US3630199A - Unitized injection system - Google Patents

Abstract

A disposable syringe including a barrel having one medicinal solution therein and a cannula extending therefrom, and a vial removably attached to the barrel and receiving the cannula for isolated storage of a second medicament. With the barrel and vial in assembled, storage position, the syringe cannula tip is imbedded in a plug fixedly attached to the bottom wall of the vial, thereby preventing intermixing of the substances. However, when the parts are manipulated to a mixing position the cannula tip is withdrawn from the plug and air is introduced into the vial, thereby permitting a quantitative mixing of the substances under favorable pressure conditions. After mixing the syringe is removed completely from the vial, used in the regular manner, and the entire system thrown away.

Description

United States Patent [72] Inventors Decatur, Ga. 30033 [21]- Appl. No. 40,663 [22] Filed May 26, 1970 [45] Patented Dec.28,l971

[54] UNITIZED INJECTION SYSTEM 6 Claims, 5 Drawing Figs.

[52] U.S.Cl l28/218M [51] lnt.Cl A61m 5/00 [50] Field of Search 128/218 R, 218 M, 218N,2l8 P,218 PA,218 D, 220, 215

[56] References Cited UNITED STATES PATENTS I 3,327,710 6/1967 Freeberg et a1 128/218 M 3,330,282 7/1967 Visser et al. 128/218 M X 3,397,694 8/1968 Ogle 3,489,147 1/1970 Shaw ABSTRACT: A disposable syringe including a barrel having one medicinal solution therein and a cannula extending therefrom, and a vial removably attached to the barrel and receiving the cannula for isolated storage of a second medicament. With the barrel and vial in assembled, storage position, the syringe cannula tip is imbedded in a plug fixedly attached to the bottom wall of the vial, thereby preventing intcrmixing of the substances. However, when the parts are manipulated to a mixing position the cannula tip is withdrawn from the plug and air is introduced into the vial, thereby permitting a quantitative mixing of the substances under favorable pressure conditions. After mixing the syringe is removed completely from the vial, used in the regular manner, and the entire system thrown away.

UNITIZED INJECTION SYSTEM BACKGROUND OF THE INVENTION A number of combination syringe 'and vial mixing containers have recently been developed to facilitate the dispensing of certain medication. Many of the newer medications, especially the antibiotics, have a longer storage life in dry form. Such devices take advantage of the longer life and comprise, generally, a syringe and a storage vial removably assembled thereto to provide separate storage compartments for two substances. See, for example, US. Pats. Nos; 3,327,710; 3,330,281; 3,330,282; 3,332,421; 3,336,924; 3,397,694; and 3,416,657. In operation the assembly is manipulated to bring the two substances together for mixing, whereupon the syringe is removed from the vial ready for use.

A number of problems associated with the earlier devices have arisen, however, one of which is involved with the problem of pressure. It is commonly known that in removing medications from a sealed vial by insertion of the cannula through a stopper in the neck thereof, a negative pressure created as the medication is being removed must be overcome. Procedures have been developed to overcome this con dition so that the medication can be accurately and easily removed. An opposite pressure condition (positive pressure) arises with regard to earlier devices developed for use as combination syringes and mixing containers. In such cases, a substance is generally introduced into a closed or sealed system for mixing, creating a condition of positive pressure which sometimes makes the device awkward to handle and mixing difficult.

An additional problem attendant to the use of earlier known devices relates to the means for maintaining separation of the substances until time for mixture and use. The separating means, in some instances, is no more than a plug or a ball valve that is interjected into and obstructs the passageway connecting the storage containers. In operation, the obstruction is dislodged in preparation for mixing the substances. Upon dislodgement, however, the plug or ball valve, whichever the case might be, remains within the vial and represents danger in the form of interference with the proper mixing or, more importantly, the proper dispensing of the solution by drifting into and obstructing the fluid flow path.

Finally, problems have arisen in connection with some of the earlier known devices which prevented satisfactory mixing and dispensing of the substances contained therein. For example, in some cases the syringe barrel itself was used as the container for mixing the substances before their being dispensed, and as such it was too small to accommodate suitable mixing without unreasonably long periods of agitation. Also, some of the earlier known devices were fabricated with small cavities that could sometimes entrap air, thereby introducing air bubbles into the loaded syringe. The cavities, additionally, were responsible for the prevention of complete expulsion of one substance out of its respective container and into the adjacent container, thereby preventing a quantitative mixture of the substances with the result being that an incomplete mixture of the substances and/or an incomplete quantity of was administered by the syringe.

SUMMARY OF THE INVENTION The present invention, on the other hand, includes a syringe containing a first medicament threadably received within the mouth of a mixing vial containing a second medicament, providing thereby separate containers for the storage of at least two ingredients which may be mixed immediately prior to use. During storage, a sealing means isolates one chamber from another and prevents inadvertent mixing by imbedding the tip of the syringe cannula into a rubber plug fixedly mounted in the bottom wall of the mixing vial. Possibility of the plugs obstructing the flow of the medicine subsequent to displacement of the cannula is therefore avoided. Removal of the cannula tip from the plug is accomplished by merely rotating the syringe one-half turn relative to the mixing vial. Upon such rotation the threaded connection between the syringe and the vial, causes a relative separation therebetween, therefore positioning the cannula within the vial with the tip thereof spaced from the plug allowing the complete expulsion of the solution contained in the syringe barrel through the cannula and into the mixing vial. After mixing with the second medicament in the vial, the mixture is aspirated into the syringe, the vial is removed and the syringe is ready for use.

To avoid the pressure problems previously described, resultant from performing the previous steps in a closed system, a venting means provides communication between the mixing vial and the atmosphere when the syringe is moved from the storage to the mixing position.

It is therefore an object of this invention to provide an improved unitized injection system utilizing a disposable combination syringe and mixing vial.

It is another object of the invention to provide a device of the type described wherein a first medicament is maintained separately from a second medicant during a storage period, then mixed immediately prior to use.

It is still another object of this invention to provide a device of the type described wherein complete mixing of the substances and complete expulsion of the mixture from the syringe is enhanced.

Some of the objects of the invention having been stated, other objects will appear as the description proceeds, when taken in connection with the accompanying drawings, in which:

FIG. I is a longitudinal view, partially in section, of a device employing the invention, the device being illustrated in position for storage;

FIG. 2 is a section view similar to FIG. 1, except illustrating the parts in position for mixing:

FIG. 3 is an enlarged sectional view, with parts broken away, of the cannula base in the position illustrated in FIG. 1;

FIG. 4 is an enlarged view of the cannula base similar to FIG. 3, except showing the parts in the mixing position illustrated in FIG. 2;

FIG. 5 is a longitudinal view, partially in section, illustrating the syringe shown in FIGS. 1 and 2 with the mixing vial removed.

Turning now to the drawings, and particularly to FIGS. 1 and 2, the unitized injection system, as contemplated by this invention, is referred to generally by thereference character 10 and comprises the combination of asyringe 20 and a mixing vial 30. Syringe 20 is threadably received within the mouth ofvial 30 to selectively seal the contents ofsyringe 20 from that ofvial 30, thus providing at least twoseparate storage compartments 29 and 39 for the separate storage of two or more substances until such time as their mixing and use is desired.

Syringe 20 preferably includes atubular barrel 21 having an upperopen end 22 which slidably receives aplunger 23, and alower end 24 having an opening therein for the discharge of a solution through acannula 25 extending therefrom. Aboss 26, surrounding the base ofcannula 25, protrudes from the outer surface oflower end 24, and provides a means for fixedly attaching an exteriorly threadedcannula base 27 thereto. It should be understood, however, thatbase 27 could be formed integral with the outside oflower end 24 ofbarrel 21.

Flanges l8 and 19 extend radially outward frombarrel 21 adjacent theopen end 22, thereby providing finger grips, adapted for use in cooperation withloop 17 on the exposed end ofslidable plunger 23 to facilitate the manipulation of the parts during use.

Referring now to the combination storage and mixingvial 30, shown in FIGS. I and 2, the upper end ormouth 31 ofvial 30 includes interior threads mating with and receiving the threadedbase 27 ofsyringe 20. Atop wall 32 having an opening orpassageway 33 therein extends inwardly from the sidewalls ofvial 30 at a point below themouth 31 of vial 30 a distance approximately equaling the length ofhub 27. Cannula 25 protrudes through the opening 33 into theinterior 39 of mixing vial 30. Awasher 34 is positionedatop wall 32, which in the position shown in FIG. 3, engages the free end ofbase 27 to seal the connection betweensyringe 20 andvial 30. Arubber plug 35 is fixedly received within a recess in theinner bottom wall 37 ofvial 30 and aligned with the longitudinal dimension ofcannula 25 so that whensyringe 21 is threaciably attached to vial 30 (FIGS. 1 and 3) in the storage position, the point ofcannula 25 is imbedded therein thus sealing the opening incannula 25 and preventing intermixing of the substances incompartments 29 and 39.

Thestorage compartment 29 for solution X is defined by the bottom wall ofplunger 23,barrel 21, and the hollow passageway ofcannula 25, while themixing compartment 39 in via! 30 is defined bywall 32 sealed bywasher 34 andhub 27,vial wall 38,cannula 25, andplug 35. Substance X which is generally a solution and substance Y, which may be either a liquid or a powder soluble in substance X, can be stored in isolation incompartments 29 and 39 respectively, free from contamination from the air outside the syringe and from intermixing within.

Additionally, thewall 38 ofvial 30 includes anair vent 36 therethrough at a point slightly abovewall 32, so positioned as to clearhub 27, then in the retracted position shown in FIGS. 2 and 4 to provide communication betweenmixing compartment 39 and the atmosphere.Beads 11 and 12 or other similar indicating marks may be provided on the outer walls ofsyringe 20 andvial 30 and, in initial misaligned position, indicatehub 27 covers andseals air vent 36, while in aligned position withhub 27 in retracted position, indicatehub 27 has cleared and openedair vent 36.

All of the parts of the invention described herein, with the exception ofplug 35,washer 34 andcannula 25, can be made from glass, plastic or other suitable material that is adapted to be sterilized easily.Plug 35 andwasher 34 are made from materials that will not impart chemical or particulate contamination to the contents ofcompartments 29 and 39, such as a high-quality natural or synthetic rubber or a resilient plastic.

In operation, the use of this syringe is initiated by rotatingsyringe 20 relative tovial 30 so as to align marks 1] and 12 as illustrated in FIGS. 2 and 4. As a result thesyringe 20 is partially separated fromvial 30,hub 27 clearspassageway 36, and the tip ofcannula 25 is slightly withdrawn fromplug 35. Theplunger 23 is then urged intobarrel 21, causing the solution X therein to be completely expelled intovial 30 causing mixture with substance Y. After mixing,plunger 23 is returned to its retracted position (FIG. 1) causing aspiration of the mixture back intosyringe 20. Movement ofhub 27 to aposition clearing passageway 36 permits air to escape fromvial 30 when solution X is being expelled intovial 30, as well as permitting air to entervial 30 when the mixture is being aspirated therefrom, therefore, permitting the mixing and aspirating to be carried out under conditions of neutral pressure.Vial 30 is then unscrewed and completely removed fromsyringe 20 and either discarded or retained, if desired, to covercannula 25 between uses ofsyringe 20. After removal ofvial 30,syringe 20 is ready for use charged with a mixture XY (FIG. 5).

While the preceding description has disclosed a specific em bodiment of this invention in its preferred form, it is to be understood that various changes in details and arrangement may be made without departing from the spirit and scope of the invention.

We claim: 1

l. A unitized injection assembly comprising:

a. a vial having an open end defining a combination first storage and mixing compartment;

b. a hypodermic syringe including a second, storage compartment, a plunger reciprocable within said second compartment, and a cannula having a base, said base of the cannula including means for attaching said vial thereon with the cannula extending into the via; c. sealing means engageable with the free end of said cannula for isolating said first and second compartments from each other;

d. said vial being movable relative to said syringe between a first, storage position in which the open end of said vial is engaged with'the opposed, adjacent end of said syringe and the free end of said cannula is in engagement with said sealing means, thus forming a seal between said first and second compartments, and a second, mixing position with said open end of the vial spaced slightly from the opposed end of said syringe and the free end of said cannula withdrawn from said sealing means to permit communication between said first and second compartments; and

e. a venting means for allowing air to enter the vial in said second position.

2. The injection assembly according to claim I wherein said sealing means comprises a plug fixedly mounted on the bottom wall of the vial, said plug being in alignment with the longitudinal dimension of said cannula.

3. The injection assembly according to claim 1 wherein said venting means comprises a passageway through the sidewall of said vial at a point on a level with said cannula base, said base blocking said passageway in said first, storage position and clearing said passageway in said second, mixing position, whereby the vial is vented in the mixing position to facilitate mixing of the substances therein.

4. The injection assembly according to claim 3 wherein indicating means are provided on said vial and said syringe to indicate the position of said base relative to said passageway.

5. The injection assembly according to claim 1 wherein said attaching means comprises external threads on said cannula base and mating internal threads on the inner wall of said vial adjacent said open end.

6. The injection assembly according to claim I wherein a first medicament is provided in said first compartment, and a second medicament is provided in said second compartment, said first and second medicaments being isolated from each other in said first position, yet permitted to mix in said second position.

Claims (6)

1. A unitized injection assembly comprising: a. a vial having an open end defining a combination first storage and mixing compartment; b. a hypodermic syringe including a second, storage compartment, a plunger reciprocable within said second compartment, and a cannula having a base, said base of the cannula including means for attaching said vial thereon with the cannula extending into the via; c. sealing means engageable with the free end of said cannula for isolating said first and second compartments from each other; d. said vial being movable relative to said syringe between a first, storage position in which the open end of said vial is engaged with the opposed, adjacent end of said syringe and the free end of said cannula is in engagement with said sealing means, thus forming a seal between said first and second compartments, and a second, mixing position with said open end of the vial spaced slightly from the opposed end of said syringe and the free end of said cannula withdrawn from said sealing means to permit communication between said first and second compartments; and e. a venting means for allowing air to enter the vial in said second position.

2. The injection assembly according to claim 1 wherein said sealing means comprises a plug fixedly mounted on the bottom wall of the vial, said plug being in alignment with the longitudinal dimension of said cannula.

3. The injection assembly according to claim 1 wherein said venting means comprises a passageway through the sidewall of said vial at a point on a level with said cannula base, said base blocking said passageway in said first, storage position and clearing said passageway in said second, mixing position, whereby the vial is vented in the mixing position to facilitate mixing of the substances therein.

4. The injection assembly according to claim 3 wherein indicating means are provided on said vial and said syringe to indicate the position of said base relative to said passageway.

5. The injection assembly according to claim 1 wherein said attaching means comprises external threads on said cannula base and mating internal threads on the inner wall of said vial adjacent said open end.

6. The injection assembly according to claim 1 wherein a first medicament is provided in said first compartment, and a second medicament is provided in said second compartment, said first and second medicaments being isolated from each other in said first position, yet permitted to mix in said second position.

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