Patent Description:
Administering an injection is a process which presents a number of risks and challenges for users and healthcare professionals, both mental and physical. Drug delivery devices typically fall into two categories - manual drug delivery devices or autoinjectors. In a conventional manual device, manual force is required to drive a medicament through a needle. This is typically done by some form of plunger that has to be continuously pressed during the injection. There are numerous disadvantages associated with this approach. For example, if the plunger is released prematurely, the injection will stop and may not deliver an intended dose. Further, the force required to push the plunger may be too high (e.g., if the user is elderly or a child). And, aligning the injection device, administering the injection and keeping the injection device still during the injection may require dexterity which some patients (e.g., elderly patients, children, arthritic patients, etc.) may not have.

Autoinjector devices aim to make self-injection easier for patients. A conventional autoinjector may provide the force for administering the injection by a spring, and trigger button or other mechanism may be used to activate the injection. Autoinjectors may be single-use or reusable devices.

<CIT> discloses a drug delivery device according to the state of the art.

It is desirable to administer the full dose in order to achieve full effectiveness of the medicament within the patient.

An object of the present disclosure is to provide an improved drug delivery device.

The object is achieved by a drug delivery device according to claim <NUM>.

Exemplary embodiments are provided in the dependent claims.

According to the present disclosure, a drug delivery device comprises at least a housing adapted to receive a cartridge or primary container with a piston and a plunger slidably disposed in the housing and adapted to drive the piston for delivering a drug or a medicament. The device further comprises a drive spring pre-loaded between the housing and the plunger so as to urge the plunger towards a distal direction. Furthermore, an audible and/or tactile indicator, e.g. a resilient force member, is provided, e.g. disposed at a proximal end of the device, in particular at a proximal end of the housing. A trigger mechanism for activating the indicator is provided and arranged between the indicator and the plunger, wherein the trigger mechanism is configured to support the indicator in an initial state of the device and/or during delivery of the medicament and to couple with the plunger to activate the audible and/or tactile indicator at or near an end of delivery, in particular when the plunger is in a distal position.

In particular, the trigger mechanism engages with the plunger to activate the audible and/or tactile indicator at or near the end of delivery of the medicament. In an exemplary embodiment, upon activating of the indicator said indicator disengages from the support of the trigger mechanism.

According to another aspect, as the trigger mechanism is being engaging with the plunger the trigger mechanism is being disengaged from the indicator to activate the indicator. In particular, the indicator can deform or relax when its support is disengaged. For instance, the indicator can disengage from the support by the trigger mechanism.

According to the disclosure, the indicator is engaged, e.g. in contact, with the trigger mechanism in the initial state and during injection. In particular, the trigger mechanism supports the indicator in an initial state, e.g. unbiased state, or in a biased state. Alternatively, the trigger mechanism may hold or press the indicator in or into an initial state, e.g. unbiased state, or in or into a biased state. Furthermore, the trigger mechanism only supports the indicator before its activation.

In particular, the housing may comprise an inner surface forming a cavity configured to retain the cartridge or a drug container or primary container. The primary container comprises an inner surface forming a cavity configured to slidably receive the piston. Due to coupling of the plunger and the piston, the piston moves in the distal direction when the plunger moves in the distal direction for delivering the medicament.

Such a drug delivery device ensures that the trigger mechanism fires or activates the indicator regardless of the length of the plunger. Hence, the length of the plunger could be changed without affecting activation or firing of the indicator. Furthermore, the number of parts, which would have to be replaced to accommodate a change in dose delivered by the drug delivery device, is minimised.

In an exemplary embodiment, the trigger mechanism comprises at least one structure resiliently abutting the plunger. In particular, the at least one structure resiliently abuts the plunger before activating of the indicator. The at least one structure may protrude from an indicator holder towards the plunger. Alternatively, the at least one structure may protrude from the housing towards the plunger. The housing can also be configured to hold the indicator. In this embodiment, the holder may be formed as a part of an inner housing so a separate indicator holder is not required. In detail, the structure may protrude from the housing, for example from an inner part of the housing towards the plunger.

According to another aspect of the present disclosure, the structure may have an inclined surface. The inclined surface ensures guiding and coupling with the plunger. In particular, the structure may comprise a proximal inclined end and a distal stepped edge. The distal stepped edge secures coupling with the plunger.

In an exemplary embodiment, the structure comprises at least one fin.

Furthermore, the plunger may comprise at least one cut-out adapted to receive the at least one structure at or near the end of delivery, in particular when the plunger is in a distal position.

In an exemplary embodiment, the cut-out comprises a lateral inclined edge. The lateral inclined edge supports and ensures catching of the fin. Furthermore, the cut-out may comprise a distal stepped edge. This edge secures the coupling with the fin, in particular with the distal stepped edge of the fin.

In a further exemplary embodiment, the indicator comprises two adjacent fins and the plunger comprises two corresponding adjacent cut-outs adapted to receive the fins.

According to another aspect of the disclosure, a needle sleeve is telescopically coupled to the housing and has an inner surface with at least one radially inwardly protruding guide rail extending in parallel to a longitudinal axis.

Furthermore, the plunger may comprise at least one radially outwardly protruding guide pin.

In an exemplary embodiment, the guide pin and the guide rail are configured to engage each other, e.g. coaxially to the longitudinal axis.

According to a further aspect of the disclosure, the guide pin may comprise a guide pin surface engaging a corresponding guide rail surface of the guide rail. In particular, the guide pin surface and the guide rail surface may be oppositely inclined to each other. For example, the guide pin surface and the guide rail surface may be engaged to each other in an angle between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°.

In an exemplary embodiment, the guide pin is formed as a protruding boss. The guide pin may comprise an inclined distal end. The inclined distal end ensures correct positioning and alignment, in particular for controlling rotation of the plunger to ensure that the fin will fall into the cut-out.

Furthermore, the guide rail may be formed as a protruding elongated rib extending in parallel to the longitudinal axis. The elongated rib ensures a guiding of the pin during delivery of the medicament.

Moreover, the drug delivery device may be an auto-injector, a pen-injector or a syringe. The primary container may be prefilled with a drug.

The drug delivery device, as described herein, may be configured to inject a drug or medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector.

The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about <NUM> to about <NUM>. Yet another device can include a large volume device ("LVD") or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> minutes) to deliver a "large" volume of medicament (typically about <NUM> to about <NUM>).

Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about <NUM> cP to about <NUM> cP (<NUM> - <NUM> Pa·s).

Consequently, a drug delivery device will often include a hollow needle ranging from about <NUM> to about <NUM> Gauge (<NUM> - <NUM> O. mm) in size. Common sizes are <NUM> and <NUM> Gauge (<NUM> - <NUM> O.

The delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device. The one or more automated functions of an auto-injector may be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation may be a one-step or multi-step process. That is, a user may need to activate one or more activation mechanism in order to cause the automated function. For example, a user may depress a needle sleeve against their body in order to cause injection of a medicament. In other devices, a user may be required to depress a button and retract a needle shield in order to cause injection.

In addition, such activation may activate one or more mechanisms. For example, an activation sequence may activate at least two of needle insertion, medicament injection, and needle retraction. Other devices may operate with sequence independent steps.

The present disclosure will become more fully understood from the detailed description given below and the accompanying drawings, which are given by way of illustration only, and do not limit the present disclosure, and wherein:.

According to some embodiments of the present disclosure, an exemplary drug delivery device <NUM> is shown in <FIG>.

Device <NUM>, as described above, is configured to inject a drug or medicament into a patient's body.

Device <NUM> includes a housing <NUM> which typically contains a reservoir or cartridge containing the medicament to be injected (e.g., a syringe <NUM> or a container) and the components required to facilitate one or more steps of the delivery process.

Device <NUM> can also include a cap assembly <NUM> that can be detachably mounted to the housing <NUM>, in particular on a distal or front end D of the device <NUM>. Typically, a user must remove cap assembly or cap <NUM> from housing <NUM> before device <NUM> can be operated.

As shown, housing <NUM> is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The housing <NUM> has a distal region <NUM> and a proximal region <NUM>. The term "distal" refers to a location that is relatively closer to a site of injection, and the term "proximal" refers to a location that is relatively further away from the injection site.

Device <NUM> can also include a needle sleeve <NUM> coupled to the housing <NUM> to permit movement of the sleeve <NUM> relative to the housing <NUM>. For example, the sleeve <NUM> can move in a longitudinal direction parallel to longitudinal axis X. Specifically, movement of the sleeve <NUM> in a proximal direction can permit a needle <NUM> to extend from distal region <NUM> of housing <NUM>.

Insertion of the needle <NUM> can occur via several mechanisms. For example, the needle <NUM> may be fixedly located relative to housing <NUM> and initially be located within an extended needle sleeve <NUM>.

Proximal movement of the sleeve <NUM> by placing a distal end of sleeve <NUM> against a patient's body and moving housing <NUM> in a distal direction or sleeve <NUM> in a proximal direction will uncover the distal end of needle <NUM>. Such relative movement allows the distal end of needle <NUM> to extend into the patient's body. Such insertion is termed "manual" insertion as the needle <NUM> is manually inserted via the patient's manual movement of the sleeve <NUM> relative to the housing <NUM> and the needle <NUM> or reverse.

Another form of insertion is "automated," whereby the needle <NUM> moves relative to housing <NUM>. Such insertion can be triggered by movement of sleeve <NUM> or by another form of activation, such as, for example, a button <NUM>. As shown in <FIG>, button <NUM> is located at a proximal or back end P of the housing <NUM>. However, in other embodiments, button <NUM> could be located on a side of housing <NUM>. In further embodiments, the button <NUM> has been deleted and is replaced for instance by a sleeve trigger mechanism, e.g. provided by pushing the needle sleeve <NUM> inside the housing when the drug delivery device is put onto an injection side.

Other manual or automated features can include drug injection, automatic needle insertion or needle retraction, or both. Injection is the process by which a bung or piston <NUM> is moved from a proximal location within a cartridge, container or syringe <NUM> to a more distal location within the syringe <NUM> in order to force a medicament from the syringe <NUM> through needle <NUM>.

In some embodiments, an energy source, e.g. a drive spring <NUM> is arranged in a plunger <NUM> and is under compression before device <NUM> is activated. A proximal end of the drive spring <NUM> can be fixed within proximal region <NUM> of housing <NUM>, and a distal end of the drive spring <NUM> can be configured to apply a compressive force to a proximal surface of piston <NUM>. Following activation, at least part of the energy stored in the drive spring <NUM> can be applied to the proximal surface of piston <NUM>. This compressive force can act on piston <NUM> to move it in a distal direction. Such distal movement acts to compress the liquid medicament within the syringe <NUM>, forcing it out of needle <NUM>.

Following injection, the needle <NUM> can be retracted within sleeve <NUM> or housing <NUM>. Retraction can occur when sleeve <NUM> moves distally as a user removes device <NUM> from a patient's body. This can occur as needle <NUM> remains fixedly located relative to housing <NUM>. Once a distal end of the sleeve <NUM> has moved past a distal end of the needle <NUM>, and the needle <NUM> is covered, the sleeve <NUM> can be locked. Such locking can include locking any proximal movement of the sleeve <NUM> relative to the housing <NUM>.

Another form of needle retraction can occur if the needle <NUM> is moved relative to the housing <NUM>. Such movement can occur if the syringe <NUM> within the housing <NUM> is moved in a proximal direction relative to the housing <NUM>. This proximal movement can be achieved by using a retraction spring (not shown), located in the distal region <NUM>. A compressed retraction spring, when activated, can supply sufficient force to the syringe <NUM> to move it in a proximal direction.

Following sufficient retraction, any relative movement between the needle <NUM> and the housing <NUM> can be locked with a locking mechanism. In addition, button <NUM> or other components of device <NUM> can be locked as required.

In some embodiments, the housing may comprise a window 11a through which the syringe <NUM> can be monitored.

In the present specification, the term "distal section/end" refers to the section/end of the device <NUM>, or the sections/ends of the components thereof, which during use of the device <NUM> is located closest to a medicament delivery site of a patient. Correspondingly, the term "proximal section/end" refers to the section/end of the device <NUM>, or the sections/ends of the components thereof, which during use of the device <NUM> is pointing away from the medicament delivery site of the patient.

In the shown exemplary embodiments, the drug delivery device <NUM> comprises the housing <NUM> with a front case <NUM> and a rear case <NUM>. The front case <NUM> is adapted to hold the medicament container or primary container <NUM>, such as a syringe. The medicament primary container is referred to hereinafter as the "syringe <NUM>". The syringe <NUM> may be a pre-filled syringe, in particular a <NUM> pre-filled syringe, containing a medicament and having the needle <NUM> arranged at a distal end of the syringe <NUM>. In another exemplary embodiment, the medicament container may be a primary container which includes the medicament and engages a removable needle (e.g., by threads, snaps, friction, etc.).

The drug delivery device <NUM> may be configured as an autoinjector or as a manual drug delivery device.

Moreover, the drug delivery device <NUM> comprises an audible and/or tactile indicator <NUM> providing an audible and/or tactile indication to a user of the device <NUM> at the end of delivery of the medicament. In particular, the indicator <NUM> produces an audible and/or tactile feedback for a user or patient indicating completion of medicament delivery. In other words: The indicator <NUM> is provided to indicate to a user or a patient that the full dose of medicament was spent.

In an exemplary embodiment, the indicator <NUM> is disposed at the proximal end P of the device <NUM>. For example, the indicator <NUM> is arranged at a proximal end of the housing <NUM> and inside the housing <NUM>.

Further, a trigger mechanism <NUM> is arranged between the indicator <NUM> and the plunger <NUM>. The trigger mechanism <NUM> is configured to support the indicator <NUM> in an initial state of the device <NUM>, for example during storage and transportation as well as during delivery of the medicament and to couple with the plunger <NUM> to activate the indicator <NUM> at an end of delivery.

In particular, the trigger mechanism <NUM> engages with the plunger <NUM> to activate the audible and/or tactile indicator <NUM> at or near the end of delivery of the medicament.

In an exemplary embodiment, upon activating of the indicator <NUM>, said indicator <NUM> can disengage from the support of the trigger mechanism <NUM>. In particular, as the trigger mechanism <NUM> is being engaging with the plunger <NUM> near or at the end of delivery of the medicament, the trigger mechanism <NUM> is being disengaged from the indicator <NUM> to activate it. For example, the indicator <NUM> can deform or relax when its support is disengaged. For instance, the indicator <NUM> can disengage from the support by the trigger mechanism <NUM>.

For example, the indicator <NUM> is engaged, e.g. in contact, with the trigger mechanism in the initial state and during injection. In particular, the trigger mechanism <NUM> supports the indicator <NUM> in an initial state, e.g. unbiased state, or in a biased state. Alternatively, the trigger mechanism <NUM> may hold or press the indicator <NUM> in or into an initial state, e.g. unbiased state, or in or into a biased state. Furthermore, the trigger mechanism <NUM> only supports the indicator <NUM> before its activation and releases it upon activating.

In an exemplary embodiment, the indicator <NUM> is formed as a biasing member, a spring, a laminated spring, a flat spring, a plate spring or a leaf spring.

In an exemplary embodiment, the trigger mechanism <NUM> comprises at least one structure, e.g. a protrusion, a flap, projection, resiliently abutting the plunger <NUM>. In particular, the at least one structure resiliently abuts the plunger <NUM> before activating of the indicator <NUM>.

In particular, a part of the trigger mechanism <NUM>, e.g. one surface side, for instance an outer side of the trigger mechanism <NUM>, abuts and supports the indicator <NUM> and an opposite surface side, e.g. an inner side of the trigger mechanism <NUM>, abuts the plunger <NUM> before activating of the indicator <NUM>, e.g. before and during delivery of the medicament. Upon activating of the indicator <NUM>, the trigger mechanism <NUM> disengages from indicator <NUM> and a part of the trigger mechanism <NUM> couples or engages with the plunger <NUM>.

<FIG> respectively show embodiments of the indicator <NUM> which will be described further below.

<FIG> shows a longitudinal section of an exemplary embodiment of the rear case <NUM>. In an assembled state, the rear case <NUM> serves for example as a drive subassembly <NUM> of the drug delivery device <NUM>.

The drive sub assembly <NUM> is a sub assembly of the drug delivery device <NUM> and comprises the components required to deliver the medicament. The drive subassembly <NUM> comprises for example the rear case <NUM>, the plunger <NUM>, the drive spring <NUM> and the indicator <NUM>. The drug delivery device <NUM> further comprises a front sub assembly (not shown separately) to allow for flexibility as to the time and location of manufacture of the subassemblies and final assembly with the syringe <NUM>.

According to the present embodiment, the rear case <NUM> comprises two support arms <NUM> adapted to support an axial position of the syringe <NUM> during storage, transportation and medicament delivery. The support arms <NUM> project distally from a proximal case end <NUM> of the rear case <NUM>. The rear case <NUM> further comprises additional flexible projections <NUM> that project distally from the distal end of the rear case <NUM> as well. In detail, the flexible projections <NUM> project distally from the distal end of the support arms <NUM>.

The projections <NUM> are adapted to damp impact forces and thus to stabilize the syringe <NUM> during storage, transportation and delivery.

In an exemplary embodiment, the indicator <NUM> is arranged on the housing <NUM>, in particular on the rear case <NUM>. In detail, the indicator <NUM> is arranged on an outer side of at least one of the support arms <NUM>. In this embodiment, in which the indicator <NUM> is arranged on the rear case <NUM>, the trigger mechanism <NUM> is also arranged on the rear case <NUM>. In detail, the trigger mechanism <NUM> is arranged on an inner side of the support arm <NUM> and thus on a side opposite the side of the support arms <NUM> where the indicator <NUM> is arranged. The trigger mechanism <NUM> is adapted to damp impact forces and thus to stabilize the indicator <NUM> in its biased state during storage, transportation, and medicament delivery.

In an alternative embodiment, the indicator <NUM> may arranged on a holder (not shown) which is arranged in the housing <NUM>. The trigger mechanism <NUM> may then also be arranged on the holder in a similar manner as on the rear case <NUM>.

In an assembled state, the indicator <NUM> is arranged within the device <NUM> at the proximal end P of housing <NUM>. A proximal end of the plunger <NUM> is at least partially received within the rear case <NUM>. The rear case <NUM> is closed at its outer proximal end <NUM>.

In detail, the indicator <NUM> is held in the rear case <NUM> such that the longitudinal axis X is in parallel with a longitudinal extension of the drug delivery device <NUM>. The indicator <NUM> may be coupled to the drug delivery device <NUM> by a snap connection, wherein one or more of the tabs <NUM> are engaged within a number of corresponding openings <NUM> in the rear case <NUM>. In another exemplary embodiment, the indicator <NUM> is held in the rear case <NUM> by a frictional connection, such as a screw or rivet connection or interference fit.

<FIG> and <FIG> show the indicator <NUM> in a pre-assembly state and initial or relaxed state S1. <FIG> shows the indicator <NUM> in an assembly state in the rear case <NUM> and in a primed or biased state S2 and <FIG> shows the indicator in the biased state S2, too.

The indicator <NUM> comprises a resilient force member <NUM>, e.g. having a substantially rectangular shape, comprising a longitudinal axis running in parallel to the longest side of the outer circumference of the resilient force member <NUM>. In other embodiments, the resilient force member <NUM> may have a triangular shape or any other geometrical shape suitable to couple the indicator <NUM> to the device <NUM>, e.g. an autoinjector.

The resilient force member <NUM> may be designed as a monostable leaf spring comprising a resilient material, e. spring steel or spring plastic. Thus, the resilient force member <NUM> is capable of residing in two states. That is, the resilient force member <NUM> may assume two different conformations, one of them stable with limited or no application of an external force and the other one unstable. For example, these two states can include a first or relaxed state S1 (or pre-assembly state, or trigged state, or initial state), in which the resilient force member <NUM> has a first conformation. In a second or biased state S2 (or primed state), the resilient force member <NUM> can have a second conformation. In <FIG>, the resilient force member <NUM> is in the relaxed state S1 which can correspond to the pre-assembly state as well as to a state at the end of medicament delivery.

In a possible embodiment, the resilient force member <NUM> comprises a longitudinal bend <NUM>. The longitudinal bend <NUM> can be arranged generally in the centre of the resilient force member <NUM> running in parallel to the longitudinal axis X. The longitudinal bend <NUM> can divide the indicator <NUM> into two wing-shaped sections angled to each other with an angle less than <NUM> degrees. In in the illustrated perspective of <FIG> and <FIG>, the wing-shaped sections are angled downwards.

Furthermore, the resilient force member <NUM> can comprise one or more tabs <NUM> projecting perpendicularly to the longitudinal axis X from the outer circumference. Specifically, the resilient force member <NUM> can include one, two, three, four or more tabs <NUM>.

As shown in <FIG>, the resilient force member <NUM> includes two tabs <NUM>, wherein one of the tabs <NUM> is arranged opposite the other tab <NUM>. In another embodiment (not shown), the resilient force member <NUM> can include pairs of tabs <NUM> located generally opposite each other. The pairs of tabs <NUM> are arranged spaced to each other in the direction of the longitudinal axis X. In another exemplary embodiment, the number and arrangement of the tabs <NUM> may differ from the shown exemplary embodiment. In an exemplary embodiment, the tabs <NUM> may be angled with respect to the wing-shaped sections to facilitate assembly of the drug delivery device <NUM>.

For assembling the indicator <NUM> into the drug delivery device <NUM>, the resilient force member <NUM> is bent in the centre about an axis A running perpendicular to the longitudinal axis X. The bending angle may be less than <NUM> degrees. This bending is achieved by applying a predetermined force onto or near the centre point of the resilient force member <NUM> when engaging the tabs <NUM> within the openings <NUM> in the rear case <NUM>. As a result, the resilient force member <NUM> changes from the relaxed state S1 into the biased state S2. Two ends <NUM>. <NUM>, <NUM>. <NUM> of the resilient force member <NUM> at opposite ends along the longitudinal axis X are angled upwards from the centre point <NUM> in the illustrated perspective of <FIG>, which shows the biased state S2. Hence, the biased state S2 corresponds with the primed state, wherein the resilient force member <NUM> stores a certain amount of energy.

After removing the applied force, the resilient force member <NUM> is held in the biased state S2 as it is shown in <FIG> and described below.

The resilient force member <NUM> is in the biased state S2 and held in the rear case <NUM> by the snap connection as described above. The distally pointing end <NUM>. <NUM> of the resilient force member <NUM> and the biased state S2 of the indicator <NUM> is supported and activated by the trigger mechanism <NUM> arranged on the support arm <NUM> as described further below.

The proximally pointing end <NUM>. <NUM> of the resilient force member <NUM> is free and not in contact with any other component and located above the trigger mechanism <NUM> or another section of the rear case <NUM>.

After changing from the relaxed state S1 into the biased state S2 as described before, only a small force may be required to hold the resilient force member <NUM> in the biased state S2. This is achieved by the longitudinal bend <NUM> that provides a bent cross section of the resilient force member <NUM> which buckles into a new configuration by changing from the relaxed state S1 into the biased state S2. In this configuration, a stiffness of the material structure is significantly reduced and thus only a small holding force is required to maintain the resilient force member <NUM> in the biased state S2.

In detail, the trigger mechanism <NUM> comprises at least one structure <NUM> resiliently abutting the plunger <NUM>. The structure <NUM> may protrude from an indicator holder towards the plunger <NUM>. The structure <NUM> may be formed as a fin. The protruding structure <NUM> is referred to hereinafter as "fin <NUM>". Due to the support of the fin <NUM> on the plunger <NUM> during storage, transportation and delivery, the indicator <NUM> is supported in its biased state S2, too.

In detail, the at least one fin <NUM> protrudes from the housing <NUM>, in particular from the rear case <NUM>, e.g. from its inner support arm <NUM> towards the plunger <NUM>. The support arm <NUM> is formed as an indicator holder. The indicator <NUM> and the fin <NUM> are arranged on opposite surface side of the support arm <NUM>. The indicator <NUM> is held on a surface side of arm <NUM> facing to the outer housing <NUM>. The fin <NUM> is formed on the opposite side of the arm <NUM> facing inwards and towards to the plunger <NUM>.

Alternatively, the fin <NUM> may protrude from a separate indicator holder (not shown) towards the plunger <NUM>. The separate indicator holder may be arranged between the indicator <NUM> and the plunger <NUM> within the housing <NUM>.

In an exemplary embodiment, the fin <NUM> has an inclined surface <NUM>. In particular, an upper or top surface of the fin <NUM> is rounded or inclined. The inclined surface <NUM> ensures guiding along the plunger <NUM> during delivery of the medicament.

Further, the fin <NUM> may comprise a proximal inclined end <NUM> and a distal stepped edge <NUM>. The proximal inclined end <NUM> allows an easy coupling of the fin <NUM> with the plunger <NUM>. The distal stepped edge <NUM> is configured to secure the coupling of the fin <NUM> with the plunger <NUM>.

According to another aspect of the disclosure, the plunger <NUM> comprises at least one cut-out <NUM> adapted to receive the at least one fin <NUM> at the end of delivery, for example when the plunger <NUM> is in the distal position. Due to the fin <NUM> falling into the cut-out <NUM> at the end of delivery, the indicator <NUM> relaxes and generates an acoustic noise. Additionally, the indicator <NUM> may be configured to generate a tactile feedback on the outer housing <NUM>, too. The indicator <NUM> thus provides an end-of-delivery feedback to a user.

Furthermore, the cut-out <NUM> may comprise a lateral inclined edge <NUM>. Such a lateral inclined edge <NUM>. <NUM> facilitates the fin <NUM> falling into the cut-out <NUM>. The cut-out <NUM> may further comprise a distal stepped edge <NUM>. The distal stepped edge <NUM>. <NUM> corresponds with the distal stepped edge <NUM> of the fin <NUM> to facilitate the coupling of the fin <NUM> and the cut-out <NUM>.

In the exemplary embodiment, the trigger mechanism <NUM> comprises two adjacent fins <NUM> and the plunger <NUM> comprises two correspondingly adjacent cut-outs <NUM> adapted to receive the fins <NUM>. The two fins <NUM> are arranged spaced to each other in the direction of the transversal direction. The pair of fins <NUM> protrudes from the inner surface of the rear case <NUM> facing the plunger <NUM> when received inside the housing <NUM>. The radially inwardly protruding and adjacent fins <NUM> abut the plunger <NUM>, thereby supporting the resilient force member <NUM> in its biased state S2. In another exemplary embodiment, the number and arrangement of the fins <NUM> may differ from the shown exemplary embodiment.

In another exemplary embodiment, the number and arrangement of the indicators <NUM> and trigger mechanism <NUM> may differ from the shown exemplary embodiment. The device <NUM> may comprise two trigger mechanism <NUM> and two indicators <NUM> described above. Each of a pair of trigger mechanism <NUM> and indicators <NUM> may be arranged on one of the support arms <NUM> of the rear case <NUM>.

For delivering a medicament, as can be seen in more detail in an exploded view in <FIG>, the plunger <NUM> is driven by a drive spring <NUM> that is arranged between the plunger <NUM> and the rear case <NUM>. The drive spring <NUM> may be arranged within the plunger <NUM> and be pre-loaded such as to urge the plunger <NUM> towards the distal end D of the device <NUM>.

As can be seen in detail in <FIG>, two circumferentially adjacent cut-outs <NUM> corresponding to the adjacent fins <NUM> of the trigger mechanism <NUM> are arranged near the proximal end P of the plunger <NUM>. The plunger <NUM> is aligned in an angular position relative to the rear case <NUM> such that each of the fins <NUM> is axially aligned with its corresponding cut-out <NUM>. During the injection, the plunger <NUM> is translated in a distal direction towards a distal position until reaching a position at the end of the injection, where the fins <NUM> will snap into the cut-outs <NUM>. Thereby, the resilient force member <NUM> will relax from its biased state S2 into its relaxed state S1. An audible and/or tactile click emitted upon this relaxation indicates the end of the injection process to the user.

As shown in <FIG>, the fins <NUM> are formed in the shape of shark fins with a proximally arranged inclined end <NUM> and with a distally arranged stepped edge <NUM>. Thereby, the resilient force member <NUM> relaxes immediately with a sharp click noise, when the plunger <NUM> reaches its distal end position.

<FIG> shows a further aspect of the disclosure concerning the sleeve <NUM> comprising a guide rail <NUM>. <FIG> shows a guide pin <NUM> corresponding to the guide rail <NUM> and protruding from a proximal end of the plunger <NUM>. <FIG> is a schematic view of a guiding mechanism for guiding the plunger <NUM> along the needle sleeve <NUM> due to the interrelation of guide pin <NUM> and guide rail <NUM>.

In detail, the needle sleeve <NUM> is telescopically coupled to the housing <NUM> and has an inner surface <NUM> with at least one radially inwardly protruding guide rail <NUM> extending in parallel to the longitudinal axis X. The guide rail <NUM> is formed for example as a protruding rib elongated parallel to the longitudinal axis X.

Furthermore, the plunger <NUM> may comprise at least one radially outwardly protruding guide pin <NUM>. In an exemplary embodiment, the guide pin <NUM> and the guide rail <NUM> are configured to engage each other, e.g. coaxially to the longitudinal axis X. In particular, the guide pin <NUM> engages the at least one guide rail <NUM> as best seen in <FIG>.

In more detail, the guide pin <NUM> may comprise a guide pin surface <NUM>. <NUM> engaging a corresponding guide rail surface <NUM>. <NUM> of the guide rail <NUM>.

Furthermore, the guide pin surface <NUM>. <NUM> and the guide rail surface <NUM>. <NUM> may be oppositely inclined to each other. For example, the guide pin surface <NUM>. <NUM> and the guide rail surface <NUM>. <NUM> are engaged to each other in an angle between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°.

In an exemplary embodiment, the guide pin <NUM> is formed as a protruding boss as shown in <FIG>. The guide pin <NUM> may comprise an inclined distal end <NUM>. The inclined distal end <NUM>. <NUM> ensures correct positioning and alignment, in particular controlling rotation of the plunger <NUM> to ensure that the fin <NUM> will fall into the cut-out <NUM>.

Moreover, the drug delivery device <NUM> may be an auto-injector, a pen-injector or a syringe. The primary container or syringe <NUM> may be prefilled with a drug.

Exemplary insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω)-carboxyheptadecanoyi) human insulin. Exemplary GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-<NUM> / Byetta / Bydureon / ITCA <NUM> / AC-<NUM> (a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, rExendin-<NUM>, CJC-<NUM>-PC, PB-<NUM>, TTP-<NUM>, Langlenatide / HM-11260C, CM-<NUM>, GLP-<NUM> Eligen, ORMD-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, Nodexen, Viador-GLP-<NUM>, CVX-<NUM>, ZYOG-<NUM>, ZYD-<NUM>, GSK-<NUM>, DA-<NUM>, MAR-<NUM>, MAR709, ZP-<NUM>, ZP-<NUM>, TT-<NUM>, BHM-<NUM>. MOD-<NUM>, CAM-<NUM>, DA-<NUM>, ARI-<NUM>, ARI-<NUM>, Exenatide-XTEN and Glucagon-Xten.

Antibody fragments that are useful in the present disclosure include, for example, Fab fragments, F(ab')<NUM> fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies.

Basic salts are e.g. salts having a cation selected from an alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.

Claim 1:
A drug delivery device (<NUM>) comprising at least:
- a housing (<NUM>) adapted to receive a primary container (<NUM>) with a piston (<NUM>),
- a plunger (<NUM>) slidably disposed in the housing (<NUM>) and adapted to drive the piston (<NUM>) for delivering a medicament,
- a drive spring (<NUM>) pre-loaded between the housing (<NUM>) and the plunger (<NUM>) so as to urge the plunger (<NUM>) in a distal direction (D),
- an audible and/or tactile indicator (<NUM>) providing an indication to a user at or near an end of delivery of the medicament, wherein the indicator (<NUM>) is a biasing member,
- a trigger mechanism (<NUM>) arranged between the indicator (<NUM>) and the plunger (<NUM>),
wherein the trigger mechanism (<NUM>) comprises at least one structure (<NUM>) resiliently abuting the plunger (<NUM>),
wherein the plunger (<NUM>) provides at least one cut-out (<NUM>) adapted to receive the at least one structure (<NUM>) at or near the end of delivery of the medicament,
wherein the cut-out (<NUM>) comprises a lateral inclined edge (<NUM>.<NUM>),
wherein the drug delivery device (<NUM>) ensures that the trigger mechanism activates the audible and/or tactile indicator (<NUM>) regardless of the length of the plunger (<NUM>), and
wherein the trigger mechanism (<NUM>) is configured
- to support the indicator (<NUM>) in an initial state of the device (<NUM>) and during delivery of the medicament, wherein the at least one structure (<NUM>) is supported by the plunger (<NUM>) and thereby supports the indicator (<NUM>) in a biased state (S2), and
- to couple with the plunger (<NUM>) to activate the audible and/or tactile indicator (<NUM>) at or near the end of delivery of the medicament, wherein the at least one cut-out (<NUM>) receives the at least one structure (<NUM>).