Improved hinge for a safety needle device

Abstract

The present invention provides a safety device (8) for a medical injection needle comprising a protective shield (19) pivotally coupled to a carrier (18), wherein the carrier (18) is configured to be secured directly or indirectly to a needle hub having a sharp tip of a needle projecting therefrom. The protective shield (19) is configured to move from a before-use initial shielding position to a during-use non-shielding position and to an after-use final shielding position. The safety device (8) comprises a combined control mechanism (retention mechanism and stop means) to inhibit the disengagement of the respective pivot members (40, 41) of supporting arms (26, 27) and the carrier (18) and restrict excess pivoting movement of the protective shield (19) relative to the carrier (18) beyond an after-use final shielding position. This mechanism restricts / limits the extent of the pivotal movement of the protective shield (19) beyond a predetermined final locking position. In addition, the mechanism inhibits / prevents the disengagement of the respective pivotal members (40, 41) of the protective shield (19) and the carrier (18) which thereby strengthens the safety device (8) and reduces the risk of the protective shield 19 from becoming separated relative to the carrier (18) during use. Any such separation would expose the used needle (11).

Description

[0001] Improved Hinge for a Safety Needle Device

[0002] FIELD OF THE INVENTION

[0003] This invention relates to a hinge for a safety needle device which may be used in association with a syringe having a medical needle projecting forwardly therefrom. In its preferred aspects, this invention concerns improvements in a hinge for a pivotable protective shield of a safety needle device arranged to confer needlestick protection to a medical needle projecting forwardly from a single-use syringe.

[0004] BACKGROUND TO THE INVENTION

[0005] A syringe provided with a medical needle as employed in this invention is intended to be used to penetrate a human or animal body, or for other medical uses such as the penetration of a pierceable membrane of an intravenous medication system. In the following all medical uses of the syringe and needle will be described simply as the penetration of a body, even though specific embodiments may be intended for other medical uses.

[0006] A syringe having a needle permanently secured thereto is frequently pre- filled with a liquid drug or medicament and then is used only once to perform an injection. Once used, the syringe and needle must be disposed of in a safe manner. To protect any people who might have to handle such a syringe, either before or after performing an injection, it is becoming a requirement of health and safety legislation as well as best practice to provide the needle with some kind of safety device to minimise the risk of accidental needlestick injury.

[0007] Typically, such a safety device may have a shield which is mounted on the syringe and is slidable axially or pivotably movable between a needle protecting position and a non-protecting position. After performing the invention, the shield is moved to an after-use final position at which the needle is shielded. A hinge or pivotable arrangement is provided to facilitate the movement of the shield to the after-use final position. During this movement, there is a risk that the shield may be pivoted too far such that the shield fails and inadvertently breaks away or disconnects from the device. Such an eventuality will expose the used needle and thereby create a needlestick hazard and risk.

[0008] An abutment face may be provided to identify the maximum pivotal movement of the shield. These devices are relatively small and are constructed from plastics materials. The small abutment face may cause parts of the shield to deflect and / or deform such that the shield travels over and or past the abutment surface. Again, this may inadvertently expose the used needle.

[0009] In addition, as the shield pivots to the final position, a part of the shield may be deflected over and or miss a locking surface which may similarly cause any blocking surface on the shield to move outwardly away and become mis-aligned with the abutment face. This defection of the shield may also cause the pivotal / hinge mechanism to open apart such that mutually engaged pivot members move away and detach from each other and thereby encourage the shield to disengage and detach from the pivotal arrangement. This disengagement may be further encouraged by the deflection of the shield locking abutment face which may be guided by the respective abutment face in a direction which weakens or even disconnects the engagement of the pivotal members of the protective shield.

[0010] It is an aim of the present invention to overcome at least one problem associated with the prior art whether referred to herein or otherwise.

[0011] SUMMARY OF THE INVENTION

[0012] According to a first aspect of the present invention there is provided a safety device for a medical injection needle comprising: a protective shield pivotally coupled to a carrier, wherein the carrier is configured to be secured directly or indirectly to a needle hub having a sharp tip of a needle projecting therefrom, and the protective shield is configured to move from a before-use initial shielding position to a during-use non-shielding position and to an after-use final shielding position; the protective shield comprises: a longitudinal axis, a distal portion for surrounding at least the sharp tip of the needle at the before-use initial shielding position and at the after-use final shielding position, an intermediate portion proximal to the distal portion and comprising a resiliently deformable region providing at least one locking portion to lock the protective shield relative to the carrier in the after-use final shielding position; and a proximal portion which is proximal to the intermediate portion and comprising supporting arms having first pivot members arranged thereon for pivotal engagement with the carrier; wherein the carrier comprises: a longitudinal axis; a lug projecting distally, the lug having a locking abutment surface to engage with the locking portion to lock the protective shield relative to the carrier in the final shielding position; second pivot members located proximally to the lug and arranged for pivotal engagement with the supporting arms; and wherein the longitudinal axis of the carrier is aligned with the longitudinal axis of the protective shield when the protective shield is at the before-use initial shielding position; and the resiliently deformable locking portion engages with the locking abutment surface of the lug to block movement of the shield from the after-use final shielding position towards a non-shielding position; characterised in that: the safety device comprises a control mechanism to inhibit the disengagement of the respective first and second pivot members and also restrict excess pivotal movement of the protective shield relative to the carrier beyond the after-use final shielding position; the mechanism comprising: a recessed retaining slot provided on the carrier and located proximal to the second pivot members; and wherein the recessed slot is transversely elongated relative to the longitudinal axis of the carrier; at least one retention member extending from the proximal end of the supporting arm and located within the recessed slot to inhibit disengagement of the first and second pivot members; and wherein the second pivot members are positioned on side walls of the carrier and located relative to the recessed slot, so as to cause a portion of the retention member to rotationally locate within the recessed slot at a first position when the protective shield is at the before-use initial shielding position; and wherein at least one portion of the protective shield is provided with at least one abutment surface and is arranged to rotationally engage against a stop surface located on the carrier and / or the needle hub; so that after use, movement of the protective shield to the after-use final shielding position causes the retention member to rotationally locate within the recessed slot to a second position and said abutment surface to rotationally engage against the stop surface to restrict excess pivotal movement of the protective shield beyond the afteruse final shielding position.

[0013] Preferably the protective shield comprises two supporting arms and an associated retention member extends from the proximal end of each of the supporting arms and each retention member may be arranged to engage with an associated recessed slot. Preferably the protective shield and the carrier are coupled together by two pairs of pivot members.

[0014] Preferably the first position of the retention member comprises an initial position.

[0015] Preferably the second position of the retention member comprises a final position. Preferably the first position is angularly offset from the second position.

[0016] Preferably in the first position, the retention member is captured in the recessed slot to inhibit the disengagement of the respective first and second pivot members and more preferably with the protective shield in the before-use initial shielding position. Preferably in the second position, the retention member is captured in the recessed slot to inhibit the disengagement of the respective first and second pivot members and more preferably with the protective shield in the after-use final shielding position.

[0017] Preferably the protective shield comprises a plurality of abutment surfaces. Preferably each abutment surface is arranged to engage a respective stop surface (which may be provided on the carrier and / or needle hub).

[0018] The abutment surface may comprise a primary abutment surface. The abutment surface may comprise an auxiliary (secondary) abutment surface. The protective shield may comprise one or more primary abutment surfaces and / or one or more auxiliary abutment surfaces.

[0019] Preferably the retention member locates in the recessed slot in the before-use initial shielding position. Accordingly, the retention member may relocate back within the recessed slot in the final shielding position. In the final shielding position, the retention member may locate (substantially) fully in the recessed slot. The retention member is arranged to be positioned further in the recessed slot in the second position relative to the first position.

[0020] Preferably the carrier and hub together form a carrier assembly. The carrier assembly may provide the stop surface to rotationally engage the abutment surface.

[0021] The abutment surface in the form of a primary abutment surface may be provided on the retention member. The abutment surface in the form of an auxiliary abutment surface may be provided on an internal surface and / or an external surface of the protective shield.

[0022] The stop surface may be in the form of an interior stop surface and may be provided in the recessed slot. Preferably the recessed slot is provided with an interior stop surface to restrict pivoting movement of the protective shield relative to the carrier, and the interior stop may be formed on an internal side wall at one end of the recessed slot.

[0023] Preferably the primary abutment surface comprises the retention member.

[0024] The resiliently deformable region may comprise a resiliently deformable zone. The locking portion may comprise a locking member. The intermediate portion may comprise two resiliently deformable locking members. The locking abutment surface may comprise an inner blocking surface. The lug may comprise an outer surface and an inner blocking surface adjoined by two profiled flanks.

[0025] The stop surface may be in the form of an exterior stop surface and may be provided on an outer portion of the carrier and is preferably located outside of the recessed slot. Preferably the recessed retaining slot includes an exterior stop surface and the supporting arm includes an auxiliary abutment surface (or secondary abutment surface) arranged to rotationally engage against the exterior stop surface of the recessed slot to further restrict excess pivotal movement of the protective shield beyond the after-use final shielding position.

[0026] Preferably the internal side wall at one end of the recessed slot is arranged generally perpendicular to the exterior stop surface.

[0027] The internal side wall at one end of the recessed slot may be arranged generally perpendicular to the external face (external open face) and / or to the transversely elongated recessed slot.

[0028] Preferably the primary and auxiliary abutment surfaces abut and contact against the respective interior and exterior stop surfaces of the recessed slot to resist and / or arrest and / or halt the pivoting movement of the protective shield beyond the afteruse final shielding position.

[0029] Preferably the recessed slot comprises a first internal side wall providing the (interior) stop surface and an internal end wall displaced proximally from the (exterior) stop face.

[0030] The recessed slot may comprise a first internal side wall (providing the (interior) stop surface), a second internal side wall and an internal end wall. Preferably the internal end wall is perpendicular to the first internal side wall and the second internal side wall. Preferably the internal end wall spans and / or extends between the first internal side wall and the second internal side wall. The retaining recessed slot may comprise two internal radially spaced apart walls relative to the longitudinal axis of the carrier.

[0031] Preferably the interior stop surface is generally aligned with the longitudinal axis of the carrier. Preferably the first internal side wall and / or the second internal side wall are aligned with the longitudinal axis of the carrier. Preferably the internal end wall of the recessed slot is aligned perpendicularly relative to the longitudinal axis of the carrier.

[0032] Preferably the exterior stop surface is aligned perpendicularly relative to the longitudinal axis of the carrier. Preferably the external face of the recessed slot is aligned perpendicularly relative to the longitudinal axis of the carrier.

[0033] Preferably the retention member is arranged to freely rotationally move within the recessed slot until the (primary) abutment surface (or (primary) abutment face) contacts and abuts the (interior) stop surface.

[0034] The protective shield (and preferably the retention member) may be frictionally engaged relative to the carrier and this may enable the protective shield to be held at any desired rotational position. The retention member may be frictionally engaged within the recessed slot to hold the protective shield at any desired position. The retention member and / or the carrier (and preferably in the recessed slot) may comprise a frictionally engaging surface and / or comprise corresponding detents to hold the protective shield in any desired position.

[0035] Preferably the retention member rotationally locates at least partially within the recessed slot in the before-use initial shielding position and is rotationally moved (completely) out of the recessed slot when the protective shield is moved to the during-use non-shielding position and is then rotationally moved back into the recessed slot in the after-use final shielding position.

[0036] The retention member may rotationally locate at least partially within the recessed slot in the before-use initial shielding position and it may also rotationally locate at least partially within the recessed slot when the protective shield is moved to the during-use non-shielding position and may also locate at least partially within the recessed slot in the after-use final shielding position

[0037] The control mechanism may comprise a dual-purpose, dual-function mechanism.

[0038] Preferably the interior stop surface is angularly displaced relative to the exterior stop surface. The interior stop surface may be substantially perpendicular relative to the exterior stop surface.

[0039] The interior stop surface may be substantially aligned with the longitudinal axis of the carrier.

[0040] The exterior stop surface may extend substantially perpendicularly relative to the longitudinal axis of the carrier.

[0041] The interior surface face and / or the exterior stop surface may comprise planar / flat contact abutment surfaces. Preferably the primary abutment surface is angularly displaced relative to the auxiliary abutment surface. The primary abutment surface may be substantially perpendicular relative to the auxiliary abutment surface.

[0042] The primary abutment surface may be angularly displaced relative to the longitudinal axis of the protective shield. The primary abutment surface may be at angle in the range of 5 degrees to 15 degrees relative to the longitudinal axis of the protective shield.

[0043] The auxiliary abutment surface may be angularly displaced relative to the longitudinal axis of the protective shield. The auxiliary abutment surface may be at angle in the range of 75 degrees to 85 degrees relative to the longitudinal axis of the protective shield.

[0044] The primary abutment surface and / or the auxiliary abutment surface may comprise planar / flat contact surfaces.

[0045] The retaining recessed slot may provide an inner lateral control surface which prevents transverse outwards movement of the protective shield. Preferably the inner lateral control surface prevents transverse outwards movement of at least the supporting arms incorporating a part of the proximal portion of the protective shield. The inner lateral control surface may directly contact and prevent transverse outwards movement of the retention member and, in particular, when the retention member is partial or completely located with the recessed slot.

[0046] Preferably the retention member is integral with the protective shield and together they preferably form a unitary component / element.

[0047] Preferably the safety device comprises two retention members which may be provided on respective proximal faces of two supporting arms which may be provided on opposing lateral / transverse sides of the protective shield. Similarly, the carrier may provide two retaining recessed slots which may be provided on opposing lateral / transverse side walls of the carrier.

[0048] The or each retention member may comprise a fin element having a curved / arcuate surface and an end face comprising the (primary) abutment surface.

[0049] The retention member may have a thickness less than the thickness of the adjacent supporting arm. A stepped face or edge may be provided between the retention member and the supporting arm and this stepped face may provide the (auxiliary) abutment surface upon the supporting arms.

[0050] The primary abutment surface and the interior stop surface are arranged to commence contact at the same, or substantially the same time as contact commences between the auxiliary abutment surface and the exterior stop surface. The primary abutment surface and the interior stop surface are arranged to commence contact at the same, or substantially the same, relative position between the protective shield and the carrier as contact commences between the auxiliary abutment surface and the exterior stop surface.

[0051] The locking members may locate adjacent the respective profiled flanks of the lug when the longitudinal axis of the protective shield is aligned with the longitudinal axis of the carrier. The locking members and the profiled flanks may comprise cooperating drive surfaces to engage and resiliently deform the locking members in an outward transverse direction relative to the longitudinal axis of the protective shield when the shield is moved inwardly to the after-use final shielding position. The drive surfaces may disengage to allow the locking members to return resiliently inwardly towards an undeformed condition so as to locate adjacent the underside of the inner blocking surface of the lug to lock the protective shield at the after-use final shielding position. Preferably (thereafter) forced movement of the protective shield outwardly towards a during-use non-shielding position forces the resiliently deformable locking members to compress against the inner blocking surface of the lug. Preferably this compressive force between the inner blocking surface and the locking members urges the locking members inwardly and further away from the profiled edge of the flanks of the lug to enhance the blocking action of the inner blocking surface against the locking member.

[0052] Preferably the protective shield extends along the longitudinal central axis of the shield from a proximal end to a distal end. Preferably the carrier extends along the longitudinal central axis of the shield from a proximal end to a distal end.

[0053] Preferably, before use, in the initial shielding position, the medical needle extends along a longitudinal axis and is aligned with the longitudinal axis of the carrier. Preferably the needle comprises a sharp tip. Preferably the medical needle is mounted on the needle hub to project distally therefrom, with the sharp tip located at the furthermost distal end.

[0054] Preferably, the needle hub is located and fixedly engaged within the carrier such that the longitudinal axis of the hub is aligned with the longitudinal axis of the carrier.

[0055] Preferably the lug comprises two profiled flanks providing two profiled flank surfaces which adjoin the outer surface and the inner blocking surface. Preferably the two profiled flanks (surfaces) are substantially parallel. Preferably the two profiled flank (surfaces) comprise lateral surfaces relative to the longitudinal axis of carrier. Preferably the two profiled flank (surfaces) extend substantially linearly along the longitudinal axis of the carrier in a distal direction. Preferably the or each flank (surface) comprises a (lateral) side of the lug.

[0056] Preferably the two profiled flanks (surfaces) extend at an angle relative to the longitudinal axis of the carrier in a distal direction. Preferably the or each profiled angled flank (surface) comprises a (lateral) side of the lug.

[0057] Preferably each profiled flank (surface) provides a drive surface to cooperate with a respective drive surface on the locking member. Preferably each locking member is arranged to travel in a first direction over the drive surface of a flank of the lug during movement towards the after-use final shielding position. Preferably each locking member is deformed in an outward transverse direction (perpendicular to the longitudinal axis of the protective shield and / or the carrier) during movement over the drive surface in the first direction. The or each locking member may be deformed in both a transverse direction and the or each locking member may also move radially in an outward direction generally perpendicular to the longitudinal axis of the shield.

[0058] Preferably the or each cooperating drive surface comprises a flared surface. Preferably the or each cooperating surface comprises a stepped surface. Preferably the or each cooperating drive surface comprises a curved or arcuate surface which may be flared outwardly. Preferably the extent of deformation / deflection of the locking member increases as the locking member moves over the respective drive surface in the first direction.

[0059] Preferably the lug comprises a distal end surface which locates in opposition to a proximal surface provided on the protective shield. Preferably there is a gap between the distal end surface of the lug and the proximal surface provided on the protective shield and the gap is maintained as the protective shield moves between the before-use initial shielding position to the during-use non-shielding position and to the after-use final shielding position.

[0060] Preferably the lug comprises a distal end profile which engages a proximal end profile provided on the protective shield when the protective shield is in the beforeuse position. Preferably the engaging profiles disengage when the protective shield is moved outwardly to the during-use position and reengage and disengage when the shield is moved to the final after-use position. The reengagement and disengagement generating an audible and or tactile feedback to user to indicate that the protective shield is located at the after-use final shielding position.

[0061] Preferably the or each locking member comprises a resiliently deformable portion which is integrally formed on the intermediate portion of the protective shield. The or each locking member may comprise a corner section having a tip. Preferably the tip provides an initial point of contact against the inner blocking surface of the lug when the protective shield is moved outwardly from the after-use final shielding position. Preferably forced movement of the protective shield outwardly towards a during-use non-shielding position causes the initial point of contact area of the tip against the inner blocking surface of the lug to increase. Preferably this contact area will increase in size proportionally relative to the increase in the force applied in the attempt to move the protective shield outwardly and away from the after-use final shielding position.

[0062] Preferably the inner blocking surface of the lug provides a curved / arcuate or angled surface across a transverse plane. Preferably the inner blocking surface provides a concave partially cylindrical surface.

[0063] Preferably the inner blocking surface comprise an edge to guide the or each locking member underneath and onto the inner blocking surface. The edge may comprise a chamfered edge.

[0064] Preferably an outer surface of the or each locking member is curved / arcuate across a transverse plane relative to the longitudinal axis of the protective shield. Preferably the outer surface provides a convex partially cylindrical surface.

[0065] Preferably an outer surface of the or each locking member is flat and or curved / arcuate across a transverse plane relative to the longitudinal axis of the protective shield.

[0066] Preferably an inner surface of the or each locking member is curved / arcuate across a transverse plane relative to the longitudinal axis of the protective shield. Preferably the inner surface provides a concave partially cylindrical surface.

[0067] The distal portion of the protective shield may comprise a narrow gap located on the intermediate portion of the protective shield and generally aligned with the longitudinal axis of the shield to facilitate the outward resilient movement of the or each locking member.

[0068] The proximal portion of the protective shield may comprise a gap generally aligned with the longitudinal axis of the shield to facilitate the outward resilient movement of the or each locking member. The gap may extend centrally between the first locking member and the second locking member. The gap may extend from the proximal surface of the intermediate portion of the protective shield. The gap may extend linearly along the intermediate portion of the protective shield. The gap may comprise a linear gap.

[0069] The distal portion may comprise a distal region / part / segment / length of the protective shield. The intermediate portion may comprise an intermediate region / part / segment / length of the protective shield. The proximal portion may comprise a proximal region / part / segment / length of the protective shield.

[0070] Preferably the pivotal axis of the protective shield locates proximally relative to the locking members and more preferably proximally relative to any and all contact between the or each locking member and the inner blocking surface of the lug in the after-use final shielding position.

[0071] Preferably the supporting arms are provided on the proximal portion of the intermediate portion of the protective shield and may form the proximal portion of the protective shield. Preferably the supporting arms extend proximally away from the locking members.

[0072] The safety device may comprise a needle cover to overlie the medical needle to protect the needle and / or prevent drug leakage from the sharp tip. The needle cover may comprise a longitudinal axis and a profile at a proximal end configured to engage a profile on a distal end of the needle hub to create a substantially airtight seal therebetween to maintain the sterility of the enclosed medical needle within the needle cover when the needle cover is located at a first position relative to the needle hub. Preferably, in the initial shielding position, the needle cover is located within the protective shield at said first position, whereat the longitudinal axis of the needle cover is aligned with the longitudinal axis of the needle. Preferably a part of the needle cover and a part of the protective shield are configured to engage when the protective shield is at the initial shielding position to releasably maintain the needle cover within the protective shield at said first position to prevent drug leakage and maintain the sterility of the medical needle during storage of the syringe. Preferably the part of the protective shield engaging the part of the needle cover prevents distal movement of the needle cover relative to the needle hub away from the first position until the protective shield is moved to the during-use non-shielding position. Preferably the protective shield is arranged to move outwardly away from the needle cover and is configured to be manipulated by a user away from the initial shielding position to the during-use non-shielding position prior to use of the safety needle device; said movement of the protective shield away from the initial shielding position disengages the protective shield from the needle cover to thereafter allow (subsequent) detachment of the needle cover distally away from said first position to uncover the medical needle.

[0073] The protective shield may be connected and secured to the carrier by a control hinge arrangement. The control hinge arrangement may define a fixed rotational axis about which the protective shield rotates relative to the carrier. The fixed rotational axis may provide a revolute joint between the protective shield and the carrier.

[0074] The rotational axis of the protective shield may comprise a movable axis and may be an unfixed rotational axis. For example, pivot members in the form of elongated or elliptical or enlarged slots or openings may be provided which may enable pivot members located therein to pivot and also to slide (move translationally) within the elongated or elliptical or enlarged slots or openings.

[0075] Preferably the protective shield is arranged to pivot from the initial shielding position to the during-use non-shielding position. The protective shield may comprise two first pivot members which may be engaged within two second pivot members on the carrier. The first pivot members of the protective shield may comprise two stub axles which may be engaged within two corresponding apertures on the carrier which form the second pivot members. The first and second pivot members may define a pivoting axis for the protective shield. The second pivot members may be located on two opposed outer side faces of the carrier. The outer side faces of the carrier being formed by an internal opening that projects distally from the proximal end of the carrier. The outer side faces may provide recessed (flat / planar) walls and these walls may extend distally from a distal portion of the carrier. The outer side faces may extend from the distal portion to a proximal end of the carrier. The distal portion may extend from a distal end of the carrier to the outer side faces.

[0076] The carrier may comprise two second pivot members which may be engaged within two first pivot members on the protective shield. The second pivot members of the carrier may comprise two stub axles which may be engaged within two corresponding apertures on the protective shield which form the first pivot members. The first and second pivot members may define a pivoting axis for the protective shield.

[0077] The protective shield may be arranged to move, and preferably pivotally and or rotationally move, and more preferably sequentially / successively move between: the (before use) initial shielding (unlocked) position; a (during-use) non-shielding position; and a (after-use) final shielding (locked) position.

[0078] The protective shield may be arranged to move, and preferably pivotally move, and more preferably sequentially / successively move between: a storage position (before use); an operative position (during-use); and a safety (locked) position (after-use). In the after-use final position, the sharp tip of the medical needle may be deflected away from the longitudinal axis of the needle hub and or syringe barrel. In the afteruse final shielding position, the medical needle may be deformed and preferably is non-linear. Preferably with this deformation the medical needle is not re-usable.

[0079] In the after-use final shielding position, the or each locking member and the underside inner blocking surface of the lug may be resiliently engaged due to the flexural resilient deflection of the medical needle.

[0080] In the after-use final shielding position, the or each locking member and the underside inner blocking surface of the lug may be resiliently engaged due to the flexural resilient deflection of the locking member against the underside of the inner blocking surface of the lug.

[0081] The protective shield may comprise a longitudinally extending opening. The protective shield may comprise a partial cylindrical tubular shield in which a longitudinal opening is provided along at least a portion of the longitudinal length and preferably for the full longitudinal length of the protective shield.

[0082] The carrier may comprise a tubular ring component. The carrier may comprise a ring component having a hollow centre portion to receive the needle hub. The carrier may comprise a securement member to secure the carrier (and the safety device) to a syringe. The securement member may comprise an internal rib located within the hollow centre and which may be secured to a (rear facing) shoulder provided on the hub of the syringe. The internal rib may comprise a circumferential rib on an inner surface of the carrier and may extend around or partly around the inner circumferential surface of the ring component to encapsulate a part of the needle hub. A part, and preferably an arcuate part of the internal rib may be resiliently movable outwardly to enable a (rear facing) shoulder on the needle hub to pass the internal rib such that the internal rib flexes outwardly and then resiliently return towards an original / initial state to thereafter prevent removal of the syringe from the carrier. The internal hollow portion of the carrier may comprise securement members to attach onto standard female Luer needle hubs having needles already attached thereon and with the sharp needle tip projecting distally therefrom. The female Luer hub being suitable for receiving syringes having male Luer cone connectors.

[0083] The protective shield may comprise clasping means to clasp and / or grip or loosely hold and retain the needle cover in the first position. The clasping means may comprise one or more clasps provided on the protective shield and preferably on edges (or adjacent to edges) of a longitudinal opening of the protective shield. The clasping means may provide a restraining force which must be overcome in order to move the protective shield outwardly from the initial shielding position to the during-use non-shielding position. The clasping means (preferably together with the pivotable coupling / control hinge arrangement) may form a sub-assembly comprising the carrier, the protective shield and the needle cover and wherein this sub-assembly is maintained and held together as a complete unitary assembly and is preferably self-supporting and preferably wherein the complete unitary assembly is suitable for mechanical handling within automated assembly machines.

[0084] The safety device may comprise gripping means to grip the needle cover in the first position. The gripping means may bite into and / or penetrate into a surface of the needle cover. The gripping means may comprise one or more gripping elements which may comprise sharp edges which may engage in the material of the needle cover.

[0085] The protective shield (or needle shield) may comprise a resiliently deformable (elastomeric / resilient) locking region, zone or portion to lock the protective shield relative to the carrier in the final shielding position. The locking portion may comprise a proximal region, zone or portion of the protective shield.

[0086] The carrier may comprise a locking abutment surface to lock the protective shield relative to the carrier in the final shielding position. The locking abutment surface may be provided on a part of the carrier. The locking abutment surface may be provided on the carrier as a lug which preferably extends in a distally direction forwardly (outwardly) from the carrier.

[0087] The locking portion or region of the needle shield may engage with the locking abutment surface in the final shielding (safety) position. A sliding surface of the locking portion may be arranged to travel over a sliding surface of the carrier or the lug when moving from the non-shielding position to the final shielding position. The locking portion and / or the lug may resiliently deform as the locking portion moves over the distal end of locking abutment surface of the lug. In the final shielding position, the locking portion and the locking abutment surface of the lug are in an undeformed and unstressed (relaxed) condition / state.

[0088] In the final shielding position, the locking portion and the abutment surface may be resiliently engaged due to the flexural distortion of the deformed medical needle.

[0089] According to a second aspect of the present invention there is provided a method of protecting a medical needle comprising providing a safety device for a medical injection needle which comprises: a protective shield pivotally coupled to a carrier, wherein the carrier is configured to be secured directly or indirectly to a needle hub having a sharp tip of a needle projecting therefrom, and the protective shield is configured to move from a before-use initial shielding position to a during-use non-shielding position and to an after-use final shielding position; the protective shield comprises: a longitudinal axis, a distal portion for surrounding at least the sharp tip of the needle at the before-use initial shielding position and at the after-use final shielding position, an intermediate portion proximal to the distal portion and comprising a resiliently deformable region providing at least one locking portion to lock the protective shield relative to the carrier in the after-use final shielding position; and a proximal portion which is proximal to the intermediate portion and comprising supporting arms having first pivot members arranged thereon for pivotal engagement with the carrier; wherein the carrier comprises: a longitudinal axis; a lug projecting distally, the lug having a locking abutment surface to engage with the locking portion to lock the protective shield relative to the carrier in the final shielding position; second pivot members located proximally to the lug and arranged for pivotal engagement with the supporting arms; and wherein the longitudinal axis of the carrier is aligned with the longitudinal axis of the protective shield when the protective shield is at the before-use initial shielding position; and the resiliently deformable locking portion engages with the locking abutment surface of the lug to block movement of the shield from the after-use final shielding position towards a non-shielding position; characterised in that: the method comprising restricting excess pivotal movement of the protective shield relative to the carrier beyond the after-use final shielding position, and also inhibiting the disengagement of the respective first and second pivot members, wherein the safety device comprises a control mechanism comprising: a recessed retaining slot provided on the carrier and located proximal to the second pivot members; and wherein the recessed slot is transversely elongated relative to the longitudinal axis of the carrier; at least one retention member extending from the proximal end of the supporting arm and locatable within the recessed slot to inhibit disengagement of the first and second pivot members; and wherein the second pivot members are positioned on side walls of the carrier and located relative to the recessed slot, so as to cause a portion of the retention member to rotationally locate within the recessed slot at a first position when the protective shield is at the before-use initial shielding position; and wherein at least one portion of the protective shield is provided with at least one abutment surface and is arranged to rotationally engage against a stop surface located on the carrier and / or the needle hub; so that after use, movement of the protective shield to the after-use final shielding position causes the retention member to rotationally locate within the recessed slot to a second position and said abutment surface to rotationally engage against the stop surface to restrict excess pivotal movement of the protective shield beyond the after-use final shielding position.

[0090] BRIEF DESCRIPTION OF THE DRAWINGS

[0091] The present invention will now be described, by way of example only, with reference to the drawings that follow, in which:

[0092] Figure 1 is a perspective view of an embodiment of a safety device and a syringe prior to attachment together;

[0093] Figure 2 is a perspective view of a first preferred embodiment of the safety device attached to the syringe with the protective shield in a before -use initial (unlocked) shielding position;

[0094] Figure 3 is a perspective view of the first preferred embodiment of the safety device attached to the syringe with the protective shield in a during-use non-shielding position and a cover removed;

[0095] Figure 4 is a perspective view of the first preferred embodiment of the safety device attached to the syringe after an injection with the protective shield in an after-use final (locked) shielding position; Figure 5 is a perspective view of the first preferred embodiment of the safety device with the protective shield in a during-use non-shielding position;

[0096] Figure 6 is a schematic perspective view of the first preferred embodiment of the safety device with the protective shield in the during-use non-shielding position;

[0097] Figure 7 is a schematic perspective view of the first preferred embodiment of the safety device with the protective shield in a first intermediate position moving from the during-use non-shielding position towards an after-use final (locked) shielding position;

[0098] Figure 8 is a schematic perspective view of the first preferred embodiment of the safety device with the protective shield in a second intermediate position moving from the during-use non-shielding position towards an after-use final (locked) shielding position;

[0099] Figure 9 is a schematic perspective view of the first preferred embodiment of the safety device with the protective shield in an after-use final (locked) shielding position;

[0100] Figure 10 is a schematic side view of the first preferred embodiment of the safety device with the protective shield in the during-use non-shielding position;

[0101] Figure 11 is a schematic side view of the first preferred embodiment of the safety device with the protective shield in the first intermediate position moving from the during-use non-shielding position towards an after-use final (locked) shielding position;

[0102] Figure 12 is a schematic side view of the first preferred embodiment of the safety device with the protective shield in the second intermediate position moving from the during-use non-shielding position towards an after-use final (locked) shielding position;

[0103] Figure 13 is a schematic side view of the first preferred embodiment of the safety device with the protective shield in the after-use final (locked) shielding position;

[0104] Figure 14 is a perspective view of a second preferred embodiment of the safety device prior to use;

[0105] Figure 15 is a schematic perspective view of the second preferred embodiment of the safety device with the protective shield moving towards the after-use final (locked) shielding position;

[0106] Figure 16 is a schematic perspective view of the second preferred embodiment of the safety device with the protective shield in the after-use final (locked) shielding position and being forced towards a non-shielding position;

[0107] Figure 17 is a top plan view of the second preferred embodiment of the safety device with the protective shield in the after-use final (locked) shielding position;

[0108] Figure 18 is a perspective schematic cross-section of a preferred embodiment of the protective shield and the carrier with the protective shield in the after-use final (locked) shielding position and being forced towards a non-shielding position;

[0109] Figure 19 is a perspective view of a preferred embodiment of a carrier;

[0110] Figure 20 is a perspective view of a preferred embodiment of a protective shield;

[0111] Figure 21 is a perspective view of a third preferred embodiment of a safety device having a female luer connector for connection to a male luer connector of a syringe with the protective shield in a before-use initial (unlocked) shielding position;

[0112] Figure 22 is a perspective view of the third preferred embodiment of the safety device having a female luer connector for connection to a syringe having a male luer connector with the protective shield in a during-use non-shielding position and a cover removed;

[0113] Figure 23 is a perspective view of the third preferred embodiment of the safety device attached to the luer portion of a syringe after an injection with the protective shield in an after-use final (locked) shielding position;

[0114] Figure 24 is view of a user holding the syringe with the safety device in a before-use initial shielding position;

[0115] Figure 25 is a view of a user grasping the protective shield in the before-use initial shielding position;

[0116] Figure 26 is a view of a user moving the protective shield from the before-use initial shielding position to the during-use non-shielding position;

[0117] Figure 27 is a view of a user removing the needle cover from the needle in the during-use non-shielding position;

[0118] Figure 28 is a detailed view of a side cross section of an embodiment of the safety needle assembly and a side view of the syringe attached together with the protective shield in the final shielding position showing a proximal region of the protective shield in a locked position relative to a locking projection; and

[0119] Figure 29 is a detailed view of a side cross section of an embodiment of the safety needle assembly and a side view of the syringe attached together showing the proximal region of the protective shield in an unlocked position relative to the locking projection.

[0120] DESCRIPTION OF THE PREFERRED EMBODIMENTS Throughout this specification and with reference to the figures, a safety needle assembly or safety device 8 is shown and described herein which provides for shielding of a sharp tip of a needle 11 of a syringe. As used herein, the term “distal” and / or “forwards” or” forwardly”, and derivatives thereof, refer to the direction generally towards the patient end for use, and the term “proximal” and / or “rearwards” or “ rearward ly”, and derivatives thereof, is used to describe the direction away from the patient during-use. As shown in the figures and as will be described, the proximal end of the safety needle assembly attached to a distal end of a syringe (medical injection needle) 10.

[0121] Referring initially to Figures 1 to 4, there is shown a syringe 10 having a needle 11 staked-in to the nose 12 of the syringe 10 and secured by adhesive, and a safety device 8 to confer protection on the needle 11 . The nose 12 of the syringe 8 serves as a hub for the needle 11 and defines a rearwardly facing shoulder 14 and forwardly of that shoulder 14 the nose 12 is provided with a bulbous profile which defines an engagement face 15. Centrally of the nose 12, a small mass of adhesive 16 serves to secure the needle 11 in a bore extending through the nose 12. The safety device 8 includes a carrier 18 in the form of a ring (tubular body or sleeve section) for a protective shield 19 (needle shield) and the protective shield 19 is movable (specifically, pivotable / tiltable / rotatable) with respect to the longitudinal axis of needle 11 . The carrier 18 has a bore for the nose 12 of the syringe 10, an inwardly directed rib being formed in the bore for engagement behind the shoulder 14 when the safety device 8 is fitted to the syringe 10 so as to hold the safety device 8 to the syringe 10. This provides a secure single use snap lock permanent fit for the safety device 8 to the syringe 10.

[0122] The protective shield 19 is arranged to securely maintain the position of a (soft rubber) needle cover 23 within the safety device 8. The soft needle cover may be entirely made of a soft material or may comprise just a portion / part made of a soft material. It should be readily appreciated that the needle cover 23 enables the sharp tip of the needle 11 to penetrate partially into an internal soft surface to allow the functionality of the needle cover 23 and other parts / surfaces of the needle cover 23 may not be soft and may in fact be more rigid than the soft part.

[0123] The protective shield 19 denies the user access to the needle cover 23 in the initial before use position (a shown in Figure 2). A user is subsequently provided with access to the needle cover 23 only once the protective shield 19 has been moved to the during-use non-shielding position (as shown in Figure 3). In this movement, the engagement between the needle cover 23 and the protective shield 19 is also released.

[0124] Furthermore, the protective shield 19 provides visual indicators in the form of arrows 45 to guide the user on how to commence the operational use of the safety device 8. As shown in Figure 6, an arrow or two arrows 45 are provided on the protective shield 19 to indicate to a user the initial operation within an operational sequence. A user may instinctively seek to remove the needle cover 23 by pulling it off the needle in a distal direction. However, with the present invention, in the initial position, access to the needle cover 23 is denied. Accordingly, the arrows 45 provide a simple visual instruction and universally understood guide to instruct the user how to move the protective shield 19 outwardly in order to commence the operational sequence and to initiate the functional movement of the protective shield 19 relative to the needle cover 23 to expose the needle cover. Accordingly, the arrows 45 provide the user with initial instructions to move the protective shield 19 outwardly, which then enables the needle cover 23 to be then instinctively grasped by the user and removed from the needle, which then the exposes the needle 11 ready for performing the injection.

[0125] Thus, prior to use of the syringe 10 and safety device 8, the protective shield 19 must first be moved to a during-use non-shielding position to gain access to the needle cover 23. Once the injection has been performed, the protective shield 19 is moved to an after-use final locked shielding position to (permanently) shield the needle (as shown in Figure 4). In this final locked position, the present invention provides an improved locking mechanism to prevent the protective shield 19 from being forced and moved (intentionally or unintentionally) back to a non-shielding position. In particular, this locking mechanism provides a compression arrangement which automatically increases the locking strength as the force to move the protective shield 19 towards a non-shielding position is increased. This compression arrangement thereby does not include relatively small and weak locking hooks and latches placed under tensional loads. Such tensioned hook and latch arrangements have a tendency to disengage and release a protective shield from a locked position. Therefore, an increase in the force when applied to the prior art designs of the protective shield towards the non-shielding position increases the tensile forces and increases the likelihood of such prior art locking hook and latch designs to fail.

[0126] The protective shield 19 includes first pivot members in the form of a pair of stub axles 40 which project inwardly (as shown in Figure 20). The carrier 18 includes second pivot members in the form of a corresponding pair of holes 41 for rotatably engaging the stub axles 40 (as shown in Figure 19). The carrier 18 comprises two side walls 36, 37 on which the holes 41 are provided. These side walls 36, 37 comprise recessed / cut-away / openings such that flat surfaces may be provided. These side walls 36, 37 extend from a proximal portion 33 of the carrier 18 to a distal end of the carrier 18. The present invention provides a control mechanism to inhibit the disengagement of the respective first and second pivot members 40, 41 (and also restrict excess pivotal movement of the protective shield relative to the carrier beyond the after-use final shielding position a previously described). The inhibition of the disengagement is provided in both the before-use initial shielding position (see Figures 2, 21 and 24-26) and also in the after-use final shielding position (see Figures 4, 9, 13, 16, 18 and 23). For example, any outward deflection or gaping of the protective shield 19 / support arms 26, 27 may move the pivot members 40 to or towards a disengaged position. The pivot members 40 are integrally formed on the protective shield 19 such that this outward deflection of the protective shield 19 causes the pivot members 40 to move outwardly towards disengagement. In these two position (before-use and after-use), each retention member 70, 71 is captured in an associated recessed slot 42, 43 which thereby prevents the significant separation of the first pivot members 40 (stub axles) on the protective shield 19 outwardly to a disengaged position relative to the second pivot members 41 (holes) on the carrier 18. In particular, these stub axles 40 are simply aligned, e.g. slidably moved and then automatically / naturally engage within the holes 41 and therefore no intrinsic retaining force is provided between the stub axles 40 and the holes 41. The lack of any intrinsic retaining force thereby increases the risk of disengagement. Accordingly, the disengagement of the stub axles 40 would be possible without the retention members 70, 71 being in a captive position within an associated recessed slot 42, 43. Shaped stub axles and / or retaining holes may be provided to produce such a natural retaining force. However, this may increase the complexity of the assembly so the present invention enables pivot members 40, 41 without any intrinsic retaining force to be used or alternatively the present invention increases the retaining ability of such intrinsically held pivot members. The retention members 70, 71 are initially held and locate at a first position with the protective shield 19 in the before-use initial shielding position. The retention members 70, 71 are finally held and locate at a second position with the protective shield 19 in the after-use final position. It will be appreciated that the first position is therefore different from the second position. Specifically the first position is angularly offset from the second position since the protective shield 19 is similarly angled downwardly in the final position with the needle 11 in a bent configuration. The control mechanism thereby significantly increases the reliability of the assembly by maintaining the protective shield 19 engaged with the carrier 18 / hub assembly since the pivot members 40, 41 cannot be disengaged in either the initial (first) position or the final (second) position. In some embodiments, the stub axles 40 may have a spherical surface, e.g. a partially spherical, for example hemi-spherical (or slightly less than hemi-spherical) such that the stub axles 40 are easily located into the holes 41 since this provides a simple assembly step. This again improves the assembly of the device since these products are generally produced in high speed assembly process.

[0127] It should be noted that the preferred embodiments shown in the figures all include two retention members 70, 71 . However, in some embodiments (not shown) there may be a single retention member or there may be more than two retention members (for example three, four, five or more). Such embodiments may still function and achieve the functional result but some of these such arrangements may not be optimal and the preferred embodiments comprise two retention members and specifically, each supporting arm provides a single retention member which may primarily inhibit the disengagement of an associated pair of pivot members.

[0128] The carrier also provides an opening 35 which extends all the way through from a proximal end to a distal end such that the hub is engageable and securable therein. The protective shield 19 is therefore rotatably or pivotably movable relative to the carrier 18. In particular, when the carrier 18 (and thence the safety device 8) is attached to the syringe 10, the protective shield 19 is pivotably movable relative to the longitudinal axis of needle 11 . The protective shield 19 is initially positioned with a longitudinal axis 21 which is generally parallel to the longitudinal axis of the needle 11 and the protective shield 19 is also generally aligned with the needle 11 in this initial as supplied configuration before use as shown in Figure 2.

[0129] The protective shield 19 comprises a partial or incomplete longitudinal tubular sleeve section which circumferentially extends a majority of the way around the circumferential outer surface of the needle cover 23. In this way, a longitudinal opening is formed which enables the semi-tubular sleeve section of the protective shield 19 which accommodates and retains and maintains the needle cover at an initial shielding position before use, to be moved outwardly away from the enclosed needle 11. The protective shield 19 has a distal end 50 which provides the outermost or most distal extent of the safety device 8. Specifically, the distal end 50 of the protective shield 19 extends distally at least the same but preferably beyond the distal end 24 of the cover 23. This forward extent of the shield thereby defines the ideal distal dimension for use with standard nest and tub packaging systems. This distal dimension of the protective shield 19 (with the enclosed needle cover) in the present invention is designed and configured to be no greater than or equivalent to the dimension of standard needle covers used in existing nest and tub systems, such that no modifications need to be made to any of the packaging components used in these standard syringe handling assembly lines to accommodate the safety device 8. As mentioned above, the protective shield 19 includes an internal shoulder which engages the needle cover to block distal movement of the needle cover 23 away from the first position during assembly of the device 8 onto the syringe 10 and instead urges the cover 23 towards the syringe 10 in the initial position. Wherein, in use, the protective shield 19 is first manipulated manually by the user to move outwardly towards a during-use non-shielding position as shown in Figure 3. This movement causes the shoulder to disengage from a step on the needle cover, and this movement may also release and or relax any urging or compressive forces acting on the cover that was pushing the cover proximally towards the syringe 10.

[0130] In the outwardly pivoted position shown in Figure 3, the needle cover 23 is exposed and can be manually grasped and manipulated by a user and withdrawn from the needle in a distal direction in readiness to perform the injection. The needle cover 23 can therefore be removed as shown in Figure 3 and can be discarded or placed aside for later disposal, with the syringe and safety device ready for performing an injection.

[0131] After the injection has been performed, it is necessary to protect the sharp tip of the needle 11 . This is achieved through the inward movement of the protective shield 19 into a locked (after-use) final shielding position. In the preferred embodiments, this movement is achieved manually by the intervention of a user to provide what is termed “active protection” of the sharp tip of the needle 11 . The protective shield 19 is pivoted inwardly and an inner surface of the protective shield 19 may abut and contact the end region of the needle 11 , provided the needle is of sufficient overall length. The pivotal movement is continued further such that the protective shield 19 may deflect / flex the shaft of the needle 11. In this position, the longitudinal axis of the protective shield 19 is angled relative to the longitudinal axis of the syringe 10 and carrier 18. This protects and shields the sharp tip of the needle 11 and also prevents re-use of the needle 11 . Note (provided the needle is of sufficient length) that whilst the resilient characteristics of the metallic medical needle tend to resist the inward movement of the shield, this reactive force is very low and is easily overcome by the user as the shield is moved to the after-use final shielding position.

[0132] In this after-use final shielding position shown in Figure 4, the protective shield 19 is locked in the after-use final shielding position relative to the carrier 18 and syringe 10. The present invention provides an improved locking mechanism arrangement for this after-use final shielding position.

[0133] As shown in Figure 19, the carrier 18 comprises pivot members 41 in the form of axle holes / recesses / indentations arranged for pivotal engagement with supporting arms 26, 27 of the protective shield 19; and the hollow interior of the ring shaped carrier provides outer side faces for the location of the pivot members 41 . In addition, the carrier 18 provides the lug 60 projecting distally in which the lug 60 has an outer surface 62 and an inner blocking surface 63 adjoined by profiled flank surfaces 66, 67. As shown in Figure 5, the carrier 18 comprises the lug 60 which locates and projects distally relative to the pivotal members 41 . The lug 60 comprises a distal projection extending from a distal end of the carrier 18. The protective shield 19 is provided with a corresponding gap for this lug 60 in order to cooperate therewith and provide the improved locking functionality. A distal most edge 64 or end of the lug 60 is spaced from and is separated by a separating-gap from a proximal most surface edge 92 of the gap in the protective shield 19. Accordingly, these two surfaces 64, 92 do not touch or engage at all through the operational sequence.

[0134] In some embodiments (not shown), the lug comprises a distal end profile which engages a proximal end profile provided on the protective shield when the protective shield is in the before-use position. Preferably the engaging profiles disengage when the protective shield is moved outwardly to the during-use position and reengage and disengage when the shield is moved to the final after-use position. The reengagement and disengagement generating an audible and or tactile feedback to user to indicate that the protective shield is located at the after-use final shielding position.

[0135] As shown in Figure 17, the protective shield 19 provides locking members 80, 81 on either side of a gap located between the two locking members 80, 81 . The protective shield 19 comprises a first (distal) portion 30, a second (intermediate) portion 32 and a third (proximal) portion 34. These portions 30, 32, 34 are integral and continuous and are formed on the unitary component of the protective shield 19. These portions 30, 32, 34 may be defined as regions or parts or segments or zones along the protective shield 19. The distal portion 30 surrounds at least the sharp tip of the needle 11 at the before-use initial (unlocked) shielding position and at the after-use final (locked) shielding position. The intermediate portion 32 is proximal to the first portion 30 and distal to the third portion 34. Accordingly, the second portion 32 extends between the first portion 30 and the third portion 34. The second portion 32 comprises the at least one resiliently deformable locking member 80, 81 and preferably provides two locking members 80, 81 . The third portion 34 is proximal to the second portion 32 and comprises supporting arms 26, 27 having pivot members 40 arranged thereon for pivotal engagement with the carrier 18. These three portions 30, 32, 34 thereby define the location of the pivot axis which is located on the third portion 34 proximally with respect to the locking members 80, 81 .

[0136] As shown in Figure 5 to Figure 13, the present invention provides a safety device 8 comprising a combined control mechanism (retention means and stop means) to inhibit the disengagement of the respective pivot members of the supporting arms and the carrier and restrict excess pivoting movement of the protective shield relative to the carrier beyond the after-use final shielding position. This mechanism restricts / limits the extent of the pivotal movement of the protective shield 19 beyond a predetermined final after-use locking position. In addition, the mechanism inhibits / prevents the disengagement of the respective pivotal members of the protective shield 19 and the carrier 18 which thereby strengthens the safety device 8 and reduces the risk of the protective shield 19 from becoming separated relative to the carrier 18 during use. Any such separation would expose the used needle 11.

[0137] In the safety device 8, the protective shield 19 is manually moved by the user to the final locking position and the present invention provides sensory feedback through the use of a lock and stop mechanism. This feedback signals and indicates to the user that no further pivotal movement is required and also signals that the locking arrangement is in a position at which it is engaged. Without such feedback, an inexperienced user may pivot the protective shield 19 an insufficient amount so as not to activate the locking arrangement, allowing the protective shield 19 is freely rotate back to a position in which the used needle is exposed. Alternatively, an inexperienced user may over rotate the protective shield 19 such that a part of the safety device 8 fails or breaks and, again, introduces the risk of exposing the used needle.

[0138] The protective shield 19 and or the supporting arms may comprise a retention member 70, 71 on either lateral side. Each retention member 70, 71 is arranged to engage with an engagement portion 38, 39 on the carrier 18.

[0139] As shown in Figure 5, Figure 10 and Figure 20, the retention member 70, 71 comprises an extension projecting from the proximal end of the support arm 26. The extension may comprise a fin or flange element. The retention member 70 is of a reduced thickness relative to the adjoining portion of the support arm 26. The proximal end of the shield and hence the retention member 70 locates proximally relative to the pivotal axis when the protective shield is in the initial shielding position.

[0140] The engagement portions 38, 39 of the carrier 18 provide recessed retaining slots 42, 43 for receiving the respective retention member 70, 71. In particular, the retention members 70, 71 enter into the recessed slots 42, 43 at a predetermined relative angular rotational position between the protective shield 19 and the carrier 18. Once the retention member 70, 71 is received and located in the respective recessed slot 42, 43, this then prevents significant lateral / radial movement of the retention members 70, 71 outwardly. This thereby prevents the support arms 26, 27 and, importantly, the pivotal members of the carrier 18 moving outwardly away from the sides of the carrier, and potentially disengaging from the pivotal members located on the carrier 18. Each engagement portion 38, 39 and specifically each recessed slots 42, 43 provides an interior stop surface (primary or first limiting (or abutment) face) 48, 49 and an exterior stop surface (auxiliary or secondary or second limiting (or abutment) face) 46, 47. The term auxiliary abutment surface (or face) is used throughout this specification although this could be replaced with the term secondary abutment surface. The exterior stop surface(s) 46, 47 provides a surface around the entry to the respective recessed retaining slot(s) 42, 43. The exterior stop surface (limiting face) 46, 47 is arranged for contact with the associated proximal face of the protective shield 19 and specifically the support arm 26, 27. This proximal surface thereby provides an auxiliary abutment surface 72, 73.

[0141] The engagement portions 38, 39 provide the interior stop surfaces face 48, 49 and these are provided within the recessed slot 42, 43 and comprises an upper internal control face of the recessed slot 42, 43. Each interior stop surface 48, 49 is arranged for contact with an associated primary abutment surface 74, 75 (or primary abutment face) provided on the respective retention member 70, 71 . Preferably the or each retention member 70, 71 comprises a (associated / respective) primary abutment surface 74, 75 (or face). In particular, each retention member 70, 71 comprises a planar surface 74, 75 and a profiled outer surface 76, 77 to allow entry of the retention member 70, 71 into the recessed slot 42, 43 in rotational sense in a curved or arcuate path as defined by the pivot axis. For completeness, each retention member 70, 71 has an outer lateral planar side and an internal planar side. The interior / exterior stops are arranged to arrest rotational movement of the shield and, in particular, the stops locate in the rotational paths of the respective abutment surfaces as the protective shield 19 as the protective shield pivotally rotates from the during-use non-shielding position to the after-use shielding position.

[0142] In the preferred embodiments, the recessed slot 42 comprises a first internal side wall providing the interior stop surface 48, a second (opposite) internal side wall and an internal end wall. The internal end wall is perpendicular to the first internal side wall and the second internal side wall and spans and / or extends between the first internal side wall and the second internal side wall. The recessed slot 42 also includes two internal radially spaced apart walls relative to the longitudinal axis of the carrier 18. An inner lateral control surface of the radially outermost wall may directly contact and prevent transverse outwards movement of the retention member 70 when the retention member 70 is partially or completely located with the recessed slot 42.

[0143] In some embodiments, the recessed slot 42 may have a single internal side wall (which provides the interior stop surface 48) and the opposite side may be open. This may enable the retention member 70 to rotationally enter / leave the internal space of the recessed slot 42 through this open ended side and / or from the open end opposite to the internal end wall which is provided with the interior stop surface 48.

[0144] The primary stop / abutment and the auxiliary stop / abutment are configured to function in unison. Accordingly, the positional arrangement of the stops 46, 47, 48, 49 and the abutment faces 72, 73, 74, 75 are arranged to make contact concurrently as the designed maximum rotational limit of the protective shield is achieved, such that the two abutment faces and stops provided on each side of the protective shield 19 make contact, so as to arrest and restrict further pivotal rotational movement of the shield beyond the after-use final shielding position. These stops / abutments are arranged to occur once the protective shield 19 has been rotationally pivoted to a safe after-use final shielding position and whereat the protective shield 19 is rotationally displaced at an angle away from the longitudinal axis of the carrier and the needle 11 may also be deflected at an angle away from the longitudinal axis of the needle hub.

[0145] The movement and operational sequence of the protective shield 19 with respect to the retention mechanism and the various stop means will now be described with reference to Figure 5 to Figure 13.

[0146] With the protective shield 19 in a during-use non-shielding position or an outermost rotational position (see Figure 5, Figure 6 and Figure 10), the needle 11 will be exposed and the injection can be performed. The retention member 70 is located out of, and disengaged from, the recessed slot 42. However, in this position there will be no significant lateral forces moving the pivot members towards a disengaged position such that lateral reinforcement is not required.

[0147] In some embodiments, the retention member 70 is always located and / or captured within the recessed slot 42. For example, the retention member 70 commences in the recessed slot at the first position with the protective shield 19 at the before-use initial shielding position. During, and following, the movement of the protective shield 19 to the during use non-shielding position, the retention member 70 stays captured within the slot. At the after-use final shielding position, the retention member 70 also remains within the recessed slot 72. Accordingly, in such examples, the capturing of the retention member 70 always inhibits / prevents disengagement of the pivot members.

[0148] After performing the injection, the user manually pivots the protective shield 19. At a first intermediate position, the retention member 70 will pivot and enter rotationally into the recessed slot 42, as shown in Figure 7 and Figure 11. Further pivotal movement to a second intermediate position causes the retention member 70 to enter rotationally further into the recessed slot 42, as shown in Figure 8 and Figure 12. It should be noted that this second intermediate position is the same as the before-use initial non-locked position. Accordingly, in the original as supplied position prior to use, the protective shield 19 is securely attached to the carrier 18 since the retention members 70, 71 are received within the recessed slots 42, 43 and therefore, the safety needle device provides a very compact and secure configuration that is both robust and requires much less shelf storage space before use.

[0149] From the second intermediate position, the user pivots the protective shield 19 further until the stop limiting abutment function activates / operates and provides the necessary feedback to the user to cease pivotal movement of the shield. As shown in Figure 9 and Figure 13, in this configuration, the retention member 70 is fully located within the recessed slot 42, the exterior face 46 is abutting the auxiliary abutment surface 72 and the interior stop surface 48 is abutting the primary abutment surface 74. In this position, the outer lateral face 78 of the retention member 70 is located in opposition to the inner lateral control face 52 of the recessed slot 42. This arrangement thereby maintains the pivotal members securely engaged and prevents the protective shield 19 from becoming detached from the carrier. For example, at the end of the pivotal rotational movement, any unnecessary additional extra or excess rotational movement of the shield may cause the plastics material of protective shield 19 and / or carrier 18 to deform or deflect such that the pivot members may become disengaged. The present invention provides an improved safety arrangement to prevent such incidents.

[0150] As shown in Figure 18, the safety device 8 may include two opposing locking members 80, 81. These locking members 80, 81 comprise resilient regions or portions of the protective shield 19 at a proximal end of the second portion 32 and are integral with the protective shield 19. The locking members 80, 81 function as flexible flaps which resiliently move / deflect between unlocked and locked positions as will be described. During this movement / deflection, the locking members 80, 81 (resilient / flexible flaps) move apart and away from one another along a transverse axis 20 with respect to the longitudinal (distal-proximal) axis 21 of the protective shield / needle 19, 11. The locking members 80, 81 when flexed outwardly may also move in a radial sense outwardly and return resiliently inwardly in a radial sense relative to the transverse axis when returning to an unstressed relaxed condition. In the preferred embodiments, the locking members 80, 81 are integral with the protective shield 19 such that there is no single pivot axis as the material of the protective shield 19 is deformed or gapes apart in response to a force applied to the locking members and correspondingly resiliently return to an unstressed and relaxed condition when the force applied to the locking members is relaxed, to thereby define the locking members 80, 81 and the associated essential functionality.

[0151] Each locking member 80, 81 provides an engaging inner edge 84, 85 and the engaging edges 84, 85 of the two locking members 80, 81 are opposing and define the space therebetween. In the preferred embodiments, the engaging edges 84, 85 are parallel and extend along a longitudinal axis of the protective shield 19 when viewed from above (see Figure 17). Similarly, in the preferred embodiments, the lug 60 has flanks 66, 67 comprising linear parallel edges, when viewed from above (see Figure 17) which extend along a longitudinal axis of the carrier 18. Accordingly, the space in the protective shield has linear edges. The relative movement of the protective shield 19 over the lug 60 of the carrier 18 causes a distal portion of the protective shield 19 to gape and move apart as the locking member 60 moves relatively therethrough.

[0152] As shown in Figure 19, the lug 60 has an outer surface 62 and an inner blocking surface 63. In the initial (unlocked) shielding portion shown in Figure 14, the locking members 80, 81 are disengaged and resting on the flank surfaces 66, 67 of the lug, so that the protective shield 19 can be pivotally moved outwardly and the locking members 80, 81 do not engage with the lug 60. In some embodiments (not shown) a frictional or detent arrangement can be provided to retain the shield at the beforeuse initial shielding position, until the retaining means is overridden when the shield is moved outwardly to the before-use position. However, in the final (locked) position shown in Figure 17, at least a portion of the locking members 80, 81 locate directly adjacent to (preferably abutting) the underside of the inner blocking surface 63 of the lug 60. It can be seen from Figure 17, that any attempt in a returning movement of the protective shield 19 to an unshielding position will be prevented due to the locking members 80, 81 being at least partially located underneath the sides of the lug 60. Furthermore, due to the arrangement of the present invention, it can be seen that such a return movement or force will cause the locking members 80, 81 to be urged further underneath this inner blocking surface 63 (as shown in Figure 18) and the contact surface area therebetween will be increased. This will increase the blocking resistance and will strengthen the resistive locking force. The locking members 80, 81 would be compressed against the inner blocking surface 63 of the lug 60. Each locking member 80, 81 provides a focused point of contact on the apexes 88, 89 in which the resistive movement and force will commence. Each apex 88, 89 will initiate the contact between the respective locking member 80, 81 and the inner blocking surface 63. As the force applied to move the protective shield to a nonshielding position increases the contact area with the inner blocking surface 63 will emanate from and progress outwardly from the respective apex 88, 89 bending the apexes and the corner portion of the locking members inwardly. Accordingly, as the force applied to move the shield outwardly increases the mutual contact area will increase from each apex 88, 89 as the contact area spreads outwardly from each apex.

[0153] As shown in Figure 15, as the protective shield 19 is moved towards the final locked shielding position, the locking members 80, 81 contact respective drive surfaces 68, 69 of the lug 60. The rotational movement of the protective shield 19 causes the two locking members 80, 81 to be moved apart, specifically outwards in a transverse direction relative to the longitudinal axis of the shield. This transverse movement continues until the locking members 80, 81 define a gap therebetween sufficient through which the lug 60 can pass. The drive surfaces 68, 69 may be linear / flat / planar although they are preferably arcuate / curved from the outer extent to the inner extent in a radial direction.

[0154] As the tips or flaps / edges 82, 83 of the locking members 80, 81 pass the outermost projecting parts of the flanks 66, 67, the continued pivotal movement of the protective shield 19 allows the locking members 80, 81 to resiliently move back inwardly towards a relaxed condition / configuration. Specifically, the locking members 80, 81 will tend to snap back towards each other and immediately locate underneath the inner blocking surface 63 of the lug 60, as shown in Figure 16. This snap-back motion of the locking members 80, 81 to the underside of the blocking surface 63 of the lug 60, also provides a confirmatory audible and or tactile haptic feedback to indicate to the user that the protective shield is safely locked at the afteruse final shielding position. In some embodiments (not shown) the drive surfaces 68, 69 may also comprise stepped profiles to create an audible and or tactile feedback to the user to confirm that the locking members 80, 81 have transitioned past the outermost projecting parts of the flanks 66, 67 and that the shield is safely locked in the after-use final shielding position.

[0155] In this position, it can be seen that any movement of the protective shield 19 back towards a non-shielding position will cause the locking members 80, 81 to now engage forcefully with the underside of the inner blocking surface 63. The upper surfaces 86, 87 of the locking members 80, 81 are preferably curved to form apexes 88, 89, although in some embodiments these upper surfaces could be a flat surface. The engagement of the upper surfaces 86, 87 of the locking members 80, 81 with the inner blocking surface 63 causes the locking members 80, 81 to deflect inwardly relative to the longitudinal axis of the protective shield, such that a greater contact area is generated / created between the locking members 80, 81 and the inner blocking surface 63 as the outward force applied to the shield is increased. Accordingly, resistance to the movement of the protective shield towards an unsafe non-shielding position also increases. Importantly, the increase in the force applied to open the shield outwardly towards a non-shielding position, compresses the locking members 80, 81 which also naturally increases the ultimate strength of the locking mechanism arrangement.

[0156] As shown in Figure 14 to Figure 20, the distally projecting lug 60 of the carrier 18 comprises two flanks 66, 67 which extend along the outer lateral sides of the lug 60. These flanks 66, 67 each have cooperating profiled surfaces which provide corresponding drive surfaces 68, 69. The second region of the protective shield 19 provides the two locking members 80, 81 to engage with the two flanks 66, 67 of the lug 60. The protective shield 19 may be provided with a slot 90 to aid the outward movement / deflection of the two locking members 80, 81 away from and towards each other. The linear extent of the slot 90 correspondingly increases or decreases the force required to move the locking members 80, 81 apart. In some embodiments, the protective shield 19 may have no slot. Such an arrangement may provide increased rigidity for the protective shield 19 and the associated locking members 80, 81

[0157] During the inward pivotal rotational movement of the protective shield 19, the locking members 80, 81 of the protective shield 19 resiliently deform over the profiled flank surfaces 66, 67 provided by the lug 60 on the carrier 18, as shown in Figure 15 and as depicted by diametrically opposed arrow heads. This transverse outward movement of the locking members also urges and / or moves the respective pivot members 40, 41 outwardly and relatively away from each other and towards a disengaged position. In particular, the stub axles 40 are provided on (the proximal portion 34 of the protective shield 19 and the locking members 80, 81 are integral with the protective shield 19 and are provided on the intermediate portion 32. According, as the intermediate portion 34 (with the locking members 80, 81 ) is urged / moved transversely outwardly the stub axles 40 provided on the inner surface of the proximal portion 34 of the protective shield 19 also tend to move transversely outwardly and away from the holes 40 provided in the carrier 18 side walls 36, 37 which remains undistorted. The retention members 70, 71 are similarly integral with the protective shield 19 and will also tend to move / deflect in a similar manner outwardly. However, during this phase of the movement, the retention members 70, 71 are received within the recessed slots 42, 43 and an outer surface / lateral face 78, 79 of the retention members 70, 71 would contact an inner lateral control surface 52, 53 of the recessed slot 42, 43 such that this outwards movement is restrained and controlled and therefore inhibits and prevents the disengagement of the pivot members 40, 41 . The locking members 80, 81 travel over the flanks 66, 67 of the projecting lug 60 and eventually pass over the outermost edges of the lug 60. At this point, the resilient properties of the material forming the locking members 80, 82 may “snap back” and then relax into the original unstressed condition / state and any deformation of the locking members 80, 82 is then fully released.

[0158] The locking of the protective shield 19 in this after-use final shielding position protects the sharp tip of the needle 11 and the inclined angle of the protective shield 19 also provides a visual indication that the safety device 8 has already been used. Furthermore, if the needle shaft has been deformed this may also serve to provide a visual clue prevent the needle 11 from being re-used.

[0159] The protective shield 19 provides deformable zones for the locking members 80, 81 and comprises resilient / elastic properties. In some embodiments, these zones or regions may comprise a reduced or increased thickness (i.e., a relatively thin or thick zone / region) or have a tapered sectional thickness to provide the required deformable properties for the zones / regions in order form the locking members 80, 81. The protective shield 19 typically comprises a moulded plastics material or polymer material to provide the required resilient elastic properties. The material may comprise a thermoplastic material having resilient deformable plastic properties which enable the locking members 80, 81 to deform or flex transversely outwardly during the movement of the protective shield 19 to the locked position and the lug 60 may have a profile shaped to cause and / or enhance said outward deformation or flexing of the locking members 80, 81 . The material and / or the dimensions in this zonal region allow and permit the elastic deformation in order to allow movement the protective shield 19 to the locked final position.

[0160] As shown in Figure 21 to Figure 23, the safety device 8 can also be used in conjunction with a standard needle and hub having a female Luer connection arrangement and whereby In Figure 21 to Figure 23 the safety device 8 has been fitted onto the hub of a standard needle having a female Luer slip connector 17 secured within the hollow carrier body to form a complete assembly. The female Luer slip connector 17 enables the safety device 8 assembly to be connected to a conventional syringe having a male Luer spigot connector. The Luer connector 17 may include a Luer taper socket for engagement with a Luer male spigot at the distal end of the syringe. The needle hub is located and engaged within the hollow carrier may provide a Luer slip and or a Luer lock connection means.

[0161] By way of a complete description of the safety device, the protective shield 19 may include grip portions on the outer surface to aid the manual manipulation of the protective shield 19. These grip portions may comprise ribs extending on the outer surface. The protective shield 19 also comprises retaining means in the form of retaining clasps 44 to maintain the protective shield 19 in the initial position.

[0162] These retaining clasps (not shown) may be arranged to bite into the needle cover to forcefully hold the needle cover within the protective shield at a first position before use.

[0163] These retaining clasps 44 comprise shaped lugs having inner arcuate surfaces to locate around a part of the outer circumferential surface of the needle cover 23 to either grip or loosely hold the cover 23. The two clasps 44 are spaced apart to provide a release gap therebetween. The extent of this release gap is less than the outer diameter of the cover 23 at the point where the clasps locate around the needle cover. However, this cover 23 is made from a resiliently deformable material such that the cover 23 in this area can be deformed sufficiently to enable the cover 23 to pass through the release gap during use, and or the sides of the shield will flex outwardly to allow the clasps to travel over the needle cover. The extent of this force is controlled by the size of the release gap and the type of material of the cover 23 and the shield. In particular, the release force is controlled to be sufficient to prevent any accidental and inadvertent movement of the protective shield 19 from this initial position but to allow a user to still move the protective shield 19 to the open position relatively easily albeit with some tactile resistance.

[0164] The clasps 44, together with the pivotable coupling / control hinge arrangement and shield arrangement, form a sub-assembly comprising the carrier 18, the protective shield 19 and the needle cover 23 and this sub-assembly is maintained together as a unitary assembly and is preferably self-supporting. The creation of the subassembly helps with the handling and fitting of the device onto a syringe before use or during the manufacturing process.

[0165] Figure 28 and Figure 29 show a locking arrangement in detail and this figure also provides details of another example of an abutment blocking surface to restrict excess pivotal rotational movement of the protective shield 19 beyond the final shielding position. By way of example, the locking arrangement comprises a proximal region 152 of the protective shield 19. In particular the material of the protective shield 19 may comprise a thermoplastic material having resilient deformable plastic properties which enables the proximal region 152 to deform or flex outwardly during the movement of the protective shield 19 to the locked position and the lug 154 may have a profile shaped to cause said outward deformation or flexing of the region 152. The outer surface of the lug 154 comprises a sliding surface 157 over which a part of the protective shield 19 is arranged to move during movement of the shield 19 to the locked position. In the final after-use shielding locked position shown in Figure 28, the prior deformation of the proximal region 152 has dissipated and the proximal region 152 is in its undeformed and unstressed original relaxed condition or state. In this locked position, a gap or space 159 may be defined between the contact or abutment faces 153, 155 of the protective shield 19 and the lug 154, as shown in Figure 28. This demonstrates that the deformation of the proximal region 152 has dissipated and the proximal region 152 and the associated adjacent zones has returned to its original relaxed unstressed condition / state. However, in other designs of this locking / blocking arrangement the abutment faces may remain engaged and in a stressed condition / state. Furthermore, the (complementary angled) end abutment faces of the protective shield 19 and the lug 154 are angled and formed to encourage engagement of the abutment faces to prevent slippage which might enable pivotable return movement of the protective shield 19 towards a position in which the needle 11 may be exposed and present a hazard.

[0166] As further shown in Figure 28, the protective shield 19 may provide an (auxiliary) abutment surface 170 in the form of an internal surface to restrict excess pivotal rotational movement of the protective shield 19 beyond the final shielding position. In this specific example, the abutment surface 170 is provided on an internal or inner surface of the protective shield 19 and is arranged to abut against a counteracting stop surface 172 provided on a part of the nose 12 of the syringe 10. For example, the protective shield 19 will pivot until this abutment surface 170 contacts and abuts against the outer stop surface 172 provided by the hub or nose 12 of the syringe 10. This then physically prevents and / or restricts further pivotal movement beyond this final after-use shielding position. It will be appreciated that such an abutment surface 170 may locate on another part of the protective shield 19 and may be arranged to also abut another part of the carrier 18 and / or the syringe 10 providing the stop surface 172. One abutting part (abutment surface 170) is provided on the protective shield 19 and a counteracting stop surface 172 is provided on the combined carrier 18 / syringe 10 assembly (this combination may be known as a carrier assembly). For example, the abutment surface 170 may be provided on a clasp, step, protuberance, tab, projection, flange on an internal / inner or external / exterior portion or feature of the protective shield 19. Similarly, the carrier 18 / syringe 10 assembly provides a counteracting stop surface 172 which again may be in the form of clasp, step, protuberance, tab, projection, flange.

[0167] The above described abutment surfaces 170 (and any other abutment surface) may be provided as the sole abutment surface or may be used in conjunction with one or more primary abutment surfaces and / or one or more auxiliary (secondary) abutment surfaces. The engagement of these plurality of abutment surfaces may be adaptable such that one or more primary abutment surface may be initially engaged followed by one or more auxiliary abutment surfaces or the auxiliary abutment surface(s) may initially engage followed by one or more primary abutment surfaces. In addition, or alternatively, the abutment surfaces may be engaged in unison and essentially / substantially simultaneously. In addition, or alternatively, the abutment surfaces may be arranged in pairs on each lateral side with each abutment surface in a pair being engaged in unison and essentially / substantially simultaneously or alternatively out of step and sequentially.

[0168] After the injection has been performed, it is necessary to protect the sharp tip of the needle 11. This is achieved through the inward rotational movement of the protective shield 19 into a locked (after use) final shielding position. In the preferred embodiments, this movement is achieved manually by the intervention of a user to provide what is termed “active protection” of the sharp tip of the needle 11 . The protective shield 19 is pivoted rotationally inwardly (manually by the user) and an inner surface of the protective shield 19 may abut and contact the end region of the needle 11 , depending on the needle length. The pivotal rotational movement is continued further such that the protective shield 19 deflects / flexes the shaft of the needle 11. In this position, the longitudinal axis of the protective shield 19 is angled relative to the longitudinal axis of the syringe 10 and carrier 18. This protects and shields the sharp tip of the needle 11 and also prevents re-use of the needle 11. Note that whilst the resilient characteristics of the metallic medical needle tend to resist the inward movement of the shield, this reactive force is very low and is easily overcome by the user as the shield is moved to the final shielding position.

[0169] In this final shielding position shown in Figure 28, the protective shield 19 is locked in the final shielding position relative to the carrier 18 and syringe 10. A locking portion (member) is provided to engage with a locking abutment surface to maintain this locked position. During the inward pivotal movement of the protective shield, a proximal region 152 of the protective shield 19 resiliently deforms over a distal edge of the carrier 18 provided by a projection (lug) 154 on the carrier 18. The proximal region 152 travels over the projecting lug 154 and eventually passes over the edge of the projection 154. At this point, the resilient properties of the material forming the proximal region 152 may snap back into the original unstressed relaxed state and any deformation of the proximal (abutment) region 152 may then be released.

[0170] The forward (distal) facing abutment surface 155 of the projecting lug 154 may be angled to maintain the protective shield 19 in the locked position. In particular, the forward facing surface 155 may be angled rearwardly from the outer surface to the inner surface. This angled surface thereby prevents the abutment edge of the resiliently deformable proximal region 152 from being able to travel back over the projecting lug 154 to a non-shielding position, to prevent any attempt to later move the shield away from the final shielding position. In some embodiments, the rearward facing abutment surface 153 of the proximal region 152 of the protective shield 19 may be angled to maintain the protective shield 19 in the locked position. In some embodiments, both the forward facing surface 155 of the projecting lug 154 and the rearward facing abutment surface 153 of the protective shield 19 are angled to maintain the protective shield 19 in the locked position.

[0171] The locking of the protective shield 19 in this final shielding position protects the sharp tip of the needle and the angle of the protective shield 19 also provides a visual indication that the safety device 8 has already been used. Furthermore, if the needle 11 shaft has been deformed this may also serve to provide a visual clue prevent the needle 11 from being re-used.

[0172] Figure 28 and Figure 29 show the locking arrangement of the shield in more detail. The outer surface of the lug 154 comprises a sliding surface 157 over which a part of the protective shield 19 is arranged to move during rotational movement of the shield to the locked position. The inner surface of the protective shield 19 provides a sliding surface 156 in order to aid the sliding movement of the protective shield 19 to the locked final shielding position. In particular, the inner sliding surface 156 of the protective shield 19 is arranged to slide over the outer sliding surface 157 of the lug 154. To move to the locked position, the protective shield 19 is pivoted relative to the carrier 18 which causes the sliding surfaces 156, 157 to move relative to each other such that the sliding surface 156 of the protective shield 19 slides over the sliding surface 157 of the lug 154. The sliding surface 156 of the protective shield 19 (sliding on the sliding surface 157 of the lug 154) then reaches the distal edge of the projection (lug) 154 and the rotational force applied by the user to move the shield to the protecting position, causes a zone within the proximal region 152 of the protective shield 19 to deform outwardly relative to an adjacent zone within the proximal region 512 of the protective shield 19. The deformable zone and the adjacent zone are provided on a continuous (and homogenous) portion of the protective shield 19.

[0173] The proximal region 152 of the protective shield 19 provides a deformable zone and comprises resilient / elastic properties. In some embodiments, this zone or region may comprise a reduced or increased thickness (i.e., a relatively thin or thick zone / region) or have a tapered sectional thickness to provide the required deformable properties for this zone / region of the proximal region 152. The protective shield 19 would typically comprise a moulded plastics material or polymer material to provide the required resilient elastic properties. The material may comprise a thermoplastic material having resilient deformable plastic properties which enable the proximal region 152 to deform or flex outwardly during the movement of the protective shield 19 to the locked position and the lug 154 may have a profile shaped to cause said outward deformation or flexing of the region 152. The material and / or the dimensions in this zonal region allow and permit the elastic deformation in order to allow rotational movement the protective shield 19 to the locked final position. As shown in Figure 28, in the final shielding locked position, the prior deformation of the proximal region 152 has dissipated and the proximal region 152 is in its undeformed and unstressed original relaxed condition or state. In particular, in this locked position, a gap or space 159 may be defined between the contact or abutment faces 153, 155 of the protective shield 19 and the lug 154, as shown in Figure 28. This demonstrates that the deformation of the proximal region 152 has dissipated and the proximal region 152 and the associated adjacent zones has returned to its original relaxed unstressed condition / state. Furthermore, the (complementary angled) end abutment faces 153, 155 of the protective shield 19 and the lug 154 engage to prevent pivotable return movement of the protective shield 19 towards a position in which the needle 11 may be exposed and present a hazard.

[0174] As shown in Figure 24 to Figure 27, the present invention provides a safety device 8 which is easy to manufacture and intuitively easy to operate with little or no formal instructions, or training being necessary. It is appreciated, that formal instructions would be given although there is a practical consideration that such written information may not be studied in detail before use or fully understood due to the language used. As shown in Figure 23, a user will naturally hold the syringe typically in the non-dominant hand with the safety device 8 (fully enclosing the needle) with the device pointing upwardly. As mentioned above, the safety device 8 includes arrows 45 on either side and these arrows 45 are relatively large and are in a clear and distinctive in a colour which would typically contrast with the colour of the protective shield 19 on which they are either embossed or printed. The arrows 45 may also form a tactile and raised indicator to further indicate not only the directional rotational movement in which the protective shield 19 should be moved, but also provide a “target area” as to where the shield should be first gripped between thumb and finger.

[0175] The two arrows 45 provide grips on which a user would naturally grasp the protective shield 19, in particular, between the forefinger and thumb of one hand whilst the syringe 10 is gripped by the other hand (as shown in Figure 24). The orientation and direction of the two arrows 45 thereby clearly instruct a naive novice user to rotationally pivot the protective shield 19 from the before-use initial shielding position to the during-use non-shielding position (as shown in Figure 25). In this position, the needle cover 23 is exposed and as such a cover 23 will be familiar to the user and would naturally require an axial distal movement to remove the needle cover 23 from the needle 11 . Such a movement would be well known to a user from standard syringe-cover combinations. The cover 23 may also be of a contrasting colour (grey for example) to further signify that the needle cover 23 is separable from the remaining apparatus. Once removed, the user can perform the injection with the protective shield 19 being position out of the way.

[0176] Once the injection has been performed, the user may naturally try to shield the exposed and used needle 11 . The only movement possible is to pivot the protective shield 49 rotationally inwardly until the device provides the confirmatory audible and / or tactile haptic feedback (as mentioned earlier) to indicate to the user that the protective shield 19 is safely locked at the after-use final shielding position. Accordingly, the present invention provides a simple and easy method of operation which is clearly indicated due to the insignia and / or contrasting colours of the various key components.

[0177] Overall, the present invention provides a safety needle device 8 which can be used with standard prefillable syringes within standard nest and tub packaging systems due to the dimensions (length and diameter) of the safety device 8 to replace ordinary non-safety needle cover devices, and importantly the device 8 provides a more secure way of attaching and retaining needle covers on entirely standard prefillable syringes. Once the injection has been completed, the protective shield 19 is pivoted rotationally inwardly until a locking means is engaged in the after-use final shielding position with the needle 11 and the protective shield 19 is maintained at an angle offset from the longitudinal axis of the syringe 10. In the final position, the protective shield 19 may contact the sharp tip of the needle 11 and may flex the needle 11 away from its central longitudinal axis. In some embodiments, the protective shield 19 may not touch or deform the needle in the final position. In particular, with relatively short needles, the final position will protect the used needle but there may be no deformation of the needle 11. In other embodiments, the inner surface of the protective shield 19 may touch or make relatively little contact with the needle 11 in the final position. In yet further embodiments, the protective shield 19 may significantly deform the needle. The present invention provides an improved hinge for the protective shield to limit the pivoting movement of the protective shield and to prevent over-pivoting and also prevents / inhibits the disengagement of the pivot members of the carrier and the protective shield.

[0178] The present invention may be used with pre-filled or pre-fillable glass or plastic syringes. In summary, the present invention provides a safety needle device for a syringe to replace non-safety standard needle covers and which does not require bespoke or modified nest / tray and tub packaging designs and can be integrated into entirely standard tray / nest and tub packaging systems.

Claims

CLAIMS1 . A safety device for a medical injection needle comprising: a protective shield pivotally coupled to a carrier, wherein the carrier is configured to be secured directly or indirectly to a needle hub having a sharp tip of a needle projecting therefrom, and the protective shield is configured to move from a before-use initial shielding position to a during-use non-shielding position and to an after-use final shielding position; the protective shield comprises: a longitudinal axis, a distal portion for surrounding at least the sharp tip of the needle at the before-use initial shielding position and at the after-use final shielding position, an intermediate portion proximal to the distal portion and comprising a resiliently deformable region providing at least one locking portion to lock the protective shield relative to the carrier in the after-use final shielding position; and a proximal portion which is proximal to the intermediate portion and comprising supporting arms having first pivot members arranged thereon for pivotal engagement with the carrier; wherein the carrier comprises: a longitudinal axis; a lug projecting distally, the lug having a locking abutment surface to engage with the locking portion to lock the protective shield relative to the carrier in the final shielding position; second pivot members located proximally to the lug and arranged for pivotal engagement with the supporting arms; and wherein the longitudinal axis of the carrier is aligned with the longitudinal axis of the protective shield when the protective shield is at the before-use initial shielding position; and the resiliently deformable locking portion engages with the locking abutment surface of the lug to block movement of the shield from the after-use final shieldingposition towards a non-shielding position; characterised in that: the safety device comprises a control mechanism to inhibit the disengagement of the respective first and second pivot members and also restrict excess pivotal movement of the protective shield relative to the carrier beyond the after-use final shielding position; the mechanism comprising: a recessed retaining slot provided on the carrier and located proximal to the second pivot members; and wherein the recessed slot is transversely elongated relative to the longitudinal axis of the carrier; at least one retention member extending from the proximal end of the supporting arm and located within the recessed slot to inhibit disengagement of the first and second pivot members; and wherein the second pivot members are positioned on side walls of the carrier and located relative to the recessed slot, so as to cause a portion of the retention member to rotationally locate within the recessed slot at a first position when the protective shield is at the before-use initial shielding position; and wherein at least one portion of the protective shield is provided with at least one abutment surface and is arranged to rotationally engage against a stop surface located on the carrier and / or the needle hub; so that after use, movement of the protective shield to the after-use final shielding position causes the retention member to rotationally locate within the recessed slot to a second position and said abutment surface to rotationally engage against the stop surface to restrict excess pivotal movement of the protective shield beyond the afteruse final shielding position.

2. A safety device for a medical injection needle according to Claim 1 in which, in the first position, the retention member is captured in the recessed slot to inhibit the disengagement of the respective first and second pivot members with the protective shield in the before-use initial shielding position and, in the second position, the retention member is captured in the recessed slot to inhibit thedisengagement of the respective first and second pivot members and with the protective shield in the after-use final shielding position.

3. A safety device for a medical injection needle according to Claim 1 or Claim 2 in which the protective shield comprises a plurality of abutment surfaces and each abutment surface is arranged to engage a respective stop surface which is provided on the carrier and / or the needle hub.

4. A safety device for a medical injection needle according to any preceding claim which the protective shield comprises one or more primary abutment surfaces and one or more auxiliary abutment surfaces.

5. A safety device for a medical injection needle according to any preceding claim which the abutment surface in the form of a primary abutment surface is provided on the retention member.

6. A safety device for a medical injection needle according to any preceding claim in which the abutment surface in the form of an auxiliary abutment surface is provided on an internal surface and / or an external surface of the protective shield.

7. A safety device for a medical injection needle according to any preceding claim in which the stop surface is in the form of an interior stop surface and is provided in the recessed slot and wherein the recessed slot is provided with the interior stop surface to restrict pivoting movement of the protective shield relative to the carrier, and the interior stop may be formed on an internal side wall at one end of the recessed slot.

8. A safety device for a medical injection needle according to any preceding claim in which the recessed retaining slot includes an exterior stop surface and the supporting arm includes an auxiliary abutment surface arranged to rotationally engage against the exterior stop surface of the recessed slot to further restrict excess pivotal movement of the protective shield beyond the after-use final shieldingposition.

9. A safety device for a medical injection needle according to Claim 8 in which the internal side wall at one end of the recessed slot is arranged generally perpendicular to the exterior stop surface.

10. A safety device for a medical injection needle according to Claim 9 in which the internal side wall at one end of the recessed slot is arranged generally perpendicular to the transversely elongated recessed slot.

11. A safety device for a medical injection needle according to any preceding claim in which the recessed slot comprises a first internal side wall providing the stop surface and an internal end wall.

12. A safety device for a medical injection needle according to any preceding claim in which the recessed slot comprises a first internal side wall providing the stop surface, a second internal side wall and an internal end wall.

13. A safety device for a medical injection needle according to Claim 12 in which the internal end wall is perpendicular to the first internal side wall and the second internal side wall.

14. A safety device for a medical injection needle according to Claim 12 or Claim 13 in which the internal end wall spans between the first internal side wall and the second internal side wall.

15. A safety device for a medical injection needle according to any preceding claim in which the retaining recessed slot comprises two internal radially spaced apart walls relative to the longitudinal axis of the carrier.

16. A safety device for a medical injection needle according to any preceding claim in which the stop surface comprises an interior stop surface which is alignedwith the longitudinal axis of the carrier.

17. A safety device for a medical injection needle according to any preceding claim in which the stop surface comprises an exterior stop surface which is aligned perpendicularly relative to the longitudinal axis of the carrier.

18. A safety device for a medical injection needle according to any preceding claim in which the retention member is arranged to freely rotationally move within the recessed slot until the abutment surface contacts and abuts the stop surface.

19. A safety device for a medical injection needle according to any preceding claim in which the retention member rotationally locates at least partially within the recessed slot in the before-use initial shielding position and locates completely out of the recessed slot in the during-use non-shielding position and locates completely in the recessed slot in the after-use final shielding position.

20. A safety device for a medical injection needle according to Claim 8 when dependent upon Claim 7 or any one of Claim 9 to Claim 19 when dependent upon both Claim 7 and Claim 8 in which the interior stop surface is substantially perpendicular relative to the exterior stop surface.

21. A safety device for a medical injection needle according to Claim 4 or any one of Claim 5 to Claim 20 when dependent upon Claim 4 in which the primary abutment surface is substantially perpendicular relative to the auxiliary abutment surface.

22. A safety device for a medical injection needle according to any preceding claim in which the retaining recessed slot provides an inner lateral control surface which prevents transverse outwards movement of the protective shield.

23. A safety device for a medical injection needle according to any Claim 22 in which the inner lateral control surface directly contacts and prevents transverseoutwards movement of the retention member when the retention member is partially or completely located with the recessed slot.

24. A safety device for a medical injection needle according to any preceding claim in which the retention member is integral with the protective shield and together they form a unitary component.

25. A safety device for a medical injection needle according to any preceding claim in which the safety device comprises two retention members which are provided on respective proximal faces of two supporting arms which are provided on opposing lateral sides of the protective shield.

26. A safety device for a medical injection needle according to any preceding claim in which the carrier provides two retaining recessed slots which are provided on opposing lateral sides of the carrier.

27. A safety device for a medical injection needle according to any preceding claim in which the or each retention member comprises a fin element having a curved surface and an end face comprising the abutment surface.

28. A safety device for a medical injection needle according to any preceding claim in which the retention member has a thickness less than the thickness of the adjacent supporting arm and a stepped face is provided between the retention member and the supporting arm and this stepped face provides the abutment surface.

29. A safety device for a medical injection needle according to Claim 4 or any one of Claim 5 to Claim 28 when dependent upon Claim 22 in which the primary abutment surface and the interior stop surface are arranged to commence contact at substantially the same relative position between the protective shield and the carrier as contact commences between the auxiliary abutment surface and the exterior stop surface.

30. A safety device for a medical injection needle according to any preceding claim in which the first pivot members provided by the protective shield comprise two stub axles which are engaged within two corresponding apertures on the carrier which form the second pivot members.31 . A method of protecting a medical needle comprising providing a safety device for a medical injection needle which comprises: a protective shield pivotally coupled to a carrier, wherein the carrier is configured to be secured directly or indirectly to a needle hub having a sharp tip of a needle projecting therefrom, and the protective shield is configured to move from a before-use initial shielding position to a during-use non-shielding position and to an after-use final shielding position; the protective shield comprises: a longitudinal axis, a distal portion for surrounding at least the sharp tip of the needle at the before-use initial shielding position and at the after-use final shielding position, an intermediate portion proximal to the distal portion and comprising a resiliently deformable region providing at least one locking portion to lock the protective shield relative to the carrier in the after-use final shielding position; and a proximal portion which is proximal to the intermediate portion and comprising supporting arms having first pivot members arranged thereon for pivotal engagement with the carrier; wherein the carrier comprises: a longitudinal axis; a lug projecting distally, the lug having a locking abutment surface to engage with the locking portion to lock the protective shield relative to the carrier in the final shielding position; second pivot members located proximally to the lug and arranged for pivotal engagement with the supporting arms; andwherein the longitudinal axis of the carrier is aligned with the longitudinal axis of the protective shield when the protective shield is at the before-use initial shielding position; and the resiliently deformable locking portion engages with the locking abutment surface of the lug to block movement of the shield from the after-use final shielding position towards a non-shielding position; characterised in that: the method comprising restricting excess pivotal movement of the protective shield relative to the carrier beyond the after-use final shielding position, and also inhibiting the disengagement of the respective first and second pivot members, wherein the safety device comprises a control mechanism comprising: a recessed retaining slot provided on the carrier and located proximal to the second pivot members; and wherein the recessed slot is transversely elongated relative to the longitudinal axis of the carrier; at least one retention member extending from the proximal end of the supporting arm and locatable within the recessed slot to inhibit disengagement of the first and second pivot members; and wherein the second pivot members are positioned on side walls of the carrier and located relative to the recessed slot, so as to cause a portion of the retention member to rotationally locate within the recessed slot to a first position when the protective shield is at the before-use initial shielding position; and wherein at least one portion of the protective shield is provided with at least one abutment surface and is arranged to rotationally engage against a stop surface located on the carrier and / or the needle hub; so that after use, movement of the protective shield to the after-use final shielding position causes the retention member to rotationally locate within the recessed slot at a second position and said abutment surface to rotationally engage against the stopsurface to restrict excess pivotal movement of the protective shield beyond the afteruse final shielding position.

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