US 3074540 A
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Description (OCR text may contain errors)
Jan. 22, 1963 F. R. BEICH ErAL PACKAGE FOR STERILE ARTICLES 2 Sheets-Sheet 1 Filed July 31, 1959 I/NVENTORS:
Jan. 22, 1963 F. R. BEICH ETA].
PACKAGE FOR STERILE ARTICLES 2 Sheets-Sheet 2 Filed July 31, 1959 j e wZwfiry/a, By AT7'OiNEVS. 7;
United States Patent 3,674,540 PACKAGE FOR STERILE ARTICLES Frank R. Beich, Wilmette, William G. Whitney, Evanston,
and Aldean W. Whitton, J12, Gienview, 111., assignors to American Hospital Supply Corporation, Evanston,
111., a corporation of Illinois Filed July 31, 1959, Ser. No. 830,738 Claims. (Cl. 20643) This invention relates to a package, and more specifically, to a package particularly adapted for use in sterilizing and storing instruments such as hypodermic needles and other articles.
While wrappers for the protection of sterilized instruments such as hypodermic needles have been known in the past and are presently commercially available, such wrappers have certain drawbacks which often destroy their usefulness for their intended purposes. For one thing, the presently available needle wraps are often difficult to open in the instructed manner, especially in times of emergency when such operations must be performed hastily. Even when such a wrapper is opened properly, there is the danger that as the needle is removed its cannula will brush against the fibers along the torn edge of the package or will come into contact with the non-sterile exterior of the wrapper, thereby breaking the intended chain of instrument sterility between the time of sterilization in said package and the time of opening the package for actual use of the instrument. Also, because of the flexible or pliable nature of the Wrapper walls, there is the ever-present danger that the needle will pierce the wrapper walls as the package is handled, with the result that the needle will become contaminated before use.
Accordingly, it is a principal object of the present invention to provide a package which overcomes the afore mentioned defects and disadvantages. Another object is to provide a substantially rigid package for sterilizing instruments and for maintaining such instruments in sterilized condition thereafter.
Another important object of the present invention is to provide a package having a hard shell for protecting a sterilized hypodermic needle contained therein, the package being provided with means for exposing the hub end of the needle so that it may be quickly and easily attached to a syringe and withdrawn from the package in sterile condition. In this conection, it is a specific object to provide a needle container which may be used as a stand to protect the needle against contamination after the package has been opened and the hypodermic syringe has been connected to the needle hub. Another object is to provide a container for hypodermic needles which will tend to retain the needles even after the container has been opened, thereby preventing the needles from accidentally dropping out of the container and becoming contaminated.
A still further object is to provide a hard-shell container in which instruments such as hypodermic needles are packaged in individual compartments for sterilization and storage. Furthermore, within each compartment the cannula portion of the needle is centered and protected therein against damage and contamination. An additional object of this invention is to permit mass-production packaging with sterilization therein of instruments in individual or multiple packages. This invention also provides multiple instrument packages for inventory control and ease of handling, while at the same time allowing for subsequent detachment of individual packages for use of the instruments contained therein. Other specific objects and advantages will appear as the specification proceeds.
The invention is shown, in an illustrative embodiment, by the acompanying drawing, in which:
FIGURE 1 is a perspective view of a sealed needle package embodying the present invention;
FIGURE 2 is an inverted and exploded perspective view of the components of the needle package shown in FIGURE 1;
FIGURE 3 is an enlarged vertical section of the sealed package, taken along line 33 of FIGURE 1;
FIGURE 4 is an enlarged vertical section of the package similar to FIGURE 3 but showing one of the needle containers in open condition;
FIGURE 5 is a vertical cross-sectional view taken along line 55 of FIGURE 4;
FIGURE 6 is a vertical cross-sectional view taken along line 6-6 of FIGURE 4;
FIGURE 7 is a broken perspective view of an empty needle container of the present invention shown in open condition;
FIGURE 8 is a top plan view of the package shown in FIGURE 1; and
FIGURE 9 is a side elevational view showing the needle package in combination with a hypodermic syringe.
In the embodiment of the invention illustrated in the drawings, the numeral 10 generally designates a package comprising a cover or shell 11, a fiat bottom wall or sheet 12, and hypodermic needles 13. To illustrate the cover construction clearly, only a single needle 13 is shown in FIGURE 2, although it is to be understood that a plurality of such needles would normally be carried within the multiple chambers or compartments of the package. Needle 13 is entirely conventional in construction and is provided with a cannula portion 14, an enlarged hub portion 15 of rectangular cross-section, and a typical Luer fitting 16. As is well known, the Luer fitting 16 is adapted to receive the tapered end, or the corresponding Luer-Lok fitting, of a syringe to provide an interconnection between the parts.
Cover or shell 11 is molded from a sheet of hard, non-stretchable and at least semi-brittle plastic material such as polystyrene, particularly copolymers of styrene with acrylonitrile or butadiene. Cellulose butyrate and the more rigid formulation of cellulose acetate might also It is to :be understood that any or a variety of materials having similar properties of brittleness and non-stretchability might be used in forming the hard cover or shell 11. Preferably, the material from which the shell is formed is transparent or at least sufliciently clear to permit the inspection and identification of articles carried within a sealed package.
As shown most clearly in FIGURE 2, the plastic cover defines a plurality of needle-receiving chambers or pockets 17 which extend transversely of the sheet and which are arranged in longitudinal series therealong. To conserve space and to provide a compact package, we prefer to arrange successive pockets of the series in alternately apposing transverse directions, although it will be apparent that other arrangements might be provided. Furthermore, while the cover is shown with twenty pockets or chambers 17 in alternating apposition, it will be understood that a greater or smaller number may be provided, depending upon the desired needle-holding capacity of the package.
Since all of the chambers or pockets of the plastic cover are of substantially identical size and shape, only one such pocket will be described in detail for illustrative purposes. Referring to FIGURE 3, it will be seen that plastic shell 11 is provided with a forward portion 18 containingin the chamber portion defined thereby the cannula 14 of a needle, an intermediate portion 19 which snugly houses the hub 15 of the needle, and a rear portion 20 which extends over the Luer fitting 16 and which continues rearwardly in spaced relation therebehind. Intermediate portion 19 generally follows the contour of the needle hub and, when viewed in crosssection (FIGURE has a generally inverted U-shaped configuration with the inner surfaces thereof in contact with, or in closely spaced relation to, the outer side and top surfaces of the rectangular hub.
It will also be noted from FIGURE 3 (and from the exploded view of FIGURE 2 showing a multiple needle package in inverted condition) that shell 11 is open at its bottom to provide access for chamber 17 and to permit the placement of hypodermic needle 13 therein before bottom sheet 12 is secured in place. An integral flange 21 extends outwardly about the periphery of each needlereceiving shell and has its underside in surface contact with the top surface of bottom sheet 12. Thus, when flange 21, which extends along a single horizontal plane, is secured to the bottom closure sheet 12, the needlecontaining chamber 17 is completely sealed.
Sheet 12 is formed of paper or any other suitable material, such as plastic sheet material, which is durable and flexible, and which is effective for excluding moisture and airborne bacteria under normal conditions from the sterilized needle 13 contained within chamber 17. When steam or gas are employed in the sterilizing procedure, we prefer to employ a gas-permeable paper or sheet. However, when the sterilization is accomplished by dry heat, the sheet may be formed of a material which. is impervious to gas or steam. The sheet should be of a material whichtwill prevent contamination of the instrument, and we find that standard label stock and a variety of other sheet materials are effective in excluding moisture and airborne bacteria under normal conditions and thus preserving the needle, after sterilization, in sterilized condition. 7
The bottom closure sheet may be secured to the planar undersurface portions 21 of the cover by any suitable means. For instance, if the backing sheet is formed of a thermoplastic material compatible with the cover material, then the cover and backing may be heat sealed together. The backing sheet might be provided with. a heat-sealing coating, such as a film composed of a conventional heat-sealing lacquer, so that when heat is applied the sheet will be permanently bonded to the cover shell. Any suitable glue or adhesive capable of maintaining an effective seal over a range of temperatures, including sterilizing temperatures where heat sterilization is to be employed, may be used.
From an examination of FIGURES 3 and 6, it will be observed that the cannula portion of needle 13 is suspended within chamber 17 in spaced relation with reference to the enclosing portion 18 of the shell. Intermediate shell portion 19, which fits closely about the hub of the needle, as well as closure sheet 12 which engages the undersurface of the needle hub, restrain axial and transverse movement of the suspended cannula and therefore maintain its surface in fully exposed condition within the chamber so as to insure effective sterilization thereof and prevent damage, dulling or contamination by contact with or by puncture of the package.
As illustrated in FIGURES 3 and 7, the front of rear shell portion 20 has a generally U-shaped configuration and defines a cross-sectional area of greater vertical and lateral dimensions than any other portion of chamber 17. Also, it will be seen that at the rear of the intermediate shell portion 19 is an outwardlyand slightly forwardly extending integral flange 22 which has its outermost periphery continuous with the forward U-shaped edge of rear shell portion 20. By reason of this configuration, there is defined between the rear and intermediate shell portions a predetermined line of'fracture or structural weakness 23 which will form a clean break or fracture (FIGURES 4 and 7) in response to applied forces tending to separate these shell portions. The abrupt change in shell contour along line 23, defines an area or line of relative structural weakness and, since the plastic material from which the shell is formed is non-elastic and brittle in character, a downward force applied against the rear shell portion in the direction of the arrow shown in FIGURE 4, will produce a sharp, clean fracture. As the rear shell portion 20 is urged downwardly by finger pressure applied to the concave rear bearing surface thereof, the foldable backing 12 acts as a hinge along the transverse plane of fracture to permit downward swinging movement of part 20. Referring to FIGURES 4 and 7, it will be noted that the rear surface of flange 22 frames the opening to chamber 17 and, since this surface is sterile because of its previous location within the sealed container, there is no danger that the needle will become contaminated should it come in contact with surface 22 as that needle is removed from the package. Thus, flange 22 contributes in defining a line of structural weakness for the opening of the package, and also provides a protective frame about the opening to reduce the chances for needle contamination upon removal from the package.
Where the package contains a plurality of needles, as indicated in FIGURES 1 and 8, we provide spaced slits 24 extending inwardly from opposite side edges of the package to facilitate the opening of the needle-containing chambers and to permit the opening of separate chambers while others in the series remain closed. Also, as shown most clearly in FIGURES 7 and 8, perforation lines 25 extend between opposing slits 24 to permit detachment of individual needle packages without breaking the seal of any of the remaining chambers in the composite package.
Inv the use of a structure of the present invention, a plurality of hypodermic needles are placed within the chambers 17 of an inverted shell, and closure sheet 12 is then secured or bonded to the under surface areas of the shell which lie along the same horizontal plane. After the needles have been thus sealed within the package, the entire package may be placed within an autoclave or heat chamber where dry heat or steam may be employed to effect the desired sterilization of the needles, or the needles may be sterilized by gas after or during the packaging operation. After sterilization of the needles, the sealed package is removed and is stored until the needles are to be used. If desired, the packaged needles may be resterilized after the lapse of a period of time following the date of first sterilization.
When one or more of the sterilized and packaged needles are required for use, an operator may grip the entire package in one hand and with the thumb of his other hand press downwardly against the rearwardly sloping portion 20 of a needle-enclosing shell to bring about fracture of that shell, as shown in FIGURE 4. Then, still gripping the entire package, the operator may insert thev tapered end of a syringe into the exposed Luer fitting of the needle to frictionally interconnect the parts and to permit withdrawal of the sterilized needle from its chamber. Alternatively, the operator may first separate one or more of the needle containers from the composite package by tearing or breaking the package along the lines of perforation 25. The individual needle packages may then be opened and the needles may be removed in the manner already described. I
'FIGURE 9 illustrates how an individual needle package may be used as a stand to support, and protect a needle after it has. been connected to a syringe 26. The
folded back portion 20 of the shell rests upon a supporting surface and maintains the remainder of the package, along with the connected end of the syringe, in elevated condition. In this manner, the needle is protected from contamination during the interval between opening of the package and the actual use of the needle, except while out of the package during the filling of the syringe with medicament. This is especially useful when the needle and syringe' are filled with'the medicament well in advance of the injection of the medicament, such as occurs in a hospital when the injections are prepared at a nursing station and subsequently administered in a patients room.
In opening the package for removal of a needle, it is important to bend the hinged rear portion 20 of the container so that the backing of the hinged portion engages, or is nearly in engagement with, the backing of the remainder of the package. In other words, to fully open the package, the hinged portion should be swung about an arc in excess of 90 degrees (FIGURES 7 and 9). In this way, the U-shaped forward edge of shell portion 20 will be swung away from the open mouth of chamber 17 and will not engage a needle as it is removed from the package. It will be apparent that if needle contarnination is to be avoided, the needle should not contact any portion of the packages outer surface or the broken edges of that package which previously defined the predetermined line of fracture.
Since the intermediate portion of the shell generally follows the contour of the needle hub and since the opening or mouth defined by that portion after the shell has been broken open is smaller than the maximum cross sectional dimensions of the hub, there is no danger that a needle will accidentally drop from the package after it has been opened. Thus, the constriction of the shell directly in front of the line of fracture restrains the needle and permits needle removal only when some withdrawing force is applied which is sufficiently great to distort or bend the backing sheet at the entrance of the cavity as the hub of the outwardly moving needle bears thereagainst. However, since the resistance of the package to needle removal is ordinarily weaker than the frictional or locking connection between the needle hub and a syringe attached thereto, removal of a needle may be easily and quickly accomplished first connecting the fitting of a syringe to the needle while it remains within the opened package and thereafter pulling the syringe outwardly to withdraw the connected needle from the container.
While the present package is well suited for use in connection with hypodermic needles, it is apparent that other instruments, particularly surgical instruments and articles to be used in hospitals and clinics which should be stored and maintained for use in sterilized condition, may be enclosed in a package embodying our invention.
In the foregoing specification we have set forth a specific embodiment of the invention in considerable detail for purposes of illustration, but it is to be understood that such details may be varied widely by those skilled in the art without departing from the spirit and scope of the invention.
1. An instrument package comprising an imperforate shell of hard, non-stretchable plastic material defining at least one elongated chamber for receiving an instrument therein and being open at its bottom, said shell having an outwardly projecting transverse flange, said flange merging at a sharp angle along its outermost limits with an end portion of said shell to provide a line of structural weakness extending along a transverse plane and being adapted to fracture upon downwardly flexure of said end portion, an elongated instrument disposed within said chamber, and closure means closing said bottom opening and sealing said instrument within said chamber, said closure means being endable and providing a transverse hinge for downward pivotal movement of said end portion of said shell, said transverse plane of the line of weakness traversing the longitudinal axis of said instrument adjacent one end of the same, the surface of said flange facing said end portion of said shell being disposed within said chamber prior to fracturing of said shell and defining a sterile area between the line of fracture and said instrument within the package when said package is opened following sterilization.
2. A hypodermic needle package comprising an elongated imperforate shell integrally formed from a hard and substantially non-stretchable plastic material, said shell defining at least one elongated chamber for receiving a hypodermic needle therein and being open at its underside to provide access to said chamber, a bottom closure sheet formed of bendable material and secured to said shell to seal the bottom opening of said chamber, said elongated shell having a forward portion adapted to contain the cannula of a hypodermic needle, an intermediate portion adapted to receive the hub of said needle, and a rear portion extending rearwardly from said intermediate portion, said shell providing an outwardly projecting transverse flange between said rear and intermediate portions, said flange merging at a sharp angle along its outer limits with said rear portion of said shell to provide a line of structural weakness extending along a transverse plane and adapted to break in response to applied tensioning forces tending to pivot said rear portion downwardly about a transverse hinge line extending across said foldable bottom closure sheet, said flange having its rear surface disposed within said chamber prior to fracturing of said shell and defining a sterile area between the line of fracture and the hub of a needle within said package when said package is opened following sterilization.
3. A needle package comprising an elongated imperforate shell integrally formed from a substantially non-stretchable plastic material, said shell defining at least one elongated chamber for receiving a hypodermic needle therein and being open at its underside to provide access to said chamber, a hypodermic needle disposed within said chamber, said shell having a forward portion enclosing the cannula of said needle, an intermediate portion snugly receiving the hub of said needle, and a rear portion projecting rearwardly from said intermediate portion, said shell providing between said rear and intermediate portions an outwardly projecting transverse flange, said flange being disposed adjacent the hub of said needle and merging at a sharp angle along its outermost limits with said rear portion of said shell to provide a line of structural weakness extending along a transverse plane and adapted to fracture in response to an applied tensioning force tending to urge said rear portion downwardly with reference to the adjacent intermediate portion of said shell, said flange having its rear surface disposed within said chamber prior to fracturing of said shell and defining a sterile area between the line of fracture and the hub of said needle when said package is opened following sterilization, and a flat bendable bottom closure means for closing the open underside of said shell and for sealing said needle within said chamber, whereby, said rear portion may be pivoted downwardly about a hinge line extending across said bendable closure means to fracture said shell along said line of weakness and to expose the hub of the needle within said chamber.
4. A package for sterile articles comprising an imperforate elongated shell of brittle, substantially nonstretchable plastic material defining a chamber for receiving an article therein and being open at its bottom, said shell having an outwardly projecting transverse flange merging at a sharp angle along its outer limits with an end portion of said shell to provide a line of structural weakness extending along a transverse plane and being adapted to fracture upon relative downward pivotal movement of said end portion, and means sealing off the bottom opening of said shell to maintain an article within said chamber in sterile condition and providing a transverse hinge for said downward pivotal movement of said end portion, said flange providing a transversely extending surface portion being disposed within said chamber prior to fracture of said shell and defining a sterile area between the line of fracture and an article within said package when said package is opened following sterilization.
5. An instrument package comprising an imperforate shell of hard, non-stretchable plastic material defining at least one elongated chamber for receiving an instrument therein and being open at its bottom, said shell having an outwardly projecting transverse flange, said flange merging at a sharp angle along its outermost limits withv an end portion of said shell to provide a line of structural weakness extending along a transverse plane and being adapted to fracture upon downward fiexure of said end portion, an instrument disposed within said chamber, and closure means closing said bottom opening and sealing said instrument within said chamber, said closure means being bendable and providing a transverse hinge for downward pivotal movement of said end portion of said shell, said instrument comprising a hypodermic needle provided with hub and cannula portions received within 8 said shell, the cannula portion of said needle being suspended Within said chamber in spaced relation with ref erence to the inner surfaces of said shell, said transverse plane of the line of weakness traversing the hub of said needle inwardly from the end thereof.
References Cited in the file of, this patent UNITED STATES PATENTS 2,499,313 Hoag Feb. 28, 1950 2,750,719 Wandelt June 19, 1 956 2,836,942 Miskel June 3, 1958 2,874,836 Wertepny Feb. 24, 1959 2,892,538 Middleton et a1 June 30, 1959 2,990,948 Zackheim July 4, 1961