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.

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.

This specification describes a drug delivery device, for example a one shot auto-injector, which may aid the patient in performing the injection correctly.

<CIT> discloses a supplementary device configured to be attached to a drug delivery device, the supplementary device comprising: a non-contact sensor configured to output signals indicative of the position of a moveable component within the drug delivery device; and a processor configured to receive the signals output from the non-contact sensor and to determine based on the signals whether the drug delivery device is in a pre-activation state or a post-activation state.

<CIT> a dosage monitoring device for use in conjunction with a liquid dispenser includes a memory, a quantity sensor configured to determine the quantity of an individual dispensed dosage and to record the quantity in the memory, a dispensing sensor configured to sense when said individual dosage is dispensed and to record the event of dispensing in the memory, and feedback means that is configured to make the quantity of the individual dosage available for display. The dosage monitoring device is releasably attachable to the liquid dispenser and can be re-used.

<CIT> discloses a system comprising a sensor assembly adapted to measure a magnetic field, and a moveable element adapted to be moved relative to the sensor assembly between two positions by a combined axial and rotational movement, the rotational movement having a pre-determined relationship to the axial movement. A magnet is mounted to the moveable element and configured to generate a spatial magnetic field which relative to the sensor assembly varies corresponding to both the axial and rotational movement of the magnet and thus the moveable element. A processor is configured to determine on the basis of measured values for the magnetic field an axial position of the moveable element.

A first aspect provides a drug delivery device including a body and a movable component arranged inside the body, a dosage selection and injection mechanism setting the position of the movable component inside the body depending on a selected dosage, a non-contact sensor configured to output signals indicative of the position of the movable component inside the body, and a processor configured to receive the signals output from the non-contact sensor and to determine based on the signals whether the movable component is either in an initial position inside the body corresponding to no selected dosage or in a selected dosage position, wherein upon determining that the movable component has changed its position back from the selected dosage position to the initial position, the processor is configured to cause an indication to be output which informs a user regarding a dwell time of the drug delivery device.

This allows the drug delivery device to notify a user regarding the dwell time after the end of an injection and helps to improve the usage of the drug delivery device by the user. Using a non-contact sensor allows to monitor the drug delivery device without any increase in friction on the mechanical components of the drug delivery device. The moveable component within the drug delivery device and the dosage selection and injection mechanism are already present in the design of the drug delivery device and therefore no significant modifications to the way in which this drug delivery device operates are required to implement the device disclosed herein. Thus, the increases in the complexity of manufacture of the drug delivery device are minor.

The drug delivery device may further comprise a display unit. Causing an indication to be output may comprise causing one or more graphical elements to be displayed on the display unit, the graphical elements communicating a progress of the dwell time. Thus, a user can easily see the progress of the injection and how long to hold the device after the end of the injection.

The drug delivery device may further comprise a transmission unit. Causing an indication to be output may comprise causing one or more signals to be transmitted by the transmission unit, the signals communicating a progress of the dwell time. The transmitted signal(s) may for example be received by an external electronic device of the user, such as a computer or a smart phone, and processed by the device, for to notify a user of correct usage of the drug delivery device such as displaying assisting information, for example hints.

The transmission unit may be a wireless unit for transmitting data to one or more external devices. The transmitted data particularly comprises dwell time data and an identifier of the drug delivery device. For example, dwell time data could be transmitted to the user's computer or smart phone wirelessly, for example over a Bluetooth® connection. The user can for example install a program on its computer or smart phone for assisting and monitoring usage of the drug delivery device, and the program can process the data received from the transmission unit of the drug delivery device.

The non-contact sensor may be a capacitive sensor. A capacitive sensor may be implemented at relatively less technical expenses, particularly when using some of the components of the drug delivery device as sensor part. For example, the body, the movable component and the dosage selection and injection mechanism may form at least a part of a dielectric layer of the capacitive sensor. The position of the movable part inside the body may then influence the measured capacitance due to the changing air volume inside the body, i.e. when the movable part is moved far out of the body, the air volume inside the bode is higher than in case the movable part is moved inside the body. The changing air volume may cause a measurable capacitance change.

In order to obtain detectable capacitance changes of the capacitance sensor by the movable component, the body, the movable component and parts of the dosage selection and injection mechanism may be made of one or more materials selected to obtain a dielectric constant of the capacitive sensor sufficient to detect whether the movable component is either in an initial position inside the body corresponding to no selected dosage or in a selected dosage position, wherein the one or more selected materials may comprise plastics and particularly metal. In other words, the materials used for the body, the movable component and parts of the dosage selection and injection mechanism may be selected such that their dielectric constant creates a detectable capacitance, and that a movement of the movable component may alter the dielectric constant in a detectable range.

Particularly, at least one movable part of the dosage selection and injection mechanism may be made of metal, and the at least one metal part may influence the dielectric property of the capacitive sensor. For example, the at least one metal part of the dosage selection mechanism may be a drive spring of an injection mechanism of the drug delivery device.

The capacitive sensor may comprise opposing sets of at least two electrically conductive parts with a first part being a layer arranged on at least a part of the outside of the body. One or more of the at least two electrically conductive parts may be integrated into or arranged under a label of the drug delivery device. For example, a first part may be a metal layer deposited on a part of body. A second part of the at least two electrically conductive parts may be a layer being arranged on at least a part of the outside of the body and opposite to the first part. For example, the second part may be as the first part a metal lay deposited on the opposite side of the body, on which the first part is layered, such that the body, the movable component and most parts of the dosage selection and injection mechanism are arranged between the two metal layers and a capacitance may be obtained, which can be measured.

A second part of the at least two electrically conductive parts may be also arranged inside the body and opposite to the first part with the body, the movable component and the dosage selection and injection mechanism at least partly arranged between the first and the second part. For example, the second part may be a part of the dosage selection and injection mechanism, such as a metallic inner part, for example a spring.

The processor may be configured to measure the capacitance of the capacitive sensor when no dosage is selected and the movable component is in the initial position inside the body, to store the measured capacitance as reference value, to detect a capacitance change when a dosage is selected, to detect a further capacitance change due to an injection and to determine the end of the injection when the measured capacitance correlates with the reference value.

The dosage selection and injection mechanism may comprise a display for the selected dosage, wherein the display may be coupled to a rotatable component for dosage selection, and wherein the rotatable component may be coupled to a displacement mechanism for displacing the movable component with regard to the body. By rotating the rotatable component, the user can select a certain dosage to be injected. The rotation and dosage selection may be transferred by means of the displacement mechanism to a certain displacement of the movable component with regard to the body. Particularly, the higher dosage is selected, the more the displacement mechanism may move the movable component out of the body so that the air volume inside the body increases and the measurable capacitance changes accordingly.

The processor is further configured to cause an indication to be output which informs a user of the end of the dwell time of the drug delivery device. The indication may be a visible and/or an audible signalling to the user or a signal transmitted to an external device such as a smartphone, which can itself signal to the user the end of the dwell time.

The processor may be configured to cause an indicator signal to be output at the start and/or the end of the dwell time of the drug delivery device. The indicator signal may be for example a visible and/or audible signal, such as activation of a LED or outputting a characteristic sound.

The drug delivery device may a powered auto-injector and wherein a dispensing mechanism of the powered auto-injector is powered by a pre-compressed spring.

The processor may be further configured to record information on an injection, particularly date and time of the injection.

A second aspect of this disclosure relates to a drug delivery device as disclosed herein and containing a medicament.

In the following, embodiments will be described with reference to an auto-injector. The present disclosure 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> 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>) and a further cap <NUM>' (also referred to herein as the inner needle cap or INC <NUM>'). The body <NUM> comprises an outer housing <NUM>. The outer housing <NUM> is an elongate tube. The outer housing <NUM> includes a cartridge holder or syringe holder (not shown) which supports a cartridge or syringe <NUM> containing liquid medicament <NUM>. Hereafter the description shall refer to a cartridge <NUM>, which is supported by a cartridge holder (not shown).

The outer housing <NUM> also houses a dosage selection and injection or dispense mechanism (not shown) for causing dispensing of a selected dosage of the medicament <NUM> during injection. The dosage to be dispensed can be selected by means of a rotary knob <NUM> at the distal ned D of the auto-injector <NUM>. The selection is shown on a mechanical scale <NUM>' coupled with the rotary knob <NUM> through a window <NUM>" in the outer housing <NUM>.

A hollow needle <NUM> communicates with an interior volume of the cartridge <NUM> and serves as a conduit for liquid medicament <NUM> during injection. The needle <NUM> and the cartridge <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 cartridge <NUM> to as to expel medicament contained within the cartridge <NUM> through the needle <NUM> under action of the dispense mechanism.

The dispense mechanism is mechanically coupled to the piston <NUM> of cartridge <NUM>. The dispense mechanism is configured to move the piston axially along the cartridge <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. 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>, 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> and INC <NUM>' are removed from the device <NUM> by the user. Next, the dosage of the medicament <NUM> to be injected is selected by the user by turning the rotary knob <NUM> until the desired dosage is displayed on the mechanical scale <NUM>'. The, 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 cartridge <NUM> through the needle <NUM> into the injection site of the patient.

The cartridge <NUM> is transparent and a window <NUM> is provided in the housing <NUM> coincident with the cartridge <NUM> so that the medicament <NUM> contained within the cartridge <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 cartridge <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.

The proximal end P of auto-injector <NUM> can be protected with pen cap <NUM>', which may be after usage of the auto-injector <NUM> mounted on the body <NUM> covering the proximal end P.

<FIG> shows a simplified schematic illustration of the injection device and sensor components of the for capacitive sensing of the status of the injection device.

From the injection device, the body <NUM> and a movable component <NUM> within the body are shown. The movable component <NUM> may comprise one or more parts of the dosage selection and injection or dispense mechanism, or may comprise the entire dosage selection and injection or dispense mechanism. The movable component <NUM> may also comprise at least metallic part, while all other parts as well as the body <NUM> are made of plastics, for example ABS (Acrylonitrile butadiene styrene) or POM (Polyoxymethylene). The metallic part may be for example a spring, or a sleeve. At the end of the movable component <NUM>, the rotatory knob <NUM> for dosage selection and dispense button <NUM> are arranged.

By rotating the knob <NUM>, a user may select the dosage to be dispensed. Rotation of the knob <NUM> results in a movement of the component <NUM> inside the body <NUM> along its longitudinal axis. Thus, the position of the component <NUM> in relation to the body <NUM> is changed. For example, a clockwise rotation of knob <NUM> may result in that the component <NUM> is moved outside the body <NUM>, in <FIG> in the right direction as shown in the middle of <FIG>, where the component <NUM> is moved wide out of the body <NUM>. On the contrary, counter-clockwise rotation of the knob <NUM> may move the component <NUM> into the body <NUM> until the know <NUM> abuts on the edge of the body <NUM> and delimits a further move of the component <NUM> inside the body <NUM>.

The outside of the body <NUM> comprises two metallic layers <NUM>, <NUM>' arranged opposite to each other. Both layers <NUM>, <NUM>' may cover only a part of the outside of the body <NUM>, and each may comprise an electrical connector <NUM>, <NUM>' for connection with electronics of the injection device. The layers <NUM>, <NUM>' may extend along the longitudinal axis of the body <NUM> over a range, which comprises nearly the entire displacement of the movable component <NUM> inside the body <NUM>, as shown in <FIG> by the double arrow at the top and the dashed vertical lines.

The displacement of the movable component <NUM> with regard to the body <NUM> by rotating the rotary knob <NUM> depending on the selected dosage alters the air volume from a smaller air volume <NUM> inside the body <NUM> to a larger air volume <NUM>'. On the contrary, the air volume <NUM>' is reduced to the air volume <NUM>, when the movable component <NUM> is moved deeper inside the body <NUM> by selecting a respective dosage through rotating the rotary knob <NUM>.

The alteration of the air volume <NUM>, <NUM>' and the displacement of the movable component <NUM> inside the body <NUM> influences the dielectric constant of the dielectric layer formed between the metallic layers <NUM>, <NUM>'. This again results in change of the capacitance of the capacitor formed by the metallic layers <NUM>, <NUM>' and the dielectric layer between them and formed by the air volume <NUM>, <NUM>', the body <NUM>, and the movable component <NUM>. The diagram at the bottom of <FIG> represents the change of the capacitance over the displacement s of the movable component <NUM>. At position (<NUM>), the capacitance is high since the movable component <NUM> is entirely moved into the body <NUM> and the air volume <NUM> is as small as possible. Thus, the dielectric constant is higher than at position (<NUM>), where the movable component <NUM> is entirely moved out of the body <NUM> and the air volume <NUM>' is as large as possible. The capacitance decreases therefore from position (<NUM>) of the movable component <NUM> to position (<NUM>) of the movable component <NUM>. This change of the capacitance is measurable and may be used for informing a user of the dwell time as will be explained below.

<FIG> shows a block diagram of electronic components of an injection device such as the injection device <NUM> of <FIG> equipped to measure the capacitance of the capacitor formed by the metallic layers <NUM>, <NUM>' and the components therebetween. The electronic components may comprise a processor <NUM>, which may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. Processor <NUM> executes program code (e.g. software or firmware) stored in a program memory <NUM>, and uses a main memory <NUM>, for instance to store intermediate results. Main memory <NUM> may also be used to store a logbook on performed ejections/injections. Program memory <NUM> may for instance be a Read-Only Memory (ROM), and main memory may for instance be a Random-Access Memory (RAM).

The injection device may optionally further comprise at least one input transducer, for example a button (not shown in <FIG>). This input transducer allows a user to turn on/off the electronics of the injection device, 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 injection device to another device), or to confirm something. In some other embodiments, the injection device may be automatically turned on/off via a sensor (not shown) detecting whether the ONC is put onto the injection device or not.

Processor <NUM> controls a display unit <NUM>, which may be embodied as a Liquid Crystal Display (LCD) or an e ink display. Display unit <NUM> is used to display information to a user of injection device, for instance on present settings of injection device, or on a next injection to be given. Display unit <NUM> may also be embodied as a touch-screen display, for instance to receive user input.

Processor <NUM> also controls the capacitive sensor <NUM> (formed by formed by the metallic layers <NUM>, <NUM>' and the components therebetween and connected to the processor <NUM> via connections <NUM>, <NUM>'). The measurements received from the capacitive sensor <NUM> are indicative of the position of the movable component <NUM> within the body <NUM> of the injection device <NUM>. The capacitive sensor <NUM> may collectively be referred to as non-contact sensor, since it is able to sense the absolute position and movement of components within the attached injection device <NUM> without contact between the sensor and any of the components sensed. The processor <NUM> receives these signals (voltage measurements) from the capacitive sensor <NUM> via connections <NUM>, <NUM>' and infers an operational state of the injection device <NUM> and causes information regarding the timing of the operation of the injection device <NUM> to be recorded in the main memory <NUM> and/or transmitted to an external device via a wireless unit <NUM>. The operation of the sensor is described in greater detail with respect to <FIG>.

Processor <NUM> controls the 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 may also include a time stamp associated with an injection.

Processor <NUM> may receive an input from an ONC sensor (not shown), which is operable to detect whether the outer needle cap <NUM> is present, i.e. to detect whether the outer needle cap <NUM> is coupled to the injection device <NUM>. A battery <NUM> powers the processor <NUM> and other components by way of a power supply <NUM>. The removal of the ONC <NUM> is detected by the ONC sensor and can be used as a wake-up or switch on trigger. Thus, the injection device may automatically turn on and begin its monitoring processes when the ONC <NUM> is removed. Similarly, when the ONC <NUM> is replaced the injection device may automatically power off, thus saving battery power.

The electronics of <FIG> is thus capable of determining information related to a condition and/or use of injection device <NUM>. This information may be displayed on the display <NUM> for use by the user of the device. The information may be either processed by injection device <NUM> itself, or may at least partially be provided to another device (e.g. a blood glucose monitoring system or a computing device).

The processor <NUM> may be configured to receive signals form the ONC sensor and to detect when the ONC <NUM> is not attached to the injection device <NUM>. If the user stores the injection device <NUM> without the ONC <NUM> attached, then the needle <NUM> can become clogged. Therefore, the injection device <NUM> may be configured to produce an indicator signal if the processor <NUM> detects that the ONC <NUM> has been un-attached for a predetermined length of time following an injection operation. The indicator signal may be sent via the wireless unit <NUM> to the external user device such that the user can be alerted to the need to replace the ONC <NUM> even if they have moved away from the injection device <NUM>. Alternatively, or in addition, the indicator signal may comprise the injection device <NUM> displaying words and/or graphics on the display unit <NUM> or producing sound.

The injection device <NUM> comprises a capacitive sensor formed by the metallic layers <NUM>, <NUM>' and the components therebetween. Referring now to <FIG>, the operation of the capacitive sensor will be described in greater detail.

<FIG> illustrates shows diagrammatically a cut-away through the injection device <NUM> when the injection device is in a pre-injection configuration and a post injection configuration (also referred to as pre-activation and post-activation). The injection device <NUM> comprises a drive spring <NUM>, which is pre-compressed during assembly of the injection device <NUM>. The drive spring <NUM> is maintained in this pre-compressed state until an injection is performed. When a user triggers an injection operation by pressing dose dispense button <NUM>, the dispense mechanism is released and the drive spring decompresses so as to dispense medicament from the cartridge <NUM>.

Various components of the capacitive sensor <NUM> are shown schematically in the lower image in <FIG>. The capacitive sensor <NUM> comprises opposing sets of at least one electrically conductive plate (in <FIG> the metallic layers <NUM>, <NUM>'). The plates are connected in a circuit so as to form a capacitor. The injection device <NUM> occupies the space between the plates and functions as the dielectric layer of the capacitor. The capacitive sensor <NUM> sends signals to the processor <NUM> via which the processor <NUM> can determine the effective capacitance. For example, the processor <NUM> may control the application of charge to one plate of the capacitive sensor <NUM> and then measure the time taken for the capacitive sensor <NUM> to discharge.

The upper image in <FIG> shows the approximate position of the drive spring <NUM> before an injection has been performed. The drive spring <NUM> is compressed, with the coils of the spring being closely spaced or touching. The lower image in <FIG> shows the approximate position of the drive spring <NUM> after the energy stored therein has been released during an injection process. The coils of the drive spring are spaced further apart. In some embodiments, the drive spring is metallic.

<FIG> is a graph showing an exemplary relationship between capacitance and charge before, during and after an injection process. Before the injection device <NUM> is used, the capacitance measured by the capacitive sensor <NUM> is relatively high, due to the presence of a greater amount of the drive spring <NUM> in the region between the capacitor plates and the non-selection of a dosage, which results in the movable component <NUM> entirely positioned within the body <NUM> of the injection device <NUM>. Then, a user selects a dosage to be injected by rotating the rotation knob <NUM> and displacing the movable component <NUM> such that it is moved out of the body <NUM> of the injection device <NUM>, which results in a decrease of the capacitance measured by the capacitive sensor <NUM> until the dosage is set (at point "set dose" in <FIG>). The drive spring <NUM> is part of the movable component <NUM> and moved out of the body <NUM>. The start and end points of the medicament ejection process are shown by the injection time arrow. The injection and medicament ejection are started when the user presses the dispense button <NUM>. This incurs that the movable component <NUM> is moved again into the body <NUM> while the drive spring <NUM> uncoils. Thus, the materials of the movable component <NUM> is disposed in the region between the capacitor plates of the capacitance sensor <NUM> until the movable component <NUM> reaches its start position, i.e. when no dosage is selected. Therefore, the capacitance measured by the capacitive sensor <NUM> increases during the ejection. After the injection device <NUM> has been used, the capacitance measured by the capacitive sensor <NUM> has reached its start value again.

The processor <NUM> may be configured to determine that an injection has been completed if the measured capacitance reaches the second time its start value (designated as "injection completed" in <FIG>). The processor <NUM> is configured to compare the capacitance measurements on a continuous basis during the injection with the capacitance measured at the beginning of usage of the injection device <NUM> and before a dosage was selected. This measured capacitance is stored in the main memory <NUM> as initial capacitance. After storing the measured capacitance, the processor <NUM> may set a flag indicating that it is ready for capacitance measurements during the injection. The processor <NUM> then continuously receives and processes measurements from the capacitive sensor <NUM>. When the processor <NUM> detects that the user has pressed the dispenser button <NUM>, for example by detecting a sudden increase of the measured capacitance, it may compare each received capacitance measurement with the stored initial capacitance. When the processor <NUM> detects that the received measurements of the capacitance correlate with the stored initial capacitance, it starts an internal timer set to a predefined holding time. The processor <NUM> may at the same time cause an indication to be output for informing the user of the end of the injection and the beginning of a dwell time. The indication may be a signal to configure the display unit <NUM> to display information on the end of injection and begin of dwell time. Also, a sound may be generated via some sound equipment. When the timer reaches the dwell time, the processor <NUM> may cause a further indication to be output for informing the user of the end of dwell time. The indication may be a signal to configure the display unit <NUM> to display information on the end of dwell time. Also, again, a sound may be generated via some sound equipment.

The capacitive sensor <NUM> may be shielded to protect it from external electromagnetic impulses.

The processor <NUM> may be configured to record a user's injection history. The processor <NUM> may have an internal clock to create time stamps associated with the injection events. The clock may be a relative clock or an absolute clock. The injection device <NUM> may be configured to communicate with an external device through wireless unit <NUM> and the external device may provide an absolute time.

When a user performs an injection, this may be detected by the capacitive sensor <NUM> as described above. A time stamp associated with the injection may then be created by the processor <NUM>. The processor <NUM> may also record and associate with the time stamp the type of medicament injected, using for example previously read information. An external device (not shown) in the user's possession may be registered and associated with the injection device <NUM>. The external device may be a mobile computer or smart phone via the wireless unit <NUM>. The mobile computer or smart phone may run a computer program for managing the user's medical records and injection history. The injection device <NUM> may be configured to communicate the recorded injection information to the external device.

The processor <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 injection device <NUM>. For example, the processor <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>. Alternatively, the processor <NUM> may be configured to calculate a time at which the user should next perform an injection based on the injection history. For example, 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. The processor may use the previous injection history to calculate a medical regimen for the user.

When the processor <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> 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.

Examples above relating to insulin, for diabetic users, are illustrative. The present disclosure is also applicable to any users who may become impaired. For instance, patients who require cardiovascular medication or patients who require painkillers, such as a COX-<NUM> inhibitor.

The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. Alternatively, or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste <NUM>, for example, without limitation, main groups <NUM> (anti-diabetic drugs) or <NUM> (oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type <NUM> or type <NUM> diabetes mellitus or complications associated with type <NUM> or type <NUM> diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-<NUM>), GLP-<NUM> analogues or GLP-<NUM> receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-<NUM> (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analogue" and "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); 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.

Examples of GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-<NUM>, Byetta®, Bydureon®, a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), 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.

An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia.

The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

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, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies.

Claim 1:
A drug delivery device (<NUM>) comprising:
a body (<NUM>) and a movable component (<NUM>) arranged inside the body;
a dosage selection and injection mechanism (<NUM>, <NUM>) setting the position of the movable component inside the body depending on a selected dosage;
a non-contact sensor configured to output signals indicative of the position of the movable component inside the body; and
a processor (<NUM>) configured to receive the signals output from the non-contact sensor and to determine based on the signals whether the movable component is either in an initial position inside the body corresponding to no selected dosage or in a selected dosage position, wherein upon determining that the movable component has changed its position back from the selected dosage position to the initial position, the processor is configured to cause an indication to be output which informs a user regarding a dwell time of the drug delivery device;
wherein the processor is further configured to cause an indication to be output which informs a user of the end of the dwell time of the drug delivery device;
wherein the non-contact sensor is a capacitive sensor and wherein the body, the movable component and the dosage selection and injection mechanism form at least a part of a dielectric layer of the capacitive sensor; and
wherein the processor is further configured to measure the capacitance of the capacitive sensor when no dosage is selected and the movable component is in the initial position inside the body, to store the measured capacitance as a reference value, to detect a capacitance change when a dosage is selected, to detect a further capacitance change due to an injection and to determine the end of the injection and beginning of the dwell time when the measured capacitance correlates with the reference value.