US3375825A - Prefilled syringe - Google Patents

Description

A ril 2, 1968 G. H. KELLER PREFILLED SYRINGE Filed Sept. 2, 1965 2 Sheets-Sheet 1 IN VENTOR. 4/5; A f ,6

4 94,, p V MM G. H. KELLER April 2, 1968 PREFILLED SYRINGE 2 Sheets-Sheet 3 Filed Sept. 2, 1965 United States Patent 1 O ABSTRACT OF DISCLOSURE A prefilled syringe assembly having a barrel portion for'containing medicament. A stopper which may be coupled to a plunger rod seals the rear end of the barrel and a diaphragm seals the forward end. A cap is mounted on the forward end of the barrel to maintain the diaphragm in sealing engagement with the barrel. The forward portion of the cap forms a support to receive the hub support cooperate in determining the position of the cannula relative to the barrel and diaphragm. A cannula shield protects the forward penetrating end of the needle and is mounted on the hub in a manner to facilitate arming of the syringe and also may be removed from the hub and coupled with the stopper to act as a plunger rod.

This application is a continuation-in-part of my earlier filed application Ser. No. 425,786, filed Jan. 15, 1965.

It istherefore a principal object of this invention to provide an improved prefilled syringe construction of the type disclosed in the aforementioned pending patent application as well as a construction requiring a minimum number of parts, each individually simple to manufacture and assemble, therefore reducing the overall cost of the syringe. i

A prefilled syringe assembly in accordance with. this invention includes a syringebarrel for containing the desired medicament. The rear endof the interior of the barrel is sealed by means of a stopper provided with structure forcoupling with a plunger rod. The forward end of the barrel interior is sealed by means of a diaphragm. A cap is adapted to be mounted on the forward end of the barrel for maintaining. the diaphragm seal in this sealing relationship. This cap isprovided with an integral of support at its forward end for receiving the hub of a cannulahub assembly. Cooperating surfaces of the cannula and hub support determine the farmed? and unarmed position of the syringe at which the inner end of a double bevel ended hypodermic cannula-has penetrated the diaphragm seal to communicate its lumenwith the barrel interior and at a position at which the inner end of the cannula is spaced from the diaphragm and poised to be inserted therethrough, respectively, A cannula shield protects the forward mounted on the cannula hub ina manner to facilitate arming of thensyringet'The shield also serves the dual purposeof. being av plunger rod having structure adapted to be' coupled with that of the stopper upon removal from the cannula may also incorporate structure that facilitates gas sterilization and structure capable of being prepackaged in the manner disclosed in my earlier aforementioned pending patent application. i a I i Other objects and advantages willv become apparent from the following detaileddescription which is to be taken in conjunction with the accompanying drawings illustrating a somewhat preferred embodiment of this invention and in which: 7

FIG. 1 is a side elevational view of a prepackaged penetrating end ofthe needle and is i hub. The syringeassembly of this invention 3,375,825 Patented Apr. 2, 1968 syringe incorporating the teachings of the present invention;

FIG. 21's anexploded elevational view thereof;

FIG. 3 is a longitudinal sectional view thereof along the line 3-3 of FIG. 1;

FIG. 4 is a somewhat similar longitudinal sectional view showing the syringe in an armed position ready to use at which the plunger rod shield is coupled with the stopper in the barrel;

FIG. 5 is an enlarged elevational view partly in section showing the interior construction of the cap which is adaptedlto be coupled with the forward end of the syringe barrel;

FIG. 6 is a top plan view of the cap;

FIG. 7 is an enlarged fragmentary sectional view showing the disposition of parts of the syringe while unarmed and poised ready for penetration of the diaphragm seal; and

FIG. 8 is a similar view showing the disposition of parts upon arming of the syringe with the inner end of the cannula penetrating the diaphragm.

In the drawings, a prefilled syringe 20 is shown in assembled condition containing a medicament or other preparation which, in a number of contemplated applications is preferably out of contact with the typically employed stainless steel hypodermic cannula. The medicament is adapted to be contained in a barrel 22 having a rear flanged end 24 and a forward reduced tip 26 having a flanged end 28 and innergroove 30. The rear end of the interior of the barrel 22 is adapted to be sealed or closed by means of a stopper 32 which may have one of a number of fittings similar to the internal threads 34 for coupling with mating threads of a plunger rod shield 36. As will be appreciated, the barrel 22 with stopper 32 mounted in place may aseptically be filled. with the selected medicament through the relatively wide mouth of the tip 26 following sterilization. The sterile forward end of the assembly may then be aseptically assembled on the tip 26 in a manner to be described.

The forward end of the syringe barrel 22 is sealed by a penetrable diaphragm seal 36. This diaphragm is effective in sealing off the bore of the tip and is adapted to be penetrated by the inner end of a double ended needle or cannula for purposes of providing access to this bore and consequently the contents of the barrel. A cap 38 of plastic material cooperates with the tip 26 of the barrel in securing the diaphragm seal 36 thereto. In accordance with a successful embodiment of this invention, the cap 38 was fabricated of Celcon resin which is essentially composed of ethyl cellulose and plasticizers. The cap 38 includes a radially extending flange portion 40 having an internal face adapted to be associated directly with the forward face of thediaphragm seal 36. A radial rib 42 is provided on the exterior of the tubular cannula hub supporting portion 44 for cooperating with surfaces of the cannula hub in determining the syringe .unarmedf and armed positions. The cap 3.8 is also provided with an integral ferrule portion-46 which is adapted ,to secure the cap 38 together with the diaphragm seal 36 to the barrel tip 26. In this connection an annularinwardly extendingrib 48is adapted to be forced over the flange 28 at the tip 26 as a result of the inherent elasticity of the: plastic material employed for fabricating the cap 38. This movement is facilitated bythe rearward bevelled face 50 of the rib 48 which in elfect produces a camming action. The forward face 52 of the rib 48 is, however, substan tially normal to the longitudinal axis of the cap and thereby provides a relatively firm surface-to-surface engagement with the rear face of the flange 28 for purposes of securely anchoring the cap thereto, The rear'end of the ferrule portion 46 is providedwith a seriesoftuniformly spaced longitudinal notches 54 which not only facilitates the mounting of the cap 38 on the barrel tip 26 but also serves to stabilize the cap 38 thereon by resiliently engaging with the radially outwardly extending surface 56 at the forward end of the barrel 22.

The longitudinally extending space slots 54 not only serve to stabilize the cap against rocking or lateral movement but at the same time provide some degree of tolerance between the cap and syringe barrel whereby the desired concentrated line contact can be obtained between the rib 80 and the diaphragm seal 36. In this manner the cap 38 is effective in mounting the diaphragm seal 36 and the hypodermic needle assembly to the reduced forward tip of a barrel fabricated of glass. As mentioned in my earlier filed application, the exterior tolerances of such glass tips are difficult to maintain within acceptable ranges and in a number of instances a wobbly association typical of prior art assemblies has detracted both structurally and functionally from acceptable syringe construction.

With the use of a plastic cap 38 it is extremely desirable to obtain, maintain and assure an optimum and adequate seal between the diaphragm seal 36 and the barrel tip 26. With this in mind the present invention provides for ribbing 80 on the inner face of the flange 40 of the cap 38. This ribbing is preferably in annular form and as close to the cap axis as possible and at the same time preferably possesses a radius smaller than that of the bore through the tip 28 of the barrel. This ribbing operates to concentrate the pressure exerted by the cap 38 on the seal 36 and in turn the seal 36 on the tip 26. By eating the ribbing as close to the axis as possible while within the confines of the bore of the tip 26 the effect of cocking or tilting of the assembly supported by the barrel tip 26 will be minimized. In other words, if wobbling occurs and pressure relieved due to this action, the concentrated pressure points will operate to maintain the desired seal between seal 36 and barrel tip 26.

A hypodermic needle or cannula assembly 60 having particular application along with this invention comprises a cannula 62 having a forward bevelled penetrating end 64 and a rear bevelled penetrating end 66. This cannula 52 is secured to a hub 68. A number of strategically located recesses 60 for receiving a suitable adhesive having bonding affinity for the cannula 62 serves to facilitate the securement both through bonding and the mechanical interlock of this construction. An epoxy bonding system has .proven satisfactory particularly in those instances when a stainless steel cannula 62 is employed. The forward end 72 of the hub 68 is in the form of a reduced boss providing a surface comparable with the plunger rod shield 34, as shown. The rear end of the hub 68 is open and is adapted to advantageously fit over the forward tubular portion 44 of the top 38. A pair of spaced annular accommodating grooves 76 and 78 in the hub 68 are adapted to receive the radial rib 42 in cooperation therewith for purposes of determining the desired forward extreme of the needle assembly 60 at which the inner penetrating end 66 of the cannula is poised for penetration of the diaphragm 36 and the inner penetrating position at which the inner bevelled end 66 penetrates the diaphragm 36 to thereby expose the contents of the barrel 22 for injection purposes. This rib and groove arrangement defines the unarmed and armed positions respectively. A positive position for the armed condition facilitates shield removal and minimizes the possibility of unarming an armed syringe. The inherent resiliency and elasticity of the synthetic organic resins from which the hub 68 is ordinarily fabricated will permit this form of cooperating structure.

With respect to the filling and sterilization and packaging of the syringe of this invention, reference should be made to my above-mentioned earlier filed pending patent application.

Although a single somewhat preferred embodiment of this invention has been disclosed and described in detail herein, it should be understood that this invention is in no sense limited thereby and its scope is to be taken by that of the appended claims.

I claim:

1. A prepackaged syringe assembly comprising a tubular barrel containing a medicament and having a forward transversely extending shoulder and having a restricted forward flanged end extending from the shoulder and rear end, a stopper closing the rear end of the barrel, a penetrable diaphragm sealing the forward end of the barrel resilient cap means for supporting a needle and securing the diaphragm to the barrel flanged forward end including a needle hub support of tubular configuration and a ferrule portion integral therewith for securing the diaphragm to the barrel flanged forward end, the ferrule portion having an integral radially inwardly extending annular rib adapted to engage with surfaces of the flange end of said barrel to thereby affix said cap means thereto, said ferrule portion having a series of spaced slots which cooperate in permitting the ferrule portion to be forced over the flanged end of the barrel in securing the cap means thereto, and which are adapted to interengage the shoulder so as to facilitate the prevention of rocking of the cap means with respect to the tubular barrel 3 the double pointed hypodermic needle having its rear end proximal the forward face of the diaphragm, a hub having a forward end secured intermediate the needle ends and having a rear end tubular in configuration in substantial concentric relation with respect to the needle, the tubular rear end of the hub being disposed over the forward end of the hub support in substantial telescopic and sliding relationship, the inner face of the tubular rear end of the hub and outer face of the forward end of the support presenting raised and recessed portions which operate to determine the syringe unarmed position at which said rear end of the needle is proximal the forward face of the diaphragm and an unarmed position at which the rear end of the needle is forced to penetrate the diaphragm upon application of deliberate force to the hub to communicate the lumen of the needle with the interior of the barrel.

2. The invention in accordance with claim 1 wherein said cap means include internal ribbing integral therewith and in engagement with the diaphragm for creating concentrated pressure points for purposes of obtaining maximum pressure and sealing between the diaphragm and the flanged end of the barrel.

3. The invention in accordance with claim 1 wherein a plunger rod shield is disposed around the forward end of the needle and has a closed forward end and an open rear end, said rear end being mounted on the forward end of the needle hub, and the forward end of the shield having surfaces cooperable with surfaces of said stopper in providing a coupling means for coupling the shield to said stopper to thereby render the shield operable as a plunger rod in facilitating the dispensing of the medicament from the barrel.

4. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end extending from a forward transversely extending shoulder of a tubular syringe barrel adapted to contain a medicament said assembly comprising a penetrable diaphragm adapted to seal the forward end of the barrel, resilient cap means for supporting a needle and securing the diaphragm to the barrel flanged forward end including a needle hub support of tubular configuration and a ferrule portion integral therewith for securing the diaphragm to the barrel flanged forward end, the ferrule portion having an integral radially inwardly extending annular rib adapted to engage with surfaces of the flanged end of said barrel to thereby affix said cap means thereto, said ferrule portion having a series of spaced slots which cooperate in permitting the ferrule portion to be forced over the flanged end of the barrel in securing the cap means thereto, and

which are adapted to interengage the shoulder so as to facilitate the prevention of rocking of the cap mean with respect to the tubular barrel a double pointed hypodermic needle having its rear end proximal the forward face of the diaphragm, a hub having a forward end secured intermediate the needle ends and having a rear end tubular in configuration in substantial concentric relation with respect to the needle, the tubular rear end being disposed over the forward end of the hub support in a substantial telescopic and sliding relationship, the inner face of the tubular rear end of the hub and the outer face of the forward end of the support presenting raised and recessed portions which operate to determine the syringe unarmed position at which the rear end of the needle is proximal the forward face of the diaphragm and an armed position at which the rear end of the needle is forced to penetrate the diaphragm upon application of deliberate force to the hub to communicate the lumen of the needle with the interior of the barrel.

5. The invention in accordance with claim 4 wherein said cap means include internal ribbing integral therewith and in engagement with the diaphragm for creating concentrated pressure points for purposes of obtaining maximum pressure and sealing between the diaphragm and the flanged end of the barrel.

6. The invention in accordance with claim 4 wherein a plunger rod shield is disposed around the forward end of the needle and has a closed forward end and an open rear end, said rear end being mounted on the forward end of the needle hub, and the forward end of the shield having surfaces cooperable with surfaces of said stopper in providing a coupling means for coupling the shield to said stopper to thereby render the shield operable as a plunger rod in facilitating the dispensing of the medicament from the barrel.

References Cited UNITED STATES PATENTS 2,828,743 4/1958 Ashkenaz et al l28-2l8 2,865,372 12/1958 Miskel l28218 2,957,501 10/1960 Holmes 128-272 XR 3,288,320 11/ 1966 Swanson 31539 3,025,988 3/1962 Williams 21541 2,251,527 8/ 1941 Smith 128272 XR RICHARD A. GAUDET, Primary Examiner.

D. L. BAKER, Assistant Examiner.

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