United States Patent Killinger 1451 July 30, 1974 [54] VIAL AND SYRINGE ASSEMBLY 3,397,694 8/1928 ggle 1218/8316. 28 3,489,147 1 l9 0 h 2 218M 1 Memo" Frem Kllhnger, Portage M|ch- 3,542,023 11/1970 0;: 128/218 M [73] Assignee: a l cmnpany Kalamam FOREIGN PATENTS OR APPLICATIONS 1,441,390 11/1968 Germany 128/220 [22] Filed: Oct. 25, 1972 1,358,072 3/1964 France 128/220 [21] Appl. No.: 300,649
r Primary ExammerR1chard A. Gaudet Related Apphcat'on Data Assistant Examiner-J. C. McGowan [63] Continuation-impart of Ser. Nos. 212,592, Dec. 27, Attorney, Agent, 0! Firm-Woodhams, Blanchard &
1971, and Ser. No. 287,661, Sept. 11, 1972. Flyfi [52] US. Cl. 128/272, l28/DIG. 26, 206/632 R v 51 1m. (:1. A6lj 1/06 [571 ABSTRACT [58] Field of Search..... 128/218 R, 218 D, 218 NV, A syringe having a needle connected to one end 128/218 M, 218 N, 218 C, 218 F, 220, DIG. thereof and a hollow cylindrical chamber adapted for 26, 215, 272, 216, 218 DA; 206/632 R, 43 R communication with said needle. A vial has a sealed opening and a hollow cylindrical portion of reduced [56] References Cited diameter extending beyond the seal. The needle is UNITED STATES TE T 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 2,904,043 9/1959 Friedman 128/218 D vial- An elongated tubular Sheath extends between and 3.336.924 8/1967 Sarnoff ct a1. 128/272 is slidably supported upon the syringe and the vial. 3,368,557 2/1968 Hus-sing ct a1 128/221 3.373.743 3/1968 SalTir 128/218 Nv 5 Clams, 9 Drflwmg Figures ans-26.261
PAIENTEDJULBOIQH I saw 2 or z S r n -1L 1 VIAL AND SYRINGE ASSEMBLY 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 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 v 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 Ill-III in FIG. 2.
FIG. 4 is a sectional view similar to FIG. 2 and showing an alternate seal for the vial.
FIG. 5v 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 (FIGS. 1 and 2) is comprised of asyringe 11 connected to avial 12'. by anintermediate structure 13. Thesyringe 11 has a barrel l6 andplunger 17 which may be of conventional structure. The loweropen end portion 18 of thebarrel 16 is of reduced diameter and has an opening 19 into which the upper end of the needle orcannula 26 is snugly received and firmly held. The reducedportion 18 forms ashoulder 24 at the lower end of the main body of thebarrel 16. Thecannula 26 is sharpened at its lower end.
Thevial 12 has aneck 35 with anopening 36 which is closed by a seal, such as theflanged stopper 37, which is in turn held in place by the enlarged,integral collar 38 at the lower end of thesleeve 39. That is, thesleeve 39 has anintegral shoulder 42, which bears downwardly against the flange of thestopper 37, and thecollar 38 has a rollededge 40 which holds it tightly upon theneck 35 of thevial 12.
A substantially cylindrical sheath 43 (FIG. 2) is capable of extending from surrounding engagement with the lower end of thebarrel 16 to surrounding engagement with the enlargedcollar 38 ofsleeve 39. Saidsheath 43 has a centralcylindrical opening 44 the upper portion of which is sleeved snugly but slidably upon thelower end 18 ofbarrel 16. Saidsheath 43 has an upper enlargedportion 46 with an inside diameter approximately equal to the outside diameter of the main body of thebarrel 16 adjacent the reducedportion 18.
The lower end of the wall defining the central opening 44 (FIG. 3) has an annular, inwardly projectingridge 48 which coacts with outwardly projecting, annular ridges on thesleeve 39. In this case, there are tworidges 49 and 49A near the upper end of the sleeve and one ridge 49B near the lower end. Theridge 48 is located between the upper tworidges 49 and 49A when the lower end of thecannula 26 is spaced from, or at least is not penetrating through, thestopper 37. Thesheath 43 can be moved downwardly relative to thesleeve 39 into a position where theridge 48 is below thelowermost ridge 498, at which time theneedle 26 penetrates completely through thestopper 37. Also, during this movement, the enlargedcollar 38 on thesleeve 39 is slidably but snugly moved further into the opening defined by the enlargedportion 52 at the lower end of thesheath 43 and coaxial with thecentral 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. Thestopper 37, which is held in place by thecollar 38 on thesleeve 39, will be unperforated.
Thesyringe 11 may contain a liquid and have aplunger 17 within the upper end of the barrel l6.
Thesheath 43 is sleeved upwardly over thecannula 26 until theupper end 46 of thesheath 43 slightly overlaps the lower end of the barrel l6, and thelower end 18 of thebarrel 16 is snugly disposed within the upper end of theopening 43. The assembledsheath 43 andsyringe barrel 16 can now be simultaneously held in one hand while thevial 12 is engaged in the other hand, and thesleeve 39 on thevial 12 is first inserted into the opening in the enlargedlower end 52 of the sheath and then slid into the lower end of thecentral opening 44. This sliding connection will be terminated when theridge 48 on the wall defining thecentral opening 44 is located between theridges 49 and 49A on thesleeve 39. At this time, thelower end 52 of thesheath 43 will be telescoped slightly over theenlarged collar 38 of thesleeve 39, and the lower sharpened end of theneedle 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 thebarrel 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 thebarrel 16 and the vial 12 (FIG. 2). Theplunger 17 is now moved downwardly within thebarrel 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. Theassembly 10 is now inverted from its FIG. 1 position and theplunger 17 is pulled away (downwardly) from thebarrel 16 whereby the mixture of diluent and medicine is transferred into the syringe.
Thesheath 43 andvial 12 are now moved downwardly away from the syringe so that the lower end of thecannula 26 is exposed. The liquid medicine can now be administered to the patient in a perfectly normal and conventional manner.
Thestopper 37 of FIG. 3 may be replaced by the stopper 56 (FIG. 4) in which the lower end ofcannula 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 thebarrel 16 through theneedle 26.
However, in the modified syringe andvial assembly 60 of FIG. 5, a cylindrical seal orvalve 61, preferably fabricated from a resiliently flexible material such as synthetic rubber, is disposed within the lower end of thebarrel 16A. Theseal 61 has a centrally disposed,transverse membrane 62 with aslit 63 therein which normally remains closed and, accordingly, prevents seepage or leakage of the diluent from within thebarrel 16A until theplunger 17A is positively urged downwardly toward said seal. Under such urging, themembrane 62 opens along theslit 63, as shown in FIG. 7, so that the diluent can move through the seal and thence into and through theneedle 26A.
Because of theseal 61 in theassembly 60, the lower tip of theneedle 26A can be spaced from thestopper 64 during storage of the assembled and filledsyringe assembly 60. However, when thesyringe 11A is moved toward thevial 12A, theneedle 26A (FIG. 6) pentrates completely through thestopper 64. The syringe of FIG. 5 is then gently shaken to mix the diluent with the medicament after which said syringe assembly is inverted. Theplunger 17A is moved away from thebarrel 16A whereby the mixture of diluent and medicament in the diluted or dissolved form is drawn from the vial, back through theseal 61 and into the barrel. If theseal 61 moves with theplunger 17A as it is retracted, there is no problem because the plunger will move theseal 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 abarrel 71, apiston 72 disposed within saidbarrel 71, arod 73 connected at one end to said piston, and acannula 74 connected to the other end of therod 73. Thepiston 72 androd 73 may be referred to in combination as aplunger 75. Asheath 76 is provided to cover the cannula prior to use thereof.
Thebarrel 71 is cup-shaped, preferably cylindrical, axially elongated and it may be fabricated from glass, plastic or some other substantially rigid material.
Thepiston 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 saidbarrel 71, which with said piston defines achamber 77. Thepiston 72 preferably has a plurality, here three, of radially extending, spacedridges 78 which improve the sealing engagement between it and the inner wall of the barrel In a preferred embodiment of the invention, the piston has twocoaxial recesses 81 and 82 in the opposite axial ends thereof, which recesses are spaced from each other to form a relativelythin membrane 83 integral with thepiston 72. Themembrane 83 has aslit 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 disposedflanges 88 and 89 (FIG. 9) integral with said rod and located near the lower end thereof. Thelower flanges 88 and 89, as shown in FIG. 9, are elongated transversely of saidrod 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 therod 73 relative to thebarrel 71.
Therod 73 has an integral, upwardly extending and substantiallycylindrical stem 92 which is of approximately the same diameter as the inside diameter of thecylindrical recess 82 in thepiston 72. Thestem 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 thepiston 72 after it is inserted into therecess 82.
The lower end of therod 73 is provided with anintegral nozzle 98 which is coaxial and substantially cylindrical but preferably has an outer surface which converges slightly downwardly. Apassageway 99 extends substantially coaxially completely through therod 73 including thestem 92 andnozzle 98. Therod 73 may be fabricated from plastic, glass or any other convenient material. When thestem 92 is properly disposed within therecess 82, the upper end of thestem 92 is preferably spaced a short distance from themembrane 83.
Thecannula 74 may be substantially conventional with a sharpenedtip 103 at the lower end thereof. The upper end of thecannula 74 is firmly embraced by and affixed to the taperednozzle 98 so that the cannula communicates with thepassageway 99.
Thesheath 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 thenozzle 98. Saidsheath 76 is preferably provided at its upper edge with a radially outwardly extendingflange 104 to facilitate assembly.
The lower end of thesheath 76, including theenlarged end 106, may be identical with the corresponding structure in thesheath 43A, described above. Also, thevial 107, thesleeve 108 and thestopper 109 may be substantially identical to the corresponding parts of theassembly 60 disclosed in H6. 5 and discussed above.
Normally, thebarrel 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. Thepiston 72, having been connected to thestem 92 of therod 73, will then be inserted into thechamber 77 of thebarrel 71. Usually,piston 72 wil be moved downwardly into thebarrel 71 so that any air on top of the liquid can escape up through the slit in themembrane 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 thepassageway 99 in therod 73. Thesheath 76 is then telescopically mounted upon thenozzle 98 so that accidental disengagement therebetween is not likely to occur. Thesheath 76 is then mounted upon thesleeve 108 and thevial 107 whereby the syringe andvial assembly 71 are ready for storage or shipment, as desired.
When it becomes desirable to use thesyringe assembly 71, the syringe is moved toward the vial until theneedle 74 penetrates thestopper 109. The medicine and diluent are mixed and drawn back into thebarrel 71. The sheath and vial are then removed from the syringe so that thecannula 74 is exposed. Thesyringe barrel 71 is then placed in the hand of the operator so that the first and second fingers of such hand are disposed between theflanges 88 and 89 on opposite sides of therod 73. The upper closed end of thebarrel 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, thepiston 72 is moved into thebarrel 71 whereupon the liquid in thechamber 77 is expelled through the .slit in themembrane 83, through thepassageway 99 and into thecannula 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.
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 chamher;
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 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 secondend 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 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 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;
tion, 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 toclaim 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.
larged relative to the other end of said center por-