WO2003097133A1 - Injection device with automatically retractable needle - Google Patents

Injection device with automatically retractable needle Download PDF

Info

Publication number
WO2003097133A1
WO2003097133A1 PCT/GB2003/002132 GB0302132W WO03097133A1 WO 2003097133 A1 WO2003097133 A1 WO 2003097133A1 GB 0302132 W GB0302132 W GB 0302132W WO 03097133 A1 WO03097133 A1 WO 03097133A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
needle
plunger
device
drive member
Prior art date
Application number
PCT/GB2003/002132
Other languages
French (fr)
Inventor
Jeremy Marshall
Original Assignee
Owen Mumford Limited
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 to GB0211294.4 priority Critical
Priority to GB0211294A priority patent/GB0211294D0/en
Application filed by Owen Mumford Limited filed Critical Owen Mumford Limited
Publication of WO2003097133A1 publication Critical patent/WO2003097133A1/en

Links

Classifications

    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which the triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A61M5/326Fully automatic, i.e. in which the triggering does not require a deliberate action by the user
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2086Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
    • 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
    • A61M2005/3143Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Abstract

An injection device has a needle which, when the device is operated, is first caused to project, then liquid is forced out through it, and finally the needle is automatically retracted. The needle extends forwardly from a capsule that can slide longitudinally within a barrel-like body, a relatively weak spring normally maintaining the capsule and needle retracted. A more powerful spring acts oppositely on a plunger formed by rod parts (27A, 27B) which, when released, shoots the capsule forward by acting on the liquid therein, and then forces the liquid out through the projecting needle. At the end of the forward stroke the plunger and capsule are decoupled and the weak spring returns the exhausted capsule and its needle to the retracted position. A lost motion connection provided by a piston (31) of the rod part (27A) acts as a damper in a cylinder (32) of the rod part (27B), to ensure that the full dose is ejected from the needle before decoupling occurs.

Description

INJECTION DEVICE WITH AUTOMATICALLY RETRACTABLE NEEDLE

This invention relates to injection devices, and in particular medical ones where the needle is retracted and thus made safe after use.

Such injection devices are in increasing demand for obvious reasons. There is great danger in a discarded syringe with a possibly infected needle. It is highly desirable that retraction of the needle after use should not only be possible but also be automatic. It should not rely on the user making it safe by some manipulation which can all too easily be overlooked. Also, with the increasing use of self-administered drug therapy, there is a demand for a device whereby the syringe needle is not normally visible to the user before or after the injection.

In GB-A-728248 hypodermic injection apparatus is described which meets these requirements. But the various embodiments are of considerable complexity, and therefore expense, and it is believed that none of them ever came into common use. Even though the apparatus was safe before and after injection, that is now not enough: it should preferably be cheap enough to be used once and then disposed of.

The apparatus of GB-A-728248 employs a powerful spring which, when released, thrusts forward on an ampoule and needle carrier. This projects the needle into the flesh of the patient. At the end of this phase, the spring is automatically decoupled from the carrier but continues to act on a plunger which co-operates with a piston within the ampoule. Thus the contents of the ampoule are squeezed out through the needle by the spring. At the end of this phase, the spring is automatically decoupled from the plunger, leaving the ampoule and needle carrier free to be acted upon by a relatively weak return spring, which urges the carrier back to a retracted position. There are therefore two decouplings and the complexity referred to above is largely attributable to these. An improvement over these arrangements was developed and is described in our European Patent 0516473. However, even this arrangement can have a problem with dosage delivery. The length tolerances of the syringe, the syringe plunger and other features of the device almost invariably result in premature triggering occurring before delivery of the drug is complete. The invention aims to alleviate this problem.

According to the present invention there is provided an injection device comprising a barrel, a spring loaded drive member therein, release mechanism for allowing said member to be sprung forwardly within the barrel, a spring loaded, charged capsule within the barrel, a needle associated with the capsule initially in a retracted position at the forward end of the barrel, the spring loading of the capsule being in opposition to but weaker than the spring loading of said drive member, a plunger with which the forward end of said drive member co-operates, and a decoupling mechanism for decoupling the plunger from said drive member at the end of the forward stroke, the arrangement being such that said forward stroke first drives the capsule and the needle to a needle projecting position, said drive member acting through the plunger and the capsule charge, and secondly forces the plunger to eject the capsule charge through the needle, the capsule spring loading being then freed by the decoupling mechanism to return the capsule to the needle retracted position, the plunger including a two-part section with a delayed-motion connection therebetween whereby, in operation, the delayed-motion connection acts to delay full actuation of the plunger to the position where the decoupling mechanism is activated until such time as the plunger completes the full stroke needed to eject the required charge through the needle.

No decoupling is required at the end of the first phase; the spring loaded drive member having relatively easily projected the needle carries on more slowly against the resistance of the capsule charge whose only escape is through the needle. The delayed-motion connection ensures that the plunger operates to eject the required full charge of liquid through the needle before the decoupling mechanism can operate to return the capsule to the needle retracted position, whereupon ejection of the charge ceases.

In the preferred arrangement the two-part section will incorporate a damper. The two-part section could be in the form of a piston and cylinder and the damper acts to delay completion of the stroke of that piston into the cylinder. The damper then can comprise an air bleed hole at the base of the cylinder, or a leaky seal of the piston contacting the internal walls of the cylinder.

The capsule will conveniently be a proprietary syringe with its plunger removed and replaced by said plunger which co-operates with said drive member. Preferably, the spring loading will be provided by coil springs co-axial within the barrel. The decoupling means is ideally provided by the rear end of said plunger which is abutted by said drive member and which is adapted to be deformed when it comes into co-operation with the capsule. For example, the rear end of the plunger may be bifurcated and there may be exterior projections on the fingers formed thereby, said projection when engaged by the capsule on entry therein causing the fingers to be wedged together and in this constricted condition to be free to enter a passage within the drive member.

The drive member will generally have a catch which initially is engaged with the barrel, holding the forward spring energised. The release mechanism, which may be a button-like rear end cap, frees this catch. For a better understanding of the invention, some embodiments will now be described, by way of example, with reference to the accompanying drawings, in which: Figures 1-4 are longitudinal sections of an injection device in progressive stages of operation; and

Figure 5 is a sectional enlarged detail of part of the plunger of the device of Figures 1 to 4. The injection device of Figures 1 to 4 has a stepped barrel 1 reducing towards the forward end where there is a cap 2 which is removed for use. At the rear end there is a cap 3 which is snapped on by its peripheral flange and which has an inner annulus 4 and a central tab 5. The cap 3 is rotatable on the barrel 1 and its central portion can be flexed inwards, axially of the barrel, by virtue of an annular weakness 6 near the periphery.

The largest diameter portion 7 of the barrel houses a bottle shaped drive member 8 whose neck is towards the rear and which has a central aperture in its base. The neck 9 is bifurcated and extends through an aperture 10 defined by an inwardly extending flange 11. Beyond that flange the drive member 8 terminates in out-turned hooks with bevelled surfaces 12 with which the annulus 4 cooperates. At the other, forward end of the drive member 8, there is an outward flange 13, and a coil spring 14 surrounding the member acts between this and the flange 11. As shown in Figure 1 , with the drive member 8 captive to the rear of the barrel, this spring is at its maximum compression. The transition between the rear portion 7 and the intermediate portion 15 of the barrel 1 is internally defined by an annular rib 16. At the forward end of this portion 15 there is another annular rib 17 and initially a charged capsule 18 is located by these ribs, a surrounding coil spring 19 reacting against the rib 17 and urging a flange 20 at the rear of the capsule against the rib 16. The spring 19 is somewhat weaker than the spring 14 and the forward travel of the capsule, when this spring 19 becomes compressed, is limited by spacers 21 extending rearwardly from the rib 17 to provide an abutment for the flange 20. The leading portion of the capsule 18, with a needle 22, is located in the forward end portion 23 of the barrel, the tip of the needle being set back from the end. Initially, the needle 22 is sheathed in a self-sealing silicon rubber shroud 24, protecting against contamination and leakage. The shroud is captive within an inward tubular extension 25 of the cap 2 and so is pulled off when that cap is removed just prior to use.

A plunger 26 is formed by a two-part rod 27A, 27B and a piston 28 within the capsule 18. They are not connected: the piston is provided with the capsule 18, which may be filled with its charge and plugged by the piston quite separately from the assembly of the syringe. The rear end of the rod 27 is bifurcated and near the extreme end the resultant fingers are enlarged to form exterior shouldered abutments 29 against which the annular base of the drive member 8 acts. Near the root of the bifurcation there are further enlargements 30 on opposite sides with sloping surfaces which will wedge into the rear end of the capsule 18, as described below, to close the tips of the fingers together. The two parts 27A and 27B of the rod are interconnected by a piston 31 within a cylinder 32.

For use, the cap 2 is removed taking with it the shroud 24, and the cap 3 is turned through 90° from the "safe" position in Figure 1 , where the tab 5 is holding the hooks 12 apart and firmly engaged with the flange 11. The cap 3 is shown in the "use" position in Figures 2, 3 and 4. The device is then applied to where the injection is to be made and the centre of the cap 3 is pressed. The annulus 4 wedges the hooks 12 together and frees them from the flange 11. The spring 14 is then free to act and it shoots the drive member 8 forwards. The fluid in the capsule is virtually incompressible and it has a very narrow means of escape through the needle 22. The plunger 26 is therefore acting on a substantially solid body and it carries the capsule 18 forwards, compressing the spring 19. This action terminates as shown in Figure 2, with the needle 18 projecting and the flange 20 hard up against the spacers 21.

With the capsule 18 arrested, the plunger 26 carries on under the influence of the dominant spring 14, forcing liquid out through the needle 22. As it reaches the end of the forward stroke (Figure 3) the wedges 30 act to squeeze the bifurcated end of the rod part 27A together, thus bringing the abutments 29 within the compass of the aperture at the base of the drive member 8. At this point, the drive member 8 is arrested by the rib 16, and so the spring 19 can then act, carrying the capsule 18 back with the rod end 27A passing into the drive member 8 until the flange 20 abuts the forward side of the rib 16 (Figure 4). This is the initial position of the capsule, and the needle is safe within the barrel. However, the geometry and length tolerances of the parts of the device may be such that the plunger rod 26 reaches the position where the abutments 29 enter the drive member 8 before the full required charge has been ejected from the capsule 18. In order to prevent this, the arrangement of the piston 31 within the cylinder 32 is such as to create a delayed-motion connection, whereby the full stroke of the plunger 26 to cause the wedges 30 to enter the capsule 18 is delayed until the rod part 27B has travelled sufficiently far to eject the required amount of charge from the capsule 18. The delayed-motion connection between the two parts 27A and 27B of the rod is shown in detail in Figure 5. It will be seen that the piston 31 incorporates a ring seal 33. One means of achieving a delayed-motion action of the movement of the piston 30 into the cylinder 32 would be to create the seal 33 as a "leaky" seal. Additionally or alternatively a controlled air bleed hole 34 can be provided at the base of the cylinder 32. The delayed-motion connection will be arranged to operate until such time as the rod part 27B has fully evacuated the syringe. The rod part 27A will then continue to be driven into the capsule 18 until it abuts the top of the rod part 27B, so that the wedges 30 will interact with the capsule 18 to enable the abutments 29 to be released from the drive member 8 (as in Figure 3 of the drawings).

In order to resist the possibility that the rod part 27B might creep into rod part 27A (during storage, especially with the needle end uppermost), there could be a light clip-fit as between the ribs 37, 38. These ribs would be overridden easily by the spring 14 when the device is operated.

Drugs are currently available pre-packaged in cartridges, similar to conventional syringes but with no end flanges. Such a cartridge has a cap with a pierceable rubber membrane at the reduced diameter delivery end which accepts a double-ended needle. This is packaged inside a shield which enables it to be fitted safely and easily, as well as giving it temporary protection. To provide a flange that would make it usable with the device described above, the cartridge may be fitted inside a sleeve-like carrier. This would be similarly contoured, with a neck surrounding the delivery end of the cartridge and an outwardly projecting flange performing the function of the flange 20 at the opposite end. The neck could be threaded to retain the needle.

Claims

1. An injection device comprising a barrel, a spring loaded drive member therein, release mechanism for allowing said member to be sprung forwardly within the barrel, a spring loaded, charged capsule within the barrel, a needle associated with the capsule initially in a retracted position at the forward end of the barrel, the spring loading of the capsule being in opposition to but weaker than the spring loading of said drive member, a plunger with which the forward end of said drive member co-operates, and a decoupling mechanism for decoupling the plunger from said drive member at the end of the forward stroke, the arrangement being such that said forward stroke first drives the capsule and the needle to a needle projecting position, said drive member acting through the plunger and the capsule charge, and secondly forces the plunger to eject the capsule charge through the needle, the capsule spring loading being then freed by the decoupling mechanism to return the capsule to the needle retracted position, the plunger including a two-part section with a delayed-motion connection therebetween whereby, in operation, the delayed-motion connection acts to delay full actuation of the plunger to the position where the decoupling mechanism is activated until such time as the plunger completes the full stroke needed to eject the required charge through the needle.
2. A device as claimed in claim 1 , wherein said two-part section incorporates a damper.
3. A device as claimed in claim 2, wherein the two-part section is in the form of a piston and cylinder and the damper acts to delay completion of the stroke of that piston into the cylinder.
4. A device as claimed in claim 3, wherein the damper comprises an air bleed hole at the base of the cylinder.
5. A device according to claim 3, wherein the damper comprises a leaky seal of the piston contacting the internal walls of the cylinder.
6. A device as claimed in any one of claims 1 to 5, wherein the capsule is a proprietary syringe with its plunger removed and replaced by said plunger which co-operates with said drive member.
7. A device as claimed in any one of claims 1 to 6, wherein the spring loading is provided by coil springs co-axial within the barrel.
8. A device as claimed in any one of claims 1 to 7, wherein the decoupling mechanism is provided by the rear end of said plunger which is abutted by said drive member and which is adapted to be deformed when it comes into cooperation with the capsule.
9. A device as claimed in Claim 8, wherein said rear end of the plunger is bifurcated and there are exterior projections on the fingers formed thereby, said projections, when engaged by the capsule on entry therein, causing the fingers to be wedged together and in the constricted condition to be free to enter a passage within the drive member.
10. An injection device substantially as herein described, with reference to the accompanying drawings.
11. Any novel combination of features of an injection device as described herein and/or as illustrated in the accompanying drawings.
PCT/GB2003/002132 2002-05-17 2003-05-16 Injection device with automatically retractable needle WO2003097133A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB0211294.4 2002-05-17
GB0211294A GB0211294D0 (en) 2002-05-17 2002-05-17 Improvements relating to injection devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20030725413 EP1507566A1 (en) 2002-05-17 2003-05-16 Injection device with automatically retractable needle
JP2004505128A JP2005525879A (en) 2002-05-17 2003-05-16 Injection device comprising an automatic retractable needle

Publications (1)

Publication Number Publication Date
WO2003097133A1 true WO2003097133A1 (en) 2003-11-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2003/002132 WO2003097133A1 (en) 2002-05-17 2003-05-16 Injection device with automatically retractable needle

Country Status (4)

Country Link
EP (1) EP1507566A1 (en)
JP (1) JP2005525879A (en)
GB (1) GB0211294D0 (en)
WO (1) WO2003097133A1 (en)

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