CA2096662C - Syringe - Google Patents

Syringe Download PDF

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Publication number
CA2096662C
CA2096662C CA002096662A CA2096662A CA2096662C CA 2096662 C CA2096662 C CA 2096662C CA 002096662 A CA002096662 A CA 002096662A CA 2096662 A CA2096662 A CA 2096662A CA 2096662 C CA2096662 C CA 2096662C
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Canada
Prior art keywords
vial
piston
neck
cylindrical
retention means
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Expired - Lifetime
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CA002096662A
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French (fr)
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CA2096662A1 (en
Inventor
David L. Reynolds
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Duoject Medical Systems Inc
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Duoject Medical Systems Inc
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Priority claimed from GB9024710A external-priority patent/GB2249727A/en
Application filed by Duoject Medical Systems Inc filed Critical Duoject Medical Systems Inc
Publication of CA2096662A1 publication Critical patent/CA2096662A1/en
Application granted granted Critical
Publication of CA2096662C publication Critical patent/CA2096662C/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M5/3137Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A61M2005/3139Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A bottomless vial (2) for forming a syringe has a strengthening bead (6) at its wider open end to which a combination finger grip and piston retainer can be secured.
The bead is formed at least partly inward of the main portion of the inner surface of the sidewall (4) of the body, so as to reduce or eliminate projection of the bead beyond the main portion of the outer surface of the sidewall (4). By forming the bead by flaring of a reduced diameter end portion (74) of the body, this objective can be achieved whilst providing a flare (76) which assists insertion of the piston and a shoulder (84) to retain the finger grip and piston retainer (16).

Description

2U956~~
SYRINGE -This invention relates to prefilled syringes for use in medical or veterinary treatment.
In the applicant's published European Patent Application 0298585, there is disclosed a syringe system based on the concept of a "bottomless vial" in which the conventional base of a glass vial is replaced by a rubber piston which forms a hermetic seal with the walls of the vial, and which has a downward extension within the vial which can be coupled to a syringe plunger. When a plunger is so coupled to the piston, and an adaptor is applied to a cap of the vial, the vial is converted into a syringe.
An extremely important advantage of a syringe based upon such a bottomless vial, as compared to conventional prefilled syringe systems, is that it can be sterilized, filled and capped utilizing conventional vial filling equipment generally available and in use in the pharmaceutical industry, rather than requiring specialized capital intensive filling systems, and that the number of clean room operations required in production of the product is greatly reduced as compared with known syringe assembly and filling systems. As described in more detail in the above application, t.'~e system is also extremely versatile in that the "bottomless vial" can form the basis of a wide range of syringe delivery systems.
The very reason for the advantages of the above system, namely that the vials can be sterilized, filled and capped utilizing conventional vial filling machinery, is also a limitation in certain applications, since the vials must remain stable whilst passing through the machinery, which in turn limits the permissible height of the vial relative to its diameter. This problem is aggravated by the necessity for providing a bead around the external periphery of the bottom of the vial, both in order to 20JGGG> - 2 _ provide necessary strength to the glass and to provide means for anchoring a component of the syringe such as a combined piston retainer, plunger grip and plunger guide which is applied after filling of the vial, by pressing it over the bead. The projection of the bead, although kept to a minimum, interacts with the beads of adjacent vials and other obstructions in such a manner as to reduce the stability of the vial. There are also constraints on the shaping of the bead so as to prevent ramping effects as the beads interact which tend to promote tipping.
Additionally, the application of the adaptor to the cap of the vial is an additional clean-room operation which is not required during the filling of conventional vials.
Although it is generally considered that the inner side walls of syringes should be smooth and unobstructed, it has now unexpectedly been found that considerable advantages can be obtained by forming the peripheral bead at the base of a "bottomless vial" at least partially inwardly of an internal wall of the glass body of the vial. This makes it possible for any external extent of peripheral bead to be reduced or eliminated, which improves the stability of the vial and enables its height to diameter ratio to be somewhat increased. It is also found that a versatile combined finger grip and plunger guide of much simplified construction yet improved performance can be utilized in conjunction with the modified bead.
It is also found that in many applications it is possible to dispense with the application of a separate adaptor to the cap of the vial by incorporating an adaptor into the cap structure in a manner which does not interfere with normal operation of the conventional vial capping machinery.
_ _. , These and other features of the invention are set forth in the appended claims.
For a better understanding of the invention, reference may be had to the following description of preferred embodiments thereof, with reference to the accompanying drawings in which:
Figure 1 is an exploded isometric view of the components of a first embodiment the syringe;
Figure 2 is a vertical section through a vial l0 portion of the syringe, ready for filling;
Figure 3 is a longitudinal section through an assembled syringe, after discharge of its contents;
Figure 4 is a fragmentary longitudinal section on an enlarged scale of a portion of the syringe shown in Figure 3, showing a modification of the arrangement shown in that Figure; and Figure 5 is an enlarged vertical section through the bead of a second embodiment of the syringe, also showing adjacent parts of a modified piston retainer and finger grip.
Referring to Figures 1 - 4 of the drawings, a syringe comprises a syringe barrel in the form of a somewhat elongated glass vial 2, of which the bottom wall is absent apart from a slight inward projection of a strengthening bead 6 formed at the bottom of a side wall 4 of the vial and best seen in Figure 4. In the example shown the strengthening bead 6 also has a very slight outward projection, but this is far smaller than would be necessary if the bead were formed wholly externally of the side wall 4, and may be entirely eliminated. In any event, the outward extent of the proj ection should be insuf f icient to prevent vials from standing very closely adjacent to one another without sufficient space to tip. Typically the projection will not exceed about one fifth of the total thickness of the bead. The projection of the bead on the i 20JG6fi~ - 4 inside should also be limited, both so that the head 10 of a moulded rubber piston 8 can be inserted into the vial past the projection (this is facilitated by the presence of peripheral grooves 12 in the head between sealing lands 14), and so that a sleeve 18 of a combined finger grip, piston stop and plunger guide 16 (henceforth referred to as the finger grip) can be pushed past the projection whilst remaining a snug fit within the side wall of the vial.
Insertion is facilitated by the slight flare provided at the bottom entry to the vial body by the rounding of the bead, and the insertion is readily mechanised.
The piston 8 is also provided with an integrally moulded downward extension 20 which is formed with a central cavity 23 to increase its flexibility relative to the head 10 of the piston which is substantially solid.
The piston is dimensioned so that when it is inserted in the vial 2, the lands 14 are compressed sufficiently to form a hermetic seal against the interior of wall 4 whilst permitting the piston to be moved longitudinally of the vial. Initially, the piston is located at the bottom of the vial (see Figure 2), with the bottom of extension 20 just within the vial so that it does not affect the ability of the vial to stand upright on its base formed by the bead 6. The location of the fairly massive solid rubber piston 8 at the base of the vial helps stabilize the empty vial 2, even when the height of the latter is somewhat greater relative to its diameter than is normally required for stability. The practical limit of the height to diameter ratio is set entirely by the requirement that the vials can be conveyed through a conventional vial filling and capping machine in a sufficiently stable manner to permit reliable operation of the machine at an acceptable speed. In the example shown, the vial has an outside diameter of approximately 3 cm and a height of 12.8 cm. For this diameter a height of 14 centimetres is believed to approach the practical limit for stability, but this ratio will vary _. WO 92/08507 PCT/CA91 /00409 - 20966~~
somew~ ~t according to the relative wall thickness of the vial :_~~d the weight of the piston. Provided that the outward projection of the bead 6 is insufficient to affect stability, so that -.~e vials can jostle without applying 5 tipping force to each other, and assuming use of a piston generally as described, the maximum ratio attainable should be greater than 4, but will be less than 5.
The stopper 22 and cap 24 applied by the conventional vial filling and capping machinery may be of conventional construction, although the stopper 22 is preferably designed substantially to fill the neck of the vial so as to minimize dead space above the piston when the latter is pushed to the top of the vial (See Figure 3).
This ensures that as much as possible of the contents of a syringe formed from the vial can be expelled by movement of the piston.
The cap 24 is preferably modified as shown in Figure 3 and Figure 5 . In Figure 3 , a conventional main cap cooperates with a moulded plastic adaptor assembly comprising an annular flange 26 within the cap, a cylindrical extension 28 extending through the cap and a thin diaphragm 30 closing a bottom end of the extension.
An internal thread 32, similar to that provided on conventional syringe adaptors for receiving needles, such as those sold under the trade-mark LUER-LOK, is formed within the adaptor. A removable push on cap may be provided to close the open end of the adaptor during storage, being removed prior to use. In Figure 4, the cylindrical extension 28 is formed integrally with the aluminum cap, again with an internal thread 32. I have found that the extension 28 can be accommodated by conventional vial capping machinery, at any rate with no more than minor modification, without interfering with the capping process, whilst the provision of such an extension
2~9fi 66 enables the elimination of a separate adaptor cap, and the additional assembly step required to apply it.
In order to convert the vial into a syringe, either a double ended needle 34 of the blood collecting type may be applied directly to the extension 28 (See Figure 4 ) or an adaptor 3 6 ( See Figures 1 and 3 ) may be provided for any needle or alternative delivery device equipped with a standard syringe coupling so as to provide the latter with the capability of penetrating the stopper 22, as well as the diaphragm 30 if present. The adaptor 36 has a needle 38 and external thread 40 at one end, the needle providing the penetration function and the thread 40 engaging the thread 32, while its other end provides an internally threaded socket 42 and coaxial spigot 44 for forming a fluid-tight coupling to the needle or the like.
Prior to fitting the double ended needle 34, or needle and adaptor 36, a plunger 46 is applied to the extension 20 of the piston. The plunger has a shaft 48, of cruciform cross-section in the example shown, an internally threaded sleeve 50 at its one end, and an end flange 52 at its other end. The sleeve 50 has internal multistart threads 54, complementary to external multistart threads 56 on the extension 20. The lands between the threads 54 on the sleeve 50 and the threads 56 on the extension 20~ both stop short respectively of the outer end of the sleeve 50 and the inner end of the extension 20 so as to form abutments which prevent the sleeve 50 from being screwed tightly against the underside of the head 10 of the piston.
This means that any tilting forces applied to the plunger are applied to the relatively flexible extension 20 and not directly to the head 10, thus minimizing the risk of breaking the hermetic seal between the head 10 and the vial.
SUBSTITUTE SHEET
21, .12. 92 ~9 i The plunger is formed of a hinge-forming synthetic plastic such as a pharmaceutical grade polypropylene, and a generally semicircular peripheral portion 62 of the flange and is separated from the remainder by a slot 64, remaining connected only by thin, hinge-forming connections 66. This portion 62 provides a f finger loop which can be pulled rearwardly, as shown by broken lines in Figure 1, to facilitate handling of the plunger. As a supplemental or alternative feature, a notch 71 may be formed in the shaft 48 of the plunger, to provide a hook by means of which the syringe may be suspended when used in certain infusion applications.
In order to provide the various functions of preventing total withdrawal of the piston, forming a guide for the plunger and restricting its tilting movements, and providing a finger grip for the user, the combined finger grip 16 and retainer is pressed into the bottom of the vial 2 after filling and capping of the latter. It comprises the sleeve 18 and a peripheral flange forming oppositely extending finger tags 68. It is also moulded from pharmaceutical grade plastic such as polypropylene. The sleeve 18 is a resilient press fit in the open end of the vial 4 so that it is slightly compressed by the internal projection of the bead 6 during insertion. Insertion of the retainer 16 may be facilitated by moderate warming of at least the retainer and the slight flare provided by the rounding of the bead 6 also facilitates insertion. Beneath the grips 68 of the sleeve has shallow arcuate grooves 70 in which a portion of the bead 6 snaps as the sleeve is pressed home. Forces applied to the grips 68 tending to pull the sleeve 18 away from the vial in turn tend to deform the sleeve 18, in such a manner as to increase the grip of the i grooves 70 on the portion of the bead thus resisting withdrawal of the sleeve 18.
During the manufacture, the empty vials 4 are conveyed through a conventional sterilizing station, the piston 8 is inserted in each vial 4, and the latter is filled and capped utilizing conventional vial filling and capping machinery (but preferably using a modified cap as shown in Figures 1 and 3 or Figure 5). The guide and finger grip 16 is then pressed into the base of the vial, which is shipped with the plunger 46 unattached. Prior to use, the plunger 46 is screwed onto the piston, and a needle or the like is applied to the extension 28, utilizing an adapter 36 if necessary so as to penetrate the stopper 22, at which point the syringe is ready for use.
A modified configuration of the bottom end of the vial body is shown in Figure 5, in which an alternative approach is utilized to bringing the bead at the bottom end substantially within the diameter of the cylindrical vial body. Peripheral beads around the openings of glass bodies of this type are conventionally formed by flame softening the glass and adjusting the positioning and profile of the bead by rolling the body against suitable forming surfaces. In the Figure 5 embodiment, a bottom portion 74 of the body 4 is flame softened and rolled so as slightly to reduce its diameter over about a length of typically 5-6 mm, with a fairly conventional out-turned rounded bead 6 formed by flaring the bottom of this reduced diameter section. The reduction in diameter is such that at least the greater part of the bead is within the general diameter of the body, but is not so great as to require excessive force in inserting the piston. In the example shown, the outside diameter of the bead is very slightly greater I

_ g _ than the general outside diameter of the body but this need not be so. In a typical example, the inside and outside diameters of the main portion of the vial body are 27 mm and 30 mm respectively, providing a wall thickness of 1.5 mm, and the reduction in diameter at the bottom is about 1 mm. The bead can then be formed by flaring the bottom end of the vial without increasing the outside diameter of the bead significantly beyond that of the main portion of the vial, typically by no more than 0.5 mm. A significant flare 76 can be provided which facilitates insertion of the piston despite the reduction in diameter of the bottom of the body, and, because of the flare, the bottom contact line 78 of the vial when free-standing on a plane surface is substantially coincident with the outside diameter of the main body 4 of the vial, thus maximizing stability. Juxtaposition of the vial bodies in the event of jostling on a line will prevent any ramping tendencies which might otherwise occur with a flared bottom configuration of this type.
Whilst the presence of the piston after its insertion in the vial body acts to introduce a substantial mass which tends to stabilize the vial, the mass of the piston relative to that of the vial body will decrease as the height of the latter increases.
Nevertheless it will result in a smaller elevation of the center of gravity of the assembly as the vial becomes higher than would otherwise be the case. It is also desirable that the vial bodies be stable without the piston present so that they may be conveyed through a sterilizer prior to insertion of the pistons. The present invention is particularly valuable in this respect since the disturbing influence of a bead at the open end projecting beyond the diameter of the main i - 9a -portion of the body is particularly severe under such conditions.
In order to cooperate with the modified vial body profile, the finger grip/retainer 16 must also be modified. The groove 70 is replaced by a bead 80 at the upper end of the cylindrical portion 18, which bead may be moulded with slots 82 if necessary to facilitate insertion, and/or the component 16 may be warmed to facilitate insertion. The bead must retain the component with sufficient tenacity to withstand pressures from the piston which may be developed through pressure build-up in the vial during normal storage, although it should be noted that contact of the piston on the bead may actually help retain it by forcing it against the shoulder 84. Alternatively or additionally, claws 86 may be moulded onto the component 16 to retain it by engagement with the bead 6. If the portion 18 of the component 16 is dimension so as to abut the lower face of the piston, it will further assist in stabilizing the latter and maintaining an hermetic seal.

Claims (16)

CLAIMS:
1. A pharmaceutical vial used for forming a barrel and a piston of a syringe after being filled by conveying it through vial filling and capping machinery, comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral edge defining an inner periphery of an open opposite end, and a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body for subsequent connection to a syringe plunger, and the vial being stable when standing on the peripheral edge such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means for engagement with complementary configurations of a tubular piston retaining member subsequently inserted within said open end of the body to resist overpressure within the body, wherein the retention means and the peripheral edge are integral with a lower end portion of the body which is formed at least partially inwardly of the projected circumference of said main inner cylindrical surface so that the retention means and the peripheral edge are located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial;
said vial further including a pharmaceutical product within the chamber, a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck, and including a finger grip and piston retainer member, characterized in that the finger grip and piston retainer member includes a tubular member which is a press fit within the open end of the body of the vial, and a flange at an outer end of the tubular member providing outwardly extending finger tabs, the tubular member being recessed in its external surface adjacent the flange in the vicinity of the finger tabs so as to receive the retention means inward of the interior wall of the body.
2. A vial according to claim 1, wherein any external extent of the retention means and the peripheral edge beyond said projected circumference is no more than 20%
of their total radial extent.
3. A vial according to claim 2, wherein the vial has a height which is about 4 times its diameter.
4. A vial according to claim 1, wherein the lower end portion of the body includes a cylindrical bottom portion which is beneath the piston, and is of reduced external diameter, and wherein the peripheral edge is formed on a flare of the open end of the body.
5. A vial according to claim 1, wherein the lower end portion of the body includes a cylindrical bottom portion which is of reduced internal and external diameter such as to provide a peripheral shoulder between said main inner cylindrical surface and an internal cylindrical surface of said bottom portion, and wherein an outer cylindrical surface of said bottom portion has an external peripheral projection which is essentially within the projected circumference of a main cylindrical external surface of the body, at least one of said shoulder and said peripheral projection forming said retention means, and the reduction of internal diameter of the bottom portion not being such as to prevent insertion of the piston therethrough.
6. A vial according to any one of claims 1 - 4 wherein the cap is provided with a concentric tubular outward extension for receiving one of a double ended hollow needle and an adaptor for receiving a single ended hollow needle such that one end of the double ended needle, or a hollow needle provided on the adaptor, can penetrate the stopper.
7. A syringe kit, including:
(i) a first subassembly comprising:
(a) a pharmaceutical vial used for forming a barrel and a piston of a syringe, said vial comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral edge defining an inner periphery of an open opposite end;
(b) a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body;
(c) a pharmaceutical filled within said vial above said piston through the open neck of the vial; and (d) a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck;
(ii) a plunger engageable with said coupling means of the piston to enable the piston to be projected toward said neck;
said vial being stable when standing on the peripheral edge such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means, characterized in that the retention means and the peripheral edge are integral with a lower end portion of the body which is formed at least partially inwardly of the projected circumference of said main inner cylindrical surface so that the retention means and the peripheral edge are located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial.
8. The syringe kit according to claim 7, further comprising a tubular piston retaining member inserted within said open end of the body to resist overpressure within the body, said tubular piston retaining member engaging said positive retention means.
9. A pharmaceutical vial used for forming a barrel and a piston of a syringe after being filled and capped, comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral rounded edge defining an inner periphery of an open opposite end, and a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body for subsequent connection to a syringe plunger, and the vial being stable when standing on the open end of the body such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means for engagement with complementary configurations of a tubular piston retaining member subsequently inserted within said open end of the body to resist overpressure within the body, wherein the retention means is formed by shaping a lower end portion of the body to have a reduced internal diameter such that the retention means is formed by an upwardly facing shoulder at the top of the lower end portion which projects inwardly of the projected circumference of said main inner cylindrical surface, and the lower end portion is located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial;
said vial further including a pharmaceutical product within the chamber, a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck, the cap being provided with a concentric tubular outward extension for receiving one of a double ended hollow needle and an adaptor for receiving a single ended hollow needle such that one end of the double ended needle, or a hallow needle provided on the adaptor, can penetrate the stopper, and including a finger grip and piston retainer member, wherein the piston retainer member includes a tubular member which is a press fit within the open end of the body of the vial, and a flange at an outer end of the tubular member providing outwardly extending finger tabs, the tubular member being recessed in its external surface adjacent the flange in the vicinity of the finger tabs so as to receive the retention means inward of the interior wall of the body.
10. A vial according to claim 9, wherein a generally cylindrical bottom portion of the body is of reduced internal and external diameter such as to provide a peripheral shoulder between said main inner cylindrical surface and an internal cylindrical surface of said bottom portion, and an outer cylindrical surface of said bottom portion has an external periphery which is essentially within the projected circumference of a main cylindrical external surface of the body, said shoulder forming said retention means, and the reduced internal diameter of the bottom portion being insufficient to prevent insertion of the piston therethrough.
11. A pharmaceutical vial used for forming a barrel and a piston of a syringe after being filled and capped, comprising a cylindrical glass vial body having at one end an integral open neck and a peripheral external flange around an outer end of the neck, a peripheral rounded edge defining an inner periphery of an open opposite end, and a piston of resilient material having a cylindrical head within and concentric with the cylindrical glass body, the piston maintaining a slidable hermetically sealing relationship with a main inner cylindrical surface of the body, and being located to define a chamber of volume equal to the nominal capacity of the vial between the piston head and the neck of the vial, the piston having integral coupling structure wholly within the body for subsequent connection to a syringe plunger, and the vial being stable when standing on the open end of the body such that it can be conveyed while so standing through vial filling and capping machinery without tipping over, the body being formed adjacent said open end with peripheral radially extending positive retention means for engagement with complementary configurations of a tubular piston retaining member subsequently inserted within said open end of the body to resist overpressure within the body, wherein the retention means is formed by shaping a lower end portion of the body to have a reduced internal diameter such that the retention means is formed by an upwardly facing shoulder at the top of the lower end portion which projects inwardly of the projected circumference of said main interior cylindrical surface, and the lower end portion is located essentially within the projected circumference of a main cylindrical external surface of the body such as to leave the external surface of the body free of projections having an adverse effect on the stability of the vial;
said vial further including a pharmaceutical product within the chamber, a needle penetrable stopper inserted in the neck, and an annular cap crimped over said stopper and the flange of the neck to retain the stopper in hermetic engagement with the neck, the cap being provided with a concentric tubular outward extension for receiving one of a double ended hollow needle and an adaptor for receiving a single ended needle, or a hollow needle provided on the adaptor, can penetrate the stopper, and including a finger grip and piston retainer member, wherein the piston retainer member includes a tubular member which is a press fit within the open end of the body of the vial, and a flange at an outer end of the tubular member providing outwardly extending finger tabs, the tubular member being recessed in its external surface adjacent the flange in the vicinity of the finger tabs so as to receive the retention means inward of the interior wall of the body.
12. A vial according to claim 11, wherein a generally cylindrical bottom portion of the body is of reduced internal and external diameter such as to provide a peripheral shoulder between said main internal cylindrical surface and an internal cylindrical surface of said bottom portion, anal an outer cylindrical surface of said bottom portion has an external periphery which is essentially within the projected circumference of a main cylindrical external surface of the body, said shoulder forming said retention means, and the reduced internal diameter of the bottom portion being insufficient to prevent insertion of the piston therethrough.
13. In a method of producing a prefilled syringe for administering a pharmaceutical preparation, said syringe comprising a generally cylindrical syringe body having a neck at one end and a side wall having a bead finish at the other end, at least a component of the preparation filled into said body, an elastomeric closure closing the body at the neck end and secured by a cap, and an elastomeric piston at said other end forming a hermetic seal with an inside surface of said side wall, needle means for movement. relative to the cap to penetrate the elastomeric closure, and plunger means for connection to an outer side of the piston, the improvement wherein:
the syringe is produced by associating components, including said plunger and said needle, with a prefilled vial produced by:
forming said body with height to diameter ratio such that the body is stable, and so that any outward extent of the bead is insufficient to result in interference such as would cause tipping, when the body is conveyed standing on said other end through equipment for filling and capping pharmaceutical vials;
inserting said elastomeric piston wholly within said other end of the body to form a vial open at the neck;
and filing said vial through said neck with said pharmaceutical preparation component, and then applying said elastomeric closure on said cap, whilst conveying the vial standing on said other end through equipment for filling and capping pharmaceutical vials.
14. A method according to claim 13, wherein the association of other components includes engaging a piston retainer within said other end of the vial after filling and capping, and wherein the vial with the piston retainer applied is heat sterilized.
15. A method according to claim 13, wherein the step of forming said body so that any outward extend of the bead is insufficient to result in interference such as would cause tipping includes forming the bead to provide an upwardly facing shoulder projecting inwardly of the wall of the body.
16. A method according to claim 13, wherein the step of forming said body so that any outward extent of the bead is insufficient to result in interference such as would cause tipping includes slightly reducing the diameter of a bottom portion of the body, and flaring the open end of said reduced diameter portion of the body to form said bead.
CA002096662A 1990-11-14 1991-11-13 Syringe Expired - Lifetime CA2096662C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9024710A GB2249727A (en) 1989-11-16 1990-11-14 Syringe vial
GB9024710.7 1990-11-14
PCT/CA1991/000409 WO1992008507A1 (en) 1990-11-14 1991-11-13 Syringe

Publications (2)

Publication Number Publication Date
CA2096662A1 CA2096662A1 (en) 1992-05-15
CA2096662C true CA2096662C (en) 2004-04-20

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CA002096662A Expired - Lifetime CA2096662C (en) 1990-11-14 1991-11-13 Syringe

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EP (1) EP0557344A1 (en)
JP (1) JP3313706B2 (en)
AU (1) AU661282B2 (en)
CA (1) CA2096662C (en)
FI (1) FI110308B (en)
NO (1) NO306381B1 (en)
WO (1) WO1992008507A1 (en)

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GB9310084D0 (en) * 1993-05-17 1993-06-30 Reynolds David L Improvements in pharmaceutical containers
JPH08164205A (en) * 1993-12-30 1996-06-25 Eisai Co Ltd Prefilled syringe and gasket falling-off preventing jig and sterilization method using the jig
DE4434644C2 (en) * 1994-09-28 1997-08-07 Schott Glaswerke Container for the storage and administration of injection, infusion and diagnostic preparations
DE19723851C1 (en) 1997-06-06 1998-10-08 Schott Glas Handle bar for prefilled disposable syringes
WO2003008022A1 (en) * 2001-07-16 2003-01-30 Eli Lilly And Company Cartridge-free, multi-dose injection apparatus
DE102004009919B4 (en) 2004-02-20 2007-02-08 Schott Ag Syringe, especially for medical applications
GB2467904B (en) * 2009-02-17 2013-06-12 Oval Medical Technologies Ltd Drug container and delivery mechanism

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FR1433318A (en) * 1962-10-12 1966-04-01 Development of double-ampoule syringes for hypodermic injection
US3967759A (en) * 1971-11-11 1976-07-06 Mpl, Inc. Syringe assembly with contained pop-out elastic plug seal
CH591866A5 (en) * 1975-11-05 1977-09-30 Lezard Sa
US4072149A (en) * 1976-08-09 1978-02-07 Tischlinger Edward A Nose cap and diaphragm assembly for injector
JPS5858285A (en) * 1981-10-01 1983-04-06 Katayama Chem Works Co Ltd Aqueous rust preventive material for metal
JPS59100433U (en) * 1982-12-24 1984-07-06 株式会社トツプ Syringe with cartridge inserted
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US4861335A (en) * 1985-07-26 1989-08-29 Duoject Medical Systems Inc. Syringe
JPH0253749U (en) * 1988-10-07 1990-04-18
JPH0725951Y2 (en) * 1988-10-14 1995-06-14 株式会社トップ Injection tool

Also Published As

Publication number Publication date
WO1992008507A1 (en) 1992-05-29
NO931611L (en) 1993-05-14
JPH06504452A (en) 1994-05-26
EP0557344A1 (en) 1993-09-01
AU661282B2 (en) 1995-07-20
FI932219A0 (en) 1993-05-14
NO306381B1 (en) 1999-11-01
JP3313706B2 (en) 2002-08-12
CA2096662A1 (en) 1992-05-15
FI932219A (en) 1993-05-14
FI110308B (en) 2002-12-31
AU8923491A (en) 1992-06-11
NO931611D0 (en) 1993-05-04

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