US3084793A - Sterile package and method - Google Patents

Description

April 9, 1963 G. A. PITMAN' 3,084,793

STERILE PACKAGE AND METHOD JNVENTOR. G/LBERT A. P/TMAN www A 7' TOPNE VS G. A. PITMAN April 9, 1963 STERILE PACKAGE AND METHOD 2 sheets-sheet 2 Filed July 27, 1959 INVENTOR. GLBERT A.' P/TMAN ATTORNEYS United States atent hhce 3,084,793 Patented Apr. 9, 1953 3,084,793 STERILE PACKAGE AND MEFHD Giibert A. hitman, San Leandro, Calif., assigner to Crown Zeiierbach Corporation, San Francisco, Calif., a corporation of Nevada Fiieri .iniy 27, 195:9, Ser. No. 829,759 6 Ciaixns. {Ci. Minn-63.2)

This invention relates generally to a sterile package. More particularly this invention relates to a package in which a sterile medical product, such as a hypodermic syringe or the like, is encased and in which such product is maintained sterile until the same is ready for use. Furthermore, the invention relates to a sterile package comprising a sealed yet breathable pouch type container which is formed of fluid and gas impervious and impermeable material so that the product therein is isolated from the bacteria in the surrounding atmosphere and which includes a so-called breathing wick which is bacteria impervious yet is elfective to provide a conduit or channel through which suitable sterilizing media may pass into the pouch interior after the same has been sealed.

It has been known generally in the art heretofore to employ containers for the packaging of sterile medical products. However, in such prior art constructions sterilization of the medical product has been effected before the same was inserted into the container and before such container was sealed. This prior art sterilization procedure is an expensive and difficult operation in that the entire container sealing mechanism must be maintained sterile throughout the sealing operation so that the medical product in the container will not become contaminated during container sealing.

In addition, it has been generally known in the prior art heretofore to employ paper or like pouches which are completely pervious to fluids and gases in which medical products have been inserted and to sterilize the same after sealing by passing a sterilizing medium such as steam at elevated temperatures through the walls thereof into contact with the products therein. This prior art arrangement, however, fails to protect the sterile product therein during subsequent shipment, storage and prior to use in that should such sterilized containers become damp or wet, for example when used during wartime or the like in the field, contamination of the product can readily result due to deterioration of the pouch material. In addition, if such pervious constructions have been subjected unknowingly to a contaminating inliuence such as moisture, and should the same subsequently become dried without having actually come apart, there is no definite way of knowing that the same had been contaminated previously. As a result, use of the product therein subsequently could result in infection being imparted to the person upon whom the product is used.

Sterile packages of the present invention, however, employ a iiuid and gas impervious and impermeable container which may be sterilized through a breathing wick after sealing so that the expense and inconvenience of maintaining the sealing apparatus sterile is dispensed with. In addition, because the breathable container is formed from a material which is impervious to fluids and gases, contamination of the product therein after sterilization by moisture and the like is precluded.

Accordingly, objects of the present invention include the provision of a breathable container package which may be sterilized after sealing; the provision of a breathing wick in a sterile package through which a sterilizing medium may be introduced into a package; the provision of a container having visual sterility check means incorporated therewith; and the provision of a method of steriiizing a medical product after the same has been inserted into a sealed container. These and other objects will become evident from studying the following description in which reference is directed to the accompanying drawings.

FIG. l is a plan View of a sealed sterile package of the present invention illustrating in phantom lines a medical product retained therein;

FIG. 2 is a plan view of a modified package construction; y

FIG. 3 is a plan view of a further modification of a sterile package;

FIG. 4 is a plan view of a package of the type shown in FIG. l which is enclosed in a similar sterile package;

FIG. 5 is a sectional View on an enlarged scale of the package of FIG. 1 taken in the plane of line 5 5 thereof;

FiG. 6 is an end view of the package of FIG. l on the same scale as FIG. 5 and taken inthe plane of line 6 6 of Fi'G. l;

FiG. 7 is a plan view of an upper corner of the package ofFiG. l on an enlarged scale;

PEG. 8 is a side elevation of the package corner of FIG. 7;

FIG. 9 illustrates a series of sterile packages positioned in a carton;

FIG. l0 illustrates a series of cartons of the type shown in FG. 9 positioned in a large shipping carton in which the individual packages may be sterilized simultaneously prior lto shipment.

It has been known in medical circles heretofore that fibrous materials such as cotton and paper are effective to preclude contamination of medical products after the same have been sterilized. In hospitals and doctors oiiees, it is a frequent practice for sterile articles to be wrapped in a cotton towel or the like which permits air passage therethrough but the iibres of which filter out and preclude passage of contaminating bacteria with the air so that sterility is maintained.

This invention utilizes the ability of a brous material to preclude bacteria passage therethrough and involves the provision of a fibrous conduit or wick in an otherwise fluid and gas impervious container. By providing such a fibrous wick, a medical product may be inserted into a container and the container sealed to exclude bacteria from the surrounding atmosphere so that the only passage of gas into or out of the container must be effected through the wick. In this manner, the air trapped in the pouch when the same is sealed may be Withdrawn through the wick and a suitable sterilizing medium substituted therefor to effect sterilzation of the product therein. After sterilization, sterility of the product is maintained in that, while the sterilizing medium may leave the container and air is free to pass into or out of the container through the wick, bacteria from the atmosphere will be filtered out and its passage stopped by the wick.

While many container constructions may be employed in the sterile package of this invention, desirably substantially fiat pouch type containers are employed. Such pouches are formed from a web or sheet of material at least the inner surface of which is composed of a uid and gas impervious heat scalable material so that when the pouches are formed ends thereof may be rapidly sealed by application of heat.

Such sheets desirably are multi-ply, the outer ply of which may be formed of paper, foil or the like, while the inner ply may be a lrn of a suitable `impervious heat scalable material, such as a thermo-plastic resin, examples of which are polyethylene, Plioiilm or the like. if desited, a -resinous lacquer coating also may be employed.

if it is desired that the pouch be transparent, the outer ply may be of cellophane or glassine, with the inner ply being a transparent resin such as polyethylene. Alternatively, the outer ply may be of a high density polyethylene with the iner ply being of a lower density polyethylene to facilitate heat sealing of the pouch. Also, the pouches could be formed of a free single-ply film of polyethylene or the like.

The web constructions described hereinabove are applicable to each of the pouch constructions described hereinafter.

As shown in FIGS. l, 7 and 8 one pouch embodiment comprises a body 1 formed from a flat two ply sheet of iiuid and gas impervious material defined by an outer ply 2 of paper or the like and an inner heat sealable impervious ply 3. The sheet is folded upon itself to provide opposite pouch walls, each of Which has an inner heat scalable surface. After folding and filling, such pouch is heat sealed in any desired sequence along each of three ends or extremities thereof to provide three fin- type seams 4, 6 and 7 respectively. In the embodiment illustrated a medical syringe 8 and a hypodermic needle 9 are packaged in the container. It should be understood that other sterile medical instruments and products such as gauze bandages, gloves, sutures and the like also may be packaged therein.

As Shown in FIG. 6 each sealed iin is effected by the inner heat sealable surfaces of the opposite walls flowing together to completely seal the container end.

Extending between opposite ns 4 and 6 in the direction of a folded edge 11 of the pouch is an elongated wick 12. Desirably such wick `is formed of a fibrous woven, braided or twisted material, a good example of which is a cotton cord. Wick 12 need not be of unduly large size and it has been found that an eight ply cotton string of the type commonly used in grocery stores and butcher shops is effective for this purpose. Such a string is approximately only 1/16 `inch in diameter. For other pouches, smaller or larger wicks may be used as determined by the pouch size.

Wick 12 extends between opposite seams '4 and 6 and communicates with the hollow interior 13 of the pouch as Shown in FIG. 5. FIG. 6 shows the manner in which the wick end is bonded in and surrounded by the heat scalable material 3 of a seam so that the only passage of gas into or out of the pouch through the sealed end is through wick 12. That is, the wick is securely clamped between opposite wall portions of the respective tins so that no channels or passageways exist about the periphery of the wick in that the heat scalable material iiows therearound and to a certain extent flows into the wick to eliminate all such peripheral channels.

Wick 12 is capable of acting as a pouch opening tear strip in that the same extends between opposite ends of the pouch. That is, if a fin is grasped in the vicinity of a wick end, such as the upper right hand corner of the pouch in FIG. 1, the pouch may be torn along the length of the wick and the Wick will be effective to sever the folded edge 11 of the pouch so that the contents thereof may be easily removed. If desired, a tear initiating notch 14 may be provided in the iin-type seam to facilitate container opening.

The Wick may be positioned at other locations than along the folded edge 11 as shown if so desired, it only being necessary that the ends of the wick extend through the container so that the pouch interior is connected by means of the fibrous wick with the surrounding atmosphere.

A pouch modification 16 is shown in FIG. 2 and is of the so-called pillow type construction which comprises a pair of opposite n-type heat sealed seams 17 and 18 between which extends a fibrous Wick 12 of the type described previously so that the same is capable of the dual purpose of providing a pouch opening tear strip and a gas pervious channel or conduit as mentioned previously.

The pouch of FIG. 2 desirably is formed from a at sheet of paper folded upon itself twice to provide a heat sealed or adhesively secured longitudinal seam 19 extending between opposite pouch extremities. Desirably a tear initiating notch 14 is provided in this pouch embodiment also.

if desired, a pillow type pouch having opposite fin-type seams also may be formed from an extruded tubular sleeve in which a Ilongitudinal seam of the type shown at 19 in FIG. 2 is not necessary. That is, if a thermoplastic material such as polyethylene is extruded in preformed tubular shape, it is merely necessary to seal opposite ends thereof to provide a sealed pouch construction.

A further pouch embodiment 21 is shown in FIG. 3 which comprises four fin- type seams 22, 23, 24 and 26 respectively. This pouch may be formed from two sheets of iiuid and gas impervious material of the type described previously which are sealed together along their margins or may be formed from one sheet folded upon itself and sealed along all four margins thereof. In the embodiment illustrated, a short wick or wicks 27 are employed which do not extend the entire distance between opposite seams of the pouch but instead are positioned to extend merely from the interior of the pouch .through a seam thereof. Any number of such Short w-icks may be employed and may be positioned through the pouch as desired.

It Should be understood that similar short wicks may be employed in place of the long wicks disclosed in either of the pouch modifications described previously.

Short wicks 27 perform their intended function adequately, namely they provide gaseous conduits by means of which a gas may pass between the interior and exterior of the pouch.

In each of the pouches illustrated and described herein the wicks thereof terminate substantially ush with the outer extremities of the sealed seams through which they extend so that projecting wick ends are eliminated which might accidentally be engaged to effect accidental pouch opening. In addition, by terminating the wick ush with the sealed extremity of the pouch a minimum wick surface area is exposed to the atmosphere through which bacterial iiow may be initiated.

While in many -instances sealed pouch type containers are desirable for packaging medical products as illustrated, it should be understood that various other impervious containers, such as boxes, cartons or the like may be provided with gas pervious wicks of the type described, the invention being equally effective regardless of the coniguration and type of container into which it is incorporated.

Because after initial sterilization of the pouch and its contents the exterior thereof may become contaminated during handling and shipment, it frequently is desirable to package a sterile pouch within another similar pouch as shown in FIG. 4. Such figure illustrates an outer sealed pouch 28 having a gas pervious wick 29 extending between opposite seams thereof while a similar sealed pouch 31 having a gas pervious wick 32 therein is positioned inside vof the outer pouch 28. In this manner the sterile contents of the inner pouch 31 are always maintained sterile until the same are ready for use.

As an example of the purpose of this construction, attention is directed to a desirable hospital operating room procedure. If the outer pouch 28 becomes contaminated during handling and shipment, the `same may be opened in a separate non-sterile hospital room and need not be taken into a sterile hospital operating room. That is, inner pouch 31 and Iits contents may be removed outside of the operating room and positioned without direct handling thereof onto a sterile tray and carried into the operating room at which time the `inner pouch may be opened and its contents removed for use during the operation. Because each of the inner and outer pouches have gas pervious wicks therein the contents of inner pouch 31 may be sterilized simultaneously with sterilization of outer pouch 2S.

lt is not necessary under all conditions that the means surrounding the sterile medical product With-in outer pouch 28 be a sealed pouch of the type illustrated at 3l. As noted previously cotton cloth or paper is effective to preclude bacterial transfer therethrough. If desired, for example, the medical product may be wrapped in absorbent cotton, a cotton cloth or paper and inserted into outer pouch 2,8 before the same is sealed. Because the cotton, cloth or paper are gas pervious, sterilizing media introduced into outer pouch 2g may be brought in contact with the medical product in the cotton, cloth or paper tc sterilize the same. rl`=he cotton, cloth or paper may be removed when the outer pouch is opened and transferred in fully sterile condition into an operating room or the like as described previously.

terilization of a pouch and its contents may be effected in the following manner. After the medical product to be sterilized has been inserted into ka breathable pouch and the pouch completely sealed as described previously, the same is inserted into a pressure vessel, such as a conventional autoclave. Thereafter, by applying suction to the autoclave, the air therein is withdrawn and the air from the interior of the pouch is also withdrawn through the fibrous Wick provided. After complete withdrawal of the air from the pouch interior, a suitable sterilizing medium is introduced into the autoclave and automatically fills all spaces previously evacuated of air. That is, by introducing Such sterilizing medium into the autoclave at atmospheric pressure or above, the previously evacuated air spaces are filled with the sterilizing medium and complete sterilization of the medicaly product in thel pouch is effected. If desired the evacuation and sterilizing medium substitution procedure may be repeated several times to insure complete sterilization of the product in the pouch. Desirably, evacuation of the pouch is effected at a rate within the capacity of fiow through the wick so that bursting of the pouch is precluded.

The entire sterilizing operation for single pouches can be completed in a period of several minutes, which time is dependent upon the size of the fibrous wick employed and the internal volume of the pouch. By increasing wick size, sterilizing time may be decreased and vice versa.

Pouches of the present invention also may be sterilized in batch processes by packaging a series of sealed and filled pouches in a pervious, non-air tight paperboard or like carton 32 as shown in FIG. 9. Thereafter, a plurality of such filled cartons 32 may be inserted into a large shipping carton 33 and enclosed therein. Shipping carton 33 also desirably is of a pervious, non-air tight construction formed from paperboard or the like. Thereafter the shipping carton 33 may be inserted into an autoclave and the evacuation of air from and substitution of a sterilizing medium into each of the individual pouches within the individual cartons 32 may be effected simultaneously.

Such a batch process sterilization need not take any longer than sterilization of individual pouches. If a large shipping carton contains several hundred individual pouches, sterilization of the same can be effected in the same short period of time required to sterilize a single pouch. This is so because the shipping cartons employed, as noted previously, are pervious to gas passage and are not sealed air tight. That is, the individual cartons after closing have adequate passages through or between their closure flaps so that the rate yof gas passage in or out of the cartons is determined primarily by the wick size of the individual pouches in the same manner as wick size determines gas flow rate of a single pouch.

As described hereinbefore, desirably the inner ply 3 of each pouch is formed of a heat sealable material. lf desired, however, the ends of the pouches may be sealed by employing adhesive. Heat sealing thereof is preferred however. Desirably the pouches are formed, filled and sealed on automatic pouch machines in one continuous operation with the sterilization operation being performed at` some subsequent time. l

While various sterilizing media may be employed with the present invention, dry gaseous media which are effective at room or low temperatures, such as formaldehyde and ethylene oxide vapors, have been found suitable. By moderately heating the same to a level `well below boiling, such as, for example, C., such dry gaseous vapors are rendered highly effective for sterilizing medical products. The moderate temperature employed, while not being effecitve to produce sterilization in and of itself, is particularly desirable in that low melting point objects, such as plastic hypodermicsyringes and the like are widely used in medical fields today. As a result, sterilization thereof with high temperature steam or the like is not possible in that the high temperatures required for steam sterilization would result in damage to the plastic articles to be sterilized. In addition, steam sterilization would possibly adversely affect the sealed seams of the pouch type containers. Moderate temperature formaldehyde or ethylene oxide is desirable as a result.

By providing the bacteria proof wick in each pouch, vapors such as formaldehyde and ethylene oxide may readily be substituted for air withdrawn from the sealed pouch in the manner described without ldanger of subsequent contamination so long as the pouch is unopened. While two suitable sterilizing media have been mentioned, it should be understood that other suitable gaseous media also may be employed, desirably those which are effective at moderate `or room temperatures.

The'present invention also includes a built-in safety feature which readily indicates whether or not a pouch subjected to a suction atmosphere has `been properly sterilized. As described, each pouch to be sterilized is completely sealed with the wick therein providing a gaseous conduit between the pouch interior and exterior. Should such conduit be inadvertently closed off during the sealing yoperation so that air may not be withdrawn therefrom, when the completely closed pouch is subjected to a partial vacuum in the autoclave, the pouch will rupture or explodev as the air surrounding the same is evacuated. As a result, after the sterilizing operation is cornpleted, it is a simple matter to determine which pouch contents may have been exposed to recontamination. This built-in safety feature readily indicates that ruptured pouches are not suitable for use and the contents thereof may be removed and placed in another pouch for subsequent sterilization.

lf desired additional indicating means may be employed with each pouch to indicate whether the pouch has been sterilized or if, after sterilization, the sterilized condition has changed and the pouch has become contaminated. For example, each breathable wick may be thoroughly impregnated with a suitable indicator composition which indicates by color when the pouch has been completely sterilized or when the sterile condition has changed and the pouch has become contaminated.

For example, if formaldehyde is chosen as the sterilizing medium, the pouch wick may be impregnated with a chemical composition commercially known as Schiffs Reagent which is a commercially available analine dye which normally possesses a red color. By bleaching out this red color in a well-known manner before impregnation of the breathable wick with a bleach reactive with formaldehyde, the wick may be impregnated and still retain its original color. However, when the wick is subjected to the passage of formaldehyde therethrough to effect sterilization of the pouch contents, the formaldehyde reacts with bleach in the Schiffs Reagent to overcome the effect of the bleach and to restore the red color to the reagent. Thereafter, it can immediately be determined visually whether or not the pouch has been subjected to a formaldehyde sterilizing operation.

If desired, other suitable indicators also may be employed, depending upon the sterilizing medium chosen,

which will indicate sterility or lack of sterility `of a given pouch.

From the foregoing it should be understood that following sterilization of a pouch, air from the atmosphere is free to pass between the pouch interior and exterior and the sterilizing medium initially positioned in the pouch interior may pass therefrom without adversely effecting or contaminating the sterilized pouch contents. This is so because the fibrous material of the breathable wick lters out and traps all bacteria which may be present in the atmosphere surrounding the pouch following sterilization so that the pouch contents are maintained sterile until used.

While it is desirable to use low ltemperature sterilizing media, the pouch is formed from a fluid and gas irnpervious material such as metal foil, which is capable of withstanding hot steam or the like, high temperature sterilizing media also may be employed. However, the moderate temperature media discussed herein are preferred.

By employing the method disclosed herein a suitable container of any 'given type or construction may be completely sterilized and the contents thereof maintained sterile until the container is opened. While the breathable wick may be applied to the respective containers in any suitable manner desirably the same are positioned in an open container end prior to sealing of the same on the same automatic machine employed for forming, lling and sealing the containers. Other application methods which may become obvious to one skilled in the art also may be employed however. Soi long as the end of the wick is securely bonded in the container so that the only avenue of g-as travel is through the wick, the manner in which the wick is attached to the pouch and its location therein may be varied to meet a particular need.

Because containers sterilized in the manner described are readily usable, the same are particularly well suited for use by emergency ambulance crews, military first aid units, doctors on call and the like who require sterile instruments or products and who do not have the necessary facilities available for sterilizing the same on the spot. In addition, because of the safety factor imparted to the pouches of this invention by the indicators incorporated therewith or the explosive safety feature thereof, when a pouch reaches its intended user a visual check thereof -rnay readily determine whether or not the same might have been contaminated.

Having made a full disclosure of this invention reference is directed to the `appended claims.

I claim:

l. A package comprising a sealed pouch type container, land a product to be sterilized retained in the interior of said container; said container comprising opposite walls arranged in .generally face-to-face relationship, at least the inner surface of each tof said walls comprising a thermoplastic 'heat sealable material which is impervious to the passage of fluid and gases under normal conditions; each margin of one of said opposite walls being connected with a corresponding margin of the other of said opposite walls whereby all margins of said container sare closed to retain said product therein; at least two of said closed container margins comprising substantially broad at continuous fin type seams, said two seams dening generally opposite margins of said container, each -of said opposite seams being defined by corresponding facing and contacting marginal areas of said opposite Walls which have their inner liuid and gas impervious surfaces heat sealed together uninterruptedly between opposite spaced apart edges dening opposite borders of said areas, such heat sealing extending over the full extent of contact of said areas between said borders so that a generally broad so'lid and continuous heat sealed seam free of unsealed areas is dened between said borders; `and a breathing wick of brous material which is pervious to gases and impervious to bacteria extending cornpletely across said container between and through each of said opposite seams along another margin of said container, opposite end portions of said wick extending through said opposite seams from the interior of said container between the continuously heat sealed inner surfaces which define said opposite seams to the exterior of said container so that the opposite outer ends of said wick are exposed to the atmosphere surrounding said container; the impervious heat sealed material of said Wall inner surfaces in s-aid opposite seams being in intimate contact with and surrounding said wick end portions about their entire peripheries in said opposite seams so that said wick is securely bonded between said wall inner surfaces in said opposite seams and provides the only gas passage therethrough; each of said closed container margins being fluid and gas impervious under normal conditions with said wick providing the sole and exclusive passage for gases between the interior and exterior o-f said container whereby contaminated air trapped within said container dur-ing sealing thereof is withdrawable from said container solely through said wick, and whereby a gaseous sterilizing medium is substitutable for such withdrawn air solely through said wick into contact with said product in said container interior, so that said product may be sterilized after the same has been sealed in :said container; said wick .after product sterilization serving as Ia bacteria filter to preclude contamination of said product so long as said container walls remain intact and sealed together along said seams; said wick being graspable for tearing said container along the length of said another margin thereof for effecting easy opening of said container to gain access to said product after sterilization thereof.

2. A package comprising a sealed pouch type container, and a product to be sterilized retained in the interior of said container; said container comprising opposite walls arranged in ygenerally face-to-face relationship, at least the inner sur-face of each of said walls comprising a thermoplastic heat sea-lable material which is impervious to the passage of lluid and gases under normal conditions; each margin of one of said opposite walls being connected with a corresponding margin of the other of said opposite walls whereby all margins of said container are closed to retain said product therein; at least two of said closed container margins comprising iin type seams, said two seams ydefining generally opposite margins of said container, each of said opposite seams being defined by corresponding facing and contacting areas of said opposite walls which have their inner fluid and gas impervious surfaces heat sealed together; and a breathing wick of fibrous material which is pervious to gases and impervious to bacteria extending `completely across said container between and through each of said opposite seams along another margin of said container, opposite end portions of said wick extending through said opposite seams from the interior of said container between the heat sealed inner surfaces which define said opposite seams to the exterior of said container so that the opposite outer ends of said wick are exposed to the atmosphere surrounding said container; the impervious heat sealed material of said wall inner surfaces in said opposite seams being in intimate cont-act with and surrounding said wick end portions about their entire peripheries in said opposite seams so that said wick is securely bonded between said wall inner surfaces in said opposite seams and provides the only gas passage therethrough; each of said closed container margins being uid and gas impervious under normal conditions with said Wick providing the sole and exclusive passage for gases between the interior and exterior of said container whereby contaminated air trapped within said container during sealing thereof is withdrawable from said container solely through said wick, and whereby a Agaseous sterilizing medium is substitutable for such withdrawn air solely through said wick into contact with said product in said container interior, so that said product may be sterilized after the same has been sealed in said container; said -wick after product sterilization serving as a bacteria filter to preclude contamination of said product so `long as said container walls remain intact and sealed together along said seams; said Wick being graspable for tearing said container along the length of said sealed container having gas and fluid impervious Walls, and a gas pervious and bacteria impervious fibrous wick extending between the interior and exterior of `said second container which provides lthe -sole passage through which another margin thereof for eiecting easy opening of said 5 entrapped air and a gaseous sterilizing medium may pass.

container to gain access to said product after sterilization thereof.

3. The package of claim 2 in which said wick is a thin bacteria impervious cotton cord.

4. The package of claim 2 in which said Wick is im- 10 pregnated with an indicator whereby the sterile condition of said package may be determined Visually by viewing the color of said Wick.

5. The package of claim 2 in which said product in said container interior is surrounded by means which is impervious to Ibacteria for maintaining said product sterile after lsaid ycontainer is opened.

6, The package of claim 5 in which said means surrounding said product comprises a second and separate References Cited in the file of this patent UNITED STATES PATENTS 2,402,982 Steenbergen July 2, 1946 2,542,957 Adams Feb. 20, 1951 2,883,262 Borin Apr. 21, 1959 2,947,415 Garth Aug. 2, 1960 OTHER REFERENCES Modern Packaging Encyclopedia Issue for 1961, volurne 34, Number 3A, published by Packaging Catalog Corp., Emmett Street, Bristol, Conn. (Pages 149 to 152 only.) (Copy available in Division 40.)

Claims (1)

1. A PACKAGE COMPRISING A SEALED POUCH TYPE CONTAINER, AND A PRODUCT TO BE STERILIZED RETAINED IN THE INTERIOR OF SAID CONTAINER; SAID CONTAINER COMPRISING OPPOSITE WALLS ARRANGED IN GENERALLY FACE-TO-FACE RELATIONSHIP, AT LEAST THE INNER SURFACE OF EACH OF SAID WALLS COMPRISING A THERMOPLASTIC HEAT SEALABLE MATERIAL WHICH IS IMPERVIOUS TO THE PASSAGE OF FLUID AND GASES UNDER NORMAL CONDITIONS; EACH MARGIN OF ONE OF SAID OPPOSITE WALLS BEING CONNECTED WITH A CORRESPONDING MARGIN OF THE OTHER OF SAID OPPOSITE WALLS WHEREBY ALL MARGINS OF SAID CONTAINER ARE CLOSED TO RETAIN SAID PRODUCT THEREIN; AT LEAST TWO OF SAID CLOSED CONTAINER MARGINS COMPRISING SUBSTANTIALLY BROAD FLAT CONTINUOUS FIN TYPE SEAMS, SAID TWO SEAMS DEFINING GENERALLY OPPOSITE MARGINS OF SAID CONTAINER, EACH OF SAID OPPOSITE SEAMS BEING DEFINED BY CORRESPONDING FACING AND CONTACTING MARGINAL AREAS OF SAID OPPOSITE WALLS WHICH HAVE THEIR INNER FLUID AND GAS IMPERVIOUS SURFACES HEAT SEALED TOGETHER UNITERRUPTEDLY BETWEEN OPPOSITE SPACED APART EDGES DEFINING OPPOSITE BORDERS OF SAID AREAS, SUCH HEAT SEALING EXTENDING OVER THE FULL EXTENT OF CONTACT OF SAID AREAS BETWEEN SAID BORDERS SO THAT A GENERALLY BROAD SOLID AND CONTINUOUS HEAT SEALED SEAM FREE OF UNSEALED AREAS IS DEFINED BETWEEN SAID BORDERS; AND A BREATHING WICK OF FIBROUS MATERIAL WHICH IS PERVIOUS TO GASES AND IMPERVIOUS TO BACTERIA EXTENDING COMPLETELY ACROSS SAID CONTAINER BETWEEN AND THROUGH EACH OF SAID OPPOSITE SEAMS ALONG ANOTHER MARGIN OF SAID CONTAINER, OPPOSITE END PORTIONS OF SAID WICK EXTENDING THROUGH SAID OPPOSITE SEAMS FROM THE INTERIOR OF SAID CONTAINER BETWEEN THE CONTINUOUSLY HEAT SEALED INNER SURFACES WHICH DEFINE SAID OPPOSITE SEAMS TO THE EXTERIOR OF SAID CONTAINER SO THAT THE OPPOSITE OUTER ENDS OF SAID WICK ARE EXPOSED TO THE ATMOSPHERE SURROUNDING SAID CONTAINER; THE IMPERVIOUS HEAT SEALED MATERIAL OF SAID WALL INNER SURFACES IN SAID OPPOSITE SEAMS BEING IN INTIMATE CONTACT WITH AND SURROUNDING SAID WICK END PORTIONS ABOUT THEIR ENTIRE PERIPHERIES IN SAID OPPOSITE SEAMS SO THAT SAID WICK IS SECURELY BONDED BETWEEN SAID WALL INNER SURFACES IN SAID OPPOSITE SEAMS AND PROVIDES THE ONLY GAS PASSAGE THERETHROUGH; EACH OF SAID CLOSED CONTAINER MARGINS BEING FLUID AND GAS IMPERVIOUS UNDER NORMAL CONDITIONS WITH SAID WICK PROVIDING THE SOLE AND EXCLUSIVE PASSAGE FOR GASES BETWEEN THE INTERIOR AND EXTERIOR OF SAID CONTAINER WHEREBY CONTAMINATED AIR TRAPPED WITHIN SAID CONTAINER DURING SEALING THEREOF IS WITHDRAWABLE FROM SAID CONTAINER SOLELY THROUGH SAID WICK, AND WHEREBY A GASEOUS STERILIZING MEDIUM IS SUBSTITUTABLE FOR SUCH WITHDRAWN AIR SOLELY THROUGH SAID WICK INTO CONTACT WITH SAID PRODUCT IN SAID CONTAINER INTERIOR, SO THAT SAID PRODUCT MAY BE STERILIZED AFTER THE SAME HAS BEEN SEALED IN SAID CONTAINER; SAID WICK AFTER PRODUCT STERILIZATION SERVING AS A BACTERIA FILTER TO PRECLUDE CONTAMINATION OF SAID PRODUCT SO LONG AS SAID CONTAINER WALLS REMAIN INTACT AND SEALED TOGETHER ALONG SAID SEAMS; SAID WICK BEING GRASPABLE FOR TEARING SAID CONTAINER ALONG THE LENGTH OF SAID ANOTHER MARGIN THEREOF FOR EFFECTING EASY OPENING OF SAID CONTAINER TO GAIN ACCESS TO SAID PRODUCT AFTER STERILIZATION THEREOF.

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