Drug delivery device

Abstract

The present disclosure relates to a method of pairing an electronic data logging device (100) of a drug delivery device (1) with an external electronic device (65) and a corresponding drug delivery device (1), wherein the drug delivery device (1) comprises: - a housing (32) for containing the medicament (27), the housing (32) being further configured to receive and / or mechanically engage with the electronic data logging device (100), - a first device component (301) and a second device component (302), wherein the first device component (301) is movable relative to the second device component (302) from a first position state (351) to at least a second position state (352), - wherein the first device component (301) comprises a first outer surface (311), wherein the second device component (302) comprises a second outer surface (312), and wherein at least one of the first outer surface (311) and the second outer surface (312) comprises at least a first code portion (321) of a pairing code (320) for establishing a communication link (66) between the electronic data logging device (100) and the external electronic device (65), - wherein the pairing code (320) is visually identifiable from outside of the drug delivery device (1) only when the first device component (301) is in the second position state (352) relative to the second device component (302).

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the field of drug delivery devices for administering a dose of a medicament. The present disclosure particularly relates to drug delivery devices operable to cooperate with an electronic data logging device, wherein the data logging device is further connectable to an external electronic device. The present disclosure particularly relates to the field of establishing or providing a communication link between a data logging device adapted for a drug delivery device and an external electronic device. The present disclosure further relates to a method of pairing an electronic data logging device of a drug delivery device with an external electronic device. BACKGROUND

[0002] Drug delivery devices for setting and dispensing a single dose or multiple doses of a medicament are generally known in the art. Typically, such devices can have essentially similar use as a common syringe.

[0003] Drug delivery devices such as injection or inhalation devices (e.g. pen-type injectors) have to meet a number of user-specific requirements. For example, in case the patient suffers from a chronic disease such as diabetes, the patient can be physically infirm and can also have impaired vision. Therefore a suitable drug delivery device especially intended for home medication requires a robust construction and should be easy to use. Furthermore, handling of the device and its components and general handling should be obvious and easily understandable. Such an injection device should provide setting and subsequent dispensing of variable sized doses of a medicament. Furthermore, the dose setting as well as the dose dispensing procedure must be easy to operate and must be unambiguous.

[0004] The medicaments to be dispensed or expelled by a drug delivery device can be provided and contained in multi-dose cartridges. Such cartridges typically comprise a glass barrel which is sealed in the distal direction by means of a pierceable seal and which is further sealed in the proximal direction by a bung. For reusable drug delivery devices, empty cartridges can be exchanged for new ones. In contrast thereto, drug delivery devices of the disposable type are readily equipped with such cartridges. When the medicaments in the cartridges have been dispensed or used up, they are discarded in their entirety.

[0005] For some drug delivery devices such as pen-type injection devices, the user has to set a dose of equal or variable size by rotating a dose dial in clockwise or counter-clockwise direction with respect to the body or housing of the injection device. In order to inject and expel a dose of liquid medicament, the user has to depress a trigger or dose button in distal direction and thus towards the body or housing of the injection device. Typically, the user exerts a distally directed pressure on the dose button, which is located at the proximal end of the dose dial and the dose dial sleeve, with his thumb, while holding the housing of the injection device with the remaining fingers of the same hand.

[0006] For mechanically implemented injection devices, it is desirable to enable precise, reliable and quasi-automatic monitoring and / or collection of injection related data during use of the injection device. Mechanically operated injection devices can be equipped with an electronically implemented additional device or data logging device configured to monitor user induced operation of the injection device.

[0007] Some data logging devices can be configured for attachment to an injection device. Some data logging devices can be embedded or arranged in an injection device. Other drug delivery devices can be electronically implemented, thus they comprise an integrated electronic unit configured for and operable to monitor operation of the drug delivery device over time. Here, the data logging device is provided by the integrated electronic unit.

[0008] During repeated use of the respective drug delivery device, administration details and patient specific data can be logged and stored in such data logging devices. It is generally desirable to gain access to the respective data stored in the data logging device, e.g. for patient monitoring and / or for optimizing long term therapy. The data logging device can be configured to establish a communication link with an external electronic device. The communication link can be of wireless or wired type. Data collected or at least temporarily stored in the data logging device can be rather sensitive and / or vulnerable. Misuse or unauthorized access to this data should be prevented and avoided.

[0009] To prevent unauthorized access to the data, establishing a communication link between the data logging device and the external electronic device can require authorization. Here, the data logging device and / or the external electronic device can be implemented to establish the communication link only upon confirmation or input of a suitable key or code. Generally, such a pairing code can provide security to prevent misuse or unauthorized access to data stored in the data logging device, if the pairing code is only known to authorized personnel.

[0010] On the one hand, such a key or code should be explicitly available to authorized personnel, e.g. to a healthcare provider or to a patient. On the other hand, such a pairing code should not be directly recognizable from the outside of the drug delivery device, thus providing sufficient data security. Regulatory requirements can further specify that such a pairing code must be visible from the outside of the injection device or data logging device.

[0011] Therefore, there is a need to provide an improved drug delivery device configured to provide a pairing code for establishing a communication link between an electronic data logging device and an external electronic device. On the one hand, the drug delivery device should prevent unauthorized access to the pairing code. On the other hand, the drug delivery device should effectively provide unobstructed and explicit access to the pairing code to authorized personnel. SUMMARY

[0012] To address the above needs, according to the features of the independent claims, an improved drug delivery device for administering a dose of a medicament and a method of pairing an electronic data logging device of a drug delivery device with an external electronic device are provided. Further features of the device and the method are subject of the dependent claims.

[0013] In one aspect, an improved drug delivery device for administering a dose of a medicament is provided. The drug delivery device is operable to cooperate with an electronic data logging device. The drug delivery device comprises a housing for containing a medicament. The housing is further configured to receive or to mechanically engage with the electronic data logging device. The housing can be configured to contain the data logging device. The data logging device can be implemented as a separate device connectable to the housing of the drug delivery device or as a movable component of the drug delivery device. For other examples, the electronic data logging device is integrated into the drug delivery device and belongs to the drug delivery device.

[0014] The drug delivery device comprises a first device component. The drug delivery device further comprises a second device component. The first device component is movable relative to the second device component at least from a first position state to at least a second position state.

[0015] The first device component comprises a first outer surface. The second device component comprises a second outer surface. At least one of the first outer surface and the second outer surface comprises at least a first code portion of a pairing code. The pairing code can be used to establish a communication link between the electronic data logging device and the external electronic device. The pairing code can be required to establish the communication link. The pairing code can be a security code requested by at least one of the electronic data logging device and the external electronic device to establish the communication link. The pairing code can comprise or constitute a key required to establish a connection between the electronic data logging device and the external electronic device. Typically, the pairing code is available or required to establish a secure connection between the data logging device and the external electronic device.

[0016] The pairing code can comprise or also constitute at least one of a binding code or a session key. The pairing code can also be used as a password or passcode to establish a long-term authentication between the drug delivery device and the electronic data logging device.

[0017] Typically, the electronic data logging device and the external electronic device each comprise a wireless and thus non-mechanical contact-based communication interface. To establish the communication link between the wireless communication interfaces of the electronic data logging device and the external electronic device, at least one of the wireless communication interfaces is configured to perform a pairing routine or pairing procedure, e.g. based on a well-defined wireless communication standard.

[0018] Generally, the communication link and the way of communication between the data logging device and the drug delivery device is not limited to a specific wireless communication technology wireless communication standard. The present disclosure is generally applicable to all available types of non-mechanical contactless communication links that require a secure connection and / or authentication during the establishment between the respective communication interfaces of the data logging device and the drug delivery device.

[0019] For some examples, the communication link is an electromagnetic communication link, which can provide or support non-contact charging, radio frequency based communication such as WiFi, Bluetooth, RFID, NFC, GSM, UMTS, LTE or others. For further examples, the communication link is based on optical transmission in the infrared or visible spectral range. For further examples, the communication link is based on acoustic signals.

[0020] The execution of the pairing routine comprises an authentication step. Herein, at least one of the external electronic device and the electronic data logging device is operable to request a pairing code associated with the other one of the external electronic device and the electronic data logging device. For some embodiments, the pairing code, typically associated with the electronic data logging device, can be communicated or transmitted to the external electronic device. The user can be prompted to confirm the pairing code by entering it into an input interface of at least one of the electronic data logging device and the external electronic device before the respective communication link can be established. For other embodiments, at least one of the electronic data logging device and the external electronic device can be operable to visually or audibly present the pairing code, which must be confirmed and / or approved by the user of the respective device before the communication link will be established.

[0021] For some examples, the pairing code provided on the drug delivery device characterizes the drug delivery device and / or the medicament intended for the drug delivery device or arranged within the drug delivery device. Thus, different types of drug delivery devices can be distinguished from each other by different pairing codes. The same drug delivery device, i.e. a drug delivery device equipped with the same medicament, can be provided with a common or identical pairing code.

[0022] The pairing code can contain a unique information or a unique identification of the medicament located inside the drug delivery device. This is particularly the case if the drug delivery device is a pre-filled drug delivery device, e.g. a pre-filled injection device, which will only be equipped with one type of medicament.

[0023] By arranging or integrating the data logging device on or in the housing of the drug delivery device, the data logging device can log the configuration of the drug delivery device. By entering the pairing code provided on the drug delivery device into or with the external electronic device, the external electronic device is naturally provided with the unique information or unique identification of the medicament located inside said drug delivery device upon confirming that the data logging device is paired with the external electronic device.

[0024] Furthermore, and alternatively, for example, when the electronic data logging device is fixedly and non-removably arranged inside or on the drug delivery device, the electronic data logging device can be pre-programmed and provided with sufficient information allowing to identify the type of medicament and / or the type of drug delivery device the electronic data logging device is actually attached to. Furthermore, upon or during the integration of the electronic data logging device into or with the drug delivery device, the pairing code can be provided on the first and / or second device component as well as in the electronic memory of the electronic data logging device. Also, a unique assignment between the pairing code provided on the drug delivery device itself and the unrelated pairing code stored in the memory of the electronic data logging device can be provided.

[0025] For some examples, the pairing code comprises at least 3 digits, at least 4 digits, at least 5 digits, at least 6 digits or any larger number of digits. Herein, a digit can comprise a number, a letter or any other visually recognizable sign.

[0026] The pairing code is only visually recognizable from the outside of the drug delivery device when the first device component is in the second position state relative to the second device component. Thus, the pairing code is recognizable from the outside of the drug delivery device when and as long as the first device component is in the second position state. In all other position states (e.g. in the first position state or in other position states of the first device component relative to the second device component), the pairing code is not recognizable from the outside of the drug delivery device.

[0027] Herein, the pairing code or at least a part thereof can be hidden or covered by at least one of the first device component or the second device component. For some examples, the pairing code is visible from the outside of the drug delivery device even when the first device component is outside or deviates from the second position state. Herein, the pairing code can be provided with a complementary code such as a hidden code part which is not distinguishable from the pairing code. Even though the code can be visible, it cannot be unambiguously visually recognized as long as the first device component is outside the second position state relative to the second device component.

[0028] The drug delivery device can be implemented as an inhaler, an injection device or an infusion device. The drug delivery device can be implemented as a pen-type injector. The electronic data logging device can be integrated into the drug delivery device or it can be provided as a separate data logging device or an add-on device which is configured for releasable or non-releasable attachment to the drug delivery device. Typically, the data logging device comprises at least one sensing component which is configured to detect and / or quantitatively determine the setting and / or dispensing of a dose of a medicament. Typically, the data logging device comprises an integrated circuit, e.g. provided on a printed circuit board (PCB). The data logging device typically comprises a processor and a memory. The data logging device further comprises a communication interface. The communication interface can comprise a wireless transceiver in order to establish a wireless communication link to an external electronic device.

[0029] The external electronic device can be implemented as a personal digital device such as a smart watch, an activity watch, a mobile phone, a tablet computer or a personal computer. The data logging device and the external electronic device can be implemented to establish a wireless communication link in accordance with a standardized wireless communication protocol, e.g. based on radio frequency communication such as RFID, NFC or Bluetooth.

[0030] The pairing routine of the electronic data logging device and the external electronic device is in particular implemented as a request or confirmation of a pairing code. The pairing code provided by the drug delivery device can have to be entered into at least one of the data logging device and the external electronic device. For some examples, the pairing code can be visually displayed to a user of the drug delivery device, e.g. by at least one of the data logging device and the external electronic device. The user can then be prompted to confirm that the displayed pairing code is identical to the pairing code provided on the drug delivery device. In this way, misuse of data stored in the electronic data logging device can effectively be prevented.

[0031] The pairing code which can be necessary to establish the communication link can only be visually recognizable or discernible from the outside of the drug delivery device when the first device component is in the second position state relative to the second device component. In all other available position states of the first device component relative to the second device component, the pairing code is hidden or indistinguishable from other code information provided on the outside of the first device component and / or the second device component.

[0032] In this way, the improvement of the drug delivery device provides two alternative approaches. In the case of one approach, the pairing code provided on at least one of the first device component and the second device component is at least partially covered by the other one of the first device component and the second device component when and as long as the first device component is in a position state other than or not overlapping with the second position state relative to the second device component. In the case of this approach, the first device component and the second device component are typically displaceable relative to each other in an interleaved manner.

[0033] Therefore, the component in the first and second device components that provides at least the first code portion is at least partially received inside the other of the first and second device components. Thus, at least a portion of the first code portion provided on the outer surface of at least one of the first and second device components is hidden by the other of the first and second device components. Here, the first and second device components overlap each other. They can be arranged in an interleaved or at least partially nested manner. In the first position state, the degree of overlap is relatively large, thereby covering or hiding at least a portion of the first code portion. When in the second position state, the degree of overlap decreases so as to expose the first code portion or the entire pairing code.

[0034] According to the second alternative method, the pairing code is permanently visible on the exterior of both the first and second device components. Here, the pairing code is provided with a supplementary code, thus having a hidden code portion indistinguishable from the pairing code. As long as both the pairing code and the supplementary hidden code portion are visible on the exterior of the drug delivery device, the pairing code cannot be visually identified because the corresponding user is unaware of the total length and position of the relevant pairing code from the indistinguishable combination of the pairing code and the hidden code.

[0035] Here, the pairing code can be concealed within a supplementary hidden code portion. Only when the first device component is moved relative to the second device component to the second position state, the (multiple) supplementary and / or hidden code portions are hidden or covered, making the remaining pairing code identifiable from the outside of the drug delivery device.

[0036] In the current context, the positional state between the first device component and the second device component includes their relative position and relative orientation. In both the first and second positional states, at least one of the position and orientation of the first device component differs from the corresponding position or orientation of the second device component.

[0037] The first and second device components can be mechanically engaged directly or indirectly. Furthermore, the first and second device components can be either threaded or slidably engaged. The first and second device components can also be rotatably engaged or rotatably locked.

[0038] The movement of the first device component from the first position state toward and into the second position state may include at least one of rotational motion, sliding motion, or helical motion (and thus a combination of rotational and sliding motion). The first device component and the second device component may be permanently connected, for example, by threaded engagement or by slotted chain links.

[0039] For example, the first position state of the first device component and the second device component can coincide with an initial state of the respective components, e.g. the drug delivery device is handed over to a patient or a customer in said initial state. The second position state of the first device component and the second device component can coincide with a specific device configuration. For some examples, the preparation of the drug delivery device for the administration of a dose of medicament requires a movement of the first device component relative to the second device component. For some examples, the setting of a dose of medicament requires a movement of the first device component relative to the second device component; or vice versa. For some examples, the expelling or dispensing of a dose of medicament requires a movement of the first device component relative to the second device component.

[0040] The second position state of the first device component relative to the second device component is a characteristic relative position and / or a characteristic relative orientation of the first device component relative to the second device component. The user of the drug delivery device is very well aware of this characteristic part and moves the first device component relative to the second device component to reach the second position state almost without difficulties.

[0041] Typically, the second position state in which the pairing code is visually recognizable or recognizable from the outside of the drug delivery device does not coincide with the initial device configuration. Making the pairing code visually recognizable from the outside of the drug delivery device always requires a well-defined user-induced movement of the first device component relative to the second device component.

[0042] Generally, it is only relevant that the first device component is moved relative to the second device component. Whether the first device component is actually subjected to a movement relative to the environment is completely irrelevant. In order to reach the second position state, the first device component can be, for example, fixed by the hand of the user while the second device component is moved relative to the first device component.

[0043] According to a further example, the first code portion or the pairing code is provided on the first outer surface. At least a part of the first code portion or at least a part of the pairing code is hidden by the second device component when the first device component is outside the second position state. In this way, and as long as the first device component is outside or does not overlap the second position state, the entire pairing code cannot be visually recognized from the outside of the drug delivery device. Here, the respective part of the first outer surface provided with the first code portion or provided with the entire pairing code is covered by the second device component. Typically, the second device component or at least the part thereof which spatially overlaps the first device component is opaque.

[0044] In this way, the first code portion or the entire pairing code is revealed when the first device component reaches the second position state relative to the second device component. As long as the first device component and thus the first code portion or the entire pairing code is in the first position state, at least a part of the first code portion or a respective part of the entire pairing code is not discernible from the outside of the drug delivery device. In this position state, and as long as the first device component is outside the second position state, the entire pairing code cannot be visually identified from the outside of the drug delivery device. A communication pairing between an electronic data logging device (e.g. attached to or integrated into the drug delivery device) and an external electronic device is not possible, and data stored in the electronic data logging device is protected against misuse.

[0045] According to another example, the first outer surface is provided with one of the first code portion and the pairing code. The first outer surface is further provided with a first hidden code portion. The hidden code portion is indistinguishable from the first code portion or from the pairing code. At least a part of the hidden code portion and an indistinguishable constituent of at least one of the first code portion and the pairing code is discernible from the outside of the drug delivery device when the first device component is outside the second position state (e.g. when the first device component is in a third position state relative to the second device component).

[0046] The hidden code portion can be a code of the same type as the pairing code. For some examples, the pairing code can comprise a number or a string of characters. The hidden code portion can comprise a comparable number or string of characters. The font, size and style of the string of the pairing code and the hidden code portion can be identical or equivalent, thus indistinguishable. The hidden code portion can be aligned directly with the first code portion and / or with the pairing code.

[0047] The first code portion or the pairing code can be embedded or framed by the first hidden code portion. A user can not be aware of the length of the string of the constituent of the first hidden code portion and at least one of the first code portion and the pairing code. Thus, as long as the pairing code or its first code portion is provided on the first outer surface together with the first hidden code portion, the pairing code is intermingled or mixed with the hidden code portion and becomes visually indistinguishable.

[0048] For some examples, the first code portion or the entire pairing code can be completely invisible and thus can be completely hidden by the second device component when the first device component is in the first position state. The first code portion or the entire pairing code becomes successively visible as the first device component moves from the first position state towards the second position state.

[0049] When the second position state is reached, the relevant first code portion or the entire pairing code can be revealed from the second device component. As the second device component is further moved in the same direction towards the third position state, a hidden code portion provided on the first outer surface becomes visible and revealed in addition to the first code portion and / or the entire pairing code.

[0050] As the first hidden code portion is usually indistinguishable from the first code portion or from the pairing code, the combination of the first hidden code portion with the first code portion and / or with the pairing code is practically not usable for the user, as the relevant pairing code or its relevant code portion cannot be identified in the indistinguishable code constitution provided on the first outer surface of the first device component.

[0051] This provides another security feature preventing misuse or unauthorized access to data stored in the electronic data logging device. Identifying the entire pairing code visually requires knowledge about a rather specific and explicitly defined second position state of the first device component relative to the second device component.

[0052] According to another example, the first hidden code portion is hidden by the second device component when the first device component is in the second position state. Here, the first hidden code portion can be masked or occluded by the second device component. Thus, and when in the second position state, the relevant portion, thus the first code portion or the entire pairing code, becomes distinguishable from or distinguishable in the constitution of the first hidden code portion with at least one of the first code portion and the pairing code.

[0053] According to another example, the pairing code comprises a first code portion and a second code portion. The first code portion is provided on the first outer surface. The second code portion is provided on the second outer surface. Here, the entire pairing code is split between the first device component and the second device component. The first code portion is provided on the first outer surface of the first device component and the second code portion is provided on the second outer surface of the second device component. The entire pairing code is a combination of the first code portion and the second code portion. Thus, to visually identify the entire pairing code, the first code portion and the second code portion have to be recombined and / or have to complement each other.

[0054] For this example, both the first code portion and the second code portion can be permanently visible from the outside of the drug delivery device. To recombine the pairing code at the second code portion from the first code portion, it can be necessary to arrange the first code portion and the second code portion in an explicitly defined or predefined manner. For some examples, the first code portion and the second code portion have to be aligned in a specific configuration known only to the user of the drug delivery device.

[0055] For some examples, only one of the first code portion and the second code portion can be permanently visible on one of the first outer surface and the second outer surface, respectively. The movement of the first device component relative to the second device component can cause the degree of mutual spatial and non- translucent overlap of the first outer surface and the second outer surface to be modified.

[0056] Thus, in the first position state, only the second code portion can be visible from the outside of the drug delivery device, while the first code portion or a part thereof remains revealed by the second device component. The movement of the first device component relative to the second device component into the second position state is accompanied by a movement of the first code portion relative to the second code portion. Here, the first code portion can be revealed from the second device component.

[0057] Furthermore, when the first device component is in the second position state relative to the second device component, the first code portion can complement the second code portion to constitute or reconstitute the pairing code.

[0058] When the first device component is in the second position state, the first code portion and the second code portion reconstitute each other and constitute the pairing code.

[0059] For other configurations, and when the first device component is in the second position state relative to the second device component, the combination of the first code portion visible from the outside of the drug delivery device and the second code portion visible from the outside of the drug delivery device can also be aligned or reconstituted with each other, but can not be operable and can not provide the pairing code. In such position state of the first device component and the second device component, which is distinct from or different from the second position state, the reconstitution of the first code portion and the second code portion is distinct from the pairing code, and thus does not represent or reconstitute the pairing code required to establish or set up a communication link between the electronic data logging device and the external electronic device.

[0060] According to another example, at least one of the pairing code and the first code portion extends along a first direction on at least one of the first device component and the second device component, thus on at least one of the first outer surface and the second outer surface. Here, the first device component can be movable relative to the second device component along the first direction. This is particularly useful in case, for example, the pairing code or the first code portion is provided on the first outer surface and wherein, for example, the first outer surface of the first device component is at least partially covered by the second device component at least when the first device component is in the first position state. As the first device component moves towards the second position state, more and more of the first outer surface is revealed from the second device component.

[0061] For some examples, at least a portion of the first device component can be located inside the second device component when in the first position state. As the first device component moves towards the second position state, the first outer surface can continuously protrude from one end of the second device component, or the respective first outer surface can extend into an aperture of the second device component, such that more and more of the first code portion or the entire pairing code becomes recognizable and visible by protruding from one end of the second device component or by appearing in the aperture of the second device component.

[0062] As the first device component moves along the first direction relative to the second device component when subjected to the movement from the first position state towards the second position state, an increasing portion of the first code portion and the pairing code becomes recognizable.

[0063] According to further examples, the second outer surface of the second device component is further provided with a second hidden code portion. The second hidden code portion is indistinguishable from the second code portion provided on the second outer surface. When the first device component is in the second position state, the first code portion is aligned with the second code portion. As long as the first device component is outside the second position state, the first code portion can be offset from the second code portion. Here, the first code portion can be aligned with a portion or a part of the second hidden code. The combination and alignment of the second hidden code or the part thereof with the first code portion can not constitute or recombine the pairing code.

[0064] According to further examples, the second hidden code extends along a second direction on the second outer surface. Typically, the second direction can be distinguishable from the first direction along which the first code portion extends. For some examples, the second hidden code can extend along a tangential direction of the tubular and / or elongated second device component. The first code portion can extend along a first direction which can coincide with a longitudinal axis of the elongated (e.g. tubular) first device component or the second device component.

[0065] When the first code portion extends along the first direction and when the second code portion and / or the second hidden code extends along the second direction, wherein the first direction and the second direction extend at a predefined non-zero angle relative to each other, the recombination and constitution of the pairing code can require the first device component to move along the second direction from the first position state towards the second position state. Then, the movement of the first device component along the first direction relative to the second device component can be optional only.

[0066] The first direction and the second direction can extend perpendicular to each other. The pairing code can be recombined by a straight line intersecting at least one of the first code portion and the second hidden code portion and a part of the other one of the first code portion and the second hidden code portion.

[0067] According to another example, the first code portion or a part thereof is aligned with the second hidden code portion when the first device component is outside the second position state. The alignment of the first code portion with a part of the second hidden code portion is ineffective for recombining or constituting the pairing code. The first code portion can exclusively be aligned with the second hidden code portion or with a part thereof when and as long as the first device component is outside the second position state, thereby effectively impeding a visual recognition of the pairing code in the overlap of the first code portion and the second hidden code portion.

[0068] According to a further example, at least one of the second hidden code portion and the second code portion extends along a second direction. The first device component is movable relative to the second device component along the second direction. For some examples, the first direction extends along a symmetry axis or longitudinal axis of a housing of the drug delivery device. The second direction can extend in a tangential or circumferential direction relative to such an elongated (e.g. tubular) housing. The first direction and the second direction can extend at a predefined non-zero angle relative to each other. The first direction and the second direction can extend perpendicular to each other.

[0069] According to another example, the drug delivery device comprises a first marker and a second marker. The first marker is provided by or connected to the first device component. The second marker is provided by or connected to the second device component. The first marker can be provided on the first outer surface. The second marker can be provided on the second outer surface. The first marker is subjected to a movement relative to the second marker when the first device component is moved relative to the second device component.

[0070] The first marker and the second marker are visually aligned, visually overlap or mechanically engage when the first device component reaches the second position state relative to the second device component. By means of the first marker and the second marker, the second position state of the first device component and the second device component can be identified. At least one of the first marker and the second marker is permanently visible to a user of the drug delivery device. The other one of the first marker and the second marker can be temporarily hidden by the other one of the respective first device component and second device component.

[0071] When the first device component is moved relative to the second device component and when the second position state is reached, the first marker and the second marker align with each other, visually overlap or mechanically engage, thereby indicating to the user that the second position state has been reached and that the pairing code is now visually recognizable from the outside of the drug delivery device.

[0072] For some examples, the first indicia comprises an identification feature on the first surface of the first device component. The first indicia can comprise a specific character or visual sign, such as a letter or a number. The second indicia can comprise, for example, a visual sign, a character or a number on the second outer surface. For some examples, the second indicia can comprise an aperture in the second device component. The second indicia can also comprise a pointer. For example, when the second device component is or forms part of a housing of a drug delivery device, it can comprise an aperture through which at least a portion of the first device component, typically the first outer surface, provided with the first indicia, can be visually identified or detected.

[0073] For some examples, the first indicia and the second indicia comprise engagement features of mutually corresponding and / or complementary shape, such as a protrusion and a corresponding recess. In this way, the first indicia and the second indicia can mechanically engage when the first device component and the second device component reach the second position state.

[0074] For some examples, the drug delivery device comprises a number sleeve on which a number sequence is printed. The number sequence is indicative of the size of the actually set dose. The first indicia can correspond to a specific predefined dose size, for example, it can be represented by a predefined number of dose sizes, for example, 25 unit dose sizes. Here, the number sleeve can represent the first device component. The second device component can be represented by the housing of the drug delivery device, for example, by the body of the housing or by the cartridge holder.

[0075] When implemented as the body of the housing of the drug delivery device, the second device component can comprise an aperture or window through which at least a portion of the first device component located thereunder is visible. In case the first indicia, for example, in the form of a specific and predefined dose size, is displayed in the aperture or dose window of the second device component, thus in the dose window of the housing or body of the drug delivery device, this can be a clear indication to the user of the drug delivery device that the first device component has reached a predefined second position state in which the counterpart code is recognizable from the outside of the drug delivery device.

[0076] According to further examples, the first device component is one of a dose dial, a dial extension, a number sleeve and a protection cap of a pen-type injection device. The dose dial typically is subjected to a rotational movement during and / or for setting of a variable size dose. During dose setting, the dose dial is typically subjected to a rotation relative to a housing of the drug delivery device. The dose dial can also be subjected to a combined longitudinal sliding movement relative to the housing, e.g. serving as the second device component according to the terminology of the present invention. Furthermore, the dose dial can be subjected to a rotation and a longitudinal movement relative to the combination of the housing or body of the drug delivery device. Thus, the dose dial can be subjected to a helical movement relative to the housing or body when setting a dose.

[0077] The same applies to the dial extension. The dial extension can be subjected to a longitudinal sliding movement during dose setting and / or during dispensing or expelling of a medicament dose. The dial extension can be subjected to a combined longitudinal sliding movement and rotational movement. The dial extension or components thereof can be subjected to a helical movement relative to the housing of the drug delivery device, e.g. during and / or for setting or expelling of a medicament dose. The number sleeve can form a part of the dial extension.

[0078] For some examples, the number sleeve is retained inside the housing of the drug delivery device. The number sleeve is rotationally supported in or on the housing of the drug delivery device. For some examples, the number sleeve is locked in a longitudinal direction relative to the housing. For further examples, the number sleeve is threadedly engaged with the housing. When subjected to a movement relative to the housing, it can then follow a helical path relative to the housing.

[0079] For other examples, the protection cap configured to cover a dispensing or expelling end of the drug delivery device can be implemented as the first device component according to the above terminology. The protection cap can be rotationally supported on a distal end of the housing of the drug delivery device. It can be freely orientable in a plurality of rotational states relative to the housing. The protection cap can be detachably locked to the housing relative to a longitudinal direction. The protection cap can be snap-fitted or click-fitted to the housing.

[0080] For other examples, the second device component is one of a housing, a body of the housing and a cartridge holder of a pen-type injection device.

[0081] For some examples, the second device component can comprise a dosing element which is slidably supported in the housing of the drug delivery device and rotationally locked to the tubular housing of the drug delivery device. The dosing element can for example be in threaded engagement with the number sleeve. The dosing element can comprise a window or aperture through which a portion of the number sleeve is discernible or visible. For implementations of the dosing element, the number sleeve can be locked in the longitudinal direction to the housing of the drug delivery device. It can be free to rotate relative to the housing. The dosing element can also belong to or can form part of a dial extension.

[0082] The dosing element which acts as the second device component itself can be slidably supported in a longitudinal aperture of the housing. Here, the housing can act as the first device component. The dosing element can comprise a recess or dosing aperture through which a selected portion of the number sleeve underneath is revealed. When in threaded engagement with the number sleeve, rotation of the number sleeve causes longitudinal displacement of the dosing element relative to the aperture of the housing.

[0083] An outer surface of the dosing element can be provided with at least a first code portion of a pairing code. By setting a dose of a prescribed or predefined size, the dosing element, i.e. the second device component, moves relative to the housing, i.e. relative to the first device component. In this way, the first device component can reach a second position state relative to the second device component; and vice versa. In this position state, at least the first code portion or the entire code as provided on the outer surface of the dosing element can become discernible in the longitudinal aperture of the housing.

[0084] During dialling or setting of a dose, the number sleeve can be subjected to a rotational movement relative to the housing. Due to the threaded engagement with the number sleeve and the rotational interlock with the housing, the dosing element can slide along the rotating number sleeve, thus visually exhibiting a consecutive number sequence or dose size indication displayed in the window or aperture of the dosing element.

[0085] The body of the housing is typically a proximal portion of the housing. The body can be configured to house or accommodate a drive mechanism of the drug delivery device. The body can be non-releasably or non-detachably connected to a cartridge holder of the pen-type injection device. The cartridge holder can be particularly adapted to accommodate a cartridge filled with a medicament. For disposable devices, the cartridge filled with the medicament is readily arranged inside the housing, typically inside the cartridge holder. The cartridge holder can be non-releasably or non-detachably connected to the body of the housing of the drug delivery device.

[0086] The above concept of providing first and second device components of a drug delivery device that are movable relative to each other can be mapped and transferred to a number of components of a pen-type injection device. For example, a first code portion can be provided at or near the proximal end of a protective cap and a consecutive second code portion can be provided at or near the distal end of the body of the housing of such a pen-type injection device. The protective cap can be freely rotatable about the longitudinal axis relative to the body. Only in one or some other normally available position state of the protective cap and the body, the respective first and second code portions are aligned with each other, thus making the pairing code visually recognizable from the outside of the drug delivery device. For other configurations, the protective cap can be adapted to cover at least a portion of the pairing code when assembled or attached to the body. Detaching the protective cap can then reveal the pairing code.

[0087] According to another example of a drug delivery device, a cartridge filled with a medicament is arranged inside a housing. In this way, the drug delivery device is a drug device combination. It can be implemented as a disposable device with a cartridge that is easily assembled therein. It can also be configured and implemented as a reusable device. Here, the cartridge holder is detachably connected to the proximal body of the drug delivery or injection device, thus allowing replacing an empty cartridge with a new, thus filled cartridge.

[0088] According to a further example, an electronic data logging device is integrated in the drug delivery device. The data logging device can be integrated and / or assembled inside the drug delivery device, inside the housing of the drug delivery device or inside the dial extension of the drug delivery device. For other examples, the electronic data logging device is provided as a separate data logging device. It can comprise at least one fastening feature to engage with a corresponding or complementary shaped fastening feature at a predefined position of the drug delivery device.

[0089] When implemented as a separate electronic data logging device, the data logging device can be attachable or can be easily attached, for example, to the proximal end of the drug delivery device. For some examples, the data logging device is attached to at least one of the dial extension and / or the dose dial and the trigger of the pen-type injection device.

[0090] According to another aspect, the disclosure relates to a method of pairing an electronic data logging device of a drug delivery device with an external electronic device. The drug delivery device comprises a first device component movable relative to a second device component. The first device component comprises a first outer surface. The second device component comprises a second outer surface. At least one of the first outer surface and the second outer surface comprises at least a first code portion of a pairing code. The pairing code is visually recognizable from the outside of the drug delivery device only when the first device component is in a second position state relative to the second device component.

[0091] The method comprises a step of setting at least one of the external electronic device and the data logging device into a pairing mode. Prior to, during or after the first device component is moved relative to the second device component from a first position state, in which the pairing code is not visually recognizable, to a second position state, in which the pairing code is visually recognizable. Thereafter, and when the first device component has reached the second position state relative to the second device component, the pairing code, as now visually recognizable from the outside of the drug delivery device, is actually visually recognized or captured, e.g. by a person.

[0092] The recognized pairing code is then used to establish and / or to set up a communication link between the external electronic device and the data logging device. Depending on the specific implementation of the pairing routine, the user can be prompted to enter the pairing code, e.g. into the external electronic device or into the data logging device. For other examples, the pairing code can be visually or audibly presented by at least one of the data logging device and the external electronic device. The user can then be prompted to confirm the pairing code. In case the pairing code proposed by any of the data logging device and the external electronic device in the process of pairing the two devices does not match the pairing code visually recognizable from the outside of the drug delivery device, the user should abort and cancel the pairing routine in order to prevent misuse or unauthorized use of data stored in the data logging device.

[0093] It should further be noted that the present method of pairing an electronic data logging device with an external electronic device by means of a drug delivery device is universally applicable and can be performed by any type of drug delivery device as described above. Thus, any features, benefits and effects described above in connection with the drug delivery device equally apply to the pairing method; and vice versa.

[0094] According to a further aspect, the present disclosure relates to a medicament injection system. The injection system comprises a drug delivery device or injection device as described above. The injection system further comprises a data logging device which is integrated into the drug delivery device or which is attachable to the drug delivery device. Herein, the data logging device is configured and implemented to establish or to set up a communication link, e.g. a wireless communication link, to an external electronic device, such as a smart watch, a mobile phone, a tablet computer or a personal computer. In this regard, all features, effects and benefits as described above equally apply to the medicament injection system.

[0095] According to another aspect, the medicament injection system further comprises an external electronic device which is configured to establish and / or to set up a communication link, e.g. a wireless communication link, to the data logging device.

[0096] The injection system further comprises an external electronic device which is configured to establish a communication link to the data logging device.

[0097] Generally, the scope of the disclosure is to be defined by the contents of the claims. The injection device is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. In this regard, the disclosure encompasses any combination of the claims and any technically possible combination of features disclosed in connection with different examples or embodiments.

[0098] In the present context, the term "distal" or "distally" relates to the end of the injection device facing the injection site of a human or animal. The term "proximal" or "proximally" relates to the opposite end of the injection device, which is furthest away from the injection site of a human or animal.

[0099] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical formulation containing 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 humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose a disease or used to otherwise enhance physical or mental well-being. A drug or medicament can be used for a limited period, or on a regular basis, as for chronic disorders.

[0100] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API can 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 or single stranded DNA (including naked DNA and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0101] A drug or medicament can be contained in a primary package or "drug container" adapted for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store a drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store a drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20°C) or 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 preparation to be administered (e.g., an API and a diluent, or two different drugs), one 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 prior to and / or during dispensing into the human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers) and allow the user to mix the two components prior to dispensing, if desired. Alternatively, or additionally, the two chambers can be configured to allow mixing as the components are being dispensed into the human or animal body.

[0102] The drug or medicament contained in the drug delivery devices described herein can be used for therapy and / or prophylaxis in a number of different types of medical treatment. Examples of diseases to be treated include, e.g., diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic diseases such as deep vein or pulmonary thromboembolism. Further examples of diseases to be treated are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in, e.g., the

[0103] Examples of APIs used in the treatment and / or prophylaxis of diabetes mellitus type 1 or type 2 or complications associated with diabetes mellitus type 1 or type 2 include an insulin (e.g., human insulin, or a human insulin analogue or derivative, glucagon-like peptide-1, a GLP-1 analogue or a GLP-1 receptor agonist, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refer to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, such as the structure of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide, and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituent, such as a fatty acid, is bound to one or more amino acids. Alternatively, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0104] Examples of insulin analogues 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 proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0105] 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-Y-glutamyl)-des(B30) human insulin, B29-N-ooxypentadecanoyl-Y-L- glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxycar- boxyheptadecanoyl)-des(B30) human insulin and B29-N-(ooxycarboxyhepta- decaoyl) human insulin.

[0106] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixliraptid Exendin-4, a 39 amino acid peptide produced by the salivary glands of the Gila monster), Liraplutid Semaglutid, Taspoglutid, Albiglutid Dulaglutid 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, MAR 709, 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.

[0107] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterollowering antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0108] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0109] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Turopin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonal- F, Buserelin, Nafarelin, and Goserelin.

[0110] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, a low molecular weight heparin or ultra-low molecular weight heparin or a derivative thereof, or a sulfated polysaccharide (e.g. a polysulfated version of the above-mentioned polysaccharides), and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is Enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0111] The term "antibody", as used herein, 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. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be of an isotype or subtype that normally does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding portion of an antibody.

[0112] The term "fragment" or "antibody fragment" refers to polypeptides (e.g., antibody heavy and / or light chain polypeptides) derived from antibody polypeptides molecules that do not comprise a full-length antibody polypeptide but that still comprise at least a portion of a full- length antibody polypeptide that is capable of binding to antigen. Antibody fragments can comprise a cleaved portion of a full-length antibody polypeptide, although the term as used herein is not limited to such cleaved fragments. Antibody fragments that are useful in the present application 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 bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0113] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining correct positioning of the CDR sequences to permit 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 certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0114] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0115] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in drug delivery devices for drugs or pharmaceutical preparations. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0116] Those skilled in the art will understand that various components of the APIs, formulations, instruments, methods, systems, and embodiments described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0117] It will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from its scope. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of this disclosure. Attached Figure Description

[0118] In the following sections, several examples of the injection device and the method of pairing the data recording device with an external electronic device will be described in more detail with reference to the accompanying drawings, wherein:

[0119] Figure 1 schematically illustrates an example of a drug delivery device implemented as an injection device.

[0120] Figure 2 schematically illustrates several components of the drug delivery device of Figure 1.

[0121] Figure 3 is a schematic block diagram of an example of an electronic data recording device.

[0122] Figure 4 schematically illustrates an electronic data recording device integrated into a drug delivery device.

[0123] Figure 5 schematically illustrates a portion of a drug delivery device, wherein a first device component and a second device component carry pairing code portions for establishing a communication link between a data recording device and an external electronic device, wherein the first device component and the second device component are in a first position state.

[0124] Figure 6 illustrates an example from Figure 5, where the first and second device components are in the second position state.

[0125] Figure 7 schematically illustrates another example of a drug delivery device provided with a pairing code, wherein the first device component and the second device component are in a first position state.

[0126] Fig. 8 shows the example of Fig. 7 with the first and second device parts in a second position state,

[0127] Fig. 9 shows the first and second device parts of Figs. 7 and 8 in a third position state, and

[0128] Fig. 10 shows a flow chart of a method of pairing an electronic data logging device with an external electronic device by using a pairing code as provided by a drug delivery device according to any one of Figs. 1 to 9. DETAILED DESCRIPTION

[0129] An example of a drug delivery device 1 for using a dose of medicament 27 is shown in Figs. 1 and 2. The drug delivery device 1 is implemented as an injection device 30. The injection device 30 is a hand-held pen-type syringe. The injection device 30 can be implemented as a disposable injection device 30. It can comprise a pre-filled cartridge 6 arranged inside a cartridge holder 14. For the disposable injection device 30, the cartridge holder 14 can be non-detachably connected to the body 10 of the housing 32 of the injection device 30.

[0130] For other examples, the injection device 30 is a reusable injection device, wherein the cartridge holder 14 is detachably connected to the body 10 for replacing an empty cartridge 6. At or near the distal end of the housing 32, thus at the distal end of the cartridge holder 14, a hub 28 is provided which is configured to mount or engage with an injection needle 15. The hub 28 can be implemented as a threaded hub and the injection needle 15 can comprise a needle hub which is correspondingly threaded to provide a threaded engagement with the hub 28.

[0131] Typically, the injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 and / or a protection cap 18 which is configured to enclose and protect the distal section of the housing 32 of the injection device 30. The body 10 can comprise and form a main housing portion which is configured to house a drive mechanism 34 as shown in Fig. 2. The cartridge holder 14 can be considered as a distal housing component of the injection device 30. The cartridge holder 14 can be permanently or releasably connected to the body 10 or main housing.

[0132] The cartridge 6 comprises a cylindrical or tube-shaped barrel 25 which is sealed in the proximal direction 3 by a bung 7 located inside the barrel 25. The cartridge six can be pre-filled with a liquid medicament 27. The bung 7 is displaceable in the distal direction 2 relative to the barrel 25 of the cartridge 6 by means of a piston rod 20 of a drive mechanism 34. The distal end of the cartridge 6 is sealed by a pierceable seal 26 which is configured as a septum and which can be pierced by a proximally pointing tip of an injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is penetrated, thereby establishing a fluid transfer path to the interior of the cartridge 6.

[0133] When the injection device 1 is configured to administer, for example, human insulin, the dose set by the dose dial 12 at the proximal end of the injection device 1 can be displayed in so-called International Units (IU, where 1 IU is the biological equivalent of about 45.5 pg of pure crystalline insulin (1 / 22 mg)). The dose dial 12 can comprise a sleeve-shaped knob at the proximal end of the housing 32 of the injection device 30.

[0134] As further shown in Figs. 1 and 2, the body 10 comprises a dose window 13 which can be in the form of an aperture in the body 10. The dose window 13 allows the user to view a limited portion of a number sleeve 80 which is configured to move when the dose dial 12 is turned. The number sleeve 80 and the dose window 13 provide a visual indication of the currently set dose. The dose dial 12 can rotate on a helical path relative to the body 10 when turned during dose setting and / or dispensing or expelling.

[0135] For some other types of injection devices, the dose dial 12 can be locked to the body 10 in the longitudinal direction. It is then restricted to rotational movement relative to the body 10 for dose setting.

[0136] The injection device 30 can be configured such that turning the dose knob 12 causes a mechanical click sound to provide acoustic feedback to the user. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. Upon insertion of the needle 15 into a skin portion of a patient and upon pushing the trigger 11 or injection button, the insulin dose displayed in the dose window 13 is ejected from the injection device 1. When the needle 15 of the injection device 1 remains in the skin portion for a certain time after pushing the trigger 11, a higher percentage of the dose is actually injected into the patient. The ejection of the insulin dose can also cause a mechanical click sound, but it is different from the sound produced when using the dose dial 12.

[0137] In the illustrated embodiment, during delivery of an insulin dose, the dose dial 12 is turned to its initial position in the axial movement, that is to say without rotation, while the number sleeve 80 is rotated to return it to its initial position, for example, to display a dose of zero units.

[0138] The injection device 30 can be used for several injection processes until the cartridge 6 is empty or the medicament in the injection device 1 reaches an expiration date (e.g. 28 days after first use).

[0139] At least some components of an example of the drive mechanism 34 are shown in more detail in Fig. 2. The drive mechanism 34 comprises a plurality of mechanically interacting components. The flange-like support of the housing 10 comprises a threaded axial through opening which is in threaded engagement with the thread 22 of the piston rod 20. The distal end of the piston rod 20 comprises a bearing 21 on which a pressure foot 23 is freely rotatable with the longitudinal axis of the piston rod 20 as the axis of rotation. The pressure foot 23 is configured to abut axially against a proximally facing thrust-receiving face of the bung 7 of the cartridge 6. During the dispensing action, the piston rod 20 is rotated relative to the housing 10, thereby undergoing a distally directed advancement motion relative to the housing 10 and thus relative to the barrel 25 of the cartridge 6. As a result, due to the threaded engagement of the piston rod 20 with the housing 10, the bung 7 of the cartridge 6 is displaced in the distal direction 2 by a well-defined distance.

[0140] Further, a dose dial sleeve, also denoted as number sleeve 80, is provided. The number sleeve 80 is located radially inside the housing 10. A helical groove 81 is provided around the outer surface of the number sleeve 80. The body 10 is provided with a helical rib at the inside wall portion of the insert 62 which seats into the helical groove 81 of the number sleeve 80. The tubular insert 62 is inserted into the proximal end of the tubular body 10. Alternatively, such a helical rib can also be provided directly on the inside of the sidewall of the body 10. The helical rib and the insert 62 are rotationally and axially fixed to the body 10. A first stop and a second stop can be provided on the body 10 to limit the dose setting procedure during which the number sleeve 80 is rotated with a helical motion relative to the housing 10.

[0141] A dose dial grip in the form of a dose dial knob 12 is provided around the outer surface of the proximal end of the number sleeve 80. The outer diameter of the dose dial knob 12 typically corresponds and matches the outer diameter of the proximal end of the body 10. The dose dial knob 12 is fastened to the number sleeve 80 to prevent relative movement therebetween. The dose dial knob 12 is provided with a central opening.

[0142] The trigger 11, also denoted as dose button, is essentially T-shaped. It is provided at the proximal end of the injection device 10. The shank 64 of the trigger 11 extends through an opening in the dose dial 12. The shank 64 and thus the trigger 11 is held for limited axial movement relative to the number sleeve 80. The head of the trigger 11 is generally circular. A trigger side wall or skirt extends from the periphery of the head and is further adapted to seat in a proximally accessible annular recess of the dose dial 12.

[0143] For dialling a dose, the user rotates the dose dial 12 in the dose incrementing direction 4, e.g. clockwise. The dialling of a dose can be accompanied by a click sound. In this way, audible and / or tactile feedback of the dialled dose is provided. The dialling of a dose is further accompanied by a rotation of the number sleeve 80, which starts to extend from the body 10 in the proximal direction 3 when dialling in the dose incrementing direction 4, e.g. in the clockwise direction.

[0144] The number sleeve 80, the dose dial 12 and the trigger can form part of a dial extension 70, thus an assembly of components of the drive mechanism 34, which starts to extend or displace from the proximal end of the body 10 when a dose is dialled. During the dispensing of a dose, thus when the user depresses the trigger 11 in the distal direction 2, the dial extension 70 is subjected to a movement in the distal pointing direction, thus along the distal direction 2, relative to the body 10. During this dispensing movement, the number sleeve 80 is subjected to a rotation in the dose decrementing direction 5, e.g. counter clockwise.

[0145] The expelling or drive mechanism 34 as described above is only an embodiment of one of a plurality of different configurations of drive mechanisms that can typically be implemented in a disposable or reusable pen-type injector. Drive mechanisms as described above are explained in more detail in e.g. WO 2004 / 078239 A1, WO 2004 / 078240 A1 or WO 2004 / 078241 A1, the entire contents of which are incorporated herein by reference.

[0146] The drug delivery device 1, thus the injection device 30, can further be equipped with a data logging device 100 as shown in Fig. 3 or Fig. 4. The data logging device 100 can be integrated into the injection device 30. It can be positioned in a hollow reception provided by at least one of the trigger 11 and the dose dial 12. For other examples, the data logging device 100 is a separate component that is detachably connected to the body 10 or to some other part of the housing 32 of the injection device 30.

[0147] Thus, Fig. 2 illustrates a medicament injection system 102. The medicament injection system 102 comprises an injection device 30 and at least a data logging device 100. The data logging device 100 can be attached to the injection device 30. It can be detachably connected or detachably fixed to the housing 32 of the injection device 30. Alternatively, the data logging device 100 is integrated into the injection device 30. The medicament injection system 102 can further comprise an external electronic device 65. The external electronic device 65 can be implemented as a portable electronic device. It can comprise a smart watch, a smart phone, a tablet computer or a personal computer. The external electronic device 65 and the data logging device 100 are configured to establish a communication link 66, e.g. a wireless communication link, in order to transfer data therebetween.

[0148] The data logging device 100, as schematically represented in Fig. 3, typically comprises a sensor, e.g. in the form of a rotational sensing assembly 200, by means of which a relative rotation of at least one component of the drug delivery device 1, e.g. during at least one of dose setting and dose dispensing, with respect to another component of the drug delivery device 1 can be determined or quantitatively measured.

[0149] The data logging device 100 can be integrated into the drug delivery device 1 or can be provided as a separate additional device. When provided as a separate additional device, the data logging device 100 can be provided with its own housing 101 which is attachable to the housing 32 of the injection device 30 or the drug delivery device 1.

[0150] The data logging device 100 comprises one or more processors 240, such as microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), etc., and a memory 114. The memory 114 can comprise a program memory and a main memory which can store software for execution by the processor 240 and data generated or captured during use of the data logging device 100, such as counted pulses, derived dose sizes, time stamps, etc. An optional switch 122 connects a power source 120 to the electronic components of the data logging device 100, including the rotational sensing assembly 200. A display 118 can or can not be present. The rotational sensing assembly 200 can be coupled to a first member 201 and a second member 202. It comprises at least one sensor 220 connected or attached to the second member 202 and further comprises at least one signal generator 210 connected or attached to the first member 201.

[0151] For the present implementation of the rotation sensing assembly 200 in the data logging device 100, one of the first member 201 and the second member 202 can be connected or fastened to the housing 32 of the injection device 30 and the other of the first member 201 and the second member 202 can be connected or fastenable to the rotatable dose dial 12 of the injection device 30, for example.

[0152] The data logging device 100 typically comprises an interface 124 connected with the processor 240. The interface 124 can be a wireless communication interface for communicating with another external electronic device 65, for example in the form of a portable electronic device, via a wireless communication protocol or network, such as Wi-Fi or Bluetooth®. The wireless communication interface can be operable in the radio frequency range. For example, the wireless communication interface can be based on radio frequency identification technology, referred to as RFID, which allows compatible hardware to power and communicate with otherwise unpowered and passive electronic tags using radio waves. It can thus be used for identification, authentication, and tracking.

[0153] For other examples, the interface 124 is implemented as a wired communication link, such as a receptacle for receiving a Universal Serial Bus (USB), mini-USB or micro-USB connector. To this end, the interface 124 comprises a transceiver 126 configured for transmitting and receiving data. Fig. 3 depicts an example of an injection system in which the additional device 100 is connected to the external electronic device 65 via a communication link 66 for data transfer. The data connection 66 can be of the wired or wireless type.

[0154] For example, the processor 240 can store the determined delivered dose and time stamp of an injection administered by the user and subsequently transfer the stored data to the external electronic device 65. The computer 65 maintains a treatment log and / or forwards the treatment history information to a remote location, for example for review by medical personnel.

[0155] ​The add-on device 100 or data collection device can be configured to store data such as delivered medicament doses and timestamps for a number of injection events, such as 35 or more injection events. According to a once-daily injection therapy, this would be sufficient to store a treatment history of about one month. The data storage 114 can be organized in a first-in-first-out manner, ensuring that the most recent injection events are always present in the memory of the data collection device 100. Once transferred to the external electronic device 65, the injection event history in the add-on device 100 can be deleted. Alternatively, the data is retained in the add-on device 100 and the oldest data is automatically deleted once new data is stored. In this way, the log in the data collection device builds up over time during use and will always include the most recent injection events. Alternatively, other configurations can include storage capacity for 70 (two injections per day), 100 (three months), or any other suitable number of injection events, depending on the therapy needs and / or preferences of the user.

[0156] In another embodiment, the interface 124 can be configured to transmit information using a wireless communication link and / or the processor 240 can be configured to transmit such information to the external electronic device 65 periodically.

[0157] The processor 240 can control the optional display 118 to show determined medicament dose information and / or to show the time elapsed since delivery of the last medicament dose. For example, the processor 240 can cause the display 118 to periodically switch between showing the most recently determined medicament dose information and the elapsed time.

[0158] The power supply 120 can be a battery. The power supply 120 can be a button cell or a plurality of button cells arranged in series or in parallel. A timer 115 can also be provided. In addition to or as an alternative to turning the add-on device 100 on and off, the switch 122 can be arranged to trigger the timer 115 upon engagement and / or disengagement. For example, if the timer 115 is triggered on both engagement and disengagement of the first and second electrical contacts of the switch or on both operation and stop of operation of the switch 122, the processor 240 can use the output from the timer 115 to determine the length of time the trigger 11 was pressed, for example to determine the duration of the injection.

[0159] Alternatively or additionally, the processor 240 can use the timer 115 to monitor the length of time that has elapsed since the completion of an injection, as indicated by the disengagement of the respective switch component or the cessation of operation of the switch 122. Optionally, the elapsed time can be shown on the display 118. Also optionally, when the switch 122 is next operated, the processor 240 can compare the elapsed time to a predetermined threshold to determine whether the user is attempting to administer another injection too soon after the previous injection, and if so, generate an alert such as an audible signal and / or warning message on the display 118 or via the output 116. The output 160 can be configured to generate an audible sound or cause a vibration, thus generating a haptic signal, for example, for alerting the user.

[0160] The sensing assembly 200 as shown in Fig. 3 can be implemented as a rotational sensing assembly. It can comprise a first member 201 and a second member 202. The first member 201 is rotatable relative to the second member 202 about a rotational axis 203. Typically, the first member 201 and the second member 202 are coaxially arranged about the rotational axis 203. For some examples, the first member 201 and the second member 202 are arranged axially adjacent about the rotational axis 203. The first member 201 and the second member 202 can be directly mechanically engaged. For other examples, the first member 201 and the second member 202 are mechanically disengaged from each other. Herein, the first member 201 and the second member 202 can be separately arranged or rotationally supported in or at the housing 32 of the injection device 30 or in or at a respective housing 101 of a separate additional device 100.

[0161] Typically, at least one of the first member 201 and the second member 202 is rotationally supported in or on the housing 10 of the injection device 1. For some examples, both the first member 201 and the second member 202 can be rotationally supported on or about the housing 32. Typically, and depending on the specific implementation or integration of the rotational sensing assembly 200 in the injection device 30, one of the first member 201 and the second member 202 is rotationally locked to the housing 32, while the other one of the first member 201 and the second member 202 is rotationally movable relative to the housing 10. Typically, one of the first member 201 and the second member 202 is rotatable relative to the housing 32 about the rotational axis 203. The second member 202 can be represented by the dose dial 12. The first member 201 can be represented by the trigger 11. During at least one of the setting and the dispensing of a dose, the second member 202 is subjected to a rotation relative to the first member 201. The degree of relative rotation between the first member 201 and the second member 202 directly indicates the actual set and / or dispensed dose size.

[0162] The rotation sensing assembly 200 can comprise a printed circuit board 260 as illustrated in Fig. 4. The processor 240 can be arranged on the printed circuit board 260 together with the at least one sensor 220. The printed circuit board 260 can further be provided with the power supply 120. The power supply 120 can be located on one side of the printed circuit board 260. The processor 240 and / or the at least one sensor 220 can be arranged on the same side or on opposite sides of the printed circuit board 260.

[0163] In order to provide sufficient data security, the establishment of the communication link 66 between the data logging device 100 and the external electronic device 65 requires the use of a pairing code 320. Due to regulatory requirements, the pairing code 320 can have to be visible or recognizable from the outside of the drug delivery device 1. However, it should not be directly visible to anyone who has access to the drug delivery device 1. In order to prevent an unauthorized pairing of the electronic data logging device 100 and the external electronic device 65, the pairing code 320 is hidden by a component of the drug delivery device 1 and has to be revealed by an action of the user. According to a further option, the pairing code 320 is split or distributed over at least two device components 301, 302. In order to reassemble the pairing code 320, the first device component 301 and the second device component 302 would have to be moved into a predefined position state.

[0164] In the example of Figs. 5 and 6, at least one of the dial extension 70 and the number sleeve 80 provides the first device component 301 which is movable relative to the second device component 302. The second device component 302 can be provided by the body 10 of the housing 32 of the injection device 30. The first device component 301 is at least partially contained or received inside a hollow section of the second device component 302. As is apparent from a comparison of Figs. 5 and 6, the first device component 301 is displaceable or movable relative to the second device component 302 along a longitudinal direction, thus towards the proximal direction 3. Optionally, the first device component 301 can also be rotatable relative to the second device component 302.

[0165] The mutual engagement of the first device component 301 and the second device component 302 can only allow and support a helical movement of the first device component 301 relative to the second device component 302. The first device component 301 is provided with a first outer surface 311. On the first outer surface 311, at least a first code portion 321 of the pairing code 320 is provided. Typically, the establishment or setup of the communication link 66 between the data logging device 100 and the external electronic device 65 requires the entire pairing code.

[0166] The second device component 302 comprises a second outer surface 312. On the second outer surface 312, a second code portion 322 is provided. The recombination of the second code portion 322, thus the character "B", and the number and character sequence "123ABC" of the first code portion 321 constitutes or complements the pairing code 320. The pairing code 320 is only supplemented and recombined from the first code portion 321 and the second code portion 322 when the first device component 301 is in a predefined second position state 352 relative to the second device component 302.

[0167] This specific position state is characterized by the relative position of the first device component 301 and the second device component 302 and / or a predefined rotational orientation of the first device component 301 and the second device component 302 relative to each other. The second position state 352 can be characterized and can be identified by a first marker 303 of the first device component 301 which is configured to coincide, align or spatially overlap with a second marker 304 provided by the second device component 302. Here, the second marker 304 is an aperture in a side wall of the second device component 302. The aperture 304 can coincide with the above described dose window 13. The first marker 303 can be a selected or predefined number or symbol of a plurality of available numbers or symbols provided on the outer surface 311 of the first device component 301, e.g. implemented as the number sleeve 80. In the currently shown example, the first marker 303 is the number 25, also indicating that 25 units of a dose have actually been set in the current configuration of the first device component 301 and the second device component 302.

[0168] In the currently shown example, the second device component 302 is further provided with a second code portion 322. The second code portion 322 and the first code portion 321 have to be aligned along a straight line or along a helical line in order to reconstitute the pairing code 320 required for establishing or setting up the communication link 66.

[0169] For the currently shown example, the second code portion 322 is provided on the second outer surface 312 in combination with a second hidden code portion 336. The second hidden code portion 336 provides a certain additional or complementary code portion which is generally indistinguishable from the second code portion 322. The second hidden code portion 336 can comprise a plurality of characters, symbols or numbers which are to be aligned with the second code portion 322. When, for example, not properly informed by a user manual of the drug delivery device, an authorized user of the drug delivery device 1 does not know which one of the second hidden code portion 336, e.g. the letters "A" or "C", and the second code portion 322 character "B", is to be aligned with the first code portion 321 in order to recombine and constitute the pairing code 320.

[0170] In the example of Figs. 5 and 6, the second hidden code portion 336 extends along a second direction 4. The second direction can extend at a predefined angle relative to the first direction 3. The first code portion extends along the first direction 3 and the second hidden code portion 336 extends along or parallel to the second direction 4. When the first device part 301 is subjected to movement relative to the second device part 302 along the first direction 3 and along the second direction 4 to reach the second position state 352, the intersection of the longitudinal extension of the first code portion 321 with the second hidden code portion 336 can point or indicate to the second code portion 322.

[0171] In the currently shown example and when, for example, the dose of medicament to be dialed does not match the first indicia 303, there will be an alignment mismatch between the first code portion 321 and the second code portion 322 and thus the paired code 320 will not properly appear.

[0172] In another example as shown in the sequence of Figs. 7 to 9, the second device part 302 is free of a second code portion 322 or a second hidden code portion 336. There, the second device part 302 is opaque and receives at least a portion of the first device part 301 within its empty interior. In the first position state 351 as shown in Fig. 7, the first outer surface 311 of the first device part 301 is hardly visible from the outside of the injection device 30. Upon movement of the first device part 301 relative to the second device part 302, a portion of the first outer surface 311 is revealed from the second device part 302.

[0173] The movement of the first device part 301 relative to the second device part 302 from the first position state 351 as shown in Fig. 7 towards and into the second position state 352 as shown in Fig. 8 can be performed during setting of a dose of medicament. Thus, the user manual for pairing the electronic data logging device 100 and the external electronic device 65 can instruct the user of the injection device 30 to dial 25 standard units. This dialing or dose setting movement, for example by movement of the first device part 301 relative to the second device part 302, results in a combined rotation and longitudinal displacement of the first device part 301 relative to the second device part 302.

[0174] As shown in Fig. 8, the first device part 301 protrudes in longitudinal direction from the longitudinal end, thus from the proximal end of the first device part 302. Accordingly, a respective portion of the first outer surface 311 appears. When the second position state 352 as shown in Fig. 8 is reached, only the entire paired code 320 is visually recognizable from the outside of the drug delivery device 30. Here, only and exclusively the paired code 320 is revealed.

[0175] As is apparent from the further illustration of Fig. 9, and thus when the first device part 301 is moved further, e.g. in the proximal direction 3 relative to the first device part 302 and beyond the second position state, another portion of the first outer surface 311 is revealed. The further portion of the first outer surface 311 is provided with a first hidden code portion 335. The first hidden code portion 335 is indistinguishable from the first code portion 321 or from the pairing code 320. Thus, in the configuration as shown in Fig. 9, a user of the device will not be able to visually identify which portion of the indistinguishable combination of the pairing code 320 and the first hidden code portion 335 should be used or which portion thereof is relevant for initiating or approving a pairing between the data logging device 100 and the external electronic device 65.

[0176] For typical implementations of the drug delivery device 30, the first device part 301 is movable relative to the second device part 302 from the first position state 351, such as illustrated in Figs. 5 and 7, to the second position state 352, as illustrated in Figs. 6 and 8, and vice versa (from the second position state 352 towards and into the first position state 351), without dispensing a dose of the medicament 27.

[0177] In Fig. 10, a flow chart of a pairing method of the data logging device 100 with the external electronic device 65 is illustrated. Typically, the pairing method can be performed using a drug delivery device 1 or an injection device 30 as described above in connection with the external electronic device 65 and the data logging device 100, the data logging device being provided as a separate data logging device 100 or being integrated into the drug delivery device 1.

[0178] For establishing the communication link 66 between the data logging device 100 and the external electronic device 65 in the first step 400, at least one of the external electronic device 65 and the data logging device 100 is set into a pairing mode. Typically, the external electronic device 65 and the data logging device 100 are configured to establish a wireless communication link, e.g. using a standardized RF connection protocol such as Bluetooth. In a subsequent step 402, the first device part 301 is moved relative to the second device part 302 from the first position state 351, in which the pairing code 320 is not recognizable, into the second position state 352. In a subsequent step 404, the pairing code 320 is visually identified by a user of the drug delivery device. In a further step 406, the communication link 66 between the external electronic device 65 and the data logging device 100 is established or approved using the pairing code 320 as identified by the user in step 404.

[0179] List of reference signs

[0180] 1 drug delivery device

[0181] 2 distal direction

[0182] 3 first direction

[0183] 4 second direction

[0184] 5 dose decrement direction

[0185] 6 cartridge

[0186] 7 bung

[0187] 8 drive mechanism

[0188] 9 dose setting mechanism

[0189] 10 body

[0190] 11 trigger

[0191] 12 dose dial

[0192] 13 dose window

[0193] 14 cartridge holder

[0194] 15 injection needle

[0195] 16 inner needle hub

[0196] 17 outer needle hub

[0197] 18 protective cap

[0198] 19 protrusion

[0199] 20 piston rod

[0200] 21 bearing

[0201] 22 threaded section

[0202] 23 pressure foot

[0203] 25 barrel

[0204] 26 seal

[0205] 27 medicament

[0206] 28 spigot

[0207] 30 injection device

[0208] 32 housing

[0209] 34 drive mechanism

[0210] 62 insert

[0211] 64 handle

[0212] 65 external electronics

[0213] 66 communication link

[0214] 70 dial extension

[0215] 80 digital sleeve

[0216] 81 recess

[0217] 100 data logging device

[0218] 101 housing

[0219] 102 medicament injection system

[0220] 114 memory

[0221] 115 timer

[0222] 116 output

[0223] 118 display

[0224] 120 power source

[0225] 122 switch

[0226] 124 interface

[0227] 126 transceiver

[0228] 200 sensing assembly

[0229] 201 first member

[0230] 202 second member

[0231] 203 rotational axis

[0232] 210 signal generator

[0233] 220 sensor

[0234] 240 processor

[0235] 260 printed circuit board

[0236] 301 device component

[0237] 302 device component

[0238] 303 indicia

[0239] 304 indicia

[0240] 311 outer surface

[0241] 312 outer surface

[0242] 320 pairing code

[0243] 321 code portion

[0244] 322 code portion

[0245] 335 code portion

[0246] 336 code portion

[0247] 351 position state

[0248] 352 position state

[0249] 353 position state

Claims

1. A drug delivery device (1) for administering a dose of a medicament (27), the drug delivery device (1) being operable to cooperate with an electronic data logging device (100), the drug delivery device (1) comprising: - a housing (32) for containing the medicament (27), the housing (32) being further configured to receive and / or mechanically engage with the electronic data logging device (100), - a first device component (301) and a second device component (302), wherein the first device component (301) is movable relative to the second device component (302) from a first position state (351) to at least a second position state (352), - wherein the first device component (301) comprises a first outer surface (311), wherein the second device component (302) comprises a second outer surface (312), and wherein at least one of the first outer surface (311) and the second outer surface (312) comprises at least a first code portion (321) of a pairing code (320) for establishing a communication link (66) between the electronic data logging device (100) and an external electronic device (65), - wherein the pairing code (320) is visually identifiable from outside of the drug delivery device (1) only when the first device component (301) is in the second position state (352) relative to the second device component (302).

2. The drug delivery device (1) according to claim 1, wherein the pairing code (320) is a security code requested by at least one of the electronic data logging device (100) and the external electronic device (65) to establish the communication link (66).

3. The drug delivery device (1) according to claim 1 or 2, wherein at least one of the external electronic device (65) and the electronic data logging device (100) is operable to request the pairing code (320) associated with the other one of the external electronic device (65) and the electronic data logging device (100).

4. The drug delivery device (1) according to any one of claims 1 or 2, wherein the pairing code (320) contains unique information or a unique identification of the medicament (27) located inside the drug delivery device (1).

5. The drug delivery device (1) according to any one of claims 1 or 2, wherein the movement of the first device component (301) from the first position state (351) towards and into the second position state (352) comprises at least one of a rotational movement, a sliding movement or a screwing movement.

6. The drug delivery device (1) according to any one of claims 1 or 2, wherein the first device component (301) and the second device component (302) are permanently connected.

7. The drug delivery device (1) according to any one of claims 1 or 2, wherein the first code portion (321) or the pairing code (320) is provided on the first outer surface (311), and wherein at least a portion of the first code portion (321) or the pairing code (320) is hidden by the second device component (302) when the first device component (301) is in the second position state (352) other than.

8. The drug delivery device according to any one of claims 1 or 2, wherein the first outer surface (311) is provided with one of the first code portion (321) and the entire pairing code (320), and wherein the first outer surface (311) is further provided with a first hidden code portion (335), which is indistinguishable from the first code portion (321) or from the pairing code (320) such that the font, size and style of the number or string of characters of the first hidden code portion (335) is the same or equivalent to the font, size and style of the number or string of characters of the first code portion (321), wherein at least a portion of the first hidden code portion (335) is distinguishable from the indistinguishable constitution of at least one of the first code portion (321) and the pairing code (320) from the outside of the drug delivery device (1) when the first device component (301) is in the second position state (352) other than.

9. The drug delivery device (1) according to claim 8, wherein the first hidden code portion (335) is hidden by the second device component (302) when the first device component (301) is in the second position state (352).

10. The drug delivery device (1) according to any one of claims 1 or 2, wherein the pairing code (320) comprises the first code portion (321) and a second code portion (322), wherein the first code portion (321) is provided on the first outer surface (311), and wherein the second code portion (322) is provided on the second outer surface (312).

11. The drug delivery device (1) according to claim 10, wherein the first code portion (321) and the second code portion (322) recombine and constitute the pairing code (320) from each other when the first device component (301) is in the second position state (352).

12. The drug delivery device according to any one of claims 1 or 2, wherein at least one of the pairing code (320) and the first code portion (321) extends along a first direction (3), and wherein the first device component (301) is movable relative to the second device component (302) along the first direction (3).

13. The drug delivery device (1) according to claim 10, wherein the second outer surface (312) is further provided with a second hidden code portion (336), which is indistinguishable from the second code portion (322), such that the font, size and style of the number or string of characters of the second hidden code portion (336) is the same or equivalent to the font, size and style of the number or string of characters of the second code portion (321), and wherein the first code portion (321) is aligned with the second code portion (322) when the first device component (301) is in the second position state (352).

14. The drug delivery device (1) according to claim 13, wherein the first code portion (321) or a portion thereof is aligned with the second hidden code portion (336) when the first device component (301) is outside the second position state (352).

15. The drug delivery device (1) according to claim 13, wherein at least one of the second hidden code portion (336) and the second code portion (322) extends along a second direction (4), and wherein the first device component (301) is movable relative to the second device component (302) along the second direction (4).

16. The drug delivery device (1) according to any one of claims 1 or 2, further comprising a first marker (303) and a second marker (304), wherein the first marker (303) is provided by or connected to the first device component (301), and wherein the second marker (304) is provided by or connected to the second device component (302), wherein the first marker (303) is subject to a movement relative to the second marker (304) when the first device component (301) is moved relative to the second device component (302), and wherein the first marker (303) and the second marker (304) are visually aligned, visually overlap or mechanically engage when the first device component (301) reaches the second position state (352) relative to the second device component (302).

17. The drug delivery device (1) according to claim 16, wherein the second marker (304) comprises an aperture in the second device component (302) through which at least a portion of the first outer surface (311) provided with the first marker (303) can be visually recognized or detected.

18. The drug delivery device (1) according to any one of claims 1 or 2, wherein the first device component (301) is one of a dose dial (12), a dial extension (70), a number sleeve (80) and a protection cap (18) of a pen-type injection device (30).

19. The drug delivery device (1) according to any one of claims 1 or 2, wherein the second device component (302) is one of a housing (32) of a pen-type injection device (30), a body (10) of the housing (32) and a cartridge holder (14).

20. The drug delivery device (1) according to any one of claims 1 or 2, wherein a cartridge (6) filled with a medicament (26) is arranged inside the housing (32).

21. The drug delivery device (1) according to any one of claims 1 or 2, wherein the drug delivery device (1) is implemented as an inhaler, an injection device or an infusion device.

22. A drug injection system (102) comprising; - a drug delivery device (1) according to any one of the preceding claims, - a data logging device (100) integrated into the drug delivery device (1) or attachable to the drug delivery device (1), wherein the data logging device (100) is configured and implemented to establish or set up a communication link to an external electronic device.

23. The drug injection system (102) according to claim 22, further comprising an external electronic device (65) configured to establish and / or set up a communication link to the data logging device (100).

24. A method of pairing an electronic data logging device (100) of a drug delivery device (1) with an external electronic device (65), wherein the drug delivery device (1) comprises a first device component (301) movable relative to a second device component (302), wherein the first device component (301) comprises a first outer surface (311), and wherein the second device component (302) comprises a second outer surface (312), and wherein at least one of the first outer surface (311) and the second outer surface (312) comprises at least a first code portion (321) of a pairing code (320) which is visually recognizable from outside of the drug delivery device (1) only when the first device component (301) is in a second position state (352) relative to the second device component (302), the method comprising the steps of: - setting at least one of the external electronic device (65) and the data logging device (100) into a pairing mode, - moving the first device component (301) relative to the second device component (302) from a first position state (351) in which the pairing code (320) is not recognizable, to the second position state (352), - visually recognizing the pairing code (320) from outside of the drug delivery device (1), - using the pairing code (320) for establishing a communication link (66) between the external electronic device (65) and the data logging device (100).

25. The method according to claim 24, wherein using the pairing code (320) comprises: - presenting the pairing code (320) by at least one of the data logging device (100) and the external electronic device (65) and prompting a user to confirm the pairing code, or - entering the pairing code (320) into one of the external electronic device (65) and the data logging device (100). - entering the pairing code (320) into one of the external electronic device (65) and the data logging device (100). - entering the pairing code (320) into one of the external electronic device (

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