US3062371A - Internally sterile composite package - Google Patents

Description

Nov. 6, 1962 D. PATIENCE INTERNALLY STERILE COMPOSITE PACKAGE 2 Sheets-Sheet 1 Filed Dec. 10. 1959 Nov. 6, 1962 D. PATIENCE 3,062,371

INTERNALLY STERILE COMPOSITE PACKAGE Filed Dec. 10, 1959 2 Sheets-Sheet 2 10 ii i4 J5" 62 INVENTOR.

fu a'erzce/ United States atent 3,052,371 Patented Nov. 6, 1962 Free 3 062 371 INTERNALLY srERrLE coMPosrrn PACKAGE Donald Patience, Westmont, 111., assignor to The Kendall Company, Boston, Mass., a corporation of Massachusetts Filed Dec. 10, 1959, Ser. No. 858,615 7 Claims. (Cl. 206-63.2)

This invention is concerned with composite packages which permit full control of the sterile contents during opening and from which the contents may be removed readily and routinely in sterile condition. More particularly this invention is concerned with those packages in which the integral contents may be grasped through the package during partial opening after which free re moval of the unattached sterile contents may be effected without contact with the outer contaminated surfaces of the package.

Various types of sealed packages for sterile products are well known and have been used for many years. Some such packages have had no special provision for opening but rather have had to be torn or cut to remove the contents. Not infrequently, in the process of cutting or tearing such packages, the non-sterile outer surfaces come into contact with the sterile inner surfaces if not with the contents themselves. In addition, unless extreme care is taken in the removal of the contents, they may rub across or touch a non-sterile cut or torn edge of the package. There is, therefore, considerable danger of contact contamination with such packages even though the contents of the package may be held securely through the package while the latter is being torn or cut open. Recognition of this fact is evidenced by numerous attempts to provide packages which reduce the hazards. Prominent in these attempts has been the use of double envelope packages. Such double envelopes do not completely solve the opening problem, however and, because of that and because of the multiplicity of operations necessary to remove the sterile contents, have found little acceptance.

Recently there has come upon the market in the surgical dressing field, in the surgical instrument field and generally in the surgical liquid and powder field, peelable packages heat-sealed around their peripheral edges and with opening tabs at one end. These packages while they provide some improvement in convenience over the double envelope type of package, are generally lacking in several respects. These deficiencies have been re sponsible for their failure to win complete acceptance by the surgical professional. One of the difficulties en countered with this type of package has been the fact that once the package has started to open, there is no positive restraint upon the degree to which the opening will progress. Another difficulty is that in using both hands, as is necessary, the sterile contents are left in the container in an uncontrolled condition. That is, the contents are free to move about and contact non-sterile edges or even to fall out when the package is being opened.

Control of the sterile contents has been realized with some adhesive bandage packages by actually adhering the contents to the package so that during the process of opening, the contents, due to an adhesive bond with the package, are unable to move about with respect to it. Such adhesive bandage packages are shown in US.

Patents No. 2,806,593 to Abbott and No. 2,721,550 to Banff. These packages while they achieve control of the contents have the disadvantage that the contents must be completely uncovered before they may be removed, hence the contents cannot be made available with a single opening motion. Furthermore, this method of control, while it may be satisfactory for adhesive bandages, is applicable to almost no other contained material. Adhesive means for controlling the contents are not generally satisfactory because normally the mere association of foreign matter with the contents is highly objectionable regardless of whether the properties of the contents are affected.

What the surgical world has been searching for, therefore, is a package permitting full control of the sterile contents, single motion opening and unrestricted removal of the contents in sterile condition.

It is the primary object of this invention to provide a composite internally sterile package which may be held in one hand with full control of the contents and which may be opened with a single motion of the other hand so that a pocket is exposed from which the sterile contents may be lifted Without contacting non-sterile portions of the package.

It is another object of the invention to provide such easily openable sterility-preserving packages of a variety of materials and in a variety of forms.

Other objects and features of the invention will be apparent from the specifiction and from the drawings and their descriptions.

In the drawings:

FIG. 1 is an isometric view of a closed composite package typical of this invention, the container being formed from a single sheet.

FIG. 2 demonstrates a step in opening a package similar to FIG. 1 containing a sterile gauze dressing.

FIG. 3 illustrates the package of FIG. 2 fully opened and presenting its contents.

FIG. 4 is a cross section of FIG. 1 taken along the broken line 44 of FIG. I viewed from the direction of the arrows and including typical contents.

FIGS. 5, 6 and 7 show in cross section, alternative constructions of composite packages of the invention.

FIG. 8 illustrates in cross section, a composite package of the invention wherein the outer container is made from two sheets.

FIG. 9 illustrates in cross section, a composite package of the invention wherein the outer container is made from three sheets.

I accomplish the objects of the invention by providing a composite package formed of a back panel and at least two overlapping front panels all enclosing the unattached sterile contents. Preferentially, all three of these panels are made of one sheet folded at the ends, but any two or more of the panels may be separate sheets. In any event, Whether the panels are made of one sheet, two sheets, three sheets or more, the front panels have overlapping end portions which are strippably sealed together transversely intermediate the package ends and at the side edges so that a portion of the outer overlapping front panel projects beyond the seal. This projecting portion of the outer front panel forms a flap for opening the package. The underlying front panel may also have a flap formed by folding back the underlying end portion. If this underlying flap extends to the sides and is long enough, the transverse and side seals joining the outer front panel and the underlying front panel may occur in the underlying flap portion. Where this is the case, the underlying flap portion preferably should extend far enough beyond the transverse seal so as to permit this underlying flap to be clamped to the package between the thumb and fingers of one hand reaching from the package end. The thus joined front panels are sealed around their borders to the borders of the underlying back panel. Preferentially, all of the seals are strippable seals, but only the outer of the overlapping front panels is required to be strippable from the underlying front panel and at least in part from the back panel, so that stripping of the outer front panel reveals the sterile contents preferably projecting from an open pocket formed of part of the back panel and what was the underlying front panel.

In contrast to control achieved by anchoring the contents to the package by adhesive which inhibits exposure and ready removal of the contents, the packages of this invention permit positive control achieved by anchoring the unattached integral contents to the package by means of temporary pressure exerted by one hand thus permitting rapid exposure of contents for uninhibited removal by a single movement of the other hand.

I prefer that there be a sterile border of package material on each side of the sterile contents of the packages of this invention over which portions of the sterile contents may slide during removal without contamination. Where the sterile contents are relatively free to move within the package prior to opening as they are in some of the packages of this invention, the contents may assume a position closely adjacent a sealed border. In such cases the sterile material may possibly contact the non-sterile edge of the package during its removal unless care is taken. But if a sufficiently broad sterile area separates the contents from this non-sterile edge, routine removal Without contamination may be accomplished. In general, I have found that the dangers of contamination of the contents by contact With the non-sterile edges of the packages of this invention become substantially nil (especially if the contents are centered before opening) when there is sufficient sterile wrapping material including the seal extending on each side of the sterile contents to amount to about a quarter of an inch or more. I find the best results are obtained when the area of the seal is greater than about one half of this total distance. In any event, integral sterile contents should not exist in the package in such a way that the material tends to expand in width While it is being removed so as to occupy a space wider than the back panel of the package.

Referring once more to the drawings:

In FIG. 1 a typical internally sterile composite package 10 is illustrated as consisting of an overlying front panel 11, an underlying front panel 16 with a flap 13, and a back panel 12. A pocket is formed by sealing the underlying front panel 16, preferably excepting flap 13 to the back panel at their adjacent side edges by the seal 17. The sterile contents may be any integral material such as a gauze dressing, a hypodermic syringe, a scalpel, a dry suture and the like. Or the contents may be a combination of liquid and integral material such as a catgut suture in its tubing fluid. The seal 17 may be either a permanent seal which is preferred where liquids are involved or it may be strippable. The latter type of seal has some manufacturing advantages and permits the package to be opened fully to provide a sterile surface it that should be desired. The package is closed by strippable seal 14 which seals the overlying front panel 11 to the back panel 12 at the adjacent side edges, and to the flap 13 both along portions of its side edges and in a transverse zone joining the side edge seals. A portion of panel 11 projects beyond this transverse seal to provide an opening flap.

In FIGS. 2 to 4, the package of FIG. 1 is shown with a contained sterile gauze dressing. In opening the package of FIG. 1 containing an integral dressing as in FIGS.

2 to 4, the portion of the panel 11 projecting beyond the transverse seal is grasped between thumb and forefinger of one hand while the pocket portion of the package and its contents are clamped together by the other hand with the thumb pressing the flap 13 to the pocket. With one upward and backward motion of the one hand the strippable seals, joining panel 11 with flap 13 and with the side edges of panel 12, are stripped and panel 12 is folded back, as is illustrate-d in FIG. 3, leaving the sterile contents preferably projecting from the pocket and surrounded by sterile packaging portions. The sterile contents may be removed from the package without contaminating contact.

In FIG. 5 the construction is very similar to that of FIGS. 14 except that the flap on the underlying relatively short front panel 23 is eliminated, and the overlying front panel 21 is strippably sealed by seal 24 to the underlying front panel 23 instead of the flap thereof. The underlying front panel 23 and the back panel 22 are sealed by the edge seal 27 to form a pocket in which the contents 15 are contained. The package is opened in the same way as before, considering the elimination of the flap on the underlying front panel.

In FIG. 6 the underlying front panel '33 is relatively long, thus creating a long pocket when sealed at the adjacent side edges to the back panel 32. Overlying front panel 31, on the other hand, is relatively short and the strippable seal 34 joining panel 31 to panel 33 and to panel 32 is relatively short.

In FIG. 7 panels 41 and 43 are about equal in size, which is the preferable construction. The pocket is formed by sealing panel 43 to panel 42 by side edge seal 47, while strippable seal 44 seals panel 41 to panels 42 and 43.

In FIG. 8 the panels are not formed of a single sheet; rather panel 53 is a separate sheet which is sealed to panel 52 both at the end edge and the side edges. Panel 51 is sealed by strippable seal 54 to both panel 53 and panel 52.

In FIG. 9 back panel 62 and front panels 63 and 61 are all separate sheets joined at their adjacent end edges. Panel 61, in the illustrated construction, is sealed to panels 62 and 63 by strippable seal 64, whereas panels 62 and 63 are sealed together with permanent seal 67.

The preferred method of utilizing the packages of this invention is to grasp the flap of the outer front panel between the thumb and forefinger, while clamping the contents in the pocket with the other hand as is illustrated in FIGS. 2 and 3. The front outer panel is then stripped back in a single motion so that the contents are left protruding from the pocket, from which position they may be plucked readily by a sterile forceps. The sterile contents, while in the pocket, are surrounded by sterile packaging material, hence there is very little chance that they may be contacted accidentally by non-sterile portions of the package.

The container portions of the composite packages of this invention may take a variety of forms in addition to those resulting from structural differences due to variations in the number of sheets from which the containers are formed. It has already been pointed out that the underlying front panel may contain a flap, as is illustrated in FIG. 1, or no flap at all, as is illustrated in FIGS. 5 to 9. Obviously, where there is a flap on this panel it may be wholly inside the package and in the form of a narrow folded-back tongue, in which case the seal between the front panels occurs outside the area of the underlying front panel flap. Likewise, the outer front panel may have various forms of flaps projecting beyond its seal with the underlying front panel. The two front panels, disregarding flaps, may be of relatively equal lengths, as is illustrated in FIGS. 4, 7, 8 and 9, which perhaps is the preferred form, or the underlying panel may extend the full length of the package with the outer front panel being confined to the overlapping portion only, going even farther in this direction than is illustrated in FIG. 6, or on the other hand, the underlying panel may be confined to the overlap portion only and the outer front panel may extend the full length of the package, going even farther in this direction than is illustrated in FIG. 5. The construction wherein the two panels are substantially the same length has the advantage that, when the outer front panel is peeled back, the integral contents may be half contained in the pocket with the other half protruding from the pocket, as is illustrated in FIGS. 2 and 3. Where the underlying front panel is very short, most of the integral contents may protrude from the shallow pocket when the outer panel is peeled back. On the other hand, when the underlying front panel extends almost the full length of the package, it may be that none of the contents will protrude when the outer panel is peeled back making it necessary to reach in between the sterile lips of the pocket with a forceps or other sterile instrument to withdraw the contents from the pocket. In regard to the shape of the transverse seal which seals the outer and underlying front panels together, it is perhaps preferable that the seal be along diverging lines from a mid-point at the fiap end of the outer panel. However, other shapes of seals are suitable.

The preferred method of providing the strippable or peelable feature to at least the outer front panel is to coat areas in register on the panels to be stripped with a tacky latex sealant. The type of sealant illustrated in Patent No. 2,529,060 or pressure-sensitive adhesives generally are suitable. It is important that the sealant material at the time the seal is made be sufficiently deformable so as to fill any crevices which might otherwise exist where the thicknesses change, as at point 18 in FIG. 1, from four (or in some cases three) panels to two. This sealant may or may not later harden and lose its tack due 'to crosslinking, polymerization, loss of fluid or other causes. ants permit the use of mechanical sealing equipment which routinely produces packages which are impervious to bacteria without special precautions. It is possible, however, by exercising caution, to obtain packages which are impervious to bacteria with heat sealable materials and heat sealing techniques in sealing the packages of this invention. Such scaling is preferred where a package impervious to moisture or gas is desired. It is obvious, however, that while heat sealing methods may be employed in some packages of this invention, such methods do not routinely produce packages impervious to bacteria as do the preferred methods using soft tacky sealants.

With regard to the material from which the panels of the packages of this invention may be made, it is preferable that the panels where possible be of porous paper of the type now extensively used in autoclaving materials in sealed paper packages. Autoclaving after packaging is not essential, however, because packages may be sterlized initially either before closing under aseptic conditions, or by insertion of chemical agents, such as ethylene oxide, which sterilize after the package is closed, or by the use of electron beam methods. In any event, suitable packages for liquid or oxidizable materials or other contents may be formed utilizing films and metallic foils for the package panels. Laminates of various combinations of foil, film and paper may also be used for this purpose. The tensile strength of the material from which the package panels are produced does have a bearing on whether a particular strippable seal material may be used. It is obvious that if the panel tensile strength is low and the force necessary to peel the strippable seal is high, the panel may tear. However, I have produced packages which functioned perfectly, from a number of sealing materials and from a number of panel materials. Examples which are representative of the invention, but not by any means limitations upon its scope, are as follows:

In all of the examples the transverse seals and the seals on one side were made before the contents were entered. Thereafter the other side seals were made closing the packages.

Such seal- 7 6 Example 1 20-30# white sulphite paper was coated in pattern form with natural latex in a thickness which, if coated overall, would weigh 1-1.5 pounds per ream. A package of the type illustrated in FIG. 1 was sealed by rolling with a 3 pound weight twice over at a speed of 12 inches per minute, the contents being a gauze dressing. After autoclaving and ten days storage, the seals peeled readily with a single motion of one hand while the contents were held through the package in the other hand. The dressing was revealed protruding from the package pocket from which it was removed with a sterile forceps. Tests demonstrated that the dressing was sterile.

Example 2 Panels made from 2 mil aluminum sheet foil coated with a thin coat of polyvinyl chloride (about .7 mil) were made up into a package of the type illustrated in FIG. 1, containing an ethylene oxide, alcohol and water sterilizing fiuid and a 5 foot length of catgut mounted in a coil on cardboard. The strippable seals were made at a pressure in the range of 20 to 40 pounds per square inch in the temperature range of 300 to 340 F. The package did not leak. After 10 days the strippable seals peeled back readily with a single motion of one hand while the suture and its card were held through the package With the other hand. The suture was revealed projecting on its card from the pocket. The suture was pliable and sterile when tested.

Example 3 Panels were made of film of 2 mil high-density linear polyethylene (.5-.9 melt index) laminated 'to 1 mil or less of low density polyethylene (1.5-2.5 melt index). The panels were sealed with low density sides face-to-face into a package of the type illustrated in FIG. 1 containing a composite perforated film and cotton felt dressing. The panels were sealed at about 300 F. and at 15 to 20 pounds per square inch pressure. The package was sterilized with a mixture of C0 and 10% ethylene oxide gas by weight and 15 pounds pressure for 15 hours. The seals peeled readily by a single motion of one hand when the package and contents were grasped with the other hand as on FIGS. 2 and 3. This action revealed the dressing protruding from the pocket. Testing demonstrated its sterility.

Example 4 3040# kraft paper was coated with 'a 1:1 water dilution of Darex Everflex A (polyvinyl alcohol) in patterned strips which were sealed together to make a package of the type illustrated in FIG. 7, containing a hypodermic syringe. The seals were made at temperatures of 330- 350 F. and pressures from 40-500 pounds per square inch. After autoclaving and storing 10 days, seals peeled readily by a single motion of one hand while the springe was grasped with the other hand through the package. The syringe was found sterile upon being tested.

Example 5 Panels of 1 mil polyethylene terephthalate film were sealed by treating the portions to be sealed with a mixture of 90% benzyl alcohol and 10% ethyl alcohol, and immediately sealing at 25 pounds per square inch and at a temperature of 275-300 F. dwell time 1 /2 seconds to form a package of the type illustrated in FIG. 1. Immediately before sealing the final seal a gauze dressing and 5 drops of chilled 10% ethylene oxide in 70% ethyl alcohol were placed in the package. After 10 days the seals peeled readily in a single motion of one hand while the dressing was grasped through the package with the other hand. The dressing was sterile upon being tested.

Example 6 Panels of ordinary household waxed paper were made into a package of the type illustrated in FIG. 1. The panels were sealed at a temperature of 225 F. and 15 pounds per square inch to contain a non-woven cotton felt dressing. The package was sterilized by accelerated electrons, dosage 2 megarads. After 10 days the seals peeled readily in a single motion of one hand while the dressing was held through the package in the other hand. The dressings provided sterile upon testing.

Example 7 Panels of 30-40%; kraft paper were coated in pattern form with a solution of the pressure-sensitive adhesive of US. Patent No. 2,177,627, Example D, less the pigment, in toluene. After evaporation of the solvent from the adhesive, a package of the type illustrated in FIG. 1 was sealed adhesive to adhesive by rolling with a 3 pound weight twice over with a speed of 12 inches per minute, to contain a gauze dressing. The seal was adequate after autoclaving to preserve the packages in a condition impervious to bacteria. After 10 days the panels peeled readily in a single motion of one hand while the dressing was grasped through the package with the other hand. The dressing was sterile when tested.

The packages of this invention undoubtedly have their greatest utility where the contents are integral, that is, where the contents may be removed as a unit. In this respect while some of the advantages of a single envelope 'are lost it is possible by utilizing a second inner envelope to package various liquids, creams, ointments, powders, granulations and other particulate materials so that the inner envelope is maintained completely sterile but readily available. One may remove such an inner envelope with a sterile forceps and cut off a corner of the package with a sterile instrument. Obviously one may also utilize the single envelope of the packages of this invention to contain such pourable materials directly but care must be used in opening such packages.

I claim:

1. An internally sterile composite package comprising a single sheet folded transversely three times to form a back panel, a top front panel, a bottom front panel and an intermediate front panel, said panels having portions of their respective side edges adjacent, said back panel and said bottom front panel being joined at their adjacent side edges by a breakable seal to form an open pocket at one end of said back panel, said pocket having as its open edge the folded edge common to said bottom front panel and said intermediate front panel, and having as its bottom the folded edge common to said bottom front panel and said back panel, said top front panel having a top folded edge common with said back panel, said open edge traversing said back panel and having spaced relationship with said top folded edge, sterile contents unattached to said pocket but disposed partially therein and pro ecting partially therefrom, said top front panel extending over said projecting portion of said contents and overlying the adjacent edges of the back panel and that portion of said intermediate front panel adjacent said open edge, being removably sealed at its side edges to the respective adjacent side edges of said back panel and said intermediate front panel and transversely of said intermediate front panel between the sealed side edges to form a complete enclosure normally impervious to bacteria for said sterile contents, said top front panel being peelable from said intermediate panel and at least partially from said back panel whereby said open pocket with its projecting contents is uncovered permitting ready removal of said contents in sterile condition without detachment from said pocket, said intermediate front panel and said top front panel having unsealed areas extending outwardly beyond a common seal.

2. The composite package of claim 1 wherein the sterile contents comprise a surgical dressing.

3. The composite package of claim 1 wherein the sterile contents constitute a surgical instrument.

4. The composite package of claim 1 wherein the contents include a coiled surgical suture.

5. The composite package of claim 1 wherein the sheet is paper.

6. The composite package of claim 1 wherein the sheet is a thermoplastic film.

7. The composite package of claim 1 wherein the unsealed area of said intermediate front panel extends farther beyond a common seal than the unsealed area of said top front panel.

References Cited in the file of this patent UNITED STATES PATENTS 2,172,455 Samuel Sept. 12, 1939 2,410,438 Fields Nov. 5, 1946 2,668,769 Schlienz Feb. 9, 1954 2,721,550 Bantf Oct. 25, 1955 2,965,223 Schladermundt et al Dec. 20, 1960 FOREIGN PATENTS 603,211 Germany Sept. 6, 1934

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