Improved seal for a safety needle device

Abstract

The present invention provides a safety needle device (8) with a tamper evident (indication of first use) seal. The safety device (8) comprises a protective shield (19) pivotally coupled to a carrier (18), and the protective shield (19) is configured to pivotally rotate outwardly from a before-use initial shielding position to a during-use non-shielding position. The protective shield (19) comprises two supporting arms (26, 27) which provide shearing surfaces (110, 111) aligned with the longitudinal axis of the protective shield (19). The tamper proof arrangement comprises a seal member 100 to overlay the shearing surfaces (110, 111) when the protective shield (19) is in the before-use shielding position. The seal member (100) is secured to the safety device (8) so as to overlay the shearing surfaces (110, 111) and span the gap between the supporting arms (26, 27). During the movement of the protective shield (19) from the before-use initial shielding position to the during-use non-shielding position, the shearing surfaces (110, 111) rotate outwardly to thrust against the overlying seal member (100) to thereby irrevocably damage and or distort a part of the seal member (100). Accordingly, as soon as the protective shield (19) is moved from the initial before-use shielding position towards the during-use non-shielding position, the seal member (100) is irrevocably deformed or damaged such that it is clearly evident that the safety device (8) has at least been partially used for an injection sequence.

Description

[0001] Improved Seal for a Safety Needle Device

[0002] FIELD OF THE INVENTION

[0003] This invention relates to a seal 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 seal 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. It is advantageous for a user to know when a syringe has been used or partially used to prevent a user from inadvertently reusing a needle. Tamper proof seals are known and are used to reveal if a container has been opened or interfered with. Such tamper proof seals include labels or stickers or adhesive tape which span between two portions of a container and prevent the two portions from moving to an open position without at least partially destroying the seal, for example, the label / sticker / tape may be ripped, tom, stretched or deformed. This destruction may clearly indicate that a user has either opened or attempted to open such a container. This destruction of the tamper proof seal may require a significant amount of force which may impact on any fragile contents which are being protected. For example, with safety needle devices, a fragile and delicate needle is being protected and it is critical that this needle is not damaged during the opening of the safety needle device. A needle cover is generally removed along the axis of the needle and a tamper proof seal may be used to attach the cover to the syringe. In order to break this seal, a user could apply a relatively large axial pulling force to try and break the seal between the cover and the syringe. This may require a high manual force and results in uncontrolled movements which may put the user / patient at risk and or poses a risk to damaging the needle.

[0008] Alternatively, the user may naturally twist the cover relative to the syringe to apply a destruction force. This may efficiently break the seal but may cause the needle, and in particular the tip of the needle, to be damaged. The tip of a needle may include a specific shape (e.g. bevel) to assist in penetration. This shape is by definition very small and may provide the required sharp edges / points. This tip may initially, before use, be retained in a resilient rubber portion of the cover such that any twisting will cause the tip of the needle to become damaged by moving within the resilient material. Additionally, this twisting action can cause “coring” of the rubber portion, so that the interior of the hollow needle can become blocked with rubber particles “cored out” from the resilient rubber portion. Accordingly, such natural twisting movement can result in damaged needles, and specifically needle tips, which a user may not realise. In addition, delicate tamper proof seals may be provided which can be easily broken such as provided by fragile labels with significant pre-broken portions. This arrangement may only require a small force to complete the detachment of the two portions of the tamper proof seal. However, such fragile labels may be inadvertently broken during handling or transportation. Any such inadvertent destruction will render the device unusable since it will signify that it has already been used or tampered with. Accordingly, these unreliable tamper proof seals result in the destruction of usable needle injection devices and liquid medicaments.

[0009] 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.

[0010] SUMMARY OF THE INVENTION

[0011] According to a first aspect of the present invention there is provided an assembly comprising a safety device for a medical injection needle and a tamper proof arrangement, the safety device 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 pivotally rotate outwardly from a before-use initial shielding position to a during-use nonshielding position and pivotally rotate inwardly 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, and a proximal portion comprising supporting arms having pivot members arranged thereon for pivotal engagement with the carrier; and wherein each arm is spaced apart one from the other to form a gap therebetween to straddle the carrier; wherein the carrier comprises: a longitudinal axis; pivot members arranged for pivotal engagement with the supporting arms in order for the protective shield to pivot about a pivot axis relative to the carrier; 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 assembly being characterised in that: each supporting arm provides a shearing surface which is aligned with the longitudinal axis of the protective shield, the shearing surfaces being arranged to pivotally rotate outwardly about the pivot axis as the protective shield moves from the before-use initial shielding position to the during-use non-shielding position, the tamper proof arrangement comprises a seal member to overlay the shearing surfaces when the protective shield is in the before-use shielding position, wherein the seal member is secured to the safety device so as to overlay the shearing surfaces and span the gap between the supporting arms, and wherein during the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position, the shearing surfaces rotate outwardly to thrust against the overlying seal member to thereby irrevocably damage and or distort a part of the seal member.

[0012] Preferably each shearing surface is arranged to impact and / or collide against a part of the seal member during the movement of the protective shield from the beforeuse initial shielding position to the during-use non-shielding position.

[0013] Preferably each shearing surface is arranged to (thrust against and) directly abut and / or contact a part of the seal member during the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position.

[0014] Preferably the seal member comprises an inner surface and an outer surface and wherein the inner surface is arranged to overlay and / or to be secured to one or other or both the protective shield and the carrier. Preferably each shearing surface is arranged to directly abut and / or contact or thrust against an inner surface of the seal member during the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position.

[0015] The seal member may overlay the shearing surfaces and at least a part of the carrier.

[0016] Preferably the seal member is arranged to be adhered to a part of the protective shield and / or a part of the carrier.

[0017] Preferably the seal member is arranged to be adhered only to a part of the protective shield.

[0018] Preferably the seal member is arranged to be adhered only to a part of the carrier.

[0019] Preferably the seal member comprises a hoop or band of tubular form that is arranged to overlay and / or enclose a part of the protective shield and a part or all of the carrier.

[0020] Preferably the seal member comprises a constricting hoop or band of tubular form that is arranged to overlay and / or enclose a part of the protective shield and a part or all of the carrier.

[0021] Preferably the seal member comprises a hoop or band of tubular form that is made from a “heat shrinkable” material that is shrunk onto the safety device so as to enclose the shearing surfaces.

[0022] Preferably each shearing surface provides an edge which distorts, damages or severs a part of the seal member.

[0023] Preferably each shearing surface provides a toothed or serrated profiled edge which bites into and distorts, damages or severs a part of the seal member.

[0024] Preferably each edge is arranged to thrust against the seal member to urge outwardly away from an outer surface of the carrier and / or the protective shield and may at least initially create two distorted, damaged or severed zones or portions of the seal which extend from where the shearing surfaces contact the inner surface of the seal member.

[0025] Each shearing surface may create a distorted zone or portion and / or a penetrated zone or portion within part of the seal member.

[0026] Each shearing surface may create a tom, cut or ripped, ragged or partially severed zone or portion within part of the seal member.

[0027] The seal member may be arranged to extend at least partially around a circumference of the safety device and preferably extends at least partially around an outer surface of the protective shield and carrier.

[0028] The seal member may be arranged to extend at least partially around a circumference of the safety device and preferably extends around a proximal outer surface of the protective shield comprising the supporting arms.

[0029] The seal member may be arranged to extend at least partially around a circumference of the safety device and preferably extends around a proximal outer surface of the protective shield comprising the supporting arms having shearing surfaces.

[0030] Preferably the shearing members create tears, cuts and or deformations at two spaced apart locations or zones on the seal member. A section of the seal member extending between these two locations may remain adhered / attached and / or secured to the carrier, and or a section of the seal member extending between these two locations may remain adhered / attached to the proximal outer surface of the protective shield comprising the supporting arms.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] The distal portion of the protective shield may comprise a distal region / part / segment / length of the protective shield. The proximal portion of the protective shield may comprise a proximal region / part / segment / length of the protective shield.

[0035] Preferably the pivotal axis of the protective shield locates proximally relative to a distal edge of the seal member.

[0036] Preferably the pivotal axis of the protective shield is located underneath the seal member.

[0037] Preferably the supporting arms are provided on the proximal portion of the protective shield and may form the proximal portion of the protective shield. Preferably the supporting arms extend proximally away from the distal portion of the protective shield.

[0038] Preferably the supporting arms are spaced laterally apart relative to the longitudinal axis of the protective shield and wherein the space between arms provides a gap between the shearing members.

[0039] 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.

[0040] 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. 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.

[0041] Preferably the protective shield is arranged to pivot outwardly from the initial shielding position to the during-use non-shielding position.

[0042] The protective shield may comprise two pivot members which may be engaged within two pivot members on the carrier. The protective shield may comprise two stub axles which may be engaged within two corresponding apertures on the carrier. The pivot members may define a pivoting axis for the protective shield. The 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.

[0043] The carrier may comprise two pivot members which may be engaged within two pivot members on the protective shield. The carrier may comprise two stub axles which may be engaged within two corresponding apertures on the protective shield. The pivot members may define a pivoting axis for the protective shield.

[0044] 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.

[0045] 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).

[0046] 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.

[0047] 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.

[0048] 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. 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.

[0049] 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.

[0050] According to a second aspect of the present invention there is provided a method of indicating use of a medical injection needle comprising: providing an assembly comprising a safety device for the medical injection needle and a tamper proof arrangement, the safety device 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 pivotally rotate outwardly from a before-use initial shielding position to a during-use nonshielding position and pivotally rotate inwardly 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, and a proximal portion comprising supporting arms having pivot members arranged thereon for pivotal engagement with the carrier; and wherein each arm is spaced apart one from the other to form a gap therebetween to straddle the carrier; wherein the carrier comprises: a longitudinal axis; pivot members arranged for pivotal engagement with the supporting arms in order for the protective shield to pivot about a pivot axis relative to the carrier; 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 assembly being characterised in that: each supporting arm provides a shearing surface which is aligned with the longitudinal axis of the protective shield, the shearing surfaces being arranged to pivotally rotate outwardly about the pivot axis as the protective shield moves from the before-use initial shielding position to the during-use non-shielding position, the tamper proof arrangement comprises a seal member to overlay the shearing surfaces when the protective shield is in the before-use shielding position, wherein the seal member is secured to the safety device so as to overlay the shearing surfaces and span the gap between the supporting arms, and the method comprising: moving the protective shield from the before-use initial shielding position to the during-use non-shielding position, and rotating the shearing surfaces outwardly to thrust against the overlying seal member to thereby irrevocably damage and or distort a part of the seal member.

[0051] BRIEF DESCRIPTION OF THE DRAWINGS The present invention will now be described, by way of example only, with reference to the drawings that follow, in which:

[0052] Figure 1 is a perspective view of an embodiment of a safety device and a syringe prior to attachment together;

[0053] 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;

[0054] 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 needle cover removed;

[0055] 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;

[0056] Figure 5 is a perspective view of an embodiment of a carrier;

[0057] Figure 6 is a perspective view of an embodiment of a protective shield;

[0058] Figure 7 is a perspective view of a first preferred embodiment of a safety device and a syringe prior to attachment together;

[0059] Figure 8 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 shielding position;

[0060] Figure 9 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 shielding position and with a seal member secured around the safety device; Figure 10 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 with the seal member indicating the outward movement of the protective shield;

[0061] Figure 11 is a perspective view of the first preferred embodiment of the safety device attached to the syringe with the protective shield in a returned position with the seal member indicating prior outward movement of the protective shield;

[0062] Figure 12 is a perspective view of a second preferred embodiment of the safety device attached to the syringe with the protective shield in a during-use nonshielding position with the seal member indicating the outward movement of the protective shield;

[0063] Figure 13 is a perspective view of the second preferred embodiment of the safety device attached to the syringe with the protective shield in a returned position with the seal member indicating prior outward movement of the protective shield;

[0064] Figure 14 is a perspective view of a third preferred embodiment of the safety device attached to the syringe with the protective shield in a during-use non-shielding position with the seal member indicating the outward movement of the protective shield;

[0065] Figure 15 is a perspective view of the third preferred embodiment of the safety device attached to the syringe with the protective shield in a returned position with the seal member indicating prior outward movement of the protective shield;

[0066] Figure 16 is a perspective view of a fourth preferred embodiment of a safety device and a syringe prior to attachment together with the seal member displaying text secured around the safety device; Figure 17 is a perspective view of a fourth preferred embodiment of the safety device attached to the syringe with the protective shield in a before-use initial shielding position with the seal member displaying text secured around the safety device.

[0067] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] 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.

[0069] 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 10 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. The protective shield 19 is arranged to securely maintain the position of a (for example a soft rubber) needle cover 23 within the safety device 8. The 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 portion 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 portion / part.

[0070] The protective shield 19 denies the user access to the needle cover 23 in the initial before use position (as 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 outwardly 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.

[0071] 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 and then moved to an after-use final locked shielding position to (permanently) shield the needle (as shown in Figure 4). During this movement the protective shield 19 is returned to the initial shielding position and then pivoted rotationally further inward to the after-use final locked shielding position.

[0072] The protective shield 19 includes a pair of stub axles 40 which project inwardly (as shown in Figure 6. The carrier 18 includes a corresponding pair of holes 41 for rotatably engaging the stub axles 40 (as shown in Figure 5). 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 needle 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 and aligned 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.

[0073] 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.

[0074] 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 and rotate 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 engagement face 15 of the syringe 10.

[0075] The safety device 8 provides clasping means or gripping means to form a subassembly comprising the carrier 18, the protective shield 19 and the needle cover 23 and wherein this sub-assembly is maintained and held together as a complete unitary assembly and is preferably self-supporting. The seal member 100 may be secured around the safety device 8 to help maintain this self-supporting subassembly configuration, for example, the seal member 100 acts as a section of tape to help maintain this configuration. In particular, this complete unitary assembly is suitable for mechanical handling within automated assembly machines. Attachment of the seal member 100 onto the safety device 8 maintains the longitudinal axis of the carrier 18 to be aligned with the longitudinal axis of the protective shield 19 when the protective shield 19 is at the before-use initial shielding position. In addition this ensures that the protective shield 19, the carrier 18 and the needle cover 23 are maintained together as a unitary self-supporting safety needle assembly for attachment onto the distal end of the syringe 10 (see Figure 7 and Figure 16).

[0076] As shown in Figure 5, the carrier 18 provides a gripping arrangements to grip and retain a proximal end 72 of the needle cover 23. The proximal end 72 of the needle cover 23 is enlarged to provide the step or a shoulder as mentioned above, as shown in Figure 3. The gripping arrangement comprise inward surfaces 70, 71 provided on the carrier 18 and these comprise a first inner surface 70 and a second opposing surface 71 . The first surface 70 comprises the inner surface of the lug 60 and the second surface 71 may be provided on a second opposing lug 74. The two surfaces are disposed spaced apart by a distance which grips and / or loosely holds and / or may resi liently deform a part of the proximal end 72 of the needle cover 23. The two inner surfaces 70, 71 are arcuate and are arranged to extend partially around the circumference of the proximal end 72 of the needle cover 23 in the gripped position, for example in the before-use shielding position. The orientation of the surfaces 70, 71 retain the needle cover 23 along the longitudinal axis of the safety device 8 (and aligned with the longitudinal axis of the needle 11 ). The needle cover 23 is thereby maintained by the inner surfaces 70, 71 and is also gripped through the engagement between the inner shoulder (or rib) of the protective shield 19 and step on the needle cover 23. With the protective shield 19 in the outer pivoted position, a user is able to manually grasp the needle cover 23 and pull the needle cover 23 out of this retained position from between the inner surfaces 70, 71. As shown in Figure 5, the carrier provides abutment means in the form of two opposed abutment surfaces 76. These abutment surfaces 76 are provided on internal surfaces of the two lugs 60, 74. These abutment surfaces are arranged to contact the proximal end of the cover 23. Accordingly, the cover 23 (in particular the proximal end of the cover 23) is gripped and clamped. For example, the proximal end of the cover is gripped radially inwardly by the two internal surfaces 70, 71 and the step of the cover 23 is clamped between the abutment surfaces 76 of the carrier 18 and the internal rib / shoulder provided on the protective shield 19. The abutment surfaces 76 locate adjacent (preferably directly adjacent) to the internal surfaces 70, 71 . A proximal end of the cover 23 thereby (directly) abuts an internal part (or parts) of the carrier adjacent to the internal surfaces 70, 71 .

[0077] Furthermore, the protective shield 19 and the carrier 18 may also be engaged to each other such that unintentional relative pivoting movement is prevented. In some preferred embodiments, the protective shield 19 is held / maintained in either a nonshielding during-use position and / or the initial before-use position by frictional engagement of the respective pivot members and / or by inter-engagement of respective detent / facets provided between the protective shield 19 and the carrier 18. Specifically the protective shield 19 is held at the initial and / or in-use positions. The seal member 100 secures around the periphery of the safety device 8 to prevent such relative pivoting movement. In addition or alternatively, an anti-pivoting arrangement may be provided on the carrier 18 and / or protective shield 19 to retain the rotational alignment of the protective shield 19 relative to the carrier 18. In some embodiments, the respective pivot members 40, 41 are arranged to produce the required resistive force, for example due to the relative sizes / shapes of the respective pivot members 40, 41 and / or by the provision of detents / recesses on the pivot members 40, 41 at specific positions. In some embodiments a detent or detents are provided on one of the carrier 18 or protective shield 19 to engage with the other component to prevent unintentional pivoting movement. Engagement recesses may be provided to retain the alignment in the before-use shielding position. This anti-pivoting arrangement would require a user to physically overcome an initial retaining resistance in moving (pivoting) the protective shield 19 away from the before-use shielding position. In addition or alternatively, an antipivoting or retaining arrangement may be provided to retain the protective shield 19 in the during-use non-shielding position (as shown in Figure 3). Again, frictional engagement between the pivot members 40, 41 , may produce the anti-pivoting engagement (for example, the relative clearance between the pivot members 40, 41 and / or tighter fit, interference fits for the pivot members 40, 41 and / or the shapes of the articulating surfaces / pivoting surfaces, and / or relative sizes of the pivot members 40, 41 (stub axles / holes). In addition or alternatively, detents and / or engagement recesses may be provided on the carrier 18 and / or the protective shield 19 at a position (or positions) which would retain and hold the protective shield 19 in the outwardly pivoted position. Again, this would require a user to physically overcome a resistive force to move the protective shield 19 back inwardly. Such an arrangement assists in maintaining the protective shield 19 in the outer position and prevents the protective shield 19 from interfering with the actual injection technique. Both the initial and the outer anti-pivoting arrangement require the user to consciously and positively move the protective shield 19 and the user will receive the feedback for the commencement of these movement and actions.

[0078] 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 to expose the needle 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. 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 inwardly towards the initial before use shielding position and is then pivoted further 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 inward 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.

[0079] 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 permanent locking mechanism arrangement for this after-use final shielding position.

[0080] As shown in Figure 5, 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 a lug 60 projecting distally. The preferred embodiments shown in the figures include a distal end wall for the protective shield 19. However, it should be appreciated that in some examples of the present invention, the distal end of the protective shield 19 may be open and not blocked by such an end wall. The use of an open ended protective shield 19 may be advantageous in some situations. As shown in Figure 6, a proximal portion 34 of the protective shield 19 is located proximally relative to a distal portion 30 of the protective shield 19. The protective shield 19 comprises a first (distal) portion 30, a second (intermediate) portion 32 and a third (proximal) portion 34. The proximal portion 34 comprises supporting arms 26, 27 having pivot members 40 arranged thereon for pivotal engagement with the carrier 18. The proximal and distal portions 30, 34 thereby define the location of the pivot axis which is located on the proximal portion 34 proximally with respect to a distal edge 102 of a seal member 100.

[0081] The seal member 100 provides visual feedback to the user and indicates whether the protective shield 19 of the syringe 10 has been moved outwardly to a (during- use) non-shielding position. Accordingly, the present invention provides a tamper proof arrangement whereby the movement of the needle shield 19 from the beforeuse initial shielding position towards the during-use non shielding position irrevocably damages and or distorts the seal member 100 so as to provide a permanent visual indication. In particular, the seal member 100 may be stretched or cut / torn damaged, severed or partially severed such that it is unambiguous that the syringe 10 has been used or the syringe contents tampered with or at least that the protective shield 19 has been (forcibly) moved away from the before-use initial shielding position towards a during-use non-shielding position. The seal member 100 may therefore comprise a non-elastic material or a material which is unlikely to inadvertently / accidentally be torn / ripped or damaged easily.

[0082] In the preferred embodiment, the seal member 100 comprises a strip or band of material which locates around at least a part of the circumference of the protective shield 19. The seal member 100 may be secured around the complete periphery of the protective shield 19, as shown in Figure 9.

[0083] The seal member 100 may be applied in position around the protective shield 19 after the safety device 8 has been attached to the syringe 10 or during the assembly of the safety device 8. The safety device 8 (or safety needle assembly) is provided as a sub-assembly component which is secured to the syringe to provide the shielding functionality for the needle 11 provided by the syringe 10. Affixing the seal member 100 after the safety device has been fitted to the syringe, may help to prevent the seal member 100 from becoming damaged until the seal member 100 is needed. Visible damage to the seal member 100 prior to protecting the needle 11 may give a false indication and create unnecessary waste of an otherwise useable syringe and needle. However, in some embodiments, the seal member 100 may be applied around the protective shield 19 before the safety device 8 has been attached to the syringe 10, as shown in Figure 7 and Figure 8 and Figure 16 and Figure 17. This enables the safety device 8 to be provided as a complete sub-assembly component which is simply secured to the syringe 10 and does not require any further assembly process steps, for example to apply the seal member 100. Accordingly, in this arrangement, the assembly of the final product may be simplified since the final syringe and needle product is ready for processing as soon as the safety device 8 is secured to the end of the syringe 10.

[0084] Regardless of whether the seal member 100 is applied before or after attachment of the safety device 8 to the syringe, the seal member 100 functions in the same way and this is shown in Figures 7 to 15.

[0085] A first preferred embodiment of the seal member is shown in Figures 7 to 11 . The seal member 100 comprises a band or hoop of material which can be torn / ripped or damaged. For example, the band may comprise a paper-based material. In this example, the seal member 100 is adhered around the complete periphery of the safety device 8 and locates over the longitudinally extending interfaces between the protective shield 19 and the carrier 18. Specifically, the seal member 100 covers or overlays at least a part of the longitudinally upper outer surfaces of the supporting arms 26, 27. These longitudinal upper surfaces provide shearing surfaces 110, 111. The supporting arms 26, 27 are spaced apart one from the other to form a gap therebetween to straddle the carrier 18. For example, one supporting arm 26 locates to one lateral side of the carrier 18 and the other supporting arm 27 locates to the other lateral side of the carrier 18. The gap is therefore provided between the supporting arms 26, 27, as shown in Figure 6, and a gap is also provided between the two shearing surfaces 110, 111. Each shearing surface 110, 111 may provide a toothed or serrated profiled edge which bites into and distorts, indents, damages or severs a part of the seal member 100.

[0086] The seal member 100 overlays and is positioned relative to the shearing surfaces 110, 111 such that movement of the protective shield 19 relative to the carrier 18 causes the shearing surfaces to impact the sealing member 100. The seal member 100 comprises a distal edge 102, and a proximal edge 103. The seal member 100 is positioned such that the shearing surfaces 110, 111 locate below and at least partially between the distal edge 102 and the proximal edge 103.

[0087] Each shearing surface 110, 111 comprises respective distal ends 112, 113 and proximal ends 114, 115. In the preferred embodiment, the pivot arrangement is positioned along the safety device 8 at a proximal location to the distal ends 112, 113. As the protective shield 19 is pivoted outwardly away from the initial position to the during use position, the shearing surfaces 110, 111 similarly rotate outwardly to pivot around the pivot axis. In particular, the distal ends 112, 113 and a distal section of the shearing surfaces 110, 111 will pivot upwardly and outwardly (clockwise form the aspect shown in Figure 9) towards the seal member 100 and a proximal section of the shearing surfaces 114, 115 pivot downwardly in a proximal direction so as to slice and or tear into the seal member 100. During this movement at least a part of the proximal section of the shearing surfaces 110, 111 will be brought into contact with the inner surface of the seal member 100. The continued movement will then force the shearing surfaces 110, 111 to break / snap / tear / rip and damage the seal member 100. In particular, a distal section of the shearing surfaces 110, 111 will in effect provide an edge (or blade) which generates a tear / rip commencing from the distal edge 102 of the seal member 100. As the pivotal movement continues to the during use non-shielding position the shearing surfaces 110, 111 will continue to increase and lengthen this tear in a proximal direction towards the proximal edge 103 of the seal member. The shearing surfaces 110, 111 extend along the longitudinal direction of the safety device 8 (and / or the longitudinal direction / axis of the protective shield 19 / carrier 18). In particular, the shearing surfaces 110, 11 1 extend linearly along the longitudinal axis of the safety device 8. The shearing surfaces 110, 111 extend perpendicularly relative to the orientation of the seal member 100, for example the seal member 100 extends as a ring or band of material around the (circular) periphery of the safety device 8 whereas the shearing surfaces 110, 111 extend along a part of the longitudinal length of the safety device 8 which is substantially cylindrical. The longitudinal orientation of the shearing surfaces 110, 111 thereby provides the shearing surfaces with an initial leading point of contact and the shearing surfaces 110, 111 act as blades to cut or distort or damage the sealing member 100. This blade action is highly leveraged due to the large degree of rotation through which the protective shield 19 is manipulated outwardly by the user to the operative position (during-use) position, which is typically greater than 90 degrees of rotation, resulting in a powerful and reliable action which minimises the initial force required to commence the severing / cutting action or impart sufficient force to start to distort or create permanent damage to the seal member 100. As described above, the swept circumferential distance of the protective shield 19 from gripped position is far in excess of the swept circumferential distance of the shearing surfaces / cutting blades and this provides advantages in relation to the leverage. In particular, a user will grasp or grip a part of the protective shield 19 at a location which is distally located from the pivot axis relative to the shearing surfaces 110, 111. Accordingly, the resulting force generated at the shearing surfaces 110, 111 is greater than that applied at the gripping position due to the decreased distance between the shearing surfaces 110, 111 and the pivot axis. Accordingly, this reduces the effort required by the user and places less stress on the protective shield 19 whilst still creating significant and substantial shearing forces along the shearing surfaces 110, 111. The present inventio therefore utilises the moments and leverage of the structural arrangement to multiply up the force applied by the user to create significant shearing forces to provide for reliable disruption / damage of the seal member 100 and this may also help prevent damage to any smaller areas / more fragile parts within the safety device 8, for example, the forces are multiplied up between the gripping location and the shearing surfaces 110, 111 around the pivot axis.

[0088] In the preferred embodiment, each shearing surface 110, 111 produces and forms damaged zones that comprise a tear or crumpled indents which extend into the longitudinal length of the sealing member 100 from the distal edge 102 and towards the proximal edge 103 of the sealing member 100, as shown in Figures 12, 13, 14 and 15. Accordingly, these zones unambiguously identify and signal to a user that the safety device 8 has been operated or perhaps tampered with. Outward movement of the protective shield from a storage position (before use) may cause the complete disruption of the seal member 100 such that the seal member 100 or a part thereof becomes detached from the safety device 8. This arrangement will be determined by the type of seal member, the material from which it is made and also how the seal member 100 is attached to the safety device 8. For example, the inner surface of the seal member 100 may be substantially completely covered with an adhesive (for example, a self-adhesive surface) such that all of the seal member 100 remains attached to the safety device 8 after the tamper proof seal operation has been activated, as shown in Figure 13 and Figure 15. Alternatively, the inner surface of the seal member 100 may only have localised coverage (spots) or partial coverage with an adhesive (self-adhesive) such that a part or parts of the seal member 100 may detach away from the carrier 18 after the operation as shown in Figure 11 . As shown in Figure 11 , an adjoining section of the seal member 100 may detach from between the two cuts that are formed by the two shearing surfaces 110, 111 because only one of the cuts has fully severed through the seal member. For example, the seal member 100 may only be adhered at a point or section located 180 degrees offset around the safety device 8 away from the shearing surfacesl 10, 111. Following the complete cutting of the band of the seal member 100, the seal member 100 remains attached to the safety device and does not separate and fall away from the safety device, as shown in Figures 10 and 11 .

[0089] In a second preferred embodiment as shown in Figure 12 and Figure 13, the shearing surfaces 110, 111 are arranged to produce partial cuts which extend proximally from the distal edge 102 of the seal member 100. In this arrangement, the shearing surfaces 110, 111 each produce cuts but these do not completely break through the seal member 100. After operation, the seal member 100 will remain attached to the safety device 100 in the same manner as before the operation. However, these cuts will clearly indicate the operation of the safety device 8, as shown in Figure 13 and a flap may be produced between the two partial cuts. In this embodiment, the proximal edge 103 of the seal member 100 locates in a position such that the shearing surfaces 110, 111 do not move proximally beyond this position when the protective shield 19 is in the outermost pivoted position operative position (during-use). For example, the proximal edge 103 may be positioned proximally relative to the proximal end of the carrier 18. In addition, the proximal end or edge 103 of the seal member 100 may locate around the syringe 10 and a part of the seal member 100 may be adhered around the periphery of the syringe 10. In some embodiments, the seal member 100 is provided as part of a label which is adhered to the barrel of the syringe 10. For example, the seal member 100 may be provided by a standard label which is conventionally adhered to the (glass) barrel of a syringe. These standard labels may be substantially transparent and display information relating to the contents of the syringe and / or to identify the specific syringe and this may be required and compulsory. In this arrangement, the standard label is extended longitudinally such that it may then fulfil two functions (i.e. the standard label display requirements and the seal member 100 functionality). The standard label extends longitudinally along the barrel of the syringe 10 and provides a distal end which is securable / adherable around the safety device 8. In such embodiments, the distal end of the standard barrel label provides the seal member 100. The distal end of this label which is adhered to the safety device 8 provides the functionality of the seal member 100 (e.g. the tamper proof arrangement) whereby the distal end overlays the shearing surfaces 110, 111 when the protective shield 19 is in the before-use shielding position. In other embodiments, a distal portion of the standard barrel label may wrap around a part or all of the safety device 8 to form an outer sheath or outer wrapping which is not glued or adhered to safety device 8 and wherein this distal portion of the standard barrel label provides the functionality of the seal member 100. In some embodiments, this distal portion of the standard barrel label wrapped around the safety device 8 can be torn or peeled away by the user and detached from the remainder of the standard label which is fixed and adhered to the syringe before performing an injection. The shearing surfaces 110, 111 are arranged to rotate outwardly and thrust against the distal end of the standard label (i.e. the seal member 100) and the distal end of the standard label will thereby be irrevocably damaged and / or distorted. The proximal end of this label is adhered and positioned on the barrel of the syringe 10 as with current conventional standard labels. The standard label may be provided with a line of weakness to assist in the detachment of the distal end from the body of the standard label, i.e. this line of weakness enables a user to easily tear the label along this line in a controlled and reliable manner). This may be advantageous when the safety device 8 is removed from the syringe 10 for disposal at the end of the process. Such a line of weakness may comprise a line created by serrations, perforations, scored lines, etc. to enable a user to tear the distal end (i.e. the seal member 100 adhered to the safety device 8) from the body of the label which may remain adhered to the barrel of the syringe 10.

[0090] In another preferred embodiment, the seal member 100 may be arranged to be distorted or deformed, as shown in Figure 14 and Figure 15. The seal member 100 may comprise a plastics material or at least a plastics-based material (e.g. a polymer). This material may not be resilient and the deformation / distortion is not elastic such that the original shape and form of the seal member 100 is not recovered on removal of the forces from the shearing surfaces 110, 111 against the seal member 100.

[0091] The seal member 100 may comprise a plastics film comprising properties / characteristics that are altered by deformation / distortion. For example, the seal member 100 may comprise a smart plastics film which changes colour due to stress. The shearing surfaces 110, 111 may therefore create different coloured areas on the seal member 100 to indicate the used / unsafe state of the safety device 8 and indicates the prior use or operation of the safety device 8.

[0092] As clearly shown in Figure 15, the resulting deformation of the seal member 100 is clear and indicates the prior use or operation of the safety device 8 as provided by the movement of the protective shield 19 from the initial shielding position. This clear indication may also show that an attempt has been made to tamper with the injection device and or the syringe and its contents.

[0093] It will be appreciated in some embodiments that the material of the seal member 10 may be elastic but the movement of the shearing surfaces 110, 111 cause the stress in the seal member 100 to be greater than the elastic limit of the material. This elastic limit may be reached almost instantaneously such that it is not possible for a user to move the protective shield 19 by any significant amount without the tamper proof evidence providing the required visual feedback of the movement / operation. The material may be distorted / stressed beyond its yield point.

[0094] The seal member 100 may include a pattern (decorative pattern), or information (text / image) to enhance the identification of the tamper evident seal. In particular, the seal member may include one or more concentric annular parallel lines that are indented or printed onto the seal. Because, as any damaged caused within the damage zones of the seal member are very easily identified by a user, due to the visual disturbance or misalignment of the parallel lines that will occur at these damage zones. The ability of a user to identify any distortion / disruption or cutting of the seal member 100 may be enhanced through the use of this further arrangement. In addition, or alternatively, small partial cuts may be pre-formed or lines of weakness may be provided within the seal member 100 to enhance the ability to signal the any previous use or operation of the safety device 8. For example, lines of weakness may be provided to produce a predefined cut or cuts relatively easily without the use of excessive forces. Such pre-formed partial cuts or lines of weakness may also cause a plastics type seal member 100 to be used in producing a cut rather than just a paper-based seal member 100. Furthermore, the pattern on the seal member 100 may be arranged to significantly alter on distortion or disruption. Such changes may be irreversible such that it would not be possible for a user to be able to restore the original configuration of the seal member 100 following the activation of the tamper evident seal. As described above, the seal member 100 comprises paper, especially a very fibrous paper that tears raggedly. In some embodiments, the seal member 100 comprise a polymer film and may comprise a film that changes colour when stressed. The seal member 100 may have a robust adhesive layer and a weak frangible layer that can become fractured when stressed or disturbed. The seal member 100 comprises a tamper-evident label that makes it impossible to remove without leaving obvious signs of tampering. These features include patterned void messages, hidden images, and frangible slits or cuts. Additionally, the seal member 100 may be arranged to split or separate from the packaging if an attempt to remove them is made. Once removed, the seal member 100 may lose the structural integrity and cannot be reattached and, therefore, makes it clear that tampering has occurred. As is typical with tamper evident seals, the disruption (irrevocable damage and / or distortion) of the seal member 100 creates audible feedback, for example, a snap / crack which is generated as the seal breaks at the damaged zone(s).

[0095] Some seal members 100 comprise a material in the topmost layer which is a very thin, delicate material that lacks internal strength and structural integrity. As a result, the layer breaks into small pieces if someone attempts to remove or reposition it. If the seal member 100 is tampered with, the frangible face material breaks apart and reveals the permanent adhesive underneath with elements like a void message, leaving a piece of obvious visual evidence behind. As mentioned above, the seal member 100 may comprise perforations and security cut labels are stickers with pre-made perforations or cuts on the surface. For example, when the face material is removed, it leaves behind a noticeable pattern of lines, dots, circles, or cuts, making it easy to identify prior use or tampering attempts.

[0096] Overall, the present invention provides a safety needle device 8 with a tamper evident (indication of first use) seal 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. As soon as the protective shield 19 is moved from the initial before-use shielding position towards the during-use non-shielding position, the seal member 100 is irrevocably deformed or damaged such that it is clearly evident that the safety device 8 has at least been partially used for an injection sequence. Once the injection has been completed, the protective shield 19 is pivoted 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.

[0097] 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 . An assembly comprising a safety device for a medical injection needle and a tamper proof arrangement, the safety device 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 pivotally rotate outwardly from a before-use initial shielding position to a during-use nonshielding position and pivotally rotate inwardly 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, and a proximal portion comprising supporting arms having pivot members arranged thereon for pivotal engagement with the carrier; and wherein each arm is spaced apart one from the other to form a gap therebetween to straddle the carrier; wherein the carrier comprises: a longitudinal axis; pivot members arranged for pivotal engagement with the supporting arms in order for the protective shield to pivot about a pivot axis relative to the carrier; 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 assembly being characterised in that: each supporting arm provides a shearing surface which is aligned with the longitudinal axis of the protective shield, the shearing surfaces being arranged to pivotally rotate outwardly about the pivot axis as the protective shield moves from the before-use initial shielding position to the during-use non-shielding position, the tamper proof arrangement comprises a seal member to overlay theshearing surfaces when the protective shield is in the before-use shielding position, wherein the seal member is secured to the safety device so as to overlay the shearing surfaces and span the gap between the supporting arms, and wherein during the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position, the shearing surfaces rotate outwardly to thrust against the overlying seal member to thereby irrevocably damage and or distort a part of the seal member.

2. An assembly according to Claim 1 in which each shearing surface is arranged to thrust against and directly abut and / or contact a part of the seal member during the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position.

3. An assembly according to Claim 1 or Claim 2 in which the seal member comprises an inner surface and an outer surface and wherein the inner surface is arranged to overlay one or other or both the protective shield and the carrier.

4. An assembly according to any one of Claim 1 to Claim 3 in which the seal member comprises an inner surface and an outer surface and wherein the inner surface is arranged to be secured to one or other or both the protective shield and the carrier.

5. An assembly according to Claim 4 in which the seal member is arranged to be adhered to a part of the protective shield and / or a part of the carrier.

6. An assembly according to any preceding claim in which the seal member comprises a hoop or band of tubular form that is arranged to overlay and / or enclose a part of the protective shield and a part or all of the carrier.

7. An assembly according to any preceding claim in which each shearing surface provides an edge which distorts, damages or severs a part of the seal member.

8. An assembly according to any Claim 7 in which each edge is arranged to urge the seal member outwardly away from an outer surface of the carrier and / or the protective shield and at least initially creates two distorted, damaged or severed portions of the seal which extend from where the shearing surfaces contact the inner surface of the seal member.

9. An assembly according to any preceding claim in which each shearing member creates a distorted portion and / or a penetrated portion within part of the seal member.

10. An assembly according to any preceding claim in which each shearing member creates a torn, cut or ripped or partially severed portion within part of the seal member.

11. An assembly according to any preceding claim in which the seal member is arranged to extend at least partially around a circumference of the safety device.

12. An assembly according to any preceding claim in which the seal member extends around a proximal outer surface of the protective shield comprising the supporting arms.

13. An assembly according to any preceding claim in which the shearing members create tears, cuts and or deformations at two spaced apart locations on the seal member.

14. An assembly according to any Claim 13 in which a section of the seal member extending between these two locations remains secured to the carrier.

15. An assembly according to any preceding Claim 14 in which the section of the seal member extending between these two locations remains adhered to the proximal outer surface of the protective shield comprising the supporting arms.

16. An assembly according to any preceding claim in which the protective shield extends along the longitudinal central axis of the shield from a proximal end to a distal end and the carrier extends along the longitudinal central axis of the shield from a proximal end to a distal end.

17. An assembly according to any preceding claim in which, 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.

18. An assembly according to any preceding claim in which 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.

19. An assembly according to any preceding claim in which the pivotal axis of the protective shield locates proximally relative to a distal edge of the seal member.

20. An assembly according to any preceding claim in which the pivotal axis of the protective shield is located underneath the seal member.21 . An assembly 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.

22. An assembly according to Claim 21 in which the supporting arms extend proximally away from the distal portion of the protective shield.

23. An assembly according to any preceding claim in which the supporting arms are spaced laterally apart relative to the longitudinal axis of the protective shield and wherein the space between arms provides the gap between the shearing surfaces.

24. An assembly according to any preceding claim in which the protective shieldcomprises two pivot members which are engaged within two pivot members on the carrier.

25. A method of indicating use of a medical injection needle comprising: providing an assembly comprising a safety device for the medical injection needle and a tamper proof arrangement, the safety device 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 pivotally rotate outwardly from a before-use initial shielding position to a during-use nonshielding position and pivotally rotate inwardly 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, and a proximal portion comprising supporting arms having pivot members arranged thereon for pivotal engagement with the carrier; and wherein each arm is spaced apart one from the other to form a gap therebetween to straddle the carrier; wherein the carrier comprises: a longitudinal axis; pivot members arranged for pivotal engagement with the supporting arms in order for the protective shield to pivot about a pivot axis relative to the carrier; 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 assembly being characterised in that: each supporting arm provides a shearing surface which is aligned with the longitudinal axis of the protective shield, the shearing surfaces being arranged to pivotally rotate outwardly about the pivot axis as the protective shield moves fromthe before-use initial shielding position to the during-use non-shielding position, the tamper proof arrangement comprises a seal member to overlay the shearing surfaces when the protective shield is in the before-use shielding position, wherein the seal member is secured to the safety device so as to overlay the shearing surfaces and span the gap between the supporting arms, and the method comprising: moving the protective shield from the before-use initial shielding position to the during-use non-shielding position, and rotating the shearing surfaces outwardly to thrust against the overlying seal member to thereby irrevocably damage and or distort a part of the seal member.

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