US 3826260 A
A syringe barrel having a perforable seal closing an end thereof and a hollow cylindrical portion of reduced diameter extending beyond the seal. A vial having a stoppered opening and a hollow cylindrical portion of reduced diameter extending beyond the stopper. A double-ended cannula is slidably received in the reduced portions of the barrel and the vial for perforating the seal and the stopper to communicate with and between the interiors of the syringe and the vial. A support on the cannula is removably engaged with the reduced portion of the barrel. An elongated tubular sheath extends between and is slidably supported upon the cannula support and the reduced portion of the vial.
Description (OCR text may contain errors)
United States Patent 1191 Killinger July 30, 1974 [5 VIAL AND SYRINGE COMBINATION 3,563,373 2/1971 Paulson 128/218 M  Inventor. Fred M. Klllinger, Portage, Mich. Primary Examiner Richard A Gaudet [7 Assignw h pj p y, 1 m z Assistant Examiner-J. C. McGowan Mlch- Attorney, Agent, or FirmWoodhams, Blanchard and 22 Filed: Dec. 27, 1971 Flynn A syringe barrel-having a perforable seal closing an 1.8- CI. end thereof and a hollow cylindrical portion of re- [5 l l "It. duced diameter extending beyond the seal A vlal hay- 1 Field of Search 2, 213 N, 218 NV, ing a stoppered opening and a hollow cylindrical por- 128/25, 221, 218 M tion of reduced diameter extending beyond the stopper. A double-ended cannula is slidably received in References Cited the reduced portions of the barrel and the vial for per- UNITED STATES PATENTS forating the seal and the stopper to communicate with 2,627,857 2/1953 Marcelli 128/218 F and between the interiors of the Syringe and the vial- 2,724,383 11/1955 Lockhart 128/272 x A pp o e cannula is removably gag with 3,336,924 8/1967 Sarnoff et al. 128/272 the reduced portion of the barrel. An elongated tubu- 3,368,557 2/1968 Hassing et a1 128/221 lar sheath extends between and is slidably supported 3.371825 4/1968 Keller 128/221 upon the cannula support and the reduced portion of 3.392,726 7/1968 Pochyla et al. 128/272 the viaL 3.397.694 8/1968 Ogle 128/272 3.406.686 10/1968 1 Claim, 7 Drawing Figures Keller l28/2l8 NV VIAL AND SYRINGE COMBINATION BACKGROUND OF THE INVENTION This invention relates in general to a device for storing and administering medicaments and, more particularly, to a type thereof including a sealed syringe holding a diluent, a sealed vial holding a medicament and interconnecting means for holding the syringe and vial together and for effecting selective communication between said syringe and said vial, whereby said diluent can be mixed with said medicament and thereafter administered to a patient by a cannula which is attached to the syringe and is part of the connecting means.
Persons familiar with preparation and use of parenteral medicaments have long been aware of the fact that certain medicaments tend to lose their effectiveness rather soon after they are mixed with a diluent in preparation for administration. Thus, they must be stored in a dry or non-liquid condition and then mixed with a diluent, preferably just before the medicament is administered to a'patient. Obviously, any other procedure would risk an incorrect dosage of the medicament.
In the past, it has been common practice to furnish separate vials of dry medicament and diluent and to use a conventional syringe for transferring the diluent from one vial to another for the purpose of mixing the two in order to administer the medicament. This arrangement involves the risk of contamination, the riskof an improper dose and even the risk of mixing the wrong ingredients, where the administration of the medicament must be made by unskilled persons.
Numerous attempts have been made to solve the foregoing problems as by furnishing syringes and/or vials connected together so that the supply and the administration means are part of a package which is more readily usable. However, the existing combinations or packages involving a medicament and a diluent have not proven satisfactory, heretofore, for a variety of reasons. For example, they have not satisfactorily avoided contamination, they have been too delicate for conventional storing and handling procedures, they have been too susceptible to accidental actuation whereby the materials are mixed too soon, and in general they have been almost as complicated to operate as the previous devices which they were intended to replace.
Accordingly, a primary object of this invention is the provision of a syringe and vial assembly with a connecting structure therebetween whereby the sterility of the diluent in the syringe and the medicament in the vial are maintained during the mixing of the diluent and the medicament and, at the same time, the cannula for the syringe is shielded from contamination during the mixing and up to the very moment of administration to a patient.
A further object of this invention is the provision of a syringe and vial assembly, as aforesaid, in which injectable medicaments can be safely stored for relatively long periods of time, as in drug stores, clinics and doctors offices, along with a suitable diluent in a single package capable of mixing the diluent and medicament without any likelihood of contaminating the injecting needle, the diluent or the medicament.
A further object of this invention is the provision of an assembly, as aforesaid, which is rugged so that it cannot be readily damaged during shipment or storage,
which is constructed so that accidental mixing of the diluent and the medicaments is positively opposed and yet wherein intentional mixing of the medicament and the diluent can be effected safely, easily and quickly in preparation for injection with the syringe by any person qualified to perform such an injection.
Other objects and purposes of this invention will become apparent to persons familiar with apparatus of this type upon reading the following description and examining the accompanying drawings, in which:
FIG. 1 is a side elevational view of a syringe and vial assembly embodied in the invention.
FIG. 2 is an enlarged sectional view taken along the line II-II in FIG. 1.
FIG. 3 is a sectional view similar to FIG. 2 and showing the parts thereof in different operational positions.
FIG. 4 is an enlarged fragment of FIG. 3. FIG. 5 is a sectional view taken along the line V-V of FIG. 2.
SUMMARY OF THE INVENTION The objects and purposes of the invention, including those set forth above, have been met by providing a syringe and vial assembly including a sealed syringe containing a diluent, a sealed vial containing a medicament, which may be liquid or dry, and a connection structure which includes a cannula and extends between and is supported upon the sealed ends of the syringe and the vial. The connection structure is arranged so that the sharpened ends of the cannula can be held spaced from'the seal over the open end of the syringe and the stopper closing the vial. However, by effecting relative movement of the vial and syringe toward each other, the cannula pierces the seal and the stopper, thereby communicating with and between the interiors of the syringe and the vial. Accordingly, the diluent can be moved through the cannula from the syringe into the vial after which the medicament is dissolved in the diluent and thereafter returned to the syringe by actuating the plunger thereof in the reverse direction. The syringe and cannula are now removed from the outer sheath of the connecting structure so that the cannula is exposed and can be injected into the patient for administering the dissolved medicament.
DETAILED DESCRIPTION The syringe and vial assembly 10 (FIGS. 1 and 2) is comprised of a syringe 11 connected to a vial 12 by an intermediate structure 13. The syringe 11 has a barrel 16 and plunger 17 which may be of conventional structure. The lower open end portion 18 of the barrel 16 is of reduced diameter and is covered by a sea! 19 which is held in place by the integral enlarged portion 22 of the sleeve 23 which is preferably fabricated from metal. The sleeve 23 has a shoulder 24' which forms part of the enlarged portion 22 and presses the seal 19 firmly against the lower end of the barrel 16.
A cannula 26, which is sharpened on both ends, has a hub 27 rigidly secured thereto and spaced from both ends thereof. A tubular cannula support 28 has one end thereof secured to the hub 27 which it concentrically encircles. The remainder of the tubularsupport 28 is spaced radially outwardly from the cannula and projects toward the upper end thereof. The tubular support 28 has an integral flange 29 at its upper end. The hub 27 may be made from metal or plastic and the tubular support 28 is preferably fabricated from plastic. In some circumstances, the hub 27 may be integral with and part of the tubular support 28.
The lower end portion of the sleeve 23 (FIG. 2) and the upper portion of the tubular support 28 have interfacing deformations, such as annular ridges 32 and 33, respectively, by which the spaced relationship between the upper end of the cannula 26 and the seal 19 is determined. This spaced position is shown in FIG. 2. By moving the tubular support 28, hence the cannula 26, upwardly, the ridge 33 on the tubular support 28 is moved upwardly from between the two lowermost ridges 32 on the sleeve 23 until said ridge 33 moves past the uppermost ridge 32A, during which the seal 19 is penetrated by the cannula 26. The ridge 32A and the ridge 33 hold the cannula in the penetrating position.
The vial 12 has an open end 36 which is covered by a flanged stopper'37 which is in turn held in place by the enlarged lower portion 38 of the sleeve 39. That is, the sleeve 39 has an integral shoulder 42 which bears downwardly against the stopper 37 thereby holding it tightly against the upper end 36 of the vial 12.
A substantially cylindrical sheath 43 (FIG. 2) extends from the enlarged portion 22 of sleeve 23 to the enlarged portion.38 of sleeve 39. Said sheath 43 has a central cylindrical opening 44, the upper portion of which is sleeved snugly but slidably upon the tubular support 28. Said sheath has an upper enlarged opening 46 with an inside diameter approximately equal to the outside diameter of the enlarged portion 22 of sleeve 23. Said upper opening 46 is also slightly larger than the flange 29 at the upper end of the tubular support 28. Thus, as the sheath 43 is moved upwardly relative to the syringe 11, the engagement between the flange 29 and the shoulder 47 at the lower end of the upper opening 46 act to move the tubular support 28, hence the cannula 26, upwardly with the sheath 43. At the same time, the enlarged portion 22 is received downwardly into the opening 46.
The lower end of the central opening 44 (FIG. 3) has an annular ridge 48 which coacts with annular ridges 49 on the sleeve 39. In this case, there are three ridges 49, two near the upper end of the sleeve and one near the lower end. The ridge 48 is located between the ridges 49 when the lower end of the cannula 26 is spaced from, or at least is not penetrating through, the stopper 37. The sheath 43 can be moved downwardly relative to the sleeve 39 into a position where the ridge 48 is below the lowermost ridge 49A, at which time the cannula 26 penetrates completely through the stopper 37 as shown in FIG. 3. Also, during this movement, the enlarged portion 38 on the sleeve 39 is, slidably but snugly moved upwardly into the enlarged opening 52 at the lower end of the sheath 43 and coaxial with the central opening 44.
OPERATION The assembly and operation of the syringe and via] assembly (FIG. 1), to which this application applies, will be apparent to skilled persons upon reading the foregoing description. However, for convenience, such assembly and operation will now be summarized briefly.
In assembly, the vial 12 will be filled with a medicament, which may be a liquid or a dry powdery material produced by evaporative procedures. The stopper 37, which is held in place by the sleeve 39, will be unperforated.
The syringe 11 will contain a liquid and have a plunger 17 (FIG. 1) at its upper end. The sleeve 23 (FIG. 2) will hold the seal 19 which is also unperforated The cannula support 28, which is secured to the cannula 26 through the hub 27, will be mounted upon the lower end of the sleeve 23 so that the ridge 33 near the upper end of the interior wall of the tubular support 28 is located between the two ridges at the lower end of the sleeve 23. In this position, the cannula will be spaced from the seal 19.
The sheath 43 is now sleeved upwardly over the cannula 26 and the tubular support 28 until the shoulder 47 engages the flange 29. At the same time, the upper end of the sheath 43 will preferably slightly overlap the enlarged portion 22 of the sleeve 23. The sheath 43 and syringe barrel 16 can now be simultaneously manually engaged in one hand while the vial 12 is engaged in the other hand and the sleeve 39 on the vial 12 is slidably inserted first into the enlarged opening 52 at the lower end of the sheath and then into the lower end of the central opening 44. This sliding connection will be terminated when the ridge 48 on the wall defining the central opening 44 is located between the ridges 49 on the sleeve 39. At this time, the lower end of the sheath 43 will be preferably telescoped slightly over the enlarged portion 38 of the sleeve 39.
The assembly 10 is now in condition for shipment and/or storage as long as desired. While the diluent has been disclosed in the syringe and the medicament in the vial, this situation can be reversed.
When it becomes desirable to administer the medicament in the vial, the vial and syringe are either simultaneously or sequentially urged toward the sheath so that the cannula perforates and extends completely through the seal 19 and stopper 37, thereby communicating with and between the chambers within the barrel l6 and the vial 12 as illustrated in FIG. 3. The plunger 17 is now moved downwardly within the barrel 16 whereby the liquid within the barrel is transferred through the cannula into the vial.
By a gentle shaking action, the powdered or liquid material within the vial is mixed with the diluent from the syringe. The assembly 10 is now inverted from its FIG. 1 position and the plunger 17 is pulled downwardly whereby the mixture of diluent and medicine is transferred back into the syringe.
The sheath 43 and vial 12 are now moved downwardly away from the syringe and the tubular cannula support 28 so that the lower end of the cannula 26 is exposed, as appearing in FIG. 4. The cannula will remain in position with respect to the syringe due to the interengagement of the ridges on the sleeve 23 with the ridge on the tubular support 28. That is, the upper ridge 32A will be under the ridge 33 and the lower ridges 32 may be somewhat embedded in the interior wall of the tubular support 28. The medicine can now be administered to the patient in a perfectly normal and conventional manner.
In a modified construction, the ridge 33 in FIG. 3 on 5 the tubular support 28 may be replaced with one or more annular grooves 55 FIG. 4) into which the ridges 32 are selectively and removably received.
In a further modification, the stopper 37 of FIG. 2
may be replaced by the stopper 56 (FIG. 7) in which 10 the lower end of cannula 26 is embedded to seal the end thereof.
Although particular preferred embodiments of the The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A device for storing and administering a medicament, comprising:
syringe means including a barrel having an elongated sleevelike end portion of reduced diameter, said end portion of reduced diameter having a discharge opening therethrough communicating with the interior of said barrel;
perforable seal means blocking said discharge opening, said seal means being spaced inwardly from the outer end of said discharge opening as defined adjacent the free end of said reduced diameter end portion;
vial means defining a chamber therein and having an elongated sleevelike part of reduced diameter, said sleevelike part having a flow opening therethrough communicating with said chamber;
perforable stopper means blocking said flow opening,
said perforable stopper means being spaced inwardly of said opening from the outer end thereof 40 as defined adjacent the free end of said sleevelike t; elongated double ended cannula means extending between said syringe means and said vial means, said cannula means having one end portion thereof loosely but slidably disposed within said reduced diameter end portion, the other end portion of said cannula means being loosely but slidably disposed within said reduced diameter sleevelike part; 7
support means disposed in surrounding relationship to said cannula means and fixedly secured thereto at a location disposed between the ends thereof, said support means including a portion disposed in snug, slidable, telescopic engagement with said reduced diameter end portion; releasable detent means coacting between said portion of said support means and said reduced diameter end portion for resisting movement of said cannula means relative to said syringe means; removable tubular sheath means surrounding said cannula means and extending between said syringe means and said vial means for connecting same together, said sheath means including a first annular end portion having first and second sleevelike parts of different diameters disposed in surrounding relationship to said barrel and said reduced diameter end portion, respectively, and disposed in snug slidable engagement therewith; said sheath means including a second annular end portion having first and second sleevelike parts of different diameters disposed in surrounding rela tionship to said reduced diameter part and said vial means, respectively, and disposed in snug slidable engagement therewith, whereby said sheath means can be slidably disconnected from both said, vial means and said syringe means; and
releasable detent means coacting between said reduced diameter part and said sheath means for resisting movement of said sheath means relative to said vial means.
a: :r a: