Combination Syringe And Vial

Stevens January 5, 1

Patent Grant 3552387

U.S. patent number 3,552,387 [Application Number 04/745,156] was granted by the patent office on 1971-01-05 for combination syringe and vial. Invention is credited to Peter A. Stevens.


United States Patent 3,552,387
Stevens January 5, 1971

COMBINATION SYRINGE AND VIAL

Abstract

The invention relates to a combination syringe and vial, each containing a separate chamber having an individual ingredient therein. The syringe and vial are assembled in interconnected relation to each other with the hub and cannula of the syringe extending within the vial in a manner to simultaneously support and seal the hub of the syringe with respect to a first closure in the vial and the distal portion of the cannula with respect to a second closure supported by the vial and in spaced-apart relation to the first closure, to maintain the respective chambers sealed off from each other. The first closure has a preformed axial bore extending entirely therethrough, and the second closure has a preformed axially extending channel therein. The dispensing of the ingredients occurs by displacing in a longitudinal direction the syringe and vial until the seal between the distal portion of the cannula and second closure is released, permitting movement of the plunger in the syringe to force the ingredient therein into the vial with resultant mixing of the two ingredients.


Inventors: Stevens; Peter A. (Middlebury, CT)
Family ID: 24995489
Appl. No.: 04/745,156
Filed: July 16, 1968

Current U.S. Class: 604/88; 604/201; 604/89; 604/415
Current CPC Class: A61J 1/2093 (20130101); A61J 1/2096 (20130101); A61M 5/31596 (20130101); A61J 1/2031 (20150501); A61J 1/2041 (20150501); A61J 1/201 (20150501)
Current International Class: A61J 1/00 (20060101); A61M 5/315 (20060101); A61m 005/18 (); A61m 005/24 ()
Field of Search: ;128/218,218M,218R,272

References Cited [Referenced By]

U.S. Patent Documents
3330281 July 1967 Visser
3376866 April 1968 Ogle
Foreign Patent Documents
1,167,766 Aug 1958 FR
1,064,691 Sep 1959 DT
848,081 Sep 1952 DT
Primary Examiner: Koren; Samuel
Assistant Examiner: Czerwonky; James H.

Claims



I claim:

1. A device for both maintaining separately and thereafter mixing ingredients, comprising in combination:

A. syringe means having a cannula extending therefrom and communicating with a storage chamber for containing an ingredient, said syringe means having plunger means in said storage chamber;

B. vial means having a mixing chamber for containing an ingredient, and a first opening and a second opening in spaced-apart relation, each communicating with said mixing chamber;

C. supporting means comprising first and second closure means inserted respectively in said first and second openings and having a preformed axial bore extending entirely through said first closure means and a preformed axially extending channel in said second closure means communicating with said chamber and in coaxial alignment with said axial bore for receiving said syringe means and the proximate portion of the cannula in said axial bore and the distal portion of the cannula in the axially extending channel for mounting said syringe means on said vial means to provide support at spaced-apart positions for said syringe means and said cannula, with said cannula extending into and being supported in said mixing chamber, so as to releasably connect and firmly retain said syringe means and said cannula relative to said vial means; and

D. said first and second closure means each having at least one portion thereof comprising sealing means for frictionally engaging said syringe means and said cannula distal portion in said mixing chamber, said sealing portion in said axial bore being of a diameter relative to the outer diameter of the syringe to provide sealing engagement therebetween, and said sealing portion in said axially extending channel being of a diameter relative to the outer diameter of said cannula to provide sealing engagement therebetween, such that said cannula distal portion is dislodged from said sealing means in said mixing chamber by longitudinally displacing said vial means and syringe means a preselected distance until said distal portion is removed from said sealing means, so as to permit said syringe ingredient to be discharged into said vial means and mixed with said vial ingredient, and the resultant fluent mixture can be withdrawn from said vial means into said syringe means.

2. A device according to claim 1, wherein the longitudinal length of said sealing means between said syringe means and said vial means is greater than the longitudinal length of said sealing means between the distal portion of said cannula and said vial means, so as to permit the withdrawal of said cannula from sealing engagement in said mixing chamber while said vial means remains in sealing engagement with said syringe means to maintain sterility in said mixing chamber.

3. A device according to claim 1, wherein the longitudinal length of said supporting means between said syringe means and said vial means is greater than the longitudinal length of said supporting means between the distal portion of said cannula and said vial means, so as to permit the withdrawal of said cannula from supporting engagement within said mixing chamber while said vial remains in supported relation with said syringe means to permit the mixture to be obtained.

4. A device according to claim 1, wherein said supporting means retains the distal portion of said cannula in a fixed position to prevent lateral movement thereof.

5. A device according to claim 4, wherein said distal portion is supported a length at least equal to .01 inches.

6. A device according to claim 1, wherein the total longitudinal length of said device is not increased more than 20 percent of said individual syringe means, so as to obtain a compact assembly thereof.

7. A device according to claim 1, wherein said second closure means is dimensioned with respect to said second opening in said vial means such that when positioned therein a radially inwardly directed force is applied to compress said sealing portion of said axially extending channel against said cannula to further maintain fluidtight sealing engagement therebetween.

8. A device according to claim 7, wherein the longitudinal length of said channel is at least equal to the diameter of said cannula.

9. A device according to claim 7, wherein said second closure means includes a body portion extending within said second opening and a radial flange integrally formed therewith and extending exteriorly of said vial and an overseal secured to said vial means and said radial flange said channel extending substantially the length of said body portion.

10. A device according to claim 1, wherein said second opening extends through said vial and said second closure means is sealingly inserted therein.

11. A device according to claim 1, further including overseals retaining said first and second closure means relative to said vial means.

12. A device according to claim 1, wherein said second opening terminates in said mixing chamber and forms a seat for retaining said second closure therein.

13. A device according to claim 1, wherein said first and second openings are of a circular configuration and said first opening is of a diameter equal to or greater than the diameter of said second opening to permit the displacement of said second closure through said first opening.

14. A device according to claim 1, wherein said channel terminates in an enlarged pocket contained in said second closure into which the tip of said cannula extends.

15. A device for both maintaining separately and thereafter mixing ingredients, comprising in combination:

A. syringe means having a cannula extending therefrom and communicating with a storage chamber for containing a sterile ingredient, said syringe means having plunger means in said storage chamber;

B. vial means having a mixing chamber for containing a sterile ingredient with a first opening and a second opening in spaced-apart relation, each communicating with the mixing chamber;

C. first closure means sealingly inserted in the first opening of said vial means;

D. second closure means inserted in the second opening of said vial means and fixedly secured thereto;

E. first supporting means integral with said first closure means in the form of a preformed axial bore extending entirely therethrough mounting said syringe means on said vial means so as to releasably connect and firmly hold said syringe means and the proximate end of the cannula with respect to said vial means, in said axial bore, with said cannula extending through said first closure means and into said mixing chamber;

F. second supporting means integral with said second closure means in the form of a preformed axially extending channel extending therein and communicating with said mixing chamber, so as to releasably connect and firmly hold the distal portion of said cannula within said mixing chamber relative to said vial means, such that the resistance of said respective supporting means must be overcome before longitudinally displacing said vial means and syringe means;

G. first sealing means integral with said first closure means for functioning as a seal by having at least a portion of said axial bore relative to the syringe means extending therethrough of a diameter to provide for frictionally engaging said syringe and sealing said mixing chamber from the atmosphere; and

H. second sealing means integral with said second closure means and communicating with said mixing chamber for functioning as a seal by having at least a portion of said axially extending channel in said second closure means of a diameter relative to the outer diameter of said cannula for frictionally engaging said cannula distal portion in said mixing chamber, such that it is dislodged from said sealing means by longitudinally displacing said vial means and syringe means a preselected distance until said distal portion is removed from said sealing means, so as to permit said syringe ingredient to be discharged into said vial means and mixed with said vial ingredient, and the resultant fluent mixture can be withdrawn from said vial means into said syringe means after which said supporting means is released so that said syringe means can be used to inject said mixture.

16. A device according to claim 15, wherein the longitudinal length of said first sealing means between said syringe means and said vial means in said first closure means is greater than the longitudinal length of said second sealing means between the distal portion of said cannula and said vial means in said second closure means, so as to permit the withdrawal of said cannula from sealing engagement with said second closure means while said vial means is simultaneously in sealing engagement with said syringe means to maintain sterility in said mixing chamber.

17. A device according to claim 16, wherein said second sealing means further includes said second closure means dimensioned with respect to said second opening in said vial such that when positioned therein a radially inwardly directed force is applied to compress said channel against said cannula to further maintain fluidtight sealing engagement therebetween.

18. A device for both maintaining separately and thereafter mixing sterile ingredients and for injecting the mixture, comprising in combination:

A. syringe means having a cannula extending therefrom and communicating with a storage chamber for containing a sterile ingredient, said syringe means having plunger means in said storage chamber;

B. vial means having a mixing chamber for containing a sterile ingredient with first and second openings in spaced-apart relation, each communicating with the mixing chamber;

C. first closure means sealingly inserted in the first opening of said vial;

D. second closure means inserted in the second opening of said vial;

E. first supporting means integral with said first closure means in the form of a preformed axial bore extending entirely therethrough for mounting said syringe means and the proximate portion of said cannula on said vial means so as to releasably connect and firmly hold said syringe means and cannula with respect to said vial means in said axial bore with said cannula extending into said mixing chamber;

F. second supporting means integral with said second closure means in the form of a preformed axially extending channel extending therein and communicating with said mixing chamber, so as to releasably connect and firmly hold the distal portion of said cannula within said mixing chamber relative to said vial means, such that the resistance of said respective supporting means must be overcome before longitudinally displacing said vial means and syringe means;

G. first sealing means integral with said first closure means for functioning as a seal by having at least a portion of said axial bore relative to the syringe means extending therethrough of a diameter to provide for frictionally engaging said syringe and sealing said mixing chamber from the atmosphere;

H. second sealing means integral with said second closure means and communicating with said mixing chamber for functioning as a seal by having at least a portion of said axially extending channel in said second closure means of a diameter relative to the outer diameter of said cannula for frictionally engaging said cannula distal portion in said mixing chamber and sealing said mixing chamber from said storage chamber, such that said cannula is dislodged from said closure means by longitudinally displacing said vial means and syringe means a preselected distance until said distal portion is removed from said second sealing means, so as to permit said syringe ingredient to be discharged into said vial means and mixed with said vial ingredient, and the resultant fluent mixture can be withdrawn from said vial means into said syringe means after which said first supporting means is released so that said syringe means can be used to inject said mixture;

I. said first sealing means being greater in length than said second sealing means, so as to permit the withdrawal of said cannula distal portion from sealing engagement with said second closure means while said syringe simultaneously remains in sealing engagement with said vial means to maintain sterility in said mixing chamber; and

J. said first supporting means being greater in length than said second supporting means, so as to retain said syringe means in supported position relative to said vial means by said second supporting means after said cannula is withdrawn from said first supporting means.
Description



BACKGROUND OF THE INVENTION

This invention relates to packaging, mixing and dispensing apparatus, and more particularly to such an apparatus, wherein two materials are packaged in individual containers for separate maintenance of the materials prior to their use in combination.

Much prior effort has been directed to apparatus or injectors wherein a powder and a diluent, or two diluents, are separately packaged in the required amounts, with the mixture being accomplished by injecting the diluent into the powder, and the mixture ejected as needed. Such prior effort is exemplified by U.S. Pat. No. 3,330,281, which discloses the use of a separate cap on the cannula, for example, to maintain the respective chambers containing the powder and diluent sealed from each other. The use of a cap on the cannula has the drawback of not being able to control the closure caps position after it is removed from the cannula, since a certain quantity of the mixture might be entrapped therein. An additional drawback of this device is that a positive pressure has to be applied to the plunger to force the fluid through the cannula and overcome the frictional resistance between the cap and cannula to remove the cap from the cannula. This limits the frictional fit between the closure cap and cannula since, if the frictional fit is too great the pressure applied by the plunger may not be sufficient to dislodge the cap. Another way of possibly dislodging the cap is to retract the cannula from the sterilized chamber until the cap engages the closure of the vial and is forced off it. The disadvantage of this is that the cannula is substantially removed from the sterile chamber before the mixing of the ingredients is complete which might lead to contamination thereof.

OBJECTIVES OF THE INVENTION

It is the general object of the present invention to avoid and overcome the foregoing and other difficulties of and objections to prior art practices by the provision of an improved disposable preloaded hypodermic syringe and vial.

Another object of the present invention is to provide an improved disposable preloaded hypodermic syringe and vial that is of compact configuration and minimum length.

Another object of the present invention is to provide a syringe and vial package having a positive seal between the respective chambers thereof.

Another object of the present invention is to maintain the cannula of the syringe assembly at each end thereof in a supported position during shipment and storage thereof.

Other objects and advantages of the present invention will become apparent as the disclosure proceeds.

BRIEF SUMMARY OF THE INVENTION

The inventor has discovered that a simple but unique combination of elements provides for an ideal unit that is capable of being stored for prolonged periods of time and is safe for shipment with a minimal of packaging materials required. By the present device the essential components of a package which contains a syringe and a vial, are combined without the associated other parts presently found in the art today. Therefore extraneous covers or other guards are not required and the proper dimensional relationship of the syringe and vial coact with each other to provide a unitary assembly that may be easily and conveniently placed into operation in a manner presently known by those who are using devices of a similar nature. The simplicity and uniqueness of the coaction between the basic elements is a departure from compartmented devices of the art, which demonstrates the remarkable ingenuity of the present invention which has been able to eliminate all those extraneous parts presently found in prior-art devices.

By being able to do this the inventor is also capable of providing a total assembly essentially not greater in length than the individual syringe, such that minimum packaging space is required, and considering that millions of the same are sold on a yearly basis the volume of space saved in both storage and shipment is also of an economical magnitude worthy of consideration.

The device of this invention comprises essentially means defining a pair of chambers for containing a first sterile ingredient for injection to which is affixed means defining a mixing chamber for containing a second sterile fluid ingredient for injection. A penetrable first closure 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 mixing chamber and extending through the penetrable first closure into a second closure fixedly mounted within the mixing chamber for sealing off the passageway in the cannula connecting the chambers and retaining the distal portion in a supported position.

In its preferred embodiment the device of this invention comprises a mixing vial containing a second sterile ingredient for injection atop of which is positioned a syringe containing a first sterile fluid ingredient, such as a diluent, for injection. The cannula of the syringe extends into the vial through a penetrable first closure which both seals the neck of the vial and affords rigidity in the connection between the syringe and the vial of the mounted assembly. The second closure member is fixedly mounted and contained within the vial means and is adapted to seal off the distal portion or end of the cannula inside the vial, such that a seal between the respective chambers is obtained and the distal portion of the cannula is radially supported to absorb any shock or other vibrations transmitted to the assembly. The obtainment of a mixture of the ingredients in their respective chambers is obtained by first longitudinally moving them relative to each other such that the distal end is moved and freed from its sealing engagement with the second closure member. At that time the piston of the syringe is moved axially forward such that the ingredient therein, generally a fluid, moves through the hollow cannula into the mixing chamber, causing the fluid ingredient in the syringe to mix with the 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.

The inventor has found that by providing a second closure member coupled to the opposite end of the vial, that the entire syringe assembly need only be retracted a preselected distance so as to have the open distal portion of the cannula released from the second closure member thereby permitting a greater degree of frictional resistance between the cannula and being assured of a more positive seal.

BRIEF DESCRIPTION OF THE DRAWINGS

Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself, and the manner in which it may be made and used, may be better understood by referring to the following description taken in connection with the accompanying drawings forming a part hereof, in which:

FIG. 1, is a partial cross-sectional view of a syringe and vial interconnected in accordance with the invention;

FIGS. 2--4, illustrate in schematic form the method of packaging and assembling the syringe and vial illustrated in FIG. 1;

FIGS. 5 and 6, show fragmentary cross sections of various forms of closure members to support and seal the cannula to the vial;

FIG. 7, is a partial view of an assembly with the vial partially in cross section illustrating another form of the vial of the present invention; and

FIG. 8--10, illustrate in schematic form the method of packaging and assembling the syringe and vial illustrated in FIG. 7.

DETAILED DISCUSSION OF THE INVENTION

Specific reference to the form of the present invention illustrated in the drawings, and referring particularly to FIG. 1, an assembly generally indicated by the reference numeral 10, includes in combination syringe means 12 and vial means 14 assembled and operative together to obtain the desired end usage of dispensing one or more sterilized ingredients.

The syringe means 12 has a cylindrical barrel 16 which is removably mounted on top of the vial 14. The barrel 16 terminates at its upper end in a finger engageable collar 18 and at its lower end in a hub or boss 20, which is of reduced diameter. The lower end of the barrel 16 has a cannula 22 extending therefrom and rigidly secured thereto in sealing engagement therewith and having a hollow passageway 24 communicating with the first or storage chamber 26 in the barrel 16 and at its opposite end with the distal end or portion 28 of the cannula 22 which has a pointed tip of any desired configuration. The cannula 22 may be coupled directly to the barrel without the use of a hub. Plunger 30 with thumb engageable flange 32 is slidably mounted in barrel 16. One end of the plunger extends beyond the barrel 16 and the other end is connected to the piston 34, which is exposed in the barrel 16. Annular grooves 36 may be provided in piston 34 in the form of annular ridges for slidable and sealing engagement with the interior surface 38 of the barrel 16. Accordingly, the syringe means 12 is essentially a separate assembly and as hereinafter described will be used for initially storing a first sterilized ingredient 40 contained in the storage chamber 26, and which may be in a liquid or powder form.

The vial means 14 in accordance with the embodiment illustrated in FIG. 1, includes a receptacle 42 having an interior mixing or second chamber 44 and at one end thereof having a first neck 46 terminating in a first opening 48 and at its opposite end having a second neck 50 terminating in a second opening 52, which openings may be in axial alignment with each other. First penetrable closure means 54 in the form of a closure member is secured in first neck 46, having a body portion 56 extending within the first opening 48 with an integrally formed flange 58 engaged with the upper flange edge 60 of the first neck 46. The first closure means 54 also has first supporting means associated therewith in the form of an inwardly extending opening bore 62 into which the hub 20 of the barrel 16 is received, in frictional engagement therewith, thereby lending rigidity to the assembly and sealing the interior of the vial 14 against the atmosphere. The longitudinal length of said hub 20 is indicated by the dimension E, and is intended to be greater than the axial length of the supported section of the distal portion 28 of the cannula 22, as hereinafter explained. Overseal 64 provides a tamper-proof protection for the first closure member 54 and clamps the flange 58 against the neck 46. There exists a slight frictional interference between the opening diameter of the bore 62 and that of the hub 20 such that a force is required for separation of the two.

The first closure member 54 is provided with an aperture 74 which is in coaxial alignment with bore 62 such that the cannula 22 extends therethrough. In addition a conical depression 76 is provided at the lower end of the first closure member 54 such that a well is formed when the first ingredient 40 and second ingredient 78, which also may be a liquid, powder, or combination thereof, are mixed together and removed from the mixing chamber 44.

The opposite end of the vial 14 is provided with a second closure means in the form of a closure member 66 having a body portion 68 extending into the second opening 52, and having a radial flange 70 for engagement with the lower flange end 72 of the neck 50. In like manner an overseal 64 provides tamper-proof protection for the second closure member 66. The second closure member may be inserted from the side of the receptacle or the end as shown.

The second closure member 66 is provided with sealing means and second supporting means to both seal off the passageway 24 of the cannula 22 from the mixing chamber 44 and simultaneously support the distal end 28 thereof. The sealing means is in the form of an axially extending channel 80, the axial length of the channel is indicated by the dimension L with the cannula 22 extending therein a distance C which is less than or equal to the dimension E, as hereinafter explained. The channel 80 includes a tapered opening 82 such that in assembly of the syringe means 12 and vial means 14 they may be axially directed into each other. The second closure member 66 also acts as the support means by retaining the distal portion 28 of the cannula 22 in a fixed position such that the distal portion 28 is axially supported when assembled and a seal is formed such that the first ingredient 40 which is illustrated as a liquid will remain in the storage chamber 26 and not find its way to the mixing chamber 44. The sealing engagement is provided by the depth of the distal portion 28 extending within the channel 80 as illustrated by the dimension C. The dimension C may range from .01 to .50 inches. The degree of frictional interference between the axial channel 80 having a diameter indicated by the dimension G and the outer diameter D, at the distal portion 28 may be predetermined. To assure greater sealing engagement between the second closure member 66 and cannula 22 the proper degree of frictional interference is selected.

An advantage of the present invention is that the degree of frictional interference may be controlled since a radially applied force in the direction of arrow F may be applied along the axial length characterized by the dimension C since in its preferred embodiment the dimension A of the second opening 52 is less than the dimension B of the body portion of the second closure member 66 such that the degree of frictional interference therebetween does exist and may be controlled. In this manner a minimal degree of frictional interference may be provided between the distal portion 28 and the channel 80 such that the distal portion 28 may be inserted within the channel 80 without incurring any coring, as by scraping particles of the second closure member 66 as the cannula 22 is inserted therein. Since the closure members may be made out of a rubber or plastic material coring can take place and possibly clog up the passageway 24. By being able to selectively characterize the dimensions A, B, D and G it is possible to obtain a seal with respect to all engaging surfaces of the vial, cannula and second closure member to assure maximum protection of both sealing means and support means. For certain applications the channel may be formed by embedding the distal portion within the second closure member.

Thus, second supporting means which is illustrated as integrally formed in the second closure member 66 also provides the support for the distal portion 28 such that each respective ends of the cannula 22 are supported during the entire shipment and storage up to the time of usage. This isolates the cannula and assures the proper support such that any vibrations incurred or transmitted in shipment to the assembled unit 10 will not affect the seal between the cannula 22 and the second closure member 66, and syringe means 12 and first closure member 54. By providing this structural arrangement it is possible to utilize a cannula having a smaller external diameter from the same structural material, which is generally metallic, than when same is free at one end thereof and can be freely vibrated.

In operation the user receives the assembly 10 as illustrated in FIG. 1, with the first ingredient 40 in the storage chamber 26 and the second ingredient 78 in the mixing chamber 44, and to permit the free flow of the material between the respective chambers of the syringe means 12 and vial means 14 they are moved longitudinally away from each other until the tip of the cannula 22 is dislodged from the first supporting means of the second closure member 66 by displacing them a preselected distance. When retracted the first ingredient 40, illustrated as a fluid, can be discharged into the vial means 14 and mixed with the second ingredient 78, illustrated as a powder, and the resultant fluent mixture can be withdrawn from said vial means 14 into the syringe means 12 after which the first supporting means is released so that the syringe means is removed from its assembly with the vial means and can be used to inject said mixture.

Since the axial length of support of the hub 20, as indicated by dimension E, is greater than the axial length of support of the distal portion 28 of the cannula 22, as indicated by dimension C, the hub 20 remains in sealing and supporting engagement with first closure member 54 during the mixing operation to preserve sterility. In addition the supporting means between the hub 20 and first closure member 54 assures support of the vial 14 on the syringe 12 after the distal portion 28 has been retracted from the sealing means. Thus, in accordance with the invention the syringe means 12 is only retracted a minimal distance in the direction of arrow 85 such that the sterility of the cannula is preserved since there is no substantial exposure, if any, of any portion of the cannula that is contained within one of the respective chambers and the atmosphere. This is important since it is not necessary to reinsert the cannula in order to obtain the combined mixture.

An additional important advantage of the present invention, as can now be see after a description thereof, is that the axial length T of the assembly 10 is at a minimum. The total length is kept at a minimum since the distal portion 28 is essentially at the extreme end of vial means 14. In actual practice it has been found that the assembly 10 is not increased in length by more than 20 to 30 percent of the original length of the syringe means 12. For example, if the syringe means 12 has an axial length of 5 inches then the total assembly 10 as indicated by the dimension T will not generally exceed 6 inches. This is an important factor in that it maintains the total package at a minimal length, which due to the cost of storage space and the number of units used per year is a sizable savings.

FIGS. 2 through 4 illustrate one method of assembly of the embodiment of the invention illustrated in FIG. 1, and same is accomplished such that the end package 10 has within the vial means 14 the second ingredient 78 within the mixing chamber 44 while the distal portion 28 of the cannula 22, which has a passageway 24 extending therethrough is packaged free of the second ingredient 78. To accomplish the assembly, the vial means 14 is supplied having the first closure member 54 and the associated overseal 64 in assembled relation to each other and the syringe means 12 is inserted through the aperture 74, and bore 62 in the first closure member 54 such that the distal portion 28 of the cannula 22 is contained within the mixing chamber 44, as illustrated in FIG. 2. Accordingly, the syringe means 12 is inserted through the first closure member 54 such that the distal portion 28 thereof extends within the mixing chamber 44 and in coaxial alignment with the second opening 52 of the second neck portion 50 at the opposite end of the vial 14.

The distal portion 28 of the cannula 22 is then covered as by providing a cover member 94 having radial flanges 96 which are secured to a chute 98 in the shape of a funnel having a conical portion 100 and a cylindrical portion 102, which latter portion is inserted in the second opening 52 such that the supply of the second ingredient 78 from a supply source 104 may be permitted to flow into the vial means 14 by gravity, or if desired under pressure. The supply source 104 is synchronized such that a predetermined amount of ingredient 78 is automatically placed therein. The ingredient may be either in a powder, liquid, or other forms such as a combination of the two. Once the chute 98 and the associated closure 94 is positioned in place then the vial 14 is filled with the preselected quantity of the ingredient through the opening 52. Subsequent thereto the cover member 94 is removed from over the distal portion 28 of the cannula 22 such that the second closure member 66 may be positioned in place as seen in FIG. 3.

The second closure member 66 is initially supported by support means 106 which either by friction or other means retains it in fixed position and the support means 106 by mechanical conventional means is moved axially in the direction of arrow 108, relative to the vial means 14, which may also be supported by securement means 110 in engagement with the vial means 14. Accordingly, once the second closure member 66 is inserted over the tip of the cannula 22 it is then moved axially relative to the vial 14 until it reaches the position shown in FIG. 3. The body portion 68 of the second closure member 66 is selected to have a cross-sectional area which is generally cylindrical and complementary to the opening 52 such that there is a degree of frictional resistance, as by a slight interference between the two. Accordingly, the static force supplied in the direction of arrow 108 is sufficient to overcome this frictional resistance such that the second closure member 66 is seated therein. In like manner the channel 80 in the second closure member may be of a circular cross section and dimensioned to provide an interference fit with the outer surface of the cannula 22 such that frictional interference exists. In the same manner the static force as applied in the direction of arrow 108 should also be sufficient to overcome this static force so as to obtain a double seal formed by the relative compressed surface areas of engagement of the second closure member 66 with both the vial means 14 and cannula 22.

Thus, the assembly formed in FIG. 2, is obtained by moving the vial means 14 and supported second closure member 66 axially relative to each other until the distal end 28 of the cannula 22 is positioned within the channel 80 in the form of an axial bore, and the second closure member 66 is contained within the second opening 52 whereby the seal between the two is obtained. The overseal 64 is then applied by capping means 112 which is adapted to actually force it over the second closure member 66 and the neck of the vial 14 to provide a tamper-proof assembly by applying a static force in the direction of 108.

While the axial movement of the second closure member 66 and vial means 14 towards each other occurs a frictional resistance or interference between the syringe assembly 12 and first closure member 54 is not always sufficient to prevent axial movement therebetween and accordingly retention means (not shown) for the syringe 12 and vial 14 may be utilized to maintain them in fixed relation to each other as the second closure member 66 is positioned within the second opening 52.

FIG. 5, illustrates another form of the invention in which the second closure member 66a is similar to that illustrated in FIG. 1, and has an overseal 64a that secures it to the neck 50a of the vial means 14a. Extending from the body portion 68a is a shoulder portion 84a having the axial channel 80a extending therein a distance L. In this form of the invention the axially applied pressure present in FIGS. 1 and 4, by the interference fit between the vial opening and body member is not available, and the degree of frictional interference between the axial channel 80a and the diameter at the distal portion 28a of the cannula 22a is relied upon to obtain the sealing engagement between the respective surfaces and the holding of the cannula in a fixed position against longitudinal or lateral movement.

FIG. 6, illustrates another form of the invention in which the second closure member 66b is again similar to that illustrated in FIG. 1, and includes an overseal 64b which secures the second closure member 66b to the neck portion 50b of the vial means 14b. The second closure member 66b includes an axially extending channel 80b which terminates in opening or pocket 86b into which the distal portion 28b may be positioned. A radial undercut 88b may be provided such that the axially applied force which arises due to the relative frictional interference between the outer diameter of the body portion 68b and the second opening 52b is confined to the distance C. The undercut or radial flange provides for this isolated area of radially directed pressure which simultaneously produces the sealing means that is required and axially supports the end of the cannula 22b against lateral or longitudinal movement, prior to usage.

FIG. 7, illustrates another form of the invention which is similar to FIG. 1, except that the second opening 52c in the second neck 50c of vial 14c has a closed bottom 92c to form a closure seat 90c therein. The second closure member 66c includes a body portion 68c having a diameter less than the internal diameter of the opening 52c and a flange portion 70c having a diameter designed to provide a frictional interference with the opening 52c in the mixing chamber 44c with which it communicates. The supporting and sealing means is provided by the second closure member 66c and includes an axially extending channel 80c which is in sealing engagement with the distal portion 28c of the cannula 22c may be of a selected length, as discussed with respect to FIG. 1.

The form of the invention illustrated in FIG. 7, has the advantage of not requiring the assembly of an additional overseal and in this manner the second closure member 66c is inserted through the first opening 48c and the syringe means 12c is retained in fixed position to the vial means 14c in the same manner as described with respect to FIG. 1.

FIGS. 8 through 10, illustrate the method of filling and packaging the assembly 10c, consisting of a syringe means 12c and vial means 14c in accordance with the embodiment of the invention illustrated in FIG. 7. In this embodiment the second closure member 66c is adapted to be inserted through the first opening 48c of the vial 14c and is initially supported by a support member 114c in axial alignment with the closure seat 90c which is formed by the second opening 52c and bottom 92c of the vial 14c. The second closure member 66 c is inserted through the first opening 48c and moved axially relative to the vial 14c until the second closure member 66c is contained within the closure seat 90c as illustrated in FIG. 8, and is in seated position therein. To prevent the removal during shipment of the second closure member 66c there exists a degree of frictional interference between the diameter of the closure seat 90c and the second closure member 66c which interference is overcome by the axial force in the direction of arrow 108c as the second closure member 66 c and vial 14c is moved towards each other until the position shown in FIG. 8 is reached. The vial 14c is then filled with a preselected quantity of the ingredient 78c through said first opening 48c which ingredient may be of a liquid, powder or combination thereof.

The vial is filled by inserting in the first opening 48c the chute 98c which has in communication therewith the supply source 104c which is adapted to automatically dispense predetermined quantities of the ingredient therein. The axial channel 80c is preferably covered during the filling of the vial 14c to prevent the ingredient 78 c from entering therein. This may be accomplished by retaining the support member 114c therein. Once the vial 14c is filled the first closure member 54c is inserted and said first opening 48c is dimensioned in a manner to seal off said opening from the atmosphere. Thereafter or simultaneously therewith the overseal 64c may be applied by capping means 112c to retain the first closure member and vial in position. The capping means 112c is hollow to permit the removal of the support means 114c after the vial 14c is tilted to a position in which the ingredient cannot clog up the channel 80c or aperture 74c. This may be accomplished by angularly displacing or positioning the vial as seen in respect to FIG. 10, such that the ingredient 78c, shown as a powder, is in a corner of the vial permitting the removal of the support member 114c and the assembly of the syringe 12c.

The assembled unit 10c which has the cannula 22c extending therefrom is then inserted through the opening 74c in the first closure member 54c until the distal end 28c thereof extends within the axial channel 80c of the second closure member 66c and is both axially supported and a seal is formed therebetween.

Substantially the same method of assembly as illustrated in FIGS. 8--10, may be used to assemble the embodiments illustrated in FIGS. 1, 5 and 6, in that the second closure member is first inserted in the vial, then the channel is covered and the vial filled, with the vial then being rotated leaving the channel free of the ingredients to permit the first closure member to be inserted in the first opening and the syringe thereafter positioned as seen in FIG. 1.

CONCLUSION

A particularly desirable feature of the present invention is the ease in which it can be utilized such that the sterilized ingredient portions thereof remain free of exposure from possible contamination prior to the obtainment of the mixture of the ingredients therein. In operation the vial is retracted a minimal amount generally in the range of .01 to .5 inches such that the distal end is retracted from the second closure and is free such that the plunger may be manually manipulated to dispense the ingredients from the storage chamber into the mixing chamber to have a mixture of the two materials occur. It is most important that the cannula does not have to be substantially removed from the vial to perform this mixing operation, thereby minimizing any contamination that could possibly occur.

Additionally, it is now possible to axially or longitudinally and laterally support the cannula at each end thereof so as to be assured, irrespective of the transportation, storage and handling associated with the final assembly, that there is a minimum chance of any fracture occurring either in the cannula or at its seal with the syringe. It can be appreciated that the cannula acts as a flexible member and due to vibrations transmitted to the assembly it is possible to affect a flexure thereof and a possible fracture at one or more points or particularly the seal with the syringe. If this occurs the danger of an injury resulting when the syringe is used is easily foreseeable. By being able to support the cannula at both ends thereof the degree of assurance that the package will be in usable condition is materially increased.

Considering the total number of units used per year the volume of each package becomes an important matter in the transportation, storage and the cost of manufacturing materials for packaging same. Accordingly, the present invention permits a condensed assembly since essentially the distal portion of the cannula is almost adjacent the bottom of the vial such that the longitudinal length of the assembly is substantially equal to the longitudinal length of the syringe. In prior-art practices, this is generally not the case since there is a substantial distance between the distal portion of the cannula, and the end of the components associated therewith.

While particular embodiments of the present invention have been shown and described, it will be understood that many changes and modifications may be made, and it is, therefore, intended by the appended claims to cover all such changes and modifications as fall within the true spirit and scope of the present invention.

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