Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing
Reexamination Certificate
2002-04-09
2004-09-21
Thornton, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
C053S425000, C053S466000, C053S467000, C422S028000, C422S040000, C428S036100
Reexamination Certificate
active
06793879
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to sterilization wrap. More particularly, it relates to sterilization wrap having two sheets of sterilization material.
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”.
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 and maintain sterility after the sterilization process. The wrap also protects articles during sterilization, and acts as a filtration medium for the sterilant.
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 package containing the instruments.
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 near two of the edges of the adjacent sheets. The Kimberly-Clark One Step product is described in U.S. Pat. Nos. 5,635,134 and 5,688,476.
FIG. 1
shows one of the Kimberly-Clark One Step products described in these Kimberly-Clark patents. Sterilization wrap
10
includes a top layer
12
made of SMS and a bottom layer
14
also made of SMS. 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 insuring that the two sheets are visually distinguishable as separate sheets is so that the user will know 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 will 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. Thus, there is a need for a sterilization wrap which provides two layers of protection and which overcomes the problems of the prior art.
OBJECTS OF THE INVENTION
It is therefore one object of this invention to provide an improved two-sheet sterilization wrap.
It is another object of this invention to provide a two-sheet sterilization wrap which is easy to use.
It is still another object of this invention to provide an improved two-sheet sterilization wrap which is less likely to be contaminated and is less likely to be pulled apart.
It is yet another object of this invention to provide a method for sterilizing an article utilizing an improved two-sheet sterilization wrap.
It is still another object of this invention to provided a two sheet sterilization wrap which eliminates confusion by the user regarding the number of sheets in each wrap.
SUMMARY OF THE INVENTION
In accordance with one form of this invention, there is provided a sterilization wrap made from two sheets of sterilization material. Each sheet has first, second, third and fourth edges. Each sheet includes a central portion. The first edge of the first sheet is in register with and bonded to the first edge of the second sheet. The second edge of the first sheet is in register with and bonded to the second edge of the second sheet. The third edge of the first sheet is in register with and bonded to the third edge of the second sheet. The fourth edge of the first sheet is registered with and bonded to the fourth edge of the second sheet. The central portions of each sheet are substantially not bonded together. Thus two layers of sterilization material is provided for the article to be sterilized. The region between the central portion of each sheet is protected from contaminates and the bonded edges of the wrap are readily grasped by the person wrapping the articles to be sterilized.
In accordance with another form of this invention, there is provided a method for sterilizing an article, including the step of providing the article, wrapping the article with sterilization wrap made in accordance with the above-described design, and applying sterilization conditions to the wrapped article.
REFERENCES:
patent: 3761013 (1973-09-01), Schuster
patent: 3780857 (1973-12-01), Rosano, Jr. et al.
patent: 4196245 (1980-04-01), Kitson et al.
patent: 4201031 (1980-05-01), Wiles
patent: 4342392 (1982-08-01), Cox
patent: 4581874 (1986-04-01), Rechtsteiner et al.
patent: 4644586 (1987-02-01), Padgett
patent: 4644732 (1987-02-01), Morton
patent: 4863785 (1989-09-01), Berman et al.
patent: 5072832 (1991-12-01), Valentine et al.
patent: 5635134 (1997-06-01), Bourne et al.
patent: 5638661 (1997-06-01), Banks
patent: 5673541 (1997-10-01), Arzuman et al.
patent: 5688476 (1997-11-01), Bourne et al.
patent: 5879620 (1999-03-01), Cohen
patent: 6406764 (2002-06-01), Bayer
patent: 6630104 (2003-10-01), Bayer
Bayer Robert T.
Church William F.
Everson Stephen R.
Hoge Brian G.
Pasternack David G.
Carter, Schnelder & Monteith, P.A.
Thornton Krisanne
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