U.S. patent application number 09/080707 was filed with the patent office on 2001-11-01 for two-ply sterilization wrap and method for sterilizing an article.
Invention is credited to BAYER, ROBERT T..
Application Number | 20010036519 09/080707 |
Document ID | / |
Family ID | 22159096 |
Filed Date | 2001-11-01 |
United States Patent
Application |
20010036519 |
Kind Code |
A1 |
BAYER, ROBERT T. |
November 1, 2001 |
TWO-PLY STERILIZATION WRAP AND METHOD FOR STERILIZING AN
ARTICLE
Abstract
There is provided an improved two-ply sterilization wrap and a
method for using the improved sterilization wrap to sterilize an
article. The wrap is made of a single sheet of sterilization
material. The sheet is folded forming at least one fold. The folded
sheet forms first and second overlapping panels and two layers of
sterilization material. Preferably, the panels are bonded to each
other. The folded single sheet provides two layers of sterilization
material covering the article to be sterilized.
Inventors: |
BAYER, ROBERT T.;
(ASHEVILLE, NC) |
Correspondence
Address: |
DAVID CARTER
CARTER & SCHNEDLER
P O BOX 2985
ASHEVILLE
NC
28802
|
Family ID: |
22159096 |
Appl. No.: |
09/080707 |
Filed: |
May 18, 1998 |
Current U.S.
Class: |
428/35.2 |
Current CPC
Class: |
A61L 2202/181 20130101;
A61L 2/206 20130101; Y10T 428/1345 20150115; Y10T 428/24777
20150115; A61L 2202/24 20130101; Y10T 428/1334 20150115; A61L 2/07
20130101; A61L 2/26 20130101; A61B 2090/0813 20160201; Y10T
428/1362 20150115; Y10T 428/2419 20150115; B32B 3/04 20130101 |
Class at
Publication: |
428/35.2 |
International
Class: |
B32B 001/02 |
Claims
1. A sterilization wrap comprising: a single sheet of sterilization
material; said sheet having first, second, third and fourth edges;
said sheet being folded in half, wherein a fold from said third
edge to said fourth edge is formed; said first edge is adjacent to
said second edge; first and second overlapping panels forming two
layers of sterilization material, whereby two layers of
sterilization material is provided for an article to be sterilized
by using a single sheet of sterilization material.
2. A sterilization wrap as set forth in claim 1, wherein said first
panel is affixed to said second panel by bonding said first edge to
said second edge.
3. A sterilization wrap as set forth in claim 1, wherein said third
edge has first and second portions; said fourth edge has first and
second portions; said first panel affixed to said second panel by
bonding said first portion of said third edge to said second
portion of said third edge, and by bonding said first portion of
said fourth edge to said second portion of said fourth edge.
4. A sterilization wrap as set forth in claim 1, wherein said first
edge is bonded to said second edge; said third edge having first
and second portions; said fourth edge having first and second
portions; said first portion of said third panel is bonded to said
second portion of said third panel, and said first portion of said
fourth panel is bonded to said second portion of said fourth
panel.
5. A sterilization wrap as set forth in claim 2, wherein said first
panel is affixed to said second panel by bonding said panels
together adjacent to said fold.
6. A sterilization wrap as set forth in claim 5, wherein said third
edge has first and second portions; said fourth edge has first and
second portions; said first portion of said third edge is bonded to
said second portion of said third edge, and said first portion of
said fourth edge is bonded to said second portion of said fourth
edge.
7. A sterilization as set forth in claim 3, wherein said first
panel is affixed to said second panel by bonding said panels
adjacent to said fold.
8. A sterilization wrap as set forth in claim 1, wherein said
sterilization material is SMS.
9. A two-ply sterilization wrap comprising: a single sheet of
sterilization material; said sheet being folded in half forming
first and second overlapping equally sized panels; each panel
having edges; said first panel being bonded to said second panel,
whereby the edges of said first panel are adjacent to the edges of
said second panel.
10. A sterilization wrap as set forth in claim 9, wherein each
panel has first, second and third edges; said sheet having a fold;
said first edge of each panel being opposite to said fold; said
first edge of said first panel bonded to said first edge of said
second panel.
11. A sterilization wrap as set forth in claim 9, wherein said
sheet having first, second, third and fourth edges and a fold; said
first and second edges being opposite to said fold; said third edge
including first and second portions; said first portion of said
third edge being bonded to said second portion of said third edge;
said fourth edge including first and second portions; said first
portion of said fourth edge being bonded to said second portion of
said fourth edge.
12. A sterilization wrap as set forth in claim 10, wherein said
panels are bonded along said fold.
13. A sterilization wrap as set forth in claim 11, wherein said
panels are bonded along said fold.
14. A sterilization wrap as set forth in claim 9, wherein said
material is SMS.
15. A sterilization wrap as set forth in claim 9, wherein said
panels are bonded only along portions of adjacent edges, whereby
central portions of said panels are not bonded.
16. A two-ply sterilization wrap comprising: a single sheet of
sterilization material; said sheet having first, second, third and
fourth edges; said sheet being folded in half, wherein a fold from
said third edge to said fourth edge is formed; first and second
overlapping panels forming two layers of sterilization material;
said first edge is adjacent to said second edge; said panels being
bonded together, wherein two layers of sterilization material is
provided for an article to be sterilized using a single sheet of
sterilization material.
17. A method for sterilizing an article comprising: providing an
article; wrapping the article with sterilization material which
comprises: a single sheet of sterilization material; said sheet
having first, second, third and fourth edges; said sheet being
folded in half, wherein a fold from said third edge to said fourth
edge is formed; first and second overlapping panels forming two
layers of sterilization materials; said first edge is adjacent to
said second edge, whereby two layers of sterilization material is
provided for an article to be sterilized by using a single sheet of
sterilization material; applying sterilization conditions to the
wrapped article.
18. A method as set forth in claim 17, wherein said first panel is
affixed to said second panel by bonding said first edge to said
second edge.
19. A method as set forth in claim 17, wherein said third edge has
first and second portions; said fourth edge has first and second
portions; said first panel affixed to said second panel by bonding
said first portion of said third edge to said second portion of
said third edge, and by bonding said first portion of said fourth
edge to said second portion of said fourth edge.
20. A method as set forth in claim 17, wherein said first edge is
bonded to said second edge; said third edge having first and second
portions; said fourth edge having first and second portions; said
first portion of said third panel is bonded to said second portion
of said third panel, and said first portion of said fourth panel is
bonded to said second portion of said fourth panel.
21. A method as set forth in claim 18, wherein said first panel is
affixed to said second panel by bonding said panels adjacent to
said fold.
22. A method as set forth in claim 21, wherein said third edge has
first and second portions; said fourth edge has first and second
portions; said first portion of said third edge is bonded to said
second portion of said third edge, and said first portion of said
fourth edge is bonded to said second portion of said fourth
edge.
23. A method as set forth in claim 19, wherein said first panel is
affixed to said second panel by bonding said panels adjacent to
said fold.
24. A method as set forth in claim 17, wherein said sterilization
material is SMS.
25. A method for sterilizing an article comprising: providing an
article; wrapping the article with sterilization material which
comprises: a single sheet of sterilization material; said sheet
being folded in half, thereby forming first and second overlapping
equally sized panels; each panel having edges; said first panel
being bonded to said second panel, whereby the edges of said first
panel are adjacent to the edges of said second panel; applying
sterilization conditions to the wrapped article.
26. A method as set forth in claim 25, wherein each panel has
first, second and third edges; said sheet having a fold; said first
edge of each panel being opposite to said fold; said first edge of
said first panel bonded to said first edge of said second
panel.
27. A method as set forth in claim 25, wherein said sheet having
first, second, third and fourth edges and a fold; said first and
second edges being opposite to said fold; said third edge including
first and second portions; said first portion of said third edge
being bonded to said second portion of said third edge; said fourth
edge including first and second portions; said first portion of
said fourth edge being bonded to said second portion of said fourth
edge.
28. A method as set forth in claim 26, wherein said panels are
bonded along said fold.
29. A method as set forth in claim 27, wherein said panels are
bonded along said fold.
30. A method as set forth in claim 25, wherein said material is
SMS.
31. A method as set forth in claim 25, wherein said panels are
bonded only along at least portions of adjacent edges, whereby
central portions of said panels are not bonded.
32. A method for sterilizing an article comprising: providing an
article; wrapping the article with sterilization material which
comprises: a single sheet of sterilization material; said sheet
having first, second, third and fourth edges; said sheet being
folded in half, wherein a fold from said third edge to said fourth
edge is formed; first and second overlapping panels forming two
layers of sterilization material; said first edge is adjacent to
said second edge, wherein two layers of sterilization material is
provided for an article to be sterilized using a single sheet of
sterilization material; said panels being bonded together; applying
sterilization conditions to the wrapped article.
33. A two-ply sterilization wrap comprising: a single sheet of
sterilization material; said sheet having two folds forming first
and second overlapping equally sized panels; said sheet having
first and second edges; said first edge overlapping said second
edge forming an overlapping zone; said first edge being bonded to
said second edge within said overlapping zone.
34. A sterilization wrap as set forth in claim 33, wherein said
sheet has third and fourth edges; said third edge including first
and second portions; said first portion of said third edge being
bonded to said second portion of said third edge; said fourth edge
including first and second portions; said first portion of said
fourth edge being bonded to said second portion of said fourth
edge.
35. A two-ply sterilization wrap comprising: a single sheet of
sterilization material; said sheet having two folds forming first
and second overlapping equally sized panels; said sheet having
first and second edges; said first edge overlapping said second
edge forming an overlapping zone; said sheet having third and
fourth edges; said third edge including first and second portions;
said first portion of said third edge being bonded to said second
portion of said third edge; said fourth edge including first and
second portions; said first portion of said fourth edge being
bonded to said second portion of said fourth edge.
36. A two-ply sterilization wrap comprising: a single sheet of
sterilization material; said single sheet including at least one
fold forming first and second panels; said first panel being
contiguous with said second panel; said sheet including first and
second portions; said first portion being bonded to said second
portion so that said first panel will remain contiguous with said
second panel.
37. A sterilization wrap as set forth in claim 33, wherein said
first panel is bonded to said second panel.
38. A method for sterilizing an article comprising: providing an
article; wrapping the article with sterilization material which
comprises: a single sheet of sterilization material; said sheet
having two folds forming first and second overlapping equally sized
panels; said sheet having first and second edges; said first edge
overlapping said second edge forming an overlapping zone; said
first edge being bonded to said second edge within said overlapping
zone.
39. A method as set forth in claim 38, wherein said sheet having
third and fourth edges; said third edge including first and second
portions; said first portion of said third edge being bonded to
said second portion of said third edge; said fourth edge including
first and second portions; said first portion of said fourth edge
being bonded to said second portion of said fourth edge.
40. A method for sterilizing an article comprising: providing an
article; wrapping the article with sterilization material which
comprises: a single sheet of sterilization material; said single
sheet including at least one fold forming first and second panels;
said first panel being contiguous with said second panel; said
sheet including first and second portions; said first portion being
bonded to said second portion so that said first panel will remain
contiguous with said second panel.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to sterilizing articles utilizing
sterilization wrap. More particularly, it relates to sterilization
wrap having two plies of sterilization material.
[0002] Reusable medical instruments must be sterilized prior to
each use. Normally, these instruments are sterilized by steam or
ethylene-oxide. In order for the instruments to remain sterile
after the sterilization procedure, the instruments must be wrapped
in a material called "sterilization wrap".
[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 and ethylene-oxide to penetrate through the material
to the surgical instruments, but has filtration properties
sufficient to prevent the passage of most pathogens
therethrough.
[0004] In most hospitals, there is a protocol which requires
surgical instruments to be wrapped with two separate sheets of SMS
so that in the event 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 nurse
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 wrap the
instruments again.
[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 Sterilization Wrap". One Step
Sterilization Wrap is made by bonding two separate sheets of
sterilization wrap together. The Kimberly-Clark One Step product is
described in U.S. Pat. Nos. 5,635,134 and 5,688,476. However,
because the One Step wrap requires separate sheets to be bonded
together, manufacturing costs are substantially increased. In
addition, it requires precise alignment of the two separate movable
sheets during the bonding process.
[0006] Thus there is a need for a sterilization wrap which provides
two layers of protection, yet is inexpensive to manufacture and is
easy to use.
OBJECTS OF THE INVENTION
[0007] It is therefore one object of this invention to provide an
improved two-ply sterilization wrap.
[0008] It is another object of this invention to provide a two-ply
sterilization wrap which is inexpensive to manufacture and is easy
to use.
[0009] It is still another object of this invention to provide an
improved method for sterilizing an article utilizing an improved
two-ply sterilization wrap.
SUMMARY OF THE INVENTION
[0010] In accordance with one form of this invention, there is
provided a sterilization wrap made from a single sheet of
sterilization material. The sheet has first, second, third and
fourth edges. The sheet is folded in half forming first and second
overlapping panels and two layers of sterilization material. The
fold runs from the third edge to the fourth edge. Because of the
fold, the first edge is adjacent to the second edge and thus two
layers of sterilization material are provided for an article to be
sterilized by using a single sheet of sterilization material. The
two panels may be affixed together along the first and second
edges.
[0011] In addition, the third edge includes first and second
portions and the fourth edge also includes first and second
portions. The first panel may be also affixed to the second panel
by bonding the first portion of the third edge to the second
portion of the third edge, and by bonding the first portion of the
fourth edge to the second portion of the third edge. In addition,
the two panels may be affixed together by bonding adjacent to the
fold.
[0012] In accordance with another form of this invention, there is
provided a two-ply sterilization wrap made from a single sheet of
sterilization material. The sheet is folded in half forming first
and second overlapping equally sized panels. Each panel has edges.
The first panel is bonded to the second panel so that the edges of
the first panel remain adjacent to the edges of the second
panel.
[0013] In accordance with another form of this invention, there is
provided a two-ply sterilization wrap made from a single sheet of
sterilization material. The sheet includes two folds. The sheet
includes first, second, third and fourth edges. The first edge is
adjacent to the second edge, and the third and fourth edges are
opposite from one another. The folded sheet forms two adjacent
equally sized panels. The first and second edges form an
overlapping region. The first and second edges are bonded together
along the overlapping region. The third edge includes first and
second adjacent portions, and the fourth edge includes first and
second adjacent portions. The first portion of the third edge may
be bonded to the second portion of the third edge, and the first
portion of the fourth edge may be bonded to the second portion of
the fourth edge.
[0014] In accordance with another form of this invention, there is
provided a method for sterilizing an article, including the steps
of providing an article, wrapping the articles with sterilization
wrap which is formed in accordance with one or more of the above
described designs, and applying sterilization conditions to the
wrapped article.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] 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:
[0016] FIG. 1 is a plan view of the sterilization wrap in
accordance with this invention, but prior to being folded;
[0017] FIG. 2 is a plan view of the sterilization wrap of FIG. 1,
but after having been folded, in accordance with this subject
invention;
[0018] FIG. 3 is another embodiment of the invention shown in FIG.
2;
[0019] FIG. 4 is an alternative embodiment of that shown in FIG.
2;
[0020] FIG. 4A is an alternative embodiment of that shown in FIG.
2;
[0021] FIG. 5 is an alternative embodiment of that shown in FIG.
2;
[0022] FIG. 6 is an alternative embodiment of that shown in FIG.
2;
[0023] FIG. 7 is an alternative embodiment of that shown in FIG.
2;
[0024] FIG. 8 is a perspective view of the embodiment of FIG. 3
having materials to be sterilized in preparation for wrapping;
[0025] FIG. 9 is a side elevational view of the embodiment of FIG.
1 viewed from Lines 9-9;
[0026] FIG. 10 is a right side elevational view of the embodiment
of FIG. 2;
[0027] FIG. 11 is a right side elevational view of the embodiment
of FIG. 4;
[0028] FIG. 12 is a perspective view of an alternative embodiment
of the invention;
[0029] FIG. 13 is a plan view of an alternative embodiment of FIG.
12;
[0030] FIG. 14 is a side elevational view of the embodiment of FIG.
12 viewed from Lines 14-14;
[0031] FIG. 15 is an alternative embodiment of that shown in FIG.
14;
[0032] FIG. 16 is an alternative embodiment of that shown in FIG.
12.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0033] Referring now more particularly to FIG. 1, there is provided
single sheet 10 which is made of sterilization material, which is
preferably a three-ply laminate having a layer of melt blown
polypropylene sandwiched between two layers of spun bonded
polypropylene, referred to as SMS. A side elevational view showing
the melt blown layer 12 sandwiched between spun bonded layers 14
and 16 is shown in FIG. 9. The layers 12, 14 and 16 are laminated
or fixed together by a series of closely spaced small bond points
consisting of ultrasonic welds. For simplicity, so as not to be
confused with other bond points which are used for different
purposes describe below, these SMS bond points are not shown. SMS
is commercially available from Kimberly-Clark Corporation.
[0034] Sheet 10 includes first edge 22, second edge 24, third edge
26 and fourth edge 28. Third edge 26 includes a first portion 30
and a second portion 32, which are equal in length, and fourth edge
28 includes a first portion 34 and a second portion 36, which are
also equal in length.
[0035] The single sheet of sterilization material 10 is folded in
half along the fold line indicated by dotted line 18 from third
edge 26 to fourth edge 28. The resulting folded article becomes
two-ply sterilization wrap 20, as indicated in FIG. 2.
Sterilization wrap 20 includes two equally sized panels 38 and 40
having first edge 22 which is aligned with and is adjacent to edge
24. First portion 30 of edge 26 is aligned with and is adjacent to
second portion 32 of edge 26. First portion 34 of edge 28 is
aligned with and is adjacent to second portion 36 of edge 28. As
shown in FIG. 2, a single sheet two-ply sterilization wrap has been
formed by simply folding an elongated sheet of sterilization
material in half. However, it is preferred that the two panels 38
and 40 be bonded together. The preferred method of bonding is
ultrasonic bonding which will result in bond points. Alternatively,
hot melt glue, heated knife or wire, laser, water jet, or
mechanical embossing may be used. Preferably, the central portions
41 and 43 of panels 38 and 40 are not bonded together.
[0036] When the phrase "edges are bonded together" is used herein,
it should be understood that the bonding may occur on the material
adjacent to the edges, or on the edges themselves.
[0037] In one embodiment, shown in FIG. 3, the sheets are bonded
together by a plurality of bond points 42 which are formed by
ultrasonic bonding using a known procedure. These bond points 42
are provided along edges 22 and 24 so that the panels 38 and 40 are
bonded together only along edges 22 and 24.
[0038] FIG. 4 shows an alternative embodiment, which includes a
plurality of bond points 44, which are provided along first portion
34 of edge 28 and second portion 36 of edge 28, and a plurality of
bond points 46, which are provided along first portion 30 of edge
26 and second portion 32 of edge 26.
[0039] FIG. 4A shows an alternative embodiment, which includes the
bond points 44 and 46, and also includes bond points 42 along edges
22 and 24, i.e., a combination of the embodiments of FIGS. 3 and
4.
[0040] FIG. 5 shows a modified version of the embodiment of FIG. 3,
whereby a plurality of bond points 48 are provided by bonding along
the fold line 18 so that the two panels 38 and 40 will stay
together along fold line 18.
[0041] FIG. 6 shows another alternative embodiment to that of FIG.
4, which also includes bond points 48 along fold line 18, as well
as bond points 44 and 46 described above, but omits the bond points
along edges 22 and 24.
[0042] FIG. 7 shows yet another alternative embodiment which
includes bond points 42, 44, 46 and 48 on all of the edges and the
fold of the two-ply sterilization wrap.
[0043] FIG. 8 shows the single sheet two-ply sterilization wrap
embodiment of FIG. 3 having articles 50 to be sterilized placed
thereon in preparation for wrapping. Article 50 is wrapped by
sterilization wrap 20 in a known fashion. Tape is placed over the
wrapped article and the wrapped articles 50 are subjected to
sterilization conditions, such as steam or ethylene-oxide. The
other embodiments of the invention described herein may also be
used to wrap article 50 for sterilization.
[0044] FIGS. 12 through 14 show still another embodiment of the
invention. Sterilization wrap 52 includes two plies 54 and 56,
which is preferably made from the SMS sterilization material shown
in FIG. 9. The sterilization wrap 52 is also made of a single sheet
of sterilization material, but has been folded twice, namely, at
folds 58 and 60 so that edge 62 overlaps edge 64 forming an overlap
zone 66. The edges 62 and 64 are bonded together along overlap zone
66, preferably by ultrasonic bonding, resulting in bond points 68.
The two folds 58 and 60 form first panel 70 and second panel 72,
which are equal in size and which completely overlap one another.
The third edge 74 of the single sheet includes first portion 76 and
second portion 78. First portion 76 and second portion 78 of third
edge 74 are adjacent to one another. As shown in FIG. 13, the first
portion 76 of edge 74 and the second portion 78 of edge 74 may be
bonded together, again, by using ultrasonic bonding, thereby
forming bond points 79. Likewise, the first and second portions of
the fourth edge 80 may also be bonded together in an identical
fashion.
[0045] As shown in FIG. 15, the bond points 68 may also provide
bonding between panels 70 and 72. That is, the bond 68 may go all
the way through to panel 72, which will help stabilize the
sterilization wrap.
[0046] FIG. 16 shows still another embodiment of the invention,
which is similar to that shown in FIG. 13, except that the article
is only bonded along the third edge 74 and the fourth edge 80, as
shown by bond points 82 and 84, i.e., there is no bonding along the
overlap of edges 62 and 64. Alternatively, the embodiments of FIGS.
12 and 16 could be combined, as shown in FIG. 13, so that the
overlap of edges 62 and 64 are bonded as well as edges 74 and 80.
By using the embodiments shown in FIGS. 4A, 7 and 13, there are no
loose, i.e., unsealed, edges. By sealing all edges, the fiber and
particle generation often associated with untreated edges of SMS is
reduced.
[0047] The sterilization wrap assembly of the subject invention is
easy to manufacture in that it is simply cut into the rectangular
shape shown in FIG. 1 and folded into two equal sized panels in the
shape shown in FIG. 2. Once the sheet 10 is cut, only a single
sheet is used during the manufacturing of the sterilization wrap.
Preferably, the two panels are bonded together by ultrasonic
welding, which is commonly used to manufacture SMS. Thus there is
no need for the nurse to handle two separate sheets of
sterilization wrap, nor is there a need for the manufacturer to
handle two separate sheets of sterilization wrap and bond the two
separate sheets together.
[0048] From the foregoing description of the preferred embodiments
of the invention, it will be apparent that many modifications may
be made therein. It will be understood, however, that the
embodiments of the invention are an exemplification 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.
* * * * *