US 3061087 A
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Description (OCR text may contain errors)
1962 G. w. SCRIVENS ET AI. 3,061,087
STERILE SPONGE PACKAGE Filed May 8, 1959 ATTO R N EY United States Patent Office 32,661,087 Patented Oct. 30, 1962 3,061,087 STERHE SPQNGE PACKAGE George W. Scrivens, Nixon, and Robert J. Trewella, Miiltown, N.J., assignors to Johnson 8: Johnson, a corporation of New Jersey Filed May 8, 1959, Ser. No. 811,946 1 Claim. (til. 206-632) The present invention is drawn to the sterile packaging of fiat sponges and more particularly to the packaging of flat sponges in such manner that they can be sterilized in the package and readily removed therefrom without fear of contamination.
In operating procedure, a great deal of care is taken not to contaminate the operating instruments or the dressings, sponges, and other items used during the operation. Thus, in the operating room, in order to assure asterile technique, there is generally a sterile nurse and an unsterile nurse, it being the unsterile nurses function to open packages of sterile dressings, bandages, etc., since the wrapper or outside of the package is not sterile, and to pass the sterile contents to the sterile nurse in such a manner that there is no danger of any contamination reaching the sterile nurse or the so-called sterile field. In this way, a sterile technique is maintained.
After a package having sterile contents is opened, the problem then arises of how to pass the contents to the sterile nurse without contaminating the sterile nurse or any other area in the sterile field. The present invention is drawn to so packaging fiat sponges that they can be readily sterlized after being packed so that they remain sterile until opened in the operating room and so that they can then be passed from the unsterile nurse to the sterile nurse without any danger of contamination.
It is an object of this invention to provide a package for flat sponges in which the sponges can be sterilized after the package has been scaled. It is a further object of the present invention to provide a package of sterile fiat sponges from which the sponges can be readily removed from the sterile package and passed to a sterile field without any contamination of the field. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein are set forth by way of illustration and example certain embodiments of this invention.
In accordance with the present invention, the sponges are placed in a plastic container made of a thermoplastic material having a Vicat softening temperature above 200 F. Examples of materials suitable for this purpose are linear polyethylene and polypropylene. Linear polyethylene is preferred. The container has a rim extending completely around its top open side to which is sealed a bacteria impervious porous covering paper which can be readily peeled back off of the package to expose the sterile sponges within without the cover at any time contacting the sponges. Since the container cannot be inverted to drop out the sponges onto a sterile field, for this would bring the unsterile container over the sterile field, it is necessary to provide some means whereby the sponges can be removed from the container without bringing the container or its cover into the sterile area. Accordingly, a band is passed around all of the sponges prior to packaging so that it is only necessary for the band to be grasped by a sterile instrument, such as sterilized forceps, and lifted from the container by the sterile nurse.
The invention is further described by reference to the drawings, in which:
EEG. 1 illustrates a sealed package of flat sterile sponges;
FIG. 2 shows the package with the peelable cove partially removed; and
FIG. 3 shows the sterile sponges together with the sterile strap removed from the package.
Referring to the drawings, the sponges 10 are first stacked and then held together by a band or wrap 11 formed of paper or other suitable material. The band 11 is provided with a raised ridge 18 which may either be formed by folding the band or by bringing the ends of the material together to form the ridge when the band is being formed. The ridge 18 is preferably located centrally with respect to the stack of sponges. The sponges so banded are placed in a plastic container 12 having a dished body 13 and a peripheral rim 14. The container 2 is preferably formed of a thermoplastic resin material such as polyethylene. After the banded sponges are placed in the container 12, the container is sealed closed by a paper cover sheet 15 which is sealed around its edges, as at 16, to the container rim 14. Where the container 12 is of polyethylene or other thermoplastic material, the paper cover 15 can be sealed at its edges to the rim 14, which is provided with a horizontally extending flange, through pressure and heat to provide a good seal. Otherwise, a suitable cement may be used. The paper cover 15 should preferably be of a grade such that the paper yields at the point of bonding without leaving strips of delaminated paper clinging to and extending from the tray edge when the cover is removed. Where the paper used has a tendency to peel, it should be bonded to the container rim 14 with an adhesive that will yield prior to tearing of the paper so that the paper cover can be removed Without leaving strips of paper adhering to the container.
The package must be able to breathe in order to enable the same to be properly sterilized. Also, the package must be impervious to air-borne bacteria. The pore size of the paper cover used is therefore critical. It has been found that the paper used for the cover should have an air porosity as given by the Gurley-Hill SP tester of about 45 sec. to 3500 sec./ ml. air porosity. This indication conforms with the T.A.P.P.I. method T460m-49, and is the time for passage of 100 ml. of air through 1 square inch of paper. The paper used in the cover should also have a wet tensile strength in pounds per inch width of at least 1.5 lbs. in the machine direction and 0.5 lb. in the cross direction and a dry tensile strength of at least 10 lbs. in the machine direction and 5 lbs. in the cross direction in order to be suitable for the packages of the present invention. Where tensile strength is given in the specification and claims, it is the force in pounds required to break a paper one inch in width. The preferred papers have an air porosity as given by the Gurley-Hill S-P-S tester of 65 sec. to 300 sec/100 ml., a wet tensile strength of at least 3 lbs. in the machine direction and 1.5 lbs. in the cross direction, and a dry tensile strength of at least 12 lbs. in the machine direction and 8 lbs. in the cross direction. The porosity rating and tensile strength in the above units can be obtained from most paper manufacturers for the papers they sell.
Although papers having a pore size of 45 sec. have been found to satisfactorily filterout air-borne bacteria, a nonuniform paper may give a test indicating a suitable pore size but may have several pores of a size sufficiently larger to permit the access of bacteria. It is accordingly the safest practice to check any new stock and not rely entirely on the pore size as indicated by the T.A.P.P.I. Standard T460-m49 test procedure. Also, papers used should be of a high grade and uniform quality so as to avoid the possible inclusion of inferior sheets of unsatisfactory pore size. The ability of a paper to act as a bacterial filter is tested in the following manner. The sample paper is fabricated into rectangular envelopes, and a gauze pad is placed into each envelope. The edges of each envelope are securely sealed with adhesive or cellophane tape and the packages are then steam sterilized according to USP. procedures, Sterilization Process C. Upon removal, the packages are exposed to air-borne bacterial penetration normally encountered in various storage conditions. After exposure for several Weeks, the contents of each envelope are tested for sterility as outlined in U.S.P., Sterility Tests for Liquids and Solids, Sterility Test for Purified Cotton, Gauze, and Surgical Dressings. Papers allowing no contamination are acceptable bacterial filters.
The paper cover 15 extends on one corner of the container beyond the seal line 16 to provide a tab 17. The cover is removed by simply grasping this tab and peeling back the cover, as illustrated in FIG. 2. 1
In the operating room, the unsterile nurse holds the container 12 in the palm of one hand While With the other she grasps the tab and peels back the cover 13, as illustrated in FIG. 2. After the cover is completely removed, the sterile nurse lifts out the contents of the container 12 by grasping raised ridge or fin 18 of the tie band 11 and moving the package of sterile sponges into the sterile field Where the tie band 11, after the sponges are counted, is removed leaving the stack of sterile sponges completely accessible.
The invention has been illustrated in connection with one embodiment thereof, although many modifications are Within its spirit. It is to be limited, therefore, only by the scope of the appended claim.
Having thus described our invention, we claim:
' An air permeable bacteria-proof sterile sponge package comprising a rectangularly-shaped dished container, a
horizontally extending flange around the periphery of said container, a plurality of sterile sponges in said container, a sterile band around said sponges, a single tab extending from the top of said sterile band and positioned on top of said sponges, said tab adapted to be grasped for removai of said sponges from said container when said container is opened and an air pervious bacteria impervious paper cover for said container secured to said flange in a seal line extending around the entire periphery of said container to seal the interior of said container against the entry of bacteria, said paper cover extending beyond said seal line to provide a tab portion to be grasped on opening said container, said paper cover having a porosity of 65 sec. to 300 sec., a wet tensile strength in excess of 1.5 lbs. in the machine direction and 0.5 1b. in the cross direction, and a dry tensile strength in excess of 10 lbs. in the machine direction and 5.0 lbs. in the cross direction, said paper cover being removable from said container without tearing said paper cover by grasping said tab portion and peeling back said cover.
References Cited in the file of this patent UNITED STATES PATENTS 829,923 Lee Aug. 28, 1906 1,909,126 Satterwhite May 16, 1933 2,433,056 Masci Dec. 23, 1947 2,736,656 Marshall Feb. 28, 1956 2,996,948 Zackheim July 4, 1961 FOREIGN PATENTS 442,835 Great Britain Feb. 17, 1936