This invention relates to a safety device for use with a medical needle having a sharp tip, to confer passive protection to that needle. The invention also relates to a safety needle assembly comprising such a safety device together with a medical needle and also to an injection device incorporating such a safety needle assembly.
The invention comprises an improvement to and modification of the needle safety devices described and claimed in my co-pending International Patent Application No. PCT/GB2011/050159, filed on 1 Feb. 2011, though the invention is applicable to other types of needle safety devices as well. In said application, there is described a medical needle passive safety device having a needle mount for directly or indirectly supporting a needle, a needle shielding sleeve for surrounding a supported needle and arranged co-axially with the mount so that a force applied to the sleeve slides the sleeve from a needle shielding position towards a non-shielding position. An abutment surface and a sliding surface are provided on one of the sleeve and mount and a radially deformable resilient finger is provided on the other of the sleeve and mount. When the finger is in a substantially undeformed condition, the finger blocks sliding movement of the sleeve to a non-shielding position but there is a control member initially at a set position to deform the finger radially outwardly on initial sliding movement of the sleeve to a non-shielding position so that the sleeve may continue sliding to the non-shielding position. The control member is displaced from its set position in the course of the sliding movement of the sleeve so that on subsequent return of the sleeve to its shielding position, the finger returns to its substantially undeformed condition; thereafter the finger blocks movement of the sleeve towards its non-shielding position.
With such a needle safety device, it is possible for the control member to move from its set position so that use of the device is impossible as the finger blocks movement of the sleeve to a non-shielding position. This may happen during handling of the safety device after manufacture and before the device is about to be used to perform an injection. Moreover, accidental handling of the device in preparation for its use may move the sleeve from its shielding position partway towards its non-shielding position so displacing the control member from its set position; upon the sleeve returning to its shielding position it may thereafter not be possible to use the device in the performance of an injection as again the finger will block the movement of the sleeve.
In an attempt to address the problems discussed above of safety devices as discussed above, this invention provides a medical needle safety device having a mount for a medical needle, a sleeve for shielding a mounted needle and movable from an initial shielding position to a non-shielding position, a finger provided on one of the sleeve and mount and resiliently deformable outwardly by movement of the sleeve from its initial shielding position to a non-shielding position, and a package component for the safety device which overlies at least a part of the finger to prevent outward deformation of the finger until the package component is removed from the safety device.
It will be appreciated that with the safety device of this invention, the package component prevents outward deformation of the finger until that component has been removed from the safety device. As such, the fingers will continue to block movement of the sleeve towards a non-shielding position and such movement will only be possible once the package component has been removed from the safety device.
In a preferred form of the invention, the sleeve is slidably arranged coaxially with the mount so that a force applied to the sleeve moves the sleeve from an initial needle shielding position to a non-shielding position whereat at least the tip of a supported needle is exposed beyond the sleeve; an abutment surface and a sliding surface is provided on the other of the sleeve and mount; and the finger has a part in radial alignment with the abutment surface to block movement of the sleeve from its needle shielding position. In such an arrangement, there may be a control member arranged coaxially with the sleeve and mount and slidably displaceable from a set position with respect thereto.
In one embodiment the package component is substantially tubular and is provided with an internal rib which overlies the finger to prevent the outward deformation thereof. Alternatively, the package component may closely surround the sleeve to prevent outward deformation of the finger.
With either embodiment, as the package component prevents outward deformation of the finger until the package component has been removed, the fingers themselves may resist displacement of the control member from its set position, so preventing inadvertent activation of the device and ensuring the device is available for use when the package component has been removed.
In the case of a tubular package component, it may have a closed end and an open end, the safety device being insertable into the package component and removable therefrom through the open end of the component. A sealing member may be arranged to close the open end of the package to component and so enclose the safety device therewithin. Alternatively, a removable cap may be provided for the open end of the package component.
The safety device may be associated with a medical needle having a hub received in the mount, and the sleeve being disposed in a shielding position conferring protection on the needle. Alternatively, the safety device may be associated with a single-use syringe having a needle permanently attached thereto, the syringe serving as the needle mount of the safety device and the sleeve is arranged to slide on the syringe.
In the case of a safety device associated with a single use syringe, a needle cover may be provided for the needle, the cover sealing the sharp end of the needle. The package component may include a structure for stripping the needle cover from the needle, on removing the package component from the safety device.
The safety device may have a plurality of fingers spaced around said one of the sleeve and mount, the fingers being resiliently deformable outwardly by sliding axial movement of the sleeve. Typically, a pair of opposed fingers may be provided though other numbers of fingers, such as three disposed at 120° or four arranged mutually at right angles may be provided. In such an arrangement, the resilient outward deformation of the fingers by the sliding axial movement of the sleeve stores energy for returning the sleeve to a shielding position.
By way of example only, two specific embodiments of this invention will now be described in detail, reference being made to the accompanying drawings in which:
Referring initially to
In
The sleeve 25 has a rearward part 27 which is slidably carried on the syringe barrel 21 and has a pair of diametrically opposed apertures in which are provided fingers 28 connected to the sleeve at the forward end 29 thereof. The fingers are resiliently deformable radially outwardly from their position shown in
A soft needle cover 34 is fitted to the needle 23 and seals against the nose 22, the sharp end of the needle penetrating the material of the needle cover so that the sharp end of the needle is sealed, to prevent leakage of liquid drug out of the needle.
A tubular component 35 is fitted to the safety device 24 so as wholly to surround that device prior to the use thereof. Thus, the tubular component has an outer cylindrical wall 36 and a closed front wall 37, the rear end of the cylindrical wall being open to allow the insertion of the safety device thereinto and through which the safety device may be removed from the component. Internally, a structure 38 upstands centrally from the front wall 37 that structure being provided with inwardly directed barbs 39 which bite into the soft needle cover 34, so that on pulling the tubular component away from the syringe and safety device, the soft needle cover is stripped off the needle and remains within the component.
Though not shown in the drawings, a sealing member may be provided between the tubular component 35 and the syringe barrel 21 in order that the safety device may be maintained in sterile conditions. Further, that sealing member may also provide a tamper-evident seal, in that if the seal is broken, then the syringe should not be used for performing a medical procedure.
In use, the seal (if one is provided) holding the tubular component 35 to the syringe barrel 21 should be broken so allowing the tubular component to be pulled away from the safety device 24. This simultaneously strips the soft needle cover 34 away from the needle 23, as shown in
On completion of the injection, the syringe and needle is pulled away from the injection site while the forward end of the sleeve remains in contact therewith and thus in effect moves forwardly with respect to the syringe to a needle shielding position. Frictional interengagement between the sleeve 25 and the control member 26 displaces the control member forwardly within the sleeve so that on return of the sleeve to a needle shielding position, subsequent forward movement thereof is blocked by the rearward ends 32 of the fingers 28 engaging the lugs 31.
It will be appreciated that prior to the removal of the tubular component 35 from the safety device, the outward deformation of the fingers 28 is resisted by the internal wall of the tubular component. Consequently, the sleeve 25 cannot be displaced rearwardly with respect to the syringe and needle until the tubular component has been removed. In a practical embodiment, this also serves to prevent the blocking of the rearward movement of the sleeve with respect to the syringe, prior to use of the device to perform an injection.
The safety device 40 of
The safety device 40 has a mount 48 provided with a bore which is adapted to be a close push-fit on ribbed section 49 of the needle hub 46, possibly slightly deforming the ribs to ensure there is sufficient friction between the hub and the mount. The mount has a cylindrical sliding surface 50 on which is supported a sleeve 51 arranged for axial sliding movement with respect to the mount and so also with respect to the needle. The initial needle-shielding position is shown in
The sleeve has a pair of opposed elongate apertures 54 within which are formed respective fingers 55 connected to the main part of the sleeve at the forward end 56 thereof, for serving as leaf springs. Though two such apertures each having a respective finger are shown, other numbers of apertures of fingers could be employed, ranging from a single aperture and finger up to three or more apertures and fingers. Each finger 55 is resiliently deformable radially outwardly, as will be apparent from the following description of the device.
The mount 48 includes a pair of opposed lugs 57 formed at the forward end of the sliding surface 50 of the mount, which lugs locate in the apertures 54 of the sleeve and serve to prevent removal of the sleeve from the mount, once fitted thereon and the sleeve is in its initial position shown in
A control member 60 is disposed within the sleeve 51 and in the initial setting of the device is disposed against a boss 61 formed at the forward end of the mount 48. The control member has a sufficiently large bore 62 for the needle 41 to pass easily therethrough during assembly but the bore is smaller than the diameter of the boss 61 such that the control member will bear on that boss 61 as the sleeve moves rearwardly, in the course of a procedure. Each finger 55 is formed with an opposed pair of inwardly directed protrusions 63 engageable with the external surface of the control member and disposed closely adjacent the control member in the initial setting of the device as shown in
At the forward end 56 of the sleeve, there are formed two diametrically-opposed windows 66, on a line perpendicular to that extending between the fingers 55. When the sleeve has moved fully rearwardly, so that the control member has been pushed to the forward end 56 of the sleeve, the control member will be visible through those windows 66 so as to serve as an indicator that the device has been used and now has the sleeve locked in the shielding position. This indication may be enhanced by making the control member of a brightly coloured material contrasting with the material of the sleeve.
In this embodiment, each of the mount, sleeve and control member is made of moulded plastics material. The fingers 55 are resiliently deformable radially outwardly by flexing of those fingers but in the initial position shown in
The operation of the safety device 40 described above will now be explained, following the fitting of the device to a needle 41. This action may be performed either before or after the needle hub 46 has been fitted to the Luer slip connector at the forward end of the syringe 42. The initial setting of the device is shown in
The syringe, needle and device are advanced to the injection site and the forward end 56 of the sleeve is pressed against the skin. This moves the sleeve rearwardly with respect to the mount 48 so that the protrusions 63 move up on to the outer surface of the control member 60, which remains stationary with respect to the mount. As shown in
When in the position of
When in the blocked setting of
Referring now to
The configuration of the fingers 55, the control member 60, the lugs 57 and the windows 66 are all as described above with reference to the first safety device and have the same functionality. The operation of the second device and the sequence thereof will not therefore be described again here. Suffice it to say that in the first device, the mount 48 is carried on the needle hub 46 and the sleeve 51 slides rearwardly over that mount 48. With the second device, the sleeve 51 (of the first device) serves as the mount 69 and is carried on the needle hub; the mount 48 (of the first device) serves as the sleeve 70 and slides rearwardly within the mount 69.
The device is pre-fitted with a conventional needle having a hub 77 which has a bore forming a part of a conventional syringe connector, such as a Luer slip or Luer lock connector. The hub may fit into the mount 48 of the device, as has been described above with reference to
The package of
The arrangement of
Number | Date | Country | Kind |
---|---|---|---|
10 01506.3 | Feb 2010 | GB | national |
10 17490.2 | Oct 2010 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/GB2011/050169 | 2/1/2011 | WO | 00 | 8/24/2012 |