WO2025158131A1

WO2025158131A1 - Improved restraint in a safety needle device

Info

Publication number: WO2025158131A1
Application number: PCT/GB2025/050082
Authority: WO
Inventors: Barry Peter Liversidge
Original assignee: TIP TOP COM Ltd
Current assignee: TIP TOP COM Ltd
Priority date: 2024-01-23
Filing date: 2025-01-17
Publication date: 2025-07-31
Anticipated expiration: 2026-07-23

Abstract

The present invention provides a safety needle assembly 10 comprising a carrier 18 and a needle shield 19 which is pivotally coupled to the carrier 18 and is configured to move outwardly from an initial shielding position to a non-shielding position. The carrier 18 is configured to be secured to a needle hub. The safety needle assembly 10 also includes a needle cover 23 to protect the needle 11. A restraint means provides a restraining force to resist pivotal movement of the needle shield 19 from the initial shielding position, and a control means releasably maintains the needle cover 23 within the needle shield 19. The restraining force is provided by a releasable interlock between the needle shield 19 and the carrier 18 and wherein the restraining force must be overcome in order to move the needle shield 19 outwardly from the initial shielding position to the non-shielding position. The control means comprises contact surfaces arranged on the needle shield 19, the needle cover 23 and the carrier 18, to control axial offset and/or angular misalignment of the respective longitudinal axes of the needle cover 23 and carrier18. The releasable interlock and the control means serve to maintain the carrier 18, the needle shield 19, the needle cover 23 as a unitary self-supporting safety needle assembly prior to the securement of the safety needle assembly to the needle hub.

Description

Improved Restraint in a Safety Needle Device

FIELD OF THE INVENTION

This invention relates to improved restraint in 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 restraint mechanism between a pivotable protective shield and a carrier of a safety needle device arranged to confer needlestick protection to a medical needle projecting forwardly from a single-use syringe.

BACKGROUND TO THE INVENTION

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.

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.

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 in use position. After performing the invention, the shield is moved to an after-use final position at which the needle is shielded. As described in WO 2024/134197, a pivotable shield is mounted for pivotable movement relative to a carrier and enables the shield to move from an initial shielding position to a non-shielding position and in the shielding position, the shield overlies a needle cover. When the safety needle device is attached to a medical syringe, a needle of the syringe projects and or penetrates into the needle cover and this cover may comprise a flexible (soft) cover. The protective shield includes clasps to grip and/or loosely hold the needle cover in position whilst the shield is in the shielding position. In use, the shield must be pivoted out of the way in order for a user to remove the needle cover from the needle. Such movement requires the clasping force applied by the shield to the cover to be overcome. This movement inevitably causes the needle cover to be deflected or urged to move with the pivotable shield until the clasping force is overcome to release the needle cover from the containment within clasps, and because the needle locates in the needle cover and, in particular, the tip of the needle projects or penetrates into the internal soft end portion of the needle cover to help protect the tip of the needle during storage. There is, however, a possibility for the needle to deflect and bend as the needle cover in turn is deflected by the outward pivotal movement of the shield. However, without the clasps, the needle cover would be separable from the protective shield (and the carrier) such that the safety needle device would not comprise a unitary self-supporting assembly which is easy to handle in automated high-speed assembly processes as used in the medical device industry.

Furthermore, such protective shields are naturally small and, even though the shield may comprise a rigid material, the necessary dimensions mean that the shield is likely to be deformed inwardly out of shape when gripped and squeezed by a user when moving the shield outwardly from the shielding position to the non-shielding position. Therefore, excess inward squeezing increases the inwardly directed gripping force between the shield and the needle cover and this tends to encourage the needle cover and the needle within the cover to move outwardly along with the needle shield when the needle shield is moved towards a non-protecting position, which is likely to cause deflection and damage to the delicate needle used in these types of devices.

Figures 1 and Figure 2 illustrate the above mentioned problems and shows a safety needle assembly 2 including a shield 3 pivotally connected to a carrier 5 wherein a needle of a syringe 6 locates and projects and or penetrates into an internal end of the needle cover 4. The needle cover 4, and hence the needle, will be deflected outwardly due to the movement of the shield 3 from the initial shielding (protecting) position to the (non-protecting in use) non-shielding position. Such deflections are caused both by the required clasping and/or gripping force between the shield 3 and the needle cover 4 and are exacerbated by the increase in the clasping effect due to the shield 3 being inevitably “excessively” squeezed by a user who must manually grip and subsequently pivot the shield 3 to a non-protecting position.

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.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided a medical needle cover arrangement comprising: a needle hub, the needle hub further comprising a medical needle having a longitudinal axis and a sharp tip, the medical needle being mounted on the needle hub with the sharp tip projecting distally therefrom; a safety needle assembly comprising a carrier and wherein the carrier has a longitudinal axis; a needle shield and wherein the shield has a longitudinal axis and the shield is pivotally coupled to the carrier and is configured to move outwardly from an initial shielding position to a non-shielding position and wherein the carrier is configured to be secured to the needle hub; a needle cover to protect the needle and wherein the needle cover is located within the needle shield at the initial shielding position; the needle cover comprises, a longitudinal axis, a profile at a proximal end configured to locate over a profile on a distal end of the needle hub; wherein the longitudinal axes of the carrier, the shield, and the needle cover are aligned when the needle shield is at the initial shielding position; the safety needle assembly further comprises; a restraint means providing a restraining force to resist pivotal movement of the needle shield from the initial shielding position; and a control means to releasably maintain the needle cover within the needle shield; characterised in that: the restraining force is provided by a releasable interlock between the needle shield and the carrier; and wherein the restraining force must be overcome in order to move the needle shield outwardly from the initial shielding position to the nonshielding position; and the control means comprises contact surfaces arranged on the needle shield, the needle cover and the carrier, to control axial offset and or angular misalignment of the respective longitudinal axes of the needle cover and carrier; and wherein the releasable interlock and the control means serve to maintain the carrier, the needle shield, the needle cover as a unitary self-supporting safety needle assembly prior to the securement of the safety needle assembly to the needle hub; and an abutment surface provided on the needle shield releasably engages the needle cover to resist (and or block) distal movement of the needle cover relative to the needle shield when the safety needle assembly is secured to the needle hub, until the needle shield is moved to the non-shielding position; and wherein the needle shield is configured to be manipulated to pivot outwardly away from the initial shielding position to the non-shielding position, and in particular, forced outward manipulation of the needle shield overcomes the restraining force provided by the interlock, to disengage the abutment surface from the needle cover to allow subsequent detachment of the needle cover distally away from the needle hub to uncover the medical needle. The needle cover may comprise 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 (within the shield) at the initial shielding position. In the initial shielding position, the sharp tip of the needle may penetrate into a soft part/portion of the needle cover to block fluid flow from the needle tip/end. Preferably a part of the needle cover and a part of the needle shield are configured to engage the needle cover to resist (and or block) distal movement of the needle cover relative to the needle shield when the needle shield is at the initial shielding position to releasably maintain the needle cover within the needle shield when the needle shield is at the initial shielding position to prevent drug leakage from the tip of the needle and to maintain the sterility of the medical needle during storage of the syringe.

The profile at the proximal end of the needle cover may be configured to loosely locate over a profile on a distal end of the needle hub. The needle hub may house or be provided on a (female) Luer fitting. The (female) Luer fitting may be arranged, in use, to be engaged with a corresponding (male) Luer fitting provided on a distal end of a syringe. The needle hub and Luer fitting arrangement together with the safety needle assembly may together form a sub assembly or intermediate assembly. The sub assembly may be provided in a form of packaging, and in particular, the packaging may comprise a hard outer pack or shell. The packaging may comprise a rigid or hard outer pack. The packaging may comprise a front or distal portion and a separate rear or proximal portion. The two (separate) portions may be joined together to enclose the sub assembly therein. The two portions may be joined together and held together with a tamper evident seal in the form of a label, or other form of breakable seal, for instance frangible bond consisting of adhesive or a heat seal weld to retain the two portions together until the tamper evident seal is broken prior to use of the needle safety device.

The profile at the proximal end of the needle cover may create a substantially airtight seal between the needle cover and the needle hub to maintain the sterility of the enclosed medical needle when the needle cover is located on the needle and a soft proportion of the needle cover may be provided for the sharp tip of the needle to penetrate into the needle cover when the needle cover is releasably engaged by the needle shield at the initial shielding position. The needle hub may comprise a distal end of a syringe. The syringe may have a syringe barrel including a needle hub at the distal end thereof. The syringe may further comprise a medical needle having a longitudinal axis and a sharp tip, the medical needle being mounted on the needle hub with the sharp tip projecting distally therefrom.

The needle shield may comprise clasping means to clasp and/or grip or loosely hold and retain the needle cover when the needle shield is in the initial shielding position. Preferably the clasping means comprise retaining clasps comprising shaped lugs having inner arcuate surfaces to locate around a part of an outer circumferential surface of the cover to grip or loosely hold the needle cover. Preferably the clasping means provides a restraining force, in addition to the restraining force of the interlock, which must be overcome in order to move the needle shield outwardly from the initial shielding position to the non-shielding position.

The clasping means may comprise one or more clasps provided on an internal surface of the needle shield. The clasping means may comprise one or more clasps provided on the needle shield and preferably on edges (or adjacent to edges) of a longitudinal gap of the needle shield.

Preferably the releasable interlock is formed directly between the needle shield and the carrier. Preferably the releasable interlock is formed by an interface between the needle shield and the carrier. The releasable interlock may be formed at two locations and wherein each location comprises an interface between the needle shield and the carrier.

The releasable interlock may be formed between a first interlock member on the needle shield and a second interlock member on the carrier. Preferably the interlock is formed between a pair of first interlock members on the needle shield and a corresponding pair of second interlock members on the carrier.

Preferably the carrier comprise a first pair of second interlock members and a second pair of second interlock members. The first pair of interlock members may be arranged, in use, to resist pivotal movement of the needle shield relative to the carrier from the initial shielding position and the second pair of interlock members may be arranged, in use, to resist pivotal movement of the needle shield relative to the carrier from the non-shielding position.

The (first and second) interlock members may comprise detents and facets. The first interlock member may comprise a detent. The second interlock member may comprise a facet.

The detent may comprise a projection having a shaped/profiled outer surface and wherein the shape/profile of this surface may assist in the engagement and/or disengagement of the detent with a respective facet. The detent may comprise a curved or accurate shaped outer surface. The detents may comprise partial spherical members.

The facet may be provided as a face with an engaging edge. The engaging edge may facilitate engagement and/or disengagement of a respective detent.

The first interlock members(s) may be provided on a flexible portion of the needle shield. Preferably the flexible portion is resiliently flexible and/or deformable. Accordingly the flexible portion may be arranged, in use, to flex to assist in disengagement of the first interlock member from the second interlock member. The flexible portion of the needle shield may comprise a supporting arm. The or each supporting arm may locate proximally on the needle shield. The or each supporting arm may locate laterally of the needle shield. A first supporting arm may locate on a first lateral side of the needle shield and a second supporting arm may locates on a second lateral side of the needle shield. Preferably a pair of first interlock members are provided and each first interlock member is provided on a respective flexible portion of the needle shield.

A pair of second interlock members are provided on the carrier to resist pivotal movement of the needle shield to the non-shielding position. Each of the pair of interlock members may comprise at least a part of a recess defined in the carrier. Each recess may comprise an elongate recess to allow a degree of pivotal movement between the needle shield and the carrier. Preferably the elongate recess enables the first interlock member to pivotally move and to enable the needle shield (after use) to move beyond the initial shielding position to a final shielding position and may therefor allow the needle shield to (pivotally) move from the (during-use) non-shielding position to the final shielding position (which is preferably beyond the initial shieling position).

The restraint means may be formed between a detent and a facet. The restraint means may be formed by more than one (preferably two) detents and by more than one (preferably two) facets. The detents may be provided on one of the needle carrier or the carrier and the facets may be provided on the other of the needle shield or the carrier.

A part of the needle cover may comprise a step or recess or outer projection or annular flange which may be configured to engage the abutment surface of the needle shield which may comprise a (rear/proximally facing) shoulder or inward projection in order to (releasably) engage with and maintain and hold the needle cover within the needle shield and/or carrier prior to the securement of the safety needle assembly to the needle hub. Preferably the engagement may cause a proximal portion of the needle cover to be urged proximally within the safety device. Preferably the step or recess may be located and spaced from a distal end of the needle cover.

Preferably, prior to the securement of the safety needle assembly to the needle hub, the contact surfaces control angular misalignment and a part of the needle shield may be arranged to engage the part of the needle cover and wherein a proximal face of the needle cover engages a complementary face or profile of the carrier. These surfaces may sandwich or clam p/com press or loosely hold the proximal end of the needle cover to ensure that the cover may remain perpendicular (i.e. not angularly misaligned) with the longitudinal axis of the carrier.

Preferably, prior to the securement of the safety needle assembly to the needle hub, the contact surfaces also control offset (transverse) misalignment. The contact surface may comprise one or more (for example two) upstands on the distal end of the carrier. The proximal end of the needle cover may locate between the upstands. The or each upstand may provide an internal surface which is arranged, in use to grip a part of the (proximal end) of the needle cover in the carrier. The or each upstand may abut a part of an outer periphery of the needle cover. The upstands may be offset angularly around the periphery of the needle cover. The upstands may be offset by substantially 180 degrees. A single upstand may be provided and the single upstand may extend around more than 180 degrees of the outer periphery of the needle cover. The upstand may encircle all or a majority of the outer periphery of the needle cover.

Prior to the securement of the safety needle assembly to the needle hub, a portion of internal sides of the needle shield may be arranged to prevent transverse or sideways or offset misalignment of the needle cover with respect/regards to the longitudinal axis of the carrier. Two opposing portions of the internal sides of the needle shield may be arranged to prevent transverse or sideways or offset misalignment of the needle cover with respect/regards to the longitudinal axis of the carrier.

Preferably the shield comprises gripping areas positioned to prevent the squeezing together of lateral sides of the shield (by a user). Preferably the gripping areas are positioned offset from the central longitudinal axis of the shield and the gripping areas may be positioned along an upper (non-central/offset) portion of the shield. Preferably this positioning enables a first lateral gripping area and a second lateral gripping area to locate on opposing sides of a continuous (and solid linear) section of the shield. Preferably the gripping areas locate at either end of a (substantially) rigid/solid section, and there may be little or no squeezing together of an internal chamber of the shield in which the needle cover is initially located.

A distal end of the shield may be blocked or partially blocked (e.g. by an end wall). A substantially solid section extending between the two lateral gripping areas may define a channel for receiving the needle in the final position.

The gripping areas may further provide ledges or flanges or facets which enable a user to more easily grip in order to create an outward pivoting force (initial outward lifting force).

The interlock may comprise a seal. The interlock may comprise a sealing means (member) to provide a tamper evident closure in the form of a heat sealed or glued portion. The protective shield may comprise a proximal portion comprising supporting arms having pivot members arranged thereon for pivotal engagement with the carrier. Each supporting arm may be spaced apart one from the other to form a gap therebetween to straddle the carrier. Each supporting arm may provide 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 seal member may 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. During the movement of the protective shield from the before-use initial shielding position to the during-use non-shielding position, the shearing surfaces may rotate outwardly to thrust against the overlying seal member to thereby irrevocably damage and or distort or sever a part of the seal member which may thereby disengage the interlock. 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.

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.

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.

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

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

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

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

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.

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.

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.

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

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.

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.

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

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

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.

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. 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.

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.

According to a second aspect of the present invention there is provided a method of protecting a medical needle in which the medical needle cover arrangement comprises: a needle hub, the needle hub further comprising a medical needle having a longitudinal axis and a sharp tip, the medical needle being mounted on the needle hub with the sharp tip projecting distally therefrom; a safety needle assembly comprising: a carrier and wherein the carrier has a longitudinal axis; a needle shield and wherein the shield has a longitudinal axis and the shield is pivotally coupled to the carrier and is configured to move outwardly from an initial shielding position to a non-shielding position and wherein the carrier is configured to be secured to the needle hub; a needle cover to protect the needle and wherein the needle cover is located within the needle shield at the initial shielding position; the needle cover comprises, a longitudinal axis, a profile at a proximal end configured to locate over a profile on a distal end of the needle hub; wherein the longitudinal axes of the carrier, the shield, and the needle cover are aligned when the needle shield is at the initial shielding position; the method comprising; resisting pivotal movement of the needle shield from the initial shielding position with a restraint means to provide a restraining force; and releasably maintaining the needle cover within the needle shield with control means; characterised in that: the restraining force is provided by a releasable interlock between the needle shield and the carrier; and wherein the restraining force must be overcome in order to move the needle shield outwardly from the initial shielding position to the nonshielding position; and the control means comprises contact surfaces arranged on the needle shield, the needle cover and the carrier, to control axial offset and or angular misalignment of the respective longitudinal axes of the needle cover and carrier; and wherein the releasable interlock and the control means serve to maintain the carrier, the needle shield, the needle cover as a unitary self-supporting safety needle assembly prior to the securement of the safety needle assembly to the needle hub; and an abutment surface provided on the needle shield releasably engages the needle cover to resist (and or block) distal movement of the needle cover relative to the needle shield when the safety needle assembly is secured to the needle hub, until the needle shield is moved to the non-shielding position; and wherein the needle shield is configured to be manipulated to pivot outwardly away from the initial shielding position to the non-shielding position, and in particular, forced outward manipulation of the needle shield overcomes the restraining force provided by the interlock, to disengage the abutment surface from the needle cover to allow subsequent detachment of the needle cover distally away from the needle hub to uncover the medical needle.

The present invention also provides an assembly method whereby the safety needle assembly is initially assembled and this safety needle assembly is then introduced into a main assembly line thereby simplifying and condensing the main assembly line and method. Preferably, the safety needle assembly comprises the carrier, the needle shield and the needle cover. Briefly, the present invention may provide an assembly line whereby the needle is secured within the needle hub and the safety needle assembly is then mounted to the prepared needle hub in a single step. The needle hub may be provided with a Luer fitting arrangement. The needle hub may be provided on a distal end of a syringe. Overall, a pre-assembled safety needle assembly simplifies the process significantly such that the assembly line requires less inspections which increases the reliability and speed of the process and importantly, existing assembly line machines and processes can be retained, with only minimal modifications being required.

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:

Figure 1 is a perspective view of a prior art safety device with a protective shield being moved from an initial shielding (needle protecting) position to a non-shielding (non-protecting in-use) position;

Figure 2 is a partial cross section of a prior art safety device with a protective shield being moved from an initial shielding position to a non-shielding position;

Figure 3 is a perspective view of an embodiment of a safety device and a syringe prior to attachment together;

Figure 4 is a perspective view of an embodiment of a safety device attached to the syringe with the protective shield in a before-use initial (unlocked) shielding position;

Figure 5 is a perspective view of an 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 in readiness to perform an injection; Figure 6 is a perspective view of an embodiment of the safety device attached to the syringe after an injection with the protective shield in an after-use final (locked) shielding position;

Figure 7 is an exploded perspective view of a preferred embodiment of a safety device and a part of a syringe;

Figure 8 is an exploded perspective view of a preferred embodiment of a safety device and a part of a syringe;

Figure 9 is a side view cross-section of an embodiment of a safety device;

Figure 10 is an underside perspective view of an embodiment of a safety device;

Figure 11 is a top view cross-section of an embodiment of a safety device;

Figure 12 is a perspective view of an embodiment of a carrier of a safety device;

Figure 13 is a perspective view of an embodiment of a needle cover engaged by a carrier of a safety device;

Figure 14 is a partial cross section of a safety device attached to a syringe with the protective shield in a before-use initial (unlocked) shielding position;

Figure 15 is a partial cross section of a safety device attached to a syringe with the protective shield in a during-use non-shielding position and the needle cover removed in readiness to perform an injection;

Figure 16 is a schematic perspective view of a carrier and a needle cover of a safety device illustrating axes of relative displacements;

Figure 17 is a partial cut away view of a safety device (with the majority of the protective shield removed for clarity purposes);

Figure 18 is a detailed view of a partial cut away view of a safety device;

Figure 19 is an upper perspective view of a safety device prior to attachment to a syringe;

Figure 20 is a partial detailed view of a safety device;

Figure 21 is a perspective view of a partial cut away of a safety device with the protective shield in a during-use non-shielding position and the needle cover still engaged;

Figure 22 is a detailed view of part of Figure 21 ;

Figure 23 is a perspective view of another embodiment of a safety device attached to the syringe with the protective shield in a before-use initial (unlocked) shielding position;

Figure 24 is a side view of another embodiment of a safety device attached to the syringe with the protective shield in a before-use initial (unlocked) shielding position;

Figure 25 is an exploded view of a further embodiment of a safety device for use with a needle hub having a Luer fitting arrangement;

Figure 26 is a perspective view of the further embodiment of a safety device for use with a needle hub having a Luer fitting arrangement within a hard pack packaging;

Figure 27 is a perspective view of the further embodiment of a safety device for use with a needle hub having a Luer fitting arrangement with the safety device removed from the packaging but not fitted to the nose of a syringe; Figure 28 is a perspective view of the further embodiment of a safety device for use with a needle hub having a Luer fitting arrangement with the shield rotated outwardly and the needle cover removed;

Figure 29 is a perspective view of a yet further embodiment of a safety device attached to a syringe with a seal member providing an interlock between the needle shield and the carrier; and

Figure 30 is a yet further embodiment of a safety device attached to a syringe with the seal member broken and the needle shield in the during-use non-shielding position.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Throughout this specification and with reference to the figures, a safety needle assembly or safety device 8 is shown and described herein which provides for shielding of a sharp tip of a needle 11 of a syringe. As used herein, the term “distal” and/or “forwards” or” forwardly”, and derivatives thereof, refer to the direction generally towards the patient end for use, and the term “proximal” and/or “rearwards” or “rearwardly”, 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.

Referring initially to Figures 3 to 6, 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 having a longitudinal axis) 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 carrier 18 and the needle 11 . The carrier 18 has a through bore in alignment with the axis of the carrier 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.

As will be described, the present invention can also provide a safety device 8 for use with a hub having a Luer lock needle arrangement (see Figures 25-28). In such arrangements, the needle 11 is mounted onto a hub 100 providing a Luer fitting and, in particular, the hub having an internal female Luer fitting for attachment onto a male Luer cone. The Luer fitting of the needle hub will eventually be secured to a syringe with a complementary Luer style arrangement, for example a male Luer nose/cone. In such embodiments, the Luer fitting thereby provides the mounting hub for the needle 11. In this arrangement, a product can be provided in a conventional sterile “peel apart” packaging or a hard pack packaging comprising a front (distal) packaging section 110 and a rear (proximal) packaging section 112, as shown in Figure 26. Both of these sections are made of a rigid material and provide a complete hard pack packaging. The front and rear sections could also be secured and sealed together with a tamper evident seal that would indicate to a user whether the package had previously been opened and whether the sterility of the safety needle has been compromised. In use, the packaging sections 110, 112 are separated to provide access to the safety device 8, as shown in Figure 27. In this arrangement, the safety device 8 is secured to the needle hub as provided by the Luer fitting 100. In this arrangement, the Luer fitting 100 provides engagement means in the form of cruciform ribs 114 which are engaged within the proximal end of the needle cover 23 to prevent the cover from falling distally away off the needle. However, it may be advantageous to not secure the needle cover to the hub, so that the outcome as illustrated in Figure 27 is achieved by first rotating the shield outwardly to the in-use position and then inclining the safety device downwardly to allow the needle cover to fall away from the hub to fully expose the needle. The safety device 8 provides a unitary self-supporting assembly but, in addition, the arrangement of the safety device 8 together with the hub having a Luer fitting 100 provides a further (self-supporting) sub-assembly for attachment to a syringe in which the syringe does not provide the needle 11 since this is already provided on the needle hub of the Luer fitting 100. The combined safety device 8 and Luer fitting 100 can then simply be attached to the syringe which provides a complementary male Luer fitting in order to mount the safety device 8 (and needle/needle hub) to the syringe ready for use. In the following description, it will be appreciated that either the needle hub could be provided directly on and be integral to the distal end of the syringe or could be provided by the hub of the Luer fitting 100 which will be secured to a suitable syringe. The present invention will now be described further with reference to the needle hub being integral to and provided directly on the distal end of the syringe rather than on the hub having a Luer fitting 100.

In the needle hub with a Luer fitting arrangement, the profile at the proximal end of the needle cover 23 may be configured to loosely locate over a profile on a distal end of the needle hub. However, when the needle hub is provided by the distal end of the syringe, the profile at the proximal end of the needle cover 23 may create a substantially airtight seal between the needle cover 23 and the needle hub (formed by the nose of the syringe) to maintain the sterility of the enclosed medical needle 11 when the needle cover 23 is located on the needle 11 and to prevent subsequent drug leakage from the sharp tip of the needle.

The needle cover 23 may comprise a soft unitary component comprising an elastomeric plastic polymer or rubber material. The needle cover 23 may comprise a component having an internal soft portion to enable the sharp tip of the needle 11 to penetrate into the soft portion. The needle cover 23 may also comprise a rigid portion. The rigid portion may comprise an outer rigid shell. The outer rigid shell may extend around a part or substantially all of an outer surface of the internal soft portion. The internal soft portion may comprise one or more rigid portions secured to an outer surface. The soft portion and the rigid portion may be co-moulded and/or bonded and adhered together, or be independent separate items mechanically connected.

The protective shield 19 and the carrier 18 are arranged to secure and locationally maintain the position of a (for example a soft rubber) needle cover 23 within the safety device 8 prior to the attachment of the safety device 8 onto the syringe 10. 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 expected functionality of the needle cover 23 as compared to standard ordinary needle covers 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.

The protective shield 19 denies the user access to the needle cover 23 in the initial before use position (as shown in Figure 4). 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 5). In this movement, the engagement between the needle cover 23 and the protective shield 19 to resist (and or block) distal movement of the needle cover relative to the needle shield is released as is, any tendency for the blocking engagement (between the shield and the needle cover) to urge the needle cover rearwardly in a proximal direction. In the outwardly pivoted position shown in Figure 5, 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 5 and can be discarded or placed aside for later disposal, with the syringe and safety device now ready for performing an injection.

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 (non-protecting) position to gain access to the needle cover 23. Once the injection has been performed, the protective shield 19 is then moved to an after-use final locked shielding (needle protecting) position to (permanently) shield the needle (as shown in Figure 6). 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.

As shown in Figure 7 and Figure 8, the protective shield 19 includes a pair of stub axles 40 which project inwardly. The carrier 18 includes a corresponding pair of holes 41 for rotatably engaging the stub axles 40. The carrier 18 comprises two side walls 36, 37 on which the holes 41 are provided (see Figure 12). 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 18 also provides an opening 35 which extends in longitudinal alignment with the carrier axis 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 coupled to the carrier 18 and is movable relative to the axis of 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 both outwardly and inwardly relative to the longitudinal axis of the carrier 18 and the needle 11 . The protective shield 19 when the safety device 8 is attached to the syringe 10 is initially positioned with a longitudinal axis 21 which is generally parallel and aligned to the longitudinal axis of both the carrier 18 and the needle 11 in this initial as supplied configuration before use as shown in Figures 9 to 11 . As it will be appreciated any form of pivotal attachment between the shield and the carrier will suffice, for example a “live hinge” arrangement wherein the pivotal connection between the shield and carrier is provided by a film-hinge. Typically this may require the shield and the carrier to moulded as a single component of plastics material.

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, and is later 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 and may comprise a fully or partially closed or open end.

The present invention provides control means to releasably maintain the needle cover 23 within the needle shield 19 both prior to the placement of the safety needle assembly over a needle and also during storage prior to the use of the needle. In particular, the control means maintains the needle shield 19, the needle cover 23 and the carrier 18 as a unitary self-supporting safety needle assembly 8 prior to the securement or placement of the safety needle assembly 8 over the needle of the syringe 10. This unitary self-supporting safety needle assembly 8 is shown in Figures 9-11.

The control means comprises contact surfaces arranged on each of the needle shield 19, the needle cover 23 and the carrier 18. These contact surfaces control and prevent relative axial offset movement between the respective longitudinal axes of the needle cover 23 and the carrier 18, as illustrated schematically in Figure 16. In addition, the contact surfaces control and prevent angular misalignment (relative angular displacement) between the respective longitudinal axes of the needle cover 23 and the carrier 18, again as illustrated in Figure 16.

In particular, prior to the placement of the safety needle assembly over a needle the contact surfaces control angular misalignment, for example the part of the needle shield 19 engaging the part of the needle cover 23 is complementary to the flat face of the carrier 18. These surfaces can in effect sandwich or clamp/compress or loosely hold the proximal end 72 of the needle cover 23 to ensure the cover 23 remains perpendicular i.e. not angularly misaligned with the longitudinal axis of the carrier 18.

The contact surfaces also control offset (transverse) misalignment of the needle cover, for example this may be provided by the upstands 60, 74 on the distal end of the carrier 18 wherein the proximal end 72 of the needle cover 23 is located and also a portion 79 of the internal sides of the needle shield 19 (see Figure 11 ) prevent transverse or sideways or offset misalignment of the needle cover 23 with respect and in relation to the longitudinal axis of the carrier 18.

As shown in Figure 12 and Figure 13, the carrier 18 provides contact control surfaces to maintain the needle cover 23 therewith. The contact surfaces may provide a gripping arrangement to grip and retain a proximal end 72 of the needle cover 23, or instead loosely hold the proximal end of the needle cover. The proximal end 72 of the needle cover 23 is enlarged to provide a step or a shoulder. An outer surface (or at one or more parts) of the peripheral surface of this step or shoulder provides a contact surface to engage within one or more contact surfaces provided by the carrier 18. The control 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 resil iently deform a part of the proximal end 72 of the needle cover 23. The two inner surfaces 70, 71 may be partially arcuate and are arranged to extend partially around the circumference of the proximal end 72 of the needle cover 23 in the gripped maintaining position, for example whilst the shield 19, cover 23 and carrier 18 together form a self-supporting assembly or in the in the before-use shielding position once the assembly has been placed onto/over a needle 11. In some embodiments, the carrier 18 may be provided with a recess and arranged to provide a circular contact surface to contact around the entire periphery/circumference of the shoulder/step of the needle cover 23.

The orientation of the surfaces 70, 71 retain the needle cover 23 along the longitudinal axis of the safety device 8, specifically the carrier 18 (and eventually aligned with the longitudinal axis of a needle 11 ). This retaining force maintains both the longitudinal (translational) position of the longitudinal axis of the needle cover 23 and also the angular orientation of the needle cover 23 (see Figure 16) relative to and with respect the longitudinal axis of the carrier 18.

As shown in Figure 12, the carrier 18 provides abutment means in the form of two opposed distally facing 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 whilst the safety device is in the form of an assembly prior to the placement over a needle and also in the beforeuse initial shielding position once secured onto a needle. Accordingly, the cover 23 (in particular the proximal end of the cover 23) is gripped and clamped or loosely held prior to attachment of the safety device 8 to the syringe 10. For example, the proximal end of the cover is gripped or loosely held radially inwardly by the two internal surfaces 70, 71 and the step of the cover 23 is clamped between the distal facing abutment surfaces 76 of the carrier 18 and an internal proximal facing rib/shoulder 20 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 .

The needle cover 23 is thereby maintained by the inner surfaces 70, 71 and is also gripped or loosely held through the engagement between the inner shoulder 20 (or rib) of the protective shield 19 and step on the needle cover 23.

As mentioned above and as shown in Figure 9 to 11 , the control means further comprise a contact surface 22 of the protective shield 19 provided by the internal shoulder 20 which engages the needle cover 23 to block distal movement of the needle cover 23 away from the first position both prior and during assembly of the device 8 onto the needle hub of the syringe 10 and instead urges the cover 23 towards the syringe 10 in the initial position. A corresponding contact surface 25 is provided on the needle cover 23. In particular, a distal facing surface 25 of the shoulder 72 of the needle cover 23 provides the relevant contact surface.

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 5. This movement causes the shoulder 20 to disengage from the step 72 on the needle cover 23, and this movement may also release and or relax any urging or compressive forces acting on the cover 23 that was urging the cover proximally towards the engagement face 15 of the syringe 10. With the protective shield 19 in the outer pivoted position, a user is then able to manually grasp the needle cover 23 and pull the needle cover 23 distally forward out of this retained position from between the inner surfaces 70, 71 . This thereby releases the contact between the inner surfaces 70, 71 and the outer periphery of the step 72 of the needle cover 23.

Overall, this control arrangement maintains the needle shield 19, the needle cover 23 and the carrier 18 together as a single unitary assembly prior to the attachment or securement of the assembly onto a needle to control/prevent relative axial offset movement or misalignment and or relative angular movement or misalignment of the respective longitudinal axes of the needle cover 23 and carrier 18.

The present invention also provides a restraint means providing a restraining force to prevent unwanted and or accidental unintentional pivotal movement of the needle shield relative to the carrier prior to the placement of the safety needle assembly over a needle and to also resist pivotal movement of the needle shield 19 from the initial shielding position during storage and prior to use of the needle. The restraining force is provided by a releasable interlock between the needle shield 19 and the carrier 18. The restraining force must be overcome in order to move the needle shield 19 outwardly from the initial shielding position to the non-shielding position. Importantly, this interlock arrangement acts directly between the needle shield 19 and the carrier 18 and unlike the prior art of WO 2024/134197 does not require any interaction between the shield and the needle cover, thereby preventing the possibility of unwanted damage to the delicate needle 11 that can occur due to the needle cover 23 pivoting outwardly together with the shield 19 towards the nonshielding position as previously discussed and as illustrated in Figure 1 and Figure 2. For example, prior art devices include the needle cover 23 being clasped by the shield 19 to help maintain the shield 19 with the needle cover 23 in the initial shielding position. However, as discussed, this clasping force in combination with a gripping force can have a tendency to cause the needle cover 23 to travel and move outwardly together with the shield 19 as the shield 19 is gripped and manually and pivoted towards the non-shielding position. This tendency for the cover 23 to move outwardly only stops when the needle cover 23 is released from the shield 19 but, during this movement, the needle 11 can or may become damaged. As previously described, the sharp tip of the needle 11 may project into the internal end wall of the needle cover 23, as shown in Figure 14. The needle 11 may therefore be caused to pivot around the hub and this defection of the needle 11 can subsequently damage the needle 11 which is delicate. The present invention therefore prevents any such deflection or at least minimises the possibility of this occurring.

Notwithstanding the above, in some embodiments, the needle shield 19 may comprise clasping means to clasp and/or grip or loosely hold and retain the needle cover in the initial shielding position. The clasping means may be in the form of retaining clasps comprising shaped lugs having inner arcuate surfaces to locate around a part of an outer circumferential surface of the cover 23 to grip or loosely hold the needle cover 23. The clasps are provided on an internal surface of the needle shield 19 and may be provided on edges (or adjacent to edges) of a longitudinal gap of the needle shield 19. Accordingly, the clasping means provides a restraining force, in addition to the restraining force of the interlock, which must be overcome in order to move the needle shield 19 outwardly from the initial shielding position to the non-shielding position, and of course these two forces can be tuned and balanced accordingly to optimise the proper functioning of the releasable interlocking mechanism.

The needle shield 19 is configured to be manipulated to pivot outwardly away from the initial shielding position (see Figure 14) to the non-shielding position, and in particular, forced outward manipulation of the needle shield 19 overcomes the restraining force provided by the releasable interlock. As described above, this movement also disengages the abutment surface 22 within the shield away from the needle cover 23 to allow subsequent detachment of the needle cover 23 distally away from the needle hub to uncover the medical needle 11 (see Figure 15).

The releasable interlocking mechanism comprises corresponding engagement means on the protective shield 19 and on the carrier 18. As mentioned above, this releasable interlock thereby solely relies on the resistive forces acting between the shield 19 and the carrier 18. This prevents such forces being transmitted through the needle cover 23 which could therefore in turn be transferred to the needle 11 . The interlock thereby prevents such unwanted or unintentional forces acting on the needle 11 and prevents damage to the needle 11 during the release of the shield from the initial shielding position to the non-protecting in use position.

The interlock ensures that the protective shield 19 and the carrier 18 are engaged to each other such that unwanted/unintentional relative pivoting movement is prevented. In some preferred embodiments, the protective shield 19 is held/maintained in a non-shielding during-use position and/or the initial before-use position by purely frictional engagement or by the inter-engagement of respective interlock members in the form of detent/facets provided between the protective shield 19 and the carrier 18. Specifically, the protective shield 19 can be selectively held at both the initial and the in-use positions by a first pair of interlock members (detents) on the shield 19 and two pairs of second interlock members (facets) provided on the carrier 18.

This interlock creates an anti-pivoting restrictive arrangement 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 a detent 90 or detents 90 (first interlock members) are provided on one of the carrier 18 or protective shield

19 to engage with recesses 92, 96 (second interlock members) provided on the other component to prevent unintentional pivoting movement. Figures 17 to 20 show a preferred embodiment of the interlock mechanism between the shield 19 and the carrier 18. Engagement recesses 92 may be provided to releasably 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. The restraint means may also provide an anti-pivoting or retaining arrangement which retains the protective shield 19 in the during-use non-shielding position.

In the preferred embodiments, detents 90 are provided on the shield 19. The carrier 18 provides corresponding engagement recesses 92 in to which the detents 90 are retained in the initial position. The recesses 92 provided an upper retaining face or facet 95 which prevents the detents 90 moving over unintentionally, i.e. a required and predetermined force is required to enable the detents 90 to move out of engagement with the recesses 92. These upper faces or facets 95 may comprise smoothed or curved edges to allow and/or assist in the disengagement of the detents 90. The detents 90 comprise shaped profiles which effectively provide a sliding surface. For example, the detents 90 comprise arcuate or curved engagement/projecting surfaces which engage with the upper face of the recesses 92. The detents 90 may comprise partially spherical members. This shaped surface allows a user to disengage the detents 90 by applying a required amount of force which thereby deflect and/or distorts the shield 19 and causes the relevant portions (e.g. the supporting arms 26, 27) of the shield 19 to defect outwardly in order for the detents 90 to move out of the recesses 92 and to thereby move up profiled surfaces 94 provided by the carrier 18. Accordingly this interlock requires a user to consciously disengage the detents 90 and such movement provides tactile feedback to the user. This feedback confirms the disengagement of the detents 90 which signals that the shield 19 has disengaged from the initial shielding position. In this position, the shield 19 is relatively freely rotatable on the carrier 18.

The carrier 18 further comprises retaining recesses 96 in order to retain the shield 19 in the outer during-use position. The retaining recesses 96 comprise slots 96 defined in the carrier 18 such that the detents 90 become trapped and retained in the open during-use position, as shown in Figure 21 and Figure 22. This maintains the angular open position of the shield 19 relative to the carrier 18. In particular, this helps to initially expose the needle cover 23 to assist in a user being able to manually grasp and remove the cover 23. In addition, following the removal of the cover 23, retaining the shield 19 in this open position also prevents the shield 19 from freely moving around and causing an obstruction as the needle penetrates the skin.

The retaining recesses 96 are provided on the carrier 18 at a position (or positions) which retains and holds 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 antipivoting 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.

Following use, the shape of the outer surfaces of the detents 90 assists in enabling a user to disengage the detents 96 from these recesses 96. During this movement, the supporting arms 26, 27 may resilient flex (outwards). Again, this disengagement provides tactile feedback to a user to signal that the shield 19 is now freely pivotable.

Overall, the control means comprises contact surfaces arranged on the needle shield 19, the needle cover 23 and the carrier 18, to control axial offset and or angular misalignment of the respective longitudinal axes of the needle cover 23 and carrier 18, especially in the before-use configuration.

The safety device 8 provides retaining means to form a sub-assembly 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. This enables the sub-assembly to be safely handled by high speed assembly machines for final securement or attachment onto separate needles and hubs, or for fitment onto syringes that have needles already affixed thereto.

The retaining means 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 or onto individual Luer Slip or Lock needles.

The protective shield 19 and the carrier 18 may also be engaged to each other such that unintentional relative pivoting movement is prevented. In the preferred embodiments, the protective shield 19 is held/maintained in either a non-shielding during-use position and/or the initial before-use position by inter-engagement (an interlock mechanism) of respective detent/facets or purely frictional engagement 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.

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 needlestick protection” of the sharp tip of the needle 11. The protective shield 19 is therefore pivoted by the user manually inwardly towards the initial before use shielding position and is then pivoted further 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 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.

In this after-use final shielding position shown in Figure 6, the protective shield 19 is safely locked in the after-use final shielding position relative to the carrier 18 and syringe 10. In addition, the detents 90 relocate in the initial recesses 92. These recesses provide a slot or extended recesses which allows the detent to travel further and beyond the initial position in which the longitudinal axis of the shield 19 is aligned with the longitudinal axis of the carrier 18. In the after-use final shielding position the shield 19 will have been pivoted beyond this initial before use position. In some embodiments, this enables the needle to be deformed or deflected by an internal surface of the shield 19. In some other embodiments, the needle 11 does not become deformed by an internal surface of the shield 19. For example, the shield 19 may provide an internal channel into which the needle 11 may locate in the after-use final shielding position. Such a channel enables the needle 11 to be shrouded by a greater distance than would otherwise be achievable. This channel is defined on an internal surface of the shield 19 and extends longitudinally along the internal surface. This channel is positioned to receive the needle 11 or at least a portion (distal portion) of the needle 11 in the final position.

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 an end wall 50. The use of an open ended protective shield 19 may be advantageous in some situations.

As described above, one aim of the present invention is to minimise any inwardly directed gripping forces on the needle cover 23 as the shield 19 is moved from the initial shielding position to the non-shielding position. Such gripping forces may cause the needle cover 23 to travel outwardly when the shield 19 is rotated to the in-use position which may damage the needle 11. To assist this, the shield 19 may comprise gripping areas positioned to prevent or reduce the squeezing together of the lateral sides of the shield 19 by a user. Inevitably, when a user grips the shield 19 between their fingers, a squeezing force is produced as the user grips the shield 19. Such a squeezing action is necessary to enable a user to grip the shield 19. In the present invention, the gripping areas 80 are positioned offset from the longitudinal axis of the shield 19 and the gripping area 80 are positioned along an upper portion, as shown in Figure 23 and Figure 24. Furthermore, this positioning enables the first lateral gripping area 80 and the second lateral gripping area 80 to locate on opposing sides of a continuous (and solid linear) section of the protecting shield 19. Since the gripping areas 80 locate at either end of a (substantially) rigid/solid section, there is little or no squeezing together of the internal chamber of the shield 19 in which the needle cover 23 is initially located. Accordingly, the gripping force applied by a user does not translate to a disproportionate griping/squeezing force being applied to the needle cover 23. Thereby, the present invention reduces the problem of the shield 19 being squeezed excessively inwards towards the cover 23 during the movement of the shield from the initial before-use shielding position to the during-use non-shielding position.

The distal end of the shield 19 may also be blocked or partially blocked (e.g. by end wall 50) and this may, again, strengthen the internal chamber of the shield 19 and prevent the shield 19 from being squeezed onto the needle cover 23. As described above, the substantially solid section extending between the two lateral gripping areas 80 may define the channel for receiving the needle 11 in the final position. Whilst this channel may prevent the connecting/reinforcement section from being strictly solid and continuous, this relatively small area does not significantly weaken the gripping reinforcement area since the gripping areas are offset from the central or lower end regions of the lateral sides of the shield 19. It will be appreciated that these lower end regions will provide the weakest gripping points and would be more likely to cause the lateral sides of the shield 19 to be squeezed together.

The gripping areas 80 may further provide ledges or flanges or facets 82 which enable a user to more easily grip without “over squeezing” to create the pivoting force (initial outward lifting force) without the risk of squeezing the shield together. These facets 82 enable a user to place a part of their thumb and finger under the flanges in order to then move the shield 19 outwards and to dislodge or disengage the detents 90 provided on the profiled surfaces 94 of the carrier 18.

In the before-use shielding position, the present invention may also define a spacing 30 (cavity) or clearance between the needle cover 23 and the needle shield 19, as shown in Figure 9 and Figure 11 . This spacing 30 aims to prevent the needle cover 23 from being inadvertently gripped and pivotally moved along with the shield 19 towards the non-shielding position. Accordingly, such a clearance or spacing 30 may accommodate a degree of squeezing movement without the needle cover 23 being gripped by the internal surface of the shield 19.

As described above, the restraint means provided by the releasable interlock comprises frictional and/or detent arrangements provided on one and or the other of the needle shield 19 and the carrier 18 to resist and/or restrain pivotal movement of the needle shield 19 from the initial position. The restraining/retaining means may comprise modifications to the pivot members or to regions located close to the pivot members so as to provide the requisite frictional interface between the carrier and the shield to resist unwanted rotational movement between of the shield relative to the carrier. The restraining/retaining means comprises a frictional or detent arrangement (provided) between the needle shield 19 and the carrier 18 to interlock the needle shield 19 and carrier 18 together when the needle shield 19 is at the initial shielding position. In some further embodiments, a seal (for example a sealing member/label or membrane) affixed/wrapped around both a part of the shield 19 and the carrier 18 provides a releasable mechanical interlock, that would require breaking or tearing away before the shield 19 could be moved outwardly from the initial before use position.

As shown in Figures 29 and Figure 30, the seal member 120 may be secured around the safety device 8 to create an interlock between the shield 19 and the carrier 18 and to help maintain this self-supporting sub-assembly configuration, for example, the seal member 120 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 120 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 the preferred embodiment, the seal member 120 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 29.

The seal member 120 may be applied in position around the protective shield 19 after the safety device 8 has been attached to the needle hub 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 needle hub to provide the shielding functionality for the needle 11 provided by the syringe 10.

The seal member 120 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 120 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 120 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 126, 127. 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. Each shearing surface 126, 127 may provide a toothed or serrated profiled edge which bites into and distorts, indents, damages or severs a part of the seal member 120.

The seal member 120 overlays and is positioned relative to the shearing surfaces 126, 127 such that movement of the protective shield 19 relative to the carrier 18 causes the shearing surfaces to impact the sealing member 120. The seal member 120 comprises a distal edge 122, and a proximal edge 123. The seal member 120 is positioned such that the shearing surfaces 126, 127 locate below and at least partially between the distal edge 122 and the proximal edge 123.

Each shearing surface 126, 127 comprises respective distal ends and proximal ends. In the preferred embodiment, the pivot arrangement is positioned along the safety device 8 at a proximal location to the distal ends. As the protective shield 19 is pivoted outwardly away from the initial position to the during use position, the shearing surfaces 126, 127 similarly rotate outwardly to pivot around the pivot axis. In particular, the distal ends and a distal section of the shearing surfaces will pivot upwardly and outwardly (clockwise form the aspect shown in Figure 29) towards the seal member 120 so as to slice and or tear into the seal member 100. During this movement at least a part of the shearing surfaces 126, 127 will be brought into contact with the inner surface of the seal member 120. The continued movement will then force the shearing surfaces 126, 127 to break/snap/tear/rip and damage the seal member 120. In particular, a distal section of the shearing surfaces 126, 127 will in effect provide an edge (or blade) which generates a tear/rip commencing from the distal edge 122 of the seal member 120. As the pivotal movement continues to the during use non-shielding position the shearing surfaces 126, 127 will continue to increase and lengthen this tear in a proximal direction towards the proximal edge 103 of the seal member. This overcomes the interlock and the restraining force provided by the seal member 120.

In the preferred embodiment, each shearing surface 126, 127 produces and forms damaged zones that comprise a tear or crumpled indents which extend into the longitudinal length of the sealing member 120 from the distal edge 122 and towards the proximal edge 123 of the sealing member 100. Outward movement of the protective shield from a storage position (before use) may cause the complete disruption of the seal member 120 such that the seal member 120 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 120 is attached to the safety device 8. For example, the inner surface of the seal member 120 may be substantially completely covered with an adhesive (for example, a self-adhesive surface) such that all of the seal member 120 remains attached to the safety device. Alternatively, the inner surface of the seal member 120 may only have localised coverage (spots) or partial coverage with an adhesive (self-adhesive) such that a part or parts of the seal member 120 may detach away from the carrier 18 after the operation.

Overall, a principal aim of the present invention is to prevent unwanted and or unintentional accidental pivotal movement of the needle shield 19 relative to the carrier 18 prior to the placement of the safety needle assembly 8 over a needle 11 and to also resist pivotal movement of the needle shield 19 from the initial shielding position during storage prior to use of the needle. Furthermore, it is not just the retaining means holding the shield 19 rotational stable relative to the carrier 18 and it is also in combination with the fact that the needle cover 23 has also to be held and maintained/retained because there is no needle hub present within the safety needle assembly to mount the needle cover 23 onto hence has it has to be held (by something) within the assembly prior to the assembly being fitted onto the needle hub. All other prior art safety needle assembly devices are limited to requiring the inclusion of a needle cover fitted onto a needle hub with a needle already mounted onto the hub.

The present invention enables existing (tried and tested) assembly production lines to be used. In particular, the dimensions of the safety needle assembly specifically allow the present invention to be incorporated into such pre-existing production lines. For example, in the initial position, the needle shield extends along the longitudinal axis of the carrier (and the needle) such that the shield is not angled outwardly which would increase the outer dimensions and render the device unsuitable for use with pre-existing production lines. In particular, the present invention is suitable for use with pre-existing manufacturing/production/assembly lines relating to Luer lock needles. In addition, the present invention is suitable for use with pre-existing manufacturing/production/assembly lines relating to prefillable syringes with staked in needles whereby the nose of the syringe acts as the hub. In the present invention, the safety needle assembly effectively replaces a standard/ordinary needle cover (hard or soft) which is conventionally used to cover the needle of Luer lock hub needle and also to replace rigid (or soft) needle covers used to protect the needles fitted to pref i Hable syringes.

The present invention provides a safety needle device 8 which can be used with standard prefillable syringes supplied 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 that are currently used within the pharma industry, 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 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 may be used with pre-filled or pre-fillable glass or plastic polymer syringes. Furthermore, the present invention may be used with needle hubs having Luer Lock and Luer slip attachment fittings. 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

1 . A medical needle cover arrangement comprising: a needle hub, the needle hub further comprising a medical needle having a longitudinal axis and a sharp tip, the medical needle being mounted on the needle hub with the sharp tip projecting distally therefrom; a safety needle assembly comprising: a carrier and wherein the carrier has a longitudinal axis; a needle shield and wherein the shield has a longitudinal axis and the shield is pivotally coupled to the carrier and is configured to move outwardly from an initial shielding position to a non-shielding position and wherein the carrier is configured to be secured to the needle hub; a needle cover to protect the needle and wherein the needle cover is located within the needle shield at the initial shielding position; the needle cover comprises, a longitudinal axis, a profile at a proximal end configured to locate over a profile on a distal end of the needle hub; wherein the longitudinal axes of the carrier, the shield, and the needle cover are aligned when the needle shield is at the initial shielding position; the safety needle assembly further comprises; a restraint means providing a restraining force to resist pivotal movement of the needle shield from the initial shielding position; and a control means to releasably maintain the needle cover within the needle shield; characterised in that: the restraining force is provided by a releasable interlock between the needle shield and the carrier; and wherein the restraining force must be overcome in order to move the needle shield outwardly from the initial shielding position to the nonshielding position; and the control means comprises contact surfaces arranged on the needle shield, the needle cover and the carrier, to control axial offset and or angular misalignment of the respective longitudinal axes of the needle cover and carrier; and wherein the releasable interlock and the control means serve to maintain the carrier, the needle shield, the needle cover as a unitary self-supporting safety needle assembly prior to the securement of the safety needle assembly to the needle hub; and an abutment surface provided on the needle shield releasably engages the needle cover to resist distal movement of the needle cover relative to the needle shield when the safety needle assembly is secured to the needle hub, until the needle shield is moved to the non-shielding position; and wherein the needle shield is configured to be manipulated to pivot outwardly away from the initial shielding position to the non-shielding position, and in particular, forced outward manipulation of the needle shield overcomes the restraining force provided by the interlock, to disengage the abutment surface from the needle cover to allow subsequent detachment of the needle cover distally away from the needle hub to uncover the medical needle.

2. A medical needle cover arrangement according to Claim 1 in which the needle cover comprises 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 within the shield at the initial shielding position.

3. A medical needle cover arrangement according to Claim 1 or Claim 2 in which a part of the needle cover and a part of the needle shield are configured to engage when the needle shield is at the initial shielding position to releasably maintain the needle cover within the needle shield to resist distal movement of the needle cover relative to the needle shield when the needle shield is at the initial shielding position to prevent drug leakage and maintain the sterility of the medical needle during storage of the syringe.

4. A medical needle cover arrangement according to any preceding claim in which the releasable interlock is formed directly between the needle shield and the carrier.

5. A medical needle cover arrangement according to Claim 4 in which the releasable interlock is formed by an interface between the needle shield and the carrier.

6. A medical needle cover arrangement according to Claim 5 in which the releasable interlock is formed at two locations and wherein each location comprises an interface between the needle shield and the carrier.

7. A medical needle cover arrangement according to any preceding claim in which the releasable interlock is formed between a first interlock member on the needle shield and a second interlock member on the carrier.

8. A medical needle cover arrangement according to Claim 7 in which the interlock is formed between a pair of first interlock members on the needle shield and a corresponding pair of second interlock members on the carrier.

9. A medical needle cover arrangement according to Claim 8 in which the carrier comprise a first pair of second interlock members and a second pair of second interlock members.

10. A medical needle cover arrangement according to Claim 9 in which the first pair of interlock members are arranged, in use, to resist pivotal movement of the needle shield relative to the carrier from the initial shielding position and the second pair of interlock members are arranged, in use, to resist pivotal movement of the needle shield relative to the carrier from the non-shielding position.

11. A medical needle cover arrangement according to any one of Claim 7 to Claim 10 in which the first and second interlock members comprise detents and facets.

12. A medical needle cover arrangement according to Claim 11 in which the detents comprise projections having a profiled outer surface and wherein the profile of this surface assists in the engagement and disengagement of the detent with a respective facet.

13. A medical needle cover arrangement according to Claim 11 or Claim 12 in which the facets provide a face with an engaging edge and in which the engaging edges facilitate engagement and disengagement of a respective detent.

14. A medical needle cover arrangement according to any one of Claim 7 to Claim 13 in which the first interlock members are provided on a flexible portion of the needle shield and in which the flexible portion is resil iently flexible.

15. A medical needle cover arrangement according to Claim 14 in which the flexible portion is arranged, in use, to flex to assist in disengagement of the first interlock member from the second interlock member.

16. A medical needle cover arrangement according to any one of Claim 8 to Claim 15 in which the pair of second interlock members are provided on the carrier to resist pivotal movement of the needle shield to the non-shielding position.

17. A medical needle cover arrangement according to any preceding claim in which a part of the needle cover comprises a step which is configured to engage the abutment surface of the needle shield which comprises a proximally facing shoulder in order to releasably engage with and maintain and hold the needle cover within the needle shield and the carrier prior to the securement of the safety needle assembly to the needle hub.

18. A medical needle cover arrangement according to Claim 17 in which the engagement causes a proximal portion of the needle cover to be urged proximally within the safety needle assembly.

19. A medical needle cover arrangement according to any preceding claim in which, prior to the securement of the safety needle assembly to the needle hub, the contact surfaces control angular misalignment and a part of the needle shield is arranged to engage the part of the needle cover and wherein a proximal face of the needle cover engages a complementary face of the carrier.

20. A medical needle cover arrangement according to any preceding claim in which, prior to the securement of the safety needle assembly to the needle hub, the contact surfaces control offset transverse misalignment and in which the contact surface comprises one or more upstands on the distal end of the carrier.

21. A medical needle cover arrangement according to Claim 20 in which the proximal end of the needle cover locates between two upstands and each upstand provides an internal surface which is arranged, in use to grip a part of the proximal end of the needle cover in the carrier.

22. A medical needle cover arrangement according to any preceding claim in which, prior to the securement of the safety needle assembly to the needle hub, a portion of internal sides of the needle shield are arranged to prevent transverse or sideways or offset misalignment of the needle cover with respect to the longitudinal axis of the carrier and wherein two opposing portions of the internal side of the needle shield are arranged to prevent transverse or sideways or offset misalignment of the needle cover with respect to the longitudinal axis of the carrier.

23. A medical needle cover arrangement according to any preceding claim in which the interlock comprises a seal member.

24. A medical needle cover arrangement according to Claim 23 in which the seal member comprises a constricting band of tubular form that is arranged to overlay and enclose a part of the protective shield and a part of the carrier.

25. A method of protecting a medical needle in which the medical needle cover arrangement comprises: a needle hub, the needle hub further comprising a medical needle having a longitudinal axis and a sharp tip, the medical needle being mounted on the needle hub with the sharp tip projecting distally therefrom; a safety needle assembly comprising: a carrier and wherein the carrier has a longitudinal axis; a needle shield and wherein the shield has a longitudinal axis and the shield is pivotally coupled to the carrier and is configured to move outwardly from an initial shielding position to a non-shielding position and wherein the carrier is configured to be secured to the needle hub; a needle cover to protect the needle and wherein the needle cover is located within the needle shield at the initial shielding position; the needle cover comprises, a longitudinal axis, a profile at a proximal end configured to locate over a profile on a distal end of the needle hub; wherein the longitudinal axes of the carrier, the shield, and the needle cover are aligned when the needle shield is at the initial shielding position; the method comprising; resisting pivotal movement of the needle shield from the initial shielding position with a restraint means to provide a restraining force; and releasably maintaining the needle cover within the needle shield with control means; characterised in that: the restraining force is provided by a releasable interlock between the needle shield and the carrier; and wherein the restraining force must be overcome in order to move the needle shield outwardly from the initial shielding position to the nonshielding position; and the control means comprises contact surfaces arranged on the needle shield, the needle cover and the carrier, to control axial offset and or angular misalignment of the respective longitudinal axes of the needle cover and carrier; and wherein the releasable interlock and the control means serve to maintain the carrier, the needle shield, the needle cover as a unitary self-supporting safety needle assembly prior to the securement of the safety needle assembly to the needle hub; and an abutment surface provided on the needle shield releasably engages the needle cover to resist distal movement of the needle cover relative to the needle shield when the safety needle assembly is secured to the needle hub, until the needle shield is moved to the non-shielding position; and wherein the needle shield is configured to be manipulated to pivot outwardly away from the initial shielding position to the non-shielding position, and in particular, forced outward manipulation of the needle shield overcomes the restraining force provided by the interlock, to disengage the abutment surface from the needle cover to allow subsequent detachment of the needle cover distally away from the needle hub to uncover the medical needle.