|Publication number||US3330281 A|
|Publication date||Jul 11, 1967|
|Filing date||Aug 21, 1964|
|Priority date||Aug 21, 1964|
|Publication number||US 3330281 A, US 3330281A, US-A-3330281, US3330281 A, US3330281A|
|Inventors||Melvin J Visser|
|Original Assignee||Upjohn Co|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (9), Referenced by (59), Classifications (15)|
|External Links: USPTO, USPTO Assignment, Espacenet|
July 11, 1967 M. J. VISSER 3,330,281
COMBINATION SYRINGE AND VIAL MIXING CONTAINER Filed Aug. 21, 1964 INVENTOR MELV/N J. V/SSER f/gz/re 1 BY W ATTORNEY United States Patent 3,330,281 COMBINATION SYRINGE AND VIAL MIXING CONTAINER Melvin J. Visser, Portage, Mich., assignor to The Upjohn Company, Kalamazoo, Mich., a corporation of Delaware Filed Aug. 21, 1964, Ser. No. 391,219 3 Claims. (Cl. 128-272) This invention relates to containers and, more particularly, to compartmented containers for separate maintenance of materials prior to their use in combination.
Frequently it is desired to package in a single unit dry solids and a reconstituting diluent or separately maintained liquids for mixing prior to use, as in the separate storage of sterile components of a mixture to be injected into the human or animal body. Much attention has been accorded the development of such packages for the pharmaceutical industry in recent years. Various combinations of multiple-compartmented injection units have in fact been developed, but results thus far have proved unsatisfactory for one or more of a variety of reasons which the containers of this invention are designed to overcome.
The device of this invention is remarkably simple in construction and economical to fabricate and fill. More important, however, is the provision of a unit embodying components with which the physician is already familiar. Where reconstitution or mixing of ingredients is necessary prior to use, he is thus enabled to respond in emergencies without time-consuming reflection on mechanics of operation. In this respect the device hereof, with unique coaction between its basic elements, is a departure from compartmented injection devices of the art, which demonstrate remarkable ingenuity but too often involve costly or complicated features that detract from their practical usefulness.
The device of this invention comprises essentially means defining a mixing chamber for containing a first sterile ingredient for injection to which is affixed means defining a storage chamber for containing a second sterile fluid ingredient for injection. A penetrable plug seals the open, upper end of the mixing chamber. Communication between the mixing and storage chambers is provided by a cannula mounted on the means defining the storage chamber and extending through the penetrable plug. A pressure-expellable cap closes the lower, extended end of the cannula. The storage chamber carries a plunger with piston slidable therein, whereby downward movement of the plunger and piston develops pressure to expel the cap, causing the fluid ingredient of the storage chamber to enter the mixing chamber.
In its preferred embodiment the device of this invention comprises a mixing vial containing a first sterile ingredient for injection atop of which is positioned a syringe containing a second sterile fluid ingredient, such as a diluent, for injection. The cannula of the syringe extends into the vial through a penetrable plug which both seals the neck of the vial and affords rigidity in the connection between the syringe and the vial of the mounted assembly. A sealing pop-01f cap is frictionally engaged over the extended end of the cannula inside the vial, the cap being expelled from the cannula on the downward movement of the plunger of the syringe, causing the fluid ingredient in the syringe to mix with the first sterile ingredient in the vial. The entire unit is then inverted, the syringe withdrawn to a low point in the inverted vial and the mixed ingredients drawn into the syringe in the usual manner. The syringe is then withdrawn from the vial and is ready for use.
In the drawings, FIGURE 1 is a partial cross-section of a syringe and vial united in the manner described.
FIGURE 2 shows an enlarged cross-section of the penetrable plug for receiving the syringe and sealing the vial contents from the atmosphere.
FIGURE 3 illustrates a cross-section of the pop-off cannula cap.
Referring more specifically to the drawings, it will be seen from FIGURE 1 that the syringe S has a cylindrical barrel 1 which is removably mounted atop vial 2. Barrel 1 terminates at its upper end in a finger-engageable collar 3 and at its lower end in boss 4, which is of reduced diameter. Penetrable plug 5, which is secured in neck 6 of vial 2, has a flange 18 engaged with the upper, flanged edge of the neck 6. Said plug 5 also has an upwardly opening bore 21 into which the boss 4 of barrel 1 is received, thereby lending rigidity to the assembly and sealing the interior of vial 2 against the atmosphere. Overseal 7 provides tamper-proof protection for plug 5 and clamps the flange 18 against the neck 6 to improve the seal. Plunger 8 with thumb-engageable flange 9 is slidably mounted in barrel 1. One end of the plunger extends beyond the barrel 1 and the other end is connected to the piston 10, which is disposed in the barrel 1. Annular grooves 11 in piston -10 provide annular ridges for slidable and sealing engagement with the interior surface of barrel 1. Cannula 12, which is rigidly mounted in boss 4, communicates with the chamber 1A and extends through the plug 5 into vial 2. Pop-ofi cap 13 is frictionally engaged over the free end of cannula 12, whereby depression of plunger 8 develops pressure within chamber 1A suflicient to dislodge cap 13 from the cannula 12 and cause it to fall freely into vial 2. Thereupon fluid 14 in chamber 1A can be forced into vial 2 for admixture with medicament 15 therein by downward movement of the plunger 8.
Where it is desired to reduce the overall height or the package, plunger 8 can be provided with a threaded stem 16 of reduced diameter for threadable engagement with a threaded receiver portion 17 of piston -10.
Plug 5 must not only provide an effective seal against contamination of the contents 15 of vial 2, but must also aflord substantially rigid support to the syringe mounted therein. FIGURE 2 shows more clearly a favored form of plug 5. Upper flange 18 of plug 5 has a diameter larger than the internal diameter of neck 6 of vial 2. Body section 19 of plug 5 is substantially the same diameter as the internal diameter of neck 6 and has at least one ring 20 or annular ridge intermediate its length to afford a positive seal against said neck 6. The plug 5 has a central bore 21 which extends downwardly into body section 19 intermediate its depth, said bore being of substantially the same diameter as boss 4. At least one circumferential ridge 22 extends into bore 21 from body section 19. The lower extremity of body section 19 presents a concave surface 23, which provides a low point for complete withdrawal of contents from the inverted vial after mixture of ingredients.
Pop-off cap 13 is more clearly illustrated in FIGURE 3. Reference thereto shows a generally cylindrical and cup-shaped body having a downwardly extending channel 24 of substantially the external diameter of cannula 12. Channel 24 terminates at its lower end in an enlarged cavity 25 for receiving the tip of cannula 12 without contact therewith. Intermediate the length of channel 24 is at least one annular recess 26 to facilitate presentation of a resilient and adhering surface to cannula 12. Cap 13 remains in place until downward movement of plunger 8 develops sufiicient pressure in cavity 25 to expel said cap 13 from cannula 12.
All parts in contact with medicament, with the excep tion of plug 5, piston 10 and pop-ofl? cap 13, cas "be made of glass, plastic or other suitable material that can be sterilized. Plug 5, piston 10 and pop-off cap 13 are fabricated from materials such as high quality rubber or Qsimilar materials can be suitably employed.
A particularly desirable feature of the present device is the ease with which it can be filled under aseptic conditions. With all parts and ingredients rendered sterile, the solid or liquid medicament 15 is charged to vial 2. Cannula 12 is inserted through overseal 7 and plug 5, and boss 4 positioned in bore 21. Cap 13 is applied over the tip of cannula 12, the liquid diluent or medicament 14 is charged to barrel 1, and plunger 8 with piston 10 is inserted in barrel 1. Plug 5 with the syringe unit in place is then inserted in neck '6 of vial 2 and the overseal 7 applied to complete the assembly. It is apparent that other sequences can be employed, but the important aspect to be noted is the freedom from diflicult assembly problems encountered here which commends this device to conventional manufacturing techniques.
What is claimed is:
1. A device for both maintaining separately and thereafter mixing sterile ingredients and for injecting the mixture, comprising in combination:
vial means having a neck communicating with a mixing chamber for containing a sterile first ingredient; penetra'ble plug means sealingly inserted in the neck of said vial means; syringe means having a storage chamber for containing a sterile fluid inpredient, said syringe means having plunger means in said storage chamber and having a cannula mounted thereon with a tip portion penetrating said plug means and extending into said mixing chamber;
holding means integral with said plug means and on said syringe means adjacent said cannula releasably connecting and firmly holding said syringe means with respect to said vial means; and
cap means surrounding the inner end of said cannula,
said cap means having means frictionally engaging said cannula, said cap means being spaced both from said tip portion of said cannula and from said vial, said cap means being dislodged from said cannula by the pressure developed in said syringe upon movement of the plunger means toward the cannula while said holding means are connected, whereby said fluid ingredient can be discharged into said vial means and mixed with said first ingredient, and the resulting fluent mixture can be withdrawn from said vial means into said syringe means .after which said holding means are released so that said syringe means can be used to inject said mixture.
2. A device according to claim 1 wherein the length of said cap means is less than the distance between the tip of the cannula and the wall of the vial toward whieb said cannula extends, when said holding means are c%* nected.
3. In combination:
(1) A mixing chamber for containing a first sterile ingredient for injection and having an open end;
(2) A storage chamber for containing a sterile fluid ingredient for injection afiixed to said mixing chamber;
(3) Penetrable plug means mixing chamber;
(4) A cannula extending from one end of said storage chamber through said plug into said mixing cham-' ber and communicating therebetween;
(5) A plunger mounting a piston at its lower end slidable in said storage chamber, and
sealing the open end of said (6) A sealing cap having a generally cylindrical body of resilient material nonsticking with respect to the cannula surface, said body having a channel of substantially the external diameter of said cannula extending downwardly from the upper surface of said body and terminating in an enlarged cavity for receiving the tip of said cannula, but without contact therewith, said channel having at least one annular recess intermediate the length of said channel, whereby the cap will be frictionally retained over the tip of the cannula until pressure in the cavity,
developed by downward movement of the plunger and piston, is sufficient to overcome the adhering tendency of said cap and expel it freely into the mixing chamber, thereby causing mixture in said mixing chamber of said first ingredient and said fluid ingredient, whereupon the resulting fluid mixture can be withdrawn from said mixing chamber into said storage chamber and said storage chamber separated from said mixing chamber for use.
7 References Cited UNITED STATES PATENTS 2,289,677 7/1942 Perelson 215-47 2,400,722 5/1946 Swan 2l547 X 2,591,046 4/1952 Brown 1282l8 2,666,434 1/1954 Ogle 1282.18 2,869,543 1/1959 Ratcliif et al 1. 128218 2,959,170 11/1960 Laub 128-218 FOREIGN PATENTS 64,037 5/ 1955 France. 806,736 10/ 1936 France. 1,063,341 8/ 1959 Germany.
DALTON L. TRULUCK, Examiner.
RICHARD A. GAUDET, Primary Examiner.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2289677 *||Sep 24, 1940||Jul 14, 1942||Harold N Perelson||Rubber stopper|
|US2400722 *||Jul 10, 1944||May 21, 1946||Swan Harry L||Hypodermic needle case|
|US2591046 *||Oct 18, 1948||Apr 1, 1952||Frederick M Turnbull||Hypodermic syringe assembly|
|US2666434 *||Nov 17, 1950||Jan 19, 1954||Ogle Robert W||Disposable syringe|
|US2869543 *||Aug 23, 1957||Jan 20, 1959||Iowa Cooperative Ass||Injector|
|US2959170 *||Dec 26, 1957||Nov 8, 1960||Laub Ernest S V||Hypodermic syringe|
|DE1063341B *||Aug 20, 1956||Aug 13, 1959||Heyl & Co||Injektionsspritze|
|FR64037E *||Title not available|
|FR806736A *||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3397694 *||Jul 6, 1965||Aug 20, 1968||C S M Corp||Combination syringe package, syringe and chamber|
|US3480147 *||May 22, 1967||Nov 25, 1969||American Standard Inc||Filtration system seal|
|US3552387 *||Jul 16, 1968||Jan 5, 1971||Stevens Peter A||Combination syringe and vial|
|US3735900 *||May 13, 1971||May 29, 1973||Prod Res & Chem Corp||Dual ingredient storage, intermixing and dispensing storage|
|US3915212 *||Dec 10, 1973||Oct 28, 1975||Abbott Lab||Flexible medical fluid container having a combined fill and administration port and reinforced hanger|
|US3958572 *||Dec 16, 1974||May 25, 1976||Corning Glass Works||Blood collecting and separating assembly stopper|
|US3995647 *||Sep 25, 1975||Dec 7, 1976||Kopfer Rudolph J||Combined mixer and applicator device|
|US4048999 *||Jul 12, 1976||Sep 20, 1977||Merck Patent Gesellschaft Mit Beschrankter Haftung||Two-chamber mixing syringe|
|US4066067 *||Mar 19, 1976||Jan 3, 1978||Dematex Development & Investment Establishment||Vial stopper for blood sampling device|
|US4153057 *||Jul 5, 1977||May 8, 1979||Merck Patent Gesellschaft Mit Beschrankter Haftung||Stopper for two-chamber mixing syringe|
|US4163500 *||Jan 23, 1978||Aug 7, 1979||Siemens Aktiengesellschaft||Bottle seal|
|US4200100 *||Apr 20, 1978||Apr 29, 1980||Aluminum Company Of America||Additive transfer unit with piercing member having a penetratable protective tip|
|US4210142 *||Oct 20, 1978||Jul 1, 1980||Hans Worder||Twin chamber injection syringe|
|US4226334 *||Dec 14, 1978||Oct 7, 1980||Automatic Liquid Packaging, Inc.||Stopper|
|US4243150 *||Jan 23, 1978||Jan 6, 1981||Siemens Aktiengesellschaft||Bottle seal|
|US4253459 *||Nov 19, 1979||Mar 3, 1981||Aluminum Company Of America||Additive transfer unit with stabilized sealing means|
|US4301799 *||Oct 29, 1979||Nov 24, 1981||Baxter Travenol Laboratories, Inc.||Non-collapsible medical fluid container with air vent filter|
|US4516967 *||Jul 27, 1983||May 14, 1985||Kopfer Rudolph J||Wet-dry compartmental syringe|
|US4635807 *||Sep 3, 1985||Jan 13, 1987||Schering Corporation||Stopper for sterile fluid containers|
|US4846235 *||Jun 9, 1987||Jul 11, 1989||Halliburton Company||Radioactivity shielding transportation assembly|
|US4858759 *||May 20, 1988||Aug 22, 1989||Hilti Aktiengesellschaft||Container arrangement for cartridge dispensing two-component mass|
|US4869299 *||Oct 11, 1988||Sep 26, 1989||Halliburton Company||Radioactivity shielding transportation assembly and method|
|US4927013 *||Apr 12, 1989||May 22, 1990||Eastman Kodak Company||Package for storing and remixing two materials|
|US5000331 *||Jan 23, 1990||Mar 19, 1991||Instruments For Research and Industry I2 R. Inc.||Stabilized bottle|
|US5472022 *||Nov 2, 1993||Dec 5, 1995||Genentech, Inc.||Injection pen solution transfer apparatus and method|
|US5752940 *||Apr 8, 1996||May 19, 1998||Becton Dickinson And Company||Syringe and method for lyophilizing and reconstituting injectable medication|
|US5989237 *||Dec 4, 1997||Nov 23, 1999||Baxter International Inc.||Sliding reconstitution device with seal|
|US6019750 *||Dec 4, 1997||Feb 1, 2000||Baxter International Inc.||Sliding reconstitution device with seal|
|US6022339 *||Sep 15, 1998||Feb 8, 2000||Baxter International Inc.||Sliding reconstitution device for a diluent container|
|US6063068 *||Sep 15, 1998||May 16, 2000||Baxter International Inc.||Vial connecting device for a sliding reconstitution device with seal|
|US6071270 *||Dec 4, 1997||Jun 6, 2000||Baxter International Inc.||Sliding reconstitution device with seal|
|US6090091 *||Sep 15, 1998||Jul 18, 2000||Baxter International Inc.||Septum for a sliding reconstitution device with seal|
|US6090092 *||Dec 4, 1997||Jul 18, 2000||Baxter International Inc.||Sliding reconstitution device with seal|
|US6113583 *||Sep 15, 1998||Sep 5, 2000||Baxter International Inc.||Vial connecting device for a sliding reconstitution device for a diluent container|
|US6159192 *||Dec 4, 1997||Dec 12, 2000||Fowles; Thomas A.||Sliding reconstitution device with seal|
|US6582415||May 2, 2000||Jun 24, 2003||Thomas A. Fowles||Sliding reconstitution device for a diluent container|
|US6610040||May 8, 2000||Aug 26, 2003||Baxter International Inc.||Sliding reconstitution device with seal|
|US6852103||Jan 16, 2003||Feb 8, 2005||Baxter International Inc.||Sliding reconstitution device with seal|
|US6875203||May 3, 2000||Apr 5, 2005||Thomas A. Fowles||Vial connecting device for a sliding reconstitution device for a diluent container|
|US6890328||Apr 17, 2003||May 10, 2005||Baxter International Inc.||Sliding reconstitution device for a diluent container|
|US7074216||Mar 26, 2002||Jul 11, 2006||Baxter International Inc.||Sliding reconstitution device for a diluent container|
|US7358505||Dec 23, 2003||Apr 15, 2008||Baxter International Inc.||Apparatus for fabricating a reconstitution assembly|
|US7425209||Dec 23, 2003||Sep 16, 2008||Baxter International Inc.||Sliding reconstitution device for a diluent container|
|US7533976 *||Apr 27, 2005||May 19, 2009||Hewlett-Packard Development Company, L.P.||Sealing component defining first, second, and third seals|
|US7641851||Dec 23, 2003||Jan 5, 2010||Baxter International Inc.||Method and apparatus for validation of sterilization process|
|US7669995 *||Apr 9, 2009||Mar 2, 2010||Hewlett-Packard Development Company, L.P.||Sealing component defining first, second, and third seals|
|US7934614 *||Jun 7, 2006||May 3, 2011||J. G. Finneran Associates, Inc.||Two-piece seal vial assembly|
|US8022375||Dec 18, 2009||Sep 20, 2011||Baxter International Inc.||Method and apparatus for validation of sterilization|
|US8226627||Aug 12, 2008||Jul 24, 2012||Baxter International Inc.||Reconstitution assembly, locking device and method for a diluent container|
|US8550273||Aug 31, 2010||Oct 8, 2013||Wheaton Industries, Inc.||Cryogenic vials|
|US20020172615 *||Mar 8, 2001||Nov 21, 2002||Archie Woodworth||Apparatus for and method of manufacturing a prefilled sterile container|
|US20030201239 *||Apr 25, 2002||Oct 30, 2003||Medtronic Minimed, Inc.||Radially compressed self-sealing septum|
|US20040124193 *||Dec 4, 2003||Jul 1, 2004||Ritchie Charles Buchan||Fluid storage apparatus|
|US20060246760 *||Apr 27, 2005||Nov 2, 2006||Ogle Holli C||Sealing component defining first, second, and third seals|
|US20070284330 *||Jun 7, 2006||Dec 13, 2007||J.G. Finneran Associates, Inc.||Two-piece seal vial assembly|
|US20090191742 *||Apr 9, 2009||Jul 30, 2009||Ogle Holli C||Sealing component defining first, second, and third seals|
|US20130213924 *||Sep 1, 2011||Aug 22, 2013||Datwyler Pharma Packaging International Nv||Closure stopper for pharmaceutical applications|
|DE4314090A1 *||Apr 29, 1993||Nov 3, 1994||Wolfgang Dr Vilmar||Medical kit for preparation of a drug solution|
|WO2014126742A1 *||Feb 3, 2014||Aug 21, 2014||Onpharma, Inc.||Methods and systems for buffering anesthetic solutions with controlled ph and tonicity|
|U.S. Classification||604/90, 215/DIG.800, 215/247, 141/27, 141/329, 206/221|
|International Classification||A61J1/00, A61J1/20|
|Cooperative Classification||Y10S215/08, A61J2001/201, A61J1/2096, A61J2001/2041, A61J1/2093|
|European Classification||A61J1/20F, A61J1/20D|