WO2004105842A1 - Seringues dotees d'un reducteur de debit - Google Patents

Seringues dotees d'un reducteur de debit Download PDF

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Publication number
WO2004105842A1
WO2004105842A1 PCT/GB2004/002160 GB2004002160W WO2004105842A1 WO 2004105842 A1 WO2004105842 A1 WO 2004105842A1 GB 2004002160 W GB2004002160 W GB 2004002160W WO 2004105842 A1 WO2004105842 A1 WO 2004105842A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrel
needle
assembly
restrictor
plunger
Prior art date
Application number
PCT/GB2004/002160
Other languages
English (en)
Inventor
Jeremy Francis Donnan
John Targell
Original Assignee
Nmt Group Plc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB0312036.7A external-priority patent/GB0312036D0/en
Application filed by Nmt Group Plc filed Critical Nmt Group Plc
Publication of WO2004105842A1 publication Critical patent/WO2004105842A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/508—Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

Definitions

  • This invention relates to the fitting of needle components to the barrel of a hypodermic or other syringe and, more particularly, to the structure of the barrel.
  • a barrel for use with a retractable needle assembly comprising a needle and a mounting hub for the needle, the barrel being provided with a restrictor located internally of the barrel at or adjacent an open end of the barrel, the restrictor having at least one aperture which is sufficiently small as ordinarily to retain liquid within the barrel and being adapted to allow passage of the needle and a mounting hub into the barrel.
  • liquid introduced into the barrel for example by means of a filling needle unit, may be prevented from "glugging" out of the barrel while the filling needle unit is being replaced by an injection needle unit, such egress of the liquid being restricted by virtue of surface tension effects associated with an aperture or apertures having appropriately small dimensions for the liquid involved.
  • the restrictor will be capable of preventing liquid spillage at least as long the barrel is subjected to normal handling and is not shaken violently.
  • the aperture may take various forms and the term as used herein is to construed as including a passageway along which the liquid can pass.
  • the retractable needle unit comprises a needle, a mounting hub therefor, a restrainer for holding the hub in a forward position and a retraction mechanism operable, upon release of the hub from the restrainer, to drive the needle and mounting bub rearwardly from said forward position into the barrel.
  • the plunger may co-operate directly with the restrainer to effect release of the hub or alternatively at or near the end of its forward stroke of the plunger, the forward end of the plunger may contact the restrictor so that forward movement of the plunger is transmitted through the restrictor to the restrainer in order to effect release of the hub.
  • the liquids employed will usually have, at a temperature of2O°C, a fluid viscosity in the range of 0.6 to 70 cP and a surface tension in the range of 20 to 100 dynes/cm.
  • the plunger is typically hollow and the retraction mechanism is operable to drive the needle into the hollow plunger.- . - _
  • the plunger may have a forward end which approaches said open end of 15 the barrel during discharge of liquid from the barrel and may have at its forward end a part which closes said forward end but is severable or dislodgeable from said forward end to allow the needle and mounting hub to be driven by the retraction mechanism into the hollow plunger.
  • the restrictor may be a component separate from the barrel or it may be integral with the barrel.
  • the restrictor may be deformable, e.g. resiliently deformable, at least in the region of said aperture to allow passage of the needle and mounting hub therethrough.
  • the restrictor may include a sealing formation which co-operates with part of the needle unit whereby, during an injection stroke of the plunger, discharge of liquid from the unit is confined to the pathway provided by the needle.
  • Said aperture may comprise a single hole which may be circular or which may be provided with one or more inwardly directed projections for enhancing the ability of the restrictor to prevent egress of liquid from the barrel.
  • the periphery of said aperture may be of a castellated configuration formed by said projections.
  • the projection or projections may be capable of flexing to allow such passage of the needle and hub.
  • said aperture of the restrictor may 15 be sized so that the hub and needle can pass therethrough during needle retraction.
  • said aperture may be of a size which is not sufficient to allow passage of the hub and needle.
  • the restrictor may include a portion which can be removed, e.g. broken away or dislodged, to allow passage of the needle and hub during the needle retraction process.
  • Another alternative is for the restrictor to be capable of being disrupted, e.g. by virtue of being made of a brittle or frangible material, in such a way that it no longer blocks the needle and hub when needle retraction is required.
  • the restrictor may comprise an inner portion and an outer portion, the inner portion being severable or otherwise releasable from the outer portion to create an opening sufficiently large to allow passage of the needle and hub during needle retraction.
  • the inner and outer portions may be demarcated from one another by a zone or line of weakness (e.g. generally circular) at which the inner portion is severable from the outer portion during needle retraction.
  • the zone or line of weakness may be provided by one or more webs of material interconnecting the two portions.
  • the inner and outer portions may alternatively be interconnected at a moulding interface therebetween such that the inner portion is severed or dislodged from the outer portion as the plunger approaches or reaches completion of its forward stroke.
  • the inner portion may be provided with said aperture.
  • the inner portion may be of tubular configuration defining a passageway constituting said aperture.
  • the restrictor may comprise a disc located within the barrel.
  • the disc When in situ within the barrel, the disc may be of generally conical configuration with an aperture at its "apex” and with its apertured “apex” located forwardly of the outer periphery of the disc.
  • the configuration of the disc when in situ, may be such as to include an obtuse cone angle, typically of the order of 140°.
  • the disc may be thin and flat when manufactured so that it can be pressed or cut out of strip or sheet material, injection or compression moulded or produced by other techniques so that the disc is not "handed" when manufactured but can take up the conical configuration.
  • the disc may be manufactured with a generally conical S configuration, e.g. by moulding.
  • the aperture in the disc may be a plain circular hole or it may be of other configuration.
  • its periphery may be provided with one or more fingers which will have the effect of reducing the apparent hole cross-section, thereby enhancing its ability to seal against liquid egress from the barrel.
  • the periphery of the aperture may be of castellated configuration, e.g. by virtue of one or more fingers as referred to above.
  • the arrangement may be such that the finger or fingers or other such projections are capable of flexing to allow passage of the needle and hub.
  • the disc may be self-retaining in the barrel once inserted. Its outer periphery may if desired engage with a shoulder or within a groove in the wall of the barrel so that the disc is prevented from being dislodged.
  • the outer periphery of the disc may be provided with one or more fingers and/or be castellated to aid its deformation during insertion into the barrel and/or aid its retention once inserted into the barrel.
  • the material of which the disc (or other form of restrictor) is composed may be a deformable polymeric material or an elastomeric material suitable for use in a medical syringe.
  • the material may for instance be one which is suitable for exposure to gamma radiation and/or ethylene gas sterilisation.
  • the arrangement may be such that when the needle and hub assembly is 5 fitted to the barrel, the rearward end of the needle/hub unit is located forwardly of the disc.
  • the restrictor may be in the form of an annular flange projecting inwardly of the barrel and, optionally, rearwardly also, the flange defining an aperture which is sufficiently small as ordinarily to retain liquid within the barrel.
  • This embodiment is particularly suitable for barrels which have a relatively low filling capacity, e.g. of the order of 1 cc.
  • the flange may be resiliently deflectable radially outwardly.
  • the flange may be formed integrally with the barrel adjacent its open end.
  • the flange may function also as a lip seal by co-operation with a component of the needle unit, e.g. by co-operation with a component which restrains the needle hub against retraction until the plunger approaches or reaches the end of its forward stroke.
  • the restrictor may be perforated or reticulated to prevent "glugging" of the liquid out of the barrel.
  • the restrictor may present an array of apertures distributed over the cross- sectional area of the barrel.
  • the restrictor may be of a frangible or brittle material or rendered frangible or brittle in a defined zone or zones thereof so that, during forward movement of the plunger, the integrity of the restrictor is disrupted to allow passage of the hub/needle assembly during needle retraction.
  • the restrictor may comprise an inner part and an outer part which are normally coupled together but which are released from one another as the plunger approaches or reaches completion of its forward stroke.
  • the outer part may be restrained against forward movement or only allowed to move forwardly to a limited extent relative to the barrel. After release of the inner part from the outer part, the inner part may leave an opening in the restrictor sufficiently large to allow passage of the needle/hub assembly during needle retraction.
  • the inner part may be provided with a central passageway for liquid flow into and out of the barrel, the passageway being sufficiently small as ordinarily to retain liquid within the barrel when pressure is not being applied to the plunger to move it forwardly.
  • the restrictor may be provided with an additional opening or openings of this nature in the outer part.
  • the two parts of the restrictor may be coupled together by moulding one part in the presence of the other part, e.g. by a two-shot moulding process, as disclosed in our WO 02/87669 the entire contents of which are incorporated herein by this disclosure.
  • the two parts may be coupled together via frangible sections S of material which can readily break to allow release of the inner part from the outer part when required.
  • the restrictor may be moulded from plastics material with thin webs of the plastics material interconnecting the two parts.
  • the hub and the restrainer may be formed, e.g. by a 2-shot moulding process, as plastics mouldings in such a way that the restrainer is axially captive with the hub, e.g. as disclosed in WO 02/87669 the entire contents of which are incorporated herein by this reference.
  • the arrangement may be such that the injection needle unit is engaged with the barrel through a one-way coupling means formed by interfitting components on the needle unit and the barrel whereby the injection needle once assembled to the barrel cannot be disengaged from the barrel (at least not without damaging the components).
  • the one way coupling means may comprise a threaded connection or a bayonet- type connection between a male part and a female part, one part being associated with the barrel and the other part being associated with the injection needle.
  • the one way coupling means may for example comprise a threaded connection between a male and a female part, there being a void in an upstanding portion of the thread on each part and a barb in the void on one of the parts, the arrangement being such that when the parts are threadedly engaged, resilient deformation of at least one of the parts enables the barb to latch behind an end of a thread at the void in the other of the parts to prevent subsequent disconnection of the parts.
  • the coupling may be such that an internal thread section provided on the needle unit engages with an external thread on the barrel, or vice versa.
  • Figure 1 is a longitudinal sectional view showing the barrel of a hypodermic syringe fitted with a filling needle and sheath unit, the unit being provided with a restrictor in accordance with a first embodiment of the invention
  • Figure 2 is a view similar to Figure 1 but showing the filling needle assembly removed from the barrel and the barrel filled with liquid;
  • Figure 3 is a view similar to that of Figure 2 but wherein the barrel is 20 about to be fitted with an injection needle assembly;
  • Figure 4 is an enlarged view showing the injection needle assembly fitted to the barrel
  • Figure 4A is a schematic view showing the periphery of the aperture formed in the restrictor
  • Figure 5 is a fragmentary perspective view in section of a syringe shown fitted with an injection needle of the retractable type, provided with a restrictor in accordance with a second embodiment of the invention
  • Figure 6 is a diagrammatic sectional view of a syringe showing a modification applicable to the embodiment of Figure 5;
  • Figure 7 is a fragmentary perspective view of another embodiment of the invention in which the restrictor is in the form of a frangible disc or the?like;
  • Figure 8 is a fragmentary perspective view of yet another embodiment in which the restrictor is of two part form allowing the central part to be produced with a passageway smaller than the lateral dimensions of the needle hub;
  • Figure 9 is an enlarged perspective view of the restrictor of the embodiment illustrated in Figure 8;
  • Figure 10 is a fragmentary perspective view of a further embodiment in which the restrictor comprises an outer part and a central part; and
  • Figure 11 is an enlarged perspective view of the restrictor of the embodiment illustrated in Figure 10. 5
  • the syringe of the present invention when fitted with an injection needle unit of the retractable type, may be a hypodermic needle syringe as described, for example, in WO 02/87669.
  • the plunger has a forward end which approaches the open end of the barrel during discharge of liquid from the barrel and has at its forward end a part which can be severed or dislodged from the forward end of the
  • the needle unit comprises a needle, a mounting hub therefor, a restrainer for holding the hub in a forward position and a retraction mechanism operable, upon release of the hub from the restrainer, to drive the needle and mounting hub rearwardly from said forward position into the hollow plunger.
  • the severable part is severed from the forward end of the plunger prior to or during operation of the retraction mechanism.
  • Release of the hub from the restrainer is effected by co-operation of the forward end of the plunger with the restrainer whereby forward movement of the plunger at or near the end of the forward stroke thereof is effective to displace the restrainer and effect release of the hub and the needle.
  • tubular barrel 10 of a syringe is open at its 15
  • the washer 14 may be flat having a diameter which is slightly greater than the internal diameter of the barrel at its forward end 12. When the washer 14 is pressed into the interior of the barrel, it takes up a slightly conical form by virtue of its diameter being
  • the washer may instead be manufactured with a conical configuration.
  • the periphery of the washer 14 contacts the internal wall of the barrel 10 and because of its conical configuration resists displacement in the rearward direction during filling of the barrel.
  • the washer need not be of conical configuration as long as it is secured in such a way that it is not displaced rearwardly during filling of the barrel.
  • the barrel may be provided with an internal groove or shoulder 18 in or against which the washer 14 seats.
  • the opening 16 is presented forwardly of the outer periphery of the washer.
  • the forward end of the barrel may have a conical end formation located forwardly of the washer such that the washer, when inserted, takes up the form of the forward end of the barrel.
  • the barrel is shown fitted with a unit comprising a filling needle 20 and a protective sheath 22, the unit being coupled to the forward end of the barrel by a screwthreaded connection between the rearward end portion 24 of the unit 20, 22 and a forwardly projecting collar 26 of the barrel.
  • the sheath 22 is designed to be broken off when the user is ready to use the filling needle so that the needle 20 can be inserted into a vial or other source of fluid which is to be drawn into the barrel in the usual way (involving retraction of a plunger, not shown, rearwardly along the barrel). As the fluid is drawn into the barrel, it flows directly through the opening 16 at the centre of the washer 14 and into the evacuated volume of the barrel.
  • the filling needle unit is decoupled from the barrel 10 (see Figure 2) and the injection needle unit is then fitted to the barrel (see Figures 3 and 4). If now the barrel is handled normally, e.g. inverted or shaken (but not unduly violently), the risk of the liquid drug "glugging" out of the barrel is significantly reduced by virtue of the washer 14 since the opening 16 forms a small hole at the base of a liquid filled chamber, namely the barrel, and is designed so that, because of the surface tension properties of the liquid, it cannot allow air in and liquid out at the same time, with the consequence that there is no flow either way. In this way, during interchange of needles, the liquid is retained in the barrel by the washer 14 provided that the barrel is not subjected to any unduly violent shaking or handling.
  • the injection needle unit comprises a mounting portion 28 for coupling to the barrel, an injection needle 30 carried by a hub 32 and a restrainer constituted by a crown 34.
  • the hub 32 and needle 30 are biased rearwardly by a spring 36 for retraction at the appropriate time into the barrel and associated hollow plunger within the plunger.
  • the hub 32 and crown 34 may be formed by a 2-shot moulding process so that they are captive with each other until the crown is displaced by collar 37 (see Figure 4) of the plunger so to decouple the hub 32 and crown 34 and release the hub and needle for spring-driven travel into the barrel and plunger.
  • the present invention is not limited to triggering of the needle retraction mechanism in the manner just described; other methods known in the art may be used for retaining the hub and needle and releasing the same when needle retraction is required.
  • the leading end 38 of the plunger Prior to, during or just after release of the hub from the crown, the leading end 38 of the plunger will also be separated from the plunger and be driven into the interior of the plunger.
  • the leading end of the plunger may, but need not necessarily, be produced as a 2 shot moulding as disclosed in WO 01/42164, the entire disclosure of which is incorporated herein by this reference.
  • the gap between the forward end of the washer 14 and the rearward end of the crown is minimised to reduce drug wastage.
  • the dimension of the hub is such that the hub and also the spring 36 may pass freely through the opening 16 in the washer once needle retraction has been initiated as a result of contact between the trailing end part of the crown 34 and the collar 37 of the plunger.
  • the coupling between the mounting portion of the injection needle unit and the barrel is conveniently a one-way coupling as referred to above and may be implemented for example in the manner disclosed in GB-A-2 353 078. Fitting of the filling needle assembly may be through a similar coupling means except for the omission of the locking barbs so that, in contrast with the injection needle unit, the filling needle unit may be readily removed when finished with.
  • the opening 16 in he disc is circular; 10 however, it may be of other configuration consistent with making use of surface tension effects to prevent the liquid "glugging" out of the barrel.
  • the opening 16 may be of castellated configuration as illustrated in Figure 4A so as to reduce the cross- sectional area thereof, the projections extending radially inwardly but being readily deflectable so that they do not obstruct passage of the needle/hub assembly after needle retraction has been triggered.
  • the restrictor is constituted by an annular projection or flange 100 provided internally of the forward end of the barrel 102.
  • the restrictor in this case may be formed integrally, as by plastics moulding, with the barrel.
  • the syringe is shown in a configuration in which the injection needle has been fitted following filling of the barrel with filling needle unit and removal of the latter.
  • the hub 112 and crown 108 in this embodiment are coupled together at the moulding interface 126 by two-shot moulding in such a way that the parts are mechanically connected and possibly also fused or adhered together at the interface.
  • Such an arrangement may also be employed in other embodiments of the invention illustrated herein.
  • the restrictor 100 Prior to fitting of the injection needle unit 103 and its sheath (not shown), it will be understood that the restrictor 100 will be effective to prevent spillage of liquid from the filled barrel provided that the diameter of the restrictor is sufficiently small.
  • the dimension of the opening in the restrictor 100 is determined by the need to allow passage of the assembly comprising the , needle 110 and hub 112 during operation of the needle retraction mechanism.
  • this implementation of the invention is primarily intended for low capacity and hence small diameter syringes, e.g. syringes having a filling capacity of the order of lml.
  • the dimensions of the various parts can be made smaller, consistent with securing a restrictor hole sufficiently small that, for liquids in the viscosity range typically encountered for liquids to be administered by injection, the risk of egress of liquid from the barrel is prevented in normal use.
  • typical properties for liquids to be used with syringes in accordance with the invention are a fluid viscosity in the range of 0.6 to 70 cP, (typically about 1 cP) and a surface tension in the range of 20 to 100 dynes/cm (typically about 73 dynes/cm).
  • the restrictor 100 in the embodiment of Figure 5 serves the additional function of providing a seal between the crown 108 and the internal wall surface of the barrel, being in the form of a resiliently deflectable lip seal so arranged that, during the forward stroke of the plunger (not shown), the lip seal extends inwardly and rearwardly so that it tends to deflect radially inwardly due to the pressure exerted thereby enhancing the sealing action. It will be seen that, when the crown 108 is in place and engages with the lip seal/restrictor 100, it deflects the lip seal/restrictor 100 radially outwardly. When the crown 108 is not present, the lip seal/restrictor 100 is in a relaxed undeflected condition in which the central hole is of reduced diameter compared with the diameter it expands to when the lip seal is deflected outwardly by the crown 108.
  • Figure 6 illustrates a modification of the embodiment of Figure 5 in which the restrictor 200 may again function as a resiliently deflectable lip seal but, at its inner periphery, is provided with an inwardly directed portion 220 which defines the aperture 222 through which the assembly of hub 212 and needle (not illustrated) of the injection needle unit can pass during needle retraction.
  • the portion 220 may be integrally formed with the restrictor 200 which, in turn, may be integral with the barrel 202.
  • the portion 220 may define a central circular aperture or alternatively the central aperture may be of other configuration, e.g. the portion 220 may be of castellated configuration or other configuration in which one or more parts project radially inwardly to a greater extent than other parts.
  • the central aperture 222 may be somewhat smaller than its counterpart in Figure 5 thereby permitting use of the restrictor 200 of Figure 6 with syringes over a wider range of filling capacities.
  • FIG. 7 illustrates an embodiment in which the barrel 302 is provided with a lip seal 330 as in Figures 5 and 6 but, in this case, the lip seal need not function as a restrictor.
  • a separate restrictor 300 is provided which is perforated, reticulated or otherwise formed with openings 332 which allow admission of liquid into the barrel 302 during filling but which, by virtue of surface tension effects, prevent or reduce the risk of liquid egress from the barrel when the filling unit is removed.
  • the restrictor 300 may be in the form of a perforated or reticulated disc located within the barrel and, at its outer periphery, is blocked against forward movement, e.g. by internal shoulder 334 of the barrel.
  • the restrictor 300 is adapted to co-operate with the plunger 306 in such a way that, as the plunger approaches completion of its forward stroke, an opening is created in the restrictor 300 which is sufficient to allow the assembly of hub 312 and needle (not shown) to travel beyond the restrictor location.
  • Such rearward travel of the hub and needle assembly can occur after the coupling at interface 326 is disrupted to allow hub release from the crown and the hub/needle assembly can then be driven into the hollow plunger 306 via the opemng created by release of the blocking portion 338 from the rim portion 340 (at. interface 342) as the plunger approaches or. reaches completion of its forward stroke.
  • the restrictor 300 may be frangible so that it is broken by the forward advance of the plunger 306.
  • the restrictor 300 may be fabricated from a frangible or brittle material which will readily break or it may be formed with one or more lines or zones of weakness to allow part to be broken away to form the desired hole for passage of the needle and hub assembly.
  • the restrictor 400 comprises a central part 450 and an outer part 452 which are coupled together in such a way that, at a suitable point during the forward stroke of the plunger 406, the central part 450 is freed from the outer part 452 so that the assembly of hub 412 and needle (not shown) can be driven by the spring (not shown) into the hollow plunger 406 along with the central part 450.
  • the central part 450 is provided with a passageway 454 through which liquid can pass during the filling and injection procedures. This passageway is suitably dimensioned so that the liquid filling the barrel 402 is retained within the barrel by surface tension effects during the time between removal of the filling needle unit and fitting of the injection needle unit.
  • the diameter of the passageway 454 may be of the same order as conventional Luer fittings for syringes - e.g. of the order of 2.0 mm.
  • the barrel may be provided with a lip seal 430 for co-operation with the crown 408.
  • the coupling between the parts 450 and 452 may be secured by producing the restrictor 400 by two-shot moulding of one or more plastics materials such that they are engaged with each other at the moulding interface 456, e.g. in the manner disclosed for the hub and crown in WO 02/87669.
  • the coupling at the interface may be of a mechanical nature by contouring of the parts at the interface and/or it may involve fusion or adherence of the materials at the interface.
  • coupling arrangements other than those created by two-shot moulding, may be used instead.
  • the outer part may be of conical configuration, or adopt such a configuration when inserted into the barrel, with its outer periphery contacting the inner wall of the barrel 402 so that the restrictor 400 is readily movable in the forward direction but resists movement in the rearward direction .
  • the outer part 452 may be formed with one or more openings in the form of, for example, apertures or cut-away portions 458 to provide further inlets for admission of the liquid during filling of the barrel.
  • openings 458 will be dimensioned to prevent, by surface tension effects, liquid
  • the restrictor 400 in located within the barrel 402 with a small amount of clearance X.
  • the leading end of the rim portion 440 initially contacts collar 453 of the outer part 452 while the blocking portion or nose 438 contacts the central part 450.
  • Continued forward movement of the plunger is then transmitted via leading end 462 of the outer part 452 to the crown 408 and brings the leading portion 464 of blocking portion 438 into abutment with the trailing end of the hub 412.
  • the various parts are designed so that, in the process of taking up the clearance X, the central part 450 is released from outer part 452 of the restrictor, the hub 412 is released from the crown 408 and the blocking portion 438 is released from the rim portion 440. Once these conditions are secured, the hub and needle assembly can be driven by the spring (not shown) into the hollow plunger 406 along with the central portion 450 of the restrictor 400.
  • Figures 10 and 11 show a similar embodiment to that of Figures 8 and 9 in which the two parts 550 and 552 are coupled by narrow frangible sections or webs 566 instead of by two-shot moulding.
  • the two parts may be produced as a single plastics moulding and webs 566 are defined by a circular array of openings 558 which surround the central part 550.
  • a passageway 554 is also provided in the central part 550 and liquid ingress during filling takes place through the passageway 554 and the openings 558. Liquid egress however is restricted by surface tension effects to prevent glugging of the liquid out of the barrel 502 when the latter has been filled and is yet to be fitted with the needle injection unit. . , though _ . _. .. .
  • forward movement of the plunger 506 is effective to release the various parts from one another by uncoupling the parts at the interfaces 526 and 542 and disrupting the narrow section webs 566 so that the central part 550 is freed to allow it together with the needle/hub assembly to be driven rearwardly into the hollow plunger 506 via the hole created by dislodging the blocking portion 538 from the rim 540.
  • the outer part 552 is shown in the 25 form of a conically-shaped disc with an uninterrupted outer periphery; however, if desired, its outer periphery may be provided with one or more cutaway portions as in the embodiment of Figures 8 and 9.

Landscapes

  • 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)

Abstract

Le cylindre (10) d'une seringue hypodermique possède une extrémité ouverte pouvant être raccordée à une unité à aiguille d'injection rétractable par l'intermédiaire d'une partie de montage (28) de l'unité à aiguille qui se visse dans un collier (26) au niveau de l'extrémité ouverte du cylindre. Un réducteur de débit (14) qui se présente sous la forme d'un disque déformable élastiquement ayant une ouverture centrale (16) est disposé de manière interne à l'intérieur du cylindre, en position adjacente à son extrémité ouverte. Le disque est plat et possède un diamètre qui est légèrement supérieur au diamètre interne du cylindre de sorte que, lorsque ce disque est pressé à l'intérieur du cylindre, il adopte une configuration légèrement conique. Ceci facilite la fixation de la rondelle dans une position à l'intérieur du cylindre. L'ouverture (16) est suffisamment petite de manière à retenir généralement le liquide à l'intérieur du cylindre en raison des effets tensioactifs. Ceci empêche le liquide aspiré dans le cylindre au moyen d'une unité à aiguille de remplissage de sortir du cylindre en «faisant des bulles » tandis que l'unité à aiguille de remplissage est remplacée par l'unité à aiguille d'injection. L'ouverture (16) est également conçue pour permettre le passage de l'aiguille (30) et de son embout de montage (32) à l'intérieur du cylindre et du piston creux lors de l'actionnement de l'unité à aiguille rétractable à la fin d'une course d'injection du piston.
PCT/GB2004/002160 2003-05-27 2004-05-20 Seringues dotees d'un reducteur de debit WO2004105842A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0312036.7A GB0312036D0 (en) 2002-09-25 2003-05-27 Hypodermic syringes
GB0312036.7 2003-05-27

Publications (1)

Publication Number Publication Date
WO2004105842A1 true WO2004105842A1 (fr) 2004-12-09

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ID=33484773

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KR (1) KR20060014421A (fr)
WO (1) WO2004105842A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1547634A1 (fr) * 2003-12-22 2005-06-29 Chung-Yu Yang Seringue de sécurité
WO2006119551A1 (fr) * 2005-05-11 2006-11-16 Occupational & Medical Innovations Ltd Seringue avec aiguille amovible
WO2008019034A1 (fr) * 2006-08-03 2008-02-14 Becton, Dickinson And Company Ensemble seringue et aiguille amovible présentant des caractéristiques de fixation binaires
WO2011057334A1 (fr) * 2009-11-11 2011-05-19 Unitract Syringe Pty Ltd Seringue clinique
US8613107B2 (en) 2005-03-16 2013-12-17 Dt Labs Development, Llc System, method and apparatus for electronically protecting data associated with RFID tags
US9526846B2 (en) 2009-08-19 2016-12-27 Safety Syringes, Inc. Patient-contact activated needle stick safety device

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US6074370A (en) * 1991-12-23 2000-06-13 Syringe Development Partners L.L.C. Safety syringe
GB2353078A (en) 1999-08-10 2001-02-14 Nmt Group Plc Automatic locking threaded connector
GB2356144A (en) 1999-11-10 2001-05-16 Nmt Group Plc Seal for syringe barrel
WO2001042164A1 (fr) 1999-12-10 2001-06-14 James Hardie Research Pty Limited Construction d'une paroi de faible poids
WO2002087669A1 (fr) 2001-04-26 2002-11-07 Nmt Group Plc Dispositifs de manipulation de fluide, destines notamment a une utilisation medicale
US6524278B1 (en) * 1998-09-04 2003-02-25 Nmt Group Plc Needle sheath
WO2003095004A1 (fr) * 2002-05-10 2003-11-20 Maxxon, Inc. Seringue de surete a jeter
US6712787B1 (en) * 2000-05-19 2004-03-30 Edward D. Dysarz Self destructive safety syringe

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Publication number Priority date Publication date Assignee Title
US6074370A (en) * 1991-12-23 2000-06-13 Syringe Development Partners L.L.C. Safety syringe
US5788677A (en) * 1995-08-22 1998-08-04 Botich; Michael J. Pre-filled retractable needle injection ampoules
US6524278B1 (en) * 1998-09-04 2003-02-25 Nmt Group Plc Needle sheath
GB2353078A (en) 1999-08-10 2001-02-14 Nmt Group Plc Automatic locking threaded connector
GB2356144A (en) 1999-11-10 2001-05-16 Nmt Group Plc Seal for syringe barrel
US20030023207A1 (en) * 1999-11-10 2003-01-30 Donnan Jeremy Francis Seal
WO2001042164A1 (fr) 1999-12-10 2001-06-14 James Hardie Research Pty Limited Construction d'une paroi de faible poids
US6712787B1 (en) * 2000-05-19 2004-03-30 Edward D. Dysarz Self destructive safety syringe
WO2002087669A1 (fr) 2001-04-26 2002-11-07 Nmt Group Plc Dispositifs de manipulation de fluide, destines notamment a une utilisation medicale
WO2003095004A1 (fr) * 2002-05-10 2003-11-20 Maxxon, Inc. Seringue de surete a jeter

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1547634A1 (fr) * 2003-12-22 2005-06-29 Chung-Yu Yang Seringue de sécurité
US8613107B2 (en) 2005-03-16 2013-12-17 Dt Labs Development, Llc System, method and apparatus for electronically protecting data associated with RFID tags
WO2006119551A1 (fr) * 2005-05-11 2006-11-16 Occupational & Medical Innovations Ltd Seringue avec aiguille amovible
US7854722B2 (en) 2005-05-11 2010-12-21 Occupational & Medical Innovations Ltd. Syringe with removable needle
WO2008019034A1 (fr) * 2006-08-03 2008-02-14 Becton, Dickinson And Company Ensemble seringue et aiguille amovible présentant des caractéristiques de fixation binaires
CN101522241A (zh) * 2006-08-03 2009-09-02 贝克顿·迪金森公司 具有双附接特征的注射器和可拆卸针头组件
US7922958B2 (en) 2006-08-03 2011-04-12 Becton, Dickinson And Company Method of making an elongate syringe barrel
AU2007282089B2 (en) * 2006-08-03 2013-02-07 Becton, Dickinson And Company Syringe and removable needle assembly having binary attachment features
US9526846B2 (en) 2009-08-19 2016-12-27 Safety Syringes, Inc. Patient-contact activated needle stick safety device
US11400234B2 (en) 2009-08-19 2022-08-02 Safety Syringes, Inc. Patient-contact activated needle stick safety device
US10314985B2 (en) 2009-08-19 2019-06-11 Safety Syringes, Inc. Patient-contact activated needle stick safety device
WO2011057334A1 (fr) * 2009-11-11 2011-05-19 Unitract Syringe Pty Ltd Seringue clinique
US9254365B2 (en) 2009-11-11 2016-02-09 Unitract Syringe Pty Ltd Clinical syringe with replaceable retractable needle
AU2010317659B2 (en) * 2009-11-11 2014-01-23 Unitract Syringe Pty Ltd Clinical syringe

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