Drug delivery device

Abstract

To provide a method of pairing an electronic data logging device of a drug delivery device with an external electronic device.SOLUTION: The drug delivery device comprises: a housing for housing drugs which receives an electronic data logging device and is further configured to mechanically engage with the electronic data logging device; and a first device component and a second device component. Therein: the first device component is movable relative to the second device component from a first position state to a second position state; the first device component comprises a first outer surface and 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 for establishing a communication link between the electronic data logging device and an external electronic device; the pairing code is visually identifiable from the outside of the drug delivery device only when the first device component is at the second position state relative to the second device component.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present disclosure relates to the field of drug delivery devices for administering doses of a medicament. The present disclosure particularly relates to a drug delivery device operable to cooperate with an electronic data logging device, which 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 suitable 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 technology]

[0002] Drug delivery devices for setting and dispensing a dose or multiple doses of a medicament are well known per se in the art. In general, such devices may have substantially the same purpose as a conventional syringe.

[0003] Drug delivery devices such as injection or inhalation devices, for example, pen-type injectors, must meet many user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically frail and may also have poor eyesight. Therefore, a suitable drug delivery device, especially intended for home medication, must be robust in structure and easy to use. Furthermore, the operation and overall handling of the device and its components must be straightforward and easily understood. Such an injection device should provide for the setting and subsequent dispensing of variable-sized doses of medication. Furthermore, the dose setting, together with the procedure for dose dispensing, must be easy to operate and clear.

[0004] The medicament to be dispensed or expelled by the drug delivery device can be provided and contained in a multi-dose cartridge. Such cartridges typically include a glass barrel that is sealed distally by a pierceable seal and further sealed proximally by a bung. In reusable drug delivery devices, the empty cartridge can be replaced with a new cartridge. In contrast, disposable drug delivery devices are easily equipped with such cartridges. Such drug dispensing devices are completely discarded when the medicament in the cartridge has been dispensed or used up.

[0005] In some drug delivery devices, such as pen injection devices, the user must set equal or variable size doses by rotating a dose dial in a clockwise or counterclockwise direction relative to the body or housing of the injection device to increase or decrease the dose. To inject and expel a dose of liquid medication, the user must depress a trigger or dose button in a distal direction, and thus toward the body or housing of the injection device. Typically, the user uses his or her thumb to apply distally directed pressure against the dose dial and the dose button located at the proximal end of the dose dial sleeve, 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 accurate, reliable, semi-automated monitoring and / or collection of injection-related data during use of the injection device. Mechanically operated injection devices can be equipped with electronically implemented add-on devices or data logging devices configured to monitor operations caused by a user of the injection device.

[0007] Some data logging devices may be configured to be attached to the injection device. Some data logging devices may be embedded in or located within the injection device. Some drug delivery devices may be electronically implemented, such that they include an integrated electronic unit configured and operable to monitor the operation of the drug delivery device over time. Here, the data logging device is provided by the integrated electronic unit.

[0008] Administration details and patient-specific data can be recorded and stored in such data logging devices during repeated uses of the respective drug delivery device. It is generally desirable to be able to access the respective data stored in the data logging device, e.g. for patient monitoring and / or to optimize 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 wireless or wired. The data collected or at least temporarily stored in the data logging device can be quite sensitive and / or sensitive. Misuse or unauthorized access of this data should be prevented and avoided.

[0009] To prevent unauthorized access to the data, establishment of a communications link between the data logging device and the external electronic device may require authentication, where the data logging device and / or the external electronic device may be implemented to establish a communications link only upon confirmation or entry of a suitable key or code. Generally, such pairing codes may provide security against misuse or unauthorized access to data stored in the data logging device, provided that the pairing code is only known to authorized people.

[0010] On the one hand, such keys or codes should be freely available to authorized people, e.g., healthcare providers or patients. On the other hand, to provide sufficient data security, such pairing codes must not be directly identifiable from the outside of the drug delivery device. Regulatory requirements may further specify that such pairing codes must be visible from the outside of the injection device or data logging device. Summary of the Invention [Problem to be solved by the invention]

[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 unhindered and unconditional access to the pairing code for authorized people. [Means for solving the problem]

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

[0013] In one aspect, a 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 includes a housing that contains the medicament. The housing is further configured to receive or mechanically engage the electronic data logging device. The housing can be configured to accommodate a data logging device. The data logging device may be implemented as a separate device that can be coupled to the housing of the drug delivery device or to a movable component of the drug delivery device. In other examples, the electronic data logging device is integrated into and resides in the drug delivery device.

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

[0015] The first device component includes a first exterior surface. The second device component includes a second exterior surface. At least one of the first exterior surface and the second exterior surface includes at least a first code portion of a pairing code. The pairing code is usable 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 required by at least one of the electronic data logging device and the external electronic device to establish the communication link. The pairing code can include or consist of a key necessary to establish a connection between the electronic data logging device and the external electronic device. Generally, the pairing code is usable or required to establish a secure connection between the data logging device and the external electronic device.

[0016] The pairing code may also include or consist of at least one of a bonding code or a session key. The pairing code may also serve as a password or passphrase to establish 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 include a wireless, and thus mechanically contactless, communication interface, and in order to establish a communication link between the wireless communication interface 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 procedure, for example based on a well-defined wireless communication standard.

[0018] In general, the communication link and communication method between the data logging device and the drug delivery device are not limited to a wireless communication standard of a particular wireless communication technology. The present disclosure is generally applicable to all types of available mechanically contactless communication links that require authentication to and / or during the establishment of a secure connection between the communication interfaces of, for example, the data logging device and the drug delivery device, respectively.

[0019] In some examples, the communication link is an electromagnetic communication link capable of providing or supporting radio frequency based communication, such as WiFi, Bluetooth, RFID, NFC, GSM, UMTS, LTE, contactless charging, etc. In further examples, the communication link is based on optical transmission in the infrared or visible spectrum. In further examples, the communication link is based on acoustic signals.

[0020] Execution of the pairing routine includes an authentication step, where 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 of the external electronic device and the electronic data logging device. In some embodiments, a pairing code typically associated with the electronic data logging device is also included. The pairing code received may be communicated or transmitted to the external electronic device. The user may be prompted to confirm the pairing code by entering the pairing code 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. In other embodiments, at least one of the electronic data logging device and the external electronic device may be operable to visually or audibly present a pairing code that must be confirmed and / or acknowledged by a user of the respective device before the communication link can be established.

[0021] In some examples, the pairing code provided on the drug delivery device characterizes the drug delivery device and / or the drug intended for or placed inside the drug delivery device. Different types of drug delivery devices can thus be distinguished from each other by different pairing codes. Identical drug delivery devices, i.e. drug delivery devices loaded with the same drug, can be provided with a common or the same pairing code.

[0022] The pairing code may include unique information or a unique identification of the drug located inside the drug delivery device, which applies especially when the drug delivery device is a pre-filled drug delivery device, for example a pre-filled injection device loaded with only one type of drug.

[0023] By disposing or incorporating a data logging device in the housing of the drug delivery device, the data logging device can track the configuration of the drug delivery device. Pairing the data logging device with an external electronic device, for example by entering or verifying a pairing code provided on the drug delivery device into the external electronic device, essentially provides the external electronic device with unique information or a unique identification of the medication located within the drug delivery device.

[0024] Still alternatively, for example, when the electronic data logging device is fixedly and irremovably placed in or on the drug delivery device, the electronic data logging device may be pre-programmed with sufficient information to enable it to identify the type of medication and / or the type of drug delivery device to which it is actually attached. Furthermore, pairing codes may be provided on the first and / or second device components and in the electronic memory of the electronic data logging device when or during incorporation or assembly of the electronic data logging device into or with the drug delivery device. Also, a unique assignment may be provided between the pairing code provided on the drug delivery device itself and an unrelated pairing code stored in the memory of the electronic data logging device.

[0025] In some examples, the pairing code includes at least three digits, at least four digits, at least five digits, at least six digits, or any greater number of digits, where the digits may include numbers, letters, or any other visually identifiable symbols.

[0026] The pairing code is visually identifiable from outside the drug delivery device only when the first device component is in the second position state relative to the second device component. Thus, the pairing code is identifiable from outside the drug delivery device 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 further position states of the first device component relative to the second device component, the pairing code is not identifiable from outside the drug delivery device.

[0027] Here, the pairing code or at least a part thereof can be hidden or covered by at least one of the first or second device components. In some examples, the pairing code can be visible from the outside of the drug delivery device even when the first device component is out of or offset from the second position state. Here, the pairing code can be provided with a supplementary code, such as a hidden code part that is indistinguishable from the pairing code. The code, even if visible, cannot be clearly visually identified as long as the first device component is out of or offset from 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 may be incorporated into the drug delivery device or may be provided as a separate data logging device or an add-on device configured to be releasably or non-releasably attached to the drug delivery device. Typically, the data logging device includes at least one sensing arrangement configured to detect and / or quantitatively determine the setting and / or dispensing of a dose of a drug. Typically, the data logging device includes an integrated circuit, for example provided on a printed circuit board (PCB). The data logging device typically includes a processor and a memory. The data logging device further includes a communication interface. The communication interface may include a wireless transceiver to establish a wireless communication link with 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 according to a standardized wireless communication protocol, for example based on radio frequency communication such as RFID and NFC or Bluetooth.

[0030] The pairing routines of the electronic data logging device and the external electronic device are specifically implemented to request or confirm a pairing code. The pairing code as provided by the drug delivery device may need to be entered into either the data logging device or the external electronic device. In some examples, the pairing code may be visually displayed to a user of the drug delivery device, for example, by the data logging device and / or the external electronic device. The user may then be prompted to confirm that the illustrated pairing code is identical to the pairing code provided on the drug delivery device. In this way, misuse of the data stored in the electronic data logging device may be effectively prevented.

[0031] A pairing code that may be necessary to establish a communication link is visually identifiable or discernible 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, and 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] Thus, improvements to the drug delivery device provide two alternative approaches. In one approach, a pairing code provided on at least one of the first and second device components allows the first device component to pair with the second device component. In this manner, the first and second device components are typically displaceable relative to one another in an interleaved manner, unless the first and second device components are out of or overlapping the second positional state relative to one another.

[0033] Thus, the first and second device components, which include at least the first code portion, are at least partially received inside the other of the first and second device components. Thus, at least a part of the first code portion provided on the outer surface of at least one of the first and second device components is concealed 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 manner or at least partially nested manner. In the first position state, the degree of overlap is relatively large, thereby covering or concealing at least a part of the first code portion. In the second position state, the degree of mutual overlap is reduced so as to reveal the entire first code portion or pairing code.

[0034] According to the second alternative approach, the pairing code is permanently visible on the outside of the first and second device components. Here, the pairing code is given a complementary code, and thus a hidden code portion that is indistinguishable from the pairing code. As long as both, i.e., the pairing code and the complementary hidden code portion, are visible on the outside of the drug delivery device, in or from the indistinguishable combination of the pairing code and the hidden code, each user cannot visually identify the pairing code, since they do not know the full length and position of the associated pairing code.

[0035] Here, the created pairing code can be hidden among the complementary concealment code portions, and only upon moving the first device component to a second positional state relative to the second device component are the complementary and / or concealment code portions hidden or covered, thereby making the remaining pairing code discernible from outside the drug delivery device.

[0036] In this context, a position state between a first device component and a second device component includes a relative orientation as well as a relative position between the first device component and the second device component, In the first and second position states, at least one of the position and orientation of the first device component is different from the respective position or orientation of the second device component.

[0037] The first and second device components can be directly or indirectly mechanically engaged. Additionally, the first and second device components can be threadably engaged or slidably engaged. The first and second device components can be non-rotatably engaged or non-rotatably locked.

[0038] The movement of the first device component from the first position state to the second position state can include at least one of a rotational motion, a sliding motion, or a helical motion, and thus a combination of a rotational motion and a sliding motion. The first and second device components can be permanently coupled, for example, by a threaded engagement or by a grooved link.

[0039] The first positional state of the first and second device components can correspond to an initial state of the respective components, for example, when the drug delivery device is handed over to a patient or customer. The second positional state of the first and second device components can correspond to a particular device configuration. In some examples, preparation of the drug delivery device for administering a dose of a medicament requires movement of the first device component relative to the second device component. In some instances, setting a dose of a drug requires moving a first device component relative to a second device component, or vice versa, and in some instances, expelling or dispensing a dose of a drug requires moving a first device component relative to a 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 orientation of the first device component relative to the second device component, which a user of the drug delivery device is well aware of and has little difficulty in moving the first device component relative to the second device component to reach the second position state.

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

[0042] Generally, it is only relevant that the first device component is moved relative to the second device component. It is completely irrelevant whether the first device component actually undergoes a movement relative to the environment. To reach the second position state, the first device component can be fixed, for example, by a user's hand, 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 concealed by the second device component when the first device component is out of the second position state. In this way, the entire pairing code is still not visually identifiable from the outside of the drug delivery device unless the first device component is out of the second position state or overlaps with the second position state. Here, each part of the first outer surface comprising the first code portion or comprising the entire pairing code is covered by the second device component. Typically, the second device component, or at least the part thereof that spatially overlaps with the first device component, is opaque.

[0044] Thus, the first code portion or the entire pairing code becomes apparent 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 entire first code portion or pairing code, is in the first position state, at least a portion of the first code portion or each of the entire pairing code is indistinguishable from outside the drug delivery device. In this position state, the pairing code cannot be visually identified in its entirety from outside the drug delivery device as long as the first device component is out of the second position state. Communication pairing between an electronic data logging device, for example attached or integrated in 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 exterior surface comprises one of a first code portion and a pairing code. The first exterior surface further comprises a first hidden code portion. The hidden code portion is indistinguishable from the first code portion or from the pairing code. A composition indistinguishable between at least a portion of the hidden code portion and at least one of the first code portion and the pairing code is indistinguishable from the first code portion and the pairing code when the first device component is moved out of the second positional state, e.g., when the first device component is moved to the second device component. whereas in the third position state it is discernible from the outside of the drug delivery device.

[0046] The concealment code portion may be the same type of code as compared to the pairing code. In some examples, the pairing code may include a string of numbers or letters. The concealment code portion may include an equivalent string of numbers or letters. The font, size and style of the strings of the pairing code and the concealment code portion may be the same or equivalent and thus indistinguishable. Also, the concealment code portion may be directly aligned with the first code portion and / or the pairing code.

[0047] The first code portion or the pairing code can be embedded or surrounded by the first hidden code portion. The length of the string of the first hidden code portion and the composite of the first code portion and at least one of the pairing code cannot be recognized by the user. Therefore, the pairing code, i.e., the pairing code or its first code portion, is mixed or blended with the hidden code portion and becomes visually indistinguishable as long as it is provided on the first outer surface together with the first hidden code portion.

[0048] In some examples, the first code portion or the entire pairing code can be completely invisible when the first device component is in a first position state and thus completely hidden by the second device component, and as the first device component is moved from the first position state toward the second position state, the first code portion or the entire pairing code becomes continuously visible.

[0049] Upon reaching the second position state, the entire associated first code portion or pairing code can be revealed from the second device component, and as the second device component is moved further in the same direction towards a third position state, the entire first code portion and / or pairing code as well as the concealed code portion provided on the first exterior surface become visible and apparent.

[0050] Because the first concealed code portion is generally indistinguishable from the first code portion or from the pairing code, the combination of the first concealed code portion with the first code portion and / or with the pairing code is effectively unusable to a user since the associated pairing code or its associated code portion cannot be identified in the indistinguishable code composite as provided on the first exterior surface of the first device component.

[0051] This provides an additional security feature against misuse or unauthorized access to the data stored in the electronic data logging device. Visually identifying the entire pairing code requires knowledge of a fairly specific and well-defined second location state of the first device component relative to the second device component.

[0052] According to another example, when the first device component is in the second position state, the first concealment code portion is concealed by the second device component, where the first concealment code portion can be obscured or shielded by the second device component, such that when in the second position state, the relevant portion, and therefore the entire first code portion or pairing code, becomes distinguishable from or in a composite of the first concealment code portion with at least one of the first code portion and the pairing code.

[0053] According to another example, the pairing code includes a first code portion and a second code portion. The first code portion is provided on a first exterior surface. The second code portion is provided on a second exterior surface. Here, the entire pairing code is used to pair the first device component with the second device component. The pairing code is divided between the first and second device components. The first code portion is provided on a first exterior surface of the first device component and the second code portion is provided on a second exterior surface of the second device component. The entire pairing code is a combination of the first and second code portions. Thus, to visually identify the entire pairing code, the first and second code portions must recombine and / or complement each other.

[0054] In this example, both the first code portion and the second code portion may be permanently visible from the outside of the drug delivery device. In order to recombine the pairing code from the first code portion in the second code portion, it may be necessary to arrange the first code portion and the second code portion in a well-defined or predetermined manner. In some examples, the first code portion and the second code portion need to be aligned in a specific configuration that is only visible to the user of the drug delivery device.

[0055] In some examples, only one of the first and second code portions may be permanently visible on one of the first and second exterior surfaces, respectively. By moving the first device component relative to the second device component, the degree of spatial and non-transparent overlap of the first and second exterior surfaces with each other can be altered.

[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 hidden by the second device component. Moving the first device component relative to the second device component to the second position state involves movement of the first code portion relative to the second code portion, where the first code portion can be apparent from the second device component.

[0057] Additionally, when the first device component is in a second positional state relative to the second device component, the first code portion can complement the second code portion to form or recombine a pairing code.

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

[0059] In other configurations, when the first device component is out of the second position state relative to the second device component, the combination of the first code portion visible from outside the drug delivery device and the second code portion as visible from outside the drug delivery device may also align or recombine with each other, but may be inoperative and unable to provide a pairing code. In such a position state of the first and second device components that is distinct or different from the second position state, the recombination of the first and second code portions is distinct from the pairing code and therefore does not represent or reconstitute the pairing code necessary to set up or establish a communication link between the electronic data logging device and the external electronic device.

[0060] According to another example, the pairing code and / or the first code portion extend along a first direction on at least one of the first and second device components, and thus on at least one of the first and second outer surfaces, where the first device component is movable along the first direction relative to the second device component. This can be achieved, for example, by providing the pairing code or the first code portion on the first outer surface, such that the first outer surface of the first device component is at least partially movable by the second device component, for example when the first device component is in a first position state. This is particularly useful when the first exterior surface is at least partially covered such that as the first device component is moved towards the second positional state, a greater portion of the first exterior surface can be revealed from the second device component.

[0061] In 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, and as the first device component is moved towards the second position state, the first exterior surface can continuously protrude from an end of the second device component, or each first exterior surface can continuously protrude from an end of the second device component or extend into an aperture of the second device component such that more of the first code portion or the entire pairing code is identifiable and visible by protruding from an end of the second device component or appearing in an aperture of the second device component.

[0062] During movement of the first device component from a first position state toward a second position state, the first code portion and a steadily increasing portion of the pairing code become discernible as the first device component is moved along a first direction relative to the second device component.

[0063] According to a further example, the second device component further comprises a second hidden code portion on the second outer surface. The second hidden code portion is indistinguishable from the second code portion provided on the second outer surface. The first code portion aligns with the second code portion when the first device component is in the second position state. The first code portion can be offset from the second code portion as long as the first device component is out of the second position state. Here, the first code portion can be aligned with a part or a fragment of the second hidden code. The combination and alignment of the second hidden code or a part thereof with the first code portion cannot constitute or recombine a pairing code.

[0064] According to further examples, the second concealed code extends along a second direction on the second outer surface. Typically, the second direction can be distinguished from the first direction along which the first code portion extends. In some examples, the second concealed 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 that can coincide with the longitudinal axis of the elongated, e.g., tubular, first or second device component.

[0065] If the first code portion extends along a first direction and the second code portion and / or the second concealment code extends along a second direction, where the first and second directions extend at a predefined non-zero angle with respect to each other, recombining and configuring the pairing code may require the first device component to be moved along the second direction from the first positional state towards the second positional state, where moving the first device component along the first direction relative to the second device component may then be merely optional.

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

[0067] According to another example, the first code portion or a portion thereof aligns with the second hidden code portion when the first device component is out of the second position state. The alignment of the first code portion with the portion of the second hidden code portion recombines or constitutes a pairing code. As long as the first device component is out of the second positional state, the first code portion will be exclusively aligned with or with a portion of the second concealed code portion, thus effectively preventing visual identification of the pairing code at the overlap of the first code portion and the second concealed code portion.

[0068] According to further examples, at least one of the second concealed code portion and the second code portion extends along a second direction. The first device component is movable along the second direction relative to the second device component. In some examples, the first direction extends along an axis of symmetry or along a longitudinal axis of the housing of the drug delivery device. The second direction can extend tangentially or circumferentially with respect to such an elongated, e.g. tubular, housing. The first and second directions can extend at a predefined non-zero angle with respect to each other. The first and second directions can extend perpendicularly to each other.

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

[0070] The first and second markers are visually aligned, visually overlapped, or mechanically engaged when the first device component reaches a second position state relative to the second device component. The first and second markers can be used to identify the second position state of the first and second device components. At least one of the first and second markers is permanently visible to a user of the drug delivery device. The other of the first and second markers can be temporarily hidden by the other of the first and second respective device components.

[0071] When the first device component moves relative to the second device component and the second position state is reached, the first and second markers 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 identifiable from outside the drug delivery device.

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

[0073] In some examples, the first and second markers include mating features of corresponding and / or complementary shapes, such as a protrusion and a corresponding recess, such that the first and second markers can mechanically engage when the first and second device components reach the second positional state.

[0074] In some examples, the drug delivery device includes a number sleeve having a row of numbers printed thereon. The row of numbers indicates the size of the actual set dose. The first marker can correspond to a particular predetermined dose size, and can be represented, for example, by a predetermined number of dose sizes, for example, a dose size of 25 units. 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 a body of a housing of a drug delivery device, the second device component may include an aperture or window through which at least a part of the first device component located underneath is visible. The appearance of a first marker, e.g. in the form of a specific and predefined dose size, in the aperture or in the dose window of the second device component, and thus in the dose window of the housing or body of the drug delivery device, may be a clear indication to a user of the drug delivery device that the first device component has reached a predefined second position state, whose pairing code is identifiable from the outside of the drug delivery device.

[0076] According to a further example, the first device component is one of the dose dial, dial extension, number sleeve, and protective cap of a pen injection device. The dose dial typically undergoes a rotational movement during and / or for setting a dose of variable size. During dose setting, the dose dial typically undergoes a rotation relative to the housing of the drug delivery device. The dose dial can undergo a combined longitudinal sliding movement relative to the housing, e.g., can also serve as a second device component according to the terminology of this specification. Furthermore, the dose dial can undergo a combined rotational and longitudinal movement relative to the housing or body of the drug delivery device. Thus, the dose dial can undergo a helical movement relative to the housing or body when the dose is set.

[0077] The same can be applied to the dial extension. The dial extension can be adapted to undergo a longitudinal sliding movement during setting of a dose of the drug and / or during dispensing or expelling of the dose. The dial extension can be adapted to undergo a combined longitudinal sliding and rotational movement. The dial extension or a component thereof can be adapted to undergo a helical movement relative to the housing of the drug delivery device, for example, during and / or for setting or expelling of a dose of the drug. The number sleeve can form part of the dial extension.

[0078] In some examples, the number sleeve remains internal to the housing of the drug delivery device. The number sleeve is rotatably supported in or on the housing of the drug delivery device. In some examples, the number sleeve is longitudinally locked relative to the housing. In further examples, the number sleeve is threadably engaged with the housing. And, the number sleeve can follow a helical path relative to the housing when movement occurs relative to the housing.

[0079] In another example, a protective cap configured to cover the dispensing or dispensing end of the drug delivery device can be implemented as a first device component according to the above terminology. The protective cap can be rotatably supported on the distal end of the housing of the drug delivery device. The protective cap can be freely oriented in a number of rotational states relative to the housing. The protective cap can be removably locked to the housing in a longitudinal direction. The protective cap can be clipped or snapped onto the housing.

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

[0081] In some examples, the second device component may include a gauge element that is slidably supported in the housing of the drug delivery device and non-rotatably locked to the tubular housing of the drug delivery device. The gauge element may be threadably engaged with, for example, the number sleeve. The gauge element may include a window or aperture through which a portion of the number sleeve is discernible or visible. Implementation of the gauge element may allow the number sleeve to be longitudinally locked to the housing of the drug delivery device. The number sleeve may be freely rotatable relative to the housing. The gauge element may also belong to or form part of the dial extension.

[0082] The gauge element, acting as the second device component itself, can be slidably supported within a longitudinal aperture of the housing, where the housing can act as the first device component. The gauge element can include a recess or gauge aperture through which a selected portion of the underlying numeral sleeve is revealed. Upon threaded engagement with the numeral sleeve, rotation of the numeral sleeve results in longitudinal displacement of the gauge element relative to the aperture of the housing.

[0083] At least a first code portion of the pairing code can be provided on the outer surface of the gauge element. By setting a dose of a prescribed or predetermined size, the gauge element, i.e. the second device component, is moved 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 gauge element, can be discernible within the longitudinal aperture of the housing.

[0084] During dose dialing or dose setting, the number sleeve can be caused to undergo rotational movement relative to the housing. Through threaded engagement with the number sleeve and rotational interlock with the housing, the gauge element slides along the rotating number sleeve, thereby providing a visual indication of a series of numbers or dose size appearing in a window or aperture in the gauge element.

[0085] The body of the housing is typically the proximal part of the housing. The body can be configured to house or accommodate the drive mechanism of the drug delivery device. The body can be non-releasably or removably coupled to a cartridge holder of a pen injection device. The cartridge holder can be particularly adapted to accommodate a cartridge filled with a drug. In a disposable device, the cartridge filled with a drug is easily placed inside the housing, typically inside the cartridge holder. The cartridge holder can be non-releasably or removably coupled to the body of the housing of the drug delivery device.

[0086] The above-mentioned concept of providing a first and second device component of a drug delivery device movably relative to one another can be mapped and transferred to multiple components of a pen injection device. For example, a first code portion can be provided at or near the proximal end of a protective cap, and a continuous second code portion can be provided at or near the distal end of the body of such a pen injection housing. The protective cap can freely rotate about a longitudinal axis relative to the body. Only in one or several further generally available positional states of the protective cap and the body are the respective first and second code portions. The portions are aligned with each other so that the pairing code is visually identifiable from the outside of the drug delivery device. In other configurations, a protective cap may be suitable to cover at least a portion of the pairing code when assembled or attached to the body. The pairing code can then be revealed by removing the protective cap.

[0087] According to another example of a drug delivery device, a cartridge filled with a medicament is placed inside the housing. Thus, the drug delivery device is a combination drug device. The drug delivery device can be implemented as a disposable device in which the cartridge is easily assembled. The drug delivery device can also be configured and implemented as a reusable device. Here, a cartridge holder is removably coupled to the proximal body of the drug delivery or injection device, thus allowing the empty cartridge to be replaced with a new, and thus filled, cartridge.

[0088] According to a further example, the electronic data logging device is integrated into 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. In another example, the electronic data logging device is provided as a separate data logging device. The electronic data logging device can include at least one fastening feature that engages with a corresponding or complementary shaped fastening feature at a predetermined location of the drug delivery device.

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

[0090] According to another aspect, the present 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 includes a first device component movable relative to a second device component. The first device component includes a first exterior surface. The second device component includes a second exterior surface. At least one of the first exterior surface and the second exterior surface includes at least a first code portion of a pairing code. The pairing code is visually identifiable from outside the drug delivery device only when the first device component is in a second positional relationship relative to the second device component.

[0091] The method includes setting at least one of the external electronic device and the data logging device into a pairing mode, before, during or after which the first device component is moved from a first position state in which the pairing code is indistinguishable relative to the second device component to a second position state in which the pairing code is visually identifiable. Thereafter, when the first device component reaches the second position state relative to the second device component, the pairing code, now visually identifiable from outside the drug delivery device, is actually visually identified or captured, for example by a person.

[0092] The determined pairing code is then used to establish and / or configure a communications link between the external electronic device and the data logging device. Depending on the particular implementation of the pairing routine, the user may be prompted to enter the pairing code, for example, into the external electronic device or into the data logging device. In other examples, the pairing code may be visually or audibly presented by at least one of the data logging device and the external electronic device. The user may then The user may be prompted to verify the pairing code. If the pairing code proposed by either the data logging device or the external electronic device in the process of pairing the two devices does not match the pairing code visually identifiable from outside the drug delivery device, the user should stop, abort and cancel the pairing routine to prevent misuse or unauthorized use of the data stored in the data logging device.

[0093] Furthermore, it should be noted that the present method of pairing an electronic data logging device with an external electronic device using a drug delivery device is broadly applicable and may be performed with any type of drug delivery device as described above, and thus, any features, advantages, and benefits as described above in relation to the drug delivery device apply equally to the pairing method, and vice versa.

[0094] According to a further aspect, the present disclosure relates to a drug injection system. The injection system includes a drug delivery device or injection device as described above. The injection system further includes a data logging device integrated into or attachable to the drug delivery device. Wherein the data logging device is configured and implemented to establish or configure 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. To this extent, all features, effects, and advantages as described above apply to the drug injection system as well.

[0095] According to another aspect, the medication injection system further includes an external electronic device configured to establish and / or configure a communication link, for example a wireless communication link, to the data logging device.

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

[0097] Generally, the scope of the present disclosure is defined by the content of the claims. The injection device is not limited to a particular embodiment or example, but includes any combination of elements of different embodiments or examples. To that extent, the present disclosure encompasses any combination of the claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0098] As used herein, the terms "distal" or "distal end" refer to the end of the injection device that faces towards the injection site on a person or animal, and "proximal" or "proximal end" refer to the opposite end of the injection device that is furthest away from the injection site on a person or animal.

[0099] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0100] As described below, a drug or pharmaceutical agent may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and The drugs may include, for example, proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into vectors, plasmids, or molecular delivery systems such as liposomes. Mixtures of one or more drugs are also contemplated.

[0101] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to optionally allow mixing of the two components by a user prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0102] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0103] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma- ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., by the addition of one or more organic residues. It refers to a polypeptide having the molecular structure of human insulin in which a substituent (e.g., a fatty acid) is attached to one or more of the amino acids. Optionally, one or more of the amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are 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 in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may 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 e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0106] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0107] Examples of oligonucleotides include, for example, co-transferases for the treatment of familial hypercholesterolemia. the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®), or RG012 for the treatment of Alport syndrome.

[0108] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0109] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0110] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), 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 an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with crossover binding region orientation.

[0112] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as 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 regions 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 in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper positioning of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with an antigen.

[0114] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0115] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0116] It will be understood by those skilled in the art that modifications (addition and / or deletions) can be made to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

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

[0118] In the following, a number of examples of injection devices and methods for pairing the data logging device with an external electronic device will be described in more detail with reference to the drawings. [Brief description of the drawings]

[0119] [Figure 1] FIG. 1 illustrates a schematic diagram of an example of a drug delivery device implemented as an injection device. [Diagram 2] FIG. 2 shows a schematic diagram of a number of components of the drug delivery device of FIG. 1. [Diagram 3] FIG. 1 is a schematic block diagram of an example electronic data logging device. [Figure 4] FIG. 13 shows a schematic diagram of an electronic data logging device integrated into the drug delivery device. [Diagram 5] FIG. 1 is a schematic diagram of a portion of a drug delivery device having first and second device components carrying pairing code portions for setting up a communication link between a data logging device and an external electronic device, the first and second device components being in a first position state. [Figure 6] FIG. 6 illustrates the example of FIG. 5, where the first and second device components are in a second position state. [Figure 7] FIG. 2 is a schematic diagram illustrating another example of a drug delivery device with a pairing code, the first and second device components being in a first position state. [Figure 8] FIG. 8 illustrates the example of FIG. 7, where the first and second device components are in a second position state. [Figure 9] FIG. 9 shows the first and second device components of FIGS. 7 and 8 in a third positional state. [Figure 10] 10 is a flow chart illustrating a method for 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 of FIGS. 1-9. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0120] One example of a drug delivery device 1 for administering a dose of a medication 27 is shown in Figures 1 and 2. The drug delivery device 1 is implemented as an injection device 30. The injection device 30 is a handheld pen-type injector. The injection device 30 can be implemented as a disposable injection device 30. The injection device 30 can include a pre-filled cartridge 6 disposed inside a cartridge holder 14. In the case of a disposable injection device 30, the cartridge holder 14 can be permanently coupled to the body 10 of the housing 32 of the injection device 30.

[0121] In another example, the injection device 30 is a reusable injection device, and the cartridge holder 14 is removably coupled to the body 10 for replacing the empty cartridge 6. At or near the distal end of the housing 32, and thus at the distal end of the cartridge holder 14, is provided a socket 28 configured to mount or engage with the injection needle 15. The socket 28 may be implemented as a threaded socket, and the injection needle 15 may include a needle hub that is correspondingly threaded to provide threaded engagement with the socket 28.

[0122] Typically, the injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 and / or protective cap 18 configured to surround and protect a distal section of the housing 32 of the injection device 30. The body 10 may include and be formed with a main housing member configured to house the drive mechanism 34, as shown in FIG. 2. The cartridge holder 14 may be considered a distal housing component of the injection device 30. The cartridge holder 14 may be permanently or releasably coupled to the body 10 or the main housing.

[0123] The cartridge 6 includes a cylindrical or tubular barrel 25 that is sealed in the proximal direction 3 by a bung 7 located inside the barrel 25. The cartridge 6 may 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 a piston rod 20 of a drive mechanism 34. The distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum, which is pierceable by the proximally directed tip of the 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 pierced, thereby establishing fluid transfer access to the interior of the cartridge 6.

[0124] If the injection device 1 is configured to administer, for example, human insulin, the dose set by a dose dial 12 at the proximal end of the injection device 1 can be displayed in so-called international units (IU), with 1 IU being bioequivalent to approximately 45.5 μg of pure crystalline insulin (1 / 22 mg). The dose dial 12 can include a sleeve-like knob at the proximal end of the housing 32 of the injection device 30.

[0125] As further shown in Figures 1 and 2, the body 10 includes a dose window 13, which may be in the form of an aperture in the body 10. The dose window 13 allows a user to view a limited portion of a number sleeve 80 that is configured to move when the dose dial 12 is turned. The number sleeve 80 and dose window 13 provide a visual indication of the dose currently set. The dose dial 12 may rotate on a helical path relative to the body 10 when turned during setting and / or dispensing or expelling a dose.

[0126] In other types of injection devices, the dose dial 12 can be longitudinally locked to the body 10 and the dose dial 12 can be rotated relative to the body 10 to set the dose. The rotational movement of the actuator can be restricted to a rotational movement relative to the actuator.

[0127] The injection device 30 can be configured to provide acoustic feedback to the user by generating a mechanical click sound when the dose knob 12 is turned. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is pierced into the patient's skin area, the insulin dose displayed in the dose window 13 is expelled from the injection device 1 when the trigger 11 or injection button is pressed. If the needle 15 of the injection device 1 remains in the skin area for a period of time after the trigger 11 is pressed, a high percentage of the dose is actually injected into the patient's body. The expulsion of the insulin dose can also generate a mechanical click sound, but this is different from the sound generated when using the dose dial 12.

[0128] In the illustrated embodiment, during delivery of an insulin dose, the dose dial 12 is turned with axial motion, i.e., without rotation, to an initial position, while the number sleeve 80 rotates back to its initial position, for example to display a dose of 0 units.

[0129] The injection device 30 can be used for several injection processes until the cartridge 6 is empty or the expiry date of the drug in the injection device 1 is reached (eg 28 days after first use).

[0130] FIG. 2 shows at least some components of an example of the drive mechanism 34 in more detail. The drive mechanism 34 includes a number of mechanically interacting components. A flange-like support of the housing 10 includes a threaded axial through-bore in threaded engagement with the thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a bearing 21 on which a presser 23 is free to rotate about the longitudinal axis of the piston rod 20. The presser 23 is configured to axially abut against a proximally facing thrust receiving surface of the bung 7 of the cartridge 6. During a dosing movement, the piston rod 20 rotates relative to the housing 10, which results in a distally directed forward movement relative to the housing 10 and thus relative to the barrel 25 of the cartridge 6. As a result, the bung 7 of the cartridge 6 is displaced in the distal direction 2 by a well-defined distance due to the threaded engagement of the piston rod 20 with the housing 10.

[0131] The body 10 further comprises a dose dial sleeve, also indicated as number sleeve 80. The number sleeve 80 is located radially inward of the housing 10. The number sleeve 80 comprises a helical groove 81 around its outer surface. The body 10 comprises a dose window 13 through which a portion of the outer surface of the number sleeve 80 is visible. The body 10 further comprises a helical rib on the inner sidewall portion of the insert piece 62, which helical rib seats in the helical groove 81 of the number sleeve 80. The tubular insert piece 62 is inserted into the proximal end of the tubular body 10. Alternatively, such a helical rib may be provided directly on the inner sidewall of the body 10. The helical rib is non-rotatably and axially fixed to the body 10 together with the insert piece 62. The body 10 may be provided with first and second stops to limit the dose setting procedure in which the number sleeve 80 rotates in a helical motion relative to the housing 10.

[0132] A dose dial 12 in the form of a dose dial grip is disposed about the outer surface of the proximal end of the number sleeve 80. The outer diameter of the dose dial 12 typically corresponds to and matches the outer diameter of the proximal end of the body 10. The dose dial 12 is secured to the number sleeve 80 to prevent relative movement between the dose dial 12 and the number sleeve 80. The dose dial 12 is provided with a central opening.

[0133] The trigger 11, also shown as a dose button, is substantially T-shaped. The trigger 11 is provided at the proximal end of the injection device 1. A stem 64 of the trigger 11 extends through an opening in the dose dial 12. The stem 64, and therefore the trigger 11, is fitted to a number sleeve 80. The head of the trigger 11 is generally circular. A trigger sidewall or skirt extends from the periphery of the head and is further adapted to seat within a proximally accessible annular recess of the dose dial 12.

[0134] To dial in a dose, the user rotates the dose dial 12 along the dose increment direction 4, e.g., clockwise. Dialing the dose may be accompanied by an audible click. In this manner, audible and / or tactile feedback of the dose being dialed is provided. Dialing the dose is further accompanied by rotation of the number sleeve 80, which begins to extend from the body 10 in the proximal direction 3 when dialed along the dose increment direction 4, e.g., in a clockwise direction.

[0135] The number sleeve 80, the dosing dial 12 and the trigger may thus form part of the dial extension 70 and an assembly of components of the drive mechanism 34 that extend or become displaced from the proximal end of the body 10 as the dose is dialed in. During dose dispensing, thus when the user presses the trigger 11 in the distal direction 2, the dial extension 70 undergoes a distally directed and thus along the distal direction 2 relative to the body 10. During such dosing action, the number sleeve 80 undergoes a rotation, e.g., counterclockwise, along the dose reduction direction 5.

[0136] The ejection or drive mechanism 34 as described above is merely illustrative of one of several different configurations of drive mechanisms that may be implemented in a generally disposable or reusable pen injector. Drive mechanisms as described above are described in more detail, for example, in WO 2004 / 078239 A1, WO 2004 / 078240 A1 or WO 2004 / 078241 A1, the disclosures of which are incorporated herein by reference in their entireties.

[0137] The drug delivery device 1, and thus the injection device 30, may further comprise a data logging device 100, as shown in Fig. 3 or Fig. 4. The data logging device 100 may be incorporated into the injection device 30. The data logging device 100 may be located within a hollow receptacle provided by at least one of the trigger 11 and the dose dial 12. In other examples, the data logging device 100 is a separate component removably connectable to the body 10 or to some other part of the housing 32 of the injection device 30.

[0138] Thus, Fig. 2 illustrates a drug injection system 102. The drug injection system 102 includes an injection device 30 and at least a data logging device 100. The data logging device 100 may be attachable to the injection device 30. The data logging device 100 may be removably connectable or removably securable to the housing 32 of the injection device 30. Alternatively, the data logging device 100 is integrated into the injection device 30. The drug injection system 102 may further include an external electronic device 65. The external electronic device 65 may be implemented as a portable electronic device. The external electronic device 65 may include a smart watch, a smartphone, 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, for example a wireless communication link, to transfer data between them.

[0139] A data logging device 100 as shown diagrammatically in FIG. 3 typically includes a sensor, e.g. in the form of a rotation sensing arrangement 200, by means of which the relative rotation of at least one component of the drug delivery device 1 with respect to another component of the drug delivery device 1 is determined, e.g. during at least one of setting a dose and dispensing a dose, or It can be measured quantitatively.

[0140] The data logging device 100 may be integrated into the drug delivery device 1 or may be provided as a separate add-on device. If provided as a separate add-on device, the data logging device 100 may be provided with its own housing 101 that is attachable to the housing 32 of the drug delivery device 1 or the injection device 30.

[0141] The data logging device 100 includes one or more processors 240, such as a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate array (FPGA), etc., along with a memory 114. The memory 114 can include program memory and main memory, which can store software executed by the processor 240 and data generated or captured during use of the data logging device 100, such as counted pulses, derived dose size, timestamps, etc. An optional switch 122 connects the power source 120 to the electronic components of the data logging device 100, including the rotation sensing arrangement 200. A display 118 may or may not be present. The rotation sensing arrangement 200 can be coupled to a first member 201 and a second member 202. The rotation sensing arrangement 200 includes at least one sensor 220 connected or attached to the second member 202, and further includes at least one signal generator 210 connected or attached to the first member 201.

[0142] In this embodiment of the rotational sensing arrangement 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 fastened to, for example, a rotatable dose dial 12 of the injection device 30.

[0143] The data logging device 100 typically includes an interface 124 connected to the processor 240. The interface 124 may be a wireless communication interface that communicates 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, RFID or NFC (near field communication). The wireless communication interface may be operable in the radio frequency range. For example, the wireless communication interface may be based on radio frequency identification technology (known as RFID), which allows compatible hardware to use radio waves to power and communicate with electronic tags that are inherently unpowered and passive. Thus, the wireless communication interface can be used for identification, authentication and tracking.

[0144] In other examples, the interface 124 is implemented as a wired communication link, such as a socket that receives a Universal Series Bus (USB), mini-USB, or micro-USB connector. To this end, the interface 124 includes a transceiver 126 configured to transmit and receive data. Figure 3 shows an example of an injection system in which the add-on device 100 is connected to an external electronic device 65 via a communication link 66 for data transfer. The data connection 66 may be wired or wireless.

[0145] For example, the processor 240 can store the determined delivered drug amount and a timestamp for an injection as administered by a user, and then transfer the stored data to the external electronic device 65. The device 65 can maintain a treatment log and / or transfer treatment history information to a remote location, for example for review by a medical professional.

[0146] Add-on device 100 or data collection device may include any of the following: , can be configured to store data such as delivered drug amount and timestamps for a number of injection events. With a once-daily injection regimen, this is sufficient to accommodate approximately one month of treatment history. The data memory 114 can be organized in a first-in, first-out manner, ensuring that the most recent injection event is 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 may be deleted. Alternatively, such data remains in the add-on device 100, and the oldest data is automatically deleted as new data is stored. In this way, the log in the data collection device is accumulated over time during use and will always include the most recent injection events. Alternatively, other configurations can have a storage capacity of 70 (twice daily), 100 (three months), or any other suitable number of injection events depending on treatment requirements and / or user preferences.

[0147] In another embodiment, the interface 124 may be configured to transmit information using a wireless communication link and / or the processor 240 may be configured to periodically transmit such information to the external electronic device 65.

[0148] The processor 240 can control the optional display 118 to display determined drug dosage information and / or to display the time elapsed since the last drug dose was delivered. For example, the processor 240 can cause the display 118 to periodically switch between displaying the most recent determined drug dosage information and displaying the time elapsed.

[0149] The power source 120 may be a battery. The power source 120 may be a coin cell battery or multiple coin cells arranged in series or parallel. A timer 115 may also be provided. In addition to or instead of switching the add-on device 100 on and off, the switch 122 may be arranged to trigger the timer 115 when engaged and / or disengaged. For example, if the timer 115 is triggered by both the engagement or disengagement of the first and second electrical contacts of the switch, or by both the activation and deactivation of the switch 122, the processor 240 may 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.

[0150] Alternatively, or in addition, processor 240 may use timer 115 to monitor the amount of time that has elapsed since an injection was completed, as indicated by the time of disengagement of the respective switch components or deactivation of switch 122. Optionally, the elapsed time may be displayed on display 118. Also optionally, when switch 122 is next operated, processor 240 may compare the elapsed time to a predetermined threshold to determine whether the user may be attempting to administer another injection too soon after the previous injection, and if so, generate an alert, such as an audible signal and / or a warning message, on display 118 or via output 116. Output 160 may be configured, for example, to generate an audible sound or induce a vibration, i.e., generate a tactile signal, to alert the user.

[0151] The sensing arrangement 200 as shown in FIG. 3 may be implemented as a rotating sensing arrangement. It may include a first member 201 and a second member 202. The first member 201 is rotatable relative to the second member 202 about a rotation axis 203. Typically, the first member 201 and the second member 202 are arranged coaxially about the rotation axis. In some examples, the first member 201 and the second member 202 are arranged axially adjacent about the rotation axis 203. The first member 201 and the second member 202 may be directly mechanically engaged. In other examples, the first member 201 and the second member 202 may be mechanically disengaged from each other. Here, the first member 201 and the second member 202 can be separately arranged or rotatably supported in or on the housing 32 of the injection device 30 or in or on the respective housing 101 of a separate add-on device 100.

[0152] At least one of the first member 201 and the second member 202 is typically rotatably supported in or on the housing 10 of the injection device 1. In some examples, both the first member 201 and the second member 202 can be rotatably supported on or with respect to the housing 32. Typically, depending on the specific implementation or integration of the rotation sensing arrangement 200 in the injection device 30, one of the first member 201 and the second member 202 is non-rotatably locked to the housing 32, while the other of the first member 201 and the second member 202 is rotatably movable with respect to the housing 10. Typically, one of the first member 201 and the second member 202 is rotatable with respect to the housing 32 about the rotation 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 setting and / or dispensing of a dose, the second member 202 undergoes rotation relative to the first member 201. The degree of relative rotation between the first member 201 and the second member 202 is directly indicative of the size of the dose actually set and / or dispensed.

[0153] The rotation sensing arrangement 200 may include a printed circuit board 260, as shown in Figure 4. The processor 240 may be provided on the printed circuit board 260 along with at least one sensor 220. The printed circuit board 260 may further include a power source 120. The power source 120 may be located on one side of the printed circuit board 260. The processor 240 and / or the at least one sensor 220 may be provided on the same or opposite side of the printed circuit board 260.

[0154] 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 may have to be visible or identifiable from outside the drug delivery device 1. However, it should not be directly visible to anyone who has access to the drug delivery device 1. To prevent unauthorized pairing of the electronic data logging device 100 with the external electronic device 65, the pairing code 320 must be concealed by a component of the drug delivery device 1 and revealed by a user's action. According to another option, the pairing code 320 is split or distributed over at least two device components 301, 302. To recombine the pairing code 320, the first and second device components 301, 302 must be moved to a predefined position state.

[0155] In the example of Fig. 5 and Fig. 6, at least one of the dial extension 70 and the number sleeve 80 provides the first device component 301 movable relative to the second device component 302. The second device component 302 may be provided by the body 10 of the housing 32 of the injection device 30. The first device component 301 is at least partially housed or received inside a hollow section of the second device component 302. As is evident 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 the longitudinal direction and thus towards the proximal direction 3. Optionally, the first device component 301 may be rotatable relative to the second device component 302.

[0156] Interengagement of the first and second device components 301, 302 results in a second device configuration 3, the data logging device 100 may be connected to an external electronic device 65 via a first external surface 311. The first external surface 311 may only enable and support spiral movement of the first device component 301 relative to the element 302. The first device component 301 comprises a first external surface 311. The first external surface 311 is again provided with at least a first code portion 321 of a pairing code 320. Typically, the entire pairing code is required to establish or set up a communication link 66 between the data logging device 100 and the external electronic device 65.

[0157] The second device component 302 includes a second exterior surface 312. The second exterior surface 312 comprises a second code portion 322. The recombination of the second code portion 322, and thus the letter "B", with the string of numbers and letters "123ABC" of the first code portion 321 complements or constitutes a pairing code 320. The pairing code 320 is complemented and recombined from the first code portion 321 and the second code portion 322 only when the first device component 301 is in a second predetermined position state 352 with respect to the second device component 302.

[0158] This particular position state is characterized by the relative positions of the first and second device components 301, 302 and / or by a predefined rotational orientation of the first and second device components 301, 302 with respect to each other. The second position state 352 can be characterized and identified by a first marker 303 of the first device component 303 configured to match, align or spatially overlap with a second marker 304 provided by the second device component 302, where the second marker 304 is an aperture in the sidewall of the first device component 302. The aperture 304 can match the dosage window 13 described above. The first marker 303 can be a selected or predefined number or symbol of a multitude of available numbers or symbols, for example implemented as a number sleeve 80, provided on the outer surface 311 of the first device component 301. In the currently shown example, the first marker 303 is the number 25, also indicating that a dose of 25 units has actually been set in this configuration of the first and second device components 301, 302.

[0159] In the currently shown example, the second device component 302 is also provided with a second code portion 322. The second code portion 322 and the first code portion 321 must be aligned along a straight line or along a spiral line to reconstitute the pairing code 320 required to establish or set up the communication link 66.

[0160] In the presently illustrated example, the second code portion 322 is provided on the second outer surface 312 in combination with the second concealed code portion 336. The second concealed code portion 336 provides some further or supplementary code portion that is generally indistinguishable from the second code portion 322. The second concealed code portion 336 may include a number of letters, symbols or numbers that are aligned with the second code portion 322. Unless properly informed, for example by a user manual of the drug delivery device, an authorized user of the drug delivery device 1 does not know which of the second concealed code portion 336, for example the letter "A" or "C", and the second code portion 322, the letter "B", should be aligned with the first code portion 321 to recombine and configure the pairing code 320.

[0161] In the example of Figs. 5 and 6, the second concealed code portion 336 extends along the second direction 4. The second direction can extend at an angle to the first direction 3. The first code portion extends along the first direction 3 and the second concealed code portion 336 extends along or parallel to the second direction 4. When the first device component 301 experiences both movements along the first direction 3 and along the second direction 4 relative to the second device component 302 to reach the second position state 352, the first code portion 336 is concealed. The intersection of the longitudinal extension of cord portion 321 and second concealed cord portion 336 may point to or indicate second cord portion 322.

[0162] In the currently illustrated example, if, for example, a dose of medication is dialed in that does not match the first marker 303, there will be a misalignment between the first code portion 321 and the second code portion 322, and therefore the pairing code 320 will not appear properly.

[0163] In another example, as shown in the sequence of Figures 7-9, the second device component 302 does not have the second code portion 322 or the second concealed code portion 336. There, the second device component 302 is opaque and receives at least a portion of the first device component 301 in its hollow interior. In the first position state 351 as shown in Figure 7, the first outer surface 311 of the first device component 301 is nearly invisible from outside the injection device 30. When the first device component 301 moves relative to the second device component 302, a portion of the first outer surface 311 becomes apparent from the second device component 302.

[0164] The movement of the first device component 301 relative to the second device component 302 from a first position state 351 as shown in Fig. 7 to a second position state 352 as shown in Fig. 8 may occur in the course of setting a dose of a medication. Thus, a user manual for pairing the electronic data logging device 100 with the external electronic device 65 may instruct a user of the injection device 30 to dial in a number of 25 standard units. For example, this dialing or dose setting action, performed by the movement of the first device component 301 relative to the second device component 302, results in a combined rotational and longitudinal displacement of the first device component 301 relative to the second device component 302.

[0165] As shown in Fig. 8, the first device component 301 protrudes longitudinally from a longitudinal end, and thus from a proximal end, of the first device component 302. As a result, a respective portion of the first outer surface 311 is revealed. When the second position state 352 is reached as shown in Fig. 8, only the entire pairing code 320 is visually identifiable from the outside of the drug delivery device 30. Now, exclusively, only the pairing code 320 is revealed.

[0166] As is evident from the further illustration in FIG. 9, therefore, when the first device component 301 is moved further and beyond the second position state, e.g. along the proximal direction 3 relative to the first device component 302, a further portion of the first outer surface 311 is revealed. The further portion of the first outer surface 311 comprises a first concealment code portion 335. The first concealment code portion 335 is indistinguishable from the first code portion 321 or from the pairing code 320. Thus, in a configuration as shown in FIG. 9, a user of the device cannot visually identify which part of the indistinguishable combination of the pairing code 320 and the first concealment code portion 335 should be used or which part is relevant for initiating or approving the pairing of the data logging device 100 with the external electronic device 65.

[0167] In an exemplary embodiment of the drug delivery device 30, the first device component 301 is movable from a first position state 351 as shown in Figures 5 and 7 to a second position state 352 as shown in Figures 6 and 8, and conversely from the second position state 352 to the first position state 351, without the need to dispense a dose of drug 27 relative to the second device component 302.

[0168] FIG. 10 shows a method for pairing the data logging device 100 with an external electronic device 65. 1 shows a flowchart of the method. Typically, the pairing method can be performed in the drug delivery device 1 or the injection device 30, as described above in relation to the external electronic device 65 and the data logging device 100, either provided as a separate data logging device 100 or integrated into the drug delivery device 1.

[0169] In a first step 400, at least one of the external electronic device 65 and the data logging device 100 is set in a pairing mode in order to set up a communication link 66 between the data logging device 100 and the external electronic device 65. Typically, the external electronic device 65 and the data logging device 100 are configured to set up a wireless communication link using a standardized RF connection protocol, such as Bluetooth, for example. In a subsequent step 402, the first device component 301 is moved relative to the second device component 302 from a first location state 351, in which the pairing code 320 is indistinguishable, to a second location 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 pairing code 320 as identified by the user in step 404 is used to establish or acknowledge the communication link 66 between the external electronic device 65 and the data logging device 100. [Explanation of symbols]

[0170] 1. Drug Delivery Devices 2 Distal direction 3. First Direction 4. Second Direction 5 Direction of dose reduction 6 Cartridges 7 Stopper 8 Drive mechanism 9 Dose setting mechanism 10 body 11 Trigger 12 Dose Dial 13 Dosage window 14 Cartridge holder 15 Syringe needle 16 Inner needle cap 17 Outer needle cap 18 Protective Cap 19 Protrusion 20 Piston rod 21 Bearing part 22 Threaded Section 23 Press 25 barrels 26 Sealing part 27 Drugs 28 Sockets 30 Injection Device 32 Housing 34 Drive mechanism 62 Insert 64 Stem 65 External Electronic Devices 66 Communication Links 70 Dial extension 80 Number Sleeve 81 Groove 100 Data Logging Devices 101 Housing 102 Drug injection device 114 Memory 115 Timer 116 Output 118 Display 120 Power supply 122 Switch 124 Interface 126 Transceiver 200 Detection arrangement 201 First Component 202 Second member 203 Rotational Axis 210 Signal Generator 220 Sensors 240 processors 260 Printed Circuit Board 301 Device Components 302 Device Components 303 Marker 304 Marker 311 Exterior 312 Exterior 320 Pairing Code 321 Code Part 322 Code section 335 Code Part 336 Code Part 351 Position Status 352 Position Status 353 Position Status

Claims

1. A drug delivery device (1) for administering a dose of a medication (27), operable to cooperate with an electronic data logging device (100), comprising: a housing (32) containing the medication (27), the housing (32) being further configured to receive and / or mechanically engage an electronic data logging device (100); a first device component (301) and a second component (302), the first device component (301) being movable relative to the second device component (302) from a first position state (351) to at least a second position state (352); Including, wherein the first device component (301) includes a first exterior surface (311), the second device component (302) includes a second exterior surface (312), and at least one of the first exterior surface (311) and the second exterior surface (312) includes 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); The drug delivery device, wherein the pairing code (320) is visually identifiable from outside the medication delivery device (1) only when the first device component (301) is in a second position state (352) relative to the second device component (302).

2. The drug delivery device (1) of claim 1, wherein the first code portion (321) or pairing code (320) is provided on the first outer surface (311), and at least a portion of the first code portion (321) or pairing code (320) is concealed by the second device component (302) when the first device component (301) is out of the second position state (352).

3. 3. The drug delivery device of claim 1 or 2, wherein the first outer surface (311) comprises one of the first code portion (321) and the entire pairing code (320), and the first outer surface (311) further comprises a first hidden code portion (335) indistinguishable from the first code portion (321) or from the pairing code (320), and an indistinguishable complex of at least a portion of the first hidden code portion (335) and at least one of the first code portion (321) and the pairing code (320) is discernible from outside the drug delivery device (1) when the first device component (301) is out of the second position state (352).

4. The drug delivery device (1) of claim 3, wherein the first concealment code portion (335) is concealed by the second device component (302) when the first device component (301) is in the second position state (352).

5. The drug delivery device (1) of any one of claims 1 to 4, wherein the pairing code (320) includes a first code portion (321) and a second code portion (322), the first code portion (321) being provided on the first outer surface (311) and the second code portion (322) being provided on the second outer surface (312).

6. The drug delivery device (1) of claim 5, wherein the first code portion (321) and the second code portion (322) recombine with each other to form a pairing code (320) when the first device component (301) is in a second position state (352).

7. At least one of the pairing code (320) and the first code portion (321) extends along a first direction (3), and the first device component (301) is connected to the second device component (302). The drug delivery device according to any one of claims 1 to 6, wherein the device is movable along a first direction (3) relative to the vice component (302).

8. A drug delivery device (1) as described in any one of claims 5 to 7, further comprising a second concealed code portion (336) on the second outer surface (312) that is indistinguishable from the second code portion (322), and the first code portion (321) is aligned with the second code portion (322) when the first device component (301) is in a second position state (352).

9. The drug delivery device (1) of claim 8, wherein the first code portion (321) or a part thereof is aligned with the second concealed code portion (336) when the first device component (301) is out of the second position state (352).

10. 10. A drug delivery device as described in claim 8 or 9, wherein at least one of the second concealed code portion (336) and the second code portion (322) extends along a second direction (4), and the first device component (301) is movable along the second direction (4) relative to the second device component (302).

11. 11. The drug delivery device of claim 1, further comprising a first marker (303) and a second marker (304), wherein the first marker (303) is provided by or coupled to the first device component (301) and the second marker (304) is provided by or coupled to the second device component (302), the first marker (303) undergoes movement relative to the second marker (304) when the first device component (301) moves relative to the second device component (302), and the first marker (303) and the second marker (304) are visually aligned, visually overlapping, or mechanically engaged when the first device component (301) reaches a second position state (352) relative to the second device component (302).

12. The drug delivery device of any one of claims 1 to 11, wherein the first device component (301) is one of the dose dial (12), the dial extension (70), the number sleeve (80) and the protective cap (18) of a pen injection device (30).

13. The drug delivery device of any one of claims 1 to 12, wherein the second device component (302) is one of a housing (32) of a pen injection device (30), a body (10) of the housing (32), and a cartridge holder (14).

14. A drug delivery device according to any one of the preceding claims, wherein a cartridge (6) filled with a medicament (26) is disposed inside the housing (32).

15. A method of pairing an electronic data logging device (100) of a drug delivery device (1) with an external electronic device (65), the drug delivery device (1) comprising a first device component (301) movable relative to a second device component (302), the first device component (301) comprising a first outer surface (311), the second device component (302) comprising a second outer surface (312), at least one of the first outer surface (311) and the second outer surface (312) comprising at least a first code portion (321) of a pairing code (320), the pairing code (320) being visually identifiable from outside 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: placing 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 location state (351) in which the pairing code (320) is indistinguishable to a second location state (352); visually identifying the pairing code (320) from the outside of the medication delivery device (1); using the pairing code (320) to establish a communication link (66) between the external electronic device (65) and the data logging device (100); The method comprising:

Images