US3286832A - Sterile article package - Google Patents

Description

Nov. 22, 1966 N. J. PM GER STERILE ARTICLE PACKAGE 5 Sheets-Sheet l Filed March 30, 1966 INVENTOR NICHOLAS J. PILGER ATTORNEYS N ov. 22, 1966 N. J. PlLGr-:R 3,286,832

STERILE ARTICLE PACKAGE Filed March 30, 1966 f 5 Sheets-Sheet 2 Y l l l l INVENIOR NICHOLAS J. PILGER BY GM] PLZMM) ATTORNEYS A Nov. 22, 1966` N. J. PILGER smal-LE ARTICLE PACKAGE Filed March 5G, 1966 5 Sheets-Sheet 3 INVENTOR.

NICHOLAS J. PILGER BY 6M TQM; Malibu@ g?" ATTORNEYS United States Patent O 3,286,832 STERILE ARTICLE PACKAGE Nicholas J. Pilger, Thousand Oaks, Calif., assignor to Reynolds Metals Company, Richmond, Va., a corporation of Delaware Filed Mar. 30, 1966, Ser. No. 538,796 9 Claims. (Cl. 206-56) This invention relates to a sterile article package, and more particularly to a package envelope for gener-al pharmaceutical use formed from air-impervious sheet material for sterile articles such as surgeons blades, hypodermic needles or the like wherein the envelope is provided with unique opening means to prevent contact of -the sterile article with air-exposed portions of the envelope immediately subsequent to opening of the packglu recent years there has been increasing development of sterilized package forms as evidenced lby the patents to Nashed, 3,152,694, Svirchev, 2,866,542, and Schwartz, 3,070,255, among others. These patents are representative also of the use of plastic film-aluminum foil laminate as a sterile package material, as it possesses unique advantages in its easy handling and workability, air-impervious characteristics, ready -heat scalability, etc.

Difficulty is experienced, however, in satisfactorily opening such packages, commonly as by a pulling action to separate facing wrapper sheets to gain access to the 'sterile contents. Such opening, however, requires that the adhesive bond between the layers of the foil be sufficiently weak to permit ready yielding thereof to permit Ifull separation of the initially sealed package plies, while strong enough to insure sterility. A more effective means of opening packages is by tearing the package material directly, as in Lakso, 2,760,630. This technique, while having the advantage of quick opening, nonetheless .permits the package contents to be in undesired proximity to air-exposed and thus contaminated external package surfaces immediately adjacent the edge ofthe tear, whereby medical personnel removing the package contents are virtually obliged to place the fingers in contact with the uil-sterile package external surface, thereby increasing the probability of contamination ofthe fingers or the packaged instrument, thus defeating the sterile package purpose. Y

Accordingly, it is -an important object of the present invention to provide opening means for sterile packages wherein subsequent to opening thereof falong a line of separation, only sterile package material remains in proximity to the access `opening to the article, whereby the danger of germ or dirt contamination from the airexposed externa-l surfaces off the package is prevented.

It is another object of the present invention to provide a package having .a panel-and-pleat or folded collar arrangement in Iassociation with a rip strip for effectively opening the package and exposing outwardly facing sterile internal package surfaces, thus enhancing the maintenance of a sterile packaged contents.

It is a further object to utilize stretchablc and resilient properties of Ythe plastic film-metal rfoil laminate to enhance the contamination-preventing features of the packt age.

These and other objects of the invention will become apparent from the following description taken in connection with the accompanying drawings, in'which:

FIGURE l -is a perspective view of a .package formed in accordance with the present invention, the internal rip strip Ibein-g shown in phantom;

FIGURE 2 is a transverse sectional view along the lines 2-2 of FIGURE l, an enclosed article being shown in phantom.

FIGURE 3 is a view similar to FIGURE 2 illustrating Fice the package yas it would appear in cross section after having been opened;

FIGURE 4 is a perspective view of a modified form of package;

FIGURE 15 is illustrative of the package of FIGURE 4 when opened and a separated section removed;

FIGURE 6 is a sectional view along the lines 6--6 of FIGURE 4.

FIGURE 7 4is a view tagen along the line 7-7 of FIGURE 5 illustrating the appearance of the collar on the larger section of the package after opening;

FIGURE 8 is a plan view showing a further modified form of package, the rip strip being shown in phantom;

FIGULRE 9 is a view illustrating the appearance of the FIGURE 8 package when opened; and

FIGURE l0 is a sectional view of the U-collar configuration taken `on the line 10-10 of FIGURE 8.

Referring to the drawings, in the several forms of the invention, the envelope 1-4 is preferably formed of a lmsfoillaminate comprising aluminum foil 10 as the external surface and vapor barrier while a readily sealable adhesive film 12 such as polyethylene, corn-prises the internal sterile surface of the p-ackage envelope 14.

In the package of FIGURES l to 3, the envelope 14 is folded from `a single sheet of film-foil laminate and is provided with Ia longitudinally extending seam 16 (FIGURE 2) and a pair of transverse end seals 18, 18. One wall o'f the envelope includes a longitudinally pleated collar-like panel portion Z8 having a pair of outwardly extending portions 22 which underlie and respectively reversely fold and merge into a closure panel 24. rip strip 26 is bonded internally of the envelope to the underside of panel 24 and extends the entire length thereof, a short piece 30 thereof extending outwardly from the envelope at one or both ends. Enclosed within the envelope as indicated in dashed lines tat 32 are sterile instruments such as ampules, surgeons knife or blade, hypodermic needles, etc.

The package 14 is sterilized in conventional fashion during or subsequent to formation thereof, whereby the article 32 within fthe envelope Eas well as all internal surfaces of the envelope will be germ-free. In the ordinary handling of the package, of course, the external package surface is exposed to normal Iatmospheric and contact contamination.

In opening, grasping and pulling rip strip 30 tears panel 24 along a line defined by strip 30, thus separating panel 24 into two sections, each respectively connected to the underlying inturned portions 2v2. By virtue ofthe limited resilience o'f the plastic film 22, the upward stress of the tearing 'action in pulling the rip strip 26 along the length of panel 24 will slightly stretch the internal sterile surface '12 while the foil edge areas Y adjacent the line of separation at 34 tend to bend upwardly and outwardly. As the pulling forces terminate,

the effective elastic memory of plastic film 12 aids the Y panel edges 34 in curling outwardly from the line of separation, as clearly indicated in somewhat exaggerated yform in FIGURE 3.

By virtue thereof, it will be seen that the internal sterile envelope surface of film 12 is disposed immediately adjacent either side of access opening 36, and extends laterally therefrom along substantially theY entire length of the package, whereby upon the user inserting his fingers into the envelope to extract the contents 32 thereof, the fingers will contact only sterilized internal surfaces 12 and will not be in proximity to the air-exposed and contaminated external surface 10 of the package. Thus the contents 32, such as surgical instruments, hypodermic needles, etc., maybe removed from the package without any direct contact with the unsterile external surface 10.

The modified package 40 shown in FIGURES 4-7 is similar to that of FIGURES l-3, wherein, however, the pleated collar arrangement is disposed transversely of the envelope in substantially girdling relation thereto, rather than longitudinally thereof. As before, the package 40 is conveniently formed from a single sheet of film-foil laminate to provide an outer foil surface 10 and an inner film surface 12. The package includes a longitudinally extending side seam 42 and end seams 44, 44. As seen in FIGURE 6, the package is pleated in the manner similar to FIGURE 2, the pleat portions 48 and associated panel 50, however, extending peripherally of the package intermediate the ends thereof. Arip strip 52 underlies panel 50, and one or both ends thereof extend through the side seam 42 so as to be readily grasped when it is desired to open the package. While, as illustrated, the rip strip 52 loopsl about the package, the same may extend only the width of one side of the flattened oblong envelope, if desired.

In the package 40 as shown, when the rip strip 52 is pulled by the user, the overlying portion of the film-foil laminate panel 50 bonded thereto will be torn away, and the panel substantially completely separated along the line of the rip strip. While the side seam 42 will not usuallyk be separated by the strip 52, the same will nonetheless be capable of being readily torn by the user if desired.

In any event, -upon completion of the tearing operation by rip strip 52, and as before, stretching of the sterile film laminate will enhance self-curling of the envelope edges 54 on either side of the rip strip, whereby the same will tend to curl lbackwardly as seenin FIG- URES `5 and 7 to upwardly expose the sterile inner envelope surface. Similar curling will, of course, occur on the shorter portion of the package (not shown). Thus, as before, the article or articles 32 within the package will be readily accessible and may be grasped Without the hand of the user or the articles themselvesy coming into contact with any non-sterile external surfaces of the package.

In the form of the invention shown in FIGURES 8-10, the package 60 as before is provided with a transverse collar-like pleat formation 62 which is substantially parallel to the end seams 64, wherein, however, Vthe pleat configuration partakes of "a telescoped double-U configuration as clearly seen in FIGURE 10. Also as before, the tear strip 66 projects through the side seam 68 of the envelope without requiring any notching or cutting thereof, the tear strip being merely sealed between the facing envelope plies.

The double-U fold providing the novel collar 62 V.of FIGURES 8-10 includes features which facilitate use thereof as a temporary reclosure should all package contents not be initially removed from the envelope upon opening.

More particularly, asy seen in the enlarged view of FIGURE 10 of the drawings, the envelope wall is outwardly reversely folded and then again outwardly reversely folded to form an outer U-portion 70. The tear strip is disposed adjacent the outermost ply or panel 71 of U-portion 70. The other edge of panel 71 is reversely folded inwardly at 73 to define a second, smaller lU- portion 72 telescoped within the larger U-portion 70, the other edge 74 of U-portion 72 merging back into the Wall panel. Thus it will be seen that when the rip strip 66 separates panel 71 in similar manner as before, the foil torn thereabove and the resultantexposed surfaces following curl-back will be the internal sterile surfaces of the U-folds, as clearly seen in FIGURE 9. Note, however, that subsequent to tearing the package contents are not visible for immediate grasp inasmuch as the double-U fold still provides a telescoping closure-therearound. Upon manual separation of the opposite ends of the package to open the telescoping folded portions thereof as seen in FIGURE 9, the article 32 may be readily grasped, and it will be seen that as before, the

`article 32 is free from possible non-sterile contamination ia portion of said envelope defining a panel fhaving open-` ing means associated vtherewith vfor separating said panel along a line to gain access to said article,

a-nd means cooperating with said opening means tend-- ing Ito curl the panel areas |adjacent said separa-tion line upwardly :and outwardly there-imm no upwardly expose said sterile internal sunfaoe rthereat on either side of said sepanation line, Y whereby contact of the packaged antziole with thek rel-a- -t-vely runsterile package external surface is prevented during withdrawal of said article through said sep-v arated panel.

2. The package of claim 1 wherein said opening means comprises a rip strip disposed in underlying bonded relarton to said panel internal sulnface, and having a strip portion projecting externallly of said package for grasping. ,n

3. The package .of claim 2 wherein said package matef rial is metallic foil, and said curl means includes a plastic film bon-ded to said foil on the inside surface ofV said panel, said plastic film being yieldable .to package opening forces, and having sufficient resilience` that `upward tearing force of said rip strip slightly stretches during rupture of said panel, whereby upon cessation of .tearing forces, slight contraction of Athe plastic aids in outward curling of said panel areas.

4.` The` package of claim 2 wherein `said pane-l oon- Sttutes -a portion of a pleated oollar of said envelope,

said col'lar comprising said panel and la pleat pontionV extending inwardly of and Iunder'said panel from eachY edge thereof, each `pleat .pomtion terminating in a reversely` extending yfotld with -tlhe remainder of said envelope,

whereby upon opening of said envelope by separation of said panel, the upwardly facing internal sterile` surfaces o-f said ple-at portions are exposed, the gap p therebetween providing access to said packaged article. 5. The package of claim 4 wherein said envelope is of a generally attened, oblong configuration and saidtcol-V -lar extends longitudinally `along one side thereof.;

6. 'Ihe package of claiLm4 wherein said envelope-is of 4a Vgenerally flattened oblong configuration, and said col-Y ar extends transversely therearound in substantially girdlin-g relation mhereto.

7. The package of claim 2 wherein said panel constitutes a portion of a double U-oollan Y said collar including an outwardly reversely :folded portion of saidenvelope `merging atk an outward reverse fold with-one edge of said panel, Itogether defining an outer U-ponti'onj? rthe panel other edge menging at 'an inward reverse fold with an inner U-pontion which connects with che remainder of Isaid envelope,` with said inner U- portion being telescoped within said outer 'U-portion,

whereby separation of said panel 'along said line exposes :the sterile internal surfaces of said U portions, which may be outwardly ytelescoped to separate the same Ito gain access fbo lthe packaged article.

8. The package of claim 2 wherein said envelope com-` 5 prises a single olded sheet having a sealed margin, and said nip strip extends through said seaded margin.

9. The package of claim 4 wherein said package mate- Tial is .metallli'c foil, and Vsaid curl means includes a plastic dilm bonded to said foil on the inside surface of said panel, said plastic lm being yieldabde to 'package Opening forces, and lhavi-ng suicient resilience that upward 4tearing or of said 'ri-p strip slightly stretches said lm during rupture of said panel, whereby upon Icessati-on of tearing forces, slight contraction of the plastic .aids in outward curling of said panel areas.

No references cited.

THERON E. CONDON, Primary Examiner.

J. M. CASKIE, Assistant Examiner.

Claims (1)

1. A STERILE ARTICLE PACKAGE COMPRISING AN ENVELOPE OF AIR-IMPERVIOUS MATERIAL SURROUNDING AND ENCLOSING THE ARTICLE, SAID ENVELOPE HVING A STERILE INTERNAL SURFACE, A PORTION OF SAID ENVELOPE DEFINING A PANEL HAVING OPENING MEANS ASSOCIATED THEREWITH FOR SEPARATING SAID PANEL ALONG A LINE TO GAIN ACCESS TO SAID ARTICLE, AND MEANS COOPERATING WITH SAID OPENING MEANS TENDING TO CURL THE PANEL AREAS ADJACENT SAID SEPARATION LINE UPWARDLY AND OUTWARDLY THEREFROM TO UPWARDLY EXPOSE SAID STERILE INTERNAL SURFACE THEREAT ON EITHER SIDE OF SAID SEPARATION LINE, WHREBY CONTACT OF THE PACKAGED ARTICLE WITH THE RELATIVELY UNSTERILE PACKAGE EXTERNAL SURFACE IS PREVENTED DURING WITHDRAWAL OF SAID ARTICLE THROUGH SAID SEPARATED PANEL.

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