US 3561596 A
Description (OCR text may contain errors)
United States Patent  lnvcntor James .].KnX 2.578.394 12/1951 Blackman .7 128/218(P) AveneLNJ. 2 720.969 /1955 Kendall 206/632  App]. No. 826,143 2.728 341 12/1955 Roehr 206/43(UX) [221 Filed May20, 1969 3.380.448 4/1968 Sadove etalw 206/632  Patented Feb. 9, 1971 Prim ry Lxammer--- William T D1XS01'1, Jr.  Assignee Knox Laboratorles Inc. Y
Rahway, NJ Attorneys Kenyon & Kenyon Reilly Carr and Chapm a corporation of New Jersey 1 ABSTRACT: A coordinated system of interchangeable  PACKAGING FOR HYPODERMIC SYRINGES hypodermic syringe components is described wherein there NEEDLES AND THE LIKE are provided 35 cialmsm Drawmg l A plunger shaft element comprising a hollow shaft 1 U.S.C1 206/633, containing a hypodermic needle and having means for re- 128/218 leasably attaching the shaft to a plunger and, optionally, a  A6111 17/06 plungeqand Field of Search 7. 206/632, 2. A syringe barrel element optionally having a plunger 4 5, 1 1 396 disposed therein, a seal for the needle-receiving tip thereof References Cited 2:11:11 82122321131525: parenteral medicament between said seal UNITED STATES PATENTS FEE 6f iifeE elements may be individually packaged in a 1,462,824 7/1923 Reed et a1 285/396 sterile form. There is also described a packaged prefilled 2,550,394 4/1951 Young et a1 206/632 hypodermic syringe assembly.
PACKAGING FOR HYPODERMIC SYRINGES, NEEDLES AND THE LIKE DESCRIPTION OF THE INVENTION This invention relates to packaging for hypodermic syringes, needles and the like. More particularly, in one embodiment this invention is concerned with a coordinated system of separately packaged, interchangeablehypodermic syringe elements. In another embodiment this invention is related to a packaged preftlled hypodermic syringe.
In the past, hypodermic syringes were of the reusable type and thus required cleaning and sterilization prior to subsequent use. In addition to the expense involved in this procedure, it was quite difficult to ensure complete sterilization, particularly of the hypodermic needle. As a result, there has been an increasing tendency to use disposable syringes which are intended to be discarded after one use. Unfortunately, however, the introduction of the disposable syringe has resulted in increased complexity and frequently in increased cost. For example, a common form of disposable syringe comprises a plastic syringe barrel having a needle already affixed. Because large institutional users such as hospitals have a need for syringes and needles of varying sizes, it was found necessary to maintain a large inventory of these disposable syringes to insure the presence of sufficient numbers of each desired combination of needle size and gauge and syringe size. The magnitude of this problem is readily appreciated when it is realized that there are about 24 different combinations of needle size and gauge alone, although only 12 combinations are widely used. Because the disposable syringes are normally supplied in lots of 100, it can be seen that the result is a substantially larger inventory than would be required if needles and syringes were supplied separately.
This problem is further complicated by the increasing use of the prefill concept, whereby parenteral medicaments are sup plied by the pharmaceutical house in a measured dosage. Because each medicament may be supplied in several dosage levels, the result is a further increase inthe necessary invento' ry if the medicament is supplied in .a disposable syringe. In addition, because parenterals today must be supplied in glass containers, the commonly employed plastic disposable syringes cannot be employed for this purpose, and attempts to provide inexpensive glass syringes with needles have proven unsatisfactory. For example, in one commercially available form the syringe is filled with the medicament and a needle is then spun over a bead on the syringe tip. This technique is attended by a high breakage rate, resulting in loss of the expensive parenteral solution.
An alternative has been to supply the medicament in a glass cartridge which is placed in a fixture for injection. In general, this method has proven quite cumbersome, and the fixtures are rather complicated and expensive devices. Moreover, there is little or no standardization among pharmaceutical houses, resulting in the need for the hospital to maintain a supply of different fixtures for each pharmaceutical house.
It is an object of this invention to provide a simplified hypodermic syringe system.
It is a further object of this invention to provide packaged components for hypodermic syringes which are readily interchangeable.
Still another object of this invention is to provide an integrated system of reusable, disposable and prefilled syringes and thereby reduce hospital inventories of syringes.
These and other objects of this invention will be apparent from the ensuing specification and claims and accompanying drawings, of which:
FIGS. 1A, 1B and 1C illustrate various embodiments of one major component of the system of this invention;
FIGS. 2A and 2B illustrate various embodiments of a second major component of the system of this invention;
FIGS. 3A, 3B and 3C illustrate a preferred means for attaching a plunger shaft to the plunger of a hypodermic syringe.
FIG. 4 illustrates still another embodiment of this invention; and
FIG. 5 illustrates one method for packaging the components of the system of this invention.
In general, the objects of this invention are achieved by providing as separate elements a hypodermic syringe barrel component and a hypodermic needle-plunger shaft component. In an alternative embodiment, there is provided a prcfilled hypodermic syringe wherein the needle-shaft component is mounted on the tip of the barrel component.
With reference to FIGS. 1AIC, the syringe barrel component comprises barrel 11 which may be of plastic or glass, and may be disposable or reusable. Barrel 11 is restricted at one end to provide hypodermic needle receiving tip 13, which has a cylindrical or frustroconical outer surface whose nar rowest dimension is farthest removed from the barrel. In use a hypodermic needle is forced onto tip 13. Means for locking the needle tip may be employed if desired, but means which tend to trap contamination and make thorough sterilization impossible, such as the conventional metal sleeve locks presently employed, are not desired. Thus, the syringe barrel is preferably a unitary member formed entirely of a suitable material such as glass or plastic. A preferred means for locking the needle to the syringe comprises a circumferential groove 15 in tip 13 which cooperates with an internal circumferential bead on the inside surface of the needle hub to removably hold the needle on the barrel tip.
Although the barrel may be supplied alone, it is preferred that there be disposed inside barrel 11 a plunger 17 which has in the surface opposed to needle-receiving tip 13 means for attaching a plunger shaft thereto. Plunger 17 is desirably constructed of an inert deformable material, such as rubber, to obviate the necessity for the close internal tolerances required with the conventional ground glass plungers. If desired, plunger 17 may be provided with one or more circumferential beads 19 to insure close contact with the walls of a barrel 11.
The barrel component may be readily adapted for use as a prefill by providing tip 13 with a seal, such as rubber cap 21, and incorporating parenteral fluid 23 between plunger 17 and seal 21.
The second major component of the system of this inven tion comprises a needle-shaft component illustrated by FIGS. 2A and 2B. The essential elements of this component comprise hollow shaft 31, which may be of any desired cross section such as circular or polygonal, having proximal end 33. Proximal end 33 is open, whereas distal end 35 may be open or closed, but is preferably closed, and has means for attaching shaft 31 to plunger 17. Hypodermic needle 37 is con tained within shaft 31 whereby the point thereof extends toward but short of distal end 35. Proximal end 33 is provided with means for securely but releasably gripping the hub of needle 37 whereby the needle is retained within shaft 31. The hub of needle 37 may be wholly contained within shaft 31 or may extend beyond proximal end 33 thereof. If desired distal end 35 may be provided with plunger 17 attached thereto.
The means for attaching plunger 17 and shaft 31 may be any suitable means, although greater flexibility is attained when means for releasably attaching plunger and shaft, such as screw threads and the like, are employed. A particularly preferred means for rapid attachment and detachment of shaft 31 and plunger 17 comprises a quarter-turn spade lock as shown in FIGS. 3A-3C. Distal end of shaft 31 is provided with depending extension 38 having opposed wings 39. Plunger 17 is provided with keyway 40 terminating in an enlarged recess 40a whereby, after insertion and rotation of shaft 31 through not more than I C., for example through about the shaft and plunger are removably attached.
It can readily be seen that by the use of the basic components of the system of this invention considerable reductions in cost and inventory are possible. All elements are simple in construction and are inexpensive to produce. Moreover, the hospital or other institution needs to retain only the number of needle-shaft components and barrel components, including prefills, as are necessary to satisfy its anticipated needs.
To facilitate reduced inventories it is contemplated that, whereas syringe barrels and needles may be of different sizes, the needleareceiving tips and needle hubs are of a uniform standard size. In addition, the plunger shafts are all desirably of the same size, as are the means for attaching the plunger shaft to the plunger, although different diameter plungers may be required for different size syringes. Further simplification is achieved if at least the diameters of the syringe barrels, and thus the plungers, are standardized.
Thus, in accordance with this invention there is provided a barrel as described which optionally may be sterile and in a protective package, a sterilized needle-shaft assembly as described in a protective package, and a plunger for use in said barrel, which may be supplied separately or in combination with either the barrel or the needle-shaft assembly. The user selects a desired barrel, needle-shaft package and plunger from his supply, and, after removal of the needle-shaft assembly from the package, assembles the syringe by grasping the shaft and mounting the needle hub on the needle-receiving tip of the barrel. The shaft is then removed from the resulting needle-barrel assembly and, if the plunger is already attached o the shaft, is inserted plunger first into the bore of the barrel. Alternatively, if the plunger is already mounted in the barrel, the shaft is attached to the plunger. Finally, if the plunger is st'pplied separately, it may be mounted on the shaft or inserted in the barrel and the shaft then inserted in the barrel.
After use, the shaft is withdrawn from the barrel, optionally still attached to the plunger, and employed to remove the needle from the barrel, and the entire needle-shaft assembly is discarded. If the barrel is disposable it too is discarded or, if reusable, is sterilized prior to reuse.
For maximum flexibility it is preferred that the barrel component, whether reusable or disposable, be supplied in combination with the plunger and that the needle-shaft assembly be provided without a plunger. By employing these embodiments the coordinated syringe system of this invention comprises only four main elements; a disposable needle-shaft assembly, a disposable syringe barrel-plunger assembly, a reusable syringe barrel-plunger assembly, and a disposable prefilled barrel. It the barrels are all of a standard size the only further variation is in the needle size and the form and amount of parenteral medicament in the prefilled barrel.
It can be readily seen that the system of the present invention provides a high degree of flexibility, and an opportunity to optimize cost and safety. For example, because of its larger dimensions, especially in the diameter of the bore, sterilization of the barrel component of this invention is relatively simple, whereas complete cleaning and sterlization of fine bore needles is difficult. On the other hand, the unit cost per use of disposable syringes may be greater than the unit cost per use of reusable syringes. Accordingly, one can employ disposable needles in combination with reusable barrels, whereby optimum conditions of safety and cost are achieved.
It is recognized that in some instances speed in the utilization of prefills may be required. Accordingly, by an extension of this invention there is provided a prefill syringe assembly as illustrated by FIG. 4. In this embodiment, barrel 41, with tip 43 thereof provided with spaced circumferential grooves 45, contains plunger 47, plug 49 and, between plunger 47 and plug 49, parenteral fluid 51. Plug 49, which may be formed of rubber or other suitable material, is desirably a cylindrical member having an outer diameter approximately the same as the inside diameter of the bore of tip 43, and terminates in a head which abuts and seals the end of tip 43. A needle-shaft assembly, such as that referred to above with reference to FIG. 2, is mounted on tip 43. In this embodiment, needle 53 is a double-ended needle and has imperforate hub 55 equipped with internal head 57. As supplied, bead 57 is registered in the outermost groove in tip 43 whereby the cannula of needle 53 is short of plug 49. To use this syringe, needle 53 is urged by the use of shaft 59 toward barrel 51 whereby bead 57 registers in the innermost groove and the cannula of needle 53 penetrates through the septum of plug 49. Shaft 59 is then removed from needle 53 and removably attached to piston 47.
This embodiment possesses several advantages over previously employed devices. The groove and bead attaching means permits ready removal and replacement of the needle if desired, and yet retains the needle securely in place. Because the needle is mounted on the tip, the syringe may be quickly readied for use by forcing the cannula through the septum of the plug, followed by removal of the shaft and attachment to the plunger. The needle cannula is maintained in a sterile state by the imperforate hub and closed hollow shaft, and is not permitted contact with the parenteral medication prior to use, thus preventing possible contamination of the medication due to prolonged contact with the metal of the needle.
It is contemplated by this invention that each element can be supplied as a separate unit, preferably in an individual sterile package. Suitable packaging media are generally known with relation to the presently available disposable syringes. One particularly desirable form is the so-called peelapart package, as illustrated in FIG. 5, wherein two pieces of paper 61, desirably lined with an inert impervious material such as polyethylene 63, are sealed around a single unit in a manner such that they may be readily peeled apart, as by pulling free ends 65. Although only the plunger-needle component of FIGS. 2A and 2B has been illustrated in FIG. 5, the barrel component of FIGS. lA-IC or the assembled syringe of FIG. 4 may also be packaged in this manner. Other suitable packaging media include the conventional vacuum-formed clear plastic blisters, polyethylene bags and the like. Regardless of the form selected, the component is sterilized and packaged under sterile conditions. Although the component provided in such a package can be a reusable component, it is preferably a disposable component.
I. A package comprising in combination a hypodermic needle disposed point first in a hollow tubular member having an open proximal end and a distal end, said proximal end having means for releasably holding the hub of said needle and said distal end having means for attaching said member to the plunger of a hypodermic syringe, said combination being sterile and enclosed in a protective package.
2. A package according to claim 1 wherein a plunger is attached to said distal end, said plunger being formed from an inert deformable material.
3. A package according to claim 1 wherein said needle has an imperforate hub and on the inside surface thereof a circumferential bead adapted to releasably engage a circumferential groove on the needle receiving tip of a syringe whereby said needle may be removably attached to said syringe.
4. A package according to claim 1 wherein said needle is a single-ended needle.
5. A package according to claim 1 wherein said needle is a double-ended needle.
6. A package comprising in combination a hypodermic syringe barrel having a needle-receiving tip and mounted in the bore of said barrel a plunger formed from an inert deformable material and having means for attaching a plunger shaft to said plunger, and said combination being sterile and enclosed in a protective package.
7. A package according to claim 6 wherein said barrel contains a sterile parenteral medicament below said plunger and the bore of the needle-receiving top of said barrel is sealed.
8. A package according to claim 7 wherein said seal is a cap removably affixed to said needle receiving end.
9. A package according to claim 7 wherein said seal is a plug disposed within the bore of said needle receiving tip.
10. In a hypodermic syringe having a tip; an imperforate closure for said tip comprising a plug disposed within the bore of said tip and having a head abutting the end of said tip, said head having a diameter not greater thanthe outer diameter of said tip, a pair of longitudinally-spaced circumferential grooves in the outer surface of said tip; a hollow, doubleended needle having an imperforate hub adapted to snugly fit on said tip, said hub having an inner circumferential bead adapted to alternately removably engage each of said grooves whereby, when said bead engages the outermost of said comprises a generally cylindrical hollow member having an outer diameter approximating the inner diameter of said bore, one end of which is closed by said head.
12. Apparatus according to claim wherein said syringe contains a sterile parenteral medicament between said plunger and said plug.
13. A package comprising a sterile apparatus according to claim 10 enclosed in a protective package.
14. A package comprising a sterile apparatus according to claim 12 enclosed in a protective package.
15. A hypodermic syringe including a barrel, a piston slidable therein, a piston shaft for said piston extending beyond the end of said barrel, said shaft and piston being joined by rapidly detachable attaching means comprising cooperating male and female members, said male member being disposed on one end of shaft and said female member being disposed in said piston, whereby said shaft can be attached or detached from said piston upon rotation of said shaft about its axis through an angle of less than about 180 C.
16. A syringe according to claim 15 wherein said angle is approximately 90.
17. A syringe according to claim 15 wherein said male member comprises at least one wing extending in a generally radial direction from said piston shaft, and said female member comprises a keyway adapted to receive said male member in one orientation and terminating in an enlarged portion adapted to receive said wing on rotation of said plunger shaft and having means to prevent said rotation through an angle of more than 180 and retain said shaft on completion of said rotation.
18. A syringe according to claim 17 wherein said angle is approximately 90.
19. A syringe according to claim 18 wherein said male member comprises two opposed wings.
20. A method of assembling a hypodermic needle which comprises the steps of:
a. Providing an integral, 0ne-piece syringe barrel which is restricted at one end thereof to provide a hypodermic needle receiving tip;
b. Providing a plunger which is slidable in the bore of said barrel and has means for attaching a plunger shaft thereto;
' c. Providing a sterile package containing a hypodermic needle-plunger shaft assembly comprising:
l. A hollow plunger shaft for use in combination with said barrel and plunger having a distal and a proximal end, said proximal end having means on the inside thereof for releasably receiving the hub of a hypodermic needle, and said distal end having means for attaching said shaft to said plunger; and
2.- A disposable hypodermic needle contained in said shaft with the point thereof extending toward but short of said distal end and adapted to be mounted on said needle receiving tip;
d. Removing said assembly from said package; and
e. Placing said plunger in the bore of said barrel; attaching said needle-shaft assembly to said barrel by mounting said hub on said tip; separating said shaft from the thusassembled barrel and needle; and attaching said shaft to said plunger.
21. A method according to claim 20 wherein said barrel is provided with said plunger mounted in the bore thereof.
22. A method according to claim 21 wherein said barrel is disposable and is provided in theform of a sterile package containing the combined barrel and plunger in a protective package.
23. A method according to claim 22 wherein said barrel is provided with a seal for said needle receiving tip and, between said seal and plunger, is provided with a parenteral medicament.
24. A method according to claim 20 wherein said packaged needle-shaft assembly is provided with said plunger mounted on the distal end thereof.
25. A method according to claim 24 wherein said barrel is reusable.
26. A method for assembling a hypodermic syringe which comprises:
a. Selecting a syringe barrel from a plurality of syringe barrels, each barrel comprising an integral, one-piece member which is restricted at one end to provide a hypodermic needle-receiving tip, said barrels being of a standard size;
b. Selecting a hypodermic needle package from a plurality of packages, each package comprising a sterile hypodermic needle-plunger shaft assembly contained in a protective package, said assembly comprising a hollow plunger shaft for use in combination with said barrel and plunger having a distal and a proximal end, said proximal end having means on the inside thereof for releasably receiving the hub of a hypodermic needle, and said distal end having means for attaching said shaft to said plunger; and a disposable hypodermic needle contained in said shaft with the point thereof extending toward but short of said distal end and adapted to be mounted on said needle receiving tip; said needles being of different sizes and having hubs of the same dimensions which are adapted to be mounted on the needle-receiving tip of said barrel and said shafts being of the same size;
c. Selecting a plunger from a plurality of standard plungers adapted to fit the inside bore of said barrel;
d. Opening said package and removing said assembly therefrom;
e. Grasping said assembly by said shaft and mounting said needle on said needle-receiving tip;
f. Removing said shaft from the resulting needle-barrel assembly; and
g. Assembling said barrel, plunger and plunger shaft.
27. A method according to claim 26 wherein said barrel is provided with said plunger mounted in the bore thereof.
28. A method according to claim 27 wherein said barrel is disposable and is provided in the form of a sterile package containing the combined barrel and plunger in a protective package.
29. A method according to claim 28 wherein said barrel is provided with a seal for said needle-receiving tip and, between said seal and plunger, is provided with a parenteral medicament.
30. A method according to claim 29 wherein said packaged needle-shaft assembly is provided with said plunger mounted on the distal end thereof.
31. A method according to claim 30 wherein said barrel is reusable. 1
32. A coordinated hypodermic syringe system comprising:
a. A plurality of syringe barrels, each barrel comprising an integral, one-piece member which is restricted at one end thereof to provide a hypodermic needle-receiving tip, said barrels being of a standard size, and at least a portion thereof being disposable;
b. A plurality of plungers formed from an inert, deformable material of a standard size and adapted to fit the bore of said barrel and having means for attaching a plunger shaft thereto; and
c. A plurality of disposable hypodermic needle packages,
each package comprising a sterile hypodermic needleplunger shaft assembly contained in a protective package, said assembly comprising:
1. A hollow plunger shaft for use in combination with said barrel having a distal and a proximal end, said proximal end having means on the inside thereof for releasably receiving the hub of a hypodermic needle, said distal end having means for removably attaching said shaft to said plunger; and
34. A system according to claim 33 wherein said barrel is disposable and is provided in the form of a sterile package containing the combined barrel and plunger in a protective package.
35. A system according to claim 34 wherein said barrel is provided with a seal for said needle-receiving tip and, between said seal and plunger, is provided with a parenteral medica-- ment.