US3923059A

US3923059A - Medicament injector

Info

Publication number: US3923059A
Authority: US
Inventors: Robert W Ogle
Original assignee: IMS Ltd
Current assignee: IMS Ltd
Priority date: 1971-07-01
Filing date: 1973-10-11
Publication date: 1975-12-02
Anticipated expiration: 1992-12-02

Abstract

This patent describes a novel medicament injector device for the addition of concentrated medication to rubber stoppered solution containers comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted at least partially through the open end of the vial; the plug forming a seal engagement with the walls of the vial with a press fit; a cylindrical member having one closed end, the cylindrical member holding a needle extending inwardly into the cylindrical member and having a sharpened inner end; the cylindrical member having a tip extending outwardly from the closed end. The tip has an elongated member of generally uniform circular cross-section and a central fluid passage extending substantially the length thereof. The tip terminates in a pointed end in a zone of reduced cross-section, the zone having at least one fluid passage which communicates with the central fluid passage and forms an oblique angle with respect thereto. Interlocking means on the cylindrical member and cooperating interlocking means on the plug are provided whereby upon interlocking of the plug with the cylindrical member, the vial is first held in an assembled but non-operating position and upon further interlocking of the plug with the cylindrical member, the plug is adapted to be pierced by the needle and the needle communicated with the vial without the application of substantial axial pressure on the plug and the plug is locked securely to the cylindrical member to permit aspiration upon withdrawal of the vial or to permit expulsion of the contents of the vial into the solution container upon exertion of pressure on the vial. The pointed tip is adapted to pierce the stopper of the container without cutting loose pieces from the stopper and without the loss of any vacuum within the container.

Description

Primary Examiner-John D. Yasko Attorney, Agent, or Firm-Wills, Green & Mueth [57] ABSTRACT This patent describes a novel medicament injector de- United States Patent 1191 1111 3,923,059

Ogle Dec. 2, 1975 MEDICAMENT INJECTOR vice for the addition of concentrated medication to [75] Inventor: Robert og'le, Newport Beach, rubber stoppered solution containers comprising: a cycalif. lindrical vial having an open end and a closed end, a

' resilient plug adapted to be inserted at least partially Assigneei 1M5 Limited, South El Monte, Cfllifthrough the open end of the vial; the plug forming a [22] Filed oct 11 1973 seal engagement with the walls of the vial with a press fit; a cylindrical member having one closed end, the

[ PP 405,533 cylindrical member holding a needle extending in- Related U S Application Da'ta wardly into the cylindrical member and having a [6 C t, f f s r N 158 770 J l sharpened inner end; the cylindrical member having a o e u y tip extending outwardly from the closed end. The tip e has an elongated member of generally uniform circular cross-section and a central fluid passage extending 128/237 g z f z substantially the length thereof. The tip terminates in [58] Fie'ld 233 234 a pointed end in a zone of reduced cross-section, the

128/272 221 8 N C zone having at least one fluid passage which communicates with the central fluid passage and forms an oblique angle with respect thereto. interlocking means ['56] References Clted on the cylindrical member and cooperating interlock- UNITED STATES PATENTS ing means on the plug are provided whereby upon in- 56l,059 5/18 6 Mit h ll et al... 123/213 N terlocking of the plug with the cylindrical member, the

. v via] is first in an assembled but non. opgrating p0- 2183709] 6/1958 MCMm" et 128/214 C sition and upon further interlocking of the plug with the cylindrical member, the plug is adapted to be 3064652 11/1962 corcoranet 5 D x pierced by the needle and the needle communicated 3:207:374 9/1965 Holmes at 128/272 Ux with the vial without the application of substantial 3,376,866 4/1968 Ogle 128/272 x anal Pressure the P and the P g 15 locked 3,552,387 1/1971 Stevens 128/272 r ly to the cylindrical member to permit aspiration upon withdrawal of the vial or to permit expulsion of ZxQZ'Z SI OR SZZMC the contents of the vial into the solution container 519,998 e gium upon exertion of pressure on the vial. The pointed tip is adapted to pierce the stopper of the container without cutting loose pieces from the stopper and without the loss of any vacuum within the container.

6 Claims, 10 Drawing Figures U.S; Patent Dec. 2,1975 She et10f3 3,923,059

us. Patent De.2,1975' *sh'eetz ofg 3,923,059

US. Patent Dec. 2, 1975 Sheet 3 Of?) 3,923,059

MEDICAMENT INJECTOR BACKGROUND OF THE INVENTION This application is a continuation-in-part of application Ser. No. 158,770, filed July 1, 1971, now abandoned, the disclosure of which is expressly incorporated herein by reference.

The present invention is concerned with a device which is useful for the addition of medicinal solutions to intravenous solution containers. Various devices have been proposed for this purpose. In general, the devices involve the use of various complicated glass or plastic molded parts. The present invention, it is believed, represents a substantial advance in the art in that all of the parts present in the device can be made of readily moldable plastic and/or rubber with the exception of the vial, which vial is a simple shell vial of utter simplicity, and a conventional needle. In short, the device of the present invention can be made on a more economical basis and affords a device which is adapted to be pre-loaded at a central plant, used once at the time of injection into an intravenous bottle, and thereafter disposed of. It is becoming recognized in the art that the ultimate in the packaging of any medication is in the form of pre-loaded disposable devices. The present invention makes the application of this principal possible for the first time to the addition of medicament to intravenous solution containers. It is accordingly anticipated that this invention will be widely adopted in the art.

SUMMARY OF THE INVENTION Briefly, the present invention comprises a novel medicament injector device for the addition of concentrated medication to rubber stoppered solution containers comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted at least partially through said open end of said vial; said plug forming a sealing engagement with the walls of said vial with a press fit; a cylindrical member having one closed end, said cylindrical member holding a needle extending inwardly into said cylindrical member and having a sharpened inner end; said cylindrical member having a tip extending outwardly from said closed end, said tip being an elongated member ofgenerally uniform circular cross-section and having a central fluid passage extending substantially the length of the tip, said tip terminating in a pointed end in a zone of reduced cross-section, said zone having at least one fluid passage which communicates with said central fluid passage and forms an oblique angle with respect thereto; interlocking means on said cylindrical member and cooperating interlocking means on said plug, whereby upon interlocking of said plug with said cylindrical member said vial is first held in an assembled but non-operating position and upon further interlocking of said plug with said cylindrical member, said plug is adapted to be pierced by said needle and said needle communicated with said vial without the application of substantial axial pressure on said plug and said plug is locked securely to said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial into said solution container upon exertion of pressure on said vial, said pointed tip being adapted to pierce the stopper of said container without cutting loose pieces from the stopper and without the loss of any vacuum within said container.

It is an object of the present invention to provide a novel device for the packaging of medication.

More particularly, it is an object of the present invention to provide for the packaging of medication in a disposable device.

Still another object of the present invention is to provide a disposable device for use in the addition of medication to intravenous solution bottles.

These and other objects and advantages of the invention will be apparent from the more detailed description which follows taken in conjunction with the accompanying drawings.

At present, intravenous solutions may or may not be supplied under vacuum. Some bottled intravenous solutions are vacuum packaged. Others are not. The intravenous solutions in flexible plastic bags are not packaged under vacuum. The present invention obviates the problem of adding medication to the intravenous solution packages since the device of this invention forces the medication into the package under positive pressure. Fluid transfer is not dependent upon a vacuum being present in the package.

Further, the device of the present invention includes a significant safety feature. Additives for intravenous solutions actually contain medication in a concentration unsuitable for direct injection into the human body. In fact, many of these additives are fatal if directly injected. The large point on the device of this invention prevents the accidental injection of the concentrated medication into the body. The pointed tip of this invention also prevents coring of the rubber closure on the intravenous solution. Coring results in bits of rubber falling into the solution which can result in the injection of this dangerous blood clotting material into the patient. The pointed tip pierces the rubber rather than cutting it. The hole enlarges and stretches around the diameter of the tip. Thus, vacuum is maintained in vacuum packaged solutions. The problem created by the flap cut by a biased tip is avoided. In this invention, the tip can be twisted or rotated without the cutting off of a rubber piece whereas such manipulation of a biased tip creates the possibility of the flap being cut off as the tip is rotated to the flap adjoinment resulting in the dropping or rubber into the solution.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning to the drawings:

FIG. 1 shows a perspective view of one embodiment of the device of the present invention in a disassembled state.

FIG. 2 is a sectional view of the tip portion of the device of FIG. 1.

FIG. 3 shows, in disassembled form and sectional view, the device of FIG. 1 in relationship to a typical intravenous solution bottle.

FIG. 4 shows, in assembled form, the use of the device of FIGS. 1 and 3 for the injection of medication into an intravenous solution bottle.

FIG. 5 shows in sectional view the adaptation to the present invention to a conventional hypodermic syringe.

FIG. 6 is a perspective view of the open end of the vial and associated stopper.

FIG. 7 is another view showing the operation of FIGS. 1 and 3.

FIG. 8 is a side view of the discharge end of one type of tip used in the devices of this invention.

FIG. 9 is an enlarged view of the discharge opening in the tip of FIG. 8.

FIG. 10 is a sectional view along the line 10 10 in FIG. 9.

Turning to the drawings in greater detail, the holder of FIGS. 1, 3 and 7 comprises a generally cylindrical hollow tubular holder 10 having an open end 12 and a closed end 14. The cylindrical vial 16 has a resilient stopper 18 in its open end sealing on the inside walls of the vial 16. The stopper 18 generally, although not necessarily, has a thin imperforate central diaphragm portion. The stopper 18 is provided with an externally threaded projection 20 thereon. The tubular holder 10 has a needle 22 therein and a tip 24 on its exterior which tip is provided with a fluid passage 26 extending to

angled passages

28 and 30 which terminate in

openings

32 and 34. The tip 24 has a sharp pointed end adapted to puncture the stopper on an intravenous solution bottle.

Within the tubular holder 10, there is provided a thrust portion 36. The lower end of needle 22 communicates with the hole 38 in the closed end of the tubular holder 10. The upper end of needle 22 has a sharp terminal portion 40 having a hole 42 therein. The thrust portion 36 may also have internal threads 44 in proximity to its upper end, the threads on the projection 20 and the threads 44 being adapted when made up to cause said sharp terminal portion 40 of the needle to puncture said stopper 18. When the projection 20 is made up with threads 44, the stopper 18 functions as a piston to expel the contents of the vial 16 through needle 22 and passage 26 as said vial 16 is advanced into said tubular holder 10.

In operation, the vial 16 containing liquid medication is partially made up with the holder 10 simply by turning the vial and the threads on projection into the threads 44. The tip 24 is then used to pierce the stopper 46 on an intravenous solution bottle 48. The threads are then further made up until the thread 20 on the stopper 18 are fully made up with threads 44 as shown in FIG. 4. At this point, the sharp terminal portion 40 has punctured the stopper 18. By applying a slight further force on the vial, the vial can be advanced into the holder causing the stopper to expel the contents of the vial through the tip as shown in FIG. 4 into an intravenous solution bottle 48. The contents of the intravenous bottle is then administered to the patient in a manner familiar to those skilled in the art.

During storage, the tip 24 may be provided with a protective cover 50. This cover is removed prior to use.

All parts of this invention are preferably made of plastic, save for the vial 16 and the stopper 18. The vial is normally a glass shell vial and the stopper is made of a resilient rubber which is compatible with the medication contained in the vial.

In FIG. 5, a conventional syringe 52 provided with a reciprocating plunger 54 is used. The tip 56 is constructed substantially as previously described.

A resilient plug or stopper 18 is provided having a central bore 66 extending through the plug and bridged by the imperforate diaphragm which is punctured in use by the needle. The stopper 18 has a reduced section provided with male threads 70 and an enlarged section 72 provided with

outstanding rings

74, 76, and 78. The vial 16 may be placed in an ordinary filling machine as commonly used by pharmaceutical manufacturers and filled with a liquid injectable. Thereafter, the stopper 18 may be inserted in the vial 16 to the extent that all three of the

rings

74, 76, and 78 are contained within the vial. A holder 80 is provided which is generally cylindrical in form and has formed therein a second cylindrical member 82. The holder 80 is provided with an outwardly extending flange 84 at its open end. The interior of the cylindrical member 82 adjacent its outer end is provided with a series of female threads adapted to mate with male threads of the plug 64. The threads as just described engage with a loose fit so as to present substantially no frictional resistance to the making up of the threads and certainly insufficient resistance to overcome the press fit of the

rings

74, 76, and 78 within the via] 16. The holder is provided with a closed end 88 and an outwardly extending boss having a bore 92 therein in which is securely cemented, as by an epoxy cement, a needle which has an inwardly extending sharpened end.

Assuming that the holder or syringe is made of plastic, the tip portion 104 as shown in FIGS. 8 10 can be separately molded, from plastic, and spun-welded to the holder or syringe barrel. The tip is normally provided with two openings 106 and 108. However, three or even four openings are possible, and of course, a single opening can be provided where speedy discharge is not required. The edges 110 of the tip 104 are quite sharp to provide cutting surfaces. The point 112 facilitates the initial puncturing of the stopper on the intravenous solution bottle.

Having fully described the invention it is intended that it be limited only by the lawful scope of the appended claims.

I claim:

1. A novel medicament injector device for the addition of concentrated medication to rubber stoppered solution containers comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted at least partially through said open end of said vial; said plug forming a sealing engagement with the walls of said vial with a press fit; a cylindrical member having one closed end, said cylindrical member holding a needle extending inwardly into said cylindrical member and having a sharpened inner end; said cylindrical member having a tip extending outwardly from said closed end, said tip surrounding and extending from the lower end of said needle portion said tip being an elongated member of generally uniform circular cross-section and having a central fluid passage extending substantially the length of the tip, said tip terminating in a pointed end in a zone of reduced cross-section, said zone having at least one fluid passage which communicates with said central fluid passage and forms an oblique angle with respect thereto; interlocking means on said cylindrical member and cooperating interlocking means on said plug, whereby upon interlocking of said plug with said cylindrical member said vial is first held in an assembled but non-operating position and upon further interlocking of said plug with said cylindrical member, said plug is adapted to be pierced by said needle and said needle communicated with said vial without the application of substantial axial pressure on said plug and said plug is locked securely to said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial into said solution container upon exertion of pressure on said vial, said pointed tip being adapted to pierce the stopper of said container without cutting loose pieces from the stopper and without the loss of any vacuum within said container.

2. The device of claim 1 wherein said zone has two fluid passages forming an acute angle with respect to each other, the pointed end being positioned between said passages and being symmetrically disposed around a line running longitudinally of said central fluid passage.

3. The device of claim 1 wherein each of said two fluid passages terminates at flat surfaces on opposite sides of said tip, the cross-section of said tip otherwise being round.

4. In combination, a novel medicament injector device comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted at least partially through said open end of said vial; said plug forming a sealing engagement with the walls of said vial with a press fit; a cylindrical member having one closed end, said cylindrical member holding a needle extending inwardly into said cylindrical member and having a sharpened inner end; said cylindrical member having a tip extending outwardly from said closed end, said tip surrounding and extending from the lower end of said needle portion said tip being an elongated member of generally uniform circular crosssection and having a central fluid passage extending substantially the length of the tip, said tip terminating in a pointed end in a zone of reduced cross-section, said zone having at least one fluid passage which communicates with said central fluid passage and forms an oblique angle with respect thereto; interlocking means on said cylindrical member and cooperating interlocking means on said plug, whereby upon interlocking of said plug with said cylindrical member said vial is first held in an assembled but non-operating position and upon further interlocking of said plug with said cylindrical member, said plug is adapted to be pierced by said needle and said needle communicated with said vial without the application of substantial axial pressure on said plug and said plug is locked securely to said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial into said solution container upon exertion of pressure on said vial, and a container of intravenous solution, said container having a sealing member at one end thereof, said tip piercing said sealing member whereby the contents of said vial are transferred to said container by the exertion of pressure on said vial.

5. The device of claim 4 wherein said zone has two fluid passages forming an acute angle with respect to each other, the pointed end being positioned between said passages and being symmetrically disposed around a line running longitudinally of said central fluid passage.

6. The device of claim 4 wherein each of said two fluid passages terminates at flat surfaces on opposite sides of said tip, the cross-section of said tip otherwise being round.

Claims

4. In combination, a novel medicament injector device comprising: a cylindrical vial having an open end and a closed end, a resilient plug adapted to be inserted at least partially through said open end of said vial; said plug forming a sealing engagement with the walls of said vial with a press fit; a cylindrical member having one closed end, said cylindrical member holding a needle extending inwardly into said cylindrical member and having a sharpened inner end; said cylindrical member having a tip extending outwardly from said closed end, said tip surrounding and extending from the lower end of said needle portion said tip being an elongated member of generally uniform circular cross-section and having a central fluid passage extending substantially the length of the tip, said tip terminating in a pointed end in a zone of reduced cross-section, said zone having at least one fluid passage which communicates with said central fluid passage and forms an oblique angle with respect thereto; interlocking means on said cylindrical member and cooperating interlocking means on said plug, whereby upon interlocking of said plug with said cylindrical member said vial is first held in an assembled but non-operating position and upon further interlocking of said plug with said cylindrical member, said plug is adapted to be pierced by said needle and said needle communicated with said vial without the application of substantial axial pressure on said plug and said plug is locked securely to said cylindrical member to permit aspiration upon withdrawal of said vial or to permit expulsion of the contents of said vial into said solution container upon exertion of pressure on said vial, and a container of intravenous solution, said container having a sealing member at one end thereof, said tip piercing said sealing member whereby the contents of said vial are transferred to said container by the exertion of pressure on said vial.