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| United States Patent | 3,826,261 |
| Killinger | July 30, 1974 |
VIAL AND SYRINGE ASSEMBLY
Abstract
A syringe having a needle connected to one end thereof and a hollow cylindrical chamber adapted for communication with said needle. A vial has a sealed opening and a hollow cylindrical portion of reduced diameter extending beyond the seal. The needle is slidably receivable into the reduced portion of the vial for perforating the seal to communicate with and between the interiors of the hollow chamber and the vial. An elongated tubular sheath extends between and is slidably supported upon the syringe and the vial.
| Inventors: | Killinger; Frem M. (Portage, MI) |
| Assignee: |
The Upjohn Company
(Kalamazoo,
MI)
|
| Appl. No.: | 05/300,649 |
| Filed: | October 25, 1972 |
| Current U.S. Class: | 604/416 ; 128/DIG.26; 604/414 |
| Current International Class: | A61J 1/00 (20060101); A61M 5/28 (20060101); A61j 001/06 () |
| Field of Search: | 128/218R,218D,218NV,218M,218N,218C,218F,220,DIG.26,215,272,216,218DA 206/63.2R,43R |
| 2077240 | April 1937 | Jeffords |
| 2726656 | December 1955 | Lockhart |
| 2904043 | September 1959 | Friedman |
| 3336924 | August 1967 | Sarnoff et al. |
| 3368557 | February 1968 | Hassing et al. |
| 3373743 | March 1968 | Saffir |
| 3397694 | August 1968 | Ogle |
| 3489147 | January 1970 | Shaw |
| 3542023 | November 1970 | Ogle |
| 1,441,390 | Nov., 1968 | DT | |||
| 1,358,072 | Mar., 1964 | FR | |||
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm:
This application is a continuation-in-Part of Patent application, Ser. No. 212,592 filed Dec. 27, 1971, and entitled "Vial And Syringe Combination," and Ser. No. 287,661 filed Sept. 11, 1972, entitled "Compact Syringe."
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 having an elongated cylindrical barrel of a first outside diameter defining a chamber therein, one end of said barrel having an opening therethrough for communication with said chamber;
said barrel having an annular hub portion associated with the other end thereof and having a small opening extending axially therethrough for communication with said barrel chamber, said annular hub portion being of a second outside diameter which is substantially smaller than said first diameter and which terminates in a shoulder which extends outwardly and joins with the outer wall of said barrel;
vial means having a chamber therein, said vial means including a mouth portion defining an opening therethrough for communication with said vial chamber;
said vial means also having a neck portion of reduced diameter projecting outwardly from said mouth portion and containing an opening therethrough adapted to communicate with the opening defined by said mouth portion for permitting communication with said vial chamber;
perforable seal means fixedly positioned between said neck portion and said mouth portion for blocking said opening through said mouth portion for sealing said vial chamber;
cannula means having one end fixed within said small opening for communication with said barrel chamber, the other end of said cannula means being slidably disposed within said neck portion of reduced diameter, said other end of said cannula means being pointed and positioned adjacent said seal means for perforating same; and
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 an elongated center portion having a first bore of approximately said second diameter extending therethrough;
said tubular sheath means including a first enlarged annular end portion integrally connected to one end of said center portion and defining a second bore having a diameter substantially equal to said first diameter, said first end portion being fixedly connected pg,17 to the one end of said center portion by a first end wall extending radially therebetween, said first end portion surrounding and being snugly engaged with said one end of said barrel and said first end wall being abutted against said shoulder whereby said hub portion is disposed within and snugly engages said center portion;
said sheath means including a second enlarged annular end portion integrally connected to the other end of said center portion and defining a third bore therein having a diameter substantially greater than the diameter of said first bore, said second end portion being fixedly connected to the other end of said center portion by a second end wall extending radially therebetween, said second end portion surrounding and being snugly and slidably engaged with the mouth portion of said vial means and said second end wall being spaced from the free end of said mouth portion, the free end of said neck portion projecting into said center portion of said sheath means, whereby said sheath means can be slidably moved toward said vial means until the second end wall abuts the free end of said mouth portion for causing the pointed end of said cannula means to perforate said seal means.
2. A device according to claim 1, wherein the first and second end portions and the center portion of said sheath means are all of substantially uniform wall thickness.
3. A device according to claim 1, further including detent means coacting between said sheath means and said vial means for normally maintaining said sheath means in a position preventing perforation of said seal means by said cannula means, said detent means including coacting annular projections formed on said neck portion and said center portion.
4. A device for storing and administering a medicament, comprising:
hollow cylindrical barrel means having a closed axial end and an open axial end;
elastomeric piston means sealingly and slidably disposed within said barrel means for movement lengthwise thereof, said piston means having a central opening therethrough in a direction substantially parallel with the direction of movement of said piston means;
closure means yieldably obstructing the flow of liquid from said barrel means, said closure means comprising a membrane integral with said piston means and extending across said opening, said membrane having a slit therethrough;
elongated rod means having an end portion adjacent one end thereof extending into and firmly held within said opening in said piston means, said rod means having a central passage therethrough and being longer than said barrel means, whereby said rod means projects outwardly through the open axial end of said barrel means;
said rod means having an annular hub portion adjacent the other end thereof, and laterally projecting grip means fixed to said rod means near said other end thereof, said grip means being spaced axially inwardly from said hub portion;
vial means having a chamber therein, said vial means including a mouth portion defining an opening therethrough for communication with said vial chamber;
said vial means also having a neck portion of reduced diameter projecting outwardly from said mouth portion and containing an opening therethrough adapted to communicate with the opening defined by said mouth portion for permitting communication with said vial chamber;
perforable seal means fixedly positioned between said neck portion and said mouth portion for blocking said opening through said mouth portion for sealing said chamber;
cannula means having one end fixed within the hub portion of said rod means and communicating with the central passage extending therethrough, said cannula means projecting outwardly from said rod means in substantial alignment therewith and being pointed at the other end thereof, the other end of said cannula means being slidably disposed within said neck portion of reduced diameter and being positioned adjacent said seal means for perforating same; and
removable tubular sheath means surrounding said cannula means and extending between said rod means and said vial means for connecting same together, said sheath means including an elongated center portion having a first bore extending therethrough;
said tubular sheath means including a first annular end portion integrally connected to one end of said center portion, said first end portion surrounding and being snugly engaged with said hub portion;
said sheath means including a second annular end portion which is integrally connected to and enlarged relative to the other end of said center portion, said second end portion defining a second bore therein having a diameter substantially greater than the diameter of said first bore, said second end portion being fixedly connected to the one end of said center portion by an end wall extending radially therebetween, said second end portion surrounding and being snugly and slidably engaged with the mouth portion of said vial means and said end wall being spaced from the free end of said mouth portion, the free end of said neck portion projecting into said center portion of said sheath means, whereby said sheath means can be slidably moved toward said vial means until the end wall abuts the free end of said mouth portion for causing the pointed end of said cannula means to perforate said seal means.
5. A device according to claim 4, wherein the cylindrical hub portion of said rod means converges in a direction toward the free end thereof, and wherein said first end portion defines therein a cylindrical opening which diverges toward the free end thereof for snug frictional engagement with said hub portion.
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 needle which is attached to the syringe and is associated with the connecting means.
Persons familiar with the 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 risk of an improper dose and even the risk of mixing the wrong ingredients, where the administration of the medicament must be or could 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 useable. However, most 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 prematurely mixed and, in general, they have been almost as complicated to operate as the previous devices upon which they were intended to improve.
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 of the diluted or dissolved medicament 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 embodying the invention.
FIG. 2 is an enlarged sectional view taken along the line II--II in FIG. 1.
FIG. 3 is a sectional view taken along the line III--III in FIG. 2.
FIG. 4 is a sectional view similar to FIG. 2 and showing an alternate seal for the vial.
FIG. 5 is a sectional view similar to that in FIG. 2 and disclosing alternate structure in the syringe and vial.
FIG. 6 is a sectional view taken along the line VI--VI in FIG. 5 and showing parts thereof in different relative working positions.
FIG. 7 is a sectional view taken along the line VII--VII in FIG. 5 showing parts in different relative working positions.
FIG. 8 is a central sectional view similar to FIG. 2 and disclosing an alternate syringe construction.
FIG. 9 is a sectional view taken along the line IX--IX in FIG. 8 showing the parts in different operating positions.
For convenience in description, the terms "upper," "lower" and words of similar import will have reference to the syringe and vial assembly or parts thereof as appearing in FIGS. 1, 5 and 8. The terms "inner," "outer" and derivatives thereof will have reference to the geometric center of the assembly and major components thereof.
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 syringe containing a diluent, a sealed vial containing a medicament, which may be liquid or dry, and a connection structure which includes a needle connected to the syringe and extending toward the vial. The connection structure is arranged so that the sharpened end of the needle can be held spaced from the chamber within the vial. However, by effecting relative movement of the vial and syringe toward each other, the needle pierces the seal or stopper, thereby communicating with and between the interiors of the syringe and the vial. Accordingly, the diluent can be moved through the needle 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 needle are now removed from the outer sheath of the connecting structure so that the needle is exposed and can be injected into the patient for administering the dissolved or diluted 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 has an opening 19 into which the upper end of the needle or cannula 26 is snugly received and firmly held. The reduced portion 18 forms a shoulder 24 at the lower end of the main body of the barrel 16. The cannula 26 is sharpened at its lower end.
The vial 12 has a neck 35 with an opening 36 which is closed by a seal, such as the flanged stopper 37, which is in turn held in place by the enlarged, integral collar 38 at the lower end of the sleeve 39. That is, the sleeve 39 has an integral shoulder 42, which bears downwardly against the flange of the stopper 37, and the collar 38 has a rolled edge 40 which holds it tightly upon the neck 35 of the vial 12.
A substantially cylindrical sheath 43 (FIG. 2) is capable of extending from surrounding engagement with the lower end of the barrel 16 to surrounding engagement with the enlarged collar 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 lower end 18 of barrel 16. Said sheath 43 has an upper enlarged portion 46 with an inside diameter approximately equal to the outside diameter of the main body of the barrel 16 adjacent the reduced portion 18.
The lower end of the wall defining the central opening 44 (FIG. 3) has an annular, inwardly projecting ridge 48 which coacts with outwardly projecting, annular ridges on the sleeve 39. In this case, there are two ridges 49 and 49A near the upper end of the sleeve and one ridge 49B near the lower end. The ridge 48 is located between the upper two ridges 49 and 49A 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 49B, at which time the needle 26 penetrates completely through the stopper 37. Also, during this movement, the enlarged collar 38 on the sleeve 39 is slidably but snugly moved further into the opening defined by the enlarged portion 52 at the lower end of the sheath 43 and coaxial with the central opening 44.
OPERATION
The organization and operation of the syringe and vial 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 preparation, the vial 12 (FIG. 2) may 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 collar 38 on the sleeve 39, will be unperforated.
The syringe 11 may contain a liquid and have a plunger 17 within the upper end of the barrel 16.
The sheath 43 is sleeved upwardly over the cannula 26 until the upper end 46 of the sheath 43 slightly overlaps the lower end of the barrel 16, and the lower end 18 of the barrel 16 is snugly disposed within the upper end of the opening 43. The assembled sheath 43 and syringe barrel 16 can now be simultaneously held in one hand while the vial 12 is engaged in the other hand, and the sleeve 39 on the vial 12 is first inserted into the opening in the enlarged lower end 52 of the sheath and then slid 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 and 49A on the sleeve 39. At this time, the lower end 52 of the sheath 43 will be telescoped slightly over the enlarged collar 38 of the sleeve 39, and the lower sharpened end of the needle 26 will be embedded in, but will not penetrate through, stopper 37.
The assembly 10 (FIG. 2) 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. In such case, the plunger will be near the lower end of the barrel 16 because its first function will be to withdraw fluid from the vial.
When it becomes desirable to administer the medicament, the vial and syringe are simultaneously urged toward each other so that the cannula perforates and extends completely through the stopper 37 (FIG. 3), thereby communicating with and between the chambers within the barrel 16 and the vial 12 (FIG. 2). 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 away (downwardly) from the barrel 16 whereby the mixture of diluent and medicine is transferred into the syringe.
The sheath 43 and vial 12 are now moved downwardly away from the syringe so that the lower end of the cannula 26 is exposed. The liquid medicine can now be administered to the patient in a perfectly normal and conventional manner.
The stopper 37 of FIG. 3 may be replaced by the stopper 56 (FIG. 4) in which the lower end of cannula 26 is also embedded to seal the end thereof. In both of these embodiments, the embedding of the pointed tip of the needle into the stopper (37 or 56) prevents accidental, premature discharge or leaking of the diluent from the barrel 16 through the needle 26.
However, in the modified syringe and vial assembly 60 of FIG. 5, a cylindrical seal or valve 61, preferably fabricated from a resiliently flexible material such as synthetic rubber, is disposed within the lower end of the barrel 16A. The seal 61 has a centrally disposed, transverse membrane 62 with a slit 63 therein which normally remains closed and, accordingly, prevents seepage or leakage of the diluent from within the barrel 16A until the plunger 17A is positively urged downwardly toward said seal. Under such urging, the membrane 62 opens along the slit 63, as shown in FIG. 7, so that the diluent can move through the seal and thence into and through the needle 26A.
Because of the seal 61 in the assembly 60, the lower tip of the needle 26A can be spaced from the stopper 64 during storage of the assembled and filled syringe assembly 60. However, when the syringe 11A is moved toward the vial 12A, the needle 26A (FIG. 6) pentrates completely through the stopper 64. The syringe of FIG. 5 is then gently shaken to mix the diluent with the medicament after which said syringe assembly is inverted. The plunger 17A is moved away from the barrel 16A whereby the mixture of diluent and medicament in the diluted or dissolved form is drawn from the vial, back through the seal 61 and into the barrel. If the seal 61 moves with the plunger 17A as it is retracted, there is no problem because the plunger will move the seal 61 along with it during the subsequent injection of the medicine into the patient.
The modified syringe and vial assembly 70 (FIG. 8 and 9) is comprised of a barrel 71, a piston 72 disposed within said barrel 71, a rod 73 connected at one end to said piston, and a cannula 74 connected to the other end of the rod 73. The piston 72 and rod 73 may be referred to in combination as a plunger 75. A sheath 76 is provided to cover the cannula prior to use thereof.
The barrel 71 is cup-shaped, preferably cylindrical, axially elongated and it may be fabricated from glass, plastic or some other substantially rigid material.
The piston 72, which is fabricated from an elastomeric material, such as synthetic rubber, is substantially cylindrical in shape and slightly larger in outside diameter than the inside diameter of said barrel 71, which with said piston defines a chamber 77. The piston 72 preferably has a plurality, here three, of radially extending, spaced ridges 78 which improve the sealing engagement between it and the inner wall of the barrel 71.
In a preferred embodiment of the invention, the piston has two coaxial recesses 81 and 82 in the opposite axial ends thereof, which recesses are spaced from each other to form a relatively thin membrane 83 integral with the piston 72. The membrane 83 has a slit 84 substantially diametrical thereof and therethrough whereby said membrane acts as a valve obstructing the flow of fluids through the piston under circumstances where the pressure on opposite sides of the membrane is substantially equalized.
The rod 73 (FIG. 8) is elongated and, throughout most of its length, is X-shaped in cross section in order to minimize the amount of material utilized while maintaining adequate strength and rigidity in said rod. There are two annular and radially disposed flanges 88 and 89 (FIG. 9) integral with said rod and located near the lower end thereof. The lower flanges 88 and 89, as shown in FIG. 9, are elongated transversely of said rod 73 in one diametrical direction, and they are so spaced with respect to each other that the first and second fingers of a normal adult hand can be inserted between these two flanges for controlling the movement of the rod 73 relative to the barrel 71.
The rod 73 has an integral, upwardly extending and substantially cylindrical stem 92 which is of approximately the same diameter as the inside diameter of the cylindrical recess 82 in the piston 72. The stem 92 has an upper, annular flange 93, the peripheral surface of which is beveled so that it slopes downwardly and outwardly away from the stem and thereby resists disengagement of the stem from within the piston 72 after it is inserted into the recess 82.
The lower end of the rod 73 is provided with an integral nozzle 98 which is coaxial and substantially cylindrical, but preferably has an outer surface which converges slightly downwardly. A passageway 99 extends substantially coaxially completely through the rod 73 including the stem 92 and nozzle 98. The rod 73 may be fabricated from plastic, glass or any other convenient material. When the stem 92 is properly disposed within the recess 82, the upper end of the stem 92 is preferably spaced a short distance from the membrane 83.
The cannula 74 may be substantially conventional with a sharpened tip 103 at the lower end thereof. The upper end of the cannula 74 is firmly embraced by and affixed to the tapered nozzle 98 so that the cannula communicates with the passageway 99.
The sheath 76 is substantially cylindrical, relatively narrow in cross section and open at both ends thereof. Said sheath has, at least at its upper end, an upwardly diverging inner surface designed to sleeve snugly upon and frictionally engage the outer surface of the nozzle 98. Said sheath 76 is preferably provided at its upper edge with a radially outwardly extending flange 104 to facilitate assembly.
The lower end of the sheath 76, including the enlarged end 106, may be identical with the corresponding structure in the sheath 43A, described above. Also, the vial 107, the sleeve 108 and the stopper 109 may be substantially identical to the corresponding parts of the assembly 60 disclosed in FIG. 5 and discussed above.
Normally, the barrel 71 will be placed in an upwardly opening position and filled with a fluid, such as a diluent, prior to the assembly of the syringe. The piston 72, having been connected to the stem 92 of the rod 73, will then be inserted into the chamber 77 of the barrel 71. Usually, piston 72 wil be moved downwardly into the barrel 71 so that any air on top of the liquid can escape up through the slit in the membrane 83 and be expelled from the syringe. At the same time, the air leaving the barrel, which will normally be sterile, will purge non-sterile air from within the passageway 99 in the rod 73. The sheath 76 is then telescopically mounted upon the nozzle 98 so that accidental disengagement therebetween is not likely to occur. The sheath 76 is then mounted upon the sleeve 108 and the vial 107 whereby the syringe and vial assembly 71 are ready for storage or shipment, as desired.
When it becomes desirable to use the syringe assembly 71, the syringe is moved toward the vial until the needle 74 penetrates the stopper 109. The medicine and diluent are mixed and drawn back into the barrel 71. The sheath and vial are then removed from the syringe so that the cannula 74 is exposed. The syringe barrel 71 is then placed in the hand of the operator so that the first and second fingers of such hand are disposed between the flanges 88 and 89 on opposite sides of the rod 73. The upper closed end of the barrel 71 is pressed against the palm of the same hand, roughly adjacent the thumb. Thus, by moving the first and second fingers toward the thumb, the piston 72 is moved into the barrel 71 whereupon the liquid in the chamber 77 is expelled through the slit in the membrane 83, through the passageway 99 and into the cannula 74 from which it is discharged.
Although particular preferred embodiments of the invention have been disclosed in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed apparatus, including the rearrangement of parts, lie within the scope of the present invention.
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