Patent Description:
Injection devices are used for the convenient administration of medicaments. For example, injection devices (which may typically be in the form of a pen injector) may be used for providing a single metered dose of a medicament, such as Epinephrine, in an emergency or for providing regular metered doses of a medicament, such as Insulin. Such devices may be either single use "disposable" devices in which the device is typically provided with a syringe already installed, and which is not user-replaceable, or "reusable" devices which allow the user to replace the syringe when the medicament has been used.

It may be noted that whilst the term "syringe" is used herein for clarity and consistency, the skilled person will appreciate that this term is intended to be broadly interpreted. In some arrangements the syringe may for example be a cartridge (which, for example, may be arranged to receive a disposable needle) or other medicament container. In some arrangements the syringe/cartridge/ medicament container may formed integrally with the (or part of the) injection device.

Injection devices may be provided in the form of an "autoinjector" device in which, in addition to automating the delivery of the medicament, the device is also arranged to automate the insertion of a needle into the skin prior to the delivery of the medicament.

Injection devices generally comprise a drive mechanism which is arranged to automatically deliver a dose from the syringe, and optionally (in the case of an autoinjector) to first displace the syringe within the housing to cause needle penetration. The drive mechanism is typically released from an energised (or primed) position and may, for example, include one or more drive springs. The drive mechanism may act upon a plunger which includes or acts against a piston (also referred to as a "bung") which is slidably provided within the syringe. In the case of an autoinjector the initial stiction between the piston and syringe and the incompressibility of the medicament may resist forward movement of the piston relative to the syringe enabling the drive mechanism to initially move the syringe into the needle insertion position (whereupon further movement of the syringe is blocked and the drive mechanism will continue to move forward thus moving the piston). In other known devices additional features may be incorporated into the drive mechanism to force/control the sequencing of the needle insertion and drug delivery actions.

A trigger, for example in the form of a button on the end of the device, is generally provided to allow the user to activate the delivery sequence. It is known to provide a safety arrangement in the form of a mechanical lock (which, as is common in the art, shall be referred to herein as an "interlock") arranged to prevent actuation of the delivery mechanism by the user unless the lock is in the unlocked position. For example, such safety arrangements may require the user to perform a readying action prior to releasing the trigger or may be arranged to require the injection device to be in contact with an injection site before the trigger is able to activate the delivery mechanism. An example of a device including such an interlock arrangement is for example shown in the Applicants' earlier patent application <CIT>.

The provision of safety mechanisms is desirable to avoid inadvertent operation of injection devices (particularly, in auto-injectors where inadvertent operation could result in injury due to the projection of the needle during the insertion stage of the activation sequence). However, such arrangements may result in increased complexity of the device and potentially less intuitive use of the device for the end user. It will be appreciated that an interlock arrangement will normally be biased towards its unlocked position and the user must act against this bias when activating the device. Some users, such as the young or frail may experience difficulty, in activating a device which requires an interlock to be maintained in position whilst triggering the device.

Thus, it is desirable to provide an alternate injection device which may at least partially address some of these disadvantages.

<CIT> discloses an auto-injector for administering a medicament.

<CIT> discloses an autoinjector having an interlock arrangement.

Accordingly, in one aspect, this invention provides an injection device for delivering a dose of medicament from a syringe, the injection device comprising:.

The interlock may be biased (for example by an interlock spring) towards the locked position. The user may, typically, have to provide the relative axial movement of the forward and rearward body against the force of the bias when urging the device against an injection site. This force will generally need to be maintained until the trigger has been activated.

The drive assembly may be of the type which is released from an energised position (for example a compressed drive spring). The trigger may be associated with a latch which holds the drive assembly in the energised position prior to activation. The drive mechanism may be arranged to displace the syringe within the housing to cause needle penetration prior to the subsequent automatically delivery of a dose from the syringe.

The interlock hold arrangement provides an engagement between the rearward and forward housing to help maintain the alignment of the rearward and forward body when the interlock is in the unlocked position and the device is in contact with an injection site.

The engagement of the interlock hold arrangement is intended to assist maintenance of the interlock in the unlocked position. The engagement is only maintained whilst the device is in the unlocked interlock position and in contact with an injection site. The interlock hold arrangement may therefore be a reversible arrangement. The engagement of the interlock hold arrangement may be considered to be a temporary or holding engagement.

The interlock hold arrangement may be configured such that it is not able to maintain the alignment of the interlock without the additional force urging the device against an injection site. However, the interlock hold arrangement may provide assistance to the end user by reducing the force required to maintain the interlock in the unlocked position. The Applicant has recognised that this is particularly advantageous in improving operability without decreasing safety. In particular some users may be able to provide sufficient force to the device when presenting it to an injection site for use to initially move the interlock into the unlocked position but may then experience difficulty in maintaining the required force whilst also activating the trigger. For example users may simply forget that it is necessary to maintain the required alignment or may have difficulty due to limited strength or manual dexterity.

The interlock hold arrangement comprises an engagement feature in one of the forward or rearward body. The hold arrangement further comprises a cam surface, fixed relative to a forward facing skin abutment surface of the injection device. The cam surface moves into alignment with the engagement feature in the forward or rearward body when the interlock is in the unlocked position. The hold arrangement further comprises a resilient member which is deflected by the cam surface so as to provide a holding engagement with the engagement feature.

It will be appreciated that the engagement feature may be selected dependent upon the design of the device. For example, in some embodiments the engagement feature may be a cutout or recess. Alternatively, the engagement feature may be a projection or boss.

The resilient member may be deflected radially, for example outwardly, into holding engagement with the engagement feature (for example into the cutout or recess). At least a forward portion of the rearward body may be radially outside of at least a rearward portion of the forward body. The forward portion of the rearward body may substantially surround the rearward portion of the forward body. The resilient member may be provided on the forward body (and the cutout or recess may be provided in the rearward body).

Alternatively the other of the forward or rearward body could include a further cutout which moves into alignment with the cutout or recess of the forward or rearward body. In such an arrangement the resilient member could act to hold the cutouts or recess in alignment (for example passing through one of the cutouts into engagement with the cutout or recess of the other body portion).

The resilient member may comprise a flexible tongue formed in the side wall of the other of the rearward or forward body.

The flexible tongue extends from a first end fixed relative to the body to a free end. The free end may be arranged to be resiliently deflected, in use, by the cam surface. The free end may be a forward end and the fixed end may be the rearward end. The flexible tongue may be integrally formed with the body (for example by a U-shaped cutout in the sidewall thereof).

The injection device may further comprise a shroud assembly at a forward end of the device. The forward facing skin abutment surface may be provided by a forward face of the shroud assembly. The shroud assembly may be forwardly biased and move rearwardly in response to the forward facing skin abutment surface being pressed against an injection site. The forward bias may move the shroud assembly to a forward position in response to relief of pressure urging the forward facing skin abutment surface against an injection site. It will be appreciated that "relief of pressure" would typically be caused by the full or partial removal of the device from the injection site (for example if the user chooses not to proceed with an injection). The forward movement may be a return to the initial pre-use position (for example if the device has not been activated) or may be a movement to a second forward position in which the needle is shrouded post injection.

The cam surface may be formed on the shroud assembly, for example on a rearward portion of the shroud assembly. Advantageously, this may provide a device in which the interlock hold arrangement is automatically released if the device is removed from contact with the injection site (since the cam surface will move out of alignment due to the movement of the shroud). Thus, in some emboidments the interlock hold arrangement may be configured to be released by forward movement of the shroud assembly caused by the relief of pressure urging the forward facing skin abutment surface against an injection site.

The interlock hold arrangement may comprise a plurality of interlock hold arrangements. For example the interlock hold arrangement may comprise a pair of radially opposed interlock hold arrangements.

The rearward body may be arranged to be held by the user during use. The rearward body may be configured to slide forwardly relative to the forward body when the injection device is pressed against an injection site. The trigger may comprise a button associated with the rear body.

Whilst the invention has been described above, it extends to any inventive combination of the features set out above, or in the following description or drawings.

The invention may be performed in various ways, and an embodiment thereof will now be described by way of example only, reference being made to the accompanying drawings, in which:.

Front as used herein will be understood to refer to the end of the injector assembly (or components thereof) which, in use, are closest to the delivery needle delivery end of the injector (i.e. the end which is pointed at the skin). Rear as used herein will be understood to refer to the end of the pen injector assembly (or components thereof) which, in use, are furthest from the needle delivery end of the injector (i.e. the end which is pointed away from the skin). Forward and rearward will, likewise, be understood to refer to the directions orientated towards the front and rear of the injector assembly.

Axial, radial and circumferential may be used herein to conveniently refer to the general directions relative to the longitudinal direction of the injection device (or components thereof). The skilled person will, however, appreciated that these terms are not intended to be narrowly interpreted (and for example, the injection device may have a non-circular and/or irregular form). Typically, regardless of the chosen injector device external profile the cartridge or syringe will have a conventional generally cylindrical form and, as such, the longitudinal axis of the injection device will normally substantially coincide with (or be parallel to) the axial direction of the syringe.

As seen in <FIG>, an autoinjector <NUM> in accordance with an embodiment of the invention comprises a housing defined by a forward body <NUM> and a rearward body <NUM>. A syringe <NUM> of medicament is provided within the housing. The housing <NUM>, <NUM> has a generally elongate tubular shape with a substantially oval cross-sectional profile.

The syringe is a conventional syringe having a bung or stopper <NUM> within its body and a needle at its forward end which may initially be protected (so as to remain sterile) by a removable needle shield <NUM>. The illustrated autoinjector <NUM> is generally intended to be a single use device (although the skilled person will appreciate that the invention is not limited to such devices) and, therefore, the exploded view of <FIG> may typically represent a final assembly stage in which the syringe is placed into the housing (for example in a manufacturing facility). The end user would typically be provided with the autoinjector <NUM> preassembled around the syringe <NUM>. The autoinjector may conveniently be arranged during manufacture into a forward sub-assembly <NUM>, comprising the forward body <NUM> and those components which are initially forward of the syringe <NUM>, and a rearward sub-assembly <NUM>, comprising those components which are initially rearward of the syringe <NUM>.

An exploded view of each of the forward and rearward sub-assemblies are shown in <FIG> and <FIG>.

The forward sub-assembly <NUM> comprises the forward body <NUM> which is adapted to receive a cap <NUM> which closes the forward end of the autoinjector <NUM>. The cap <NUM> may include an internal formation, comprising rearwardly extending members <NUM>, arranged to engage the removable needle shield <NUM> of the syringe <NUM> such that removal of the cap <NUM> from the forward housing <NUM> during use also removes the removable needle shield <NUM> from the syringe <NUM>. Within the sub-assembly <NUM> there is a syringe carrier <NUM> for movably mounting the syringe within the forward body <NUM> to enable automatic needle penetration. It may be noted that prior to the removal of the cap <NUM>, the rearwardly extending members <NUM> of the cap <NUM> underlie spring fingers <NUM> of the syringe carrier <NUM>. This arrangement, thus prevents inward movement of the spring fingers <NUM> prior to removal of the cap <NUM> and, therefore, blocks unlatching of the syringe carrier <NUM> and prevents movement relative to the forward body <NUM>.

A needle shroud <NUM> is also provided and arranged to shroud the needle after use (when the syringe <NUM> and syringe carrier <NUM> are in a forward position) to prevent needle stick injuries. The shroud <NUM> is activated by a pair of side-by-side shroud springs 51a, 51b carried on a spring guide <NUM>. Whilst, the present application is not limited to any specific arrangement of the syringe carrier <NUM> and/or needle shroud <NUM>, it may be noted that the arrangement substantially corresponds to the arrangement of the Applicants' earlier International Patent Application <CIT>.

The rearward sub assembly <NUM> includes a trigger button <NUM> which is inserted into the rearward housing <NUM> from the rearward end so as to substantially close the rearward end of the injector housing. The trigger button <NUM> has a cup-like profile with side walls which are arranged to fit within (and be substantially concentric with) the rearward housing <NUM> and an end wall which closes the rear end of the housing. The trigger button includes a pair of forwardly extending resilient arms 73a and 73b which are arranged to provide an engagement between the trigger button <NUM> and the injector <NUM>, as will be described in greater detail below. For ease of manufacture and assembly the trigger could be comprised of a sub assembly of parts; however in the embodiment shown in <FIG> the trigger button comprises a single moulded part.

The rearward sub-assembly <NUM> also includes the drive mechanism <NUM>. The drive mechanism <NUM> includes a plunger <NUM> which is arranged to engage the bung of the syringe in use. The invention is not limited to any specific drive mechanism but the basic functional operation of the drive mechanism <NUM> is substantially as described, for example, in the Applicants' earlier International Patent Applications <CIT> and <CIT>. The plunger <NUM> is driven forwards in use by a pair of concentric drive springs 44a and 44b (although it will be appreciated that in other embodiments a single spring may be used) with an intermediate drive member <NUM> provided therebetween. A latch <NUM> is arranged concentrically around the drive springs <NUM>, intermediate member <NUM> and plunger <NUM>. The latch <NUM> is arranged to hold the plunger <NUM> against the bias of the springs <NUM> until the latch is released via the trigger button <NUM> (when both drive springs and the intermediate drive member are all released together). The latch <NUM> comprises a rear body portion 60b having a split cylinder profile and defining a latch aperture at its rear end and a forward connecting body portion 60b. The forward body portion 60a has an external profile substantially corresponding to the interior profile of the rearward end of the forward housing <NUM>.

For safety an interlock arrangement is provided which blocks the release of the latch <NUM> by the trigger button <NUM> unless the interlock is in an unlocked state. The interlock arrangement is moveable between a locked and an unlocked state by relative forward sliding movement of the rear body portion <NUM> relative to the front body portion <NUM>. Specifically, in use the user will grasp the device <NUM> by the rear body portion <NUM> and press the forward end of the device (i.e. of the forward assembly <NUM>) against an injection site. An interlock spring <NUM> is provided which biases the body portions <NUM>, <NUM> apart and therefore normally maintains the interlock in the locked position. The unlocking of the interlock acts against the force of the interlock spring <NUM>. The interaction between the interlock and the drive mechanism may for example be as described in the Applicants' earlier patent application <CIT>. The skilled person will appreciate that interlock arrangements as such are known and that other other interlock arrangements which utilise a relative movement between housing portions are possible. Accordingly, the application of embodiments of the invention is not intended to be limited to any specific interlock arrangement.

In accordance with an embodiment of the invention the injection device <NUM> is provided with an interlock hold arrangement <NUM> which assists the end user in maintaining the device <NUM> in the correct alignment for actuation until they have activated the trigger <NUM>. The interlock hold arrangement <NUM> comprises a cutout window <NUM> in the side wall of the rearward body housing <NUM>, a flexible tongue <NUM> formed in the sidewall of the forward body housing <NUM> and an outwardly directed radial projection or tab <NUM> at a rearward end of the shroud <NUM>. In the illustrated embodiment a pair of interlock hold arrangement 100a and 100b are provided at radially opposed locations on the device <NUM> (for simplicity the operation of a single interlock hold arrangement will be described below but it will be appreciated that each hold arrangement 100a, 100b operates in parallel and in an identical manner).

The cutout <NUM> is a simple through window in the sidewall of the rearward body housing <NUM>. Alternatively a corresponding feature could be provided in the form of a blind recess in the inner surface of the side wall.

The flexible tongue <NUM> may be formed by a U-shaped cut out in the side wall of the forward body housing <NUM>. Thus, the tongue <NUM> may extend in a generally axial direction from a rearward end which is contiguous with the side wall of the forward body housing <NUM> to a free end which is separate from the side wall. As the forward body housing <NUM> is formed from a plastic material the tongue <NUM> may resiliently deflect from its natural position (in which it is substantially co-planar with the surrounding side wall).

The tab <NUM> may be formed on any conveniently located section of the shroud <NUM> (with the other features of the interlock hold arrangement 100aligned accordingly). The tab <NUM> extends radially outwardly and is provided with outwardly tapered forward <NUM> and rearward <NUM> facing surfaces.

As shown in <FIG>, in an initial configuration with the cap <NUM> positioned on the device <NUM>, the interlock hold arrangement <NUM> is inactive. The tab <NUM> is positioned forward of the front end of the flexible tongue <NUM> (and is seated in a cutout formed ahead of the forward end thereof and the side wall of the forward body housing <NUM>). The cutout <NUM> of the rearward housing is rearward of the flexible tongue <NUM> and tab <NUM>.

The user readies the device <NUM> by removing the cap <NUM> before pressing the forward end of the device against an injection site <NUM> as shown in <FIG>. The user will grip the rearward housing <NUM> during use. As the skin abutment surface <NUM> at the forward end shroud <NUM> is initially positioned slightly forward of the forward housing <NUM> (see <FIG>) and biased forwardly by the shroud springs <NUM>, upon initial contact with the skin it is moved rearwardly as shown by arrow B. As the user urges the device against the injection site <NUM>, the rearward housing <NUM> is also moved forward relative to the forward housing <NUM> as shown by arrow A. The relative movement between the housing portions <NUM>, <NUM> brings the window <NUM> of the rearward body housing <NUM> into alignment with the flexible fingers <NUM> of the forward housing <NUM>. Due to the rearward movement of the shroud assembly <NUM> the tab <NUM> moves rearwardly relative to the flexible tongue <NUM> of the forward housing <NUM>. This movement causes the flexible fingers to ride over the sloped rearward surface <NUM> of the tab <NUM> and be cammed outwardly. As a result the flexible finger <NUM> deflects radially outwardly into the window <NUM>. Thus, in this configuration the interlock hold arrangement <NUM> is active. The positioning of the components <NUM>, <NUM>, <NUM> of the interlock hold arrangement <NUM> are selected such that this position corresponds to the position in which the relative movement between for forward <NUM> and rearward housing portions has also been sufficient to move the interlock to its unlocked position.

With the interlock hold arrangement <NUM> in the active position of <FIG> it will be seen that should the force provided by the user on the rearward housing decrease the forward end of the flexible tongue <NUM> will resist any rearward movement of the rearward body housing <NUM>. It may also be noted that the outward incline of the tongue <NUM> may provide a barb type effect in this direction. This assists the user in keeping the appropriate alignment between the body housing portions until the device has been triggered. However, in the event that the user choses not to proceed with an injection and removes the device from the injection site <NUM> without triggering the drive mechanism it will be noted that the shroud <NUM> will return to its forward position moving the tabs <NUM> forward and enabling the flexible tongues <NUM> to return to their inward position. Thus, the interlock hold arrangement <NUM> does not affect the safety of the device as once removed from the injection site <NUM> the interlock will operate normally.

<FIG> shows the configuration of the device immediately after delivery of a dose (but prior to removal from the injection site <NUM>). In this state the interlock hold arrangement <NUM> is still in its active configuration (but the user has already triggered). As explained in the applicants' earlier International Patent Application <CIT> during triggering of the injection the syringe is carried forward in the syringe carrier <NUM> and acts to release the shroud <NUM> for subsequent forward movement. The user then removes the device <NUM> from the injection site <NUM> withdrawing the needle as shown in <FIG>. The shroud is forced forward by the shroud springs <NUM> and locks out in the position shown so as to make the needle safe. The forward movement of the shroud also acts to displace the tab <NUM> forward of the flexible tongues <NUM> such that the interlock hold arrangement <NUM> is no longer active.

For completeness, an alternative embodiment is shown schematically in <FIG> to demonstrate that the arrangement of the cutout and resilient member of the invention could be reversed without altering the underlying function of the interlock hold arrangement <NUM>' (and depending upon the particular arrangement of the injection device to which an embodiment of the invention is being applied). In this embodiment, the forward body housing <NUM>' is positioned on the exterior of the rearward housing <NUM>'. Accordingly, the rearward housing <NUM>' is provided with a resilient tongue <NUM>' and the forward housing <NUM>' is provided with a cutout window <NUM>'. The interlock hold arrangement <NUM>' operates in the same manner with a tab <NUM>' displacing the tongue <NUM>' when aligned so as to engage the cutout <NUM>'. In contrast to the previous embodiment it may be noted that the free end of the tongue <NUM>' is the rearward end but this arrangement could be reversed.

The interlock hold arrangement <NUM> in accordance with an embodiment of the invention may typically be a passive arrangement in the sense that it is activated without any action being required by the user. The user may generally be unaware of the features during use but will benefit from the assistance in maintaining the correct relative position of the forward and rearward housing portions. However, if required it will also be appreciated that the interlock hold arrangement could provide an indication of the interlock being moved to the unlock position - for example the flexible tongue may be readily visible through the cutout window or the interlock hold arrangement may provide an audible or tactile indication (such as a click) when in the active position.

Claim 1:
An injection device for delivering a dose of medicament from a syringe, the injection device comprising:
a housing comprising a forward body (<NUM>) and rearward body (<NUM>) and wherein the forward body and rearward body are axially moveably interconnected;
a drive mechanism (<NUM>) arranged, in use, to deliver a dose from said syringe
a trigger (<NUM>) for activating the drive mechanism; and
an interlock having a locked position in which activation of the drive mechanism by the trigger is prevented and an unlocked position in which the drive mechanism may be activated, the interlock being moved to the unlocked position by relative axial movement of the forward body and rearward body caused by the injection device being urged against an injection site; and
characterised in that the injection device further comprises:
an interlock hold arrangement (<NUM>) comprising:
an engagement feature (<NUM>) in one of the rearward body or forward body;
a cam surface (<NUM>), fixed relative to a forward facing skin abutment surface of the injection device, which moves into alignment with the engagement feature when the interlock is in the unlocked position; and
a resilient member (<NUM>) which is deflected by the cam surface so as to provide a holding engagement with the engagement feature; and
configured to help maintain the axial position of the rearward body relative to the forward body when the interlock is in the unlocked position and the forward facing skin abutment surface is in contact with an injection site.