WO1991007199A1

WO1991007199A1 - Needle protection device

Info

Publication number: WO1991007199A1
Application number: PCT/GB1990/001789
Authority: WO
Inventors: Marc Andrew Koska
Original assignee: Agven Medical Corporation Limited
Priority date: 1989-11-20
Filing date: 1990-11-20
Publication date: 1991-05-30
Also published as: GB8926198D0; AU6719790A

Abstract

A device for protecting a syringe needle (5) comprises a blind sheath (10) having a passage means (19) provided by longitudinally extending flexible lips (18) which open in response to a force exerted through the needle (5) in a direction transverse to the longitudinal axis of the needle to permit the needle (5) to pass into the interior (14) of the sheath (10). The provision of the passage means guards against accidental needle strike, the device can be made in one piece of a suitable plastics material by injection moulding and can be fitted to currently available syringe barrels.

Description

NEEDLE PROTECTION DEVICE

DESCRIPTION

This invention relates to protective devices such as caps for needles, more particularly syringe needles .

Nowadays syringes, in particular disposable syringes, are supplied in sterile packaging with a protection cap. Such needle caps are of simple construction and comprise a one-piece plastics moulding consisting of a blind sheath which surrounds the needle, with its closed end adjacent the needle tip and a milled collar at the open end of the sheath that sealingly engages with the nose of the syringe barrel. By this means the needle cap maintains the needle sterile after removal of the sterile packaging and when properly replaced after an injection completely surrounds the needle to guard against accidental needle strike causing spread of contagious diseases.

However, because, after an injection, the only way of replacing the cap on the syringe is by a movement of the needle towards the user or vice versa unless the user is extremely careful, there is a risk that the user could miss the cap resulting in needle strike and thus the danger of infection. In cases of AIDS or hepatitis B, death can and has followed. Thus, the prior art has numerous proposals for preventing not only during, but also after, recapping accidental needle strike, ranging from needle holding devices, as disclosed in US Patent No 4,728,321, needle destruction devices as disclosed in U.K. Patent specification No 2,023,428; shield devices as disclosed in EP No 0255215, and cap locking devices as disclosed in US Patent No 4,430, 080. Since all these known devices require a movement in which the tip of the needle moves towards a user' s hand or vice versa, there is always the danger that accidental needle strike could occur. Moreover, these devices are bulky in use and expensive to produce.

Accordingly, this has led to further proposals having been made including an open ended lengthwise sliding sheath in EP No 0250104, which is mounted on the syringe barrel and is slid proximally to permit an injection and distally in the direction away from the needle tip to surround the needle after use. But the syringe barrel has to be modified and the distal end of the sheath is left open.

In other proposals, anti-needle strike protection caps involve a recapping movement that is largely transverse to the axis of the needle, for example as disclosed in U.S. Patent Nos 4,747,836 and 4,643,722, U.K. No 2215612 and PCT Publication Nos. 0 87/07162; W088/00477 and W088/07873. Out of these specifications, it is understood that only the devices disclosed in U.S. No.4,643,722; WO 88/00477 and U.K. 2,215,612 enable the needle to be maintained sterile after removal of the sterile packaging and only WO88/00477 and UK 2215612 teach needle enclosure after recapping. Without effective needle enclosure after recapping blood and/or other fluids can drip out of the cap bringing with it the risk of contamination. This problem is overcome in WO 88/00477 in which a strip is used to close a longitudinal slot after recapping and in UK 2215612 in which a pair of jaws is closed after recapping to enclose the used needle. However, in these latter two proposals, additional means which have to be separately made are required for enclosing the needle before and after use, thereby increasing expense and involving another action which can be omitted.

Because of all these disadvantages, the caps which are still used, despite the risk of accidental needle strike are the simple caps described in paragraph two of this specification.

Accordingly, the main object of the present invention is to provide a needle protection device in which the aforesaid disadvantages are overcome or at least substantially reduced.

From one aspect, the present invention consists in a device for protecting a needle, in which device at least a part of the needle may be forced in a direction transverse to the longitudinal axis of the needle.

By means of the invention the device can be made in one piece and can be fitted to the currently available disposable syringe barrels without any modification of the barrel.

So as to ensure that blood or other fluids do not drip out of the device, from another aspect the present invention consists a protection device for a needle, the device having a normally closed aperture which is openable to admit at least a part of the needle in response to a force exerted through the needle in a direction transverse to the longitudinal axis of the needle.

It may well be desirable to prevent the needle from being removed the way it has been introduced, in which case and from a further aspect, the present invention consists in a device for admitting and protecting a needle, the device having passage means through which, during admittance only, at least a part of the needle can pass in a direction transverse to the longitudinal axis of the needle.

In order to faciliate entry of the needle into the device longitudinally extending guide means, is advantageously provided.

Preferably the guide means is constituted by two wings, ribs or ridges which project outwardly of the passage means or aperture.

The entry of the needle may be further facilitated if the passage means or aperture has an entry area which is inclined in the direction towards the axis of the device.

In a preferred embodiment the aperture or passage means is constituted by two longitudinally extending flexible lips or flaps which may abut or touch each other at or adjacent their free edges and which are parted by the force exerted by the syringe needle and which close together after the needle has entered the device. Alternatively, in the case of one embodiment of passage means, the free edges of the lips may have a slight gap therebetween through which the needle may be forced. To permit the device more easily to gripped during insertion of the needle, the device is conveniently provided with one or more gripping projections, eg in the form of longitudinally extending ridges.

At its open end, the device is preferably provided with an open sided collar to permit entry of the syringe nose transversely of the needle axis during insertion.

Whilst the following feature may require modification of the syringe barrel, the invention does comprehend an embodiment in which the engagement of the collar with the syringe nose involves a first position in which the device can easily be disengaged by an axial movement away from the nose, eg to perform an injection after removal of the sterilized packaging and a second position in which the device can be securely held or even locked to the syringe nose to guard against accidental removal of the device after injection and disposal of the syringe.

The holding or locking means can be an arcuately extending ridge engaging in a complementary arcuately extending groove or alternatively a dentent or projection engaging in a complementary recess. Holding means are preferred in order to avoid the possibility of the device being inadvertently locked to the syringe barrel eg during packaging, transport or removal from the packaging.

The device may easily be made in one-piece of a suitable plastics material by injection moulding.

In a preferred embodiment, the device is in the form of a cap. In order that the invention may be more readily understood, some embodiments thereof will now be described, by way of example, with reference to the accompanying drawings in which:-

Fig. 1. is a perspective view, to an enlarged scale, of a needle protection device, made in accordance with this invention, and fitted to a syringe which is only partly shown,

Fig. 2. is a perspective view similar to that of Fig, 1, with the device removed from the syringe and showing how the syringe needle may be reinserted in the device after an injection,

Fig. 3. is an end view of the open end of the device in Fig. 2,

Fig. 4. is a cross-section taken along the line IV -IV of Fig 2, and

Figs. 5. and 6 are cross-sections of two alternative embodiments .

As shown in Fig. 1 of the drawings, the needle protection device is in the form of a cap 1, the cap being fitted on a syringe 2, of which the distal end region only of the syringe barrel 3 is shown for clarity of illustration. The syringe 2 which is of conventional shape is provided with a plunger (not shown) which abuts against the inner distal end of the barrel at the end of an injection stroke. The distal end region of the barrel 3 terminates in a nose 4 in which is mounted, and from which projects, the syringe needle 5 (Fig. 2). The nose 4 has a proximal hub or base portion 6 of lesser diameter than the syringe barrel proper, with there being a shoulder 7 therebetween and a tip portion 8 of lesser diameter from which the syringe needle projects. A shoulder 9 is located between the nose portions 6 and 8.

Referring to Figures 2 to 4, the cap 1, which is made in one-piece, conveniently of injection moulded plastics material, comprises a blind sheath 10 having a closed distal end 11 and a proximal end 12 which has an opening 13 therein. The sheath 10 is generally of triangular configuration in cross-section defining a hollow interior 14 as will be apparent from Fig 4. At the proximal end 12 of the sheath 10, an integral collar 16 is provided, which is generally of arcuate shape, (C-shaped in end view in the illustrated embodiment) as will be seen from Fig 3. A longitudinal ridge or rib 15 extends the full length of the cap (sheath and collar) to faciliate gripping of the cap 1 when uncapping and recapping the syringe needle 5 in a manner to be described. In an alternative embodiment there may be two such ridges as shown in chain lines in Fig 4. and indicated by the reference 15a.

On one side, the upper-side as illustrated, the sheath 10 has two oppositely facing longitudinally extending wall portions 17 which run from adjacent the closed end 11 to the open end 12. The wall portions 17 are inclined downwardly and inwardly towards each other and terminate in flexible lips 18 which touch or are in engagement with each other, as will be more readily apparent from Figs . 3 and 4. The lips 18 provide a normally closed longitudinally extending entry aperture or passage 19, which is openable to admit at least a part of the needle 5 by a force exerted through the needle in a direction transverse to the longitudinal axis of the needle, as indicated by the arrow 20 in Fig. 2. Thus, the needle tip 21 and a part of the needle 5 pass into the interior 14 of the sheath 10 with the shoulder 9 of the nose portion 6 lying adjacent to the proximal end 22 of the cap. Immediately the needle has entered, the lips 18 flex back to close the entry passage 19. With the needle tip 21 safely protected, the syringe nose portion 6 is pushed towards the collar 16 until it engages therewith and finally the shoulder 9 shuts against the proximal end 12 of the sheath to close the interior 14 of the sheath. Thus, any blood or other fluid dripping from the needle is contained within the sheath.

Optionally, the syringe is securely held or locked in the closed position of the sheath by means of an arcuate projection 23 on the inside of the collar 16 engaging in a complementary groove 24 in the nose portion 6 of the syringe, when the shoulder 9 abuts the proximal end 12 of the sheath.

The inclination of the wall portions 17 and the configuration of the lips 18 assist in guiding the syringe needle 5 into and through the entry passage 19. To extend the guiding area, so as further to guard against accidental needle strike, the sheath 10 is provided with two inclined guide wings 25 on opposite sides respectively of the sheath which lead into the wall portions 17.

The embodiments of Figs 5 and 6 differ from that of Fig. 2 to 4 in that the sheath 10a is of arcuate shape like the collar 16 and the sheath 10b is of U-shaped configuration respectively, when considered in cross-section. Whilst particular embodiments have been described it should be appreciated that various modifications can be made which do not depart from the scope of the invention. For example, the lips 18 could be extended inwardly for a greater distance such that their line of contact is spaced from their free edges. Moreover, the length of the collar 16 could be extended axially so that it engages with the peripheral surface of the distal end region of the barrel proper of the syringe.

In another embodiment (not illustrated) the lips could be replaced by a deformable mastic of plastics or other suitable material through which the needle can be forced and which closes up after entry of the needle into the sheath. Provided that a force is required to introduce the needle transversely into the sheath through the passage 19, the lips need not be normally closed but could have a small gap therebetween which is of lesser width then the diameter of the needle. Such an arrangement would still guard against ^"blood and other fluids leaking out of the cap.

Claims

1. A device for protecting a needle, such as a syringe needle, said device being adapted to receive and to extend at least substantially around a needle, wherein the needle may be received in said device by forcing at least a part of the needle into the device in a direction which is transverse to the longitudinal axis of the needle.

2. A device as claimed in claim 1, having a normally closed aperture or passage means and which is openable to admit at least a part of the needle in response to a force exerted through the needle in a direction transverse to the longitudinal axis of the needle.

3. A device as claimed in claim 1 or 2, and having aperture or passage means through which, during admittance only, at least a part of the needle can pass in a direction transverse to the longitudinal axis of the needle, whereby to prevent removal of the needle through the aperture or the passage means.

4. A device as claimed in claim 1, and having passage means which admits at least a part of the needle in response to a force exerted through the needle in a direction transverse to the longitudinal axis of the needle.

5. A device as claimed in anyone of claims 2 to 4 and including longitudinally extending guide means for facilitating entry of the needle into the aperture or passage means.

6. A device as claimed in claim 5, wherein the guide means is constituted by two wings, ribs or ridges .__.ch project outwardly on respectively of the aperture or passage means.

7. A device as claimed in any one of claims 2 to 6, wherein the aperture or passage means has an entry area which is inclined in the direction towards the aperture or passage means.

8. A device as claimed in any one of claims 2 to 7, wherein the aperture or passage means is provided by two longitudinally extending flexible lips or flaps which may abut or touch each other at or adjacent their free edges and which are parted by the force exerted by the needle and which close together after the needle has entered the device.

9. A device as claimed in anyone of claim 2 to 7, wherein the passage means is provided by two longitudinally extending flexible lips or flaps having free edges which are slightly spaced apart to form a gap therebetween and which are parted further by the force exerted by the needle and which resume their initial position after the needle has entered the device.

10. A device as claimed in any one of claim 1 to 9, and provided with one or more gripping projections to enable the device to be more easily gripped during insertion of the needle.

11. A device as claimed in claim 10, wherein the or each gripping projection is a longitudinally extending ridge.

12. A device as claimed in any one of claims 1 to 11, and having a closed distal end, with an open sided collar at its open end to permit entry of the syringe nose transversely of the needle axis during insertion of the needle and to engage with the syringe nose.

13. A device as claimed in claim 12, wherein engagement of the collar with the syringe nose involves a first position in which the device can easily be disengaged by an axial movement away from the nose, eg to perform an injection after removal of sterilized packaging and a second position in which the device can be securely held or locked to the syringe nose to guard against accidential removal of the device after injection and disposal of the syringe.

14. A device as claimed in claim 13, wherein the holding or locking means is an arcuately extending ridge engaging in a complementary arcuately extending groove.

15. A device as claimed in claim 14, wherein the holding or locking means is a dentent or projection engaging in a complementary recess.

16. A device as claimed in any one of claims 12 to 16, wherein the collar is extended axially to engage with the distal end region of a syringe .barrel.

17. A device as claimed in claim 4 or any one of claims 5 to 7 and 10 to 16 when appendant thereto, wherein the passage means is a defor able mastic of plastics or other suitable material through which the needle can be forced and which closes up after entry of the needle.

18. A device as claimed in any one of the preceding claims and made of a plastics material by injection moulding.

19. A device as claimed in any one of the preceding claims and in the form of a cap.