Patent Description:
Injector devices, such as auto-injectors, typically have a syringe into which a plunger is pushed to dispense medicament from the syringe. The amount of medicament in the syringe is predetermined and the plunger must complete its movement into the syringe such that the appropriate amount of medicament in the syringe is dispensed.

<CIT> discloses a drug delivery device which, in one example, comprises a container and a plunger movable in the container to deliver medicament. A tooth may be attached to the plunger and in engagement with a saw-tooth region on an inner surface of the container or housing, such that as the plunger advances, it engages the saw tooth to generate clicks/vibrations. A sensor system detects the clicks and generates a signal based on the detected clicks indicative of the medicament delivery.

<CIT> discloses a medical device including a sensor, a control unit and an attachable dispense assembly, wherein the sensor is configured to detect attachment of the dispense assembly to the medical device and the control unit is configured to determine, at least based on a signal from the sensor, whether the end of life of the dispense assembly is reached. The medical device is configured to indicate the end of life of the dispense assembly.

It is an object of the present invention to provide an advantageous injector device having a container and a plunger that is movable within the container to dispense medicament during operation of the injector device.

According to the present invention, there is provided an injector device comprising:
a container and a plunger that is movable into the container to dispense medicament during operation of the injector device; a biasing member arranged to push the plunger into the container during operation of the device; a latch arranged to hold the plunger in an initial position where the biasing member is under compression prior to operation of the injector device, wherein the plunger is configured to be rotated to disengage the latch; a switch arranged to interact with a structural element of the plunger to detect movement of the plunger during operation of the injector device, wherein the switch is arranged to be aligned with the structural element of the plunger after the plunger has been rotated; and a needle sleeve slidably mounted in the injector device and arranged such that during use the needle sleeve slides into engagement with the plunger to cause the plunger to rotate and disengage the latch.

The plunger may be configured to move from a first position to a second position to dispense medicament from the container. The switch may be arranged to interact with the structural element of the plunger at the first position and/or the second position.

The switch may be arranged to detect the start of the movement of the plunger and/or the end of the movement of the plunger. Alternatively or additionally, the switch may be arranged to detect the plunger at a point along its movement into the container.

The structural element of the plunger may be a recess or a protrusion. Alternatively or additionally, the structural element of the plunger may be an end of the plunger.

Examples of the injector device may comprise a first switch arranged to detect a recess or protrusion of the plunger, and a second switch arranged to detect an end of the plunger as the plunger moves into the container. The injector device may further comprise a housing having a distal end and a proximal end, the first switch being mounted distally of the second switch within the housing. In this example, the distal end is relatively closer to the site of injection than the proximal end.

The switch may be arranged to detect the structural element of the plunger when the plunger is rotated to disengage the latch.

The latch may comprise a collar that surrounds a part of the plunger and engages the plunger to hold the plunger in the initial position. In this example, the plunger may be arranged to be rotated relative to the collar to release the plunger for movement into the container.

In other embodiments, the injector device includes a collar that surrounds a part of the plunger. The collar engages the plunger and holds the plunger in the initial position, with the biasing member under compression prior to operation of the device. The collar can be rotated, for example manually or by an actuator, to release the plunger for movement into the container.

The switch may comprise a mechanical switch having an engaging member that contacts the plunger. The engaging member may be spring-loaded such that the engaging member is pushed against a surface of the plunger. In this way, the engaging member will engage with a structural element of the plunger as the structural element passes the engaging member.

The injector device may further comprise a communication device configured to receive a signal output by the switch.

The communication device may comprise an antenna. The antenna may be integrally formed in a part of a housing of the injector device. Alternatively, the antenna may be located inside a housing of the injector device. Alternatively, the antenna may be provided in an adhesive label that is attached to an outer surface of the injector device. In some examples, the antenna may be connected to further electronic components of the injector device via electrical connections formed that extend through a housing of the injector device.

The communication device may be configured to communicate with an external device. The communication device may be a transmitter, for example a radio transmitter. In another example, the communication device comprises a Bluetooth device. In another example, the communication device comprises a near-field communication (NFC) chip or device.

The further device may for example be an auxiliary device for communicating with the injector device. In this example, the auxiliary device may connect with more than one injector device. In other examples, the further device may be a smartphone or other handheld electronic device. The auxiliary device or the handheld electronic device may have software, for example an application (app), for connecting with, and receiving information from, the injector device.

The injector device may further comprise a processing unit configured to receive a signal output by the switch. The processing unit may process the signal, for example to determine movement of the plunger. The processing unit may be in communication with the communication unit, if provided, and may provide a signal to the communication unit.

The injector device may further comprise a feedback device configured to provide a user with information relating to movement of the plunger during operation of the injector device. The feedback device may comprise a screen, or other visual display, such as one or more LED's.

The injector device may further comprise a reservoir of liquid medicament.

According to a further aspect of the invention, there is provided a method of manufacturing an injector device, comprising arranging a container and a plunger such that the plunger is moveable into the container to dispense medicament during operation of the injector device; providing a biasing member arranged to push the plunger into the container during operation of the device; providing a latch arranged to hold the plunger in an initial position where the biasing member is under compression prior to operation of the injector device, wherein the plunger is configured to be rotated to disengage the latch; providing a switch arranged to interact with a structural element of the plunger to detect movement of the plunger during operation of the injector device, wherein the switch is arranged to be aligned with the structural element of the plunger after the plunger has been rotated; and providing a needle sleeve slidably mounted in the injector device and arranged such that during use the needle sleeve slides into engagement with the plunger to cause the plunger to rotate and disengage the latch.

A drug delivery device, as described herein, may be configured to inject a 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> Pa·s (<NUM> cP) to about <NUM> Pa·s (<NUM> cP). Consequently, a drug delivery device will often include a hollow needle ranging from about <NUM> of outer diameter to about <NUM> of outer diameter (<NUM> to about <NUM> Gauge) in size. Common sizes are <NUM> of outer diameter and <NUM> of outer diameter (<NUM> and <NUM> Gauge).

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 each be activated via an activation mechanism. Such an activation mechanism can include an actuator, for example, one or more of a button, a lever, a needle sleeve, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament. Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.

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

The device <NUM> can also include a cap <NUM> that can be detachably mounted to the housing <NUM>. Typically, a user must remove 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 A-A. The housing <NUM> has a distal region D and a proximal region P. 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 housing <NUM> to permit movement of sleeve <NUM> relative to housing <NUM>. For example, sleeve <NUM> can move in a longitudinal direction parallel to longitudinal axis A-A. Specifically, movement of sleeve <NUM> in a proximal direction can permit a needle <NUM> to extend from distal region D of housing <NUM>.

Insertion of needle <NUM> can occur via several mechanisms. For example, needle <NUM> may be fixedly located relative to housing <NUM> and initially be located within an extended needle sleeve <NUM>. Proximal movement of sleeve <NUM> by placing a distal end of sleeve <NUM> against a patient's body and moving housing <NUM> in a distal 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 needle <NUM> is manually inserted via the patient's manual movement of housing <NUM> relative to sleeve <NUM>.

Another form of insertion is "automated", whereby 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 end of housing <NUM>. However, in other embodiments, button <NUM> could be located on a side of housing <NUM>.

Other manual or automated features can include drug injection or needle retraction, or both. Injection is the process by which a bung or piston <NUM> is moved from a proximal location within a 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, a drive spring (not shown) is under compression before device <NUM> is activated. A proximal end of the drive spring can be fixed within proximal region P of housing <NUM>, and a distal end of the drive spring 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 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, 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 sleeve <NUM> has moved past a distal end of needle <NUM>, and needle <NUM> is covered, sleeve <NUM> can be locked. Such locking can include locking any proximal movement of sleeve <NUM> relative to housing <NUM>.

Another form of needle retraction can occur if needle <NUM> is moved relative to housing <NUM>. Such movement can occur if the syringe <NUM> within housing <NUM> is moved in a proximal direction relative to housing <NUM>. This proximal movement can be achieved by using a retraction spring (not shown), located in distal region D. 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 needle <NUM> and housing <NUM> can be locked with a locking mechanism. In addition, button <NUM> or other components of device <NUM> can be locked as required.

<FIG> show an example injector device <NUM> comprising a housing <NUM>, a plunger <NUM> and a syringe <NUM> similar to the example of <FIG>. The injector device <NUM> also comprises a needle <NUM> through which medicament is dispensed when the plunger <NUM> is pushed into the syringe <NUM>. In this example, the injector device <NUM> includes a spring <NUM> arranged to push the plunger <NUM> into the syringe <NUM> to force medicament through the needle <NUM> during use of the injector device <NUM>.

As shown in <FIG>, a piston <NUM> is located in the syringe <NUM> and a plunger rod <NUM> acts on the piston <NUM> to push the piston <NUM> through the syringe <NUM> and thereby dispense medicament through the needle <NUM>. The plunger rod <NUM> and piston <NUM> may be separate components or a single component, and together they form the plunger <NUM>.

As illustrated, the plunger <NUM> has locking tabs <NUM> that engage with parts <NUM> of the housing <NUM> in the position shown in <FIG> to form a latch. In the latched position, shown in <FIG>, the spring <NUM> is compressed and urges the locking tabs <NUM> on the plunger <NUM> against the parts <NUM> of the housing <NUM> such that plunger <NUM> is held in position.

The latch may be released by disengaging the locking tabs <NUM> from the parts <NUM> of the housing <NUM>. The latch may be disengaged, for example, by rotating the plunger <NUM> relative to the housing <NUM>. In another example, the latch may be disengaged by retracting the parts <NUM> of the housing <NUM>. Rotation of the plunger <NUM> or retraction of the parts <NUM> may be actuated by moving a part of the injector device <NUM>, or by a button or latch, as previously described.

In one example, the latch is disengaged by rotating the plunger <NUM>, and the plunger <NUM> is caused to rotate by an actuator. The actuator extends from the housing <NUM> proximal to the needle <NUM> and is pushed against the skin of a user during use of the device <NUM>. When pushed against the skin the actuator is moved within the housing <NUM> and causes rotation of the plunger <NUM>.

As shown in <FIG>, the plunger <NUM> has an opening <NUM> at the proximal end into which the spring <NUM> extends. The housing <NUM> includes a spigot <NUM> that extends through the spring <NUM> and into the opening of the plunger <NUM> when in the position shown in <FIG>. The opening <NUM> and spigot <NUM> help to stabilise the position of the spring <NUM> and prevent the spring <NUM> from becoming misaligned within the injector device <NUM>, which may result in the spring <NUM> not being positioned correctly to push the plunger <NUM> into the syringe <NUM>.

<FIG> shows the injector device <NUM> after the latch has been released and the spring <NUM> has pushed the plunger <NUM> into the syringe <NUM> and forced medicament out of the needle <NUM>.

Accordingly, <FIG> shows the plunger <NUM> in a first position, otherwise called a pre-dose position. <FIG> shows the plunger <NUM> in a second position, otherwise called a post-dose position.

In another example, schematically illustrated in <FIG>, a collar <NUM> is provided that surrounds a proximal part of the plunger <NUM>. The collar <NUM> is shown in cross-section in <FIG>. The collar <NUM> is retained in position relative to the housing <NUM> by retaining member <NUM>, but the collar <NUM> is able to rotate about the longitudinal axis A-A. The collar <NUM> includes a slot <NUM> that holds the locking tabs <NUM> of the plunger <NUM> until the collar <NUM> is rotated into a release position, as described below.

As shown in <FIG>, the slot <NUM> is 'L-shaped', and there is one slot <NUM> for each locking tab <NUM>. In this way, rotation of the collar <NUM> moves the locking tab <NUM> from the retaining part <NUM> of the slot <NUM> to the release part <NUM> of the slot. In the release part <NUM> the plunger <NUM> can be pushed into the syringe by the spring <NUM>, as shown in <FIG>.

In an alternative embodiment, illustrated in <FIG>, the collar <NUM> includes engaging arms <NUM> that hold the plunger <NUM> in the initial position until the collar <NUM> is rotated. In this example, before rotation a locking portion <NUM> of the housing <NUM> may be arranged to hold the engaging arms <NUM> in a position that holds the plunger <NUM> in the spring-loaded position. The engaging arms <NUM> are held in engagement with the plunger <NUM> and in this position do not permit movement of the plunger <NUM>. Rotation of the collar <NUM> about the longitudinal axis A-A moves the engaging arms <NUM> to a position where they are free of the locking portion <NUM> and can be deflected by the force of the spring <NUM> to permit movement of the plunger <NUM> into the syringe, as shown in <FIG>. That is, rotation of the collar <NUM> moves the engaging arms <NUM> out of alignment with the locking portion <NUM> of the housing, allowing the engaging arms <NUM> to be deflected from the engaged position to release the plunger <NUM>. The force of the spring <NUM> can cause the engaging arms <NUM> to deflect.

In the examples of FIGS. 3A to 4C, the collar <NUM> may be rotated by an actuator. For example, the device <NUM> may include a button that is pushed to rotate the collar <NUM>, or a part of the housing <NUM> may be rotated to rotate the collar <NUM>. Alternatively, a needle sleeve may be moved in a proximal direction when the injector device <NUM> is pushed against the skin, and the needle sleeve may engage the collar <NUM> during this proximal movement and cause the collar <NUM> to rotate and release the plunger <NUM>. In these examples, the collar <NUM> may include an angled surface that can be pushed, for example by the needle sleeve, to cause the collar <NUM> to rotate.

<FIG> and <FIG> show parts of the injector device <NUM> described with reference to <FIG>, with the plunger <NUM>, a part of the housing <NUM>, and the spring <NUM> shown. As illustrated, this example of the injector device <NUM> also comprises an electronic system <NUM>, shown here in dotted lines.

<FIG> and <FIG> show the plunger <NUM> and the locking tabs <NUM> that engage with parts <NUM> of the housing <NUM> arranged to latch the plunger <NUM> in the pre-dose position, with the spring <NUM> under compression. In this example, the latch can be released by rotating the plunger <NUM> relative to the housing <NUM> until the locking tabs <NUM> pass over the parts <NUM> of the housing, allowing the plunger <NUM> to be pushed into the syringe (not shown) by the spring <NUM>.

In this example, the electronic system <NUM> has a switch <NUM>. The switch <NUM> is mounted within the housing <NUM> and engages with the plunger <NUM>. In particular, the switch <NUM> comprises an engaging member <NUM> that is urged towards the plunger <NUM> but can be deflected inwards to change the state of the switch <NUM>.

In this example, the electronic system <NUM> also includes an electronic circuit board <NUM>, on which the switch is mounted, as shown in <FIG>. The electronic circuit board <NUM> is mounted in the housing <NUM> and is held in place by mounting features <NUM> of the housing <NUM>, as illustrated in <FIG>. In various examples, the mounting features <NUM> may be a slot, or snap-fit flaps, or fasteners, for example screws or clips.

In various examples, as described hereinafter, the electronic system <NUM> may optionally include a power source, for example a battery, a controller, and other electronic components, such as resistors, capacitors and the like. The controller may comprise a processor and/or a memory.

Also shown in <FIG> and <FIG>, the plunger <NUM> comprises a recess <NUM> that is arranged to be detected by the switch <NUM> as the plunger <NUM> is pushed into the syringe <NUM>, as explained in more detail hereinafter.

<FIG> shows the plunger <NUM> of the injector device <NUM> described above. As shown, the plunger <NUM> has locking tabs <NUM> described with reference to <FIG>, <FIG>, <FIG>, <FIG> and <FIG>, and an elongate cylindrical body <NUM>. The elongate cylindrical body <NUM> is forced into the syringe (<NUM>, see <FIG>) by the spring (<NUM>, see <FIG>) during use. An end <NUM> of the elongate cylindrical body <NUM> is the piston, or the end <NUM> of the elongate cylindrical body <NUM> abuts a piston (<NUM>, see <FIG>) located within the syringe (<NUM>, see <FIG>). The elongate cylindrical body <NUM> has an outer surface <NUM> with which the engaging member (<NUM>, see <FIG>) of the switch (<NUM>, see <FIG>) engages.

As shown in <FIG>, the outer surface <NUM> of the plunger <NUM> has a recess <NUM>. The recess <NUM> is positioned such that it is aligned with the engaging member (<NUM>, see <FIG>) of the switch (<NUM>, see <FIG>) as the plunger <NUM> moves from the pre-dose position (see <FIG>) to the post-dose position (see <FIG>). Note that in this example the position of the recess <NUM> takes into account the rotation of the plunger <NUM> to release the locking tabs <NUM>. In other examples the plunger <NUM> is not rotated, and so the position of the recess <NUM> may vary accordingly.

In some embodiments the injector device <NUM> includes a window through which the syringe (<NUM>, see <FIG>) is visible, so that the user can see the plunger <NUM> move into the syringe and dispense medicament. In this case, the recess <NUM> may be disposed such that, after rotation of the plunger <NUM>, the recess <NUM> is not visible through the window.

Returning to <FIG> and <FIG>, the switch <NUM> has two positions - a non-deflected position where the engaging member <NUM> is aligned with the recess <NUM> on the plunger <NUM> (and therefore the switch <NUM> is detecting the recess <NUM>) and a deflected position where the engaging member <NUM> is deflected by the outer surface <NUM> of the plunger <NUM> (and is therefore not detecting the recess <NUM>).

<FIG> schematically illustrate the movement of the plunger <NUM> and the engagement of the switch <NUM>. Each of <FIG> shows the plunger <NUM>, the recess <NUM>, a part of the housing <NUM>, the spring <NUM> and the switch <NUM>. <FIG> do not show the latch mechanism, for example the locking tabs <NUM> described previously.

<FIG> shows the injector device <NUM> in the pre-dose position, with the spring <NUM> under compression between the plunger <NUM> and the housing <NUM>. In this position, the engaging member <NUM> of the switch <NUM> is aligned with the recess <NUM> on the plunger <NUM>. The switch <NUM> is therefore in a first state, with the engaging member <NUM> in a non-deflected position.

In this pre-dose position, the electronic system is in an off-state. That is, the non-deflected arrangement of switch <NUM> position means that no power is provided to the electronic system. The electronic system is in a deep-sleep state, and no power is being used. The injector device <NUM> is manufactured and distributed in this state.

<FIG> shows the injector device <NUM> at the beginning of the injection process, as the latch has been disengaged and the spring <NUM> has begun to push the plunger <NUM> into the syringe (<NUM>, see <FIG>).

As shown, the recess <NUM> on the plunger <NUM> has moved and the engaging member <NUM> of the switch <NUM> is no longer aligned with the recess <NUM>. The engaging member <NUM> of the switch <NUM> has been depressed by the outer surface <NUM> of the cylindrical body <NUM> of the plunger <NUM>, changing the state of the switch <NUM>. The switch <NUM> is therefore in a second state.

The electronic system is configured such that changing the state of the switch <NUM> activates the electronic system (turns on the power).

At this point, the electronic system may be configured to log the beginning of the injection process.

<FIG> shows the position of the plunger <NUM> after the injection process has been completed, that is, the post-dose position. In this position, the plunger <NUM> has reached its fully extended position and the medicament has been dispensed from the syringe <NUM>. In this position, the end <NUM> of the plunger rod <NUM> has moved past the switch <NUM> so the engaging member <NUM> returns to its non-deflected position.

In one example, this change of state of the switch <NUM> can deactivate the electronic system. Alternatively the electronic system may include an electronic latch, for example a flip-flop circuit or a pair of cross-coupled NOR gates. The electronic latch can maintain power to the electronic system after the switch <NUM> has returned to the non-deflected state.

At this point, the electronic system may be configured to log the end of the injection process.

<FIG> show an alternative example of an injector device <NUM>, and in this example the injector device <NUM> has a plunger <NUM>, recess <NUM>, housing <NUM>, and spring <NUM> that are similar to the examples of <FIG>, described above. However, in this example, there is a first switch <NUM> and a second switch <NUM>. <FIG> schematically illustrate movement of the plunger <NUM> from the pre-dose position (<FIG>) to the post-dose position (<FIG>).

<FIG> shows the injector device <NUM> in the pre-dose position, with the spring <NUM> under compression between the plunger <NUM> and the housing <NUM>. In this example, the recess <NUM> is in a different position to that described with reference to <FIG>.

In this position, the engaging member <NUM> of the first switch <NUM> is aligned with the recess <NUM> in the plunger <NUM>, such the that first switch <NUM> is in a non-deflected position. Meanwhile, the engaging member <NUM> of the second switch <NUM> is deflected by the outer surface <NUM> of the plunger <NUM>, such that the second switch <NUM> in a non-deflected position.

In the state illustrated in <FIG>, the electronic system is in an off-state. That is, this particular arrangement of the positions of the first and second switches <NUM>, <NUM> means that no power is provided to the electronic system. Therefore, the electronic system is in a deep-sleep state, and no power is being used. The injector device <NUM> is manufactured and distributed in this state.

<FIG> shows the injector device <NUM> at the beginning of the injection action, as the latch has been disengaged and the spring <NUM> has begun to push the plunger <NUM> into the syringe (not shown).

As shown, the recess <NUM> on the plunger <NUM> has moved and the engaging member <NUM> of the first switch <NUM> is no longer aligned with the recess <NUM> - it is now deflected by the outer surface <NUM> of the plunger <NUM>. The engaging member <NUM> of the second switch <NUM> is still deflected by the outer surface <NUM> of the plunger <NUM>, as in <FIG>.

The electronic system is configured such that changing the state of the first switch <NUM> activates the electronic system (turns on the power).

At this point, the electronic system may be configured to log the start of the injection process.

<FIG> shows the position of the plunger <NUM> after the injection process has been completed, that is, the post-dose position when the plunger <NUM> has reached its fully extended position and the medicament has been completely dispensed from the syringe (not shown). In this position, the end <NUM> of the plunger <NUM> has moved past both of the first switch <NUM> and the second switch <NUM> so the engaging members <NUM>, <NUM> of the first and second switches <NUM>, <NUM> are in non-deflected positions.

Between the position of <FIG> (beginning of the injection process) and the position of <FIG> (the post-dose position) the recess <NUM> has moved past the second switch <NUM>, which has therefore changed state from a deflected position, to a non-deflected position, and then back to a deflected position. The electronic system can be configured to ignore these particular changes of state of the second switch <NUM>.

In alternative examples, the second switch <NUM> and/or recess <NUM> can be arranged such that the point at which the second switch <NUM> detects the recess <NUM> (i.e. when the second switch <NUM> moves to a non-deflected position) is at a significant position of the plunger <NUM>, for example a minimum delivery position where a minimum dose of medicament has been delivered from the syringe (not shown).

Furthermore, between the position of <FIG> (beginning of the injection process) and the position of <FIG> (the post-dose position) the end <NUM> of the plunger <NUM> has moved past the first switch <NUM>, which has therefore moved into a non-deflected position. The electronic system can be configured to ignore this change in state of the first switch <NUM>.

In addition, the electronic system may be provided with an electronic latch (flip-flop) that maintains the power supply to the electronic system after the first switch <NUM> has returned to the non-deflected position as the end <NUM> of the plunger <NUM> passes the first switch <NUM>.

In alternative examples, the first switch <NUM> and/or the recess <NUM> can be arranged such that the point at which the first switch detects <NUM> the recess (i.e. when the first switch <NUM> moves to a non-deflected position) is at a significant position of the plunger <NUM>, for example a minimum delivery position where a minimum dose of medicament has been delivered from the syringe (not shown).

In other examples of the embodiments illustrated with reference to <FIG>, the switch(es) <NUM>, <NUM>, <NUM> may interact with another structural element of the plunger <NUM>, <NUM>, other than a recess <NUM>, <NUM>. For example, the plunger <NUM>, <NUM> may comprise a recess, protrusion, shoulder or other structural element that engages with the switch(es) <NUM>, <NUM>, <NUM>. In some examples, the plunger <NUM>, <NUM> dose not comprise any particular structural element, and the switch <NUM>, <NUM>, <NUM> detects the end <NUM>, <NUM> of the plunger <NUM>, <NUM>.

As mentioned previously, the electronic system may optionally include a power source, for example a battery, a controller, and other electronic components, such as resistors, capacitors and the like. The controller may comprise a processor and/or a memory.

As described above, by monitoring the positions of the switch(es) <NUM>, <NUM>, <NUM> it is possible to determine if the plunger <NUM>, <NUM> is the pre-dose state (illustrated in <FIG> and <FIG>), if the plunger <NUM>, <NUM> is at the beginning of the injection process (illustrated in <FIG> and <FIG>), and if the plunger <NUM>, <NUM> is in the post-dose state (illustrated in <FIG> and <FIG>). The controller of the electronic system monitors the states of the switches <NUM>, <NUM>, <NUM>. The controller may be adapted to log each of these positions, for example in the memory.

The switch(es) <NUM>, <NUM>, <NUM> and recesses <NUM>, <NUM> can be arranged such that the switch(es) <NUM>, <NUM>, <NUM> detect the plunger <NUM>, <NUM> at any location along the movement of the plunger <NUM>, <NUM> from the pre-dose position to the post-dose position.

Additionally or alternatively, the controller may be adapted to provide a signal to a display. For example, the injector device <NUM>, <NUM> may comprise one or more LED indicators or LCD displays that are adapted to display indications that the plunger <NUM>, <NUM> is in a certain position.

In one example, the injector device <NUM>, <NUM> comprises an LED indicator and the controller is configured to provide signals to the LED indicator such that the LED indicator is: switched off in the pre-dose position (illustrated in <FIG> and <FIG>); switched to red at the beginning of the injection process (illustrated in <FIG> and <FIG>); and switched to green in the post-dose position (illustrated in <FIG> and <FIG>).

In another example, the injector device <NUM>, <NUM> may comprise more than one LED indicator to provide such indication to the user. For example a first LED that is switched on at the beginning of the injection process (illustrated in <FIG> and <FIG>), and a second LED that switched on in the post-dose position (illustrated in <FIG> and <FIG>).

In another example, the injector device <NUM>, <NUM> may comprise an LCD display or other similar display, and the controller may be configured to provide signals to the LCD display such that the LCD display displays information about the position of the plunger <NUM>, <NUM>. For example, the LCD display may display text or symbols that indicate that the plunger <NUM>, <NUM> is: in a pre-dose position (illustrated in <FIG> and <FIG>); at the beginning of the injection process (illustrated in <FIG> and <FIG>); and/or in the post-dose position (illustrated in <FIG> and <FIG>).

In this way, the switches <NUM>, <NUM>, <NUM> and controller inform the user about the status of the injection process. In particular, the user can be informed that the injection process has begun and can be informed that the injection process is complete. This is information is based on the position of the plunger <NUM>, <NUM>, so is a reliably accurate indication of the injection process.

In further examples, the electronic system includes a communication device. The communication device may be configured to receive information from the controller and to communicate with a further device.

In one example, the communication device comprises a transmitter, for example a radio transmitter. In another example, the communication device comprises a Bluetooth device. In another example, the communication device comprises a near-field communication (NFC) chip or device.

The further device may for example be an auxiliary device for communicating with the injector device. In this example, the auxiliary device may connect with more than one injector device. In other examples, the further device may be a smartphone or other handheld electronic device. The auxiliary device or the handheld electronic device may have software, for example an application (app), for connecting with, and receiving information from, the injector device <NUM>, <NUM>.

In these examples, the further device may comprise a memory which stores information relating to use of the injection device <NUM>, <NUM>. For example, the further device may log that one injection process was completed on a particular date at a particular time, or it may log that one injection process was started but not completed. In this way, users and/or medical professionals and/or other interested parties can review use of the injector device(s), for example to ensure correct use. Additionally, the further device may be configured to generate a warning of incomplete or inadequate use of the injector device <NUM>, <NUM>.

Additionally or alternatively, the further device may be configured to send information relating to the use of the injection device <NUM>, <NUM> to a further device or a server, such that multiple parties can access the information. Statistical analysis may be conducted on this information, possibly over a large group-set, to analyse patterns of use of the injector devices <NUM>.

The communication device may include an antenna. The antenna may be located within the housing <NUM>, <NUM>, or it may be embedded within the housing <NUM>, <NUM>, or it may be disposed on an outer surface of the housing <NUM>, <NUM>. In another example, the antenna is embedded within a panel that comprises a part of the housing <NUM>, <NUM>. This is advantageous for low power transmitters or NFC, as there will be less material between the antenna and the exterior of the injector device <NUM>, <NUM>, allowing for better communication with the further device. The antenna may be connected to an external surface of the housing <NUM>, <NUM> and the antenna may be connected with internal electronics, for example the controller. The connection may be via connection pins or other conductive connection that extends from the antenna. In one preferred example, the antenna is incorporated into an adhesive label that is applied to the exterior of the housing <NUM>, <NUM> during assembly. The adhesive label may include connection pins that provide an electrical connection to electronic components within the housing <NUM>, <NUM>.

<FIG> show alternative examples of the plunger <NUM>, <NUM> that may replace the plunger <NUM>, <NUM> in the examples of <FIG> or in the examples of <FIG>.

In the example illustrated in <FIG>, the plunger <NUM> is longer than the example plunger <NUM> of <FIG>. Such a longer plunger <NUM> may be used if the dose of the syringe (<NUM>, see <FIG>) is less, and so the piston (<NUM>, see <FIG>) of the plunger <NUM> has a starting position further towards the needle (<NUM>, see <FIG>) than in the example shown in <FIG>. The longer plunger <NUM> may have a recess <NUM> arranged as per the recess <NUM> of the example of <FIG> or as per the recess <NUM> of the example of <FIG>.

In the example illustrated in <FIG>, the plunger <NUM> is provided a first recess <NUM> and a second recess <NUM>, each being aligned with the engaging member(s) <NUM>, <NUM>, <NUM> of the switch(es) <NUM>, <NUM>, <NUM> described with reference to <FIG>. The second recess <NUM> is provided proximate to the end <NUM> of the plunger <NUM>. The second recess <NUM> is therefore arranged to replace the function of the end <NUM> of the plunger <NUM> in the example of <FIG> and <FIG>, so that the switch(es) <NUM>, <NUM>, <NUM> detects the second recess <NUM> at the end of the injection process and not the end <NUM> of the plunger <NUM>.

In some embodiments the injector device <NUM>, <NUM> includes a window through which the syringe (<NUM>, see <FIG>) is visible, so that the user can see the plunger <NUM>, <NUM> move into the syringe and dispense medicament. In these embodiments, the recesses <NUM>, <NUM>, <NUM> are located such that they are not visible through the window. In particular, the recesses <NUM>, <NUM>, <NUM> are disposed on a part of the plunger <NUM>, <NUM> that does not extend into the syringe, so is not visible through the window. Alternatively, the recesses <NUM>, <NUM>, <NUM> may be disposed such that, after rotation of the plunger <NUM>, the recesses <NUM>, <NUM>, <NUM> are not visible through the window.

In other examples, the electronic system of the injector device <NUM>, <NUM> has a sensor that detects an operating parameter of the injector device <NUM>, <NUM>. For example, the electronic system may include a temperature sensor to detect a temperature of the injector device <NUM>, <NUM> and/or the medicament in the syringe <NUM>. This information may also be communicated to a further device by the communication device. This may be useful, for example, to check that the medicament is at an appropriate temperature before the injection process is started.

In some examples, as described with reference to <FIG>, the injector device <NUM>, <NUM> may include a needle sleeve <NUM> that is moved within the housing <NUM>, <NUM> during use of the device <NUM>, <NUM>. In one example, movement of the needle sleeve <NUM> may release the latch that holds the plunger <NUM>, <NUM> in the pre-dose position. For example, movement of the needle sleeve <NUM> may cause rotation of the plunger <NUM>, <NUM>, which may release a latch and allow the plunger <NUM>, <NUM> to move into the syringe <NUM>. In another example, movement of the needle sleeve <NUM> may directly cause the plunger <NUM>, <NUM> to be pushed into the syringe <NUM>.

In these examples, the electronic system of the injector device <NUM>, <NUM> may have a sensor that detects movement of the needle sleeve <NUM>. For example, the electronic system may include a sensor that detects when the needle sleeve <NUM> has moved into a position in which the latch is moved and the spring <NUM>, <NUM> is free to push to plunger <NUM>, <NUM> into the syringe <NUM>. In this way, the electronic system is able to determine that the device is being used.

<FIG> show a schematic diagram of another example of an injector device <NUM> having a housing <NUM>, a syringe <NUM>, a needle <NUM>, and an actuator <NUM>. In this example, the actuator <NUM> is a needle sleeve. The injector device <NUM> has a sensor <NUM> that may be provided in addition to, or instead of, the sensors (e.g. switches <NUM>, <NUM>, <NUM>) previously described.

<FIG> shows a pre-dose position, where the needle sleeve <NUM> is in an extended position. In this position the needle sleeve <NUM> surrounds and protects the needle <NUM>. In this position, a proximal end <NUM> of the needle sleeve <NUM> is spaced from a proximal end <NUM> of the housing <NUM>.

When the injector device <NUM> is used, the distal end <NUM> of the needle sleeve <NUM> is pushed against the skin of the user and the needle sleeve <NUM> is thereby pushed into the housing <NUM>. This causes the needle <NUM> to be revealed and thereby pierce the skin. In addition, as the needle sleeve <NUM> slides into the housing <NUM> the proximal end <NUM> of the needle sleeve <NUM> reaches the proximal end <NUM> of the housing <NUM>, as shown in <FIG>.

A sensor <NUM>, for example a switch, proximity sensor or optical sensor, is provided at either the proximal end <NUM> of the housing <NUM> (as shown) or at the proximal end <NUM> of the needle sleeve <NUM>. Therefore, the sensor <NUM> can detect when the needle sleeve <NUM> has been pushed into the housing <NUM>, and therefore that injection process has begun.

In addition, movement of the needle sleeve <NUM> into the housing may release a latch, as previously explained, which may trigger a spring-loaded injection system. In this example, the sensor <NUM> can detect that the needle sleeve <NUM> has reached the point at which the latch is released.

In a further example, a biasing member (not shown) urges the needle sleeve <NUM> towards the position shown in <FIG>, i.e. out of the housing <NUM>. In this way, after the injector device <NUM> has been removed from the skin the needle sleeve <NUM> will return to the position of <FIG>. This can be detected by the sensor <NUM> and so the sensor <NUM> can detect the end of the injection process.

As with the examples of <FIG> and <FIG>, the electronic system may include a controller and/or a communication device to process, store and or transmit information provided by the sensor <NUM>.

In other examples, the injector device comprises an alternative actuator, for example a button or lever, that starts the injection process. In these examples, a sensor may be arranged to detect a position of the actuator. The actuator may directly push the plunger into the syringe, or the actuator may release or unlatch a pre-loaded mechanism, for example to previously described spring mechanism. Preferably, the actuator directly causes the injection process to occur, e.g. releases a spring-loaded mechanism, so that the sensor provides reliable information relating to the injection process.

<FIG> shows a process diagram for the electronic system <NUM> for the injector devices <NUM>, <NUM>, <NUM>, <NUM> previously described. As shown, the electronic system <NUM> comprises a controller <NUM>. The controller optionally includes a processer <NUM> and a memory <NUM>. The controller <NUM> is configured to receive information <NUM> from a sensor <NUM>, for example switch(es) <NUM>, <NUM>, <NUM> or sensor <NUM>.

The sensor <NUM> is adapted to detect one or more parameter associated with operation of the injector device <NUM>, <NUM>, <NUM>, <NUM>. As explained in previous examples, that parameter may be the position of a plunger <NUM>, <NUM> within the injector device <NUM>, <NUM>, or the parameter may be the position of a needle sleeve <NUM>. Alternatively or additionally, a sensor may detect a temperature of the device or medicament.

The controller <NUM> is configured to process and/or store information received from the sensor <NUM>. The injector device <NUM>, <NUM>, <NUM>, <NUM> optionally also includes a feedback device that the controller <NUM> communicates with to provide feedback to the user. For example, the controller <NUM> may be configured to control a display <NUM>, for example one or more LEDs or an LCD display, to provide visual feedback to the user. Alternatively, the controller <NUM> may be configured to communicate the information using a communication device <NUM>. As described previously, the communication device <NUM> may communicate with a further device <NUM> that may provide feedback to the user.

In one example, the communication device <NUM> comprises a transmitter, for example a radio transmitter. In another example, the communication device <NUM> comprises a Bluetooth device. In another example, the communication device <NUM> comprises a near-field communication (NFC) chip or device. The communication device <NUM> may comprise the antenna previously described.

The further device <NUM> may for example be an auxiliary device for communicating with the injector device <NUM>, <NUM>. In this example, the auxiliary device may connect with more than one injector device <NUM>, <NUM>. In other examples, the further device <NUM> may be a smartphone or other handheld electronic device. The auxiliary device or the handheld electronic device may have software, for example an application (app), for connecting with, and receiving information from, the injector device <NUM>, <NUM>.

In these examples, the further device <NUM> may comprise a memory which stores information relating to use of the injection device <NUM>, <NUM>. For example, the further device <NUM> may log that one injection process was completed on a particular date at a particular time, or it may log that one injection process was started but not completed. In this way, users and/or medical professionals and/or other interested parties can review use of the injector device(s), for example to ensure correct use. Additionally, the further device may be configured to generate a warning of incomplete or inadequate use of the injector device <NUM>, <NUM>.

Additionally or alternatively, the further device <NUM> may be configured to send information relating to the use of the injection device <NUM>, <NUM> to a further device or a server, such that multiple parties can access the information. For example, the further device <NUM> may upload information to a server via a cloud connection. Statistical analysis may be conducted on this information, possibly over a large group-set, to analyse patterns of use of the injector devices <NUM>, <NUM> for individual users or groups or users.

Without limitation, a drug delivery device may be an injector device (e.g., syringe, pen injector, auto injector, large-volume device, pump, perfusion system, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), skin patch (e.g., osmotic, chemical, micro-needle), inhaler (e.g., nasal or pulmonary), implantable (e.g., coated stent, capsule), or feeding systems for the gastrointestinal tract. The presently described drugs may be particularly useful with injector devices that include a needle, e.g., a small gauge needle.

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-carboxyhepta¬decanoyl) 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.

Claim 1:
An injector device comprising:
a container and a plunger that is movable into the container to dispense medicament during operation of the injector device;
a biasing member arranged to push the plunger into the container during operation of the device;
a latch arranged to hold the plunger in an initial position where the biasing member is under compression prior to operation of the injector device, wherein the plunger is configured to be rotated to disengage the latch;
a switch arranged to interact with a structural element of the plunger to detect movement of the plunger during operation of the injector device, wherein the switch is arranged to be aligned with the structural element of the plunger after the plunger has been rotated; and
a needle sleeve slidably mounted in the injector device and arranged such that during use the needle sleeve slides into engagement with the plunger to cause the plunger to rotate and disengage the latch.