AU2000268103B2 - A single-use syringe - Google Patents

Description

WO 01/54758 PCT/AU00/01027 1 A SINGLE-USE SYRINGE FIELD OF INVENTION The present invention relates to single-use syringes.

BACKGROUND ART In recent times there has been a proliferation of single-use syringe designs which incorporate shields that can be moved to a forward position to shield the needle after use. In most instances, the shield is locked in the forward position after use to prevent multiple uses of the syringe and/or to prevent inadvertent needle-stick injury.

Examples of syringe designs incorporating shields can be found in US Patent 5,584, 818 to Morrison, US Patent 5,492,536 to Mascia, US Patent 5,527, 294 to Weatherford, US Patent 5,591,138 to Vaillancourt, US Patent 6,099,504 to Gross, US Patent 4,820,275 to Haber, US Patent 5,269,761 to Stehrenberger, US Patent 5,562,626 to Sanpietro, US Patent 4,863,434 to Bayless, US Patent 4,985,021 to Straw, US Patent 5,057,079 to Tiemann, US Patent 5,057,086 to Dillard, US Patent 5,092,851 to Ragner, US Patent 5,201,720 to Borgia, US Patent 5,215,534 to De Harde, US Patent 5,215,535 to Gettig, US Patent 5,222,945 to Basnight, US Patent 5,290,256 to Weatherford, US Patent 5,312,372 to De Harde, and US Patent 5,360,408 to Vaillancourt.

WO 01/54758 PCT/AU00/01027 2 Most of these shielded-syringe designs are provided to the user with the shield in the retracted position and thus some triggering or manual manipulation of the shield is required to release the shield to the forward position after use. In many designs, the movement of the shield to the forward position after use is assisted by a spring.

Only a few of these known designs are provided to the user with the shield initially in the forward position. In these cases, it is necessary for the user to manipulate some form of release mechanism to enable the shield to be moved to the rearward position to expose the needle for use, and after use it is again necessary to manipulate some form of release mechanism to release the shield to the forward position. Again, many of these designs incorporate a spring which biases the shield to the forward position.

SUMMARY OF INVENTION According to one aspect the invention resides in a single-use syringe which is provided to the user with the shield in a forward position, yet requires no manual manipulation of release mechanisms or the like to release the shield to the rearward position for use, nor further manual manipulation to release and lock the shield in the forward position after use.

The above ergonomic advantages are achieved by a single-use syringe as defined in the attached claims.

WO 01/54758 PCT/AU00/01027 3 BEST MODE The invention will now be described with reference to an example for illustrative purposes and wherein:- FIGS 1 to 6 are a series of sequential longitudinal sectioned views of a singleuse syringe demonstrating operation of the single-use syringe; and FIG 7 shows the single-use syringe engaging the male port of an IV fluid bag.

Referring firstly to FIG 1, there is illustrated a pre-filled single-use syringe including a shield 12 having a shield extender 14, a barrel 16 mounted for reciprocation within the shield 12 and having a needle 18 at its forward end, and a plunger assembly 20 mounted for reciprocation within the barrel 16.

The shield 12 is generally cylindrical in shape and includes a generally cylindrical shield extender 14 at its forward end. The shield extender 14 can be selectively extended to control the depth of penetration of the needle during use as will be described in more detail later. Conventional finger receiving portions 22 are defined towards the rear end of the shield 12, the finger receiving portions 22 adapted to receive a user's fingers in the conventional manner during use. The forward end of the shield includes a circular slot 24 which engages a retains a locking member 26 during use as will be described later.

WO 01/54758 PCT/AU00/01027 4 The rearward end of the shield includes a rear collar flange 28 which limits the barrel's 16 rearward travel within the shield 12.

The barrel 16 is pre-filled with medicament and is sealed at its rearward end by the plunger assembly 20 and at the forward end by a frangible seal 30 which can be broken by the needle mount 32 prior to use as will be discussed later.

The needle 18 extends forwardly from the needle mount 32 which is itself located immediately forward of the frangible seal 30. The barrel 16 bears a generally cylindrical bifurcated locking member 26 about its forward end which is adapted to engage and be retained by the circular slot 24 in the shield 12 as will be described in greater detail later.

The plunger assembly 20 is conventional in construction and includes a piston 34 at its forward end which sealingly engages the internal bore of the barrel 16.

The plunger assembly 20 also defines a conventional thumb engaging portion 36 at its rearward end.

Referring firstly to FIG 1 there is illustrated a pre-filled single-use syringe in the form in which it would be supplied to a user. Normally, the pre-filled single-use syringe 10 would be individually packaged and supplied in a sterile plastic package which is not illustrated. Both the packaging and syringe itself would identify the medicament and volume of medicament present in the barrel of the syringe.

WO 01/54758 PCT/AU00/01027 As mentioned above, the medicament is sealed within the barrel 16 by the piston 34 of the plunger assembly 20 at the rearward end of the barrel 16 and by a frangible seal 30 at the forward end of the barrel 16.

The first step in the use of the syringe is the breaking of the frangible seal and this is best understood with comparative reference to FIGS 1 and 2.

Shield extender 14 is mounted via a coarse screw thread on the forward end of shield 12 such that rotation of shield extender 14 relative to shield 12 causes the shield extender to reciprocate in the forward or aft direction relative to shield 12.

As can be seen with reference to FIG 1, the syringe is provided with the shield extender 14 in a slightly forward position, i.e. the shield extender 14 extends slightly forward beyond the forward-most extent of the shield 12.

A cap 38 is provided, and the cap 38 has an outer skirt which is frictionally seated on the shield extender 14 as shown. The shield extender 14 also has a small outwardly extending shoulder which is engaged by the outer skirt and prevents rearward movement of the cap 38 relative to the shield extender 14.

The cap 38 also encloses the needle 18 with a rearwardly extending inner skirt which seats on the tapered forward end of the needle mount 32 as shown.

With reference now to FIG 2, the cap 38 and shield extender 14 have been rotated relative to shield 12 such that the shield extender 14 and cap have WO 01/54758 PCT/AU00/01027 6 moved in unison rearwardly relative to shield 12 until the rear end of the shield extender 14 has abutted a small outwardly extending shoulder formed on the shield 12 which prevents further rearward movement of the shield extender 14 relative to the shield 12. Simultaneously, the needle mount 12 has been driven rearwardly by the inner skirt of the cap 38 such the frangible seal 30 has been broken and the needle 18 is thus now in fluid communication with the interior of the barrel 16. The frangible seal 30 is designed to have a portion of its circumference form a "live" or integral hinge about which the remainder of the frangible seal 30 pivots. A frangible seal and live hinge per se is known from PCT/AU99/00422.

It will be noted that the needle mount 32 is non-conventional in construction in that it is cylindrical and fully contained within the seal-containing bore of the spigot-shaped nose of the barrel 16. In contrast, conventional needle mounts include a rearwardly projecting skirt which surrounds the exterior of the spigotshaped nose of the barrel 16. It is for this reason that the syringe disclosed in PCT/AU99/00422 utilised a cylindrical tube 21 intermediate the conventional needle mount 7 and frangible seal 9 for the purpose of breaking the frangible seal 9.

With reference to FIG 3, cap 38 has been removed and the needle is now ready for use with the needle being shielded, but in fluid communication with the interior of the barrel 16 which accommodates the medicament.

WO 01/54758 PCT/AU00/01027 7 Referring to FIG 3A, the shield extender 14 has been rotated in the reverse direction relative to the shield 12 such that the shield extender 14 has moved forwardly relative to shield 12 from its fully retracted position and it now extends forwardly beyond the forward-most extent of shield 12. Selective rotation of shield extender 14 relative to shield 12 allows the user to control the depth of penetration of the needle 18 during use. The further the shield extender 14 is extended beyond the shield 12, the shallower the penetration of the needle 18 in the patient.

With reference now to FIG 4, the user has begun squeezing together thumb receiving portion 36 of the plunger assembly 20 and finger-receiving portions 22 of the shield 12 in the conventional manner thereby compressing compression spring 40 which is provided between a small outwardly extending shoulder formed on the rear end of barrel 16 and a small inwardly directed shoulder formed midway along the length of shield 12.

As shown in FIG 4, the plunger assembly 20 has not yet moved forwardly relative to barrel 16 to express medicament from the needle 18. Rather, plunger assembly 20 and barrel 16 have moved forwardly in unison within shield 12 and shield extender 14. Plunger assembly 20 and barrel 16 will continue to move forward in unison until the forward end of barrel 16 engages the forward end of shield 12 whereat the compression spring 40 reaches its maximum compression.

WO 01/54758 PCT/AU00/01027 8 With reference now to FIG 5, the barrel 16 has moved to the fully forward position relative to shield 12 such that the forward end of barrel 16 engages the forward end of shield 12 and the needle 18 is maximally exposed. Thereafter, any further squeezing together of the thumb receiving portion 36 and finger receiving portions 22 in the conventional manner causes the plunger assembly to move forward relative to barrel 16 thereby expressing the medicament from the interior of the barrel 16.

With reference to FIG 5, it should be noted that the forward end of locking member 26 (which has been carried forward on the forward end of barrel 16) has engaged the circular slot 24 defined in the forward end of shield 12. The locking member 26 is thereafter retained in this position by virtue of its engagement with the slot 24.

With reference to FIG 6, the squeezing force applied by the user has been discontinued and the barrel 16 and plunger assembly 20 have moved rearwardly in unison under the influende of compression spring 20. It will be noted that locking member 26 is retained in the circular slot 24 defined in the forward end of shield 12. As barrel 16 moves rearwardly relative to shield 12, locking member 26 slides or is pulled off the forward end of barrel 16 until it is fully clear of barrel 16 as shown in FIG 6. At this stage, the rear end of locking member 26, which is formed of a resilient plastics material having a memory, snaps inwardly to adopt a truncated and bifurcated cone-like shape as shown in FIG 6. Of course, previously whilst the locking member 26 was encircling barrel 16, it adopted a bifurcated cylindrical shape. Thus, the resilient memory of the WO 01/54758 PCT/AU00/01027 9 locking member 26 causes the locking member to change shape from a generally cylindrical shape to a generally truncated cone-like shape when it is "pulled" off the forward end of the barrel 16 via its engagement with slot 24.

Once the locking member 26 has adopted the truncated cone-like shape as shown in FIG 6, subsequent forward movement of the barrel 16 relative to the shield 12 is prevented by virtue of physical interference with the locking member 26 and hence the locking member 26 prevents subsequent unshielding of the needle 18.

Referring to FIG 7, the single-use syringe can also be conveniently used in a safe manner with intravenous polybags as shown. In this regard, the forward end of the shield 12 is sized so as to closely receive the male port of a polybag as shown. Typically, these male ports are sealed by a rubber plug as shown. The needle can penetrate through the rubber plug and the medicament can then be injected into the polybag for IV feed to the patient via an established catheter or the like. After injection of the medicament into the polybag, the needle is withdrawn and the rubber plug is sufficiently resilient to be reseal the male port of the poly bag.

The present invention provides a single-use syringe which is supplied to the user with the shield in the forward or shielding position, yet requires no nonconventional manipulation or activation of release mechanisms or the like to move the shield back to the needle-exposed position for use. Furthermore, no nonconventional manipulation of release mechanisms or the like is required to release the shield to the forward protective position after use. The user simply squeezes their thumb and fingers together in the conventional manner and this single, conventional action exposes the needle 18, activates the locking member 26 via its engagement with the slot 24, and expresses the medicament. Discontinuation of the squeezing force cause the shield to return to its forward or protective position under spring bias whereat it is locked to prevent subsequent use or inadvertent needle-stick injuries.

WO 01/54758 PCT/AU00/01027 It will of course be realised that whilst the above has been given by way of an illustrative example of this invention, all such and other modifications and variations hereto, as would be apparent to persons skilled in the art, are deemed to fall within the broad scope and ambit of this invention as is herein set forth.

Claims (8)

1. A single-use syringe including:- a shield; a barrel having a needle at its forward end, the barrel being mounted for axial reciprocation within the shield between a rearward position whereat the needle is shielded and a forward position whereat the needle is exposed; characterised in that the barrel carries forward a locking member when the barrel is moved from the rearward position to the forward position, and wherein the locking member engages the shield at the forward position, and is retained in a forward position by the shield as the barrel is returned to the rearward position, the locking member preventing subsequent forward movement of the barrel.

2. A single-use syringe as claimed in claim 1, wherein the barrel is biased to the rearward position.

3. A single-use syringe as claimed in claim 1 or 2, wherein the syringe includes a plunger assembly mounted for axial reciprocation within the barrel, and wherein the plunger assembly defines a thumb receiving portion and the shield defines at least one finger receiving portion such that the thumb and finger(s) of a single hand of a user can engage the syringe to firstly move the barrel forward relative to the shield to expose the needle, and thereafter to move the plunger assembly forward relative to the barrel to express medicament. WO 01/54758 PCT/AU00/01027 12

4. A single-use syringe as claimed in claim 1, wherein the locking member initially encircles the forward end of the barrel, and wherein the locking member prevents subsequent forward movement of the barrel when it is removed from the forward end of the barrel.

A single-use syringe as claimed in claim 4, wherein the locking member is a bifurcated cylinder which adopts a truncated cone-like shape when itis rermoved from the forward end of the barrel.

6. A single-use syringe as claimed in claim 1, wherein the locking member engages, and is retained by, a slot defined in the shield.

7. A single-use syringe as claimed in claim 1, wherein the shield includes a shield extender for controlling the depth of penetration of a needle.

8. A single-use syringe as claimed in claim 1 wherein the forward end of the shield is adapted to receive the male port of an IV bag or the like.