Device for detecting the dose of medicament delivered from an injection device

Abstract

To address the common need to cost-effectively capture data related to dose and administration time in a self-medication program, the present disclosure presents a device having an attachment (100) and an injection device (200), wherein the attachment (100) is attachable to and detachable from the injection device (200), the attachment (100) houses a control unit (150); and the injection device (200) includes a passive electronic arrangement (300), and the control unit is configured to use the passive electronic arrangement to determine information associated with the dose of the medicament injected.

Description

[0001] The present disclosure relates to an apparatus for detecting the dose of medicament delivered from an injection device, and more particularly to an apparatus comprising a disposable injection device. Background Art

[0002] There are many diseases that require regular treatment by injecting medicaments. Typically, a practicing physician formulates a dosing regimen that governs the timing and dose of the injections that a patient should follow. Thus, the timing and / or dose of the injections can be different between patients and between injections. Usually, as part of the dosing management regimen, it is desirable for the user to record injection parameters, such as to monitor the effectiveness of the treatment or as feedback during the calculation of parameters for subsequent injections. This can be achieved by keeping a manual data log.

[0003] Injections can be administered by medical personnel or by the patient themselves using an injection device. An injection device (i.e., a device capable of delivering a medicament from a medicament container) typically has a syringe barrel connected to the medicament container and a dose dispensing mechanism for driving the medicament through a needle. The medicament chamber can be reusable, in which case the dose dispensing mechanism is designed to be reset, allowing an empty medicament cartridge to be replaced with a new one. Alternatively, the injection device can be disposable, in which case the injection device is disposed of when the contents of the pre-filled medicament container have been emptied. Suitably, the injection device includes a dose setting mechanism that allows the user to set or "dial" the dose of medicament to be administered.

[0004] For example, type 1 and type 2 diabetes can be treated by the patient themselves by injecting insulin doses (e.g., once or several times a day) according to a dosing regimen. WO 2004 / 078241 discloses a suitable injection device commonly known as a pen, and reference to the pen therein can be interchanged with an injection device. A disposable pen is known to be provided with a set of one-way needles that are attached to the pen prior to each use. The insulin dose to be injected and prescribed by the dosing regimen can then be manually selected, for example, by turning a dose knob to the desired volume, via the dose setting mechanism. The dose is then injected by inserting the needle into a suitable skin site and pressing an injection button of the dose dispensing mechanism. As part of the dosing regimen management, the user records the parameters of the injection. Such parameters can be, for example, one or more of the injection date and time, blood glucose results, medication and dose, and / or diet and exercise information. Summary of the Invention

[0005] According to a general aspect of the present specification, there is provided a device including an injection device and an attachment for the injection device. The injection device includes a passive electronic arrangement which, as part of a dose tracking mechanism, can be interrogated to determine information related to the position of parts of the injection device before and after injection. The attachment includes a control unit that provides a signal to the passive electronic arrangement. The attachment is removable from the injection device. The device thus utilizes the reuse of resources by reusing the control unit between injection devices. Accordingly, the cost and resources of the control unit are shared among multiple injection devices. The additional cost associated with providing the passive electronic arrangement for the injection device can be relatively low.

[0006] In an exemplary embodiment, the passive electronic arrangement on the injection device does not generate energy; rather, the control unit provides the necessary energy for the passive electronic arrangement. The electrical parameters of the passive electronic arrangement are based on the position of the parts of the injection device. When the passive electronic arrangement is energized by the control unit, the control unit uses the electrical parameters of the passive electronic arrangement to correlate with the dose of medicament injected. In the case where the injection device includes only the passive electronic arrangement, the passive electronic arrangement is not powered without interacting with the attachment. For example, the control unit of the attachment powers the passive electronic arrangement by applying a signal (e.g., voltage or current) to the passive electronic arrangement. For example, the signal is applied either by inductive coupling between the control unit of the attachment and the passive electronic arrangement.

[0007] In an exemplary embodiment, when the attachment is mounted on the injection device, the attachment can be electrically connected to the injection device. Here, the control unit is electrically connected to the passive electronic arrangement through a connector. Alternatively, in some embodiments, the control unit is inductively coupled to the passive electronic arrangement.

[0008] In an exemplary embodiment, the attachment replaces the cap of the injection device. Here, the attachment is a cap and covers a part or most of a medicament reservoir such as a cartridge or a cavity for holding a cartridge. By using the attachment as a cap to cover and protect the distal end of the injection device, removing and replacing the attachment before and after injection can be used as a trigger to cause the control unit to interrogate the passive electronic arrangement. For example, the attachment includes a switch that is actuated between states by relative movement of the attachment and the injection device. Here, one of the attachment and the injection device can include a latch, and the other can include a cooperating part such as a protrusion. During the attachment and detachment of the attachment and the injection device, the latch latches onto and releases from the protrusion. Accordingly, by the relative movement between the attachment and the injection device, the switch is pushed and pulled between states. Thus, in an exemplary embodiment, the attachment includes a switch that switches between an on and an off state by attachment and detachment of the attachment and the injection device.

[0009] By a relative linear movement in the axial direction, the attachment is suitably attached to and detached from the injection device. For example, the attachment can be attached to and detached from the injection device substantially according to the attachment and detachment of a known cap. For example, the attachment and detachment can additionally include a threaded connection between parts. Here, the attachment and detachment are at least partly achieved by a relative rotation of the parts to engage the threads of the threaded connection. In addition to optionally activating a switch, the relative movement also connects and disconnects a connector. Here, the connector on the attachment is connected to and disconnected from a corresponding connector on the injection device. In an embodiment with a linear movement, the connector on the attachment can slide into contact with the connector on the injection device. The contact can be by the abutment of the attachment and the injection device in the direction of the relative movement. Alternatively, the abutment can be in a direction transverse to the relative movement of the attachment and the injection device, and the elastic properties of one or both of the connectors or one or both of the parts in which the connectors are mounted cause a pressing abutment between the connectors.

[0010] Suitable connectors can be applied. In one exemplary embodiment, the connector is an electrode pad. The electrode pad in the attachment is connected to a control unit. The electrode in the injection device is connected to a passive electronic arrangement. The connection can be a wire or a conductive trace or any other suitable conductive wire.

[0011] The attachment can include an optional display. The control unit controls the display to show information about the injection dosage regimen and can include dosage tracking information. As part of the dosage tracking mechanism, the control unit can process pre-injection and post-injection information to determine the dosage. Alternatively, the control unit can include a communication module, and the communication module can transmit the information to a remote device for processing. Additionally or alternatively, the remote device can run an application or program to monitor the user and warn the user about the injection regimen. Here, the communication module can communicate with the remote device and can display information related to future injections, e.g., dosage and time. By housing the display and / or the communication module on the attachment, the display and the communication module can be reused between injection devices.

[0012] The attachment suitably includes a body that houses the connector and the control unit. Suitably, the body forms a cap to cover a part or a portion of the injection device. Here, the body includes a closed recess that receives the distal end of the injection device. Suitably, the closed recess covers most of the cartridge of the injection device. The body can also house the optional display. The body can include a compartment for housing a power source, e.g., a battery compartment and a battery. By housing the power source on the attachment, the passive electronic arrangement on the injection device is provided with an electrical signal through the connector. Thus, when the attachment is not attached, the passive electronic arrangement is not provided with an electrical signal.

[0013] According to an exemplary embodiment and further aspects, there is thus provided an apparatus comprising an attachment and an injection device. The attachment comprises an optional connector and a control unit. The injection device comprises a passive electronic arrangement and, in some embodiments, a corresponding connector. In some embodiments, the control unit is arranged to provide a signal to the passive electronic arrangement via an electrical connection between the respective connectors. For example, the signal is a voltage or a current. Here, the attachment is attached to the injection device while connecting the connector of the attachment to the connector of the injection device. Alternatively, the control unit is inductively coupled to the passive electronic arrangement. Here, the attachment is attached to the injection device such that the respective inductive components are close to each other.

[0014] In an exemplary embodiment, the control unit comprises an active electronic arrangement. Suitably, the active electronic arrangement comprises a battery or other power source or energy source. The active electronic arrangement forms a circuit via a connector or via a connection of inductive coupling to the passive electronic arrangement. Here, the control unit measures an electrical parameter of the circuit. As described herein, the passive electronic arrangement causes the electrical parameter of the circuit to change as the position of a part of the injection device changes, and the value of the electrical parameter represents the position of the part of the injection device. For example, the electrical parameter can be the resistance or capacitance or inductance of the circuit (and specifically of the passive electronic arrangement).

[0015] In one exemplary embodiment, the passive electronic arrangement comprises a variable electronic resistor. Here, a conductive trace provides a resistive path between two terminals. One or more brushes are arranged to move along the conductive trace in response to the movement of a part of the injection device that moves during an injection. The one or more brushes are connected to the one or more terminals such that the length of the conductive trace between the terminals changes, thereby increasing or decreasing the resistance of the passive electronic arrangement, wherein the change in resistance can be correlated to the movement or position of the part. Here, the control unit applies a signal having a voltage to the passive electronic arrangement and measures the current to determine the resistance or change in resistance of the passive electronic arrangement. The variable electronic resistor can be interrogated by the control unit, which applies signals to the passive electronic arrangement before and after an injection, and the difference in resistance is used to correlate to the displacement of the part. The displacement of the part between its pre-injection position and its post-injection position can further be correlated to the dispensed dose. A dose tracking mechanism comprises calculating the dose based on the displacement of the respective part.

[0016] In an alternative exemplary embodiment, the passive electronic arrangement includes a capacitive sensor. Here, the control unit applies a signal across two plates of the capacitive sensor separated by a gap. The plates of the capacitive sensor are provided by metallic conductive elements. The plates may be printed, or they may be cut from a sheet, or formed in any other suitable manner. As will be apparent from the following description, the plates may not be planar, but instead may be curved. By arranging a part of the injection device to be monitored in the gap between the plates, the capacitance of the passive electronic arrangement can be made to vary based on the movement or position of the part. The control unit measures the capacitance change of the passive electronic arrangement (by applying a signal to the passive electronic arrangement and detecting how it responds) and correlates the measurement with the movement or position of the part.

[0017] Suitably, the two plates of the capacitive sensor are arranged on either side of a part of the injection device. The part includes a volume, the contents of which change in response to movement of the part during an injection process. For example, the passive electronic arrangement may be arranged around a cartridge containing a liquid medicament. The dose tracking mechanism includes calculating the dose by correlating the capacitance change between a pre-injection measurement and a post-injection measurement, the capacitance change being caused at least in part by a change in the amount of liquid medicament in the volume between the plates of the capacitive sensor.

[0018] Alternatively, the dose tracking mechanism includes calculating the dose by correlating the capacitance change between a pre-injection measurement and a post-injection measurement, the capacitance change being caused by different positions of plastic and / or metallic parts in the volume between the plates.

[0019] Suitably, the plates extend along the longitudinal axis of the injection device. In some embodiments, the plates are formed within a label applied to the injection device. For example, the plates may be integrated into an information label that is applied to the injection device and carries user-readable information about the medicament. Here, electrodes or terminals may also optionally be formed on the label for electrically connecting the control unit to the passive electrical arrangement. Advantageously, by forming the passive electronic arrangement as a capacitive sensor with plates formed in a label, the label can be applied to retrofit an existing injection device. Thus, apart from the label, the other parts of the existing injection device remain completely or substantially unchanged.

[0020] In some embodiments, an RFID device is included, which typically includes an RFID chip and an antenna formed by a circuit. In operation, when the RFID device is within the reach of a reader device having an RFID reader, the antenna receives a signal from the reader device and transmits a wireless response signal based on information encoded in the memory of the RFID chip.

[0021] In a representative example that includes an RFID device, the circuit of the antenna is in a closed circuit with a passive electronic arrangement (e.g., completing the circuit and enabling the antenna to transmit a response signal). As explained herein, the passive electronic arrangement is configured to be operatively coupled to the movement of one or more components of the injection device. In this way, when the position of the components of the drug delivery device (e.g., parts of the dose dispensing mechanism) changes during that time, the configuration of the passive electronic arrangement in the circuit of the RFID device changes correspondingly. Accordingly, the resonant frequency of the RFID device changes, and this change indicates a change in the position of the components. Thus, the change in position is an indication of the dose dispensed during the dose dispensing operation.

[0022] For example, if 10 units of a medicament are delivered from the injection device in the case of a corresponding movement of the dose dispensing mechanism, the passive electronic arrangement is adjusted to correspond to the amount of 10 units, and this in turn causes a change in the resonant frequency of the RFID device, the change indicating a change of 10 units of the dose dispensing mechanism. As an illustrative example, the RFID device has a default resonant frequency of 13.00 MHz, and the passive electronic arrangement in the circuit of the RFID device is coupled to the dose dispensing device such that a change in the position of the dose dispensing mechanism causes the resonant frequency to change by +0.1 MHz for each unit dose dispensed by the dose dispensing device by changing the characteristics (e.g., resistance, capacitance, or inductance) of the circuit of the RFID device. Thus, after dispensing 10 units of the dose (and before resetting the position of the dose dispensing device), the resonant frequency of the RFID device changes to 14.00 MHz. This new resonant frequency, as read by an RFID reader, can be used as an indication that 10 units of the dose have been dispensed from the drug delivery device.

[0023] In some embodiments, the RFID chip is partially formed on an attachment and connected to the passive electronic arrangement by an electrical connector. Alternatively, the circuit of the RFID device can be formed on the injection device (e.g., within a label), and the control unit can include an RFID reader to inductively couple to the RFID device.

[0024] According to an exemplary embodiment and further aspects, there is thus provided an apparatus comprising an attachment, an injection device, and a processor for signal processing. The processor may be integral with the attachment (e.g., housed in a body), or the processor may be remote from the attachment (e.g., in a remote device). In an exemplary embodiment having the processor in a remote device, the attachment includes a communication module for transmitting information to a remote device such as a smart phone, a tablet computer, a smart watch, or other stand-alone device (e.g., a laptop computer or a PC). In some exemplary embodiments, a control unit controls the communication module to transmit the acquired information to the remote device for processing. Thus, the main electronic processing is done by the remote device using the electronics of the remote device, which then need not be replicated on the attachment. Suitably, a power supply powers the control unit and enables the controller to supply signals to the passive electronic arrangement via a connector, the communication module, and a display as required. Suitably, the power supply is housed in the body of the attachment.

[0025] In an exemplary embodiment, the processor performs processing steps for calculating the displacement of a corresponding part moving during an injection. The processor may convert the displacement into a dispensed dose measurement depending on the part being monitored. Where the processor is remote from the attachment, the processor may cause the measurement to be transmitted to the attachment. Here, the control unit includes a communication module for receiving the dose measurement. The controller controls the communication module, and the controller may control the communication module to transmit the delivered dose to a display. Here, the display is housed in the body of the attachment. The display is arranged to face the user and may be opposite the connector. A power supply is provided to power the display, the controller, and the communication module. The display may also display other information received by the communication module, such as the time or dose of the next injection. Additionally or alternatively, the processor may transmit the dose measurement for storage in an electronic log. For example, the processor may communicate with an electronic log program, etc., or as part of an integrated electronic log program, the processor may process images.

[0026] In some exemplary embodiments, the attachment includes one or more switches. The switches may interact with the controller of the control unit to know when to interrogate the passive electronic arrangement and when to transmit information to the remote device or the display via the communication module. The switches may be manually operated to indicate events before and after an injection has occurred. Alternatively, one or more switches may be automatically activated to indicate one or more events during the injection process. For example, the switches may be automatically activated to indicate the removal of the attachment from the injection device or the operation of a dose dispensing mechanism or a dose setting mechanism.

[0027] In an exemplary embodiment including a controller, the controller may include a memory for storing information from one or more interrogations of the passive electronic arrangement and auxiliary information such as the time and date of the interrogation.

[0028] In an exemplary embodiment including a communication module, the communication module may be a wireless communication module. Preferably, the wireless communication module is a short-range communication module. The operating method may include a user completing a pairing step to pair the communication module to a remote device, thereby establishing a one-way or two-way communication mode.

[0029] The axial direction is the direction along the axis of the injection device, e.g., coaxial with the axis of the syringe barrel or the direction of movement of the stopper of the medicament chamber. In an exemplary embodiment, the attachment is attached to the injection device by relative movement in the axial direction (and herein referred to as the engaging movement) between the attachment and the corresponding injection device. The engaging movement may be in the proximal-distal direction or in the opposite distal-proximal direction in the axial direction. Here, the proximal-distal direction is from the dose dispensing mechanism towards the cartridge, and the distal-proximal direction is the opposite, from the cartridge towards the dose dispensing mechanism.

[0030] In an exemplary embodiment, the attachment includes an attachment portion that restricts relative movement between the attachment and the injection device in a direction opposite to the engaging movement. In an exemplary embodiment, the abutment between the attachment portion and the injection device provides the restriction of movement. Thus, the attachment portion includes means for attaching the attachment to the injection device. Here, the attachment portion restricts relative movement between the attachment and the injection device in at least one direction. Advantageously, the restricted movement allows the attachment to be physically attached and held to the injection device. Suitably, the body includes the attachment portion.

[0031] In an embodiment including a linear engaging movement along one of the axial directions, the attachment portion and the injection device may be arranged to engage at a tapered portion. Here, at least one of the corresponding parts is tapered such that the parts engage cooperatively by friction. In one embodiment, the attachment portion is tapered. Here, the tapered portion of the attachment portion includes a first region forming opposing points spaced around the pen and a second region having opposing points spaced around the pen, wherein the distance between the points in the first region is less than the distance between the points in the second region. Thus, the restricted movement is provided by the frictional force generated by the force applied by the engaging movement. Additionally or alternatively, the injection device is tapered at the connection region adapted to receive the attachment.

[0032] In additional or alternative embodiments including a linear engaging movement, the attachment part and the injection device may be arranged to provide a positive location. For example, one of the injection device or the attachment part includes an elastic part, and the other part is arranged to move over the elastic part. Here, the elastic part provides a local restriction on the separation distance between the parts. Pushing the two parts together by the engaging movement and causing the corresponding parts to move over the elastic part creates a positive location that provides feedback to the user that the attachment has been completed. It also provides an initial resistance to the removal of the attachment in the opposite disengaging movement direction.

[0033] In some embodiments, the attachment part may include a locator for positioning the attachment on the injection device. Suitably, the locator provides a rotation key to align the attachment and the injection pen in a rotationally aligned manner relative to the axial direction. Suitably, the key prevents rotational movement of the attachment relative to the injection device when attached via a linear engaging movement along the axial direction. Here, the attachment part and the injection device are arranged to have cooperating alignment features. The cooperating alignment features may include an asymmetric cross-section relative to the axial direction, or may include protrusions and recesses on the respective parts. The locator aids in the alignment of the corresponding connectors.

[0034] In an exemplary embodiment, the attachment part engages the injection device at the midpoint of the injection device. In an exemplary embodiment, the attachment is adapted to be attached to an injection device that is a pen-type device. The pen includes a medicament chamber, a dose dispensing mechanism, and a dose setting mechanism. Suitably, the dose dispensing mechanism and the dose setting mechanism are assembled in a housing. Here, the housing may provide a connection to attach the medicament chamber, or the medicament chamber may also be assembled within the housing. In some exemplary embodiments, the housing is covered with an information label. Suitably, the information label may include a removable section for exposing a window. For example, the label may be formed with an area defined by a perforation, and the user may remove the area defined by the perforation before attaching the attachment.

[0035] In an exemplary embodiment, the injection device includes a housing, and the housing provides a receiving portion to receive the attachment part of the attachment. The receiving portion cooperates with the attachment part to position and fasten the attachment to the injection device. The receiving portion may include a locator corresponding to the locator of the attachment to aid in the alignment of the attachment with the window. Suitably, the receiving portion may be arranged adjacent to the medicament chamber or adjacent to the connection between the housing and the medicament chamber.

[0036] According to an exemplary aspect, there is thus provided an apparatus comprising an attachment and an injection device 200. The attachment includes a body that houses a connector and a control unit. The body defines an attachment portion for attaching the attachment to the injection device. The injection device includes a cartridge assembly assembled to a housing. The housing contains a dose dispensing mechanism and a dose setting mechanism. The dose dispensing mechanism includes a part that moves relative to a reference in response to movement of the dose setting mechanism. Wherein the attachment portion is particularly adapted to align the connector of the attachment with the connector of the injection device. The attachment and the injection device may be provided as a kit of parts or separately for use with each other.

[0037] According to a further aspect, there is provided a method of managing a dosing regimen. The method includes using a control unit of an attachment to provide signals to a passive electronic arrangement before and after an injection to determine displacement of parts of the injection device and, as part of a dose tracking mechanism, electronically logging the results. The method further includes attaching the attachment of the foregoing aspect to the injection device to form the apparatus of the foregoing aspect.

[0038] The method may include operatively connecting an attachment portion of the attachment to a receiving portion of the injection device. The step of operatively connecting the attachment portion and the receiving portion includes moving the attachment portion relative to the injection device. The step of operatively connecting the attachment aligns the connector of the attachment with the connector of the injection device. The step of operatively connecting the attachment may include aligning and engaging a key on the attachment with a key on the injection device to rotationally align the corresponding connectors.

[0039] Suitably, the method includes steps of removing and replacing the attachment on the injection device before and after an injection. Herein, suitably, a switch is automatically activated by removing and attaching the attachment to the injection device. Suitably activating the switch causes the control unit to provide a signal to the passive electronic arrangement.

[0040] The method may include a pairing step for pairing the attachment with a remote device. For example, pairing a communication module in the attachment with a corresponding module in the remote device. Pairing may be initiated by operating a switch of the attachment etc.

[0041] In an exemplary method, the pre-injection measurement step includes causing the control unit to provide a signal to the passive electronic arrangement, such as by applying power to the passive electronic arrangement to measure a characteristic of an electrical parameter of the passive electronic arrangement. And the post-injection measurement step includes causing the control unit to provide a signal to the passive electronic arrangement, such as by applying power to the passive electronic arrangement to measure a characteristic of an electrical parameter of the passive electronic arrangement. The pre-injection and post-injection measurement steps may be initiated by operating a switch of the attachment. In another event, the switch may be operated manually or automatically. The measurement step may include causing a communication module to transmit information to a remote device. The information may be transmitted after injection is completed or during the course of the entire injection.

[0042] In an exemplary embodiment, the method includes processing information to calculate a displacement of a part of a monitored injection device. The processing may be done by a processor of a remote device. The processing suitably includes the step of converting the calculated displacement into a dose measurement.

[0043] The processor for the processing step may be part of a remote device. Here, the exemplary embodiment includes the step of sending pre-measurement information and post-measurement information to the processor. Suitably, the transmission is done by a communication module of an attachment. Here, the communication module may also be paired with the remote device to receive the transmission. For example, the attachment may include a display, and the method includes controlling the attachment to operate the display to show information received from the remote device.

[0044] In an exemplary embodiment, the method includes the step of entering a dose calculation as part of an electronic log to record the dose measurement. The electronic log may also enter details of the injection, such as the injection time based on the time when the processor receives the information.

[0045] According to an exemplary embodiment, the method includes the step of repeatedly entering dose measurements of subsequent injections. The method further includes removing the attachment from a first injection device and re-attaching the attachment to a second injection device. For example, when the first injection device is emptied, the attachment is removed and replaced on a second replacement injection device in which the medicament is retained.

[0046] According to an exemplary embodiment, therefore, there is provided an improved attachment for an injection device, a device including the attachment and one or more injection devices, and a method of managing a dosing regimen as set forth in the appended claims. From the description of the present application and elsewhere, other features of the main improvements will become apparent. As part of the dose management method, by monitoring the movement of parts of the injection device using the attachment, the dose measurement can be electronically recorded. In addition, by housing the control unit in the attachment, resources such as the communication module and the power source can be shared among multiple injection devices. Description of the Drawings

[0047] The exemplary embodiments are described with reference to the accompanying drawings, in which:

[0048] FIG. 1 shows an exploded view of an injection device;

[0049] FIG. 2 shows an exploded parts view of the injection device of FIG. 1;

[0050] FIG. 3 shows a partial cross-sectional view through the gripping end of the assembled injection device shown in FIG. 2;

[0051] Figures 4 and 5 are illustrations of parts of Figure 3, showing conductive traces forming a variable electronic device for dose tracking;

[0052] Figure 6 is a schematic illustration of an injection device and sensor components for capacitively sensing an injection state;

[0053] Figures 7 and 8 show perspective views of an attachment for an injection device, from a front view and a rear view respectively;

[0054] Figure 9 shows a perspective view of the device, showing the attachment assembled to the injection device, with and without areas shown removed for illustrative purposes;

[0055] Figure 10 shows a schematic diagram of a switching device for a device comprising an injection device and an attachment;

[0056] Figure 11 shows a schematic plan view detailing a control layout; and

[0057] Figure 12 shows a method of managing a dosing regimen.

[0058] Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings, wherein like reference numerals always refer to like elements. Detailed Description

[0059] Figure 1 is an exploded view of an injection device 200 suitable for use in an exemplary embodiment. The injection device shown is commonly referred to as an injection pen or pen. Various designs of pens are known, and although a brief description is given herein, it will be understood that the specific construction of the pen may vary and differ from the following description.

[0060] The injection device 200 has a distal end and a proximal end. The term "distal" refers to a position relatively closer to the injection site, and the term "proximal" refers to a position relatively further away from the injection site.

[0061] The injection device 200 includes a grip assembly 202, a cap 203, and a needle assembly 204. The grip assembly is formed by a housing 210 and a cartridge assembly 220. The cartridge assembly 220 includes a cartridge holder 222 for containing a cartridge 224 that contains a medicament. As shown, the housing 210 is substantially cylindrical and has a substantially constant diameter along its longitudinal axis from a proximal end to a distal end. The longitudinal axis has a proximal-to-distal direction extending from the proximal end to the distal end and a reverse distal-to-proximal direction. A label 211 (shown in FIG. 9) is provided on the housing 210. The label 211 includes information about the medicament included in the injection device 200, including information identifying the medicament. The information identifying the medicament may be in the form of text. The information identifying the medicament may also be in the form of a color. The information identifying the medicament may also be encoded as a barcode, QR code, etc. The information identifying the medicament may also be in the form of a black and white pattern, a color pattern, or a shade.

[0062] The cartridge assembly 220 is assembled to the housing 210 to form the grip assembly 202. Suitably, the proximal end of the cartridge assembly 220 includes a connecting part (not shown), and the distal end of the housing 210 includes a corresponding connecting part (not shown) that engage with each other cooperatively to connect the two parts. As shown, the cartridge holder 222 is substantially cylindrical and has a hollow receiving portion for the cartridge 224. The cartridge includes a stopper 228 that can be advanced within the cartridge 224 during use to expel the medicament from the cartridge 224. Here, it will be understood that during injection, the needle assembly 204 cooperates with the grip assembly to act as a conduit for the medicament.

[0063] The cartridge holder 222 has an orifice 226 on one of its sides. When the cartridge 224 is contained in the cartridge holder 222, the orifice 226 allows the user to observe the cartridge 224 through the orifice 226. FIG. 1 shows the stopper 228 of the cartridge 224 visible through the orifice 226. FIG. 1 shows the cartridge holder 222 having one orifice 226. However, the cartridge holder 222 may alternatively have more than one orifice 226. For example, the cartridge holder 222 may have a first orifice 226 located on one side of the cartridge holder 222 and a second orifice located on a second side (in some cases the opposite side) of the cartridge holder 222. Thus, a first side of the cartridge 224 within the cartridge holder 222 may be visible through the first orifice 226, while a different second side of the cartridge 224 may be visible through the second orifice. Other orifice configurations may be used.

[0064] The needle assembly is shown as including a needle 206, an inner needle cap 207, and an outer needle cap 208. The needle 206 of the needle assembly 204 may be attached to the cartridge holder 222 such that the needle 206 is in fluid communication with the medicament in the cartridge 224. The needle 206 is protected by the inner needle cap 207 and the outer needle cap 208.

[0065] A removable cap 203 is attached to the cartridge assembly. When attached to the gripping assembly, the cap 203 at least partially covers the cartridge holder 222 and thus covers the cartridge 224. The cap 203 can also be attached to the gripping assembly such that it at least partially covers the cartridge holder 222 in the presence or absence of one or more of the needle 206, the inner needle cap 207, or the outer needle cap 208.

[0066] The cartridge holder 222 can have a cap retention feature 223 on an outer surface (e.g., adjacent the proximal end of the cartridge holder 222 and adjacent the attachment to the housing 210). Thus, when assembled, the cap 203 can substantially cover the cartridge assembly. The cap retention feature 223 engages a corresponding coupling feature on the inner surface of the cap 203 to hold the cap 203 in place when attached to the gripping assembly. The cap retention feature 223 can include one or more of ridges, grooves, bumps, locks, and / or dimples. In some examples, the cap retention feature is located on the housing 210 of the injection device 200.

[0067] As shown in FIG. 2, the housing 210 houses a dose dispensing mechanism and a dose selection mechanism. The dose setting mechanism is used to select the dose to be injected and to activate the dose dispensing mechanism to inject the dose. In this case, the dose dispensing mechanism is activated to drive a stopper 228 towards the distal end of the cartridge 224. The injection device 200 can be used for a number of injection procedures until the cartridge is emptied or the injection device 200 reaches an expiration date (e.g., 28 days after first use). The injection device 200 can be single-use or reusable.

[0068] To drive the stopper 228 into the cartridge 224, the dose dispensing mechanism includes a piston rod 232, a drive sleeve 234, and a trigger button 236, which act together to drive a pressure plate 237 against the stopper 228 and into the cartridge 224. The dose of medicament or drug to be dispensed from the drug delivery device 200 is selected by turning a dose knob 242, which is connected to a dose dialing sleeve 244 via a threaded insert 243, wherein rotation of the dose knob 242 causes the selected dose to be displayed in a dose window 212 in the housing 210 and causes a latch 250 to interact with the drive sleeve 234 via a spring clutch 252. The dose knob 203, the dose dialing sleeve 230, and the latch 250 together act as a dose setting mechanism. The dose dialing sleeve 244 is arranged around the latch 250, which includes a feedback mechanism 251 that generates a tactile or audible feedback as the dose dialing sleeve 244 rotates. The latch 250 is coupled to the drive sleeve 234 by a metal clutch spring 252.

[0069] The final dose nut 260 (LDN) is set on the drive sleeve 234. The final dose nut 260 is advanced by each dose dispensing operation to track the total dosage remaining in the cartridge 224. The trigger button 236 is depressed to initiate a dose dispensing operation of the drug delivery device 200. The drive sleeve 234 includes flanges 262 and 264 that project from the drive sleeve. For example, the flanges may be radial flanges. The LDN 260 is a threaded part and is suitably a half nut. The drive sleeve includes a bolt section that typically extends between the two flanges. As the drive sleeve rotates by corresponding rotation of the dose setting mechanism, the LDN 260 is moved along the drive sleeve by the cooperation of the corresponding threads. The LDN is suitably arranged to move from flange 262, which is the smallest flange that indicates the starting position of the LDN when the LDN abuts the flange and the cartridge is full. When each dose is injected, the LDN moves repeatedly along the drive sleeve. The LDN is advanced in response to rotation of the dose setting mechanism, but does not translate relative to the drive sleeve as the drive sleeve is driven during the dose dispensing operation. The LDN abuts another flange, which is the largest flange that prevents the LDN from moving and thus prevents the dose selection mechanism from selecting a dose that would exceed the remaining dose in the cartridge.

[0070] While the dose setting mechanism is shown above as the dose knob 242, the dose selection sleeve 244, and the latch 250, those skilled in the art will understand that any number of different dose setting mechanisms are available in the art for the purpose of setting the dose of a drug delivery device, and aspects of the present disclosure are compatible with other such dose setting mechanisms. Similarly, while the dose dispensing mechanism is shown as including the piston rod 232, the drive sleeve 234, and the trigger button 236, those skilled in the art will understand that many different dose dispensing mechanisms (e.g., drive mechanisms) are available in the art for the purpose of delivering or dispensing the dose of a drug delivery device, and aspects of the present disclosure are compatible with other such dose dispensing mechanisms.

[0071] Continue the operation of the drug delivery device 200 by turning the dose knob 236 such that mechanical clicks are caused by rotating the dose selection sleeve 244 relative to the latch 250 to provide acoustic feedback to the user. The numbers displayed in the dose display 212 are printed on the dose selection sleeve 244, which is contained within the housing 210 and mechanically interacts with the drive sleeve 234 via a metal spring clutch 252. When the injection button 236 is pushed, the drug dose displayed in the display 212 will be expelled from the drug delivery device 200. During the dose setting operation, the drive sleeve 234 rotates helically while the dose selection sleeve 234 spirals outward in the distal-proximal direction. When the injection button 236 is pushed, the drive sleeve 234 is released and advanced distally, which causes the rotation of the piston rod 232. The rotation of the piston rod 232 drives the pressure plate 237 against the stopper 228 of the cartridge 224, which drives the stopper 228 into the cartridge 224 to expel the medicament from the cartridge 224. A more detailed description of a representative drug delivery device is described in U.S. Patent No. 7,935,088B2, issued May 3, 2011.

[0072] Figure 3 shows the drug delivery device 200 at the end of the dose setting operation and prior to the dose dispensing operation, where the dose selection sleeve 244 and the drive sleeve 234 rotate helically relative to the housing 210 and the threaded end 233 of the piston rod 232 to set the dose. The final dose nut 260 is shown advancing along the drive sleeve 234 from an initial position to a position indicating the remaining dose in the drug delivery device 200. Upon dose dispensing of the injection button 236, the drive sleeve 234 is advanced into the housing 210 and the bearing nut 280 causes the rotation of the piston rod 232. The bearing nut 280 seats into a fixture within the housing 210 and has a thread engagement with the piston rod 232. When the piston rod 232 rotates, the piston rod 232 screws forward (relative to the housing 210) because the bearing nut 280 cannot move. The rotation of the piston rod 232 drives the piston rod 232 and the pressure plate 237 proximally in the proximal-distal direction to drive the stopper 228 into the cartridge 224. Once dispensed, the drive sleeve is in a non-dose selection position.

[0073] The dose of medicament to be expelled from the injection device 200 can be selected by turning the dose knob 242 and then displayed (e.g., in multiples of international units (IU)) via the dose window 212. An example of the selected dose displayed in the dose window 12 can be, for example, '30' IU, as shown in FIG. 1. It should be noted that the selected dose can be displayed equally well differently, e.g., by means of an electronic display.

[0074] Rotating the dose knob 242 causes a mechanical click to provide acoustic feedback to the user. The numbers displayed in the dose window 212 are printed on a sleeve 244 contained within the housing 210. When the needle 206 is inserted into a skin portion of a patient and then the injection button 236 is pushed, the dose of medicament displayed in the display window 212 is discharged from the injection device 200. When the needle 206 of the injection device 200 remains in the skin portion for a certain time after pushing the injection button 236, a higher percentage of the dose is actually injected into the patient. The discharge of the medicament dose also causes a mechanical click, which, however, is different from the sound generated when using the dose knob.

[0075] Although the pen injection device has been briefly described, other injection devices are conceivable, as known in the art.

[0076] In an exemplary embodiment, a passive electronic arrangement 300 is included on the injection device. The passive electronic arrangement can be measured by a signal that indicates information that can be associated with the position of a part of the dose dispensing mechanism, or the displacement of a part of the dose setting mechanism, or the displacement of a stop. The parts of the passive electronic arrangement 300 are operatively connected to a movable member, wherein the movement of the parts causes a change in the electrical characteristics of the passive electronic arrangement. Thus, the passive electronic arrangement can be measured to provide the displacement of the parts. Here, the displacement is calculated as the difference between the position of the corresponding part before injection and the position of the part after injection. Typically, the displacement is measured as a linear distance along the axis of the injection device.

[0077] An example of a suitable passive electronic arrangement is a variable resistor 302, which includes a conductive electrode disposed on a trace, and wherein the conductive electrode is connected to a movable member of the dose dispensing mechanism, or the trace is connected to a movable member of the dose dispensing mechanism. Suitably, as shown in FIGS. 4 and 5, these figures are illustrations of a dose dispensing mechanism including conductive electrodes 310, 312, which are disposed in separate traces 311, 313 to form a variable resistor 302 for use in a dose tracking mechanism. As will be appreciated, the variable resistor 302 can be connected to a plurality of moving parts of the injection device. The change in resistance corresponding to the change in length of the variable resistor is used as a measure of the displacement of the parts.

[0078] A suitable aspect is based on using a change in the length of a variable resistor 302 to indicate the displacement of the position of a piston rod 232 (e.g., a lead screw), which is a key component of the dose dispensing mechanism of a drug delivery device 200 for dispensing a pharmaceutical dose. When dispensing a dose, the position of the piston rod 232 changes relative to the bearing nut 280 by rotating relative to the bearing nut 280 and thus moving proximally along the axis of rotation. By arranging the two terminals of the variable resistor to be connected via a resistive trace of variable length, the length of the resistive trace between the terminals changes with the position of the piston rod 232, and a signal can be applied across the terminals and a control unit for measuring the resistance of the passive electrical arrangement. In this case, the signal can be a DC signal of a specific voltage (i.e., a non-changing signal), but alternatively, it can be an AC signal.

[0079] More specifically, FIG. 4 shows the piston rod 232 having embedded conductive elements 310, 312 and fixed brushes 316, 318 (e.g., conductive brushes) that form a variable resistor 302. The conductive elements form the resistive trace, and the fixed brushes act as the terminals of the variable resistor, where the length of the connected terminals of the resistive trace changes with the movement of the piston rod. Thus, the resistance of the passive electrical arrangement changes as the fixed brushes 316, 318 move along the embedded conductive elements 310, 312. The piston rod 232 has threads that include two parallel-oriented grooves 311, 313 that spiral along the axis of the piston rod 232. The conductive elements 310, 312 are embedded along the length of each of the two parallel-oriented grooves 311, 313 without interfering with each other, except that they are electrically connected at one end of the groove to create an open circuit across the brushes 316, 318. It will be understood that the conductive elements can alternatively be applied to the peaks between the grooves.

[0080] In operation, the piston rod 232 is driven proximally by the drive sleeve 234, and the grooves 311, 313 thread through the bearing nut 280 such that proximal movement of the drive sleeve 234 causes the piston rod 232 to rotate and thus pass through the bearing nut 280. The fixed brushes 316, 318 are disposed on the bearing nut 280 or otherwise fixed to the housing 210. A signal is applied to the variable resistor 302, and its resistance is measured (e.g., by dividing the applied voltage by the measured current flowing through the variable resistor). As explained herein, suitably, the signal is a non-changing signal or an AC / change signal that is generated by a signal generator and associated control circuitry disposed on an accessory and that is part of the control unit.

[0081] The resistance across brushes 316, 318 changes due to a change in the total length of the conductive elements 310, 312 between the brushes 316, 318. For example, as shown in FIG. 3, the fixed brushes 316, 318 contact the conductive elements 310, 312 near the proximal ends of the grooves 311, 313. The conductive elements 310, 312 are electrically connected together at either the proximal or distal ends of the grooves 311, 313, but not at both simultaneously. If at the distal ends, the circuit path from one brush 316 to the other brush 318 is down along the entire length of the first groove 311 and back up along the entire length of the second groove 313, with the piston rod 232 in a condition representing the highest resistance configuration of the system. As the piston rod 232 is driven through the bearing nut 280, the brushes 316, 318 move along the grooves 311, 313, and as the total length of the conductive elements 310, 312 between the brushes 316, 318 decreases, the resistance across the brushes 316, 318 also decreases.

[0082] Alternatively, if the conductive elements 310, 312 are electrically connected together at the proximal ends, the reverse configuration holds, and the resistance across the brushes 316, 318 is at a minimum as shown and increases as the piston rod 232 is driven through the bearing nut 280, and the total length of the conductive elements 310, 312 between the brushes 316, 318 increases.

[0083] In some cases, each specific resistance value represents a position of the piston rod 232, and thus the resistance corresponds to the amount of dose discharged from the cartridge 224 through the piston rod 232. In other cases, the change in resistance corresponds to a change in position and thus is proportional to the amount of the medicament. Therefore, the relative change in resistance, compared to the initial resistance (e.g., before injection or before first use), corresponds to the magnitude of the amount of medicament dose that has been discharged.

[0084] In some embodiments, the variable resistor 302 is used to modify the resonant frequency of the antenna of the RFID device 350 such that a change in the resistance causes a corresponding change in the resonant frequency of the RFID device 350. Typically, the RFID device 350 includes an RFID chip 351 and an antenna 353. A passive electronic arrangement (such as the variable resistor 302) forms part of the antenna circuit. In operation, the antenna 353 absorbs an incoming wireless reader signal from an external RFID reader (not shown) and forms a weak magnetic field that generates a current in the antenna to provide power to the RFID chip 351. The RFID chip 351 includes a memory that stores information related to, for example, a drug delivery device or a medicament contained therein. When power is provided to the RFID chip 351, the RFID generates a response signal in the antenna 353, which transmits the information from the RFID chip 351 to the memory as a wireless signal. This wireless signal can be received by an external RFID reader that transmitted the reader signal or by another nearby device. Here, the RFID device 350 is used to determine the resistance of the variable resistor 302 by modulating the resonant frequency of the RFID device according to the position of the plunger rod. In FIG. 4, the RFID device is shown connected across the brush.

[0085] FIG. 5 is a schematic diagram of an alternative configuration where the RFID device 350 is connected across the closed ends of the conductive elements 310, 312 and the brush 352 completes the circuit across the conductive elements 310, 312 at variable positions along the grooves 311, 313. In an example embodiment, the electrical characteristics (e.g., resistance) of the circuit of the RFID device vary according to the position of the final dose nut of the injection device. For example, the final dose nut includes a brush and the threads along which it travels include a current-carrying / conductive trace having a certain resistance. The resistance value varies with the position of the final dose nut. Adding this resistance to the RFID circuit will result in a slightly modified frequency. The value of the modified or detuned frequency can be determined by the RFID reader when receiving the signal. The amount of detuning is proportional to the distance the final dose travels along the thread. When the frequency varies with the position of the final dose nut, each position can be identified by a certain amount of detuned frequency. In some cases, when the resistance of the trace is known, the system can be calibrated during manufacturing. In some cases, the frequency difference related to the initial frequency is taken as a measure, and this difference is used to calculate the amount of medicament delivered or remaining.

[0086] In another suitable example of a passive electronic arrangement, FIG. 6 discloses an example where a capacitance sensor 400 is used to allow detection of the displacement of a dose setting mechanism. Alternatively, by placing the capacitance sensor 400 to monitor the cartridge, the capacitance sensor can be used to detect the volume of the medicament in the chamber of the cartridge.

[0087] Referring to FIG. 6, reference cartridge 224 and movable member 228 are shown in a simplified schematic illustration of an injection device and a passive electrical arrangement for capacitively sensing the state of the injection device.

[0088] As described herein, operatively connected to the movable member are a rotary knob 242 for dose selection and a dispensing button 236. By rotating the rotary knob 242, the user can select the dose to be dispensed. The dispensing button 236 can then be actuated to cause the movable member to move as the medicament is dispensed.

[0089] The outer side of the cartridge 224 includes two metal layers or plates 410, 420 arranged opposite each other. The metal layers or plates 410, 420 are connected in a circuit to form a capacitor, which is referred to in this specification as a capacitance sensor. The two layers 410, 420 can only cover a part of the outer side of the cartridge 224, and each layer can include electrical connectors 412, 422 for connection to the control unit of the injection device. The metal layers or plates 410, 420 can extend along the longitudinal axis of the housing 210 over a range that includes substantially the entire displacement of the movable member 228 inside the housing 210, as shown in FIG. 6 by the double arrow at the top and the vertical dashed line. As described herein, the processor together with the power source is suitably housed in an accessory. Here, the processor causes an indication of the measured capacitance, for example, by applying an alternating current signal to the capacitance sensor and detecting the phase difference between the voltage and current components of the signal, or by applying a charging (direct current) signal to the capacitance sensor and subsequently monitoring the voltage decay caused by the discharge of the capacitance of the capacitance sensor through a resistive element within the accessory or the injection device.

[0090] By rotating the rotary knob 242 according to the selected dose and actuating the dispensing button 236 to displace the stopper 228 relative to the cartridge 224, the volume of the medicament within the cartridge 224 is changed from the larger fluid volume 430' shown at the bottom of FIG. 6 inside the cartridge 224 to the smaller fluid volume 430.

[0091] The change in the fluid volume 430 and the displacement of the movable member 228 inside the cartridge 224 affect the dielectric constant of the dielectric layer formed between the metal layers 410, 420. This in turn results in a change in the capacitance of the capacitor formed by the metal layers 410, 420 and the dielectric layer therebetween and formed by the fluid volume 430, the cartridge 224, and the movable member 228. The graph at the bottom of FIG. 6 shows the change in capacitance as a function of the displacement of the movable member 228. At position (1), the capacitance is high because the movable member 228 is fully moved into the cartridge 224 and the fluid volume 430 is as small as possible. Accordingly, the dielectric constant is higher than the dielectric constant at position (2), where the movable member 228 is moved out of the cartridge 224 and the fluid volume 430' is as large as possible. Thus, the capacitance decreases from position (1) of the movable member 410 to position (2) of the movable member 410. This change in capacitance is measurable and can be used to inform the user of the status of the injection device.

[0092] In an exemplary embodiment, the metal layers 410, 420 are provided in a label 211 attached to the injection device. Here, the metal layers 410, 420 are formed in separate parallel regions on the label 211, and when the label 211 is wrapped around the corresponding parts of the injection device, the metal layers 410, 420 form opposing metal layers 410, 420. For example, each metal layer 410, 420 can form part of a semi-cylindrical or cylindrical surface. The label 211 can also include a shield to shield the metal layers from external electromagnetic pulses.

[0093] The movable member can include a metal portion to increase the difference between the dielectric constants as the part moves further into the space between the metal layers. Typically, other parts such as the housing 210 and the cartridge assembly 220 are made of plastic, for example, ABS (acrylonitrile butadiene styrene) or POM (polyoxymethylene).

[0094] Referring to FIG. 7, an attachment 100 is shown. The attachment 100 is adapted to be attached to an injection device 200. Suitably, the attachment 100 replaces the cap 203 of the injection device. The attachment 100 includes a body 110 that houses a control unit, a connector 120, and an optional display 140.

[0095] The body 110 forms a cavity 112 to receive the distal end of the injection device. The cavity has a closed distal end and an open proximal end. The injection device is inserted by relative movement of the injection device and the attachment 100 along the longitudinal axis. The body is sized to cover the distal end of the injection device. Suitably, the attachment 100 covers most of the distal end, for example, the attachment covers the cartridge assembly 220. Here, the proximal opening of the attachment may be arranged to connect to the injection device (such as a housing or a cartridge holder). The attachment and the injection device may include a press fit such that the attachment has a forced stop and the cooperation between the corresponding parts when assembled together provides a forced holding force between the attachment and the injection device.

[0096] The attachment is arranged to be removable from the first injection device before injection and, as known, to be replaced together with the cap 203 after injection and to substantially replace the function of the cap 203. The attachment is also suitably arranged to be removably attached to the second and subsequent injection devices. Thus, the attachment can be reused. Here, since the attachment includes the operating parts of the dose tracking mechanism, the operating parts can be reused between injection devices and especially between disposable injection devices, thereby saving resources.

[0097] The connector 120 is an electrical connector that electrically couples and decouples the attachment 100 to and from the injection device. As explained herein, the injection device includes a passive electronic arrangement. The connector 120 allows the control unit housed in the attachment 100 to be connected to the passive electronic arrangement in the injection device. Thus, the connector 120 of the attachment 100 is electrically coupled to the control unit, for example, by conductive traces or wirings within the body 110. Similarly, a corresponding connector is provided on the injection device, wherein the connector is electrically coupled to the passive electronic arrangement, for example, by conductive traces or wirings passing through a label or a housing.

[0098] In FIG. 8, the connector 120 is shown as a first electrode 121 and a second electrode 122. This provides two electrical connection lines. It will be understood that additional electrodes may be provided based on the specific passive electronic arrangement employed, or only one electrode may be provided as required. Suitably, the injection device also includes corresponding electrodes, wherein the electrodes form part of the passive electronic arrangement.

[0099] Suitably, each of the electrodes 121, 122 is a conductive pad or the like known in the art. Here, when the attachment is attached to the injection device, the conductive pads on the attachment and the corresponding conductive pads on the injection device are arranged to contact each other. For example, as shown in FIG. 9, when the attachment is attached to the injection device, the conductive pads contact by sliding over each other.

[0100] It will be understood that the body 110 of the attachment houses the connector 120 for alignment with a corresponding connector on the injection device. In the case where the corresponding connector on the injection device is arranged to be spaced apart from the part of the injection device covered by the attachment (when attached), the attachment may include a projection 114 to extend the body 110, as shown in FIG. 8, so as to cover the connector.

[0101] Returning to FIG. 7, the attachment includes an optional display. The optional display 140 is housed in the body 110 of the attachment, for example on the upper side (or user-facing side). The display 140 may be an electronic ink display module, which requires power to change the display but is capable of displaying an image (such as text) during a period without power. The power and control of the display 140 are provided by the control unit of the attachment 100. As part of a dose tracking mechanism, the display may be controlled to display information about the injection or the next injection, and may include an area for indicating the dialed / assigned final dose.

[0102] As will be described with respect to FIG. 11, the control unit 150 of the attachment may include electronic modules such as a controller 151, a power supply 190, a communication module 170, and a memory 160. The body may also provide one or more switches 130, which are operable to control one or more processing functions.

[0103] The switch 130 may be a manually operable switch. Here, the switch 130 is manually activated to indicate one or more stages of the injection process. For example, the switch may be activated after the attachment is reattached to the injection device after an injection. The activation of the switch thus indicates that an injection has occurred, and accordingly the control unit is arranged to be activated to interrogate the passive electronic arrangement in order to determine the post-injection position of the monitored part. Although pre-injection measurements may be initiated, the post-injection position of the part from the previous injection is suitably used as the first position, so that the displacement of the part can be determined and thus the dose of the injection can be determined. Alternatively, and referring to FIG. 10, the switch may be automatically activated.

[0104] In FIG. 10, one of the corresponding attachment or injection device includes a latch 510, while the other includes a projection 520. When the attachment is attached to the injection device by moving along the longitudinal axis, the latch 510 latches or releases the projection 520. In FIG. 10, the latch is shown as a resilient pawl, such that the latch can push and pull the projection. When the latch moves towards the projection, the latch abuts the projection. Before the attachment completes its movement, the projection may move to another state, such that further movement of the attachment to its attached position causes the pawl to expand to capture the projection. The elastic force of the pawl causes the pawl to hold the capture of the projection until the pawl releases the projection when the attachment is removed from the injection device, such that when the attachment is further moved to remove the attachment from the injection device, the projection is moved to another state.

[0105] The protruding movement activation switch. Thus, the switch can be automatically activated by attaching and detaching the accessory from the injection device. The activation of the switch "wakes up" the control unit, thus saving power. In FIG. 10, the switch 130 is shown as closing ("on") when the accessory is detached and opening ("off") when the accessory is reattached. It will be understood that the states can be alternated, and / or the control unit can be arranged to move to a "sleep" state after being on for a period of time. In one embodiment, the attachment cap wakes up the control unit. Here, placing the cap on the injection device triggers the control unit to interrogate the passive electrical arrangement to determine the position of the monitored movable part. In addition to triggering the measurement, the replacement accessory can also trigger the control unit 150 to display the measurement or transmit the measurement to a remote device. The control unit can be arranged to power off directly or after a short delay.

[0106] As shown in FIG. 11, the control unit 150 includes a controller 151 to control the dose tracking mechanism. A memory 160 can be provided as needed. The controller controls the optional display 140 to display an image. Although the controller 151 can include a processing module for completing the dose tracking steps, preferably, the accessory includes a communication module 170 for transmitting the acquired displacement information to a remote device for image processing. Here, the communication module is any suitable wireless communication module, such as Bluetooth, Wi-Fi, IRDA, NFC module or other short-range or medium-range communication modules. The switch 130 can be used to control the controller to establish a connection with the remote device through the communication module 170. It will be understood that in the case where the switch has an alternative function, the switch can be the same switch, or there can be multiple switches, each with its own function. Here, the switch can also be provided on the injection device when appropriate or necessary.

[0107] A power source 190 is provided in the accessory to supply power to the corresponding parts. For example, the body 110 defines a battery compartment, and the power source is a battery inserted and electrically connected in the compartment.

[0108] Referring to FIG. 12, a method of managing a dosing regimen is shown. The method includes obtaining position information of the parts at the pre-injection position in step S100. Here, the control unit is activated to provide a signal to the passive electronic arrangement via the electrical connection between the accessory and the injection device. The pre-injection information is a record indicating the position of the corresponding parts before the injection step is completed in step S200. The obtaining of the pre-injection information can be triggered by the operation of the switch 130, or alternatively, the post-injection information of the previous injection can be used or the post-injection information can be called from the memory.

[0109] Step S200 includes completing the injection step. The injection step includes using the dose setting mechanism to dial the dose to be injected and activating the dose dispensing mechanism to dispense the medicament.

[0110] In step S300, post-injection information is obtained. Again, the post-injection information is obtained by the control unit providing a signal to the passive electronic arrangement via an electrical connection, and the switch operation can be triggered to obtain the information. Suitably, the switch is automatically triggered by replacing an attachment on the injection device, which typically indicates completion of the injection process.

[0111] In step S400, an optional communication step is completed to transmit the information for processing on a remote device. Here, the post-injection information and optionally the pre-injection information are transmitted to the remote device for image processing by a processor. Alternatively, the processor is included as part of the control unit housed on the attachment.

[0112] In step S500, the information is processed to determine the displacement of the part and thus the allocated medicament. Here, in processing step S500, the processor processes the information and calculates a dose selection measurement or a dose dispensing measurement. Here, the dose selection measurement can be a calculation including the displacement of the part of the injection device and other parameters of the dose dispensing mechanism such as pitch and diameter. After calculating the dose selection measurement in the processing step, the processor can transmit the calculated measurement or other information of the injection protocol for display by the display 140.

[0113] Alternatively, step S400 can be omitted and S500 can be performed by the attachment. In these embodiments, the calculated dose may or may not be transmitted to another device.

[0114] The user can use the calculated measurement displayed in the manual log on the display 140. However, in an exemplary embodiment, the remote device includes a software application for electronically entering the calculated dose selection measurement and optionally other injection parameters. For example, dose management is implemented via a computer or the like. For example, as an application on a smartphone, or a tablet computer, etc., where the application monitors and warns the user of injection times and doses. The application can also be used to input and record injection parameters, for example, to automatically enter the time and date of the injection.

[0115] According to the above, the attachment 100 can be attached to the injection device 200, and in doing so, the attachment can be controlled to interrogate the passive electronic arrangement in the injection device. Since each injection device only requires a passive electronic arrangement, as the control unit is housed in the attachment and can be reused between devices, resources are reduced. The pre-injection information and the post-injection information are processed to calculate the dose dispensing measurement used in the dose management scheme. By electronically entering or displaying the measurement for electronic entry, the dose management scheme can be improved, for example, by improving the recording accuracy or automation of the dose selection measurement.

[0116] Although particular combinations of features are claimed in the present application, it is to be understood that the scope of the present disclosure also includes any novel feature or any novel combination of features or any generalization thereof which is disclosed explicitly or implicitly herein, whether or not it relates to the same inventive concept as that claimed in any currently claimed claim and whether or not it mitigates any or all of the same technical problems as those of the present disclosure. The applicant hereby gives notice that during the examination of this application or any further application derived therefrom, new claims may be formulated for such features and / or combinations of features.

[0117] Although several embodiments have been shown and described, those skilled in the art will understand that the embodiments can be changed without departing from the principles of the disclosed solution concept, the scope of which is defined by the claims.

[0118] The injection device may include a cartridge containing a liquid medicament or pharmaceutical agent. In an example, by pressing an injection button, a portion thereof may be discharged from the cartridge according to a dialed or preset amount.

[0119] The terms "drug" or "pharmaceutical agent" are used synonymously herein and describe a pharmaceutical preparation that includes one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or pharmaceutical agent is used to treat, cure, prevent or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical agent may be used for a limited duration or regularly for a chronic disease.

[0120] As described below, the drug or pharmaceutical agent may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes and oligonucleotides. Nucleic acids may be incorporated into a molecular delivery system (such as a vector, plasmid or liposome). A mixture of one or more drugs is also contemplated.

[0121] A drug or pharmaceutical agent can be contained in a primary package or “drug container” suitable for use in a drug delivery device. The drug container can be, for example, a cartridge, a syringe barrel, a reservoir or other rigid or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20 °C) or at refrigerated temperatures (e.g., from about -4 °C to about 4 °C). In some cases, the drug container can be or can include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dispensing into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow a user to mix the two components when needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are dispensed into a human or animal body.

[0122] The drug or pharmaceutical agent contained in the drug delivery devices described herein can be used for treating and / or preventing many different types of medical diseases. Examples of diseases include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of diseases 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 described in manuals such as: Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncological drugs)) and Merck Index, 15th edition.

[0123] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be encoded amino acid residues or other natural residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encoded amino acids), or amino acids (including non-encoded amino acids) have been added to the naturally occurring peptide.

[0124] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0125] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); 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-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0126] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide exenatide (Exendin-4, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide semaglutide, taspoglutide, albiglutide dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0127] Examples of oligonucleotides are, for example, mipomersen sodium It is a cholesterol-reducing antisense therapeutic agent for treating familial hypercholesterolemia or RG012 for treating Alport syndrome.

[0128] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0129] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, gonadotropic hormone), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0130] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., the polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. Examples of pharmaceutically acceptable salts of polysulfated low molecular weight heparin are enoxaparin sodium. Examples of hyaluronic acid derivatives are Hylan G-F 20 It is a sodium hyaluronate.

[0131] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has a reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant that does not support binding to Fc receptors, e.g., it has a mutagenized or deleted Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins with cross-over binding domain orientation (CODV).

[0132] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding antigen. Antibody fragments can include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 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 divalent, trivalent, tetravalent and multivalent antibodies), minibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies comprising VHHs. Additional examples of antigen-binding antibody fragments are known in the art.

[0133] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0134] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0135] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in the drug or agent in the drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0136] Those skilled in the art will understand that various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

[0137] Example drug delivery devices can relate to needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly divided into multi-dose container systems and single-dose (with partial or full discharge) container systems. The container can be a replaceable container or an integrated non-replaceable container.

[0138] As further described in ISO 11608-1:2014(E), multi-dose container systems can relate to needle-based injection devices with replaceable containers. In such systems, each container holds multiple doses, and the size of the doses can be fixed or variable (preset by the user). Another multi-dose container system can relate to needle-based injection devices with integrated non-replaceable containers. In such systems, each container holds multiple doses, and the size of the doses can be fixed or variable (preset by the user).

[0139] As further described in ISO 11608-1:2014(E), single-dose container systems can relate to needle-based injection devices with replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge). As also described in ISO 11608-1:2014(E), single-dose container systems can relate to needle-based injection devices with integrated non-replaceable containers. In one example of such systems, each container holds a single dose, whereby the entire deliverable volume is discharged (full discharge). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is discharged (partial discharge).

Claims

1. A device comprising an attachment (100) and an injection device (200), wherein: the attachment (100) is attachable to and detachable from the injection device (200), and the attachment (100) houses a control unit (150); the injection device (200) includes a passive electronic arrangement (300), a part of the passive electronic arrangement (300) is operatively connected to a movable part of the injection device (200), and movement of the part of the passive electronic arrangement (300) causes a change in the electrical characteristics of the passive electronic arrangement (300); the control unit is electrically connectable to the passive electronic arrangement (300) and is configured to measure the change in the electrical characteristics of the passive electronic arrangement (300) to determine information associated with the dose of medicament injected; one of the attachment (100) and the injection device (200) includes a latch (510), and the other of the attachment (100) and the injection device (200) includes a part (520) arranged to be latched and moved by the latch (510); in response to attachment of the attachment (100) to the injection device (200), the part (520) is latched and moved by the latch to activate the switch (130) of the control unit (150) from an on state to an off state or from an off state to an on state, such that when activated, the switch (130) triggers the control unit (150) to use the passive electronic arrangement (300) to determine information associated with the dose of medicament injected; and in response to detachment of the attachment (100) from the injection device (200), the part (520) is moved by the latch and then released to move the switch (130) from an off state to an on state or from an on state to an off state.

2. The device according to claim 1, wherein the attachment (100) houses a connector (120), and the injection device (200) includes a connector for cooperating with the connector (120) of the attachment to electrically connect the control unit (150) to the passive electronic arrangement (300).

3. The device according to claim 2, wherein the control unit (150) of the attachment (100) includes a controller (151) and a power source (190), and the controller (151) controls the power source (190) to apply a signal to the passive electronic arrangement via the connector (120).

4. The device according to any one of claims 1 to 3, wherein the attachment (100) forms a cap that is attached to and covers an end of the injection device (200).

5. The device according to claim 2, wherein the control unit (150) of the attachment (100) includes a controller (151) and a communication module (170), and the controller (151) controls the communication module (170) to communicate with a remote device.

6. The device according to claim 2, wherein the control unit (150) of the attachment (100) comprises a controller (151) and a display (140), and the controller (151) controls the display (140) to display information associated with the dose of medicament injected.

7. The device according to any one of claims 1 to 3, wherein the passive electronic arrangement (300) comprises a variable electronic resistor (302), or wherein the passive electronic arrangement (300) comprises a capacitance sensor (400).

8. The device according to claim 7, wherein the passive electronic arrangement (300) is the capacitance sensor (400), and the capacitance sensor comprises opposing first and second metal layers (410, 420), and the metal layers are formed in a label (211) applied around the cartridge assembly (220) or the housing (210) of the injection device (200).

9. An attachment (100), the attachment comprising: a body (110) that houses a control unit (150), the control unit (150) comprising a switch (130), wherein the attachment (100) is attached to an injection device (200) comprising a passive electronic arrangement (300), a portion of the passive electronic arrangement (300) being operatively connected to a movable part of the injection device (200), and movement of the portion of the passive electronic arrangement (300) causing a change in the electrical characteristics of the passive electronic arrangement (300); the control unit (150) is electrically connectable to the passive electronic arrangement (300) and is configured to measure the change in the electrical characteristics of the passive electronic arrangement (300) to determine information associated with the dose of medicament injected; the attachment (100) further comprises either a clamping member (510) or a corresponding part (520) that is clamped and moved by the clamping member; in response to attachment of the attachment (100) to the injection device (200), the part (520) is clamped and moved by the clamping member to activate the switch (130) from an open state to a closed state or from a closed state to an open state, such that when activated, the switch (130) triggers the control unit (150) to use the passive electronic arrangement (300) to determine information associated with the dose of medicament injected; and in response to detachment of the attachment (100) from the injection device (200), the part (520) is moved by the clamping member and then released to move the switch (130) from a closed state to an open state or from an open state to a closed state.

10. An injection device (200), the injection device (200) comprising: a passive electronic arrangement (300), a portion of the passive electronic arrangement (300) being operatively connected to a movable part of the injection device (200), and movement of the portion of the passive electronic arrangement (300) causing a change in the electrical characteristics of the passive electronic arrangement (300); wherein the passive electronic arrangement (300) is capable of being electrically connected to the attachment (100) according to claim 9 to provide information corresponding to the position of the part moving during the injection process; the injection device (200) includes either a holding member (510) or a corresponding part (520) held and moved by the holding member; in response to the attachment of the attachment (100) to the injection device (200), the part (520) is held and moved by the holding member to activate the switch (130) from an on state to an off state or from an off state to an on state, such that when the switch (130) is activated, it triggers the control unit (150) to use the passive electronic arrangement (300) to determine information associated with the dose of the medicament being injected; and in response to the detachment of the attachment (100) from the injection device (200), the part (520) is moved by the holding member and then released to move the switch (130) from an off state to an on state or from an on state to an off state.

11. The injection device according to claim 10, wherein the passive electronic arrangement (300) includes a variable electronic resistor (302), or wherein the passive electronic arrangement includes a capacitance sensor (400).

12. The injection device according to claim 11, wherein the passive electronic arrangement (300) is the capacitance sensor (400), and the capacitance sensor (400) includes opposing first and second metal layers (410, 420), and wherein the metal layers are formed in a label (211) applied around the cartridge assembly (220) or the housing (210) of the injection device (200).

13. The device according to any one of claims 1 to 3 or the injection device (200) according to any one of claims 10 to 12, wherein the injection device (200) includes a cartridge (224) containing a medicament.

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