April 16, 1968 R. w. OGLE HYPODERMIC SYRINGE WITHVIAL 2 Sheets-Sheet l FIG.6
Filed July 23,- 1965 FIG.5
FIGA
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R O T N E V W ^//7// V1 vi; @fil Uf Il 2 6 M 6% 6 5 4 6 4 2 i N///MV/l//f/w 2 i.- I e f G Z I H h//f/// BY M H TJ/YE/ April 16, 1968 R. w. OGLE HYPODERMIC SYRINGE WITHVIAL 2 Sheets-Sheet r,
Filed July 23, 1965 FIGB INVENTOR POSE/P7 VK OGLE United States Patent O 3,378,098 HYPODERMIC SYRINGE WITH VIAL Robert W. Ggle, Phoenix, Ariz., assigner to Min-Liet Corporation, Wilmington, Del., a corporation of Delaware Filed July 23, 1965, Ser. No. 474,413 Claims. (Cl. 12S-220) ABSTRACT OF THE BISCLOSURE A medicament injector comprising a cylindrical vial having an open end and a closed end and a resilient plug adapted to be inserted partially into said open end of said vail. A plurality of outwardly extending rings upon said plug engage the walis of said vial with a press fit. A cylindrical holder has an open end and a closed end and a cylindrical member within and spaced from said holder has one end engaging said closed end of said holder. The cylindrical member extends longitudinally of said holder and terminates at an open end within said holder. The holder has a needle extending outwardly from said holder and also inwardly into said holder within said cylindrical member and has a sharpened inner end. Interlocking means are on said cylindrical member and cooperating interlocking means are on said plug whereby upon insertion of said plug into said holder said vial is first held in an assembled but non-operating position and upon further insertion of said plug into said holder said plug is pierced by said needle and said needle communicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial upon exertion of pressure of said vial.
This invention relates to a combination package, vial and injector, and though it has sometimes been referred to in this art as a syringe, we .prefer to distinguish from a syringe in this invention in that a syringe ordinarily consists of a barrel which contains an injectable fluid and a plunger which propels the uid from the barrel, whereas in this invention the container for the uid also acts as a propeller or propelling agent for the iiuid and thus differs from the hypodermic syringe. However, it is noted in prior art and particularly those patents to Lockhart such as Lockhart 2,490,447 and 2,5 86,069, that this general type of injector is nevertheless termed a syringe.
It is a feature of this invention that the vial portion which contains the injectable fluid forms a separate element which may be removed from the combination filled with the desired injectable fluid with conventional filling machines, sealed with the sealing mechanism hereinafter described and then combined with the remainder of the injector to form the overall injector and/ or syringe.
It is a further feature of this invention that after the vial has been loaded and sealed as heretofore mentioned it may be combined with the barrel of the injector for storage without in any way communicating the contents of the iiuid to the barrel of the injector until precisely at the point when it is desired to use the injector.
It is a further feature of this invention that sure, positive and always effective means not relying upon mere friction are present, which enable the user i.e the physician or nurse, to aspirate the injector positively in all cases so as to prevent the injection of the medicament directly into a vital portion of the body, such as a vein, artery or organ, unless so desired.
It is a further feature of this invention that the needle of the injector in the portion extending within the injector terminates short of the surrounding cylindrical portion rather than extending at any time beyond said cylindrical Mice portion with the result that the tip of said portion of said needle is protected at all times from accidental contact which might in some manner injure or render ineffective this end of the needle.
It is a further feature of this invention that whereas said needle referred to above is at all times short of the surrounding cylindrical portion, it assures that the puncturing of the rubber stopper as hereinafter described is directed centrally thus avoiding any possibility of the needle puncturing a side of said stopper and rendering the device ineffective.
It is a further feature of this invention that the glass vial at its open end in all embodiments of this invention is reduced in diameter so that when the physician or nurse aspirates, the necked-over edge of the vial will contact the innermost rings of the stopper and provide a warning for, or actually prevents, the physician or nurse from inadvertently removing the vial from the stopper thus expelling the contents on the floor.
These and other objects, features and advantages will be apparent from the annexed specifications in which:
FIGURE 1 is a plan View of a package embodying the present invention as presented for distribution in its most preferred embodiment;
FIGURE 2 is a section taken alongline 22 of FIG- URE 1;
FIGURE 3 is a section taken alongline 3 3 of FIG- URE 4;
FIGURE 4 is a vertical section of an injector embodyine a preliminary form 0f this invention;
FIGURE 5 is a section similar to FIGURE 4 showing the first step in the use of the device shown in FIG- URE 4;
FIGURE 6 is a View similar to FIGURES 4 and 5 showing the condition of the embodiment of these figures in its final condition when the medicament has been injected into the patient;
FIGURE 7 is a vertical section similar to FIGURES 4, 5 and 6 of a second preliminary embodiment of this invention;
FIGURE 8 is a vertical section of the preferred ernbodiment of this invention which preferred embodiment is intended to be housed in the housing shown in FIG- URES l and 2 and is further illustrated as contained in said housing in FIGURE 2; and
FIGURE 9 is a fragmentary section similar to FIGURE 8 showing a different embodiment of the needle sealing means.
Referring now more particularly to the drawings and particularly to the preferred embodiment shown in FIGURE 8, the device is shown comprisng a vial 2G preferably in the form of a glass or plastic cylinder having anouter flange 21 of a closedend 22 and anopen end 23. The walls of theopen end 23 are necked-over as at 24 for a purpose hereinafter described.
A resilient plug 2S is provided having acentral bore 26 extending only part-way through the plug as clearly indicated in FIGURE 8. The plug 2S has a reducedsection 27 provided withmale threads 28 and an enlargedsection 29 provided withoutstanding rings 3o, 31 and 32. Thevial 20 may be placed in an ordinary filling machine as commonly used by pharmaceutical manufacturers and filled with a liquid injectable. Thereafter the plug 25 may be inserted in the vial 2G to the extent that all three of the rings 3i), 3i and 32 are contained within the vial and theouter ring 32 is within the necked-over end walls 24. It will thus 'be seen that the vial 2i) with the plug 25 constitutes a self-contained unit in which the medicament may be sealed in a sterile condition. Aholder 33 formed of glass or suitable plastic is provided which is generally cylindrical in form and has formed therein a secondcylindrical member 34. Theholder 33 is provided with an outwardly extendingflange 35 at its end. Thecylindrical member 34 terminates at apoint 36 well within the open end of theholder 33 as clearly indicated. The interior of thecylindrical member 34 adjacent its outer end is provided with a series offemale threads 37 adapted to mate withmale threads 28 of the plug 25. The threads as just described engage with a loose lit so as to prevent substantially no frictional resistance to the making up of the threads and certainly insufcient resistance to overcome the press tit of therings 30, 31 and 32 within thevial 20. Theholder 33 is provided with a closedend 38 and an outwardly extendingboss 39 having a bore 4i) therein in which is securely cemented, as by an epoxy cement, aneedle 41 which has an inwardly extending sharpenedend 42 and an outwardlyend 43 sharpened in the fashion of a conventional syringe cannula.
In use, assuming thevial 28 to be filled with theinjectable fluid 44 enclosed with the plug 25, the vial 2t) having the plug secured therein with all three of therings 30, 31 and 32 being inside, the necked-over end 24 is taken and inserted into theholder 33 such that themale threads 28 mate with thefemale threads 37 of thecylindrical member 34. This is the condition of the mechanism as shown in FIGURE 8.
In the condition shown in FIGURE 8 the device above described is taken and placed in the housing shown-in FiGURES 1 and 2. This housing comprises of an uppercylindrical casing 45 and alower cap 46 both of which have closed ends. The wall of thecap 46 is reduced as at 47 to form ashoulder 48 upon which thecasing 45 may -be seated and sealed with a press tit. It will be apparent that with a sterile seal at the point 4S the entire device as shown in FIGURE 8 is a sterile package contained in its sterile housing. Thecasing 45 is provided with a plurality inwardly extendingribs 49 which extend downwardly Vto aportion 50 at which point theribs 49 are of reduced width as shown at 51 forming ashoulder 52 against which theend wall 38 of theholder 33 seats when contained in the package and prevents theend 43 of the needle from striking the end of thecasing 45. T he reducedportion 47 of thecap 46 extends upwardly and provides a stop by engaging theflange 35 of theholder 33 thus securely holding the device between the two stops formed 'by theshoulder 50 and the reducedportion 47.
When it is desired to use the device of the preferred embodiment above described thecasing 45 andcap 46 are removed. The device shown in FIGURE 8 is then taken with theholder 33 gripped in the fingers of one hand and the vial 2G gripped in the lingers of the other hand. Thevial 20 is then turned in a clock-wise direction to cause themale threads 28 to mate up with thefemale threads 37 until it reaches a point at which the sharpenedend 42 of theneedle 41 pierces thewall 53 of the plug 25 thus establishing communication between theneedle 41 and bore 26 and hence the contents of thevial 20.
In practice, no matter how carefully lled thevial 20 will never be completely filled with auid 44 but will contain acertain space 54 filled with nothing Ibut air. Prior to injecting the device into the patient the physician or nurse will hold the device shown in FIGURE 8 in an upright position so as to cause the air bubble to be at the top of thevial 20, he then applies pressure on theend 22 of thevial 20 thus forcing the air in the space S4 outwardly through theneedle 41 which is continued until at least some small drop of theuid 44 is expelled from theend 43 of the cannula to demonstrate that all of the air has been evacuated.
Thereafter the physician or nurse inserts thecannula tip 43 into the patient. Before proceeding with an injection, however, it is common to aspirate such a device. This is done -by withdrawing by pulling outwardly on thevial 20 as by finger contact with theflange 21 and observing the presence or absence of lblood entering thevial 20.
Assuming the conditions to be correct the physician or nurse then proceeds with the injection of the medicament into the patient which is done simply by pressing on the closedend 22 of thevial 20 to pass the vial over the walls of thecylindrical member 34 until thebottom 22 of thevial 20 contacts thebottom ring 30 of the plug 25. This completes the injection and the device is removed from the patient.
Referring now more particularly to the device shown in FIGURES 4, 5 and 6, there is shown an embodiment of the invention which differs from the embodiment shown in FIGURE 8 in that first a needle cover orneedle housing 60 is provided having a press-fit on theboss 39 of theholder 33. This embodiment also differs in that thecylindrical member 34a as its open end is provided with aninturned flange 61. Theresilient plug 62 differs radically from the plug 25 of the embodiment shown in FIGURE 8 in that thisplug 62 has acylindrical portion 63 which adjacent its inner end is provided with a plurality of spaced extendinglips 64 which as shown in FIGURE 4 in the initial position of the device are adapted to be passed over the inwardly turned ange 61 of thecylindrical member 34a and to engage against the inside of saidange 61.
This contact of thelips 64 with theange 61 provides an' inner-locking connection which secures theplug 62 in thecylindrical member 34a.
Theplug 62 is provided with anoutstanding ring 65 and a further series ofrings 66, 67 and 68. Theplug 62 is provided with abore 69 comparable to thebore 26 in FIGURE 8 in that it does not pass entirely through theplug 62. Theplug 62 is also provided with asecond bore 70 aligned with thebore 69 leaving asolid section 71 between the twobores 69 and 70. As before, thevial 20a will contain auid 44 and anair space 54. Thevial 20a is necked-over as at 24a and in fact diers from the vial 2t) only in the absence of thetiange 21.
The above concludes the description of this embodiment of this invention of its condition as shown in FIG- URE 4. It will be noted however, that thering 66 is disposed outside the necked-over portion 24a and that further theneedle 41 is disposed inbore 70 in a sealed condition wherein it is received with a press-fit tosecurely seal this end of the needle aseptically.
Referring now to FIGURE 5, the device is shown in the lirst step which the physician or nurse performs in its use, that is theneedle housing 60 has been removed and the physician or nurse has pushed thevial 20a forward to force theplug 62 into thecylindrical portion 34a to a point whereflange 61 has engaged and lockedring 65 and thatneedle 41 has punctured thesolid section 71 thus providing communication of theneedle 41 with the contents of the vial 26a. It will be noted that thering 66 provides the necessary resistance by its contact with the necked over portion 24a to assure a lock betweenBange 61 andring 65. Continued forward movement by the physician or nurse ofvial 20a causesring 66 to snap over the neckedover portion 24a and continuing forward movement expells theair 54 at which point the patientmay be injected. The physician or nurse may aspirate by drawing backward on vial 29a because of the inner-lock of the ring and theange 61. The contents ofvial 20a are fully administered by the physician ornurse moving vial 20a in a forward motion as shown in FIGURE 6.
Referring now more particularly to the device shown in FIGURE 7 the similar parts are given similar numbers. The embodiment shown in FIGURE 7 differs Vfrom the embodiment shown in FIGURES 4, 5 and 6 only in that the liange 61a is outwardly disposed as opposed to inwardly disposedflange 61 and that thering 72 is inwardly disposed as opposed to outwardlydisposed lips 64 and that inwardly disposedring 73 provides the same aspiration lock as outwardlydisposed ring 65. The device shown in FIGURE 7 functions exactly as the device shown in FIGURES 4, and 6 with the exception that inwardly disposed rings are contacting an outwardly disposed iiange rather than vice versa.
It will be noted that in embodiments shown in FIG' URES 4, 5, 6 and 7, theneedle 41 has itsend 42 embedded in abore 70 which seals the same. It will also be noted that in the embodiment shown in FIGURE 8 that there is no bore in the plug comparable to thebore 70 of the other gures. However, it is within the compass of this invention that the concept of thebore 70 in the plug receiving theend 42 of theneedle 41 may be substituted in FIGURE 8 so that theend 42 of the needle 4l is sealed in which case a cap similar to the needle cover 6i) will be used to cover theopen end 43 of theneedle 41 and the hous ing consisting of thecasing 45 andcap 46 may be eliminated. lt is also within the concept of this invention that a plug similar to the plug 25 in that it does not have abore 70, may be utilized in the embodiment shown in FIGURES 4, 5, 6 and 7, in which case the embodiment shown in FIGURES 4, 5, 6 and 7 would not have theneedle cover 60 but would be housed in the casing comprising thecasing 45 andcap 46.
It will be appreciated by those skilled in the art that when the device shown in FIGURE 8, having the aspect of not having a sealingbore 70 for the end of theneedle 42 is used, then to maintain an aseptic condition a housing such as shown in FIGURES l and 2 is necessary. However, it will be accordingly obvious that when a plug such as shown in FIGURES 4, 5, 6 and 7 having such abore 70 sealing theend 42 of the needle is utilized then as aseptic condition is here established and that a mere needle cover 6D may complete the package and the outer housing comprising thecasing 45 andcap 46 become superuous.
As there is no rictional engagement of theplugs 25 and 62 relied upon, then thebore 70, substantially smaller in diameter than theneedle 42, must be used for an aseptic seal of said needle unless the entire unit as in FIGURE 8 is encased in an aseptic sealed outer housing as inFIG URES 1 and 2.
Stated otherwise, theplug 62 or 62a is shown as having abore 70 which receives thetip 42 of theneedle 41 with a press-lit and seals the same. This seal may obviously be accomplished in the embodiment shown in FIGURE 8 by simply putting abore 70 in the top of the plug 25 somewhat extending theneedle 41 so that thetip 42 is again received with a press-ht in thebore 70 now contained in the plug 25, as shown in FIGURE 9. A needle cover such as 69 may then be used instead ofhousing 45 andcap 46.
While there has been described what is at present considered preferred embodiments of the present invention, it will be appreciated by those skilled in the art that various changes and modifications can be made therein without departing from the essence ofthe invention and it is intended to cover herein all such changes and modilications as come within the true spirit and scope of the appended claims.
I claim:
1. A medicament injector comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted partially into said open end 0f said vial, a plurality of outwardly extending rings upon said plug engaging the walls of said vial with a press lit; a cylindrical holder having an open end and a closed end; a cylindrical member within and spaced from said holder having one end engaging said Closed end of Said holder, said cylindrical member etxending longitudinally of said holder and terminating at an open end within said holder; said holder having a needle extending outwardly from said holder and also inwardly into said holder within said cylindrical member and having a sharpened inner end; interlocking means on said cylindrical member and cooperating interlocking means on said plug; whereby upon insertion of said plug into said holder said vial is first held in an assembled but non-operating position and upon further insertion of said plug into said holder said plug is pierced by said needle and said needle communicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion ofthe contents of said vial upon exertion of pressure on said vial, said interlocking means on said cylindrical member including an inturned ange on the open end of said cylindrical member, and said cooperating means on said plug including an outwardly extending lip upon said plug adapted to engage the inner side of said inturned flange and hold said injector in assembled condition and another outwardly extending ring on Said plug spaced away from the inner end of said plug from said lip and adapted to engage the inner side of said inturned ange to hold said injector in operating condition.
2. A medicament injector comprising: a cylindrical vial having an open end and a closed end, the walls of said vial at said open end being bent inwardly to form a lip; a resilient plug adapted to be inserted partially into said open end of said Vial; a plurality of outwardly extending rings upon said plug engaging the Walls of said vial with a press tit; a cylindrical holder having an open end and a closed end; a cylindrical member within and spaced from said holder having one end engaging said closed end of said holder, said cylindrical member extending longitudinally of said holder and terminating at an open end within said holder; said holder having a needle extending outwardly from said holder and also inwardly into said holder within said cylindrical member and having a sharpened inner end; interlocking means on said cylindrical member and cooperating interlocking means on said plug; whereby upon insertion of said plug into said holder said vial is iirst held in an assembled but non-operating position and upon further insertion of said plug into Said holder said plug is pierced by said needle and said needle communicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon Withdrawal of said vial or to permit expulsion of the contents ot said vial upon exertion of pressure on said vial, and an enlarged ring on said plug engaging the lip at the inturned walls of said vial, said enlarged ring being spaced from said other ring.
3. A medicament injector comprising: a cylindrical vial having an open end and a closed end, the walls of said vial at said open end being bent inwardly to form a lip; a resilient plug adapted to be inserted partially into said open end of said vial, a plurality of outwardly extending rings upon said plug engaging the walls of said vial with a press iit; said plug having a central bore extending partly through said plug; a cylindrical holder having an open end and a closed end; a cylindrical member within and spaced from said holder having one end engaging said closed end or said holder, said cylindrical member extending longitudinally of said holder and terminating at an open end within said holder; said holder having a needle extending outwardly from said holder and also inwardly into said holder within said cylindrical member and having a sharpened inner end; interlocking means on said cylindrical member and cooperating interlocking means on said plug; whereby upon insertion of said plug into said holder said vial is rst held in an assembled but non-operating position and upon further insertion of said plug into said holder said plug is pierced by said needle and said needle communicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial upon exertion of pressure on said vial, said interlocking means on said cylindrical member including an inturned ange on the open end of said cylindrical member, and said cooperating means on said plug including an outwardly extending lip upon said plug adapted to engage the inner side of said inturned flange and hold said injector in assembled Condition and another outwardly extending ring on said plug spaced away from the inner end of said plug from said lip and adapted to engage the inner side of said inturned ange to hold said injector in operating condition, and an enlarged ring on said plug engaging the lip at the inturned walls of said vial, said enlarged ring being spaced from said other ring, said inner end of Said needle in said assembled condition entering said bore and having a press fit therein and piercing said plug when said other outwardly extending ring engages said inner side of said inturned ange.
4. A medicament injector comprising: a cylindrical vial having an open end and a closed end, the walls of said vial at said open end being bent inwardly to form a lip; a resilient plug adapted to be inserted partially into said open end of said vial, a plurality of outwardly extending rings upon said plug engaging the walls of said vial with a press fit; said plug having a central bore extending partly through said plug; a cylindrical holder having an open end and a closed end; a cylindrical member within and spaced from said holder having one end engaging said closed end of said holder, said cylindrical member extending longitudinally of said holder and terminating at an open end within said holder; said holder having a needle extending outwardly from said holder and also inwardly into said holder Within said cylindrical member and having a sharpened inner end; interlocking means on said cylindrical member and cooperating interlocking mcms on said plug; whereby upon insertion of said plug into said holder said vial is first held in an assembled but non-operating position and upon further insertion of said plug into said holder Said plug is pierced by said needle and said needle cornmunicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial upon exertion of pressure on said vial, said interlocking means on said cylindrical member including an inturned flange on the open end of said cylindrical member, and said cooperating means on said plug including an outwardly extending lip upon Vsaid plug adapted to engage the inner side of said inturned ange and hold said injector in assembled condition and another outwardly extendingrring on said plug spaced away from the inner end of Said plug from said lip and adapted to engage the inner side of said inturned flange to hold said injector in operating condition, and an enlarged ring on said plug engaging the lip at the inturned walls of said vial, said enlarged ring being spaced from said other ring, said inner end of said needle in said assembled condition entering said bore and having a press t therein and piercing said plug when said other outwardly extending ring engages said inner side of said inturned Range, and a needle cover having a closed end adapted to enclose the outwardly extending portion of said needle; said holder having a boss upon the end thereof, said needle passing through said boss and said cap having an open end adapted to engage and seal against said boss with a press tit.
5. A medicament injector comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted .partially into said open end of said vial; a plurality of outwardly extending rings upon said plug engaging the walls of said vial with a press fit; a cylindrical holder having an open end and a closed end; a cylindrical member within and spaced from said holder having one end engaging said closed end of said holder, said cylindrical member extending longitudinally of said holder and terminating at an open end within said holder; said holder having a needle extending out- Wardly from said holder and also inwardly into Said holder within said cylindrical member and having a sharp-V ened inner end; interlocking means on said cylindrical member and cooperating interlocking means on said plug; whereby upon insertion of said plug into said holder said vial is iirst held in an assembled but non-operating position and upon further insertion of said plug into said holder said plug is ,pierced by said needle and said needle communicates with said vial and said plug is locked securely in said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial upon exertion of pressure on said vial, said interlocking means on said cylindrical member including an outwardly turned ilange on the open end of said cylindrical member and' said cooperating means on said plug including an inwardly extending ange on said plug adapted to engage the inner side of said outwardly turned ange and hold said injector in assembled condition, and an inwardly extending ring on said plug spaced from said inwardly extending ange and adapted to engage the inner side of said outwardly turned ange to hold said injector in operating condition.
References Cited UNITED STATES PATENTS 1,817,003 8/1931 Hein 128--220 2,568,346 9/1951 Lockhart 12S-220 2,586,068 2/ 1952 Lockhart 128-220 2,586,069 2/1952 Lockhart 12S-220 2,922,419 1/1960 Bednarz 12S-218 3,128,766 4/1964 Mizzy 128-220 3,272,322 9/ 1966 Ogle 206-43 RICHARD A. GAUDET, Primary Examiner. D. L. BAKER, Assistant Examiner.