Patent Description:
A variety of diseases exists that require regular treatment by injection of a medicament. Such injection can be performed by using injection devices, which are applied either by medical personnel or by patients themselves.

Injection devices (i.e. devices capable of delivering medicaments from a medication container) typically fall into two categories - manual devices and auto-injectors. Injection devices can also either be disposable, whereby the device is intended to be discarded after typically one injection operation, or re-usable, whereby the device is intended to be used for multiple injection operations.

In a manual device - the user must provide the mechanical energy to drive the fluid through the needle. This is typically done by some form of button / plunger that has to be continuously pressed by the user during the injection. There are numerous disadvantages for the user from this approach. If the user stops pressing the button / plunger, then the injection will also stop. This means that the user can deliver an underdose if the device is not used properly (i.e. the plunger is not fully pressed to its end position). Injection forces may be too high for the user, in particular if the patient is elderly or has dexterity problems.

The extension of the button/plunger may be too great. Thus it can be inconvenient for the user to reach a fully extended button. The combination of injection force and button extension can cause trembling / shaking of the hand which in turn increases discomfort as the inserted needle moves.

Auto-injector devices aim to make self-administration of injected therapies easier for patients. Current therapies delivered by means of self-administered injections include drugs for diabetes (both insulin and newer GLP-<NUM> class drugs), migraine, allergies, hormone therapies, anticoagulants etc. Auto-injector devices can be used to deliver a single dose of a particular life-saving drug. For example they are often prescribed to people who are at risk for anaphylaxis. They are also often used in the military to protect personnel from chemical warfare agents. Alternatively, auto-injectors are used to administer medicaments according to a prescribed therapeutic schedule for people suffering from Multiple Sclerosis, Rheumatroid Arthritis, Anemia, e.g..

Auto-injectors are devices which completely or partially replace activities involved in parenteral drug delivery from standard syringes. These activities may include removal of a protective syringe cap, insertion of a needle into a patient's skin, injection of the medicament, removal of the needle, shielding of the needle and preventing reuse of the device. This overcomes many of the disadvantages of manual devices. Forces required of the user / button extension, hand-shaking and the likelihood of delivering an incomplete dose are reduced. Triggering may be performed by numerous means, for example a trigger button or the action of the needle reaching its injection depth. In some devices the energy to deliver the fluid is provided by a spring.

Auto-injectors may be disposable or single use devices which may only be used to deliver one dose of medicament and which have to be disposed of after use. Other types of auto-injectors may be reusable. Usually they are arranged to allow a user to load and unload a standard syringe. The reusable auto-injector may be used to perform multiple parenteral drug deliveries, whereas the syringe is disposed after having been spent and unloaded from the auto-injector. The syringe may be packaged with additional parts to provide additional functionality.

In a typical scenario a disease can be treated by patients themselves by injection of medicament doses using an auto-injector , for example on a daily, weekly, bi-weekly, or monthly basis.

The correct administration of drugs and its termination is important for the safety and efficacy of the drug (pharmacovigilance). Failures in administration through the user can be minimized by monitoring of the injection device and the application time. Typical patient failures are:.

The disclosure describes a re-usable add-on device suitable for use with one shot auto-injectors and which may record the injection history, monitor the dose administration and aid the patient in performing the injection correctly and on time. <CIT> relates to a device for attachment to an injection device.

According to a first aspect of the disclosure, there is provided system comprising a supplementary device configured to be releasably attached to a drug delivery device, the supplementary device comprising: a first non-contact sensor configured to output signals indicative of the position of a first moveable component within the drug delivery device; and a processor configured to: receive the signals output from the first non-contact sensor; determine based on the signals the moment at which the drug delivery device changes from a pre-ejection state to a post-ejection state; in response to determining that the drug delivery device has changed from the pre-ejection state to the post ejection state, cause a display of the supplementary device to visually indicate that a user should hold the drug delivery device in its current position for a predetermined period of time.

In some embodiments, the first non-contact sensor is a Hall effect sensor and the supplementary device further comprises a permanent magnet. In some embodiments, the Hall effect sensor is configured to output signals indicative of the position of the permanent magnet.

In some embodiments, the first non-contact sensor is a Hall effect sensor or an anisotropic magnetoresistive sensor. The first moveable component may comprise a ferromagnetic material, such as a ferrous material or a permanent magnet and the Hall effect sensor or anisotropic magnetoresistive sensor is configured to output signals indicative of the position of the ferromagnetic material. In some embodiments, the first moveable component comprises a permanent magnet and the Hall effect sensor or anisotropic magnetoresistive sensor is configured to output signals indicative of the position of the permanent magnet.

In some embodiments, the processor is configured to determine, based on the signals from the first non-contact sensor, whether the drug delivery device is in a pre-ejection state or a post-ejection state.

In some embodiments the signals from the first non-contact sensor are generated by changes in a magnetic field passing through the Hall effect sensor.

In some embodiments, the first non-contact sensor is an inductive sensor or a piezoelectric sensor.

In some embodiments, the first non-contact sensor is configured to detect movement of a needle shield from a needle of the drug delivery device.

In some embodiments, the supplementary device further comprises a second non-contact sensor configured to output signals indicative of the position of a second moveable component within the drug delivery device.

In some embodiments, the second non-contact sensor is a Hall effect sensor. In some embodiments, the Hall effect sensor is configured to output signals indicative of the position of the permanent magnet of the second component.

In some embodiments, the second non-contact sensor is an anisotropic magnetoresistive sensor.

In some embodiments, the processor is configured to respond to determining that a time of scheduled injection is due by changing the appearance of the supplementary device in order to become more noticeable.

In some embodiments, the processor is configured to respond to receive a user input by activating the display.

In some embodiments, when the drug delivery device is in the pre-ejection state, the user input causes the display to visually indicate that the user should remove a needle cap, insert a needle of the drug delivery device into the user and begin medicament injection.

In some embodiments, the drug delivery device is configured to respond to detection of activation of an ejection process by causing the display to visually indicate an injection is in progress.

In some embodiments, the processor is configured to determine, based on the signals from the second non-contact sensor, whether the drug delivery device is in a pre-activation state or a post-activation state.

In some embodiments, the supplementary device further comprises a locking sensor configured to output signals indicative of whether the supplementary device is secured to the drug delivery device or not.

In some embodiments, the supplementary device further comprises a wireless unit configured to transmit data to one or more external devices.

In some embodiments, the supplementary device further comprises a light emitting user input configured to change appearance.

In some embodiments, the supplementary device is configured to determine a time at which the user's next medicament dose is due.

In some embodiments, the supplementary device further comprises a light emitting user input configured to change appearance at the time at which the user's next medicament dose is due.

In some embodiments, the supplementary device further comprises an audio module and wherein the visual indication that a user should hold the drug delivery device in its current position for a predetermined period of time is accompanied by an audible indication from the audio module.

In some embodiments, the indication that the user should hold the drug delivery device in its current position for a predetermined period of time comprises a countdown timer.

In some embodiments, the supplementary device further comprises at least one memory and wherein the processor is configured to cause information relating to a last performed ejection process to be stored in the memory upon determining that the drug delivery device has changed from a pre-ejection state to a post-ejection state, wherein the information comprises at least a time stamp associated with the last performed ejection process.

In some embodiments, the processor is further configured to produce a reminder signal when the time of the user's next medicament dose occurs.

In some embodiments, the processor has access to or is configured to calculate a medical regimen associated with a user of the supplementary device, the medical regimen comprising at least a series of times at which an a medicament dose is due and wherein the processor is configured to cause a reminder signal to be produced when a next medicament dose is due according to the medical regimen.

In some embodiments, the supplementary device is further configured to send the reminder signal to one or more external devices.

In some embodiments, the supplementary device further comprises an optical sensor configured to read information visible on a housing of the injection device, the information identifying a medicament contained in the drug delivery device.

In some embodiments, the drug delivery device is a powered auto-injector.

According to a second aspect of the disclosure and not according to the claimed invention, there is provided a method of operating a supplementary device configured to be releasably attached to a drug delivery device, the method comprising: using a first non-contact sensor to output signals indicative of the position of a first moveable component within the drug delivery device; receiving the signals output from the first non-contact sensor at a processor; the processor determining based on the signals the moment at which the drug delivery device changes from a pre-ejection state to a post-ejection state; and in response to determining that the drug delivery device has changed from the pre-ejection state to the post ejection state, causing a display of the supplementary device to visually indicate that a user should hold the drug delivery device in its current position for a predetermined period of time.

The system comprises the supplementary device and the drug delivery device.

The first moveable component is a resilient member arranged to change between a first configuration and a second configuration.

According to the invention, the drug delivery device comprises a flexible arm configured to retain the first moveable component in the first configuration when it is in a first position and wherein the flexible arm is retained in the first position by contact with a part of a plunger of the drug delivery device in the pre-ejection state. In some embodiments, the first moveable component is a part of a plunger of the drug delivery device.

In some embodiments, the drug delivery device comprises a cartridge or syringe containing a medicament.

According to a further aspect and not according to the claimed invention, there is provided a method of operating the system according to the third aspect, the method comprising: removing a needle shield from the drug delivery device, inserting a needle of the drug delivery device into the user, operating a trigger of the medicament delivery device so as to move a piston and dispense a medicament.

In the following, embodiments of the present disclosure will be described with reference to auto-injectors. The present invention is however not limited to such application and may equally well be deployed with injection devices that eject other medicaments, or with other types of drug delivery devices, such as syringes, pre-filled syringes, needleless injectors and inhalers.

An injection device <NUM> (also referred to herein as a drug delivery device <NUM>) according to embodiments will now be described with reference to <FIG>. In some embodiments, the injection device <NUM> is a single use auto-injector <NUM>. The auto-injector <NUM> has a proximal end P and a distal end D. The proximal end P is directed towards the injection site of a patient during an injection while the distal end D is directed away from the injection site.

The auto-injector <NUM> comprises a body <NUM> and a cap <NUM> (also referred to herein as the outer needle cap or ONC <NUM>). The body <NUM> comprises an outer housing <NUM>. The outer housing <NUM> is an elongate tube. The outer housing <NUM> may also include a cartridge holder or syringe holder (not shown) which supports a cartridge or syringe <NUM> containing liquid medicament <NUM>.

The outer housing <NUM> also houses a dispense mechanism (not shown) for causing dispensing of the medicament <NUM> during injection. The dispense mechanism may comprise a drive mechanism.

A hollow needle <NUM> communicates with an interior volume of the syringe <NUM> and serves as a conduit for liquid medicament <NUM> during injection. The needle <NUM> and the syringe <NUM> are in a fixed position relative to each other and to the body <NUM>. A stopper, plunger, piston or bung <NUM> is moveable within the syringe <NUM> to as to expel medicament contained within the syringe <NUM> through the needle <NUM> under action of the dispense mechanism.

The dispense mechanism is mechanically coupled to the piston <NUM> of syringe <NUM>. The dispense mechanism is configured to move the piston axially along the syringe <NUM> in a proximal direction to dispense medicament <NUM> through the needle <NUM>. The dispense mechanism includes components that cooperate to apply a force to the piston <NUM> in response to an actuation input provided by a user. For example, the piston <NUM> may be spring-loaded. Here, the actuation input that triggers application of a force to the piston <NUM> is received by way of a dose dispense button <NUM> that is located at the distal end of the auto-injector <NUM>. The dispense mechanism is mechanically coupled to the dispense button <NUM>.

The body <NUM> also comprises a cap support <NUM> at the proximal end of the outer housing <NUM>. The cap support is concentric with the outer housing <NUM> and may have a smaller diameter. The cap support <NUM> extends from the proximal end of the housing <NUM>. The ONC <NUM> is received over the cap support <NUM> to close the proximal end of the body <NUM> and to cover the needle <NUM>. The ONC <NUM> comprises a cylindrical wall <NUM> and an end wall <NUM>. With the ONC <NUM> located on the body <NUM>, as shown in <FIG>, an internal surface of the cylindrical wall <NUM> abuts an external surface of the cap support <NUM> in tightly abutting relation so that the ONC <NUM> is retained thereon in an attached position.

To inject the medicament <NUM>, the ONC <NUM> is removed from the device <NUM> by the user, resulting in the arrangement shown in <FIG>. Next, the proximal end of the auto-injector <NUM> is placed against an injection site of a patient, which may be the user or another person. The user then actuates the dispense button <NUM>. This causes the dispense mechanism to force the piston <NUM> to expel medicament from the syringe <NUM> through the needle <NUM> into the injection site of the patient.

<FIG> show another type of auto-injector which can be used in some other embodiments of the disclosure. The auto-injector <NUM> has many of the same components as in the auto-injector of <FIG>, and these will not be described again. The dispense mechanism of this auto-injector is different. Here, the actuation input that triggers application of a force to the piston <NUM> is received by way of a sleeve <NUM> which is configured to trigger operation of the auto-injector. The dispense mechanism is mechanically coupled to the sleeve <NUM>. The sleeve is concentric with the outer housing <NUM> and has a smaller diameter. The sleeve <NUM> extends from the proximal end of the housing <NUM> and beyond the point of the needle <NUM> before the auto-injector is activated. The ONC <NUM> is received over the sleeve <NUM> to close the proximal end of the body <NUM>. The auto-injector has no dispense button.

To inject the medicament <NUM>, the ONC <NUM> is removed from the device <NUM> by the user, resulting in the arrangement shown in <FIG>. Next, the proximal end of the sleeve <NUM> is placed against an injection site of a patient, which may be the user or another person. The user then presses the auto-injector down with force. This causes the sleeve <NUM> to move distally into the auto-injector and to trigger the dispense mechanism. The dispense mechanism forces the piston <NUM> to expel medicament from the syringe <NUM> through the needle <NUM> into the injection site of the patient.

After a user injects a quantity of medicament into their skin, it is advantageous for the needle to be left in position for a short time (e.g. <NUM>-<NUM> seconds). This allows the medicament to be diffused away from the injection site by action of the user's blood flow. This is often referred to as "dwell time". If the needle is removed too soon after an injection, it can result in medicament being expressed from the injection site and the user therefore not receiving a full dose.

The syringe <NUM> is transparent and a window <NUM> is provided in the housing <NUM> coincident with the syringe <NUM> so that the medicament <NUM> contained within the syringe <NUM> is visible. A user of the auto-injector this is able by inspection to determine whether the entire quantity of medicament <NUM> has been ejected from the syringe <NUM> during the injection.

A label is provided on the housing <NUM>. The label includes information <NUM> about the medicament included within the injection device <NUM>, including information identifying the medicament. The information <NUM> identifying the medicament may be in the form of text. The information <NUM> identifying the medicament may also be in the form of a colour. The information <NUM> identifying the medicament may also be encoded into a barcode, QR code or the like. The information <NUM> identifying the medicament may also be in the form of a black and white pattern, a colour pattern or shading.

<FIG> is a schematic illustration of an embodiment of a supplementary device <NUM> releasably attached to injection device <NUM> of <FIG>. The supplementary device <NUM> is suitable for use with both the auto-injector shown in <FIG> and in <FIG>. Supplementary device <NUM> comprises a housing <NUM> configured to embrace the housing <NUM> of injection device <NUM> of <FIG>, so that the injection device <NUM> is at least partially retained within the supplementary device <NUM>, but is nevertheless removable from the supplementary device <NUM>, for instance when injection device <NUM> is empty and has to be replaced. The injection device <NUM> and supplementary device <NUM> may optionally comprise co-operating alignment features to ensure that the supplementary device <NUM> is correctly orientated and positioned with respect to the injection device <NUM>.

The supplementary device <NUM> has an attachment mechanism <NUM> for securing and un-securing the supplementary device <NUM> with the injection device <NUM>. The attachment mechanism <NUM> may be rotatable relative to the main body <NUM> of the supplementary device <NUM> between a locked and an unlocked position. <FIG> shows the attachment mechanism <NUM> in a locked position. <FIG> shows the attachment mechanism <NUM> in an unlocked position.

Information is displayed via display unit <NUM> of supplementary device <NUM>. The display unit <NUM> may be a colour LCD screen. The display unit may be a touch sensitive screen. For example, the display unit <NUM> may indicate the time and date of the next scheduled injection for the user of the supplementary device <NUM>. During operation of the injection device <NUM>, the supplementary device <NUM> may also display information to assist the user, as will be described in greater detail below.

The supplementary device <NUM> may also comprise at least one user input <NUM> such as a touch sensitive button. The user input <NUM> may comprise one or more LEDs. These may form a ring around the button and/or illuminate the whole of the button. The user input <NUM> may allow a user to turn on/off supplementary device <NUM>, to trigger actions (for instance to cause establishment of a connection to or a pairing with another device, and/or to trigger transmission of information from supplementary device <NUM> to another device), or to confirm something.

<FIG> illustrates some of the major internal and external components of the supplementary device <NUM> in a state where it is attached to injection device <NUM> shown in <FIG>. Externally, the supplementary device <NUM> comprises the display unit <NUM>, the user input <NUM>, attachment mechanism <NUM> and a battery compartment <NUM>.

Internally, the supplementary device <NUM> comprises electronics <NUM>. The electronics <NUM> comprise at least a processor <NUM> and memory. The electronics <NUM> may comprise both a program memory and a main memory. The processor <NUM> may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. The processor <NUM> executes program code (e.g. software or firmware) stored in the program memory, and uses a main memory, for instance to store intermediate results. The main memory may also be used to store a logbook on performed ejections/injections. The program memory may for instance be a Read-Only Memory (ROM), and the main memory may for instance be a Random Access Memory (RAM).

The supplementary device <NUM> also comprises a wireless unit <NUM>, which is configured to transmit and/or receive information to/from another device in a wireless fashion. Such transmission may for instance be based on radio transmission or optical transmission. In some embodiments, the wireless unit <NUM> is a Bluetooth transceiver. Alternatively, wireless unit <NUM> may be substituted or complemented by a wired unit configured to transmit and/or receive information to/from another device in a wire-bound fashion, for instance via a cable or fibre connection. When data is transmitted, the units of the data (values) transferred may be explicitly or implicitly defined. For instance, in case of an insulin dose, always International Units (IU) may be used, or otherwise, the used unit may be transferred explicitly, for instance in coded form. The transmitted data also includes a time stamp associated with an injection.

The supplementary device <NUM> also comprises an audio module <NUM> configured to provide audio feedback to a user of the supplementary device <NUM>. Both the wireless unit <NUM> and audio module <NUM> may be coupled to and controlled by the electronics <NUM>. The supplementary device <NUM> may optionally comprise a locking sensor <NUM> configured to sense whether the attachment mechanism is in the locked position or the unlocked position.

The supplementary device <NUM> may also comprise an optical sensor <NUM> for reading the information <NUM> identifying the medicament. The information <NUM> identifying the medicament may be the colour of the housing <NUM> of the injection device, or the colour of an area of the housing or a label affixed to the housing. In these embodiments, the optical sensor <NUM> may be a simple photometer configured to detect the colour. In some other embodiments, the information <NUM> identifying the medicament may be a QR code, or other similar encoded information and the optical sensor <NUM> may be a camera or QR code reader. Further, one or more light sources may be provided to improve reading of optical sensor <NUM>. The light source may provide light of a certain wavelength or spectrum to improve colour detection by optical sensor <NUM>. The light source may be arranged in such a way that unwanted reflections, for example due to the curvature of the housing <NUM>, are avoided or reduced. In an example embodiment, the optical sensor <NUM> is a camera unit configured to detect a code <NUM> (for instance a bar code, which may for instance be a one- or two-dimensional bar code) related to the injection device and/or the medicament contained therein. This code <NUM> may for instance be located on the housing <NUM> or on a medicament container contained in injection device <NUM>, to name but a few examples. This code <NUM> may for instance indicate a type of the injection device and/or the medicament, and/or further properties (for instance an expiration date). This code <NUM> may be a QR code <NUM>. The QR code is in general black and white and thus no colour detection is required on the part of the optical sensor <NUM>. This allows the optical sensor <NUM> to be simple and cheap to manufacture.

The processor <NUM> may be configured to check the information <NUM> read by the optical sensor <NUM> against pre-stored information in order to verify that the user is injecting the correct medicament. If the processor 25does not recognise the information <NUM> or recognises the information <NUM> as indicating a different medicament to that which the user should be receiving at that time, then the supplementary device <NUM> may produce an alarm signal. The alarm signal may comprise words or graphics displayed on the display unit <NUM> or sound produced by the audio module <NUM>. Alternatively, or in addition, the supplementary device <NUM> may send an alarm signal to an external device via wireless unit <NUM>.

The supplementary device <NUM> comprises an injection device status sensor <NUM> (also referred to herein as a non-contact sensor or first non-contact sensor). The status sensor <NUM> may take a number of forms, described in greater detail with respect to <FIG> below. The status sensor <NUM> is configured to output signals indicative of the positions of one or more components within the injection device <NUM>. The status sensor <NUM> may be referred to as a non-contact sensor, since it is able to sense the absolute position and/or movement of components within the attached injection device <NUM> without contact between the sensor <NUM> and any of the components sensed. The electronics <NUM> receive these signals and infer an operational state of the injection device <NUM> and cause information regarding the timing of the operation of the injection device <NUM> to be recorded in the main memory and/or transmitted to an external device via the wireless unit <NUM>. The exact position of the first non-contact sensor <NUM> within the supplementary device <NUM> depends upon the position and movement range of the moveable component of the injection device being measured. In the embodiments described with reference to <FIG> below, the moveable component is close to the cylindrical part of the housing <NUM> of the injection device <NUM> and separated from the distal end, e.g. approximately one quarter of the length of the injection device form the distal end. Therefore, the first non-contact sensor <NUM> is positioned adjacent the cylindrical part of the housing <NUM>, towards the proximal end of the supplementary device <NUM>. In some embodiments, the first non-contact sensor is configured to detect movement of the needle cover.

The supplementary device <NUM> may optionally comprise a second non-contact status sensor <NUM>. The second non-contact status sensor <NUM> may take a number of forms, as described in greater detail with respect to <FIG> below. The second non-contact status sensor <NUM> may be arranged within the supplementary device <NUM> so as to be adjacent the proximal end face of the attached injection device <NUM>. The second non-contact status sensor <NUM> may be configured to output signals which represent the absolute position of a second moveable component within the injection device <NUM> which is also located near to the proximal end face of the injection device <NUM>.

<FIG> and <FIG> show an example of how the status sensor <NUM> detects a change in the status of the injection device according to some embodiments of the disclosure.

<FIG> shows diagrammatically a cut-away through the injection device <NUM> of <FIG> when the injection device is in a pre-ejection configuration and a post ejection configuration (also referred to as pre-activation and post-activation). <FIG> and <FIG> omit the outer housing <NUM> and some other components of the injection device <NUM> for clarity. The injection device <NUM> comprises a drive spring (not shown), which is pre-compressed during assembly of the injection device <NUM>. The drive spring is maintained in this pre-compressed state until an injection is started. When a user triggers an injection operation by activating the needle sleeve <NUM> or by pressing dose dispense button <NUM>, the dispense mechanism is released and the drive spring decompresses so as to dispense medicament from the syringe <NUM>.

The injection device <NUM> comprises a resilient member <NUM> (also referred to herein as a moveable component <NUM>). The resilient member <NUM> is designed to change between a first configuration and a second configuration and is biased towards the second configuration (i.e. the resilient member <NUM> will be in the second configuration if no external forces act on it). In the embodiments illustrated by <FIG> and <FIG>, the resilient member <NUM> is a resilient sheet metal member in an elongate shape. The resilient member <NUM> has a groove running along the centre of its long axis which allows the resilient member <NUM> to bend along the long axis.

<FIG> show an example of the resilient member <NUM>. In <FIG>, the resilient member <NUM> is in the first configuration, while in <FIG>, the resilient member <NUM> is in the second configuration. The resilient member <NUM> may have one or more tabs on its outer edge to hold it in place within the injection device <NUM>. The first configuration has a bent or "U" shape, such that the two ends of the resilient member <NUM> are bent up while the centre is bent downwards. In the second configuration, the resilient member <NUM> is substantially flat. In both configurations, the resilient member <NUM> may be bent lengthways along the central groove.

Referring again to <FIG>, the resilient member <NUM> is retained in the first configuration by a flexible arm <NUM>. The flexible arm <NUM> abuts the outer surface of the plunger <NUM> of the injection device <NUM> when the injection device <NUM> is in a pre-ejection state and during an ejection process. The flexible arm <NUM> may be part of an inner housing <NUM> of the injection device <NUM>, or may be attached to the inner housing <NUM>. Referring to <FIG>, the plunger <NUM> advances during an ejection process to expel the medicament contained in the syringe <NUM>. At the end of the ejection process, the plunger <NUM> advances beyond the flexible arm <NUM>. The flexible arm <NUM> is biased towards the plunger <NUM> and so moves towards the centre of the injection device <NUM> once it no longer abuts against the plunger <NUM>. This releases the force on the resilient member <NUM>, which changes to the second configuration.

The status sensor <NUM> of the supplementary device <NUM> is shown schematically. All other components of the supplementary device <NUM> are omitted for clarity. In the embodiments of <FIG> and <FIG>, the status sensor <NUM> is a Hall sensor <NUM>. The supplementary device <NUM> also comprises a permanent magnet part <NUM> located near the Hall sensor <NUM>. With the arrangement shown, the voltage output of the Hall sensor <NUM> is dependent on the configuration of the resilient member <NUM>. When the resilient member <NUM> is in the second configuration (<FIG>), the resilient member <NUM> is closer to the permanent magnet <NUM>. As the resilient member <NUM> is at least partially made of a ferrous metal (i.e. a ferromagnetic material) or a material that comprises ferrite (i.e. a ferrimagnetic material), this changes the magnetic flux density at the Hall sensor <NUM>. There is therefore a change in the output voltage of the Hall sensor <NUM> at the moment when the resilient member <NUM> changes from the first to the second configuration. The electronics <NUM> receive the signals output from the sensor <NUM> and determine the time at which the change took place, i.e. the time at which the ejection process was completed. This information is recorded in the memory of the supplementary device <NUM> and may also be transmitted to an external device by the wireless unit <NUM>.

Referring to <FIG>, an alternative example of the status sensor <NUM> according to some other embodiments of the disclosure is shown. The structure and operation of the injection device <NUM> of <FIG> and the resilient member <NUM> are the same as described above and will not be described in detail again here. In this example, the sensor is an inductive sensor <NUM> (also referred to as an Eddy current sensor <NUM>). The Eddy current sensor <NUM> comprises a detection circuit and a coil <NUM> coupled to the detection circuit. When the resilient member <NUM> changes from the first configuration to the second configuration, it induces a current in the coil <NUM> which is detected by the circuit. The resilient member <NUM> may be made of a ferrite material, such as a ferritic stainless steel, such that its movement induces a current in the coil <NUM>. Again, the electronics <NUM> receive the signals output from the sensor <NUM> and determine the time at which the resilient member <NUM> changed configuration.

<FIG> show a third example of the status sensor <NUM> according to some further embodiments of the disclosure. The structure and operation of the injection device <NUM> of <FIG> and the resilient member <NUM> are the same as described above and will not be described in detail again here. In this example, the sensor is a Piezoelectric sensor <NUM>. The piezoelectric sensor <NUM> comprises a detection circuit and a piezoelectric part <NUM>, placed close to or against the housing of the supplementary device <NUM>. In these embodiments, the resilient member <NUM> is designed to make a sound, such as a sharp click, when it changes configuration. This sound produces vibrations in the piezoelectric part <NUM>, which produces a current as a result. This current is detected by the detection circuit. Again, the electronics <NUM> receive the signals output from the sensor <NUM> and determine the time at which the resilient member <NUM> changed configuration.

<FIG> and <FIG> illustrate components of an injection device <NUM> which allow the second non-contact status sensor <NUM> to determine the status of the injection device <NUM>. <FIG> shows an exemplary second moveable component <NUM>. The second moveable component <NUM> has a partial disc shape with a central bore <NUM> for rotatably mounting the component <NUM> within the injection device <NUM>. The second moveable component <NUM> also has a protrusion <NUM>, extending perpendicularly from the plane of the partial disc part. The protrusion is configured to abut or otherwise engage with the plunger <NUM> of the injection device <NUM>. The partial disc part of moveable component <NUM> further comprises an aperture or indentation 203a. The moveable component <NUM> is configured to rotate about an axis of rotation which runs through the bore <NUM> of the component <NUM>. As the moveable component is rotated during use, the aperture 203a moves within close proximity to (e.g. directly underneath) the sensor <NUM> (not shown). As the aperture 203a moves past the status sensor <NUM>, a signal is generated. In some alternative embodiments, a permanent magnet or ferritic material may replace the aperture 203a. In such embodiments, as the permanent magnet or ferritic material moves past the status sensor <NUM>, a signal is generated.

<FIG> shows components of both the injection device <NUM> and supplementary device <NUM> in situ. The housings of both the injection device <NUM> and supplementary device <NUM> have been omitted for clarity. The plunger <NUM> has one or more wings <NUM> which extend radially away from the plunger axis at the proximal end of the plunger. The housing <NUM> of the injection device <NUM> has a protrusion which acts as an axis which the second moveable component <NUM> is rotatably mounted on. The plunger <NUM> is also rotatable relative to the housing <NUM> of the injection device <NUM> and may also be mounted on this protrusion. During user activation of the ejection process, the plunger <NUM> is rotated. The abutment between the plunger wing <NUM> and second moveable component protrusion <NUM> causes the second moveable component <NUM> to rotate. Thus, the wings <NUM> can be said to "guide" the rotation of the second moveable component <NUM> because they engage with the protrusion <NUM> of the second moveable component <NUM> and cause rotation of the second moveable component <NUM>. As the second moveable component <NUM> rotates, activation of the sensor <NUM> occurs as described in the following. The supplementary device <NUM> comprises the second non-contact status sensor <NUM>, which in these embodiments is a Hall Sensor <NUM>, and a permanent magnet <NUM>. The dashed line in <FIG> represents the axis of magnetic flux which the second non-contact status sensor <NUM> is sensitive to. As the second moveable component <NUM> rotates, the magnetic flux detected by the second non-contact status sensor <NUM> changes. Once the plunger <NUM> has completed its rotation, the ejection process begins. At this point, the aperture 203a of the second moveable component <NUM> is underneath the sensor <NUM> and the voltage output of the Hall sensor <NUM> is changed. Thus the signals output by the Hall sensor <NUM> allows the processor <NUM> to determine whether the injection device <NUM> is in a pre-activation or a post-activation state. The Hall sensor may alternatively be replaced by an anisotropic magnetoresistive (AMR) sensor which is also able to detect the rotational angle of the second moveable component <NUM>.

The processor <NUM> is configured to control the display <NUM> and the user input <NUM> of the supplementary device <NUM> to guide a user through the injection device insertion, the injection process and injection device replacement and to provide reminders as to when the scheduled time for the next injection is due. The processor <NUM> also causes a dosing history to be stored in the memory of the supplementary device <NUM> and optionally transmitted via the wireless unit <NUM>.

<FIG> illustrates some of the major internal and external components of the supplementary device <NUM> according to some other embodiments of the disclosure. The supplementary device <NUM> of these embodiments is suitable for use with the sleeve activated injection device <NUM> shown in <FIG>.

The supplementary device <NUM> shown in <FIG> contains many of the same components as described with reference to <FIG>. These components serve the same function and are not described in detail again. The first non-contact status sensor <NUM> of <FIG> may be a Hall sensor, an inductive sensor or an AMR sensor. The first non-contact status sensor <NUM> may also comprise a permanent magnet or an electromagnet. The second non-contact status sensor <NUM> of <FIG> may be a Hall sensor, an inductive sensor or an AMR sensor. The second non-contact status sensor <NUM> may also comprise a permanent magnet or an electromagnet.

In all of the embodiments described herein, the first and second sensors (<NUM>, <NUM>) are referred to as non-contact sensors. However, they may each also be termed "proximity sensors", or "inductive proximity sensors" as each of the sensors is configured to have a current or signal induced in it. In contrast, an optical sensing system requires active monitoring by an image capture device, correct illumination conditions and image analysis software. Having sensors in which the movement of a particular component of the injection device <NUM> induces a signal in the sensor provides a less power intensive method of non-contact sensing.

In the supplementary device <NUM> of <FIG>, the second non-contact status sensor <NUM> is configured to detect the movement of a different type of moveable component than in the device shown in <FIG>. Therefore, the second non-contact status sensor <NUM> is located adjacent the cylindrical part of the housing <NUM> of the injection device <NUM>.

Further details of the injection device <NUM> of <FIG> and the supplementary device <NUM> of <FIG> will now be discussed with reference to <FIG>.

<FIG> is a perspective view of the injection device <NUM> of <FIG> and also illustrates schematically the first and second non-contact sensors. <FIG> shows the sleeve <NUM>. <FIG> shows the injection device <NUM> in a pre-activation state. The needle <NUM> is shielded by the sleeve <NUM>. As shown in <FIG>, the sleeve <NUM> comprises a magnetic section <NUM> (also referred to herein as a sleeve segment or a sleeve sensor segment). The magnetic section <NUM> may be inlaid into the sleeve <NUM> or stamped or printed onto the surface of the sleeve <NUM>. The magnetic section <NUM> is located at or near the distal end of the sleeve <NUM>, as shown in <FIG>. The magnetic section <NUM> may be for example a metal plate magnet or a magnetized plastic material. Alternatively, the magnetic section <NUM> may be replaced with a metal part having a high magnetic permeability.

The approximate position of the magnetic section <NUM> within the injection device <NUM> is shown in <FIG>. The magnetic section <NUM> is positioned on the outer surface of the sleeve <NUM> so as to be as close to the housing <NUM> of the injection device <NUM> as possible.

The approximate position of the second non-contact status sensor <NUM> when the supplementary device <NUM> is attached to the injection device <NUM> is also shown. The second non-contact status sensor <NUM> may be located close to the distal end of the injection device <NUM>. In the pre-activation configuration, the magnetic section <NUM> is not located underneath the second non-contact status sensor <NUM>.

The approximate position of the first non-contact status sensor <NUM> is also shown. In some particular embodiments, the first non-contact status sensor <NUM> may be located closer to the proximal end of the supplementary device <NUM> than the second sensor and may be offset from the second sensor by approximately <NUM> degrees. This may help to prevent interference between the two sensors and the magnetic segments they detect.

<FIG> illustrates the position of the components described above after the sleeve <NUM> has been activated. The sleeve <NUM> is activated by depressing it into the main body <NUM> of the injection device <NUM>. If the user has the injection device <NUM> positioned against their skin, then this causes injection of the needle <NUM> into the user. However, injection of the user is not necessary for the injection device <NUM> and supplementary device <NUM> to perform their functions. The term "ejection" is used throughout this specification to indicate that the injection device <NUM> will perform its functions (i.e. will eject medicament) irrespective of whether a user has injected themselves.

<FIG> illustrates the moment at which the sleeve <NUM> has been activated and the ejection is about to commence. Thus, the injection device <NUM> may be described as being in a post-activation state, but also in a pre-ejection state. The sleeve <NUM> has moved distally within the injection device <NUM>. The magnetic section <NUM> has therefore also moved distally and is now located underneath the second non-contact status sensor <NUM>. In some embodiments, the second non-contact status sensor <NUM> is a Hall sensor, and the movement of the magnetic section <NUM> induces a signal in the sensor. The processor <NUM> detects this signal and can infer that the injection device <NUM> has been activated. The processor <NUM> may then control the display <NUM> accordingly (see <FIG>).

As shown in detail in <FIG>, the plunger <NUM> of the injection device <NUM> may have an additional part <NUM> at its distal end. This may be referred to as the plunger section <NUM> or second magnetic section <NUM>. The plunger section <NUM> may be for example a metal plate magnet or a magnetized plastic material. Alternatively, the plunger section <NUM> may be replaced with a metal part having a high magnetic permeability. The approximate position of the plunger section <NUM> within the injection device <NUM> in the pre-ejection configuration is indicated in <FIG>.

After the injection device <NUM> has been activated, the plunger <NUM> begins to move proximally and to cause the medicament to be ejected. The plunger <NUM> continues to move until it reaches its final position, as shown in <FIG> therefore shows the injection device <NUM> in a post-ejection configuration. In this configuration, the plunger section <NUM> has moved underneath the first non-contact status sensor <NUM>. this causes a signal to be induced in the first non-contact status sensor <NUM>. The processor detects this signal and can infer that the ejection process has been fully completed. The processor <NUM> may then control the display <NUM> accordingly, for example to begin indication of a "dwell time".

<FIG> is a flow chart showing operations of the supplementary device <NUM> according to some embodiments of the disclosure. These operations are applicable to all of the embodiments of the supplementary device <NUM> described above. The operation begins at step <NUM> in which the first non-contact sensor <NUM> detects that the ejection process has ended. The processor <NUM> may receive signals from the first non-contact sensor <NUM> in order to make the determination. The first non-contact sensor <NUM> may take a number of forms as described above. In the simplest embodiments of the disclosure, the first non-contact sensor <NUM> may be the only sensor in the supplementary device <NUM> configured to monitor the attached injection device <NUM> (i.e. the second non-contact status sensor <NUM> may not be present). The determination that the ejection process has finished may be the first determination about the injection device <NUM> made by the processor <NUM>.

Upon determining that the ejection process has ended, at step <NUM> the processor <NUM> controls the display unit <NUM> to show a holding instruction. This instruction can take a number of forms, for example the words "Hold" or "Wait and Hold" may be displayed. Any other suitable words conveying the same meaning may take the place of these. Alternatively, or in addition to the words, the display may show an image or an animation to indicate that the user should leave the injection device <NUM> injected into their skin. The image or animation may be of any suitable form, for example a timer which counts up or down or a graphic which gets larger/smaller or which fills or un-fills. This holding instruction may help to ensure that the user observes the correct dwell time.

At step <NUM> the processor counts a predetermined holding time. This holding time allows the injected medicament to be diffused away from the injection site by action of the user's blood flow. A typical holding time may be between <NUM>-<NUM> seconds. Measurement of the holding time (step <NUM>) may begin simultaneously with step <NUM>. The internal counting of the holding time by the processor <NUM> may optionally be accompanied by audible feedback produced by the audio module <NUM>. The audible feedback may take any suitable form, such as a spoken countdown (e.g. <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) or a series of pips.

At step <NUM>, once the predetermined holding time is complete, the processor <NUM> controls the display unit <NUM> to discontinue the holding instruction. The holding instruction may be replaced with a confirmation that the injection is complete and/or an indication that the user can now remove the injection device <NUM>.

<FIG> and <FIG> show a flow chart illustrating optional additional operations which can be performed by the supplementary device <NUM> and exemplary wording to be displayed on the display <NUM> during the various operational stages. These operations are applicable to all of the embodiments of the supplementary device <NUM> described above. <FIG> is a continuation of <FIG>.

At step <NUM>, the supplementary device <NUM> (with an attached injection device <NUM>) determines that the time of the user's next scheduled injection is due. At this time the display <NUM> is deactivated and the supplementary device <NUM> may also be in 'sleep mode'. The electronics <NUM> may store at least the time and date of the user's next scheduled injection in the memory and the supplementary device <NUM> may be programmed to wake up form sleep mode at this time. At step <NUM>, in response to determining that the time of the user's next scheduled injection is due, the processor <NUM> causes the user input <NUM> to flash, alternate its colour or otherwise change its appearance in order to become more noticeable. In some other embodiments, the processor <NUM> may instead or in addition causes another light emitting part of the supplementary device <NUM> to change its appearance, such as one or more dedicated LEDs (not shown) or by activating and using the display <NUM>. For example, the display <NUM> may display the words "Next Injection Due" or similar.

At step <NUM>, the supplementary device <NUM> detects an input at the user input <NUM>. The user input may be a button press or touch input at the user input <NUM>. After receiving the user input, the supplementary device <NUM> activates the display4, if not already active. The display <NUM> is controlled to show the words "Remove Cap" and "Start Injection", either simultaneously or sequentially. Alternatively or in addition the display <NUM> may show one or more images or animations illustrating removal of the outer needle cap <NUM>, inserting the needle <NUM> into a user and beginning of medicament injection.

At step <NUM>, the second non-contact sensor <NUM> detects activation of the injection device <NUM> ejection process by sensing movement of the plunger <NUM>, as described above with reference to <FIG>. Once movement of the plunger <NUM> has been detected, the display <NUM> may show the words "Injection" or "Injection in Progress" or similar.

At step <NUM>, the first non-contact sensor <NUM> detects the end of the ejection process. The processor <NUM> may receive signals from the first non-contact sensor <NUM> in order to make the determination. The first non-contact sensor <NUM> may take a number of forms as described above with reference to <FIG>.

Upon determining that the ejection process has ended, the processor <NUM> controls the display unit <NUM> to show a holding instruction. For example, the words "Hold" or "Wait and Hold" may be displayed. Any other suitable words conveying the same meaning may take the place of these. Alternatively, or in addition to the words, the display may show an image or an animation to indicate that the user should leave the injection device <NUM> injected into their skin.

At step <NUM> the processor <NUM> counts a predetermined holding time. This holding time allows the injected medicament to be diffused away from the injection site by action of the user's blood flow. A typical holding time may be between <NUM>-<NUM> seconds. Measurement of the holding time (step <NUM>) may begin simultaneously with step <NUM>. The internal counting of the holding time by the processor <NUM> may optionally be accompanied by audible feedback produced by the audio module <NUM>. The audible feedback may take any suitable form, such as a spoken countdown (e.g. <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) or a series of pips.

At step <NUM>, after a further predetermined time, the supplementary device <NUM> causes the user input <NUM> to flash, alternate its colour or otherwise change its appearance in order to become more noticeable. The appearance of the user input <NUM> at this stage may be the same as in step <NUM>, or maybe different. For example, the user input <NUM> could flash a green colour in step <NUM> to indicate that the injection device <NUM> is ready to use and could flash a red colour in step <NUM> to indicate that the injection device <NUM> is empty and needs replacing. In some other embodiments, the processor <NUM> may instead or in addition causes another light emitting part of the supplementary device <NUM> to change its appearance, such as one or more dedicated LEDs (not shown). At this time, the display <NUM> may be controlled to show the words "Insert New Device", "Change Device" or similar. This may be replaced or augmented with an image or animation showing a new injection device <NUM> being inserted into the supplementary device <NUM>.

At step <NUM>, the locking sensor <NUM> of the supplementary device <NUM> detects that the attachment mechanism <NUM> has been unlocked. The processor <NUM> may receive signals from the locking sensor <NUM> in order to make this detection. The display <NUM> may be controlled to show the word "Open" or otherwise to indicate that no device is attached. Alternatively, the display <NUM> may be controlled to continue showing the words "Change Device" or similar, as shown in <FIG>.

The user then inserts a new injection device <NUM> into the supplementary device <NUM> and locks the attachment mechanism <NUM>. At step <NUM> the locking sensor <NUM> of the supplementary device <NUM> detects that the attachment mechanism <NUM> has been locked. The display <NUM> may be controlled to show the word "Locked" or otherwise to indicate that a new device has been attached. The supplementary device <NUM> may then execute a plausibility check on the new injection device <NUM>. At step <NUM>, the second non-contact status sensor <NUM> checks the position of the plunger <NUM> to make sure that the newly inserted injection device is in a pre-activation configuration. If the second non-contact status sensor <NUM> detects that the newly inserted injection device <NUM> has already been used, a warning or error message may be displayed on display <NUM>. For example, the words "Injector already used" or similar may be displayed. If it can be inferred from the signals output by the second non-contact status sensor <NUM> that a mechanical fault has occurred, such as that the injection device <NUM> was incorrectly assembled or does not contain the correct amount of medicament, suitable alarm signals and information may be generated and displayed by the supplementary device <NUM>. This may help in preventing an accidental under-dose. At step <NUM>, the optical sensor <NUM>, if present, may be used to read to information <NUM> printed on the injection device <NUM>. This allows the supplementary device <NUM> to determine that the user has inserted an injection device <NUM> containing the correct medicament, or the correct amount of medicament. If it is determined that the newly inserted injection device <NUM> contains the wrong medicament, suitable alarm signals and information may be generated and displayed by the supplementary device <NUM>.

At step <NUM>, if the plausibility checks are passed, the processor <NUM> retrieves or determines the time and date of the user's next scheduled injection. At least the next scheduled injection information may be stored in the memory of the supplementary device <NUM> and retrieved from there by the processor <NUM>. The display <NUM> is then controlled to display this information.

Alternatively, the supplementary device <NUM> may be programmed to calculate the time of the next dose using stored or retrieved information relating to the user, e.g. physiological information. In addition, the time at which the user should perform the next injection may depend on the amount of medicament previously injected and the frequency of the previous injections. If no such information is stored, the supplementary device <NUM> may be programmed to retrieve the information from an external device using wireless unit <NUM>. In a particular example, the external device may be a blood glucose meter, or a computer which stores the readings taken by a blood glucose meter. This arrangement allows the timing of the user's injections to be updated as a result of the user's blood glucose readings and communicated to the user automatically.

At step <NUM> the supplementary device <NUM> transmits data relating to the recently performed injection process to an external device via the wireless unit <NUM>. The information may contain both the type and amount of medicament injected and the exact time of administration. The processor <NUM> of the supplementary device <NUM> has an internal clock in order to create time stamps associated with the injection events. The clock may be a relative clock or an absolute clock. The external device may provide an absolute time. The external device may be a computer or smart phone running an app. The user or the user's healthcare professional may view and manage their dosage regime and the user's adherence to the regime using the external device or app.

After transmitting the data or after the information regarding the user's next scheduled injection has been displayed for a predetermined period of time, the supplementary device <NUM> enters sleep mode and the display <NUM> is deactivated. The process may then begin again at step <NUM>.

The supplementary device <NUM> may be pre-programmed with information relating to the frequency at which the user should perform injections. This programming may take the form of a maximum time between injections or a medical regimen associated with the user of the supplementary device <NUM>. For example, the supplementary device <NUM> may be pre-programmed with information specifying that the maximum time between injections should be <NUM> hours. In some other embodiments, the medical regimen may be more detailed, such as to specify specific times of day at which the user is to perform an injection operation using the injection device <NUM>.

Optionally, when the supplementary device <NUM> determines that it is time for the user to perform a subsequent injection, it causes a reminder signal to be sent via the wireless unit <NUM> to the associated external device. The external device may then notify and remind the user that their next injection is due. This is advantageous as the user may not wish to carry the injection device <NUM> and/or supplementary device <NUM> with them, but may in any case by carrying a smart phone or similar device. Thus the user can be reminded of the need for a subsequent injection via a separate device which they carry with them. Furthermore, the injection device <NUM> may need to be kept under specific conditions, such as in a refrigerator or a freezer, such that it is not possible for a user to carry the injection device with them. It is therefore easy for a user to forget about the times at which an injection needs to be performed.

The term "drug delivery device" shall encompass any type of device or system configured to dispense a volume of a drug into a human or animal body. The volume can typically range from about <NUM> to about <NUM>. Without limitation, the drug delivery device may include a syringe, needle safety system, pen injector, auto injector, large-volume device (LVD), pump, perfusion system, or other device configured for subcutaneous, intramuscular, or intravascular delivery of the drug. Such devices often include a needle, wherein the needle can include a small gauge needle (e.g., greater than about <NUM> gauge, and including <NUM>, <NUM>, or <NUM> gauge).

In combination with a specific drug, the presently described devices may also be customized in order to operate within required parameters. For example, within a certain time period (e.g., about <NUM> to about <NUM> seconds for injectors, and about <NUM> minutes to about <NUM> minutes for an LVD), with a low or minimal level of discomfort, or within 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.

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-carboxyheptadecanoyl) 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 system comprising a drug delivery device (<NUM>) and a supplementary device (<NUM>) configured to be releasably attached to a drug delivery device (<NUM>), the drug delivery device (<NUM>) comprising a first moveable component (<NUM>) and a flexible arm (<NUM>), the supplementary device (<NUM>) comprising:
a first non-contact sensor (<NUM>) configured to output signals indicative of the position of the first moveable component (<NUM>) within the drug delivery device (<NUM>); and
a processor (<NUM>) configured to:
receive the signals output from the first non-contact sensor (<NUM>);
determine based on the signals the moment at which the drug delivery device (<NUM>) changes from a pre-ejection state to a post-ejection state;
in response to determining that the drug delivery device (<NUM>) has changed from the pre-ejection state to the post ejection state, cause a display of the supplementary device (<NUM>) to visually indicate that a user should hold the drug delivery device (<NUM>) in its current position for a predetermined period of time,
wherein the first moveable component (<NUM>) is a resilient member configured to change position between:
a first configuration, when the injection device is in a pre-ejection state and during an ejection process, in which the resilient member is retained by the flexible arm (<NUM>) and the flexible arm (<NUM>) is retained in the first position by contact with a part of a plunger (<NUM>) of the drug delivery device (<NUM>); and
a second configuration, at the end of the ejection process, in which the flexible arm (<NUM>) is biased and moves towards the centre of the drug delivery device (<NUM>) and a force on the resilient member is released to change the resilient member from the first configuration to the second configuration.