Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1998-09-04
2001-06-19
McKane, Elizabeth (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S300000, C206S370000, C206S438000
Reexamination Certificate
active
06248293
ABSTRACT:
BACKGROUND
The present disclosure relates, in general, to a trayliner for a sterilization process. Even more particularly, the present disclosure relates to a trayliner for cushioning articles in a low temperature hydrogen-peroxide gas plasma sterilization system.
As is well known, articles used in the health care industry, such as surgical instruments, must be sterilized before and after each use. Many articles, such as fiber optic endoscopes, laser handpieces, power drills and ophthalmic devices, are very delicate and, thus, are preferably cushioned when being sterilized to prevent costly repairs and to reduce down time.
There are generally three sterilization processes for use on surgical equipment: high temperature steam, ethylene oxide, and low temperature hydrogen-peroxide gas plasma. For a number of well-known reasons, hydrogen-peroxide gas plasma sterilization is becoming the preferred sterilization method. For example, hydrogen-peroxide gas plasma sterilization has significantly less corrosive effect on metal surgical instruments, and leaves no residue that may cause the sterilized surgical instruments to be irritating or toxic to patients. In addition, hydrogen-peroxide gas plasma sterilization produces no toxic byproducts and requires no special ventilation or aeration.
A STERRAD® hydrogen-peroxide plasma sterilization system available from Advanced Sterilization Products of Irvine, Calif., for example, is designed to provide non- toxic, dry, low-temperature sterilization in about one hour, without toxic residues. However, the STERRAD® system is not usable with cellulose-based products like linen or paper normally used in other sterilization processes. Cellulose-based products, as well as many other materials commonly used in sterilization, are absorbent and trap fluid during the sterilization process. During hydrogen-peroxide plasma sterilization, absorbent materials can cause an unwanted residue to be left on the articles being sterilized. Thus, the use of such absorbent materials in the hydrogen-peroxide sterilization process requires different cycle parameters to achieve sterilization, without leaving a residue on the article being sterilized, in a fixed cycle of the current design.
The STERRAD™ system includes a sterilization chamber and a tray for holding surgical instruments and articles such as fiber optic endoscopes, laser handpieces, power drills and ophthalmic devices, within the sterilization chamber during the sterilization process. The tray includes a base having a multiplicity of holes for allowing plasma to flow therethrough and contact the article being sterilized during the sterilization process.
One existing trayliner for use with the STERRAD® system is available from Cygnus Medical of Branford, Conn., under the trademark Plasma-Cel™ and consists of a sheet of open cell polyethylene foam. While this trayliner is not cut to the exact dimensions of the tray, the trayliner generally covers the base of the tray of the STERRAD® system to cushion surgical instruments during the sterilization process. The open cell structure of the plastic foam trayliner allows plasma to pass directly through the trayliner, such that the foam trayliner does not interfere with the passage of plasma through the tray holes. While this particular open cell foam trayliner has been found to work with the STERRAD® system, since open cell polyethylene is relatively expensive, the Plasma-Cel™ trayliner typically is reused a number of times to make each individual trayliner cost effective. Thus, users are instructed that they may reuse the Plasma-Cel™ trayliner up to five times. It is unlikely, however, that users feel comfortable with the idea of reusing, and keeping track of the number of uses of, a sterilization trayliner in a sterile hospital environment. Thus, the relatively expensive open cell polyethylene foam trayliners are often disposed of after a single use.
What is still needed, accordingly, is a trayliner for cushioning articles, such as fiber optic endoscopes, laser handpieces, power drills and ophthalmic devices, in a hydrogen-peroxide gas plasma sterilization system. Preferably, the trayliner will have low absorbency, yet will allow the passage of plasma therethrough, such that an article can effectively be sterilized in a hydrogen-peroxide gas plasma sterilization system. In addition, the trayliner will preferably be relatively inexpensive such that disposing of the trayliner after a single use is cost effective.
SUMMARY
Accordingly, a method for sterilizing an article in a hydrogen-peroxide gas plasma sterilization unit is provided. The method includes positioning a closed cell foam plastic trayliner within the sterilization unit, positioning the article onto the trayliner, and operating the hydrogen-peroxide gas plasma sterilization unit.
According to one aspect, the foam plastic is provided as closed cell polyethylene.
According to another aspect, the foam plastic is provided as Cell-Aire® polyethylene foam.
According to an additional aspect, the foam plastic trayliner is provided with a multiplicity of holes.
According to a further aspect, the sterilization unit includes a tray having a base with a multiplicity of holes. The method further includes configuring the foam plastic trayliner with a multiplicity of holes arranged such that at least a portion of the holes of the trayliner will be generally aligned with at least a portion of the holes of the base of the tray when the trayliner is positioned on the base of the tray, and positioning the foam plastic trayliner on the base of the tray such that at least a portion of the holes of the trayliner are generally aligned with at least a portion of the holes of the base. The article to be sterilized is then placed on the trayliner in the tray, and the tray containing the trayliner and the article is placed within the sterilization unit.
According to yet another aspect, the method additionally includes removing the article from the sterilization unit after the article has been sterilized, and disposing of the foam plastic trayliner after a single sterilization process.
Another method of sterilizing an article is provided and includes positioning a closed cell foam plastic trayliner having a multiplicity of holes into a tray, and positioning the article onto the foam plastic trayliner. The tray containing the trayliner and the article is then placed in a sterilization unit, and the sterilization unit is operated.
According to one aspect, the tray includes a base with a multiplicity of holes. The method also includes arranging the multiplicity of holes of the foam plastic trayliner such that at least a portion of the holes of the trayliner will be generally aligned with at least a portion of the holes of the base of the tray when the trayliner is positioned on the base of the tray, and positioning the foam plastic trayliner on the base of the tray such that at least a portion of the holes of the trayliner are generally aligned with at least a portion of the holes of the base.
According to another aspect, the method also includes removing the tray from the sterilization unit after the article has been sterilized, removing the article from the tray, and disposing of the foam plastic trayliner.
A trayliner is provided for cushioning an article contained in a tray including a base having a multiplicity of holes. The trayliner is a closed cell plastic foam and has a multiplicity of holes arranged such that at least a portion of the holes of the trayliner will be generally aligned with at least a portion of the holes of the base of the tray when the trayliner is positioned on the base of the tray.
According to one aspect, the foam plastic comprises closed cell polyethylene.
According to another aspect, the foam plastic is Cell-AireO polyethylene foam.
Still other features and advantages will become apparent upon reading the following detailed description in conjunction with the drawings and the appended claims.
REFERENCES:
patent: D. 263076 (1982-02-01), Sandel
patent: D. 263745 (1982-04-01), Sandel
patent: 4142632 (19
Davis Phillip
DiPinto Vito L.
General Hospital Supply Corporation
McKane Elizabeth
Phillips Roger C.
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