US3392726A - Combination syringe and vial container - Google Patents

Description

July 16, 1968 G. L. POCHYLA ET Al COMBINATION SYRINGE AND VIAL CONTAINER Filed AugA 9. 1965 M, l 7 4 4 1J du f 243 3% W| il Yi@ l 0/ .d f W a W 0 4 2 9 9 5M, 4

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am /af M Mw wf United States Patent O 3,392,726 COMBINATION SYRINGE AND .VIAL CONTAINER Gerald L. Pochyla and' William R. Smith, Kalamazoo, Mich., assignors to The Upjohn Company, Kalamazoo, Mich., a corporation of Delaware Filed Aug. 9, 1965, Ser. No. 478,085

7 Claims.` (Cl. 12S- 272) ABSTRACT OF THE DISCLOSURE A combined container and injection device comprising a vial defining a mixing chamber for a first sterile ingredient and a syringe connected to the vial and defining a storage chamber for a second sterile ingredient. rA penetrable plug is inserted into the open end of the vial and a liquid-tight connector extends between the plug and the discharge end of the syringe. The connector supports a cannula having its lower end extending through the plug into the vial and its upper end embedded in the seal, which the cannula can be caused to penetrate.

This invention relates in general to a combined multiple-compartment container and injection `device and, more particularly, to a type thereof having separate compartments in which two or more ingredients may be maintained independent of each other until it is desirable to combine them, after which the two compartments can be quickly and easily placed in communication with each other by a connecting mechanism whichincludes the injection device.

Particularly in the packaging of pharmaceuticals or medicaments, it is frequently necessary or desirable to provide a unitary container in which two or rnore ingredients are placed and maintained completely separate until the use of the combined ingredients is required. As a Well-known example, some fluids, which are injected into human or animal bodies, comprise a mixture of dry powdered ingredients and a reconstituting diluent, which mixture loses its strength or otherwise becomes unacceptable after a relatively short time has elapsed. Thus, much attention has been given for many years to the development of a completely satisfactory two-compartment package or container for the pharmaceutical industry. However, existing two-compartment packages capable of use for storing the ingredients and thereafter injecting them into the human lbody have proved unsuccessful and/or unacceptable for one or ymore of a variety of reasons, which the containers of this invention are designed to overcome.

While the descriptive material contained in this application is directed primarly to the disclosure of a combined two-compartment container and injection device adapted for use in the medical field, it will be recognized that such a device may prove useful in other unrelated fields.

Accordingly, a pri-mary object of this invention has been the provision of a combined multiple-compartment container and injection device which is simple in construction, economical to fabricate, relatively easy to fill, and comprised of components with which the user, such as a physician, is already familiar, so that the ingredients can be mixed quickly, as in the case of an emergency, without time-consuming reection upon the mechanics of operating the device.

A further object ofthe invention has been the provision of a device, as aforesaid, comprised `of a syringe and a vial with connector means which is a departure from structures of the prior art, which provides a less costly and more easily operable mechanism for effecting inter- 3,392,726 Patented July 16, 1968 ICC connection and communication between the syringe and the vial without risk of contaminating the separated sterile ingredients prior to or `during the .mixing operation, and which permits easy use of the syringe to inject the mixture in a conventional manner.

Other objects and purposes of the invention will become apparent to persons familiar with this type of equipment upon reading the following descriptive material and examining the accompanying drawings, in which:

FIGURE 1 is a partially sectioned, side. elevational view of a container embodying the invention.

FIGURE 2 is a broken, sectional View substantially as taken along the line II-II in FIGURE l.

FIGURE 3 is a sectional view similar to FIGURE 2 showing parts thereof in different positions of operation.

FIGURE 4 is a sectional view taken along the line IV-IV in FIGURE 2.

FIGURE 5 is an enlarged fragment of FIGURE l with part of the connector broken away to show the seal.

FIGURE 6 is a sectional view similar to that shown in FIGURE 2 and disclosing a modified structure.

For convenience in description, the terms upper, lower and words of similar import will have reference to the device of the invention as appearing in FIGURE l. The terms innen outer and words of similar import will have reference to the central vertical axis of the device as appearing in FIGURE l.

GENERAL CONSTRUCTION The device of this invention essentially comprises a vial containing a mixing chamber in which a first sterile ingredient, such as a dried powder, is placed during the filling operation. A syringe having a storage chamber is attached to the vial by a connector, and a second sterile ingredient, such as a uid diluent, is placed in the storage chamber during the filling operation, A penetrable, preferably resiliently flexible, plug is inserted into the upper open end of the vial for sealing the mixing chamber. The substantially tubular connector is attached to and extends substantially coaxially between the stopper and the lower discharge end of the syringe. The connector includes an upper tubular member containing a liquid-tight seal, which covers the lower open end of the syringe barrel, and also includes a lower tubular member which is telescopically attached to the upper tubular member and is slideably and snugly received into a recess in the stopper. A cannula or needle is rigidly mounted upon and extends coaxially through the lower tubular member and through the lower part of the stopper. The upper end of the needle is embedded in the seal in the upper tubular member.

By -moving the tubular members toward each other, tbe needle is caused to penetrate the seal and thereby provide communication between the mixing and storage chambers. However, prior to such penetration, the ingredients in the two chambers are maintained completely separate from each other by substantially vapor-resistant seals. After the upper seal is perforated by the cannula, the syringe plunger is moved downwardly into the storage chamber whereby the diluent is forced through the cannula into the mixing chamber, whereby the combined dil-uent and serile powder, for example, can be combined byshaking the entire device. Thereafter, the contents of the -mixing chamber can be withdrawn. -by moving the plunger away from the vial, after which the syringe can be removed from the vial for use in perfor-ming an injection in a substantially conventional manner.

DETAILED DESCRIPTION As shown in FIGURE 1, which illustrates a preferred embodiment of the invention, the combined container and injection device of the invention is comprised of a vial 11 having a stopper 12 in its upper open end, a syringe 131 having a barrel 14, and a connector 17 between the barrel 14 and the stopper 12. The syringe 13 has an open upper end through which a plunger 18 extends for manual engagement at its upper end. A piston 19 is connected to the lower end of the plunger 18 and defines the upper limits of the storage chamber 22 in which a liquid diluent 23, for example, is contained. The piston 19 is preferably fabricated from a material, such as a lbutyl rubber, which is substantially impervious to the transference of moisture or vapor therethrough and which will maintain a tight seal with the inside walls of the barrel 14.

The syringe 13 may be of a substantially conventional construction, providing only that the barrel 14 has a lower end portion 24 (FIGURES 1 and 2) of reduced diameter with a radially outwardly extending bead 26 along its lower edge for reasons appearing hereinafter. The syringe may be fabricated from glass, plastic or the like. The vial 11 may also be substantially conventional in that it has a neck portion 27 at its upper end defining an opening 28 into which the stopper 12 is inserted. In this particular embodiment, the wall of the neck portion 27 defining the opening 28 is snugly engaged by annular ridges 32 on the side wall of the stopper 12, and the sidewardly extending, integral fiange 33 adjacent the upper end of the stopper 12 is in snug engagement with the upper edge of the neck portion 27.

Said stopper 12 has a preferably coaxial and upwardly opening recess 34 which provides a relatively thin, but liquid and vapor-tight end wall 36 between said recess 34 and the mixing chamber 37, the upper limits of which are defined by the lower surface 38 of the stopper 12. The depth of the recess 34 is governed largely by the desired thickness of the penetrable wall 36 and the amount of rigidity which must be provided by the stopper in the support of the connector 17. In this particular embodiment, the stopper 12 is preferably made from butyl rubber which may include additives of various known types and which has the well-known quality of being highly resistant to the transference of liquids, vapors or gases therethrough or therearound. An overseal 40, which may be metallic, rigidly secures the stopper 12 upon the neck 27 of the vial 11 in a conventional manner.

The connector 17 is comprised of an upper tubular member 39 which is preferably of circular cross section and has a lower end portion 42 of reduced diameter, which provides a radially disposed wall or shoulder 43. The upper end of the tubular member 39 is snugly sleeved upon the lower end portion 24 of the barrel 14 and the upper edge 44 of said tubular member is bent yradially inwardly in any convenient manner around the bead 26 to prevent disengagement therebetween.

A sealing member 46 is snugly disposed between the lower edge of the end portion 24 and the shoulder 43 and is preferably held under slight compression therebetween, so that it seals the opening in said end portion 24. The peripheral surface 47 of the sealing member 46 is preferably concave, whereby, as shown in FIGURE 5, a pair of radially outwardly projecting ridges 48 and 49 are provided on the peripheral surface 47 adjacent the upper and lower edges thereof. Said ridges 48 and 49 may or may not engage the inner wall of the tubular member 39. As shown in FIGURES 2 and 3, the open space or Zone 52 between the surface 47 and the adjacent surface of the tubular member 39 is reduced by either partial or complete penetration of the sealing member 46 by the cannula or needle 53. Thus, the zone 52 provides for the expansion of the sealing member 46 as it is penetrated by the needle 53.

,The connector 17 also includes a lower tubular member 56 having an upper sleeve portion 57 which is telescopically engaged with the lower end portion 42 of the tubular member 39. In this particular embodiment, the sleeve portion 57 is on the outside of the end portion 42, 'but this arrangement could be reversed. The tubular member 56 has a lower end portion of reduced inside diameter in which the cannula 53 is snugly and firmly held by means of the sleeve 58 through which the cannula extends axially. The outside diameter of the tubular member 56 is preferably slightly larger than the minimum inside diameter of the recess 34 in the stopper 12 so that said tubular member 56 can be snugly received into said recess 34 and, accordingly, firmly held with respect to said stopper 12. The radial wall o-f the recess 34 may be provided with annular, radially inwardly extending ridges 61 for the purpose of providing a more readily releasable grip, but equally firm positioning, of the tubular member 56 by said stopper 12 within the recess 34.

The lower end portion 42 of the tubular member 39 has an annular, outwardly opening groove 62 which may be formed by a pair of spaced annular ridges 63. The inner surface of the sleeve portion 57 of the tubular member 56 is provided with a radially inwardly extending, annular ridge 64 which has an inside diameter preferably of about the same diameter as the groove 62 into which the ridge 64 can be urged when the sleeve portion 57 is telescoped with the lower end portion 42 to yieldably oppose relative axial movement therebetween.

The cannula 53 is mounted within the tubular member 56 so that, as shown in FIGURE 2, its upper end is embedded in, but does not extend through, the sealing member 46 when the ridge 64 is within the groove 62. However, lby urging the vial 11 upwardly toward the radial wall 43, the ridge 64 can be manually displaced from within the groove 62 so that the upper edge of the sleeve portion 57 bears against said wall 413 and, at the same time, the upper end 66 of the cannula 53 passes through the sealing member 46 so that its passageway 67 can communicate with the storage chamber 22. When such insertion is completed, the opening at the upper end of the cannula 53 is closely adjacent the upper surface of the sealing member 46.

Operation It is probably evident from the foregoing descriptive material that the syringe 33 may be inverted and filled with a sterile ingredient, such as a liquid diluent, through its opening 25 in a substantially conventional manner after the plunger 18 has been inserted into the upper end thereof. The sealing member 46 is then assembled upon the end portion 24 of the barrel 14 so that the contents of the syringe 13 are now confined within a liquid-tight and substantially vapor-proof storage chamber 22 where they are ready for use and protected from contamination.

A sterile ingredient, such as a dry powder, is placed in the vial 11 after -which the stopper 12 is inserted Itherein and the overseal 40 is secured in place. The lower tubular member 56 is then mounted upon the stopper 12 so that the cannula 53 pierces the wall 36 in the stopper 12 and extends into the mixing chamber 37, and so that the lower end of the tubular lmember 56 is firmly seated within the recess 34 in said stopper 12. The syringe 13 is then mounted upon the vial 11 by inserting the lower end 0f the tubular member 39 into the sleeve portion Iof the lower tubular member 56 until the ridge 64 is disposed within the groove 62, whereby the upper end of the cannula 53 will be embedded in the sealing member 46, as shown in FIGURE 2. The entire container device 10, being `thus assembled, can now be stored as safely as though the two ingredients involved were placed in separate containers having no interconnection whatsoever.

The annular ridges 32 on the stopper 12 permit more.

variation in sizes and provide room for expansion of the stopper when the syringe is inserted thereinto.

When it becomes desirable to inject the ingredients of the container and injection device, it is only necessary to urge the syringe 13 and vial 11 toward each other until the upper end of the lower tubular member 56 engages the wall 43, whereupon the upper end of the cannula 53 will pierce the sealing member 46, as shown in FIGURE 3;'Thereafter, by urging the plunger 18 downwardly, the diluent in the storage chamber 22 is urged through the cannula 53 into the mixing chamber 37` wherein the dry powdered ingredient in -the vial can be reconstituted in a substantially conventional manner. The syringe, with the tubular member 56 attached thereto, ismoved away from the vial 11 in a substantially conventional manner until the lower end of the cannula 53 is adjacent the lower surface 38 of the stopper 12. The container device is then inverted so that the liquiiied contents of the mixing chamber 37 can be withdrawn therefrom into the storage chamber 22 by downward movement of the plunger 18. The syringe with the tubular member 56 attachedcan now be used in a conventional manner to inject into a human or animal body the contents of the syringe 13.

Alternate construction The alternate container device 71, shown in FIGURE 6, is substantially the same as the container device 10 except for the structure ofthe lower tubular member 56A, the -upper tubular member 39A and the sealing member 46A. The sealing member 46A within the upper tubular member has a substantially cylindrical stem 72 which extends into the opening 73 defined by Ithe lower end portion 24 of the barrel 14, so that .the thickness of the liange 74 on said sealing member 46A between the lower edge of the end portion 24 and the radial wall 43A may be somewhat less than the corresponding distance in the container device 10. The peripheral w-all 76 of the stem 72 is preferably made concave to allow for radial displacement of a portion of the material within the stem 72 when the cannula 53 is urged therethrough.

The lower end portion 42A of the tubular member 39A is provided with a pair of radially outwardly projecting, annular ridges 77 and 78 which are spaced predetermined distances from each other and from the radial wall 43A. lEach of the ridges 77 and 78 preferably has a radially disposed upper surface 79 and a downwardly converging lower surface 80.

The sleeve portion 57A of the lower tubular member 56A has a radially inwardly projecting, annular ridge 83 preferably near the upper end thereof. Said ridge 83 has a substantially radially disposed lower surface 84 which is engageable with the upper surfaces 79 on the ridges 77 and 78 when the sleeve portion 57A is telescopically mounted upon the lower end portion 42A of the tubular member 39A. The ridges 77 and 78 and the ridge 83 are :located upon their respective tubular members so that when the lower surface 84 is engaged with the upper surface of the ridge 78, the upper end of the cannula 53 will be embedded in, but will not penetrate, the stopper 12A. However, when the lower surface 84 is engaged with the upper surface of the ridge 77, the upper end of the cannula will extend through the stopper 12A and be in communication with the storage chamber 22. Otherwise, the assembly and operation ofthe alternate container 4device 71 will be substantially the same as that disclosed above with respect to the container device 10.

The wall of the neck portion 27A defining the opening 86 (FIGURE 6) may be provided with coaxial annular recesses 87 into which the corresponding annular ridges 88 are snugly but removable received when the flange 33A of the stopper 12A is against the upper edge of the neck portion 27A.

The container device 10, or the alternate device 71, may be sealed in a suitable package, such as a plastic bubble on cai-dboard, to protect the device during storage and/ or shipment.

Although particular preferred embodiments of the invention have been disclosed above for illustrative purposes, it will be understood that variations or modifications thereof, which do not depart from the scope of the appended claims, are fully contemplated. v

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A device for containing sterile ingredients for injection, comprising:

first means delinin-g a mixing chamber for containing a first ingredient;

second means defining a storage chamber for containing a uid ingredient, said first and secondmeans having openings therein communicating with their respective chambers;

penetrable plug means sealing the opening in said first means and having an outwardly opening recess;

first tubular meansaixed to said second means foi a liquid-tight connection with the opening therein, said iirst tubular means including a seal tightly'closing `said opening in said second means;

second tubular means telescopically engaged with said lirst tubular means and axially movable lengthwise thereof, said second tubular means being snugly received into and releasably held in said recess -for support of said second tubular means by said plug means, said first and second tubular means remaining telescopically engaged when said second tubular means is released from said plug means;

a cannula mounted in and extending substantially coaxially through said second tubular means, one end of said cannula extending substantially coaxially into saidv first tubular means so that the tip thereof is embedded in said seal to occupy a storage position, said second tubular means and said cannula being adapted for axial movement with respect to said rst tubular means so that said tip of said cannula pierces said seal 'and said one end communicates with said storage chamber to occupy a use position; and

plungermeans in said storage chamber -for moving the fluid ingredient therein through said cannula after said seal is pierced thereby.

2. A device according to claim lwherein the peripheral wall of said seal means is concave whereby the central portion of said seal means is spaced from said second tubular member.

3. A device according to claim 1, wherein the other end of said cannula penetrates said plug means and is in communication with the mixing chamber when in sai-d storage position.

4. A device according to claim 1, wherein said first and second tubular means have positive interitting lock means therebetween for releasably resisting relative axial movement thereof whereby said cannula is moved between said storage position an-d said use position.

5. The device of claim 1, wherein said irst and second tubular means have interengageable, first and second stop means for releasably holding said tubular means against relative axial movement when said cannula is in said storage position and said use position, respectively, the holding being more forceful in a direction opposed to the axial separation of said tubular means.

6. A device according to claim 1, wherein said first tubular means has a portion of reduced diameter with a pair of spaced and annular ridges projecting outwardly therefrom; and

wherein said second tub-ular means is sleeved over said portion of reduced diameter and has an annular, inwardly projecting ridge removably receivable between said pair of ridges when said cannula is in said storage position for releasably resisting relative axial movement between said lirst and second tubular means.

7. A device for containing sterile ingredients for injection, comprising:

first means defining a mixing chamber for containing a first ingredient;

second means defining a storage chamber for containing a second ingredient, said first and second means having openings therein communicating with their respective cham'bers;

penetra-ble plug means sealing the opening of said first means and having an outwardly opening recess;

first tubular means fixed to said second means and having a tight sealing connection with the opening therein;

seal means tightly closing said opening in said second means;

second tubular means telescopically engaged with said first tubular means and axially movable lengthwise thereof, said second tubular means being snugly received into and releasably held in said recess for support of said second tubular means by said plug means, said first and second tubular means remaining telescopically engaged when said second tubular means is released from said plug means;

a cannula mounted in and extending substantially coaxial'ly through sai-d second tubular means, one end of said cannula extending into said first tubular means so that the tip thereof is embedded in said seal and the other end of said cannula extending through said plug means and `being in communication with `said mixing chamber when said cannula is in Va storage position, said second tubular means and saidcannufla being adapted for axial movement with respect to said first tubular means so that said tip Iof said cannula penetrates said seal and communicates with said storage chamber when in a use position; and plunger means in said storage chamber for moving the second ingredient therein through said cannula after it penetrates said seal.

References Cited UNITED STATES PATENTS 2,724,383 11/1955 Lockhart 128-215 2,742,041 4/ 1956 Lipari 128-21 2,922,419 1/ 1960 Bednarz.

3,336,924 8/ 1967 Sarnoff et al 1285-272 FOREIGN PATENTS 1,063,341 8/ 1959 Germany.

D. L. TRULUCK, Examiner.

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