This invention relates to a safety device for a medical needle having a sharp tip and a mount spaced from the tip and intended for penetration of a human or animal body, or for other medical uses such as the penetration of a pierceable membrane of an intravenous medication system. The invention further relates to the combination of a safety device as aforesaid and a housing therefor, and to the combination of a safety device and a medical needle. For convenience, in the following all medical uses of the needle will be described simply as the penetration of a body, even though specific embodiments may be intended for other medical uses.
Throughout this specification the terms forward and forwardly used in relation to the safety device and a syringe refer to the end thereof which is approached to a body when a procedure is to be performed, and the direction towards that end. Conversely, the terms rearward and rearwardly refer to the end of the safety device opposed to the forward end and the direction away from that forward end.
Fluids of various kinds may be administered to a human or animal body by means of a hollow needle in conjunction with a source of the required fluid. For example, such a needle may be used in conjunction with a syringe holding a liquid drug which may be contained directly in the syringe barrel or in a cartridge located within the syringe, the needle being used to penetrate the body at the site at which the drug is to be received. Equally, body fluids may be withdrawn by using a hollow needle which is used to penetrate the body until the tip is located at the site from which fluid is to be withdrawn.
A recognised hazard for clinicians and other persons using medical needles for the above described purposes, as well as people who may be exposed to used needles in the course of the disposal of those needles, is the risk of a so-called needle-stick injury—that is to say the accidental penetration of a person's skin by the needle. Prior to the use of the needle to supply a fluid to or to withdraw fluid from a body, this rarely presents much of a problem, though once the needle has been used on a body, there is a very much higher risk of a serious consequence for a person suffering a needle-stick injury. During use of the needle to penetrate the body tissues of a patient, the needle is likely to become contaminated with various organisms; should a person subsequently suffer a needle-stick injury, infection could occur.
There have been numerous proposals for protecting the sharp tip of a used needle, in order to reduce the risk of a needle-stick injury following use of the needle. Some proposals have actually increased the likelihood of such an injury by virtue of the action which must be performed to protect the tip, even if the risk thereafter is lessened. Despite all of the proposals which have previously been made, very few have achieved commercial success, nor has there been wide acceptance by the medical industry. Many proposals are somewhat complex and involve a significantly greater manufacturing cost, and so are unacceptable on economic grounds. Others are much more difficult to use as compared to an unprotected needle, and so are rejected by clinicians. Yet further proposals do not allow compliance with best practice protocols.
A device which protects a needle tip after use without an operator having to perform any extra step on withdrawing the needle from a body is usually referred to as a passive protection device. This may be contrasted with an active protection device, where an operator is required to perform an extra step in order to protect a needle, following the withdrawal of the needle from a body. The requirement to perform an extra step leaves the needle unprotected for a longer period than with a passive protection device but conversely an active device may be much simpler in concept, easier to manufacture and more reliable in use. Further, an active protection device may also be significantly smaller than a passive device, in that an active device usually has fewer components, and so may be more acceptable to clinicians as being less obtrusive, when in use.
Health and safety legislation has led to a significant demand for protection devices for use with medical needles and which allow a clinician or perhaps others to use the needle in much the same way as is done with an unprotected needle, but which can be manufactured economically and which provide a high degree of protection against needle-stick injury. Particularly for self-injection, the protection device should be simple in concept, unobtrusive in use and easy and reliable to operate. So far, no widely accepted active protection device is available and which meets these requirements.
The present invention aims at providing a safety device advantageously in the form of an accessory for an injector such as a so-called pen injector primarily intended for self-administration of a medicament, which addresses these issues and which is both relatively simple and economic to manufacture, especially on a fully automated production line, and which does not significantly affect the performance of a conventional injection procedure when mounted on an injector.
According to this invention, there is provided a safety device for a medical needle having a sharp tip and a mount spaced from the tip, which device comprises:
It will be appreciated that the safety device of this invention is an active protection device, in that following the performance of an injection, the clinician or user of a syringe with which the device is associated has to slide the protective sleeve forwardly of the syringe until that protective sleeve reaches a protecting position, where the sleeve is locked against subsequent rearward movement to expose the needle. When the device is first fitted to a medical needle, which may or may not be attached at that point to a syringe, the sleeve is in its initial position with the locking element in the forward slot portion of greater width than the narrower part of the slot interconnecting said slot portions, and the guide element at least partially in the narrower part of the slot. Subsequent to performing the injection, the sleeve is pushed forwardly to its protecting position and when there, the locking element preferably locates in the rearward slot portion of greater width than the narrower part of the slot and thereby restrains subsequent rearward movement of the sleeve.
The portions of greater width of the slot, at the forward and rearward ends thereof, preferably extend circumferentially in both directions around the sleeve and thus to each side of the narrower part of the slot. For such a slot, the locking member preferably has a pair of locking elements of essentially the same form, arranged one to each side of the guide element whereby each locking element will be received in a respective increased width portion of the slot, with the protective sleeve both at its retracted (initial) position and at its protecting position.
The safety device may have a plurality of circumferentially-spaced slots with a like number of locking members on the support. In a preferred embodiment, there are two such slots though only one need be provided or more than two could be provided.
The guide and locking elements of the (or each) locking member advantageously are formed integrally and are resiliently deformable as a unit towards of the axis of the sleeve to permit the locking element to slide along the inner surface of the sleeve from the forward portion of the slot to the rearward portion thereof. For such an arrangement, the guide element should have a sufficient radial height to permit the guide element to remain in the slot, notwithstanding the radially inward deformation of the locking member when the locking element runs along the inner surface of the sleeve.
The support may have a flange around the rearward end thereof, which flange supports the (or each) locking member so as to project forwardly from the flange, generally parallel to the axis of the support. The locking member may be resiliently deformable in the radial direction by deformation of the locking member, or of the flange in the vicinity of the junction between the locking member and the flange.
The tubular support preferably is adapted for engagement with the mount of the needle, in such a way that once engaged, it is difficult to remove the tubular support from said mount. Locking teeth may be provided within the tubular support, to assist in this. Further, it is preferred for the tubular support to engage the mount of the needle in such a way that once the mount of the needle is fully received in the support, rotation of the support turns the mount to permit unscrewing of a needle from a syringe.
The safety device may be provided with a medical needle having a sharp tip and a mount formed as an internally threaded hub for attachment to a syringe such as a pen injector and the tubular support of the safety device being engaged with the hub. In this way, the needle may be screw-threaded on to an externally threaded boss provided at the forward end of the syringe, by grasping and rotating the protective sleeve. In the alternative, the needle mount of the needle may be formed integrally with the tubular support, which support is internally profiled for engagement with a syringe.
This invention extends to the combination of a safety device of this invention as described above and a housing therefor, which housing is closed at one end, has a greater length than the safety device and is open at its other end to permit insertion and removal of the safety device. Such a combination may be provided as a sterile package, with said other end being sealed by a removable closure. Alternatively, the housing may have an opening at one end for receiving the protective sheath of a needle which opening is sized frictionally to grip the protective sheath of a needle. Fitting the safety device to a medical needle will engage the sheath with the opening and then removing the housing from the needle will strip the protective sheath from the needle.
An alternative form of housing is a relatively loose sliding fit over the safety device but is retained thereon until an injection is to be performed, by means of a releasable interconnection between the locking member and the housing. Such a housing may be provided with a tab to assist the pulling away of the housing from the safety device but as the housing is a loose sliding fit over the safety device, that device will not be triggered by forward movement of the safety device sleeve.
By way of example only, certain specific embodiments of safety device of this invention, for use with a medical needle and syringe, will now be described in detail, reference being made to the accompanying drawings in which:—
Referring initially to
The needle 11 is carried in an internally threaded hub 14 (
The safety device of this invention and intended for use with a syringe 10 and needle 11 comprises a tubular support 20 and a protective sleeve 21 slidably mounted on the support 20. The tubular support (see particularly
At the rearward end of the support 20, there is an externally projecting flange 25 having a pair of diametrically opposed forwardly projecting arms 26. Each arm has a central guide 27 projecting radially outwardly but having a significant axial extent. To each side of the guide 27 there is provided a locking element 28 having a generally rounded rearwardly directed upper surface 29 and a generally radial abutment surface 30 at its forward end. Each arm is shown in
The protective sleeve 21 is generally tubular in form and has an internal cylindrical surface 32 which is slidably received on the outer surface 33 of the flange 25. A pair of diametrically opposed slots 34 is formed through the wall of the sleeve 21, each slot extending essentially parallel to the axis of the sleeve 21 and having a narrower part 35 and end regions 36 of greater width than the narrower part 35. As best seen in
The external surface of the protective sleeve 21 has an increased thickness in the vicinity of the rearward end regions of the slots 34, which facilitates handling of the device by holding the sleeve 21. At the forward end of the sleeve, there is formed an inwardly directed flange 39 having a central opening 40.
The use of the safety device will now be described, with particular reference to
As supplied, the safety device has the protective sleeve 21 mounted on its tubular support 20, with each central guide 27 disposed partially in the narrower part 35 of the respective slot 34, and the two locking elements 28 disposed in the increased width end regions 36 at the forward ends of the slots 34. The safety device is then offered to the syringe and is pushed fully rearwardly such that the hub 14 of the needle is received fully within the bore 22 of the tubular support and is gripped by the ribs 23 and by the teeth 24 (
Following performance of an injection, the user manually pushes the protective sleeve 21 fully forwardly of the syringe, from the rearward end of that sleeve and so with no risk of a needle-stick injury. During the initial stage of movement of the sleeve from the position shown in
When the sleeve 21 has been locked in its protecting, forward position, the sleeve may be rotated counter-clockwise (viewed from the front). The support 20 is correspondingly rotated in view of the interengagement of the sides of the locking elements 28 with the rearward end regions 36 of the slots 34, and the interengagement of the support 20 with the needle hub serves to unscrew that hub 14 from the stub 15. When free, the needle together with the safety device may be thrown away in a safe manner, such as in a sharps box. Since the needle is not re-sheathed, the risk of needle-stick injury present during re-sheathing is eliminated.
The housing 42 containing the safety device is presented to the syringe fitted with a needle (
During manufacture of the packaged safety device, a needle and hub generally as described above is fitted into the bore 22 of the tubular support 20. Since the needle is wholly protected by the housing 47 and extension 48, there is no need for a sheath to be provided on that needle. The assembly is then sterilised and closed by seal 50.
In order to use the packaged safety device of
In all of the above embodiments, the arms 26 include a central guide 27 and a locking element 28 to each side of the central guide, which locking elements are of essentially the same form. One locking element of each arm could be replaced by a rounded camming surface which comes into engagement with shoulder 37 to one side of the associated slot 34 before the sleeve 21 has moved fully forwardly to its protecting position. In view of the resilience of the arms, that rounded camming surface may serve to ensure the sleeve continues to move forwardly until the abutment surface 30 engages behind shoulder 37, even should the forward force applied to the sleeve fall away, or perhaps be removed altogether.
In the above described embodiments, the slot 34 as well as the end portions of greater width are shown as open through the wall of the protective sleeve 21. However, so long as the wall thickness of the sleeve is sufficiently great, the slots could open solely inwardly of the sleeve and be closed radially outwardly. In such an arrangement access to the locking elements would be more difficult.
The forward end of the housing 53 includes a tube 57 corresponding to extension 48 (
It will be appreciated that this alternative housing 53 holds the safety device within the housing by virtue of the interaction between the central guide 54 and the opening 55 in the housing wall 56. The housing may be pulled away from the locking member without pulling forwardly the protective sleeve of the safety device, since the protective sleeve is only a loose sliding fit within the housing. The needle sheath is stripped from the needle during this action.
Number | Date | Country | Kind |
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0618699.3 | Sep 2006 | GB | national |
PCT/GB2007/050569 | Sep 2007 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB2007/050569 | 9/21/2007 | WO | 00 | 10/27/2009 |