EP1617889A1

EP1617889A1 - Syringe system

Info

Publication number: EP1617889A1
Application number: EP20040730287
Authority: EP
Inventors: Jeremy Francis Donnan; John Targell
Original assignee: NMT Group PLC
Current assignee: NMT Group PLC
Priority date: 2003-05-01
Filing date: 2004-04-29
Publication date: 2006-01-25
Also published as: KR20060009281A; WO2004096326A1

Abstract

A syringe system comprises a cylindrical barrel (20) in which is slidable a plunger (22) for drawing liquid into and expelling it from the barrel. A filling needle unit (40) is connectable to a connection portion (24) of the barrel by an adaptor (42) to which it is releasably coupled. The adaptor (42) and at least one retraction type injection needle (14) are selectively connectable to the connection portion (24) of the barrel so that liquid can be drawn into the barrel through the filling needle unit and can be expelled from the barrel through either the adaptor, after removal of the filling needle unit, or an injection needle unit, as desired. The barrel may be provided with finger engaging flanges (28) which can be restrained by the fingers of a user during forward movement of the plunger (22) effected by the thumb, and these finger engaging flanges have substantially parallel grooves on diametrically opposite sides of the barrel for registering with guide rails, along which the barrel is fed during its production, in order to facilitate desired orientation of the barrel.

Description

SYRINGE SYSTEM This invention relates to a syringe system for use in the administration of medications, such as, drugs and the like.

It is a common, although by no means universal, practice to change the needle of a syringe after filling and before administration of the inj ection because of a perception that the original needle may become blunted, bent or subjected to loss of needle lubricant during the filling operation, for example, by insertion through the rubber cap of the vial, contaminated with a foreign substance, for example, latex from such a cap, or rendered unsterile. In the case of syringes with provision for retraction of the needle after use, as disclosed for instance in our prior specification EP-A-776225, the needle assembly tends to be specially designed for this purpose and it is not therefore practical to contemplate changing needles after filling the syringe and before administering the injection.

The invention is particularly concerned with a system which affords enhanced flexibility for the user.

According to one aspect of the present invention there is provided a syringe system comprising a barrel for receiving the liquid to be injected, a filling needle unit connectable to a connection portion of the barrel, an adaptor and at least one retraction type injection needle unit, the injection needle unit and adaptor each being connectable to the connection portion of the barrel, and a plunger movable within the barrel to draw liquid into the barrel through the filling needle unit and to expel the same from the barrel through an injection needle unit or adaptor selected for connection to the barrel.

The filling needle may be connectable to the barrel through the adaptor. To this end, the filling needle and the adaptor may be combined into a unit which is connectable to the connection portion of the barrel. For example, the filling needle unit may be releasably coupled to the adaptor which, in turn, is adapted to be connected to the barrel so that, initially, the combined unit may be fitted to the barrel to effect filling of the syringe. The user then has the option of removing the filling needle unit leaving the adaptor connected to the barrel or of removing to the combined unit so that an injection needle unit can be fitted to the barrel. The adaptor typically has a tapering nose, e.g. of generally conical configuration, with a passageway extending through it.

The adaptor and/or the injection needle unit(s), when connected to the barrel, may be arranged to sealingly engage with a lip seal provided internally of the barrel and to this end the adaptor and/or the injection needle unit(s) may be provided with a projection which extends into the barrel interior to make sealing engagement with a lip seal provided on the inner wall of the barrel.

Where the system includes more than one injection needle unit, the units may have different characteristics. The injection needle units of the system may, for example, differ from one another in terms of needle gauge and/or length and/or wall thickness

(normal, thin and ultra thin wall thickness) and/or needle tip configuration (such as triple bevel 12° cut or back cut) and/or different types of lubrication or other coatings.

The invention affords flexibility coupled with safety in that, for a given barrel, any one of multiple injection needles may be selected according to requirements and connected to the barrel connection portion in place of the filling needle and because each injection needle unit is of the retraction type, after use the injection needle is rendered inaccessible thereby avoiding the risk of needle stick injuries to the user, the patient or others. Alternatively, the adaptor may be used instead of an injection needle unit where, for instance, the medicament may be administered via an IV catheter or the like. The adaptor may be a male adaptor suitable for co-operation with a substantially complementary female component. The adaptor may for instance have the configuration of a Luer fitting.

Another aspect of the present invention is concerned with the orientation of the barrel of fluid handling devices such as syringes during high speed manufacturing production processes.

According to this aspect of the present invention there is provided. a. fluid handling device having a barrel and a plunger which is received in the barrel and which has a rear end projecting from the barrel to allow thumb pressure to be applied thereto in order to displace the plunger forwardly in the barrel, the barrel being provided with a finger-engaging flange or flanges so that the barrel can be restrained by the fingers during forward movement of the plunger effected by the thumb, the barrel and/or the finger-engaging flange or flanges being adapted to facilitate consistent orientation of the barrel when suspended between guide rails by the flange or flanges.

This aspect of the invention is particularly applicable to barrels which, in contrast to square cross-section barrels, do not inherently have any orientation features, for instance barrels of cylindrical cross-section. The adaptation of the barrel or flange or flanges allows multiple barrels to be consistently oriented as they are fed in succession along the guide rails to one or more stages of the production process, e.g. a printing stage involving application to a specific location on the barrels of graduations indicating the liquid content of the barrel after filling. In one embodiment of the invention, consistent orientation is facilitated by providing substantially parallel grooves in the finger-engaging flange or flanges on diametrically opposite sides of the barrel so that alignment of multiple barrels is obtained by registration of the guide rails within the grooves.

The grooves may be contoured so that when a barrel is randomly oriented between the guides, as soon as approximate alignment with the rails occurs, as will inevitably happen when the barrels progress along the rails, the contour biases the flange or flanges into alignment so that the guide rails become properly registered with the grooves. The depth of the grooves may vary along their length, e.g. the deepest part may be at an intermediate point between the ends of the groove. In an alternative embodiment, the orientation features may be provided on the barrel, e.g. in the vicinity of the flange or flanges so that the orientation features can cooperate with the guide rails to effect the desired orientation.

The invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figures 1 to 3 are perspective views illustrating components forming part of a syringe system in accordance with the present invention;

Figure 4 is a view similar to that of Figure 1 but shown as a longitudinal section; Figure 5 is a view similar to that of Figure 1 but showing only the Luer-type adaptor fitted to the syringe barrel; Figure 6 is a view similar to that of Figure 5 but shown as a longitudinal section; Figure 7 is a view showing a selected injection needle unit of the retractable type fitted to the syringe barrel;

Figures 8 and 9 are sectional views corresponding to Figures 2 and 3; Figure 10 is a view showing part of an assembly line along which syringe barrels are fed in succession; and

Figure 11 is a similar view to that of Figure 5 but from the underside so as to show the interaction between the guide rails and orientation features on the barrel. Referring to Figures 1 to 8, the syringe system illustrated comprises the 20 following components: (i). a barrel and plunger unit 10 (Figures 1 , 4 and 5);

(ii). a combined filling needle unit and Luer adaptor 12 (Figures 1, 4 and 5); and (iii). at least two injection needle units 14 of the retractable type (Figures 2, 3 and 6), one of which can be selected for connection to the barrel according to requirements.

The unit 10 comprises a generally cylindrical barrel 20 which receives a plunger 22. The barrel 20 has a connection portion 24 at its forward end and a fitting 26 at its trailing end. The fitting 26 includes a finger flange or flanges 28 allowing the user to control the barrel during operation of the plunger. The fitting 26 also co-operates with the thumb pad 30 of the plunger in such a way that the pad 30 enters and becomes trapped within the fitting 26 in the course of the forward stroke of the plunger 22.

The plunger 22 is generally cylindrical and is hollow. At its forward end, it is provided with a closure member 32 of the type disclosed in our International Publication Nos WO-02087669 or WO-0142104, the entire contents of which are incorporated herein by reference. The forward end of the hollow plunger 22 is also provided with an elastomeric seal 34 which makes sealing engagement with the internal surface of the < - •< barrel 20 so that liquid introduced into the barrel through its forward end is confined to the chamber delimited by seal 34.

The closure member 32 comprises a rim portion 36 fitted with a forwardly projecting blocking portion 38 of generally frusto-conical configuration so that the blocking portion 38 closes and seals the aperture in the rim portion 36. The rim portion and the blocking portion seal the forward end of the plunger to prevent ingress of liquid into the plunger interior from the interior of barrel 20.

The rim and blocking portions 36, 38 are formed as plastics mouldings by two- shot moulding so that the two portions 36 and 38 are integrated and captive with each other in such a way that they can be separated from each other in response to the application of a predetermined axial force as described in the aforementioned International Publications.

The component 12 comprises a filling needle unit 40 and a Luer adaptor 42. The filling needle unit comprises a needle 44 projecting forwardly from a supporting collar 46 with which it may be formed integrally, e.g. as a single piece plastics moulding. The needle 44 has a pointed forward end 15 capable of penetrating the rubber cap of a vial or 5 being inserted into an ampoule whose cap has been broken therefrom.

A guard 48 in the form of a generally cylindrical wall surrounds the needle 44 and may be formed integrally with the needle 44. The guard is designed to be removable from the unit 40 and may for this purpose be joined to the unit 40 by a frangible connection or connections 50 with the collar 46. The guard 48 protects the needle 44 from contact with the fingers and also prevents its pointed end from damaging and thereby compromising the sterility of primary packaging in which the filling needle unit 40 may be supplied. At its rear end, the needle unit 40 is provided with a connector 52 by means of which it is connectable to the Luer adaptor 42. The connector 52 may be integral with the collar 46 and the collar and connector 52 are formed with a bore 53 in communication with the interior of the needle 44.

The Luer adaptor comprises a Luer connector 54 in the form of a generally frusto-conical male component for insertion into the socket afforded by the connector 52 .on the filling needle unit 12. An internally screwthreaded sleeve 56 encircles the connector 54 and is adapted to co-operate with a thread section or sections 58 provided externally of the connector 52 so that the filling needle unit 40 and the Luer adaptor 42 can be interconnected by a screw fitting them together. This action causes the connector 52 to sealingly engage with the connector 54. Alternatively, the unit 40 and adaptor 42 may be interconnected by other means, e.g. a bayonet type connection, or they may be interconnected solely by friction fit of the connector 52 with the connector 54.

The connector 54 is provided with a bore 60 which provides communication between the interior of the barrel 20 and the needle 42 so that liquid can be drawn into the barrel through the filling needle by pulling the plunger 22 rearwardly in the usual fashion. The adaptor 42 is engaged with the barrel 20 by means a screwthreaded-type connection between an external screwthread section 61 on the connector portion 24 of the barrel and an internal screwthread on a rearward part 62 of the adaptor 42, which part 62 may be a continuation of the sleeve 56. This screwthreaded connection is designed to be reversible to allow the adaptor 42 to be coupled to the barrel and subsequently released.

The adaptor 42 includes a nose portion 63 for co-operation with a lip seal 64 provided on the barrel 20, e.g. within the connector portion 24 as illustrated, so as to provide an effective seal when the adaptor is screwed on to the barrel. The lip seal 64 projects radially inwardly and axially rearwardly so as to be of conical shape. The nose portion 63 is of complementary frusto-conical configuration. When the adaptor 42 is screwed on to the connector portion 24, the lip seal 64 rides over the outer surface of the nose portion 63 and is deflected radially inwardly to effect sealing. Because the lip seal projects inwardly, it will be appreciated that it will act as a cup seal so that, when liquid is being forced out of the barrel, the resulting pressure will tend to deflect the lip seal 64 radially inwardly thereby enhancing the effectiveness of the seal.

In the case of small capacity barrels, e.g. 1 ml, the lip seal 64 may be so dimensioned that when the barrel has been filled with liquid and the adaptor 42 has been removed, the aperture defined by the lip seal is sufficiently small to ensure that the liquid is retained within the barrel even when held vertically with its forward end directed downwardly.

The injection needle units 14 of the system are of the retractable type and may be of the form described in International Publication Nos WO-02087669 or WO-0142104. Each unit 14 comprises a needle 70 mounted by a spring-loaded hub 74 which, normally, is restrained axially by a stop member or restrainer 76 which, in turn is restrained against rearward axial movement relative to the housing 72. The restrainer 76 is however allowed a limited degree of forward movement relative to the housing. The arrangement of the hub, restrainer and the housing may be as disclosed in our prior specification No PCT/GB03/04099, the entire contents of which are incorporated herein by reference. The restraint imposed on the hub 74 by the restrainer 76 may be achieved by producing the components as a two shot moulding as disclosed in International

Publication No WO-02087669, the restraint being overcome by displacing the restrainer 76 axially relative to the hub 74 as the plunger 22 approaches or completes its forward stroke during a needle injection procedure. During this movement of the plunger 22, the blocking portion 38 is decoupled from the rim portion 36 with the net result that the spring loading on the hub 74 causes needle retraction by driving the hub 74 and the needle 70 rearwardly into the interior of the hollow plunger 22.

The injection needle units 14 illustrated differ in that they have different needle lengths. The system may include more than two injection needle units having different characteristics, e.g. different needle lengths and/or needle gauges, so that a suitable injection needle unit may be selected according to requirements. Although the injection needle units 14 will have different characteristics according to the nature of the injection to be administered, they will in general have many structural features in common, e.g. the dimensions of the housing, the hub and the stop element may be the same for each injection unit. To cater for different needle gauges, the hub may be formed with a needle receiving bore which is tapered and/or stepped to receive different diameter needles.

Connection of a selected injection needle unit 14 to the connection portion 24 of the barrel 20 is effected by means of a screwthreaded type connection between a rearward section 78 of the housing 72 which may be provided with an internal screwthread section or sections 80 for co-operation with the external screwthread 61 on the connection portion 24. In contrast with the connection between the Luer adaptor 42 and the barrel, the connection between each injection needle unit 14 and the barrel is, desirably irreversible so that the units 14 may be readily attached to the barrel but cannot be readily removed. This may be achieved by using a coupling of the form employing barbs, as disclosed in GB-A-2353 078, the disclosure of which is incorporated herein by this reference. By omitting the barbs for the connection between the Luer adaptor 42 and the barrel, it will be seen that the latter connection may be reversible. The needle unit(s) 14, when fitted to the barrel, make sealing engagement with the lip seal 64, i.e. by contact between the outer surface of the restrainer 76 with the seal 64.

In use, the combined filling needle unit and Luer adaptor 12 is initially fitted to the barrel so that the barrel can be filled with the liquid dose to be administered. After 5 the guard 48 has been removed and the barrel has been filled, the next stage depends on how the dose is to be administered. If it is to be administered by means of an IV access system, then the Luer adaptor 42 is used to effect connection to the access port of the IV access device, i.e. by insertion of the Luer connector 54 into the access port of the IV access device. In this case, only the filling needle unit is removed, leaving the Luer

10 adaptor 42 secured to the barrel (see Figure 6). The contents of the barrel can then be dispensed by depressing the plunger 22 in the forward direction.

The connection to the IV access device may be of the slip-type in which the connector 54 is a push-on, pull-off friction fit with the access port or it may be of the locking type in which the connector 54 fits to the access port with some form of locking

15 action which, for instance, requires turning of one component relative to the other to engage and release them. In the illustrated embodiment, the Luer connection is of the slip-type.

On the other hand, if the dose is to be administered as an injection into the patient, the combined filling needle unit and Luer adaptor 12 is wholly removed from the

20 barrel, as a unit, and the injection needle unit appropriate to the injection procedure to be carried out is irreversibly connected directly to the barrel (see Figure 7). After the Luer adaptor 42 has been removed and before the injection needle unit is aft ached, the dose may be retained in the barrel 20 by virtue of the dimensioning of the lip seal 64 in conjunction with surface tension effects, especially where the barrel is one having a

25 relatively low capacity.

• ■ •», ■ Once the desired needle injection unit has been attached, the dose is then delivered by depression of the plunger 22 and, as the plunger approaches or completes its stroke, the needle retraction mechanism is triggered to retract the needle 70 into the hollow plunger so that it is no longer accessible. At this stage, the forward end of the

30 barrel is closed by the needle housing 72 and the plunger 22 is made captive to the barrel since the pad 30 has entered the fitting 26 thereby hindering withdrawal of the plunger back out of the barrel.

It will be understood that the invention is not restricted to the embodiment exemplified in and described with reference to the drawings. For instance, although in the illustrated embodiment the filling needle unit 40 and the Luer adaptor 42 are combined, they may be entirely separate, in which case the unit 40 will be suitably adapted so that it can be directly connected to the connection portion of the barrel in substantially the same manner as the Luer adaptor is connected to the barrel.

Referring now to Figures 1, 10 and 11, to aid orientation of the barrel 20 during high speed assembly operations involving feeding a number of barrels 20 in succession, the barrel design incorporates orientation features for co-operation with guide rails 100 along which the barrels 20 are fed during the production process. As shown in Figures 1, 4 and 12, the finger flange or flanges 28 are provided on the forward side with orientation features in the form of grooves 102 on diametrically opposite sides of the barrel, the grooves being spaced so as to register with guide edges 104 of the rails 100 in such a way that, if a barrel is slightly misregistered when initially loaded on to the guide rails, the shaping of the grooves 102 tend to re-orientate the barrels as they progress along the guide rails 100. The grooves 102 for this purpose have a cross-sectional profile of curved configuration. In alternative embodiments, the orientation features may be other than grooves; for example, the barrel may be formed with one or more flats for co-operation with the guide rails.

The adaptor referred to herein may be configured in accordance with a standard Luer type fitting as currently used for a wide range of syringes, needles and other parenteral systems. However, in recent times, it has been recognised that it is desirable to have non-standard fittings (similar to Luer fittings) so as to prevent the injection of drugs intended for intravenous use into the Central Nervous System (e.g. spinal injections). The adaptor of the present invention may therefore be of a type which is non-standard (but similar to a Luer type fitting) to allow differentiation between CNS medications and injection systems and intravenous medications and injections. Whilst endeavouring in the foregoing specification to draw attention to those features of the invention believed to be of particular importance, it should be understood that the Applicant claims protection in respect of any patentable feature or combination of features disclosed herein and/or shown in the drawings whether or not particular emphasis has been placed on such feature or features.

Claims

1. A syringe system comprising a barrel (20) for receiving liquid to be injected, a filling needle unit (40) connectable to a connection portion (24) of the barrel, and a plunger (22) slidable within the barrel to draw liquid into the barrel through the filling needle unit, characterised by an adaptor (42) and at least one retraction type injection needle unit (14) selectively connectable to the connection portion (24) of the barrel (20), whereby to enable liquid to be expelled from the barrel selectively through the adaptor or an injection needle unit.

2. A syringe system according to claim 1, wherein the filling needle unit (40) is connectable to the barrel (20) by the adaptor (42).

3. A syringe system according to claim 2, wherein the filling needle (40) and the adaptor (42) are assembled into a combined a unit (12), the filling unit needle being releasably coupled to the adaptor which is connectable to the connection portion (24) of the barrel, whereby the combined unit (12) is adapted to be fitted to the barrel for filling of the syringe.

4. A syringe system according to any preceding claim, wherein a lip seal (64) is arranged internally of the barrel (20) and the adaptor (41) and/or the or each injection needle unit (14) comprises a projection (63) which extends into the interior of the barrel, when the adaptor and/or injection unit is connected thereto, so as to make sealing engagement with the lip seal.

5. A syringe system according to any preceding claim, including a plurality of the injection needle units (14) having different characteristics, for example, differing needle gauges, lengths, wall thicknesses, needle tip configurations and/or different types of lubrication or other coatings.

6. A syringe system according to any preceding claim, wherein the adaptor (42) has a tapering nose (54), for example, of generally conical configuration, with a passageway extending through the nose.

7. A syringe system according to any preceding claim 1 to 5, wherein the adaptor (42) includes a male fitting (54), for example, a Luer fitting, for cooperation with a complementary female fitting of the filling needle unit (40) or other component for connecting the component to the adaptor to the component.

8. A syringe system according to any preceding claim, wherein the plunger (12) has a rear end projecting from the barrel (20) to enable thumb pressure to be applied thereto in order to displace the plunger forwardly in the barrel, the barrel being provided with one or more finger engaging flanges (28) so that the barrel can be restrained by the fingers of a user during forward movement of the plunger effected by the thumb, and the barrel and/or the finger engaging flanges having means (102) to facilitate desired orientation of the barrel when suspended by the flange(s) between guide rails along which the barrel is fed during production.

9. A fluid handling device having a barrel and a plunger which is received within the barrel and which has a rear end projecting from the barrel to allow thumb pressure to be applied thereto in order to displace the plunger forwardly in the barrel, the barrel being provided with one or more finger engaging flanges (28) so that the barrel can be restrained by the fingers of a user during forward movement of the plunger effected by the thumb, characterised in that the barrel (20) and/or the or at least one of the finger engaging flanges (28) has means (102) to facilitate desired orientation of the barrel when suspended from the flange(s) between guide rails (102) along which the barrel is fed during production.

10. A system or device according to claim 8 or 9, wherein the orientation means comprises substantially parallel grooves (102) formed in the finger engaging flange(s) (28) and disposed at diametrically opposite sides of the barrel for registration with the guide rails.

11. A system or device according to claim 10, wherein the grooves (102) are contoured so that when a barrel (20) is randomly oriented between the guide rails (100) and as soon as approximate alignment with the rails occurs, the contour biases the flange(s) into alignment in order properly to register the grooves with the guide rails.

12. A system or device according to claim 11, wherein the depths of the grooves (102) vary along their length, for example, the deepest part is at an intermediate position between the ends of the or each groove.

13. A system or device according to claim 8 or 9, wherein the orientation means is provided on the barrel (20) in the vicinity of the flange(s) (28) so as to cooperate with the guide rails (100).