Injection device with electronic detector

Abstract

The present disclosure relates to an injection device (30) for administering a dose of medicament (27), the injection device (1) comprising: a housing (32) extending in a longitudinal direction (2, 3) and configured to house a cartridge (6) filled with the medicament (27); a drive mechanism (34) configured to operably engage with the cartridge (6) to dispense the dose of medicament (27); a first component (100) movable relative to the housing (32) in the longitudinal direction (2, 3) between an initial position and a triggered position for dispensing the dose of medicament (27); a second component (200) rotatable relative to the housing (32) for at least one of setting of the dose and dispensing of the dose; a cavity (150) provided in or formed by at least one of the first component (100) and the second component (200), the cavity (150) being dimensioned to house an electronic detector (300), wherein one of the first component (100) and the second component (200) is configured for attachment of the electronic detector (300), the electronic detector (300) being configured to identify a code (330) provided on the other of the first component (100) and the second component (200); at least a first gasket (400) fastened to one of the housing (32), the first component (100) and the second component (200) and configured to seal the cavity (150) against ingress of impurities at least when the first component (100) is in the initial position.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the field of drug delivery devices for administering a dose of a medicament. The present disclosure particularly relates to a drug delivery device having an electronic detector and / or configured to cooperate with an electronic detector for acquiring injection related information during use of the injection device. BACKGROUND

[0002] Drug delivery devices for setting and dispensing a single or multiple doses of a medicament are as such well-known in the art. Generally, such devices can have substantially similar purpose as that of an ordinary syringe.

[0003] Drug delivery devices, like injection or inhalation devices, like pen-type injectors, have to meet a number of user-specific requirements. For example, in case of patients suffering from chronic diseases like diabetes, the patients can be physically infirm and can also have impaired vision. Therefore, suitable drug delivery devices particularly intended for home medication require a robust construction and should be easy to use. Furthermore, handling of the device and its components and general handling should be intuitive and easy understandable. Such injection devices should provide setting and subsequent dispensing of variable sized doses of a medicament. Furthermore, the dose setting as well as the dose dispensing procedure must be easy to operate and has to be unambiguous.

[0004] Medicaments to be dispensed or expelled by a drug delivery device can be provided and contained in a multi-dose cartridge. Such cartridges typically comprise a glass barrel which is sealed in the distal direction by a pierceable seal and further sealed in the proximal direction by a bung. For reusable drug delivery devices, empty cartridges can be exchanged against new ones. In contrast thereto, drug delivery devices of the disposable type are already equipped with such a cartridge. When the medicaments in the cartridges are dispensed or used up, they will be disposed of as a whole.

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

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

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

[0008] During repeated use of a respective drug delivery device, administration details and patient specific data can be logged and stored in such a data logging device. It is generally desirable to gain access to the respective data stored in the data logging device, e.g. for patient supervision and / or for optimizing long term treatment. The data logging device can be configured to establish a communication link with an external electronic device. The communication link can be of wireless or wired type.

[0009] For any type of data logging device suitable for use with a drug delivery device, e.g. a pen-type injector, relative movement of at least two components of the injection device has to be detected or measured quantitatively.

[0010] For some injection devices, at least two selected components of the injection device move longitudinally and / or rotationally relative to each other. Such relative movement can occur during setting of a dose of medicament or during dispensing of a respective dose. For some devices, a user can set or select a dose of variable size, e.g. by rotating a dose dial, e.g. provided at or near a proximal longitudinal end of the injection device. Setting of a dose, e.g. turning of a dose dial, can cause rotation of a number sleeve located within a housing of the injection device. The number sleeve, typically having a sequence of dose indicating numbers, can be rotated and / or helically moved relative to the housing of the injection device.

[0011] The housing of the injection device can comprise a dose window in which a portion of the number sleeve is exposed. In some examples of injection devices, the number sleeve is part of a dial extension. For this type of injection device, the dial extension and the number sleeve move longitudinally relative to the housing or body of the injection device during setting of a dose and dispensing of a dose. To set a dose, turning of the dose dial causes combined rotation and longitudinal movement of the number sleeve and the dial extension relative to the housing of the injection device. Typically, the dial extension starts to move in a longitudinal proximal direction relative to the body or housing of the injection device.

[0012] For dispensing a dose, many injection devices provide a dose button or a trigger button at the proximal end of the injection device housing or at the proximal end of the dial extension. By pressing the trigger or the trigger button in distal direction, the engager of the drive mechanism of such an injection device engages and / or disengages from other components of the drug delivery device, thereby switching the injection device into a dispensing mode or dispensing configuration. The force exerted by the user onto the trigger in distal direction can cause the dial extension to return into the initial position. Such a return motion can be accompanied by a corresponding rotation of the number sleeve.

[0013] For a quantitative measurement or determination of the size of a dose, the amount of relative movement between at least the first and the second component of the injection device has to be measured or determined during the setting of the dose and / or during the dispensing of the dose.

[0014] For measuring the size of a dose actually set or dispensed by an injection device, e.g. by a pen-type injector, an electronic detector or an electronic detection unit can be provided, which is usually equipped with a sensor attached to, e.g., the first component, and with a scale or a code attached to the second component. During the setting of the dose or during the dispensing of the dose, the first component can perform a longitudinal and / or a rotational movement relative to the second component. Thus, the electronic sensor of the electronic detector and the associated code will be subjected to a measurable movement relative to each other.

[0015] Such an electronic detector can be implemented in many different ways. The sensor of the electronic detector can comprise one of a switch, a magnetic sensor, an optical sensor, a capacitive sensor, an acoustic sensor such as a microphone, an inductive sensor and many other types of sensors. Some commonly available sensor technologies can operate contactless. In general, the electronic components of such an electronic detector should be protected from the environment or from hazards. This can particularly apply to sensors implemented, e.g., optically, which require a rather clean environment between the electronic sensor and the corresponding optical code.

[0016] Wrapping the electronic sensor within a cover, a package or a wrap can impair the sensitivity and the accuracy of the measurement provided by the electronic detector. Since the mutually corresponding components of the electronic detector, i.e. the electronic sensor and the corresponding code, have to be provided on separate and mutually displaceable components of, e.g., the drive mechanism of the injection device, which are subjected to a relative movement during the setting of the dose or the dispensing of the dose, the possibility to wrap the entire electronic detector within a cover or a wrap is limited.

[0017] Especially for optically implemented electronic sensors, the wrapping of the optical detector or sensor can be accompanied by internal reflections or absorptions at the wrap or cover, which can have a further impact on the operation and the signal of the corresponding optical sensor.

[0018] Therefore, there is a need to provide an improved injection device suitable for or equipped with an electronic detector, wherein, on the one hand, the electronic detector is effectively protected from the environment or hazards, and, on the other hand, the protection of the electronic sensor has no or only a small impact on the operability, accuracy or long-term stability of the electronic sensor.

[0019] It is therefore an object of the present disclosure to provide an optimal balance between the accurate and reliable operation of the electronic sensor and the effective protection of the electronic sensor, in particular against moisture, dust or other impurities. SUMMARY

[0020] In order to provide a solution to the above-mentioned drawbacks, in one aspect an injection device for administering or dispensing a dose of a medicament is provided. The injection device comprises a housing extending in a longitudinal direction. The housing is configured to accommodate a cartridge filled with the medicament. The injection device further comprises a drive mechanism configured to operably engage with the cartridge, typically with a bung of the cartridge, for dispensing the dose of the medicament.

[0021] The injection device further comprises a first component movable relative to the housing in the longitudinal direction between an initial position and a triggered position for dispensing the dose of the medicament. The injection device further comprises a second component. The second component is rotatable relative to the housing for at least one of dose setting and dose dispensing. Furthermore, the injection device comprises a cavity. The cavity is provided in or formed by at least one of the first component and the second component. The cavity is dimensioned for accommodating an electronic detector. The cavity can further be enclosed or covered by at least one of the first component and the second component.

[0022] One of the first component and the second component is configured for attaching the electronic detector. The electronic detector is configured to recognize or detect a code provided on the other one of the first component and the second component. At least a first gasket is provided which is fastened to one of the housing, the first component and the second component. The gasket is configured to seal the cavity against impurities entering at least when the first component is in the initial position.

[0023] The gasket provides a sealing of the cavity against the environment and effectively prevents any impurities, such as moisture or dust, from entering the cavity in which the electronic detector and the code are provided. In this way, and as long as the first component is in and remains in the initial position, the cavity is effectively sealed and any impurities surrounding the injection device are effectively prevented from entering the cavity. In this way, the electronic detector, in particular the electronic sensor of the detector, and the code can be effectively protected against impurities, such as dust or moisture.

[0024] The seal provided by at least the first gasket is only temporarily released when the first component moves from the initial position to the trigger position and enters the trigger position. It should be taken into account that the injection device is not in use most of the time. It may be stored, for example, in a refrigerated area, and the user of the injection device may use the corresponding device only once, twice, or three times a day for a relatively limited period of time. Furthermore, during injection, the environment in which the injection device is used, if not sterile, is usually a relatively clean environment. Therefore, compared to the total lifespan of such an injection device, the total time that the injection device is typically in use, such as the total time spent setting and dispensing the dose, is relatively short.

[0025] Therefore, it is tolerable to cancel the cavity seal during dose setting and / or dose dispensing. In the initial position of the first component, the cavity is effectively sealed to the environment by at least a first gasket. During dose setting and / or dose dispensing, the seal provided by the first gasket between at least two of the housing, the first component, and the second component is temporarily canceled, thereby supporting and allowing movement of at least one of the first and second components relative to the other of the first and second components and / or relative to the housing.

[0026] In some examples, the injection device includes an electronic detector disposed within the cavity. The electronic detector is disposed or attached to one of the first and second components. Code that mates with the electronic detector is disposed or attached to the other of the first and second components.

[0027] In a typical example, the first component can be implemented as a trigger of the injection device. The first component may be located at the proximal longitudinal end of the injection device. The second component may be implemented as a dose dial rotatably supported at the proximal end of the housing of the injection device, or as a component of a selector extension of the injection device. When the injection device is equipped with a selector extension configured to move proximally relative to the housing during dose incrementing dose setting operations, and configured to move distally relative to the housing during dose dispensing and for dose dispensing, the first and second components may be disposed on and / or supported by the selector extension.

[0028] In other examples, the first component may be fixed to the housing relative to the longitudinal direction. It may be rotatably movable only relative to the housing. Here, the first component may move between an initial position and a triggered position relative to the housing and relative to the second component. Typically, the triggered position is located distal to the initial position. The first component may be biased by a spring element configured to bias the first component in the initial position, which may be a proximal position of the first component.

[0029] In some examples, e.g. when the injection device is equipped with a dial extension, at least a first gasket can be arranged between the housing and the second component. In the initial configuration, the gasket can be compressed in the longitudinal direction between the second component and the housing. Due to a dose incrementing movement of the second component, i.e. a displacement towards the proximal direction relative to the housing, the sealing provided by the gasket can be temporarily cancelled. After dispensing of a dose and when the second component returns to the initial configuration, said at least first gasket is repeatedly brought into engagement with both the housing and the second component.

[0030] According to another example, the second component can be rotatable relative to the first component during at least one of dose setting and dose dispensing. The degree of rotation of the second component relative to the first component is directly related to the size of the dose actually set or dispensed. In some examples, the second component can be rotatable relative to the housing during at least one of dose setting and dose dispensing. In some examples, the second component can undergo a dose incrementing rotation relative to the housing and / or relative to the first component when increasing the size of the dose by dialing the second component in the dose incrementing direction.

[0031] In some examples, the second component can be rotatable relative to the housing during and / or for dose dispensing. It can then be non-rotatable relative to the housing, i.e. rotationally fixed to the housing, for setting a dose or during setting a dose.

[0032] During dispensing of a dose, the second component can undergo a rotation in the opposite direction, i.e. in the second direction, i.e. in the dose decrementing direction. The rotation of the second component in the first or dose incrementing direction can be accompanied by a series of consecutive numbers appearing in the dose window of the housing in increasing order. When the second component is rotated in the second direction, i.e. in the dose decrementing direction, during dispensing of a dose, the numbers shown in the dose window appear in decreasing order.

[0033] Since the first and second components can be rotatable relative to each other during at least one of dose setting and dose dispensing, an electronic detector arranged and secured to one of the first and second components and interacting with a code provided on the other one of the first and second components is able to quantitatively measure the degree of relative rotation between the first and second components. In this way, the relative rotation between the first and second components can be precisely determined and / or measured.

[0034] According to another example, the code provided on one of the first and second components comprises a rotary code. The code can comprise a Gray code, e.g. a circular or rotary pattern of distinguishable code segments. The code segments can be distinguishable according to their magnetic, optical, visual, electrostatic, capacitive, acoustic or inductive properties. The type of distinguishable code segments is directly related to the sensitivity of the electronic sensor. Typically, the rotary code can comprise a circular structure on one of the first and second components, while the electronic sensor is axially or longitudinally adjacent to the rotary code.

[0035] Typically, the electronic sensor is longitudinally aligned with the rotary code. The electronic sensor can overlap with the position of the rotary code as seen from the longitudinal direction. For other examples, the rotary code is positioned radially offset from the electronic detector or the electronic sensor. Then, the electronic sensor and the rotary code can be located within a common longitudinal or axial plane, e.g. extending perpendicular to the longitudinal direction of the housing.

[0036] The rotary code can comprise a Gray code. The rotary code can be implemented as an absolute code or a relative code. In some examples, the rotary code can only comprise two different code segments alternatingly and adjacently arranged along the circumference of the rotary code. According to the number of code segments, the electronic sensor will be implemented to detect a degree of rotation matching the circumferential dimension of a single code segment.

[0037] For example, if the rotary code comprises 24 code segments equidistantly arranged in an alternating order along the circumference of the rotary code, the angular resolution of the electronic detector is about 15°. Thus, every 15° of rotation, the electronic sensor interacts with a different distinguishable code segment of the rotary code. The more distinguishable code segments provided on the rotary code, the higher the angular resolution of the electronic detector.

[0038] In some examples, the electronic detector can comprise at least two electronic sensors located at different circumferential positions relative to the rotary code. In such examples, both electronic sensors can interact with the same rotary code. In this way, the spatial resolution of the electronic detector and / or the position of the electronic detector can be increased. It is also conceivable that a number of rotary codes are provided on one of the first and second components, which interact with a number of electronic sensors provided on the other one of the first and second components of the injection device.

[0039] According to another example, the first component is movable relative to the second component in a longitudinal direction into a triggered position for dispensing the dose of medicament. In some examples, the first component can also be movable relative to the housing in a longitudinal direction into a triggered position for dispensing the dose of medicament. Typically, the triggered position is located distally from an initial position of the first component. In other words, the initial position of the first component is the most proximal position of the first component relative to the second component and / or relative to the housing of the injection device.

[0040] For some other examples, the first component is movable from the initial position towards and into the trigger position in a proximal longitudinal direction relative to the housing and / or relative to the second component. Here, when the trigger position is reached, the first component can be depressed in a distal direction to dispense a dose. The movement from the initial position to the trigger position can subsequently occur during dose setting.

[0041] In some examples, the first component can be longitudinally movable relative to the second component and the housing, e.g. during a dispensing action caused by a user of the injection device. In some examples, the first component can be biased relative to the second component and / or relative to the housing by a return element. The return element can be implemented as a spring, or can comprise a spring in mechanical engagement with the first component and in mechanical engagement with at least one of the second component and the housing of the injection device.

[0042] The return element, i.e. the spring, can be implemented as a so-called trigger spring for moving the first component into the initial position by default, e.g. when the first component is not depressed by a thumb of a user.

[0043] In some examples, and wherein the second component can comprise or can be implemented in or on a dial extension of the injection device, the initial position of the first component can be defined by a relative position relative to the second component. Here, during dose setting, both the second component and the first component can be subject to a common longitudinal displacement, e.g. in a proximal direction relative to the housing. During such dose setting displacement, the first component can remain in the initial position relative to the second component. The movement of the first component from the initial position to the trigger position can be obtained by a distally directed longitudinal displacement or movement of the first component relative to the second component. During this movement, the second component can be stationary relative to the housing, or can be subject to a distally directed displacement relative to the housing.

[0044] According to another example of the injection device, at least the first gasket is in sealing engagement with at least two of the housing, the first component and the second component when the first component is in the initial position. This example can include that the first gasket is in sealing engagement with the first component and with the second component when the first component is in the initial position. By transferring or moving the first component to the trigger position, the sealing engagement between the first and second components can be cancelled. This can also facilitate movement of the second component relative to the first component, in particular during dose dispensing. Here, the first component can be rotationally locked to the housing, or the first component can be in frictional engagement with a finger of a hand of a user, e.g. while the second component is rotated relative to the first component and relative to the housing.

[0045] During dose dispensing, the first component and the second component can be longitudinally displaced relative to the housing. For example, the first component can be continuously or permanently depressed in the distal direction and can be pushed into a triggered position under the action of a return element relative to the second component or relative to the housing. During dispensing of the dose, the first component can remain in the triggered position and thus in the depressed position relative to the first component, while both the first and the second component are subjected to a combined or joint longitudinal displacement relative to the housing in the distal direction.

[0046] For other examples, during dispensing of the dose, the second component can remain stationary relative to the housing. During and / or for dispensing of the dose, the first component can have to be moved into the triggered position and has to remain in the triggered position. To interrupt dispensing of the dose or at the end of the dose dispensing, the user can simply release the first component, which is pushed or automatically moved into the initial position under the influence of a return element. The movement of the first component into the initial position relative to the housing or relative to the second component reengages the seal between the first component and the second component by at least the first gasket.

[0047] Here, the at least first gasket also provides a dual function. It serves to seal a cavity formed or constituted by at least one of the first component, the second component and the housing. It also serves to provide a kind of frictional engagement between the respective components as soon as the gasket engages with at least two of the first component, the second component and the housing. In this way, the first gasket also provides a kind of frictional engagement or a kind of frictional engagement between the components of the injection device.

[0048] In another example, the second component is longitudinally or axially locked to the housing. The second component can be movable relative to the housing only in terms of rotation, typically with the long axis of the housing as the axis of rotation. Here, the first component is movable relative to the housing and the second component in the longitudinal direction between an initial position and a triggered position. When the first component is moved relative to the housing in the longitudinal direction, it is moved equally relative to the second component. This construction is particularly suitable for injection devices in which the second component, for example in the form of a dose dial, is longitudinally locked to the housing and cannot be moved relative to the housing in the longitudinal direction. Such an injection device can typically be equipped with a mechanical energy store, for example a torsion spring, which is operable to provide the drive force required for the drive mechanism to dispense the dose of medicament from the cartridge, for example by providing a corresponding torque and / or longitudinal thrust or pressure to a piston rod which is operatively engaged with the piston of the cartridge.

[0049] The above examples can also include a configuration in which at least the first gasket is in sealing engagement with the housing and with one of the first and second components. This can be particularly applicable to configurations in which the cavity is formed by at least one of the first and second components and in which the cavity is sealed by the housing, particularly when the first and / or second components are in the initial position or in the zero dose configuration, i.e. before setting a dose or after dispensing a dose.

[0050] The setting of a dose can be accompanied by or together with a longitudinal displacement of the second component by which the housing or body of the injection device is separated from any of the first and second components in longitudinal direction. Here, at the beginning of the dose setting, the sealing engagement between the housing and at least one of the first and second components is cancelled. During the setting of the dose, the sealing engagement can be cancelled. The same applies to the dispensing of the dose. At the end of the dose dispensing, i.e. when the injection device or drive mechanism reaches the zero dose configuration, the sealing engagement of the at least first gasket with the housing and with at least one of the first and second components can occur.

[0051] Generally, and as long as the first component is in the initial position relative to the second component, the at least first gasket serves to provide a frictional engagement between the first and second components. The first component can be locked in rotation to the housing. The second component can be subjected to a dialling motion or rotation for setting a dose. During the setting of the dose, the first component can remain stationary relative to the housing. In some examples, the first component can also rotate in unison with the second component. However, during the dispensing of the dose, the user's thumb typically depresses the first component in longitudinal distal direction, thereby bringing the first component into a trigger position relative to the second component.

[0052] As a result, the engager of the drive mechanism is switched and the drive mechanism is set into the dispensing mode. The longitudinal displacement of the first component relative to the second component also eliminates the sealing engagement between the first and second components by the longitudinal displacement of the gasket relative to one of the first and second components. By cancelling the sealing engagement between the first and second components, the second component is allowed to rotate relative to the first component with a reduced degree of friction compared to the configuration in which the first and second components are in sealing engagement by the at least first gasket.

[0053] According to another example, at least the first gasket is secured to one of the housing, the first part and the second part. When the first part is in the primed position, at least the first gasket is in sealing engagement with at least one of the other two of the housing, the first part and the second part. Typically, when the first part is in the initial position, at least the first gasket is in sealing engagement with at least one of the other two of the housing, the first part and the second part. In this way, at least when the first part is in the initial position, the cavity is effectively sealed against the ingress of contaminants. Movement or displacement of the first part to the primed position can then cancel the sealing engagement between the housing, the first part or the second part and the other two of the housing, the first part and the second part.

[0054] For example, when the first gasket is secured to or fixed to the first part, it can be in sealing engagement with the housing and / or with the second part as long as the first part is in the initial position. Movement of the first part into the primed position relative to the housing and / or relative to the second part is accompanied by a corresponding movement of the first gasket relative to the second part and / or relative to the housing. This combined longitudinal displacement of the first part and the gasket results in a cancellation of the sealing engagement between at least the first gasket and at least one of the second part and the housing.

[0055] For other examples, and in case the first gasket is secured to the second part or to the housing, the first gasket is in sealing engagement with the first part as long as the first part is in the initial position relative to the second part or relative to the housing. Movement of the first part relative to at least one of the second part and the housing to the primed position then at least temporarily cancels the sealing engagement between the housing and at least one of the first part and the second part. The sealing engagement can already be cancelled when the second part is moved relative to the housing, for example during setting of a dose, which can be accompanied by a longitudinal displacement of the first and second parts in proximal direction relative to the housing.

[0056] According to another example, the injection device comprises at least a second gasket. When the first gasket is secured or attached to one of the housing, the first part and the second part, at least the second gasket is secured to another one of the housing, the first part and the second part. In other words, said at least second gasket is secured to the one of the housing, the first part and the second part which is not provided with the first gasket. Typically, when the first part is in the initial position, the first gasket and the second gasket are in engagement with each other. When the first part is in the primed position, the first gasket and the second gasket are disengaged from each other.

[0057] In some examples, the first gasket is attached and / or fixed to the first component. The second gasket is attached and / or fixed to the second component. In an initial position of the first component, the first gasket and the second gasket are in mechanical engagement. The first gasket and the second gasket can abut longitudinally or radially with respect to the length of the housing. By transferring or moving the first component to a triggered position, the mutual engagement of the first gasket and the second gasket is cancelled. In this way, the seal provided by the mutual engagement of the first gasket and the second gasket is at least temporarily cancelled and the first component can be mechanically decoupled from the second component. This can facilitate the dispensing of a dose, which can be accompanied by a rotation of the second component relative to the housing and / or relative to the first component.

[0058] According to another example, at least a first gasket is provided on one of a proximal end face of the housing and a longitudinal end face of one of the first component and the second component. The longitudinal end face can be embodied as a proximal end face or a distal end face. When provided by the first component, the longitudinal end face is typically embodied as a distal end face to engage with the proximal end face of the housing. When provided by the second component, the longitudinal end face is typically embodied as a distal end face to engage with the proximal end face of the housing or it is embodied as a proximal end face to engage with the first component. When the first component is in an initial position, the at least first gasket is in sealing engagement with the proximal end face and the distal end face. The same can apply when the second component is in an initial position. Here, the at least first gasket can be arranged in an axial or longitudinal gap between the proximal end face of the housing and the distal end face of at least one of the first component and the second component.

[0059] The proximal end face can be located at a proximal longitudinal end of the housing. In some examples, the proximal end face is located distally of the proximal end of the housing but faces in a proximal direction. The same can apply to the distal end face of at least one of the first component and the second component. The distal end face can be provided at a respective distal end of at least one of the first component and the second component. In some examples, the distal end face can be located proximally of the distal end of the respective first or second component. In this case, the distal end face faces in a distal direction and is configured to sealingly engage or abut the proximal end face. Here, the at least first gasket is arranged between the distal end face and the proximal end face. The at least first gasket can seal a gap between the distal end face and the proximal end face.

[0060] According to another example, the first component comprises a first side wall and the second component comprises a second side wall. The second side wall at least partially surrounds the first side wall. The at least first gasket is fastened to one of the first side wall and the second side wall.

[0061] The at least first gasket faces the other one of the first and second side walls. In some examples, the first side wall is tubular. The second side wall is also tubular. The second side wall can completely enclose the first side wall. The first and second components can be arranged in a nested or coiled manner as seen in the longitudinal direction. The first side wall can be in a sliding engagement with the second side wall. For example, the first component can be slidably supported in, on or by the second component. Here, an outer surface of the first side wall can be in a sliding engagement with an inner surface of the second side wall. In this way, the first component can be guided longitudinally in or by the second component.

[0062] By providing the at least first gasket between the first and second side walls, a gap between the first and second side walls can be effectively closed or sealed. In some examples, the at least first gasket is fixed or fastened to an outer surface of the first side wall. When the first component is in the initial position, the at least first gasket is in a sealing engagement with an inner surface of the second side wall. By moving the first component relative to the second component in the longitudinal direction and by transferring the first component to the triggered position, the at least first gasket is moved relative to the second side wall in such a way that the at least first gasket is effectively decoupled from the second side wall. This can be achieved by moving the first gasket into a longitudinal section or region of the second side wall having an enlarged inner diameter.

[0063] This can also be achieved by simply moving the at least first gasket out of engagement with the second side wall, for example by transferring the at least first gasket beyond a longitudinal end of the second side wall.

[0064] In some examples, at least one of the first and second components comprises a cup-shaped receptacle which is effectively closed by the other one of the first and second components. The cup-shaped receptacle of at least one of the first and second components can effectively provide a cavity to receive or house an electronic detector and a corresponding code. In some examples, both the first and second components each comprise a cup-shaped receptacle. For example, the receptacle of the second component opens in a proximal direction. The cup-shaped receptacle of the first component opens in a distal direction. Here, both the first and second components can complement each other to form a cavity for an electronic detector and a corresponding code.

[0065] According to another example, the at least first gasket is attached to one of the first and second side walls. The first gasket protrudes from the respective side wall towards the other one of the first and second side walls. In some examples, when the at least first gasket is attached to an outer surface of, for example, the first side wall, the gasket can protrude radially outwardly from the first side wall. It can then engage with an inner surface of the second side wall. It can protrude towards the second side wall. The same or similar structure can be provided, wherein the at least first gasket is attached to the second side wall. Here, it can be attached or fixed to an inner surface of the second side wall and can protrude radially inwardly towards the first side wall. A radially inner end of the gasket can engage with an outer surface of the first side wall.

[0066] It is also conceivable here that the at least first gasket is attached to the first side wall and the at least second gasket is attached to the second side wall. In the case of the first component being in the initial position, the first and second gaskets can axially or longitudinally engage. By moving or displacing the first component into the triggered position, the first and second gaskets can be separated from each other in the longitudinal direction. They can be separated in the longitudinal direction, thereby cancelling the sealing engagement between the first and second gaskets, respectively, and between the first and second side walls of the first and second components.

[0067] According to another example, at least one of the first and second side walls comprises at least one of a tapered section, a curved section and a bulged section as viewed in the longitudinal direction. In addition to the tapered section, the curved section and the bulged section, the first and / or second side wall can comprise a similar tubular or cylindrical shape. By providing the tapered section, the curved section or the bulged portion on at least one of the first and second side walls, the radial gap between the respective side wall and the gasket attached to the other one of the first or second side walls can be changed by the longitudinal mutual displacement of the first and second components.

[0068] In some examples, when the first component is in the initial position, the at least first gasket provided on one of the first and second side walls can be in sealing engagement with a bulged or protruding portion of the other one of the first and second side walls. By displacing the first component into the triggered position, this engagement can be cancelled due to the longitudinal displacement of the bulged or protruding section relative to the gasket. The same approach can be applied to an outwardly curved section or a tapered section of at least one of the first and second side walls.

[0069] Generally, it is sufficient when only one of the first and second side walls comprises a radially protruding portion or a radially recessed portion, for example in the form of a tapered section, a curved section or a bulged section, while the other one of the first and second side walls has a rather straight or flat shaped geometry in the longitudinal direction.

[0070] According to another example, when the first component is in the initial position, at least the first gasket is in sealing engagement with the first side wall and in sealing engagement with the second side wall. In this way, a cavity provided or formed in the first and second components is effectively sealed and protected from the ingress of impurities.

[0071] According to another example, when the first component is in the triggered position, at least the first gasket is sealingly decoupled from at least one of the first side wall and the second side wall. Here, the triggered position is defined by a specific position of the first component relative to the second component. In this way, the sealing engagement provided by the at least first gasket between the first side wall and the second side wall can be effectively cancelled. Thus, the second side wall and hence the second component can freely rotate relative to the first component during dose dispensing.

[0072] According to another example, the first component comprises a trigger or trigger button provided at a proximal end of the injection device. The trigger is generally depressible in a longitudinal distal direction for dispensing a dose. Typically, the trigger axially engages or is permanently connected to an engager of a drive mechanism of the injection device. By depressing the trigger in a distal direction relative to the housing and / or relative to the second component and thereby depressing the first component, the engager of the drive mechanism is switched into a dispensing mode, wherein a user-induced and distally directed force applied to the trigger or dose dial extension of the injection device is transferred or transmitted into a corresponding distal displacement of the piston rod, thereby moving the piston of the cartridge relative to the cartridge body in a distal direction, resulting in a dispensing of a dose according to a longitudinal advancement movement of the piston rod relative to the cartridge.

[0073] In other embodiments of the drive mechanism, by switching the drive mechanism into the dispensing mode, a mechanical energy stored in the drive mechanism, for example a mechanical energy stored in a torsion spring, is released in order to accordingly advance the piston rod in a distal direction.

[0074] According to another example, the second component comprises one of a dose dial and a dose dial extension. The second component is rotatable relative to the housing for setting a dose of medicament. Depending on the specific embodiment of the drive mechanism, the dose dial can be fixed to the housing in a longitudinal direction and can be only rotationally supported on the housing. By rotating the dose dial extension relative to the housing (e.g. clockwise), the size of the dose can be increased. By rotating the dose dial extension in the opposite direction (e.g. counter-clockwise), the size of the dose can be decreased. During dose dispensing, the dose dial can be rotated in a dose decrement direction. In some examples, the dose dial can be stationary relative to the housing during dose dispensing.

[0075] When the second component is implemented as a dial extension, it typically occurs a longitudinal displacement in proximal direction relative to the housing during dose setting. Then, it occurs a longitudinal displacement in distal direction relative to the housing during dose dispensing. When implemented as a dial extension, the trigger is typically supported on the dial extension, thus also occurring a corresponding longitudinal displacement during dose setting and dose dispensing. However, in order to switch the drive mechanism from the default dose setting mode to the dose dispensing mode, the trigger or trigger button occurs a dedicated displacement in distal direction or a sliding movement in distal direction relative to the second component, thus relative to the dial extension.

[0076] According to another example, the injection device is equipped with a cartridge filled with a medicament. The cartridge typically comprises a tubular barrel sealed by a bung in proximal direction. The bung is typically movable within the barrel in longitudinal direction of the barrel. The distal end of the barrel or cartridge is typically sealed by a pierceable seal, for example by a septum which can be penetrated by a double pointed injection needle.

[0077] The cartridge can be easily arranged inside the housing of the injection device. The injection device can be implemented as a disposable injection device, wherein the cartridge is pre-filled and assembled inside the housing when commercially distributed or handed over to the end user or patient.

[0078] For other examples, the injection device is a reusable injection device. Here, the cartridge is replaceably arranged inside the housing.

[0079] The at least first gasket and / or the at least second gasket can comprise an annular structure. It can be provided as an O-ring. The first gasket or the second gasket can comprise an elastic material, for example a polymer or an elastomer material. The gasket can comprise for example an epoxy or a silicone or a mixture thereof. The first or second gasket can also be provided by a coating on at least one of the housing, the first component and the second component. The first or second gasket can be attached to the first component, the second component of the housing by a hot melt procedure, injection molding or insert molding. The first and / or second gasket can comprise a foamed material, for example a foamed plastic, a foamed rubber, a foamed thermoplastic material. The first and / or second gasket can comprise a thermoset material.

[0080] The first and / or second gasket can be integrally formed. They can be provided as a single component. In some examples, the first and / or second gasket can each comprise a multi-component gasket having at least a first and a second part. The first and / or second gasket can comprise a multi-component clamp or bracket to respectively surround the side wall of the first or second component.

[0081] The first or second gasket can be compressible onto at least one of the housing, the first component, and the second component. A relatively soft or elastic material for the first or second gasket provides an effective seal of the cavity. The first and / or second gasket can be adhesively or bonded attached to at least one of the housing, the first component, and the second component.

[0082] In some further examples, the electronic detector includes a printed circuit board having a processor, a battery, and an electronic sensor. In some examples, the printed circuit board of the electronic sensor can be in sealing engagement with at least one of the first gasket and the second gasket when the first component is in the initial position. The sealing engagement between the printed circuit board and the respective gasket can be cancelled by movement of the first component relative to at least one of the housing and the second component.

[0083] Generally, the scope of the disclosure is limited only by the contents of the claims. The injection device is not limited to the specific embodiments or examples, but includes any combination of elements of different embodiments or examples. In this regard, the disclosure encompasses any combination of the claims and any technically possible combination of features disclosed in connection with different examples or embodiments.

[0084] In this context, the term "distal" or "distal end" relates to the end of the injection device facing the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device, which is furthest away from the injection site of a human or animal.

[0085] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. The drug or medicament can be used for a limited period, or on a regular basis for chronic disorders.

[0086] As described below, the drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into a molecular delivery system such as a vector, a plasmid, or a liposome. Mixtures of one or more drugs are also contemplated.

[0087] A drug or medicament contained in a drug delivery device as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in publications such as the

[0088] A drug or medicament contained in a drug delivery device as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in publications such as the

[0089] Examples of APIs used in the treatment and / or prophylaxis of diabetes mellitus type 1 or type 2 or complications associated with diabetes mellitus type 1 or type 2 include an insulin (e.g., human insulin, or a human insulin analogue or derivative, glucagon-like peptide-1, a GLP-1 analogue or a GLP-1 receptor agonist, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refer to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, such as the structure of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide, and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. Insulin analogues are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide which has a molecular structure which can formally be derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituent, such as a fatty acid, is bound to one or more amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0090] Examples of insulin analogues are Gly(A21 ), Arg(B31 ), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0091] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N- palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N- palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)- des(B30) human insulin, B29-N-o-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxocarheptyl)- des(B30) human insulin and B29-N-(ooxocarheptyl) human insulin.

[0092] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlilanide , Exenatide (Exendin-4, a 39 amino acid peptide produced by the salivary glands of the Gila monster), Lirilumab Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR 709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Barnadutide (SAR425899), Exenatide-XTEN and Glucagon-XTEN.

[0093] Examples of oligonucleotides are, for example: mipomersen sodium An antisense treatment for lowering cholesterol for the treatment of familial hypercholesterolemia, or RG012 for the treatment of genetic kidney disease (Alport syndrom).

[0094] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0095] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follilutropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Teripressin, Goserelin, Triptorelin, Leuprolide, Buserelin, Nafarelin and Gonadorelin.

[0096] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, a low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g. polysulfated versions of the above polysaccharides), and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is Enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0097] The term "antibody", as used herein, refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind the Fc receptor. For example, the antibody can be of an isotype or subtype, an antibody fragment, or a mutant, that does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen binding molecule based on tetravalent, bispecific tandem immunoglobulin (TBTI) and / or a dual variable region antibody-like binding protein with crossMnning region orientation (CODV).

[0098] The term "fragment" or "antibody fragment" refers to polypeptides (e.g., antibody heavy and / or light chain polypeptides) derived from full-length antibody polypeptides that do not comprise a full-length antibody polypeptide, but that still comprise at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present application include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0099] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0100] Examples of antibodies are anti-PCSK-9 mAbs (e.g., Alirocumab), anti-IL-6 mAbs (e.g., Sarilumab), and anti-IL-4 mAbs (e.g., Dupilumab).

[0101] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in the medicaments or pharmaceutical agents in the drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0102] Those of skill in the art will appreciate that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein can be made that will fall within the scope of the present application and the whole scope of equivalents thereof.

[0103] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed disclosure without departing from the scope of the disclosure. In addition, it should be noted that any reference signs in the appended claims should not be construed as limiting the scope of the disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0104] In the following, a number of examples of injection devices and methods of pairing a data logging device with an external electronic device will be described in more detail with reference to the appended drawings, in which:

[0105] Fig. 1 schematically illustrates one example of a drug delivery device implemented as an injection device,

[0106] Fig. 2 schematically illustrates a number of components of the drug delivery device of Fig. 1,

[0107] Fig. 3 illustrates a pen-type injection device after setting of a dose,

[0108] Fig. 4 illustrates a further example of a pen-type injection device after setting of a dose, and

[0109] Fig. 5 illustrates another example of a pen-type injection device after setting of a dose and before dispensing of the dose,

[0110] Fig. 6 illustrates an example of a proximal portion of an injection device, wherein the first and second components are in an initial position,

[0111] Fig. 7 illustrates the example of Fig. 6, wherein the first component is in a triggered position,

[0112] Fig. 8 illustrates another example of a first component and a second component, wherein the first component is in an initial position,

[0113] Fig. 9 illustrates the example of Fig. 8, wherein the first component is in a triggered position,

[0114] Fig. 10 illustrates another example of a first and a second component of an injection device, wherein a cavity between the first and second components is sealable by a first gasket and a second gasket,

[0115] Fig. 11 illustrates the example of Fig. 10, wherein the first component is in a triggered position,

[0116] Fig. 12 illustrates another example of a first component and a second component, wherein the first component is in an initial position,

[0117] Fig. 13 illustrates the example of Fig. 12, wherein the first component is in a triggered position,

[0118] Fig. 14 is another example of a first component and a second component, wherein the first component is in an initial position,

[0119] Fig. 15 shows the example of Fig. 14 with the first component in the triggered position,

[0120] Fig. 16 shows another example of the first and second components with the first component in the initial position,

[0121] Fig. 17 shows the example of Fig. 16 with the first component in the triggered position,

[0122] Fig. 18 shows another example of the first and second components with the first component in the initial position,

[0123] Fig. 19 shows the example of Fig. 18 with the first component in the triggered position,

[0124] Fig. 20 shows another example of the first and second components relative to the housing of the injection device, with the first component in the initial position, and

[0125] Fig. 21 shows the example of Fig. 20 with the first component in the triggered position,

[0126] Fig. 22 shows an example in which the electronic detector is at least partially encapsulated by a gasket or seal,

[0127] Fig. 23 shows another example of an at least partially encapsulated electronic detector,

[0128] Fig. 24 shows another example of an at least partially encapsulated electronic detector, and

[0129] Fig. 25 shows a further example of an at least partially encapsulated electronic detector. DETAILED DESCRIPTION

[0130] One example of a drug delivery device 1 for administering a dose of a medicament 27 is shown in Figs. 1 and 2. The drug delivery device 1 is implemented as an injection device 30. The injection device 30 is a hand-held pen-type injector. The injection device 30 can be implemented as a disposable injection device 30. It can comprise a pre-filled cartridge 6 arranged within a cartridge holder 14. For the disposable injection device 30, the cartridge holder 14 is non-removably connected to the body 10 of the housing 32 of the injection device 30.

[0131] In other examples, the injection device 30 is a reusable injection device, wherein the cartridge holder 14 is removably connected to the body 10 for replacing an empty cartridge 6. At or near the distal end of the housing 32, thus at the distal end of the cartridge holder 14, a hub 28 is provided which is configured to mount or engage an injection needle 15. The hub 28 can be implemented as a threaded hub and the injection needle 15 can comprise a needle hub which is threadably connected to provide a threaded engagement with the hub 28, respectively.

[0132] Typically, the injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 and / or a protection cap 18 configured to surround and protect a distal section of the housing 32 of the injection device 30. The body 10 can comprise and form a main housing piece configured for accommodating a drive mechanism 34 as shown in Fig. 2. The cartridge holder 14 can be considered a distal housing component of the injection device 30. The cartridge holder 14 can be permanently or releasably connected to the body 10 or main housing.

[0133] The cartridge 6 comprises a cylindrical or tube-shaped barrel 25 sealed in the proximal direction 3 by a bung 7 located inside the barrel 25. The cartridge 6 can be pre-filled with a liquid medicament 27. The bung 7 is displaceable in the distal direction 2 relative to the barrel 25 of the cartridge 6 by a piston rod 20 of the drive mechanism 34. The distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and 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 penetrated, thereby establishing a fluid transport path to the interior of the cartridge 6.

[0134] When the injection device 1 is configured to administer, for example, human insulin, the dose set by the dose dial 12 at the proximal end of the injection device 1 can be displayed in so-called International Units (IU, where 1 IU is the biological equivalent of about 45.5 pg of pure crystalline insulin (1 / 22 mg)). The dose dial 12 can comprise a sleeve-shaped knob at the proximal end of the housing 32 of the injection device 30.

[0135] As further shown in Figs. 1 and 2, the body 10 comprises a dose window 13, which can be in the form of an aperture in the body 10. The dose window 13 allows the user to view a defined portion of a number sleeve 80 configured to move when the dose dial 12 is turned. The number sleeve 80 and the dose window 13 provide a visual indication of the currently set dose. The dose dial 12 can rotate on a helical path relative to the body 10 when turned during dose setting and / or dispensing or expelling.

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

[0137] In the illustrated embodiment, during delivery of an insulin dose, the dose dial 12 turns into its initial position in axial motion, that is to say without rotation, while the number sleeve 80 rotates back to its initial position, for example displaying a dose of zero units.

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

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

[0140] Further, a dose scale sleeve, also referred to as number sleeve 80, is provided. The number sleeve 80 is located radially inside the housing 10. A helical groove 81 is provided around the outer surface of the number sleeve 80. The body 10 is provided with a dose window 13 through which a portion of the outer surface of the number sleeve 80 can be seen. The body 10 is further provided with a helical rib at the inner side wall portion which seats in the helical groove 81 of the number sleeve 80. The helical rib is fixed to the body 10. It can be formed integrally with the body 10. First and second stoppers can be provided on the body 10 to limit the dose setting process in which the number sleeve 80 is rotated in a helical motion relative to the housing 10.

[0141] A dose dial 12 in the form of a dose dialing knob is arranged around 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 fixed on the number sleeve 80 to prevent relative movement therebetween. The dose dial 12 is provided with a central opening.

[0142] The trigger 11, also referred to as dose button, is essentially T-shaped. It is arranged at the proximal end of the injection device 10. The stem 64 of the trigger 11 extends through the opening in the dose dial 12. The stem 64 and thus the trigger 11 are constrained for limited axial movement relative to the 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 in a proximally accessible annular recess of the dose dial 12. Typically, the trigger 11 is in axial or longitudinal engagement with the engager 90, by which the drive mechanism is switchable from a default dose setting mode to a dose dispensing mode. In the dose dispensing mode, the injection device 30 is operable to expel or dispense a dose of medicament from the cartridge 6.

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

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

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

[0146] The pen-type injection device 30 as shown in Fig. 3 comprises a housing 32 having a proximal housing part denoted body 10 and a distal housing part denoted cartridge holder 14. A drive mechanism 34, not shown in detail here, comprises a dial extension 70. During setting of a dose, the dial extension 70 is displaced proximally with respect to the body 10. During dose dispensing, the dial extension 70 is displaced distally directed. The dial extension 70 comprises a dose dial 12 rotatable with respect to the body 10 for setting a dose. The size of the dose is typically displayed in a dose window 13. A number sleeve 80 can also contribute or can form part of the dial extension 70. When a dose of a certain size has been set, the number provided on the outer surface of the number sleeve 80 can be seen on the part of the dial extension 70 protruding proximally from the body 10.

[0147] For dispensing a dose, the user has to press the injection button 11 provided at the proximal end of the dial extension 70.

[0148] Another example of an injection device 30 as shown in Fig. 4 is very similar and therefore equivalent to the example as shown in Fig. 3. Here, the dial extension 70 comprises a sleeve 71 which starts to protrude proximally from the body 10 when a dose is set by dialing the dose dial 12. Also here, the dial extension 70 is moved in proximal direction 3 when a dose of increasing size is set. During dose dispensing initiated by pressing the trigger 11 in distal direction 2, the dial extension 70 is pushed back into the body 10.

[0149] For the examples of Fig. 3 and Fig. 4, as it is apparent from e.g. Fig. 1, the drive force causing the piston rod 20 to move in distal direction with respect to the body 10 and with respect to the cartridge 6 is provided by the user pushing the dial extension 70 from the dose setting position as shown in Fig. 3 and Fig. 4 into the initial configuration.

[0150] For another example of an injection device 30 as shown in Fig. 5, the drive force for moving the piston rod 20 in distal direction 2 can be provided by a mechanical energy store provided within the body 10. Said mechanical energy store can comprise a torsion spring. An example of such a drive mechanism is shown in WO 2014 / 033195 Al, the entire content of which is incorporated herein by reference.

[0151] Dialing or setting of a dose is obtained by rotation of the dose dial 12 relative to the body 10. As shown in Fig. 5, a dose of a certain size is set, and the corresponding dose size indication number is shown in the dose window 13. The dose window 13 can be a movable window displaceable in a longitudinal direction in a fixed window or aperture 8 provided in the body 10. The movable dose window 13 can be provided by a gauge element rotationally locked relative to the body 10 and longitudinally movable. While in the examples of Figs. 3 and 4, the number sleeve 80 can be threadedly engaged with the body 10, the number sleeve 80 in the example of Fig. 5 can be longitudinally or axially locked to the body 10.

[0152] For the numerous examples of injection devices 30 shown in Figs. 3-5, the dose dial 12 serves as a second component 200 that is rotatable relative to the housing 32 relative to the body 10 at least for one of dose setting and dose dispensing. The trigger 11 or trigger button is movable relative to the housing 32 or the body 10 or relative to the second component 200 for switching the injection device 30 from a dose setting mode to a dose dispensing mode. Typically, the first component 100 or the trigger 11 is movable from a proximal initial position to a distally directed trigger position, as apparent from the comparison of Figs. 6 and 7. To this end, the first component 100 is biased in the proximal direction 3 by a return element in the form of a spring 160, for example.

[0153] For some examples of the injection device 30, the second component 200 is rotated relative to the first component 100 during at least one of dose setting and dose dispensing. In order to detect and quantify the degree of relative rotation between the first component 100 and the second component 200, an electronic detector 300 is provided in a cavity 150 provided or formed by at least one of the first component 100 and the second component 200.

[0154] The electronic detector 300 comprises at least one electronic sensor 308, 310 provided or attached to one of the first component 100 and the second component 200. The electronic sensor 308, 310 communicates or interacts with a corresponding code 330 provided on the other one of the first component 100 and the second component 200. In the example shown in Figs. 6-15, the electronic detector 300 equipped with the at least one electronic sensor 308, 310 is attached and / or fixed to the first component 100. The code 330, which is implemented as a rotary code 332, for example, is provided on or fixed to the second component 200.

[0155] In the example of Fig. 6, the first component 100 is slidingly engaged with the second component 200 along the longitudinal direction. A spring 160 is provided acting between the first component 100 and the second component 200.

[0156] One end of the spring 116 is typically implemented as a longitudinally extending compression spring longitudinally abutting a distally facing abutment or abutment face 122 of the first part 100. The opposite end of the spring 160 abuts an oppositely facing abutment 220 of the second part 200. The oppositely facing abutment 220 can be provided at the bottom of a cup-shaped reception 210 provided or formed by the second part 200.

[0157] As further shown in Fig. 6, the bottom 211 of the second part 200 is provided with a code 330, for example implemented as an annular rotary code 332. The rotary code 332 faces in the proximal direction 3. The first part 100 comprises a reception 110 having a sidewall 112 open towards the distal direction 2, while the second part 200 comprises a cup-shaped reception 210 open towards the proximal direction. The reception 210 is limited by a tubular sidewall 212 which can be in sliding engagement with the complementary shaped tubular sidewall 112 of the first part 100.

[0158] In the example as shown in Fig. 6, the first part comprises a cup-shaped reception 110 limited in the proximal direction 3 by a proximal end face 106 and by a tubular sidewall 112. Towards the distal direction 2, the reception 110 comprises at least two apertures 118, 120 facing in the distal direction and aligned with respective first and second electronic sensors 308, 310 of the electronic detector 300.

[0159] As shown in Fig. 6, the electronic detector 300 is arranged inside the cup-shaped reception 110. It is fixed to the first part 100. The sensors 308, 310 are longitudinally aligned with the apertures 118, 120 of the first part 100. They face the rotary code 332. When the first part 100 is rotated relative to the longitudinal axis of the injection device 30 as the axis of rotation, the electronic detector 300 will be correspondingly rotated relative to the code 330 and relative to the rotary code 332.

[0160] Since the rotary code 332 is encoded in the circumferential direction, the respective sensors 308, 310 are operable to detect and quantitatively measure the degree of rotation of the first part 100 relative to the second part 200. As shown in Fig. 7, when the first part 100 is depressed relative to the second part 200 in the distal direction 2, a relative rotation between the first part 100 and the second part 200 typically occurs. Here, the spring 160 is compressed and the first part 100 axially or longitudinally abuts the engager 90 via the extension 92 for displacing or moving the engager 90 relative to the housing 32 or body 10 of the injection device 30, thereby switching the drive mechanism 34 into the dose dispensing mode.

[0161] As shown in Figs. 6 and 7, the abutment 122 or the bottom of the first part 100 is longitudinally abutted with the longitudinal extension 92 of the engager 90. By moving the first part 100 from the initial position as shown in Fig. 6 to the triggered position as shown in Fig. 7, the engager 90 is correspondingly moved in the distal direction relative to the second part 200 and / or relative to the body 10 or the housing 32 of the injection device 30. The movement of the engager 90 will switch the drive mechanism from the default dose setting mode to the dose dispensing mode.

[0162] At the same time, the electronic detector 300 can be activated due to the longitudinal displacement of the first part 100 relative to the second part 200 or relative to the housing 32. In addition, the electronic detector 300 can be provided with a switch or some other type of activation mechanism to set the electronic detector in the activated mode. The electronic detector 300 is generally provided with a printed circuit board 304 on which at least a processor 306 and electronic sensors 308, 310 are located. The electronic detector 300 is further provided with a battery 302.

[0163] Of course, the electronic detector 300 can further be equipped with an electronic memory which is operable to store the date and / or time of the injection and to store the size of the dose dispensed by the injection device 30. The electronic detector 300 can further comprise a clock generator in order to provide time information for storing the injection related data in the electronic memory. The electronic detector can further have a communication module which is generally implemented as a wireless communication module. The communication module is generally configured and operable to establish a communication link with an external electronic device such as a smartphone, a tablet computer, a smartwatch or some other type of mobile or stationary electronic device. With the communication module, the data captured by the electronic detector 300 can be shared with other electronic devices for data analysis.

[0164] As shown in Figs. 6 and 7, the arrangement of the first part 100 and the second part provides and forms a cavity 150 in which the electronic detector 300 and the corresponding code 330 are located and arranged. Because the first part 100 has to be movable relative to the second part 200, the entry of impurities cannot be completely avoided due to the requirement that the first part 100 and the second part 200 have to be moved smoothly relative to each other during dose setting or during dose dispensing.

[0165] Therefore, a predetermined size of a gap is always provided between the side wall 212 of the second part and the side wall 112 of the first part 100 in order to allow for a smooth or relative displacement between the first and second parts 100, 200.

[0166] In the example as shown in Figs. 8 and 9, at least a first gasket 400 is provided in the interface between the first component 100 and the second component 200. In the configuration of Fig. 8, in which the first component 100 is in an initial position relative to the second component 200, the first component 100, in particular the side wall 112 of the first component 100, is in sealing engagement with the first gasket 400. Here, the first gasket 400 is attached and fixed to the second component 200. The first gasket 400 is provided at a proximal end of the side wall 212 of the second component 200.

[0167] As can be further seen from Figs. 8 and 9, the side wall 112 of the first component 100 comprises a radially outwardly extending bulged section 117 near its distal end. In the initial position as shown in Fig. 8, the outwardly bulged section 117 is in mechanical engagement with at least the first gasket 400. In this way, the cavity 150 formed or provided by the first component 100 and the second component 200 is effectively sealed against ingress of impurities from the outside.

[0168] As shown in Fig. 9, when the first component 100 is moved or depressed in the distal direction 2 relative to the second component 200 against the action of the return spring 160, the outwardly bulged section 170 is distally displaced from at least the first gasket 400. In this way, the bulged section 117 and the side wall 112 of the first component 100 are decoupled from the first gasket 400. This mechanical decoupling between the side wall 112 and the gasket 400 allows and supports a smooth and low-friction or even frictionless rotation of the second component 200 relative to the first component 100 during dose dispensing.

[0169] Although the decoupling of the side wall 112 from the gasket 400 temporarily cancels the seal between the first and second components 100, 200, it should be noted that this cancellation of the seal of the cavity 150 only occurs for a relatively limited period of time, i.e. only during the dispensing of a dose. At the end of the dose dispensing process, and when the distally directed pushing force, typically applied by a user onto the first component 100, is no longer present, the spring 160 serves to move and return the first component 100 to the initial position as shown in Fig. 8, in which the seal between the side wall 112 and the side wall 212 is re-established.

[0170] In the example of Figures 10 and 11, a second gasket 420 is provided in the interface between the first and second components 100, 200. Here, the first gasket 400 is attached and fixed to the side wall 212 of the second component 200. The second gasket 420 is attached and fixed to the side wall 112 of the first component 100. Since at least a longitudinal portion of the side wall 112 is completely enclosed by the second side wall 212, the second gasket 420, which projects radially outward on the side wall 112, can longitudinally or axially abut or engage with the first gasket 400 provided on the side wall 212 of the second component 200. As shown in Figures 10 and 11, the first gasket 400 is provided on a radially inward portion of the side wall 212 and the second gasket 420 is provided on a radially outward portion of the side wall 112. In an initial position of the first component 100 relative to the second component 200, the first and second gaskets 400, 420 axially or longitudinally abut, thereby effectively sealing the cavity 150 provided or constituted by the cup-shaped receptacle 110, 210 of the first and second components 100, 200, respectively.

[0171] Now, since the first component 100 is subjected to a displacement towards the distal side, e.g. a sliding displacement towards the distal side relative to the second component 200, as shown in Figure 10, the first and second gaskets 400, 420 are separated from each other in the longitudinal direction. In this way, the first and second gaskets 400, 420 are separated. This separation can be sufficient to allow and support a rotation of the second component 200 relative to the housing 32 and / or relative to the first component 100.

[0172] In another example of Figures 12 and 13, the electronic detector 300, in particular the printed circuit board PCB 304 of the electronic detector 300, at least slightly projects radially outward from the side wall 112. Here, the printed circuit board 304 can also serve as a kind of distal closure of the cup-shaped receptacle 110 of the first component 100. However, the relevant electronic components of the PCB 304, i.e. the sensors 308, 310, are located on the distal-facing side of the PCB 304.

[0173] In some examples, the PCB 304 can only intersect the side wall 112 and can project radially outward from the side wall 112. In an initial configuration or position of the first component 100 relative to the second component 200, the outwardly projecting portion of the PCB 304 is in sealing engagement with the first gasket 400 provided and fixed on the side wall 212 of the second component 200. As shown in Figure 13, when the first component 100 and the PCB 304 fixed thereto are subjected to a displacement towards the distal side, the sealing engagement between the PCB 304 and the first gasket 400 is cancelled. This allows a rotation of the second component 200 relative to the first component 100 at least during dose dispensing.

[0174] In another example as shown in Figs. 14 and 15, the first gasket 400 is attached and fixed to the first side wall 112 of the first component 100. Here, the side wall 212 of the second component 200 comprises a tapered section 215. The tapered section 250 comprises an inner diameter which gradually decreases towards the proximal direction 3. As shown in Fig. 14, in the initial position of the first component 100 relative to the second component 200, the first gasket 400 is radially squeezed between the outer surface of the first side wall 112 and the inner surface of the second side wall 212. As shown in Fig. 15, when the first component 100 is displaced towards the distal direction 2 relative to the second component 200 and towards the triggered position, the first gasket 400 starts to slide along the radially widened tapered section 215 of the first side wall 212. When the triggered position as shown in Fig. 15 is reached, the first gasket 400 can disengage from the second side wall 212. Thus, the second component 200 can be freely rotated relative to the housing 32 and / or relative to the first component 100, e.g. during dispensing of a dose.

[0175] In another example as shown in Figs. 16 and 17, the first gasket 400 is again provided at or near the proximal end of the second side wall 212 of the second component 200. Here, the side wall 112 of the first component 100 comprises a radially outwardly extending bulge section 117 near the distal end of the first component 100. A radially inwardly extending, e.g. somewhat concave, curved section 115 is provided at the proximal end adjacent to the bulge section 115. The curved section 115 forms a kind of radial recess in the outer surface of the first side wall 112.

[0176] As shown in Fig. 16, in the initial position of the first component 100, the bulge section 117 axially or longitudinally abuts the first gasket 400. Here, the cavity 150 is effectively sealed against the ingress of impurities. As shown in Fig. 17, when the first component 100 is displaced towards the distal direction 2 relative to the second component 200, the radially narrowed or recessed curved section 115 moves in the distal direction 2 and aligns with the first gasket 400. Due to the reduced outer diameter of the curved section 115 compared to the bulge section 117, the sealed engagement between the first gasket 400 and the side wall 112 of the first component 100 is effectively cancelled. Thus, a smooth rotation of the second component 200 relative to the first component 100 and / or relative to the housing 32 is provided and supported.

[0177] In the example of Figs. 16 and 17, the position of the electronic detector 300 and the code 330 has been switched compared to the numerous examples described above in connection with Figs. 6-15. Here, the electronic detector 300 is provided on or in the second component 200 and the code 330 with the rotational encoding 332 is provided on the first component 100.

[0178] In Figs. 18 and 19, another example of a first and second component 100, 200 is schematically illustrated. Here, the second component 200 comprises a tubular side wall 212 and further comprises a toothed section 230 configured to engage with a correspondingly shaped toothed section 130 of the adapter 94 of the first component 100. The adapter 90 can be permanently and non-movably fixed to the first component 100. The adapter 90 and / or the first component 100 can be biased in the longitudinal direction by a spring 160. The spring 160 can push the adapter 90 and thus the first component 100 in the proximal direction 3, thereby causing the toothed section 130 of the adapter 90 to engage with the toothed section 230 of the second component 200.

[0179] In the initial configuration in which the toothed sections 130, 230 of Figs. 18 and 19 are engaged with each other, the first component 100 is rotationally locked to the second component 200. For setting a dose, both the first component 100 and the second component 200 can be rotated relative to the housing 32 or body 10 of the injection device 30. During dose setting, the first and second component 100, 200 can be rotationally locked to each other. They can also be longitudinally locked to each other.

[0180] As shown in Figs. 18 and 19, the first component 100 comprises a cup-shaped reception 110 formed by a tubular side wall at least partially surrounding the tubular or cylindrical side wall 212 at or near the proximal end of the second component 200. The cup-shaped reception 110 is open towards a code 330, for example provided on the proximally facing end face 206 of the second component 200. The code 330, for example implemented as a rotational code 332, faces the sensors 308, 310 of the electronic detector 300 attached to the first component 100.

[0181] Also here, the cavity 150 configured to accommodate both the electronic detector 300 and the corresponding code 330 is sealed against the ingress of impurities through the gasket 400 provided on the outer surface of the second side wall 212 of the second component 200. In the initial configuration as shown in Fig. 18, the gasket 400 is provided in the overlapping section of the first side wall 112 and the second side wall 212. The distal end of the first side wall 112 comprises a radially inwardly extending, for example annular protrusion, for example in the form of a radially inwardly extending ridge section 117, which axially or longitudinally engages with the first gasket 400. In this way, the cavity 150 in the interface between the first component 100 and the second component 200 is effectively sealed against the ingress of impurities.

[0182] When the first part is depressed or moved into the triggered position, as shown in Fig. 19, and when the first part 100 is longitudinally displaced towards the distal direction relative to the second part 200, as shown in Fig. 19, the protruding or inwardly bulging section 117 of the first side wall 112 is disengaged from the spacer 400 in the distal direction. At the same time, the toothed section 130 is disengaged from the corresponding or complementarily shaped toothed section 230 and decoupled, and the rotational interlock between the first part 100 and the second part 200 is thus cancelled.

[0183] Here, the second part 200 can be free to rotate relative to the first part during dispensing of a dose of medicament and during dispensing of a dose of medicament.

[0184] For the example of Figs. 18 and 19, the first part 100 has a dual function, it serves to set a dose by dialling or rotating the first part 100 in unison with the second part 200 relative to the housing 32. In addition, the first part serves as and behaves as a trigger 11. It can be depressed in the distal direction 2 relative to the second part 200 to start dispensing or expelling of a dose.

[0185] Another example as shown in Figs. 20 and 21 illustrates a dialling extension 70. Here, the first part 100 and the second part 200 constitute or form part of the dialling extension 70. The dialling extension 70, i.e. the first part 100 and the second part 200, are longitudinally moveable in unison relative to the housing 32 or body 10 of the injection device 30. In an initial position of the first part 100 relative to the housing 32, the first spacer 400 effectively seals the cavity 150 provided and confined by the first part 100, the second part 200 and the housing 32. In addition, here the first part 100 is axially abutting or permanently connected and fixed to the adapter 90.

[0186] The adapter 90 is longitudinally biased relative to the second part 200 by the return spring 160. As shown in Fig. 21, the code 330 is provided on the proximally facing end face 206 of the second part 200, and the electronic detector 300 is located within the cup-shaped reception 110 of the first part 100. The cup-shaped reception 100 can be closed by the distally facing end face 106, in which at least one aperture 118, 120 is provided to enable unobstructed interaction between at least one sensor 308, 310 of the electronic detector 300 and the code 300 provided on the end face 206.

[0187] In the example of Figs. 20 and 21, the end face 106 is provided with a spacer 400. In an initial position as shown in Fig. 20, the spacer 400 is axially sealingly abutting the end face 36 of the housing 32. Likewise, a spacer 400 can be provided on the end face 36 and can axially or longitudinally abut the end face 106 of the first part.

[0188] As shown in Fig. 21, the sealing engagement between the first component 100 and the housing 32 is cancelled when the first component 100 is moved into a trigger position for dispensing the dose of medicament. Here, in contrast to the example described above in connection with Figs. 6-19, the trigger position of the first component is offset proximally from the initial position of the first component 100. In the trigger position as shown in Fig. 21, the first component is ready to be depressed by the user to start or trigger the dispensing of the dose of medicament. To dispense the dose, the first component 100 is depressed in the distal direction 2, thereby disengaging the toothed sections 130, 230 of the engager 90 and the second component 200 in a similar manner as described above in connection with Fig. 19.

[0189] The second component 200 is then free to rotate relative to the first component 100 and relative to the housing 32. Releasing the first component 100 during or at the end of the dose dispensing causes the first component 100 to displace the engager 90 relative to the second component 200 in a proximal direction by the spring bias, thereby re-engaging the correspondingly shaped toothed sections 130, 230 and re-establishing the sealing of the cavity 150.

[0190] In the numerous examples of Figs. 22-25, the electronics detector 300 can be encapsulated by a gasket 440. Here, the gasket 440 can comprise a sealing resin or can comprise some kind of potting compound. As shown in Fig. 22, the entire proximal portion of the PCB 304 and the battery 302 can be encapsulated by the gasket 440. The sensors 308, 310 and the processor 306 can be provided on the distally facing side of the PCB 304. They can be free of the gasket or can protrude distally from the gasket 440.

[0191] For the example of Fig. 23, only the proximal portion of the PCB 304 and the battery 302 and the circumferential side section are encapsulated by the gasket 440. The proximal contact surface 303 of the battery is free of the gasket 440.

[0192] For the further example of Fig. 24, the gasket 440 only surrounds and encloses the PCB 304. Here, at least some of the electronic components of the electronics detector 300, such as the sensors 308, 310 and / or the processor 306, can be partially surrounded or at least partially encapsulated by the gasket 440. At least the sensing surfaces or sensing sides 309 of the sensors 308, 310 facing away from the PCB 304 are and remain uncovered or protrude from the gasket 440.

[0193] For the further example of Fig. 25, only the electronic components provided on the PCB 304 are encapsulated or embedded in the gasket 440. Here, the sensing or detection surfaces 309 of the sensors 308, 310 are flush with the gasket 440 and remain uncovered for unobstructed measurement and detection.

[0194] List of reference signs

[0195] 1. Drug delivery device

[0196] 2. Distal direction

[0197] 3 First Direction

[0198] 4 Second direction

[0199] 5. Direction of dose reduction

[0200] 6 medicine cartridges

[0201] 7. Plugs

[0202] 8. Fixed Window

[0203] 10 body

[0204] 11 Triggers

[0205] 12 Dosage dial

[0206] 13 Dosage window

[0207] 14. Cartridge Holder

[0208] 15 injection needles

[0209] 16 Inner needle cap

[0210] 17 Outer pin cap

[0211] 18 Protective Helmet

[0212] 20 Piston Rod

[0213] 21 Support components

[0214] 22 Threaded Section

[0215] 23 Pressure feet

[0216] 25 cylinder

[0217] 26. Seals

[0218] 27. Pharmacology

[0219] 28 sockets

[0220] 30 Injection Device

[0221] 32. Shell

[0222] 33 tags

[0223] 34 Drive mechanism

[0224] 36 end face

[0225] 64 strokes

[0226] 65 external electronic device

[0227] 66 communication link

[0228] 70 dial extension

[0229] 71 sleeve

[0230] 80 digital sleeve

[0231] 81 recess

[0232] 90 adapter

[0233] 92 extension

[0234] 100 first component

[0235] 106 end face

[0236] 110 receiving portion

[0237] 112 side wall

[0238] 115 curved section

[0239] 117 raised section

[0240] 118 aperture

[0241] 120 aperture

[0242] 122 abutment

[0243] 130 toothed section

[0244] 150 cavity

[0245] 160 spring

[0246] 200 second component

[0247] 206 end face

[0248] 210 receiving portion

[0249] 211 base

[0250] 212 side wall

[0251] 215 tapered section

[0252] 220 opposing abutments

[0253] 230 toothed section

[0254] 300 electronic detector

[0255] 302 battery

[0256] 303 contact surface

[0257] 304 PCB

[0258] 306 processor

[0259] 308 sensor

[0260] 309 surface

[0261] 310 sensor

[0262] 330 code

[0263] 332 rotation code

[0264] 400 gasket

[0265] 420 gasket

[0266] 440 gasket

Claims

1. An injection device (30) for administering a dose of medicament (27), the injection device (1) comprising: - a housing (32) extending in a longitudinal direction and configured to house a cartridge (6) filled with the medicament (27), - a drive mechanism (34) configured to operably engage with the cartridge (6) to dispense the dose of medicament (27), - a first component (100) movable relative to the housing (32) in the longitudinal direction between an initial position and a triggered position for dispensing the dose of medicament (27), - a second component (200) rotatable relative to the housing (32) for at least one of setting of the dose and dispensing of the dose, - a cavity (150) provided in or formed by at least one of the first component (100) and the second component (200), the cavity (150) being dimensioned to house an electronic detector (300), wherein one of the first component (100) and the second component (200) is configured for attaching the electronic detector (300), the electronic detector (300) being configured to identify a code (330) provided on the other of the first component (100) and the second component (200) to quantitatively measure a degree of relative rotation between the first component (100) and the second component (200), - at least a first gasket (400) fastened to one of the housing (32), the first component (100) and the second component (200) and configured to seal the cavity (150) against ingress of impurities at least when the first component (100) is in the initial position, - wherein the at least first gasket (400) is separated from the other two of the housing (32), the first component (100) and the second component (200) when the first component (100) is in the triggered position.

2. The injection device (30) according to claim 1, wherein the second component (200) is rotatable relative to the first component (100) during at least one of setting of the dose and dispensing of the dose.

3. The injection device (30) according to claim 1 or 2, wherein the code (330) comprises a rotational encoding (332).

4. The injection device (30) according to claim 1 or 2, wherein the first component (100) is movable relative to the second component (200) in the longitudinal direction to the triggered position for dispensing the dose of medicament (27).

5. The injection device (30) according to claim 1 or 2, wherein the first component (100) is biased relative to at least one of the second component (200) and the housing (32) by a return element.

6. The injection device (30) according to claim 1 or 2, wherein the seal provided by the at least first gasket (400) is temporarily cancelled when the first part (100) is moved from the initial position into the triggered position.

7. The injection device (30) according to claim 1 or 2, wherein the seal provided by the at least first gasket (400) is temporarily cancelled during at least one of the setting of the dose and the dispensing of the dose, thereby supporting and allowing a movement of at least one of the first part (100) and the second part (200) relative to the other one of the first part (100) and the second part (200) and / or relative to the housing (32).

8. The injection device (30) according to claim 1 or 2, further comprising the electronic detector (300) fixed to one of the first part (100) and the second part (200) and configured to quantitatively measure the degree of relative rotation between the first part (100) and the second part (200).

9. The injection device (30) according to claim 8, wherein the electronic detector (300) fixed to one of the first part (100) and the second part (200) is configured to interact with the code (330) provided on the other one of the first part (100) and the second part (200).

10. The injection device (30) according to claim 1 or 2, wherein the code (330) comprises a circular or rotational pattern of distinguishable code segments, wherein the code segments are distinguished according to their magnetic, optical, visual, electrostatic, capacitive, acoustic or inductive properties.

11. The injection device (30) according to claim 1 or 2, wherein the at least first gasket (400) is in sealing engagement with at least two of the housing (32), the first part (100) and the second part (200) when the first part is in the initial position.

12. The injection device (30) according to claim 1 or 2, further comprising at least a second gasket (420) fixed to one of the housing (32), the first part (100) and the second part (200) to which the first gasket (400) is not provided, wherein the first gasket (400) and the second gasket (420) are in engagement with each other when the first part (100) is in the initial position, and wherein the first gasket (400) and the second gasket (420) are disengaged from each other when the first part (100) is in the triggered position.

13. The injection device (30) according to claim 1 or 2, wherein the at least first gasket (400) is arranged on one of a proximal end face (36) of the housing (32) and a longitudinal end face (106; 206) of one of the first part (100) and the second part (200), and wherein the at least first gasket (400) is in sealing engagement with the proximal end face (36) and the longitudinal end face (106; 206) when the first part (100) is in the initial position.

14. The injection device (30) according to claim 1 or 2, wherein the first part (100) comprises a first side wall (112), wherein the second part (200) comprises a second side wall (212) at least partially surrounding the first side wall (112), wherein the at least first gasket (400) is fastened to one of the first side wall (112) and the second side wall (212) and faces the other one of the first side wall (112) and the second side wall (212).

15. The injection device (30) according to claim 14, wherein the at least first gasket (400) is attached to one of the first side wall (112) and the second side wall (212) and protrudes towards the other one of the first side wall (112) and the second side wall (212).

16. The injection device (30) according to claim 14, wherein at least one of the first side wall (112) and the second side wall (212) comprises at least one of a tapered section (215), a curved section (115) and a bulged section (117) as seen in longitudinal direction.

17. The injection device (30) according to claim 14, wherein the at least first gasket (400) is in sealing engagement with the first side wall (112) and the second side wall (212) when the first part (100) is in the initial position.

18. The injection device (30) according to claim 14, wherein the at least first gasket (400) is in sealing disengagement with at least one of the first side wall (112) and the second side wall (212) when the first part (100) is in the triggered position.

19. The injection device (30) according to claim 1 or 2, wherein the first part (100) comprises a trigger (11) arranged proximally of the injection device (30) and depressable in a longitudinal distal direction (2) to dispense the dose, and wherein the second part (200) comprises one of a dose dial (12) and a dial extension (70) rotatable relative to the housing (32) to set the dose.

20. The injection device (30) according to claim 1 or 2, wherein at least one of the first part (100) and the second part (200) comprises a cup-shaped receptacle (110, 210) enclosed by the other one of the first part (100) and the second part (200).

21. The injection device (30) according to claim 1 or 2, further comprising the cartridge (6) filled with the medicament (27) and arranged inside the housing (32).

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