Improved lock 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. Once the injection has been completed, the protective shield (19) is pivoted inwardly until a locking means is engaged in the 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). A locking member (80, 81) is located adjacent a profiled flank (66, 67) of a lug (60) when the protective shield (19) is at the before-use initial shielding position. The locking member (80, 81) and the profiled flank (66, 67) comprise cooperating drive surfaces to engage and resiliently deform the locking member (80, 81) in an outward transverse direction relative to the longitudinal axis of the protective shield (19) when the shield (19) is moved inwardly to the after-use final shielding position. The drive surfaces disengage to allow the locking member (80, 81) to return resiliently inwardly towards an undeformed condition so as to locate adjacent an inner blocking surface (63) of the lug (60) to lock the protective shield (19) at the after-use final shielding position. A return movement or force will cause the locking members (80, 81) to be urged further underneath this inner blocking surface (63).

Description

[0001] Improved Lock for a Safety Needle Device

[0002] FIELD OF THE INVENTION

[0003] This invention relates to a lock 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 lock 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 a final position at which the needle is shielded. A locking arrangement may be provided to maintain the shield in the final position. This intends to prevent the used needle from being exposed and presenting a needlestick hazard or risk. Such locking arrangements may include a hook or hooks or a latch which engage over respective surfaces, for example with an edge of an opening or upstanding edge or ridge. These hook and latch arrangements are arranged to form a latched and locked connection for the shield in the final after-use safety shielded position. However, a forced movement (intentional or unintentional) which urges the shield back towards a non-shielding unsafe position introduces a tensile force into such locking arrangements, and this tends to cause the latched hooks to gradually move towards a disengaged position relative to the engaged surface. In addition, as the force increases, the respective tensile forces within a stem of the hook or body of the latch similarly increases, and because these devices are small and these types of latched elements are relatively weak such that these tensile forces can quickly cause these types of locking arrangement to fail. Accordingly, there is a tendency for these types of locking arrangements for a safety shield to be relatively easily ‘overcome’ and moved back towards an unsafe nonshielding position which thereby risks exposure of a used needle.

[0008] 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.

[0009] SUMMARY OF THE INVENTION

[0010] 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 two resiliently deformable locking members having shaped outer surfaces; 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 an outer surface and an inner blocking surface adjoined by two profiled flanks; 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 members engage with the inner blocking 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: each resiliently deformable locking member provides an engaging inner edge and the engaging inner edges of the two locking members are opposing and define a gap or space therebetween; and wherein the engaging inner edges of the locking members are located adjacent the profiled flanks of the lug when the protective shield is at the before-use initial shielding position; and wherein the locking members and the profiled flanks comprise cooperating drive surfaces to engage and resiliently move apart the locking members away from one another 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; and wherein this transverse movement continues until the locking members define a gap or space therebetween sufficient through which the lug can pass; whereat the drive surfaces disengage to allow the locking members to return resi liently inwardly towards an undeformed condition so as to locate the outer surfaces of the locking members adjacent to the inner blocking surface of the lug to lock the protective shield at the after-use final shielding position; thereafter forced movement of the protective shield outwardly towards a nonshielding position forces the resiliently deformable locking members to compress against the inner blocking surface of the lug; and this compressive force between the inner blocking surface and the locking members urges the locking members inwardly and further underneath the inner blocking surface and away from outer edges of the profiled flanks of the lug to enhance the blocking action of the inner blocking surface against the locking members.

[0011] Preferably the inner blocking surface comprise an underside of the lug. Preferably the outer edge of the flank comprises an outer lateral edge.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] Preferably the two profiled flanks (surfaces) are substantially parallel. Preferably the two profiled flanks (surfaces) comprise lateral surfaces relative to the longitudinal axis of carrier. Preferably the two profiled flanks (surfaces) extend substantially linearly along the longitudinal axis of the carrier in a distal direction. Preferably the or each profiled flank (surface) comprises a (lateral) side of the lug.

[0016] 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.

[0017] 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.

[0018] Preferably the or each cooperating drive surface comprise a flared surface. Preferably the or each cooperating drive surface comprise a stepped surface. Preferably the or each cooperating drive surface comprise 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.

[0019] 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.

[0020] Preferably the lug comprises a distal end profile (in the region of and / or comprising a distal most edge or end of the lug) which engages a proximal e~'i—f:i- 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.

[0021] 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 away from the after-use final shielding position. Preferably forced movement of the protective shield outwardly towards a 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. Preferably forced movement of the protective shield outwardly towards a non-shielding position causes the resiliently deformable portion(s) (corner section(s) with a tip(s)) to move inwardly and / or radially inwardly in a direction generally perpendicular to the longitudinal axis of the shield.

[0022] 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.

[0023] 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.

[0024] 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. 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] Preferably the pivotal axis of the protective shield locates proximally relative to the locking member(s) 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.

[0030] 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.

[0031] 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 before-use 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 before-use 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 before-use initial shielding position to the during-use nonshielding position prior to use of the safety needle device; said movement of the protective shield away from the before-use 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.

[0032] Preferably the part of the needle shield engages the soft needle cover at a location spaced distally forwardly from a rear proximal end thereof when the needle shield is in the before-use initial shielding position to resist movement of the soft needle cover forwardly and distally away from the syringe. 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.

[0033] 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 slots may be provided which may enable pivot members located therein to pivot and also to slide (move translationally) within the slots.

[0034] Preferably the protective shield is arranged to pivot from the before-use initial shielding position to the during-use non-shielding position.

[0035] 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.

[0036] 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 firsts 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 side faces of the carrier.

[0037] The protective shield may be arranged to move, and preferably pivotally move 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.

[0038] 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).

[0039] In the 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 after-use 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.

[0040] As the protective shield is moved from the during-use non-shielding position to the after-use final shielding position, an interior surface of the protective shield is arranged to contact a part (preferably the sharp tip) of the medical needle. Preferably this contact and the further movement of the protective shield causes the protective shield to subsequently resiliently deflect the medical needle.

[0041] The deformed medical needle may resiliently urge the protective shield towards a non-shielding position and may urge an outer surface of the locking members towards and / or into contact with the inner blocking surface of the lug.

[0042] In the after-use final shielding position, the or each locking member and the lug are in an undeformed and unstressed (relaxed) condition / state.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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 portion 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.

[0047] 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 before-use initial shielding position to the during-use non-shielding position. The clasping means (preferably together with the pivotable coupling / hinge mechanism arrangement) may form a subassembly 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.

[0048] 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.

[0049] The engagement of the protective shield and needle cover during the attachment of the safety device on to the syringe introduces a compressive axial force in the distal direction in the needle cover, between a rear end of the needle cover and a location where the protective shield engages the needle cover. This may urge the rear proximal end of the needle cover rearwardly and proximally relative to the syringe, to ensure a sterile seal is maintained between the rear end of the needle cover and the needle hub. In view of the resilient nature of the needle cover, the compressive axial force in a distal direction applied to the needle cover may be maintained during manufacture, transport and storage of the syringe, so in turn ensuring that an effective seal is also maintained, even during the sterilisation process which usually subjects the closed void / space around the needle to differential atmospheric pressure which in turn generates a resultant axial force in the needle cover away from the needle hub in a distal direction. As with a conventional needle cover, the sharp tip of the medical needle may be received in the material of the needle cover so as to be sealed thereby. In addition, this confers further protection to the sharp tip of the medical needle in the various stages of the manufacture of the syringe, its sterilisation, packaging, subsequent unpacking for filling, filling and re-packaging.

[0050] 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 two resiliently deformable locking members having shaped outer surfaces; 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 an outer surface and an inner blocking surface adjoined by two profiled flanks; 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 members engage with the inner blocking surface of the lug to block movement of the protective shield from the after-use final shielding position towards a non-shielding position; characterised in that: each resiliently deformable locking member provides an engaging inner edge and the engaging inner edges of the two locking members are opposing and define a gap or space therebetween; and wherein the engaging inner edges of the locking members are located adjacent the profiled flanks of the lug when protective shield is at the before-use initial shielding position; and wherein the locking members and the profiled flanks comprise cooperating drive surfaces to engage and resiliently move apart the locking members away from one another 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; this transverse movement continues until the locking members define a gap or space therebetween sufficient through which the lug can pass; whereat the drive surfaces disengage to allow the locking members to return resiliently inwardly towards an undeformed condition so as to locate the outer surfaces of the locking members adjacent to the inner blocking surface of the lug to lock the protective shield at the after-use final shielding position; thereafter forced movement of the protective shield outwardly towards a nonshielding position forces the resiliently deformable locking members to compress against the inner blocking surface of the lug; the method comprising: engaging the locking members with the inner blocking surface; and in the after-use final shielding position, generating a compressive force to urge the locking members inwardly and further underneath the inner blocking surface and away from outer edges of the profiled flanks of the lug to enhance the blocking action of the inner blocking surface.

[0051] BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The present invention will now be described, by way of example only, with reference to the drawings that follow, in which:

[0053] Figure 1 is a perspective view of an embodiment of a safety device and a syringe prior to attachment together;

[0054] 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;

[0055] 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;

[0056] 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;

[0057] Figure 5 is a top plan view of the first preferred embodiment of the safety device attached to a syringe with the protective shield in a before use initial (unlocked) shielding position;

[0058] Figure 6 is a side view of the first preferred embodiment of the safety device attached to a syringe with the protective shield in a before-use initial (unlocked) shielding position; Figure 7 is a top plan view of the first preferred embodiment of the safety device attached to a syringe with the protective shield in an after-use final (locked) shielding position;

[0059] Figure 8 is a side view of the first preferred embodiment of the safety device attached to a syringe with the protective shield in an after-use final (locked) shielding position;

[0060] Figure 9 is a front schematic cross-section of the first preferred embodiment of the safety device attached to a syringe with the protective shield moving towards the after-use final (locked) shielding position;

[0061] Figure 10 is a front cross-section of the first preferred embodiment of the safety device attached to a syringe with the protective shield in the after-use final (locked) shielding position and being forced towards a non-shielding position;

[0062] Figure 11 is a perspective view of a second preferred embodiment of the safety device prior to use;

[0063] Figure 12 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;

[0064] Figure 13 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;

[0065] Figure 14 is a top plan view of the second preferred embodiment of the safety device with the protective shield in an after-use final (locked) shielding position;

[0066] Figure 15 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;

[0067] Figure 16 is a perspective view of a preferred embodiment of a carrier;

[0068] Figure 17 is a perspective view of a preferred embodiment of a protective shield;

[0069] Figure 18 is a top plan schematic view of the second preferred embodiment of the safety device with the protective shield moving towards the after-use final (locked) shielding position;

[0070] Figure 19 is a top plan schematic 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;

[0071] Figure 20 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;

[0072] Figure 21 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;

[0073] Figure 22 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;

[0074] Figure 23 is view of a user holding the syringe with the safety device in a before-use initial shielding position;

[0075] Figure 24 is a view of a user grasping the protective shield in the before-use initial shielding position; Figure 25 is a view of a user moving the protective shield from the before-use initial shielding position to the during-use non-shielding position; and

[0076] Figure 26 is a view of a user removing the needle cover from the needle in the during-use non-shielding position.

[0077] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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. 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 exposes the needle 11 ready for performing the injection.

[0083] Thus, prior to use of the syringe 10 and safety device 8, the protective shield 19 must first be moved to a 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.

[0084] 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 17). 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 16). 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 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.

[0085] 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.

[0086] 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 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 needle cover that was pushing the cover proximally towards the syringe 10. 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.

[0087] 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 final shielding position.

[0088] In this final shielding position shown in Figure 4, the protective shield 19 is locked in the 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 needle shielding position.

[0089] 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 flanks or 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 space 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 space in the protective shield 19. Accordingly, these two surfaces 64, 92 do not touch or engage at all through the operational sequence. Alternatively, a part (for example, a surface, rib or nodule or detent) provided or defined on the surface 92 may be arranged to engage, touch, contact a part (for example, a surface, rib or nodule or detent) on the other surface 64 to provide and / or create tactile feedback of the operational sequence. In particular, the operational movement of the protective shield 19 may be signalled to the user, for example, a tactile sensation (and or / an audible feedback, for example a click or similar noise) is created as the protective shield 19 is moved into the final shielding position. Such feedback may reassure the user that the needle is protected and safe. Furthermore, such an arrangement may also function to maintain the protective shield 19 in the initial before-use position.

[0090] 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.

[0091] 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 .

[0092] In the preferred embodiments, there are 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 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 as shown in Figure 9. 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.

[0093] 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 5). Similarly, in the preferred embodiments, the lug 60 has flanks 66, 67 having outer edges in the form of linear parallel edges, when viewed from above (see Figure 7) 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.

[0094] The lug 60 has an outer surface 62 and an inner blocking surface 63. In the initial (unlocked) shielding portion shown in Figure 5 and Figure 6 and Figure 11 , 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 before-use 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 7 and Figure 8, 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 7 and Figure 8 and Figure 10, 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 and the contact surface area therebetween will be increased as indicated in Figure 10. 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. As mentioned above, this arrangement provides a significant improvement on a locking hook(s) or latch arrangement which undergo tensile force loads in the hook(s) or latch(es) which would be increased as more force is applied in an outwardly direction to the protective shield and the resultant force would tend to encourage the detachment of the hook or latch to a disengaged position. Such an locking arrangement would tend to become weaker as the forced movement applied was increased, whereas the present invention provides an arrangement in which a greater surface area of locking member is presented to the underside of the inner blocking surface 63 of the lug 60, thereby increasing the resistive locking force as the forced applied to move the shield to a unsafe position, due to the proportional increase in surface contact of the tip of locking members 80, 81 against the inner blocking surface 63 of the lug 60. In particular, forced movement of the protective shield 19 outwardly towards a non-shielding position causes the locking members 80, 81 (and especially the corner sections providing the tips) to move inwardly and also specifically radially inwardly in a direction generally perpendicular to the longitudinal axis of the protective shield 19.

[0095] 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. As mentioned above, the force applied urges the locking members 80, 81 (and especially the apexes 88, 89) to move inwardly and also specifically radially inwardly in a direction generally perpendicular to the longitudinal axis of the protective shield 19.

[0096] As shown in Figure 9, 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 protective 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.

[0097] As the tips or flap 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 10. 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 final shielding position.

[0098] 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.

[0099] In further embodiments, feedback creating means in the form of co-operating or complimentary surfaces are provided on the protective shield 19 and the carrier 18. In particular, such surfaces may locate on the opposing surfaces provide on, at or towards the distal most edge 64 or end of the lug 60 and also on, at or towards the proximal most surface edge 92 of the space in the protective shield 19. In earlier embodiments, these surfaces 64, 92 may have been separated by a gap. However, in some embodiments contact may be caused during movement of the protective shield to the final after-use position and such contact may create feedback of such movement. In particular, a tactile sensation and / or audible feedback (e.g. a click) may be generated to assure the user that the needle 11 is safely in a protected position. One or both surfaces 64, 92 may be provided with a suitable surface or surface feature which may include a raised portion, for example, a bump, detent, rib, projection which provides an outer sliding surface over which the other surface passes. This enables the two components to relatively flip past each other and the feedback will show that locking has occurred. Such feedback may augment any feedback created by the locking members 80, 81 passing over the profiled flanks 66, 67.

[0100] 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 forced 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.

[0101] As shown in Figure 11 to Figure 14, 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 32 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.

[0102] As shown in the first embodiment Figures 1 to Figure 8, 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 and therefore require a greater force to move the locking members 80, 81 apart. In other embodiments, the length and width of the slot 90 will determine the rigidity (deformability) of the flaps of the locking members 80, 81 and the ease and amount of gape that is achievable as the locking members 80, 81 are driven over the flanks 66, 67. Accordingly, the safety device 8 can be configured depending on the materials used and the desired force the user has to apply to the protective shield to securely engage and lock the locking members 80, 81 . A longer and wider slot will provide for an easy movement to the final locked shielding position and also cause the locking members 80, 81 to be more easily compressed inwardly. Conversely, a small and narrow slot or no slot at all will require relatively more force to cause the locking members 80, 81 to deflect over the flanks 66, 67 and will then require greater force to cause the locking members 80, 81 to be compressed inwardly to resist any subsequent forced movements, assuming the material of the shield is of consistent rigidity.

[0103] During the inward pivotal 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 12 and as depicted by diametrically opposed arrow heads. These 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 (or outer edges of the profiled flanks). At this point, the resilient properties of the material forming the locking members 80, 82 may “snap back” as depicted by the inward pointing arrow heads of Figure 13 and then relax into the original unstressed condition / state and any deformation of the locking members 80, 82 is then fully released as shown in Figure 13.

[0104] The inner blocking surface 63 of the projecting lug 60 is shaped / angled to maintain the protective shield 19 in the locked position. In particular, the inner blocking surface 63 is angled / curved inwardly. This inner blocking surface 63 thereby prevents the edges and tips of the resiliently deformable locking members 80, 81 from being able to travel back over the flanks 66, 67 to a non-shielding position and instead, direct the apexes 88, 89 further inward and away from the of the flanks 66, 67 to prevent any attempt to later move the shield 19 away from the final shielding position. The outer edge(s) of the inner blocking surface 63 are angled and specifically chamfered and or stepped to guide and encourage the tip(s) 82, 83 and corresponding edges of the locking members 80, 81 to be guided under and to remain underneath the inner blocking surface 63.

[0105] In addition, the outer face 86, 87 of each locking member 80, 81 of the protective shield 19 may be curved or have a flattened angled shape to maintain the protective shield 19 in the locked position. Specifically, both the inner blocking surface 63 of the projecting lug 60 and the outer surface 86, 87 of each locking member 80, 81 of the protective shield 19 are shaped / curved or stepped to maintain the protective shield 19 in the locked position.

[0106] The locking of the protective shield 19 in this 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.

[0107] Figure 15 show the locking arrangement of the protective shield in more detail. The outer flank surfaces 66, 67 of the lug 60 comprise respective drive surfaces 68, 69 over which a part of the locking members 80, 81 are arranged to move over during movement of the protective shield 19 to the locked position. The inner surfaces 84, 85 of the locking members 80, 81 provide cooperating sliding surfaces in order to aid the sliding movement of the protective shield 19 to the locked final shielding position. In particular, the inner sliding surface 84, 85 of the locking members 80, 81 are arranged to slide over the profiled drive surfaces 68, 69 of the lug 60.

[0108] To move to the locked position, the protective shield 19 is pivoted relative to the carrier 18 which causes the inner edges of the locking members 80, 81 to move over the cooperating drive surfaces 68, 69 such that the locking members 80, 81 move outwardly in a transverse direction relative to the longitudinal axis of the safety shield. The sliding surfaces 84, 85 of the locking members 80, 81 slide on the drive surfaces 68, 69 of the lug 60 and then reach the edges of the flanks 66, 67 of the lug 60 and the rotational force applied by the user to move the protective shield 19 to the protecting position, causes the locking members 80, 81 of the protective shield 19 to deform relatively outwardly. The locking members 80, 81 are provided as a continuous (and homogenous) portion of the protective shield 19.

[0109] 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 to 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. As shown in Figure 15, in the final locked shielding position, the prior deformation of the locking members 80, 81 has dissipated as the inner edges of the locking members 80, 81 have transitioned over the cooperating drive surfaces 68, 69 and the locking members 80, 81 are now in an undeformed and unstressed original relaxed condition or state. In particular, in this locked position, the tips 82, 83 of the locking members 80, 81 which form the apexes 88, 89 locate directly adjacent to the underside of the inner blocking surface of the lug 60. This demonstrates that the deformation of the locking members 80, 81 has dissipated and the locking members 80, 81 and the associated adjacent resilient zones have returned to or at least towards the original relaxed unstressed condition / state. Furthermore, the (complementary shaped / angled) outer surfaces 86, 87 of the locking members 80, 81 and the inner blocking surface 63 of the lug 60 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.

[0110] As shown in Figure 18 and as depicted by the directional arrow heads, the locking members 80, 81 are arranged to move outwardly in a transverse direction as the protective shield 19 moves to the final locked position. In these schematic figures, the longitudinal axis 21 of the protective shield 19 and carrier 18 is shown and this is perpendicular to the corresponding transverse axis 20 of the protective shield 19 and / or carrier 18. These axes are generally linear and are shown with the protective shield 19 in the initial (unlocked) position. In this position, in use, the longitudinal axis 21 will also extend along the central longitudinal axis of the needle. Similarly, as shown in Figure 19 in the final locked position, the locking members 80, 81 will be moved inwardly in a transverse direction if a user attempts to force / move the protective shield 19 back towards a non-shielding position.

[0111] As shown in Figure 20 to Figure 22, the safety device 8 can also be used in conjunction with a standard needle having a female Luer connection arrangement and whereby in Figures 20 to Figure 22 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.

[0112] 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.

[0113] 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.

[0114] 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 the 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. In some embodiments, the safety device 8 includes gripping means to grip the needle cover 23 in the first position. The gripping means may bite into and / or penetrate into a surface of the needle cover 23. 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 23.

[0115] The clasps 44, together with the pivotable coupling / hinge mechanism 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.

[0116] As shown in Figure 23 to Figure 26, 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 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.

[0117] 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 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.

[0118] 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 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.

[0119] 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 inwardly until a locking means is engaged in the 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 lock for the protective shield to maintain the protective shield in a safe and locked final position.

[0120] 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 two resiliently deformable locking members having shaped outer surfaces; 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 an outer surface and an inner blocking surface adjoined by two profiled flanks; 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 members engage with the inner blocking 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:each resiliently deformable locking member provides an engaging inner edge and the engaging inner edges of the two locking members are opposing and define a gap or space therebetween; and wherein the engaging inner edges of the locking members are located adjacent the profiled flanks of the lug when the protective shield is at the before-use initial shielding position; and wherein the locking members and the profiled flanks comprise cooperating drive surfaces to engage and resiliently move apart the locking members away from one another 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; and wherein this transverse movement continues until the locking members define a gap or space therebetween sufficient through which the lug can pass; whereat the drive surfaces disengage to allow the locking members to return resiliently inwardly towards an undeformed condition so as to locate the outer surfaces of the locking members adjacent to the inner blocking surface of the lug to lock the protective shield at the after-use final shielding position; thereafter forced movement of the protective shield outwardly towards a nonshielding position forces the resiliently deformable locking members to compress against the inner blocking surface of the lug; and this compressive force between the inner blocking surface and the locking members urges the locking members inwardly and further underneath the inner blocking surface and away from outer edges of the profiled flanks of the lug to enhance the blocking action of the inner blocking surface against the locking members.

2. A safety device for a medical injection needle according to Claim 1 in which the outer surfaces and the inner engaging edges of the locking members form tips or flap edges that are located adjacent the profiled flanks of the lug when the protective shield is at the before-use initial shielding position.

3. A safety device for a medical injection needle according to Claim 1 or claim 2 in which each locking member provides a focused point of contact on apexes in which the resistive movement and force will commence, each apex initiates the contact between the respective locking member and the inner blocking surface.

4. A safety device for a medical injection needle according to Claim 2 in which the two profiled flanks are substantially parallel.

5. A safety device for a medical injection needle according to Claim 4 in which the two profiled flanks comprise lateral surfaces relative to the longitudinal axis of carrier.

6. A safety device for a medical injection needle according to Claim 5 in which the two profiled flanks extend substantially linearly along the longitudinal axis of the carrier.

7. A safety device for a medical injection needle according to any preceding claim in which the or each locking member is deformed in an outward transverse direction perpendicular to the longitudinal axis of the carrier during movement over the drive surface in a first direction.

8. A safety device for a medical injection needle according to Claim 7 in which the or each locking member is deformed in both a transverse direction and the or each locking member is also move radially.

9. A safety device for a medical injection needle according to any preceding claim in which the or each cooperating drive surface comprise a flared surface.

10. A safety device for a medical injection needle according to any preceding claim in which the lug comprises a distal end surface which locates in opposition to a proximal surface provided on the protective shield and there is a gap between the distal end surface of the lug and the proximal surface provided on the protectiveshield and the gap is maintained as the protective shield moves between the beforeuse initial shielding position to the during-use non-shielding position and to the afteruse final shielding position.

11. A safety device for a medical injection needle according to any preceding claim in which the or each locking member comprises a resiliently deformable portion which is integrally formed on the intermediate portion of the protective shield.

12. A safety device for a medical injection needle according to any preceding claim in which the or each locking member comprises a corner section having a tip and in which the tip provides an initial point of contact against the inner blocking surface of the lug when the protective shield is at the after-use final shielding position.

13. A safety device for a medical injection needle according to Claim 12 in which forced movement of the protective shield outwardly towards a non-shielding position causes the initial point of contact area of the tip against the inner blocking surface of the lug to increase.

14. A safety device for a medical injection needle according to Claim 13 in which this contact area increases in size proportionally relative to the increase in the force applied in the attempt to move the protective shield outwardly and away from the final shielding position.

15. A safety device for a medical injection needle according to any preceding claim in which the inner blocking surface of the lug provides a curved surface across a transverse plane.

16. A safety device for a medical injection needle according to Claim 15 in which the inner blocking surface provides a concave partially cylindrical surface.

17. A safety device for a medical injection needle according to any precedingclaim in which the inner blocking surface comprises an edge to guide the or each locking member underneath the inner blocking surface and wherein the or each edge comprises a chamfered edge.

18. A safety device for a medical injection needle according to any preceding claim in which an outer surface of the or each locking member is curved across a transverse plane relative to the longitudinal axis of the protective shield.

19. A safety device for a medical injection needle according to any preceding claim in which the protective shield comprises a slot generally aligned with the longitudinal axis of the shield to facilitate the outward resilient movement of the or each locking member.

20. A safety device for a medical injection needle according to Claim 19 in which the slot extends centrally between a first locking member and a second locking member.

21. A safety device for a medical injection needle according to any preceding claim in which the pivotal axis of the protective shield locates proximally relative to the locking member.

22. A safety device for a medical injection needle according to any preceding claim in which the supporting arms are provided on the proximal portion of the protective shield and form the proximal portion of the protective shield and wherein the supporting arms extend proximally away from locking members.

23. A safety device for a medical injection needle according to any preceding Claim 1 which the protective shield is secured to the carrier by a hinge mechanism and the hinge mechanism defines a fixed rotational axis about which the protective shield rotates relative to the carrier.

24. A safety device for a medical injection needle according to Claim 1 to Claim22 in which the rotational axis of the protective shield comprises a movable axis and is an unfixed rotational axis.

25. A safety device for a medical injection needle according to any preceding claim in which, in the after-use final shielding position, any movement of the protective shield back towards a non-shielding position causes the locking members to engage forcefully with an underside of the inner blocking surface.

26. 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 two resiliently deformable locking members having shaped outer surfaces; 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 an outer surface and an inner blocking surface adjoined by two profiled flanks; 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 members engage with the inner blocking surface of the lug to block movement of the protective shield from the after-use final shielding position towards a non-shielding position; characterised in that: each resiliently deformable locking member provides an engaging inner edge and the engaging inner edges of the two locking members are opposing and define a gap or space therebetween; and wherein the engaging inner edges of the locking members are located adjacent the profiled flanks of the lug when protective shield is at the before-use initial shielding position; and wherein the locking members and the profiled flanks comprise cooperating drive surfaces to engage and resiliently move apart the locking members away from one another 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; this transverse movement continues until the locking members define a gap or space therebetween sufficient through which the lug can pass; whereat the drive surfaces disengage to allow the locking members to return resiliently inwardly towards an undeformed condition so as to locate the outer surfaces of the locking members adjacent to the inner blocking surface of the lug to lock the protective shield at the after-use final shielding position; thereafter forced movement of the protective shield outwardly towards a nonshielding position forces the resiliently deformable locking members to compress against the inner blocking surface of the lug; the method comprising: engaging the locking members with the inner blocking surface; andin the after-use final shielding position, generating a compressive force to urge the locking members inwardly and further underneath the inner blocking surface and away from outer edges of the profiled flanks of the lug to enhance the blocking action of the inner blocking surface.

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