US3406686A - Prefilled syringe - Google Patents

Description

Oct. 22, 1968 G. H. KELLER PREFILLED SYRINGE 3 Sheets-Sheet 1 Filed Jan. 15, 1965 INVENTOR 6601965 H. A ELLEP BY Xx:

ATTORNEYS G. H. KELLER Oct. 22, 1968 EFILLED SYRINGE 3 Sheets-Sheet 2 Filed Jan. 1-5, 1965 V r r, Juli/l4 INVENTOR 650,265 A e-1.1.52

ATTORNEYS 3 Sheets-Sheet 5 Filed Jan. 15, 1965 INVENTOR b #ZkQMLQ BY aflm m d-m ATTORNEYS United States Patent 3,406,686 PREFILLED SYRINGE George H. Keller, Ridgewood, N.J., assignor to Becton Dickinson and Company, East Rutherford, N .J., a corporation of New Jersey Filed Jan. 15, 1965, Ser. No. 425,786 7 Claims. (Cl. 128-418) ABSTRACT OF THE DISCLOSURE A prefilled syringe having a barrel to hold medicament. The rear end of the barrel is sealed by means of a rubber stopper and the forward end is sealed by means of a rubber diaphragm. A ferrule maintains the rubber diaphragm in sealing relationship and also secures a tubular hub support to the forward face of the diaphragm. A tubular hub is mounted on the exterior of the support. The hub is secured in a concentric manner on a doubled ended needle. Cooperating surfaces on the needle hub and hub support determine the armed and unarmed position of the syringe at which the inner penetrating end of the needle has penetrated the rubber diaphragm and the position at which the inner end of the needle is spaced therefrom and poised to be inserted therethrough respectively. The syringe assembly incorporates construction that permits effective gas sterilization of the syringe subassemblies prior to filling of the barrel with medicament. Additionally, a package for the assembly is provided with structure which cooperates with surfaces of the syringe to maintain the syringe in unarmed position and a needle shield protects the forward end of the needle and is mounted on the hub in a manner which facilitates arming of the syringe.

This invention relates generally to a prefilled syringe construction and, more particularly, to a syringe construction providing for separation of medicament and hypodermic needle prior to use.

In many instances, it is extremely desirable to maintain a medicament or injectable substance out of contact with all metal including that of a hypodermic needle whether or not of the stainless steel variety until such time as it is desired to perform the injection. In this connection, many of the modern day drugs have a remarkable corrosive effect on the stainless steel commonly employed for hypodermic needle constructions. With time, the degradation or corrosion is appreciable. Therefore, a prepacked or prefilled syringe ready for immediate use and having a shelf life as much as one, two, three or more years has been in extreme demand. Attempts to rectify this situation and satisfy this demand have not proven satisfactory to meet all of the commercial demands and requirements.

It is, therefore, a principal object of this invention to provide an improved prefilled syringe construction satisfying the requirements of isolation of medicament and hypodermic needle in an improved manner and until an injection is desired.

Another object is to provide a prefilled syringe construction of this type which is capable of being readily and effectively assembled following filling of the syringe barrel with medicament by the drug or pharmaceutical house and at the filling site.

A further object is to provide a prefilled syringe capable of being easily filled through a relatively wide mouth by the medicament manufacturer or supplier.

Still another object is to provide a prefilled syringe having improved structural conformation and cooperation permitting acceptable gas sterilization of syringe subassemblies and subsequent assembly under aseptic conditions following the filling operation.

3,406,686 Patented Oct. 22, 1968 'ice A still further object is the provision of a sterile prefilled syringe capable of providing tampering evidence of the assembly and indication that the syringe does not satisfy the necessary requirements for performing optimum and safe injection of the medicament.

A prefilled syringe assembly in accordance with this invention will include a syringe barrel for containing the medicament, the rear end of the interior of the barrel being sealed by means of a rubber stopper and the forward end being sealed by means of a rubber diaphragm. A ferrule serves to maintain the rubber diaphragm in sealing relationship and, at the same time, also secures to the forward face of the diaphragm a hub support. This support is tubular in configuration and is adapted to receive on its exterior a hub secured in a concentric manner on a double bevel ended hypodermic needle. Cooperating surfaces on the needle hub and hub support determine the armed and unarmed position of the syringe at which the inner penetrating end of the needle has penetrated the rubber diaphragm to communicate its lumen with the interior of the barrel and the position at which the inner end of the needle is spaced from the diaphragm and poised to be inserted therethrough, respectively. A needle shield protects the forward penetrating end of the needle and is mounted on the hub in a manner to facilitate arming of the syringe.

The syringe assembly incorporates construction that permits effective gas sterilization of the syringe subassemblies prior to the filling or charging of the interior of the barrel with the selected medicament. Towards this end, the rubber diaphragm and rear end of the hub support cooperate with the ferrule in providing ports and passageways for access of the gas in order that it may be exposed to the necessary internal surfaces of this forward subassembly.

In order to assure the maintenance of sterility of the prepackaged assembly, tamper evidence is additionally introduced and, consequently, assurance that the assembly is in fact ready for a hypodermic injection. In this connection, the structure creating the tamper evidence, in accordance with the present invention, may assume one of a number of different forms. The disclosed structure is in the packaging of the syringe assembly. This.

package cooperates with surfaces of the syringe assembly in maintaining the syringe unarmed position. If the parts of the syringe are in other than that permitted by the surfaces of the package, an indication will be provided of the arming of the syringe and/ or failure of the intended sealed and sterile condition of the assembly.

Other objects and advantages will become apparent from the detailed description which is to be taken in conjunction with the accompanying drawings illustrating somewhat preferred embodiments of this invention and in which:

FIG. 1 is a side elevational view of a prepackaged syringe incorporating the teachings of the present invention;

FIG. 2 is an exploded elevational view thereof;

FIG. 3 is a longitudinal sectional view thereof along the line 33 of FIG. 1;

FIG. 4 is an enlarged fragmentary sectional view showing the disposition of parts of the syringe while unarmed and poised ready for penetration of the sealing diaphragm;

FIG. 5 is a similar view showing the disposition of parts upon arming of the syringe with the inner end of the needle penetrating the diaphragm;

FIG. 5A is a fragmentary sectional view showing an alternative form of construction for determining the syringe armed and unarmed positions;

FIG. 6 is a cross-sectional view taken along the line 6-6 of FIG. 4;

FIG. 7 is a cross-sectional view taken along the line 77 of FIG. 4;

FIG. 8 is a cross-sectional view taken along the line 88 of FIG. 4;

FIG. 9 is a cross-sectional view taken along the line 99 of FIG.

FIG. 10 is a top plan view of the syringe assembly packaged in accordance with an exemplary embodiment of the tamperproof provisions of this invention;

FIG. 11 is a longitudinal sectional view taken along the line 1111 of FIG. 10;

FIG. 12 is a cross-sectional view taken along the line 12-12 of FIG. 10; and

FIG. 13 is a cross-sectional view taken along the line 1313 of FIG. 10.

In the drawings, a prefilled syringe 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 needle. 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 inner groove 30. The rear end of the interior of the barrel 22 is adapted to be sealed or closed by means of a rubber stopper 32 which may have one of a number of fittings for engagement with a plunger 34 in order to act as a piston in expelling the contents of the barrel. It will be appreciated that the barrel having this rearwardly located stopper 32 may be aseptically filled with the selected medicament through the relatively wide mouth of the tip 26 following sterilization. The sterile forward subassembly may then be aseptically assembled on the tip 26.

In accordance with the present invention, the forward end of the syringe barrel 22 is sealed by a penetratable rubber diaphragm 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 [for purposes of providing access to this bore and, consequently, the contents of the barrel. A tubular hub support 38 is disposed forwardly of the diaphragm 36 and is formed with a radially extending flange 40 at its rear end for association directly with the forward face of the diaphragm. At an intermediate location, a radial rib 42 is provided on the exterior of the tubular wall of the support for cooperating with surfaces of a hypodermic hub in determining the syringe unarmed and armed positions. A ferrule 44, which may partake of aluminum, is adapted to secure both the support 38 and the diaphragm 36 to the tip 26. In

this connection, a radially inwardly extending flange 46 engages the forward face of the radial flange 40 of the support, with the rear end of the ferrule adapted to be crimped or suitably worked to provide a retaining lip 48 which engages with the rear of the tip flange 28. It should be understood at this juncture that neither the tip 26 nor the exterior surfaces of the ferrule 44 can serve to receive or cooperate with the typical hub of a hypodermic needle assembly [for purposes of defining an unarmed and armed surface in an acceptable manner. This results from the experienced difficulty in maintaining acceptable tolerances of the outer dimensions of the tip 26 incident to modern day glass working techniques. With this in mind, the nedle hub would have a poor fit with the glass tip and, in most instances, would be wobbly thereby detracting both structurally and fimctionally from acceptable syringe construction and certainly would raise some question as to whether a proper injection can be made.

A hypodermic needle assembly 50 having particular application along with this invention comprising a cannula 52 having a forward bevelled penetrating end 54 and a rear bevelled penetrating end 56. This cannula or needle 52 is secured to a hub 58. A number of strategically located recesses 60 for receiving a suitable adhesive having bonding affinity for the cannula 52 serves to facilitate this 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 52 is employed. The forward end 62 of the hub 58 is in the form of a reduced boss providing a surface cooperable with a protective needle shield 64, as shown. The rear end of the hub 58 is opened and is adapted to advantageously fit over the forward tubular portion of the hub support 38. An annular recess 66 in the hub 50 is adapted to receive the radial rib .42 in cooperating therewith for purposes of determining the desired forward extreme of the needle assembly 50 at which the inner penetrating end 56 of the cannula is poised for penetration of the diaphragm 36 and the inner penetrating position at which the inner bevelled end 56 penetrates the diaphragm 36 to thereby expose the contents of the barrel 22 for injection purposes. Naturally, instead of a single enlarged recess 66, a pair of spaced accommodating grooves for the radial rib 42 could have been provided. This alternative embodiment which in some instances is preferred is illustrated in FIG. 5A. The inherent resiliency and elasticity of most synthetic organic resins from which the hub 52 is ordinarily fabricated would permit this form of cooperating structure. This rib and groove arrangement defines the unarmed and armed positions. A positive position for the armed condition facilitates shield removal and minimizes the possibility of unarming an armed syringe.

Prior to filling of the syringe and assembly of the forward and rear parts, as shown in the several views, it is extremely desirable to provide means for sterilizing the forward and rear parts or subassemblies of the unit. An effective technique today is that of gas sterilization. The construction of this invention lends itself most readily to this approach. In this connection in the forward subassembly, the diaphragm 36 is provided with one or more peripheral cutout sectors 68. The inner or rear face of the flange 40 of the hub support 38 is provided with a network of radial slots 70. In this manner, the gas employed in the selected sterilizing technique will be permitted to penetrate between the ferrule 44, the cutout sectors 68, the radial slots 70 and hypodermic needle 52, its lumen and exterior surfaces. It should be understood that the radial slots will be closed by the diaphragm 36 due to the nature of the diaphragm material upon assembly of this forward subassembly on the barrel tip 26.

The barrel 22 and rear stopper 32, constituting the rear subassembly, will also have been sterilized in a suitable manner. The barrel 22 with stopper is then filled with the selected medicament while maintaining steriliity. The

sterile forward and rear parts of the syringe unit are then assembled under aseptic conditions.

In this manner, a sterile prefilled hypodermic syringe assembly 20 of improved construction and operation is contributed to the art.

Referring now to the packaging of the syringe assembly 20 and particularly the exemplary embodirnent'of tamper evidence contemplated herein, this assumes the form of a package of the prefilled syringe 20. This package 74 comprises a backing sheet 76 and a molded syringe contour receiving tray 78 suitably bonded thereto. The sheet 76 may be formed of a suitable paper which permits penetration of gas during ordinary gas sterilization techniques and of a type which facilitates the desired tamperproof evidence. This sheet 76 is covered with a heat scalable material or a suitable bonding agent for adherence with the material of the tray 78 which in a successful application of this invention was styrene. A number of prefilled syringes 20 may be packaged simultaneously by employing elongated sheets and a molded series of trays in ac-- cordance with mass production techniques. Under these circumstances, the spaced prefilled packaged syringes may be readily separated from one another by means of interrupted slits 80 of a design to allow easy separation of the syringe units.

Referring now to the tray 78, it will be noted that it forms, together with the backing sheet 76, a number of compartments which receive the various parts of the syringe 20. Thus, an annular groove 82 is provided for receiving the flanged end 24 of the barrel 22 in coopcrating to fix the disposition of the syringe in the package 74. A compartment 84 to the rear of the groove 82 accommodates the exposed portions of the plunger 34. An intermediate compartment 86 accommodates the barrel 22 as well as its tip 26 together with the ferrule 44, mounted thereon. An annular reduced neck 88 of the molded tray 78 advantageously nests into the space between the rear end of the hub 50 and the forward face of the inwardly extending radial flange 46 of the ferrule 44. In this manner, the unarmed condition of the syringe is maintained and assured during packaging and immediately prior to use. In the event the reduced neck 88 is not in'the described and illustrated nesting relationship with respect to the needle hub and ferrule, a sign is immediately created which may cast doubt as to the condition of the syringe and its sterility. A failure of the desired. nesting could indicate tampering of the syringe as well as its package. The forward compartment 90 accommodates the forward part of the needle assembly 50 as well asthe shield 64 in a manner to assure the desired association of these parts with the remainder of the syringe 20.

Assuming the tamper evidence does not indicate a breakdown of any sort in the desired relationship of parts and the maintenance of sterile conditions, the syringe 20 may be utilized by merely stripping the sheet 76 away from its associated tray 78 to expose the contained syringe 20. The syringe 20 may now be armed by forcing the needle assembly rearwardly by applying a deliberate force thereto through the shield 64 to cause the inner penetratingend 56 of the needle-52 to penetrate the diaphragm 36 affording communication between the interior of the barrel .22 and its contained medicament and the lumen of the needle. The shield 64 may now be removed to expose the outer penetrating end 54 of the needle. The needle will then be caused to penetratethe skin tissue at the desired location and the plunger 34 depressed or forced forwardly to expel the contained medicament.

. Thus, it will be appreciated by those. skilled in the art that theaforenoted objects and advantages amongst others are most effectively attained by means of the present invention. The prepackaged medicament is rather effectively separated from the hypodermic needle during storage and the contemplated shelf life of the syringe to eliminate any problem of corrosion or degradation of the needle orpossible deleterious effect on the packaged medicament. In those contemplated rare instances where the material of the diaphragm 36 may have an adverse affect on the contained medicament, an inert or nontoxic type of shield or diaphragm may be interposed between the rubber diaphragm 36 and the forward face of the barrel tip flange 28 or, for that matter, substituted for this diaphragm. An exemplary satisfactory material for this shield would be in the nature of Teflon.

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 restricted forward flanged end and rear end, a plunger closing the rear end of the barrel, a penetrable diaphragm sealing the forward end of the barrel, a plastic needle hub support of tubular configuration having a substantially uniform inner diameter along its length and having a radially outwardly extending flange at its rear end disposed against the diaphragm, a ferrule securing both the support and diaphragm to the barrel flanged forward end, a double pointed hypodermic needle having its rear end proximal the forward face of the diaphragm, a hub having a reduced forward end secured by epoxy resin 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 such that substantially all of the surface of said rear end of the hub which engages with the forward end of the hub support is positioned over the outer surface of the forward end of the hub support, an annular rim on the outer face of the hub support intermediate its ends and an annular recess on the inner face of the tubular rear end of the :hub which interengage and 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, a protective needle shield 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 reduced forward end portion of the needle hub, and finger gripping means on the hub permitting the hub to be gripped and the shield stripped therefrom.

2. The invention in accordance with claim 1 wherein a tamper-evidence means is associated with the syringe for indicating a predetermined unarmed disposition of parts of said syringe, said tamper-evidenced means being a package within which the syringe is encased, said package having separate and sealed parts and positioning means for positioning the syringe in the package in a predetermined manner and spacing means defined by surfaces of the package to determine a predetermined selected relationship between the rear end of the hub and-forward face of the ferrule, said parts comprise a substantially fiat sheet and a molded tray heat sealed to said sheet and conforming generally to the outline of said syringe.

3. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end 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, a plastic needle hub support of tubular configuration having a substantially uniform inner diameter along its length and having a radially outwardly extending flange at its rear end disposed against the diaphragm, a ferrule associated with both the support and diaphragm for securing both the support and diaphragm to the barrel flanged forward end, a double pointed hypodermic needlehaving its rear end proximal the forward face of the diaphragm, a hub having a reduced forward end secured by epoxy resin 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 a substantial telescopic and sliding relationship such that substantially all of the surface of said rear end of the hub which engages with the forward end of the hub support is positioned over the outer surface of the forward end of the hub support, an annular rim on the outer face of the hub support intermediate its end and an annular recess on the inner face of the tubular rear end of the hub which interengage and 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, a protective needle shield disposed around the forward end of the needle and having a closed forward end and an open rear end, said rear end being mounted on the reduced forward end of the needle hub, and finger gripping means 7 on the hub permitting the hub to be gripped and the shield stripped therefrom.

4. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end 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, a needle hub support of tubular configuration having a radially outwardly extending flange at its rear end disposed against the diaphragm, a ferrule associated with both the support and diaphragm for securing both the support and diaphragm to the barrel flange forward end, 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 of the hub being disposed over the forward end of the hub sup port in a substantial telescopic and sliding relationship, the inner face of the tubular end of the hub and the outer face of the forward end of the support presenting annular 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 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, a protective needle shield disposed around the forward end of the needle and having a closed forward end and an open rear end, said rear end being mounted on the forward end of the needle hub, surfaces on said diaphragm and the rear support flange being recessed and raised to define gas passageways for facilitating gas sterilization of said syringe.

5. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end 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, a needle hub support of tubular configuration having a radially outwardly eX- tending flange at its rear end disposed against the diaphragm, a ferrule associated with both the support and diaphragm for securing both the support and diaphragm to the barrel flanged forward end, 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 of the hub being disposed over the forw-ard 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 annular 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 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, a protective needle shield disposed around the forward end of the needle and having a closed forward end and an open rear end, said rear end being mounted on the forward end of the needle hub, surfaces on said diaphragm and the rear support flange being recessed and raised to define gas passageways for facilitating gas sterilization of said syringe, the periphery of said diaphragm being cut out and the rear face of the rear support flange being provided with at least one recess adapted to communicate with both surfaces of said needle and the cutout.

6. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end of a tubular syringe barrel adapted to contain a medicament, said assembly comprising a pentrable diaphragm adapted to seal the forward end of the barrel, a needle hub support of tubular configuration having a radially outwardly extending flange at its rear end disposed against the diaphragm, a ferrule associated with both the support and the diaphragm for receiving both the support and diaphragm to the barrel flanged forward end, a double pointed hypodermic needle having its rear end proximal, the forward face of the diaphragm, a hub having a for ward end secured intermediate the needle endsand having a rear end tubular in configuration in substantialconcentric relation with the respect to the needle, the tubular rear end of the hub 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 annular 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, surfaces of said diaphragm and the rear support flange being recessed and raised to define gas passageways for facilitating gas sterilization of said syringe.

7. A hypodermic needle, hub and support assembly for attachment to the forward restricted flanged end 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, a needle hub support of tubular configuration having a radially outwardly extending flange at its rear end disposed against the diaphragm, a ferrule associated with both the support and the diaphragm for securing both the support and the diaphragm to the barrel flanged forward end, 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 of the hub 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 annular 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, surfaces of said diaphragm and the rear support flange being recessed and raised to define gas passageways for facilitating gas sterilization of said syringe, the periphery of said diaphragm being cut out and the rear face of the rear support flange being provided with at least one recess adapted to communicate with both the surfaces of said needle and the cutout.

References Cited UNITED STATES PATENTS 3,179,107 4/1965 Clark 128-221 2,375,929 5/1945 Lautenschlager 128-218 2,720,969 10/1955 Kendall 206-43 X 2,828,743 4/1958 Ashkenaz 128-218.l 3,133,638 5/ 1964 Gordon 206- XI 3,207,302 9/1965 Hobbs 206-632 RICHARD A. GAUDET, Primary Examiner.

M. F. MAJESTIC, Assistant Examiner.

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