheet of
absorbent material adapted to contact the article to be sterilized;
said sheet of absorbent material enabled to wick moisture away from
the article after sterilization has taken place; and applying
sterilant to the wrapped article.
82. A method for sterilizing an article as set forth in claim 81
further including a chemical visual indicator responsive to the
presence of sterilant so as to indicate whether or not the article
has been exposed to adequate sterilization conditions.
83. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping the article to be
sterilized with sterilization wrap which comprises: at least one
sheet of sterilization material having a central portion; and a
panel attached to said central portion of said sheet of
sterilization material; the basis weight of said panel being higher
than the basis weight of said sheet of sterilization material; and
applying sterilant to the wrapped article.
84. A method for sterilizing an article as set forth in claim 83
further including a sheet of absorbent material attached to said
panel; said sheet of absorbent material enabled to wick moisture
away from the article after sterilization has taken place.
85. A method for sterilizing an article as set forth in claim 84
further including a chemical visual indicator responsive to the
presence of sterilant so as to indicate whether or not the article
has been exposed to adequate sterilization conditions.
86. A method for sterilizing an article as set forth in claim 83
further including a chemical visual indicator responsive to the
presence of sterilant so as to indicate whether or not the article
has been exposed to adequate sterilization conditions.
87. A method for sterilizing an article as set forth in claim 83
wherein said panel is absorbent; said panel enabled to wick
moisture away from the article after sterilization has taken
place.
88. A method for sterilizing an article as set forth in claim 87
further including a chemical visual indicator responsive to the
presence of sterilant so as to indicate whether or not the article
has been exposed to adequate sterilization conditions.
89. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping the article to be
sterilized in sterilization wrap which comprises: at least one
sheet of sterilization material; and a chemical visual indicator
responsive to the presence of sterilant so as to indicate whether
or not the article has been exposed to adequate sterilization
conditions; and applying sterilant to the wrapped article.
90. A method for sterilizing an article as set forth in claim 89
further including a second sheet of sterilization material; said
second sheet of sterilization material bonded to said first
sheet.
91. A method for sterilizing an article as set forth in claim 90,
wherein said chemical visual indicator is attached to said second
sheet.
92. A method as set forth in claim 89 further including a sheet of
absorbent material attached to said sheet of sterilization
material; said sheet of absorbent material adapted to contact the
article to be sterilized; said sheet of absorbent material enabled
to wick moisture away from the article after sterilization has
taken place.
93. A sterilization wrap for wrapping an article to be sterilized
comprising: a first sheet of sterilization material; said first
sheet of sterilization material having an outer periphery and a
central portion; an additional sheet of material; said additional
sheet being bonded to said first sheet; a substantial portion of
said additional sheet being adjacent to the central portion of said
first sheet; the perimeter of said additional sheet being smaller
than the perimeter of said first sheet.
94. A sterilization wrap as set forth in claim 93 wherein said
additional sheet of material includes spun-bond polypropelene.
95. A sterilization wrap as set forth in claim 93 further including
a second sheet of sterilization material; said second sheet of
sterilization material being bonded to said first sheet of
sterilization material.
96. A sterilization wrap as set forth in claim 95 wherein the
second sheet of sterilization material includes an outer periphery;
said outer periphery of said first sheet of sterilization material
being bonded to said outer periphery of said second sheet of
sterilization material.
97. A sterilization wrap as set forth in claim 95 wherein said
first and second sheets of sterilization material are made of
SMS.
98. A method for sterilizing an article comprising the steps of:
providing an article to be sterilized; wrapping said article to be
sterilized with a sterilization wrap which comprises: a first sheet
of sterilization material; said first sheet of sterilization
material having an outer periphery and a central portion; an
additional sheet of material; said additional sheet being bonded to
said first sheet; a substantial portion of said additional sheet
being adjacent to the central portion of said first sheet; the
perimeter of said additional sheet being smaller than the perimeter
of said first sheet; applying sterilant to the wrapped article.
99. A method as set forth in claim 98 wherein said additional sheet
of material includes spun-bond polypropylene.
100. A method as set forth in claim 98 further including a second
sheet of sterilization material; said second sheet of sterilization
material being bonded to said first sheet of sterilization
material.
101. A method as set forth in claim 100 wherein the second sheet of
sterilization material includes an outer periphery; said outer
periphery of said first sheet of sterilization material being
bonded to the outer periphery of said second sheet of sterilization
material.
102. A method as set forth in claim 101 wherein said first and
second sheets of sterilization material are made of SMS.
103. A method as set forth in claim 98 further including the step
of placing said article to be sterilized on said additional sheet.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to sterilization wrap. More
particularly, it relates to sterilization wrap utilizing two layers
or sheets of material.
[0002] Reusable medical instruments must be sterilized prior to
each use. Normally, these instruments are exposed to a sterilant to
achieve sterilization. As used herein, the term steriliant is meant
to refer to the sterilization effectors that are conventionally
utilized with sterilization wrap, sterilization techniques,
including but not limited to steam, ethylene-oxide, plasma, or the
like. In order for the instruments to remain sterile after the
sterilization procedure, the instruments must be wrapped in a
material called sterilization wrap prior to the sterilization
procedure.
[0003] The most common type of sterilization wrap is a three-ply
laminate consisting of a layer of melt blown polypropylene
sandwiched between two layers of spun bond polypropylene. The wrap
includes bond points all across the face of the material so that
the material is held together, i.e., laminated. This three-ply
material is commonly referred to as "SMS", which is short for spun
bond-melt blown-spun bond. Most hospitals specify SMS as the
sterilization wrap to be used because SMS is sufficiently porous to
permit steam, ethylene-oxide and other sterilization materials to
penetrate through the material to the surgical instruments, but has
filtration properties sufficient to prevent the passage of most
pathogens therethrough so as to maintain sterility after the
sterilization process. The wrap also protects articles during
sterilization, and acts as a filtration medium for the
sterilant.
[0004] In most hospitals, there is a protocol which requires
surgical instruments to be wrapped with two separate sheets of
material so that if one sheet becomes torn, there is a redundancy
which will maintain the sterility of the surgical instruments. The
wrapping of surgical instruments with two separate sheets of
sterilization wrap obviously is labor intensive in that the
clinician must first place the instruments on one sheet of
sterilization material and wrap the instruments, and then place the
wrapped package on another sheet of sterilization material and
again wrap the package containing the instruments.
[0005] In an attempt to reduce the labor required to provide dual
wrapping of surgical instruments, Kimberly-Clark Corporation has
developed a product called "One Step.RTM. Sterilization Wrap." One
Step.RTM. Sterilization Wrap is made by bonding two separate sheets
of sterilization wrap together near two of the edges of the
adjacent sheets. The Kimberly-Clark One Step.RTM. product is
described in U.S. Pat. Nos. 5,635,134 and 5,688,476.
[0006] FIG. 1 herein shows one of the Kimberly-Clark One Step.RTM.
products described in these Kimberly-Clark patents. Sterilization
wrap 10 includes a top sheet 12 made of SMS and a bottom sheet 14
also made of SMS. The lengths and widths of top sheet 12 and bottom
sheet 14 are identical and the outside edges of each layer align
with one another. The two layers of SMS are bonded together near
two opposing edges 16 and 18, as illustrated by bond lines 20 and
22. The method of bonding the two sheets together may be ultrasonic
bonding. The other two opposing edges 24 and 26 are not bonded
together so there is a visible gap 28 between sheets 12 and 14 so
that the user of the sterilization wrap visually distinguishes the
fact that there are, indeed, two sheets. Apparently the purpose for
ensuring that the two sheets are visually distinguishable as
separate sheets is so that the user knows with certainty that the
item to be sterilized has two sheet protection. However, because of
this gap 28, debris could enter the region between the two sheets.
With two of the edges being unbonded, it is possible that the
sheets become misaligned so that if a sharp object penetrates both
sheets, the resulting holes in each sheet could also become
misaligned, thus reducing ones ability to determine whether or not
there is a hole through both sheets. In addition, since edges 24
and 26 are not bonded and bond lines 20 and 22 are somewhat removed
from edges 16 and 18, fibers from those edges could become released
from the wrap. Also, since the edges 24 and 26 are not bonded, the
two sheets might be pulled apart by mistake during use.
Furthermore, since the wrap shown in FIG. 1 is not sealed right to
the edges 16 and 18, the user might perceive that there could be
contamination between the sheets.
[0007] Recently Cardinal Health has introduced a new two sheet
sterilization wrap called Simul-Wrap.RTM. which overcomes the
problems of the Kimberly-Clark One Step.RTM. product described
above. The Simul-Wrap.RTM. product is made of two identical sheets
of SMS sterilization material which are bonded together along all
four edges. The Cardinal Health Simul-Wrap.RTM. product is shown in
U.S. Pat. No. 6,517,916. However, both the One Step.RTM. product
and the Simul-Wrap.RTM. product have certain drawbacks. Neither
product is specifically engineered to wick moisture away from the
article to be sterilized after sterilization takes place. In
addition, neither product provides an indication that adequate
sterilization has been achieved.
OBJECTS OF THE INVENTION
[0008] It is, therefore, one object of this invention to provide an
improved sterilization wrap which utilizes two layers of
material.
[0009] It is another object of this invention to provide a
sterilization wrap made with two layers of material which is easy
to use.
[0010] It is still another object of this invention to provide a
method for sterilizing an article utilizing an improved
sterilization wrap.
[0011] It is further another object of this invention to provide a
sterilization wrap which will wick moisture from the sterilized
article.
[0012] It is yet another object of this invention to provide a
sterilization wrap which is less costly to manufacture than
conventional sterilization wrap.
[0013] It is another object of this invention to provide a
sterilization wrap which includes a chemical visual indicator
showing that the wrapped article has been exposed to adequate
sterilization conditions.
[0014] It is another object of this invention to provide a two
layer sterilization wrap which includes a chemical visual indicator
to distinguish the sterile field from the non-sterile field when
the wrap has been opened.
SUMMARY OF THE INVENTION
[0015] In accordance with one form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized. At least one sheet, and preferably two sheets, of
sterilization material and a sheet of absorbent material are
provided. The sheet of absorbent material is bonded to a sheet of
sterilization material. The sheet of absorbent material is adapted
to receive the article to be sterilized. The sheet of absorbent
material (a) provides sterility protection for the article in
addition to the sheet of sterilization material, and (b) wicks
moisture away from the article after sterilization has taken place.
The sheet of absorbent material may be made of cellulose or other
absorbent matter which is capable of being formed into a sheet or
layer. Preferably, the sheet of absorbent material is smaller than
the sheet of sterilization material. Also, preferably, one side of
the sheet of sterilization material has a central portion and the
sheet of absorbent material is bonded to the central portion of the
sheet of sterilization material. The sheet of sterilization
material may be a different color from the sheet of absorbent
material so that the user may readily differentiate between the two
sheets and thus distinguish where to place the article being
packaged. Also, preferably, the sheet of absorbent material is
thicker or heavier than the sheet of sterilization material. In
addition, a chemical visual indicator which changes color in the
presence of a sterilant, such as steam, may be attached to either
sheet near the article to be sterilized to indicate whether or not
the article has been exposed to adequate sterilization
conditions.
[0016] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized. At least one sheet, and preferably two sheets, of
sterilization material, and a sheet of reinforcement material are
provided. The sheet of reinforcement material is bonded to a sheet
of sterilization material. The sheet of reinforcement material is
adapted to receive the article to be sterilized. The sheet of
reinforcement material is preferably made of SMS and preferably has
a higher basis weight than the sheet or either of the sheets of
sterilization material.
[0017] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized in which at least one sheet, and preferably two sheets
bonded together at their outer peripheries, of sterilization
material are provided. The first sheet has an outer periphery and a
central portion. Also provided is an additional sheet of
reinforcement material that is bonded to the central portion of the
first sheet of sterilization material. The perimeter of the
reinforcement sheet is smaller than the perimeter of the first
sheet.
[0018] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized, including at least one sheet of sterilization material
and a sheet of absorbent material attached to the sheet of
sterilization material. The sheet of absorbent material is adapted
to contact the article to be sterilized. The sheet of absorbent
material is also capable of wicking moisture away from the article
after sterilization has taken place.
[0019] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized, including at least one sheet, and preferably two sheets
bonded together, of sterilization material, and a chemical visual
indictor responsive to the presence of sterilant. The chemical
visual indicator will indicate whether the article has been exposed
to adequate sterilization conditions.
[0020] In accordance with another form of this invention, there are
provided methods for sterilizing an article, including the steps of
providing an article to be sterilized, and wrapping the article to
be sterilized with the sterilization wraps described above, and
applying sterilant to the wrapped article.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The subject matter which is regarded as the invention is set
forth in the appended claims. The invention itself, however,
together with further objects and advantages thereof may be better
understood in reference to the accompanying drawings in which:
[0022] FIG. 1 is a perspective view of a prior art sterilization
wrap;
[0023] FIG. 2 is a perspective view of the sterilization wrap, in
accordance with one embodiment of the subject invention;
[0024] FIG. 3 is a plan view of the sterilization wrap of FIG. 2
with an article to be sterilized received thereon;
[0025] FIG. 4 is a sectional view of the sterilization wrap of FIG.
2 taken through section line 4-4.
[0026] FIG. 5 is a plan view of another embodiment of the
sterilization wrap in accordance with the subject invention.
[0027] FIG. 6 is a sectional view of the sterilization wrap of FIG.
5 taken through section lines 6-6.
[0028] FIG. 7 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0029] FIG. 8 is a sectional view of the sterilization wrap of FIG.
7 taken through section lines 8-8.
[0030] FIG. 9 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0031] FIG. 10 is a sectional view of the sterilization wrap of
FIG. 9 taken through section lines 10-10.
[0032] FIG. 11 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0033] FIG. 12 is a sectional view of the sterilization wrap of
FIG. 11 taken through section lines 12-12.
[0034] The thicknesses of the materials shown in the drawings have
been exaggerated for illustrative purposes and for ease of
understanding.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] Referring now more particularly to FIG. 2, there is provided
sterilization wrap 30 having a first sheet or layer 32 and a second
layer or sheet 34. Preferably, the first layer 32, which is the
outside layer, is made of SMS. The first layer 32 is sometimes
referred to herein as a sheet of sterilization material. The second
layer 34, which is the inside layer, may be made of cellulose or
some other absorbent material, which absorbs liquids and aids in
drying and which also permits a sterilant, such as steam or
ethylene-oxide, to pass therethrough, but inhibits pathogens from
passing therethrough. Other absorbent materials could include, but
are not limited to, absorbent synthetics such as hydrophillic
spunmelt polyolefins, polyester, nylon, as well as polyrayons and
bicomponent fibers. The second layer 34 is sometimes referred to
herein as a sheet of absorbent material. In order to reduce the
cost of the sterilization wrap 30 while not reducing its
effectiveness, the second or inside layer 34 has a smaller
perimeter than the first or outside layer 32. It is preferred that
the perimeter of the inside layer 34 be at least 25% less than the
outside layer 32.
[0036] As can be seen from FIG. 3, the inside layer 34 receives the
article to be sterilized 36 thereon. Often the article to be
sterilized is a tray containing surgical instruments. While inside
layer 34 has a smaller perimeter than outside layer 32, it should
be large enough so that when the article to be sterilized 36 is
wrapped by sterilization wrap 30, both the bottom and sides of the
article to be sterilized 36 is covered by inside layer 34.
[0037] Outside layer 32 includes a central portion 38. Inside layer
34 is adhered to the central portion 38 by means of gluing,
ultrasonic bonding or some other form of adherence. Glue spots 40
are illustrated in FIG. 4. Alternatively, inside layer 34 may be
made of SMS which does not have the liquid absorbent properties of
cellulose. The structure of inside layer 34 when it is made of SMS
is discussed below in reference to FIG. 9. In any event, this
inside layer provides abuse resistance and containment properties
over the prior art sterilization wrap described above.
[0038] By reinforcing the area of direct contact under the article
to be sterilized 36, the primary point of potential damage to the
wrap has been addressed. The method by which trays are wrapped
yield several layers of material folds on the top of the article to
be sterilized 36. In the event that wrapped articles get stacked on
top of one another, thicker and/or heavier inside layer 34 protects
the underside of the article 36 while the multiple folds are
responsive to contact on the top side of article 36.
[0039] As noted, also the inner layer 34 may be made of a moisture
absorbent material, such as cellulose, which provides an enhanced
moisture absorption function. After the article to be sterilized 36
has been sterilized, in particularly through a steam sterilization
process, moisture often remains on the article to be sterilized 36.
This moisture enhances the growth of pathogens which may not have
been killed during the sterilization process. By using an absorbent
material, i.e., absorption material, as the material for layer 34,
this moisture tends to be wicked away from the article to be
sterilized 36 and more effectively dried. Thus the chances of
pathogen growth on or around the article to be sterilized is
greatly reduced.
[0040] It is preferred that outer layer 32 be of a different color
from inner layer 34. Since inner layer 34 is always within the
sterile field, this color differential will inform the sterile
clinician that it is okay to touch any portion of the sterile field
formed by the inside surface of outer layer 32 and inside layer
34.
[0041] It is also preferred that a sterilization chemical visual
indicator 42, which may also be an integrator or emulator, be
adhered to inside layer 34 or to the inside surface 41 of outside
layer 32 in the vicinity of inside layer 34. The sterilization
indicator could be of a chemistry which meets or exceeds the
requirements of Class 1-Class 6 chemical indicators as defined by
ISO-11140-1. The sterilization indicator turns color in the
presence of steam or ethylene-oxide or other sterilant and will
remain at that color after sterilization has taken place. This
informs the clinician that the article to be sterilized has,
indeed, been exposed to adequate sterilization conditions at the
time that the clinician opens the wrapped article.
[0042] Sterilization indicators are known and two such indicators
are described in U.S. Pat. No. 4,514,361 issued to Hirsch and U.S.
Pat. No. 2,889,799 issued to Korpman, which are hereby incorporated
herein by reference. Sterilization integrators are known and one
such integrator is described in U.S. Pat. No. 4,448,548, which is
hereby incorporated herein by reference.
[0043] The sterilization wrap described above can be manufactured
using conventional equipment and techniques readily available to
those skilled in the medical fabric field.
[0044] The sterilization wrap described above may be used as set
forth below. The article to be sterilized 36, as shown in FIG. 3,
is placed on the outside surface of inner layer 34. The article to
be sterilized 36 is then wrapped utilizing standard sterilization
wrapping techniques so that a portion of the inside layer 34 covers
the bottom and sides of the article to be sterilized 36, and a
portion of the outside layer 32 also covers the top of the article
to be sterilized 36. The wrapped package is then exposed to a
sterilization process. The wrapped package is subjected to
sterilants, such as steam, ethylene-oxide or plasma, for a
predetermined period of time so that substantially all of the
pathogens which may be present on the article to be sterilized 36
are killed. The package is then stored for usage. When it is time
to use the article to be sterilized 36, the package is unwrapped by
the clinician. The sterile clinician will know it is all right to
touch the sterile field formed by the inner layer 34 because the
inner layer 34 and the outside layer 32 are different colors. The
clinician will then observe the status of sterilization indicator,
integrator, or emulator 42 to determine whether or not the article
36 has been exposed to adequate sterilization conditions. The
article to be sterilized 36 may then be used.
[0045] The above-described improved sterilization wrap provides the
two layers of protection and ease of use associated with
Kimberly-Clark's One Step.RTM. and Cardinal Health's
Simul-Wrap.RTM., while having the added features of increased
protection in the central area adjacent to the article to be
sterilized and further providing an ability to wick moisture away
from the article to be sterilized, particularly in the case of
steam sterilization, and in addition, visually informs the
clinician that the inside of the wrap is the sterile field and
visually informs the clinician that the article has, indeed, been
exposed to adequate sterilization conditions.
[0046] While FIGS. 2 through 4 show absorbent layer 34 attached to
a single sheet of sterilization material, it is preferred that two
(2) layers of sterilization material are utilized.
[0047] Referring now more particularly to FIGS. 5 and 6, two-layer
sterilization wrap 44 is provided and includes outside layer 46 and
inside layer 48, each made of SMS. The two layers 46 and 48 each
have four edges 49, 51, 53 and 55 and are bonded together at the
four edges about their outer peripheries 50, preferably by heat and
pressure. The bonded two-layer sterilization material 44 may be the
Simul-Wrap.RTM. product which is commercially available from
Cardinal Health (1500 Waukegan Road, McGaw Park, Ill. 60085) and
which is described in U.S. Pat. No. 6,517,916, the disclosure of
which is hereby incorporated herein by reference. Absorbent layer
52, which may be made of cellulose or another moisture absorbing
substance, is bonded to the outside of inner layer 48 by gluing or
another bonding technique, as illustrated by bond sites 54.
Alternatively, layer 52 may be made of SMS as discussed in
reference to FIGS. 2 and 9.
[0048] Referring now more particularly to FIGS. 7 and 8, a
sterilization indicator device 56 is attached to absorbent layer
52.
[0049] Referring now more particularly to FIGS. 9 and 10, the
absorbent layer 52 has been replaced with a reinforcement panel 58
made of SMS. Panel 58 has an equal to or higher basis weight than
either layer 46 or 48. The basis weight of panel 58 may range from
1.0 ounces per square yard (osy) to 3.0 osy. The basis weight for
each of layers 46 and 48 may range from 0.75 osy to 2.9 osy. While
reinforcement panel 58 does not provide the moisture wicking
function of absorption layer 52, it provides additional protection
for the article to be sterilized 36 as shown in FIG. 5, which is to
be placed on reinforcement panel 58. The embodiment shown in FIGS.
9 and 10 results in a more cost effective product than the use of
two full sheets of SMS, but is equal functionally, since less
material is used. FIG. 9 also shows a sterilization indicator 56
having been placed on the outside surface of inner panel 48.
[0050] The embodiment of FIGS. 11 and 12 represents a combination
of the embodiments of FIGS. 7 and 9. That is, reinforcement panel
58 is attached to inside SMS layer 48. Absorbent layer 52 is, in
turn, attached to reinforcement layer 58. Chemical visual indicator
56 is attached to absorbent layer 52. Alternatively, indicator 56
may be attached to reinforcement layer 58 or to inside layer 48. In
addition, in the embodiment of FIGS. 11 and 12, outside SMS layer
could be eliminated.
[0051] From the foregoing description of the preferred embodiments
of the invention, it is apparent that many modifications may be
made therein. It should be understood, however, that these
embodiments of the invention are exemplifications of the invention
only and that the invention is not limited thereto. It is to be
understood, therefore, that it is intended in the appended claims
to cover all modifications as fall within the true spirit and scope
of the invention.
* * * * *