Injection device having electronic detector

Abstract

The present disclosure relates to an injection device (30) for administering a dose of a medicament (27), comprising: a housing (32) extending along a longitudinal direction (2, 3) and configured to house a cartridge (6) filled with the medicament (27); a drive mechanism (34) configured to operatively engage the cartridge (6) for dispensing a dose of the medicament (27); a first component (100) movable relative to the housing (32) along the longitudinal direction (2, 3) between an initial position and a trigger position for dispensing a dose of the medicament (27); a second component (200) rotatable relative to the housing (32) for at least one of dose setting and dose dispensing; an injection device (30) comprising: a cavity (150) provided in or formed by at least one of a first component (100) and a second component (200), the cavity (150) being sized to accommodate an electronic detector (300), one of the first component (100) and the second component (200) being configured to have the electronic detector (300) attached thereto, the electronic detector (300) being configured to recognize a code (330) provided on the other of the first component (100) and the second component (200); and 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 the ingress of impurities while at least the first component (100) is in an initial position.

Description

[Technical field]

[0001] The present disclosure relates to the field of drug delivery devices for administering doses of a medicament, in particular to drug delivery devices configured to include and / or cooperate with electronic detectors for obtaining injection-related information during use of the injection device. [Background technology]

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

[0003] Drug delivery devices such as injection or inhalation devices, e.g., pen-type injectors, must meet several user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically frail and may also be visually impaired. Therefore, a suitable drug delivery device, especially intended for home medication, must be robust in construction and easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easily understandable. Such an injection device must provide for the setting of variable-sized drug doses, followed by dispensing. Furthermore, the dose setting procedure as well as the dose dispensing procedure must be easy to operate and clear.

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

[0005] In some drug delivery devices, such as pen injection devices, the user must set equal or variable size doses by rotating a dose dial in a clockwise or dose increment direction relative to the body or housing of the injection device. To inject and expel a dose of liquid medication, the user must depress a trigger or dose button in a distal direction, and thus toward the body or housing of the injection device. Typically, the user can use their thumb to apply distal pressure to the dose dial and the dose button located at the proximal end of the dose dial sleeve, while holding the housing of the injection device with the remaining fingers of the same hand.

[0006] In the case of mechanically implemented injection devices, it is desirable to enable accurate, reliable and semi-automatic management and / or collection of injection-related data during use of the injection device. Mechanically operated injection devices may include electronically implemented add-on or data logging devices configured to monitor user-induced operations of the injection device.

[0007] Some data logging devices can be configured to be attached to the injection device. Some data logging devices can be built into or located on the injection device. Other drug delivery devices can be electronically implemented and thus include an integrated electronic unit configured and operable to monitor the operation of the drug delivery device over time, where the data logging device is provided by the integrated electronic unit.

[0008] Such data logging devices are capable of logging and storing administration details and patient specific data during repeated use of the respective drug delivery device. It is generally desirable to gain access to the respective data stored in the data logging device, e.g., for patient management and / or optimization of long-term treatment. The data logging device may be configured to establish a communication link with an external electronic device. The communication link may be of the wireless or wired type.

[0009] Any type of data logging device suitable for use with a drug delivery device such as a pen injector must quantitatively detect or measure the relative motion of at least two components of the injection device.

[0010] In some injection devices, at least two selected components of the injection device undergo longitudinal and / or rotational movement relative to each other. Such relative movement may occur during setting of a dose of a medicament or during dispensing of the respective dose. In some devices, the user is able to set or select doses of variable size, for example by rotating a dose dial, for example provided at or near the longitudinal proximal end of the injection device. Setting the dose, for example dialing the dose dial, may rotate a number sleeve located inside the housing of the injection device. The number sleeve, typically with a series of numbers indicating the dose, may undergo a rotational and / or helical movement relative to the housing of the injection device.

[0011] The housing of the injection device may include a dosage window in which a portion of the number sleeve is defined. In some examples of injection devices, the number sleeve is part of the dial extension. In this type of injection device, the dial extension and the number sleeve undergo longitudinal displacement relative to the housing or body of the injection device during both dose setting and dose dispensing. In the case of dose setting, dialing the dose dial causes a combined rotational 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 longitudinally proximally relative to the body or housing of the injection device.

[0012] To dispense a dose, many injection devices are provided with a dose button or trigger button at the proximal end of the housing of the injection device or at the proximal end of the dial extension. By depressing the trigger or trigger button in a distal direction, a clutch of a drive mechanism of such an injection device is engaged and / or disengaged from a further component of the drug delivery device, thereby switching the injection device to a dosing mode or configuration. When the user exerts a distal force on the trigger, the dial extension can be returned to its initial position. Such a return movement is accompanied by a respective rotation of the number sleeves.

[0013] In order to quantitatively measure or determine the size of a dose, the amount of relative movement between at least a first component and a second component of the injection device during dose setting and / or dose dispensing must be measured or determined.

[0014] To measure the size of the dose actually set or dispensed by an injection device, e.g. a pen injector, an electronic detector or electronic detection unit can be provided, typically with, e.g., a sensor attached to a first component and a scale or code attached to a second component. During dose setting or dose dispensing, the first component can undergo longitudinal and / or rotational movements relative to the second component. Thus, the electronic sensor and associated code of the electronic detector undergo a measurable movement relative to each other.

[0015] Such electronic detectors can be implemented in many different ways. The sensors of the electronic detectors can include one of the following types of sensors: switches, magnetic sensors, optical sensors, capacitive sensors, acoustic sensors such as microphones, inductive sensors, and many other types of sensors. Some of the commonly available sensor technologies can operate contactless. Generally, the electronic components of such electronic detectors should be protected against environmental influences or hazards. This may be especially true for optically implemented sensors, which require, for example, a very clean environment between the electronic sensor and the corresponding optical code.

[0016] Encasing the electronic sensor inside a cover, envelope or wrap may be detrimental to the sensitivity and accuracy of the measurements made by the electronic detector. The possibility of encasing the entire electronic detector in a cover or wrap is somewhat limited, since the corresponding components of the electronic detector, and thus the electronic sensor and the corresponding code, must be provided on separate, mutually displaceable components, for example of the drive mechanism of the injection device, which undergo a relative movement during dose setting or dose dispensing.

[0017] Particularly for optically implemented electronic sensors, the encapsulation of the optical detector or sensor may involve internal reflection or absorption in the wrap or cover, which may further have an effect on the operation and signal generation of the respective optical sensor.

[0018] There is therefore a need to provide an improved injection device suitable for or equipped with an electronic detector, where, on the one hand, the electronic detector is effectively protected against environmental influences or hazards, and, on the other hand, the protection of the electronic sensor has no or only little impact on the operability, accuracy or long-term stability of the electronic sensor. Summary of the Invention [Problem to be solved by the invention]

[0019] It is therefore an object of the present disclosure to provide an optimal balance between accurate and reliable operation of an electronic sensor and virtually protecting the electronic sensor, particularly against moisture, dust or other impurities. [Means for solving the problem]

[0020] To provide a solution to the above-described shortcomings, in one aspect, there is provided an injection device for administering or dispensing a dose of a medicament. The injection device includes a housing extending along a longitudinal direction. The housing is configured to receive a cartridge filled with a medicament. The injection device further includes a drive mechanism configured to operatively engage the cartridge, typically with a bung of the cartridge, for dispensing the medicament dose.

[0021] The injection device further includes a first component that is movable longitudinally relative to the housing between an initial position and a trigger position for dispensing a dose of a drug. The injection device further includes a second component. The second component is rotatable relative to the housing for at least one of dose setting and dose dispensing. The injection device further includes a cavity. The cavity is provided in or formed by at least one of the first component and the second component. The cavity is sized to accommodate an electronic detector. The cavity is closed or covered by at least one of the first component and the second component.

[0022] One of the first and second components is configured to have an electronic detector attached thereto. The electronic detector is configured to recognize or detect a code provided on the other of the first and second components. At least a first gasket is provided fastened to one of the housing, the first and second components. The gasket is configured to seal the cavity against ingress of impurities at least while the first component is in the initial position.

[0023] The gasket seals the cavity against the environment and effectively prevents the ingress of impurities such as moisture or dust into the cavity in which the electronic detector and the code are located. Thus, as long as the first component is in the initial position and remains there, the cavity is effectively sealed and any impurities around the injection device are effectively prevented from entering the cavity. In this way, the electronic detector, specifically the electronic sensor of the detector as well as the code, can be effectively protected against impurities such as dust or moisture.

[0024] Only when the first component moves from the initial position towards the trigger position to the trigger position, the seal provided by at least the first gasket may be temporarily disabled. Here, it should be taken into account that the injection device is not in use most of the time. The injection device may be stored, for example, in a refrigerated area, and the user of the injection device may use the respective device for a relatively limited time for only one, two or three injections per day. Furthermore, during the injection procedure, the injection device is typically used in a relatively clean, if not sterile, environment. Thus, the total time during which the injection device is typically in use, for example for dose setting and dose administration, is relatively short, compared to the overall shelf life of such an injection device.

[0025] Thus, it is acceptable to disable the sealing of the cavity during dose setting and / or dose dispensing. In the initial position of the first component, the cavity is effectively sealed against the environment by at least the 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 disabled, thereby supporting and enabling 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 inside the cavity. The economical detector is disposed on or secured to one of the first component and the second component. A cord cooperating with the electronic detector is disposed on or secured to the other of the first component and the second component.

[0027] In a typical example, the first component can be implemented as a trigger of the injection device. The first component can be located at a longitudinal proximal end of the injection device. The second component can be implemented as a dose dial rotatably supported at a proximal end of the housing of the injection device, or can be implemented as a component of a dial extension of the injection device. When the injection device includes a dial extension configured to move proximally relative to the housing during a dose increment dose setting operation and to displace distally relative to the housing during and for dose dispensing, both the first component and the second component can be disposed on and / or supported by the dial extension.

[0028] In another example, the first component can be fixed to the housing in the longitudinal direction, but only rotatably movable relative to the housing. Here, the first component can be displaceable relative to the housing and relative to the second component between an initial position and a trigger position. Typically, the trigger position is located distal to the initial position. The first component can be realized by a spring element configured to bias the first component to the initial position. The initial position can be a proximal end position of the first component.

[0029] In some examples, for example when the injection device includes a dial extension, at least a first gasket can be provided between the housing and the second component. In the initial configuration, the gasket can be sandwiched between the second component and the housing in the longitudinal direction. When the second component undergoes a dose increment movement and thus a proximal displacement relative to the housing, the seal provided by the gasket is temporarily disabled. When the second component returns to the initial configuration after dose dispensing, at least the first gasket re-engages with both the housing and the second component.

[0030] According to further examples, the second component is 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 directly correlates to the size of the dose actually set or dispensed. In some examples, the second component is rotatable relative to the housing during at least one of dose setting and dose dispensing. In some examples, the second component undergoes a dose increment rotation relative to the housing and / or relative to the first component when the dose size is increased by dialing the second component along the dose increment direction.

[0031] In some examples, the second component is rotatable relative to the housing during and / or for dose dispensing, and then non-rotatable relative to the housing for or during dose setting, and is thus non-rotatably fixed to the housing.

[0032] During dose dispensing, the second component may undergo rotation along the opposite direction, and thus along the second direction, and thus along the dose decrement direction. Rotation of the second component along the first direction or dose increment direction may be accompanied by a succession of numbers appearing in the dosage window of the housing in ascending order. During dose dispensing, when the second component undergoes rotation along the second direction, and thus along the dose decrement direction, the numbers shown in the dosage window appear in ascending order.

[0033] Because the first and second components are rotatable relative to one another during at least one of dose setting and dose dispensing, an electronic detector provided on and fastened to one of the first and second components and interacting with a code provided on the other of the first and second components can quantitatively measure the degree of relative rotation between the first and second components. In this manner, the relative rotation between the first and second components can be accurately determined and / or measured.

[0034] According to another example, the code provided on one of the first and second components includes a rotary encoding. The code can include a Gray code, for example a circular or rotary pattern of identifiable code sections. The code sections can be identified with respect to magnetic, optical, visual, electrostatic, capacitive, acoustic or inductive properties. The type of identification code section directly correlates to the sensitivity of the electronic sensor. Typically, the rotary encoding can include a circular structure on one of the first and second components, and the electronic sensor is located axially or longitudinally adjacent to the rotary encoding.

[0035] Typically, the electronic sensor is aligned longitudinally with the rotary encoding. In a longitudinal view, the electronic sensor may overlap the position of the rotary encoding. In another example, the rotary encoding is located radially offset from the electronic detector or sensor. The electronic sensor and the rotary encoding may then be located, for example, in a common longitudinal or axial plane extending perpendicular to the longitudinal direction of the housing.

[0036] The rotary encoding may include grayscale encoding. The rotary encoding may be implemented as absolute or relative encoding. In some examples, the rotary encoding may include only two different code sections arranged alternately and adjacently along the perimeter of the rotary encoding. Depending on the number of code sections, an electronic sensor is implemented to detect the degree of rotation that matches the perimeter size of a single code section.

[0037] For example, if the rotary encoding includes 24 code sections spaced equidistantly on each other around the circumference of the rotary encoding, the angular resolution of the electronic detector is approximately 15°. Thus, the electronic sensor interacts with a different distinguishable code section of the rotary encoding every 15° of rotation. The more distinguishable code sections provided in the rotary encoding, the higher the angular resolution of the electronic detector.

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

[0039] According to another example, the first component is movable longitudinally relative to the second component to a trigger position for dispensing a drug dose. In some examples, the first component is also movable longitudinally relative to the housing to a trigger position for dispensing a drug dose. Typically, the trigger position is located distally offset 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] In some other examples, the first component is movable longitudinally proximally relative to the housing and / or relative to the second component from an initial position toward a trigger position, where upon reaching the trigger position the first component can be depressed distally for dose dispensing. Movement from the initial position to the trigger position can then occur during dose setting.

[0041] In some examples, the first component can undergo longitudinal motion relative to both the second component and the housing, for example, during a user-induced dispensing action of the injection device. In some examples, the first component can be biased against the second component and / or against the housing by a return element. The return element can be implemented as a spring or can include a spring mechanically engaged with the first component and mechanically engaged with at least one of the second component and the housing of the injection device.

[0042] The return element, and thus the spring, may be implemented as a so-called trigger spring, which acts by default to move the first component to an initial position, for example when the first component is pressed down, for example by the user's thumb.

[0043] In some examples, where the second component can include or be implemented in or on the dial extension of the injection device, the initial position of the first component can be defined by its relative position with respect to the second component. Here, during dose setting, both the second component and the first component can undergo a common longitudinal displacement, e.g., proximally with respect to the housing. During such dose setting displacement, the first component can remain in the initial position with respect to the second component. The movement of the first component from the initial position to the trigger position can be effected by a longitudinal distal displacement or movement of the first component with respect to the second component. During this movement, the second component can be stationary with respect to the housing or can undergo a distal displacement with respect to the housing.

[0044] According to a further example of the injection device, when the first component is in the initial position, at least the first gasket is in sealing engagement with at least two of the housing, the first component and the second component. The example can include that when the first component is in the initial position, the first gasket is in sealing engagement with the first component and the second component. By shifting or moving the first component to the trigger position, the sealing engagement between the first component and the second component can be defeated. That can also facilitate the movement of the second component relative to the first component, particularly in the course of dose dispensing. Here, the first component can be non-rotatably locked to the housing, or the first component can be in frictional engagement, for example, with the fingers of the user's hand, and the second component undergoes rotation relative to the first component and relative to the housing.

[0045] During dose dispensing, the first component and the second component can undergo a longitudinal displacement relative to the housing. For example, the first component can be constantly or permanently depressed in the distal direction and can be biased against the action of the return element to a trigger position relative to the second component or relative to the housing. During dose dispensing, the first component can be maintained in a trigger position relative to the second component and thus in a depressed position, and both the first and second components undergo a combined or common longitudinal displacement relative to the housing in the distal direction.

[0046] In other examples, the second component can remain stationary relative to the housing during dose dispensing. During and / or for dose dispensing, the first component may have to be moved to and maintained in the trigger position. To interrupt dose dispensing or at the end of dose dispensing, the user can simply release the first component, which is biased or automatically moved under the influence of the return element to the initial position. Moving the first component to the initial position relative to the housing or relative to the second component re-engages the seal between the first and second components by at least the first gasket.

[0047] Here, at least the first gasket also provides a double function. The first gasket serves to seal a cavity formed or constituted by at least one of the first component, the second component and the housing. Insofar as the gasket is engaged with at least two of the first component, the second component and the housing, it also serves to provide a certain frictional engagement between the respective components. In this way, the first gasket also provides a certain frictional engagement or a certain frictional clutch between the respective 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 purely rotationally displaceable relative to the housing, typically with the longitudinal axis of the housing as the axis of rotation. Here, the first component is longitudinally movable relative to both the housing and the second component between an initial position and a trigger position. When the first component is moved longitudinally relative to the housing, it is moved equally relative to the second component. Such an arrangement is particularly applicable to injection devices in which the second component, for example in the form of a dose dial, is longitudinally locked to the housing and cannot move longitudinally relative to the housing. Such injection devices can typically comprise a mechanical energy reservoir, such as a torsion spring, which is operable to provide the driving force required for the drive mechanism to dispense a dose of medicament from the cartridge, for example by providing a respective torque and / or longitudinally directed thrust or pressure to a piston rod operatively engaged with a piston of the cartridge.

[0049] The foregoing examples may also include configurations in which at least the first gasket is sealingly engageable with the housing and one of the first and second components. This may be particularly true for configurations in which a void is formed by at least one of the first and second components, as well as configurations in which the void is sealed by the housing, particularly when the first and / or second components are in an initial or zero dose configuration, i.e., before dose setting or after dose dispensing.

[0050] When the dose is set, the second component can be displaced longitudinally, which causes the housing or body of the injection device to be longitudinally separated from either the first component or the second component. Here, the sealing engagement between the housing and at least one of the first and second components is disabled at the start of the dose setting. During the dose setting, the sealing engagement can remain disabled. The same can be utilized during dose dispensing. At the end of the dose dispensing, i.e., when the injection device or the drive mechanism reaches the zero dose configuration, at least the first gasket can be in sealing engagement with the housing and at least one of the first and second components.

[0051] Generally, at least the first gasket serves to provide a frictional engagement between the first and second components as long as the first component is in an initial position relative to the second component. The first component can be non-rotatably locked to the housing. The second component can undergo rotation for dialing or dose setting. During dose setting, the first component can remain stationary relative to the housing. In some instances, the first component can also rotate together with the second component. However, during dose dispensing, the first component is typically depressed distally in a longitudinal direction with the user's thumb, which brings the first component to a trigger position relative to the second component.

[0052] As a result, the clutch of the drive mechanism is switched and the drive mechanism is set to a dispensing mode. The longitudinal displacement of the first component relative to the second component also causes the sealing engagement between the first and second components to be defeated by the longitudinal displacement of the gasket relative to one of the first and second components. By defeating 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 a configuration in which the first and second components are sealingly engaged by at least the first gasket.

[0053] According to another example, at least a first gasket is fastened to one of the housing, the first component and the second component. When the first component is in the trigger position, the at least first gasket is disengaged from the other two of the housing, the first component and the second component. Typically, when the first component is in the initial position, the at least first gasket is in sealing engagement with at least one of the other two of the housing, the first component and the second component. In this way, the cavity is effectively sealed against the ingress of impurities as long as at least the first component is in the initial position. The first component can then be displaced or moved to the trigger position to disable the sealing engagement between one of the housing, the first component or the second component and the other two of the housing, the first component and the second component.

[0054] For example, the first gasket, when fastened or secured to the first component, may be in sealing engagement with the housing and / or the second component so long as the first component is in the initial position. Movement of the first component relative to the housing and / or relative to the second component to a trigger position may correspondingly move the first gasket relative to the second component and / or relative to the housing, respectively. Such combined longitudinal displacement of the first component and gasket may result in the inability to engage sealingly between at least the first gasket and at least one of the second component and the housing.

[0055] In other examples where the first gasket is fastened to the second component or the housing, the first gasket is in sealing engagement with the first component as long as the first component is in an initial position relative to the second component or relative to the housing. Then, when the first component is moved relative to the second component and / or the housing to a trigger position, the sealing engagement between the housing and the first and / or second component is at least temporarily disabled. When the second component is moved relative to the housing, e.g. during dose setting, and thus both the first and second components can be displaced proximally relative to the housing in the longitudinal direction, the sealing engagement is already disabled.

[0056] According to a further example, the injection device includes at least a second gasket. When the first gasket is fastened or attached to one of the housing, the first component, and the second component, the at least second gasket is fastened to another one of the housing, the first component, and the second component. In other words, the at least second gasket is fastened to one of the housing, the first component, and the second component that does not include the first gasket. Typically, when the first component is in the initial position, the first gasket and the second gasket are engaged with each other. When the first component is in the trigger 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 the initial position of the first component, the first gasket and the second gasket are mechanically engaged. The first gasket and the second gasket may be in longitudinal or radial abutment with respect to the extension of the housing. By shifting or moving the first component to the trigger position, the mutual engagement of the first gasket and the second gasket is nullified. In this way, the seal provided by the mutual engagement of the first gasket and the second gasket is at least temporarily nullified, and the first component can be mechanically decoupled from the second component. This can facilitate dose dispensing, and the second component can rotate 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 the proximal end surface of the housing and the longitudinal end surface of one of the first and second components. The longitudinal end surface can be implemented as a proximal end surface or a distal end surface. When provided by the first component, the longitudinal end surface is typically implemented as a distal end surface to engage with the proximal end surface of the housing. When provided by the second component, the longitudinal end surface is typically implemented as a distal end surface to engage with the proximal end surface of the housing or as a proximal end surface to engage with the first component. When the first component is in the initial position, at least the first gasket is in sealing engagement with the proximal and distal end surfaces. The same may be true when the second component is in the initial position. Here, at least a first gasket can be disposed in an axial or longitudinal gap between a proximal end surface of the housing and a distal end surface of at least one of the first component and the second component.

[0059] The proximal end face can be located at a longitudinal proximal end of the housing. In some examples, the proximal end face is located distally from the proximal end of the housing, but faces in a proximal direction. The same may be true for the distal end face of at least one of the first and second components. The distal end face can be provided at a respective distal end of at least one of the first and second components. In some examples, the distal end face can be located proximally from the distal end of the respective first or second component. In that case, the distal end face faces distally and is configured to be in sealing engagement or sealing abutment with the proximal end face. Here, at least a first gasket is disposed between the distal end face and the proximal end face. The at least a first gasket can seal a gap between the distal end face and the proximal end face.

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

[0061] At least the first gasket faces the other of the first sidewall and the second sidewall. In some examples, the first sidewall is tubular. The second sidewall is also tubular. The second sidewall can generally surround the first sidewall. The first component and the second component can be longitudinally nested or interdigitated. The first sidewall can be in sliding engagement with the second sidewall. For example, the first component can be slidably supported within, on, or by the second component. Here, the outer surface of the first sidewall can be in sliding engagement with the inner surface of the second sidewall. In this way, the first component can be longitudinally guided within or by the second component.

[0062] The gap between the first and second sidewalls can be substantially closed or sealed by disposing at least the first gasket between the first and second sidewalls. In some examples, the at least the first gasket is fixed or fastened to an outer surface of the first sidewall. When the first component is in the initial position, the at least the first gasket is in sealing engagement with an inner surface of the second sidewall. By moving the first component longitudinally relative to the second component and by shifting the first component to the trigger position, the at least the first gasket is moved relative to the second sidewall such that the at least the first gasket is substantially disengaged from the second sidewall. This can be accomplished by moving the first gasket into a longitudinal section or region of the second sidewall that is characterized by an enlarged inner diameter.

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

[0064] In some examples, at least one of the first and second components includes a cup-shaped receptacle, and the cup-shaped receptacle is substantially closed by the other of the first and second components. The cup-shaped receptacle of at least one of the first and second components can be substantially provided with a cavity to receive or accommodate the electronic detector and the corresponding code. In some examples, both the first and second components each include a cup-shaped receptacle. For example, the receptacle of the second component is open toward the proximal direction. The cup-shaped receptacle of the first component is open toward the distal direction. Here, both the first and second components can be complementary to each other to form a cavity for the electronic detector and the corresponding code.

[0065] According to further examples, at least a first gasket is attached to one of the first sidewall and the second sidewall. The first gasket protrudes from the respective sidewall toward the other of the first sidewall and the second sidewall. In some examples, the at least a first gasket can protrude radially outward from the first sidewall, for example when attached to the outer surface of the first sidewall. At that time, it can engage with the inner surface of the second sidewall. It can protrude toward the second sidewall. The same or similar configuration can be provided with the at least a first gasket attached to the second sidewall. Here, the first gasket can be attached or secured to the inner surface of the second sidewall and can protrude radially inward toward the first sidewall. A radially inner end of the gasket can engage the outer surface of the first sidewall.

[0066] Here, it is also conceivable that at least a first gasket is attached to the first sidewall and at least a second gasket is attached to the second sidewall. With the first component in the initial position, the first gasket and the second gasket may be engaged in the axial or longitudinal direction. By moving or shifting the first component to the trigger position, the first gasket and the second gasket may be separated from each other along the longitudinal direction. They may be separated in the longitudinal direction, whereby the sealing engagement between the first gasket and the second gasket, and thus between the first sidewall of the first component and the second sidewall of the second component, is nullified.

[0067] According to a further example, at least one of the first and second side walls includes at least one of a tapered section, a curved section, and a raised section in a longitudinal direction. At a location away from the tapered section, the curved section, and the raised section, the first and / or second side wall can include a somewhat tubular or cylindrical shape. By providing at least one of the first and second side walls with a tapered section, a curved section, or a raised section, a respective radial gap between the side wall and a gasket attached to the other of the first or second side wall can be modified by a mutual longitudinal displacement of the first and second components.

[0068] In some examples, when the first component is in the initial position, at least a first gasket provided on one of the first and second side walls can be in sealing engagement with a raised or protruding section on the other of the first and second side walls. The engagement can be defeated by displacing the first component to the trigger position as the raised or protruding section undergoes longitudinal displacement relative to the gasket. The same may be true for an outwardly curved or tapered section of at least one of the first and second side walls.

[0069] Generally, it is sufficient that only one of the first and second side walls includes a radially protruding or radially recessed portion, for example in the form of a tapered, curved or raised section, and the other of the first and second side walls is somewhat straight or of uniform shape 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 sidewall and the second sidewall, such that a cavity provided or formed by the first and second components is effectively sealed and protected against the ingress of impurities.

[0071] According to a further example, when the first component is in the trigger position, at least the first gasket is sealingly disengaged from at least one of the first and second side walls, where the trigger position is defined by a specific position of the first component relative to the second component. In this manner, the sealing engagement provided by at least the first gasket between the first and second side walls can be effectively nullified. As a result, the second side wall, and thus the second component, can be freely rotatable relative to the first component during dose dispensing.

[0072] According to a further example, the first component includes a trigger or trigger button provided at the proximal end of the injection device. The trigger is typically depressible longitudinally distally for dose dispensing. Typically, the trigger is axially engaged or permanently coupled to a clutch of a drive mechanism of the injection device. By depressing the trigger, and thus the first component, distally relative to the housing and / or the second component, the clutch of the drive mechanism is switched to a dispensing mode in which a user-induced distal force applied to the trigger or dial extension of the injection device is transferred or transmitted to a respective distal displacement of the piston rod, which causes the piston of the cartridge to move distally relative to the cartridge barrel, and thus dispensing a dose according to the longitudinal forward movement of the piston rod relative to the cartridge barrel.

[0073] In other implementations of the drive mechanism, mechanical energy stored in the drive mechanism, for example mechanical energy stored in a torsion spring, is released by switching the drive mechanism to a dosing mode to advance the piston rod distally.

[0074] According to another example, the second component includes one of a dose dial and a dial extension. The second component is rotatable relative to the housing for dose setting of the medicament. Depending on the particular implementation of the drive mechanism, the dose dial can be fixed to the housing in the longitudinal direction and is rotatably supported solely on the housing. By rotating the dial extension, for example, clockwise relative to the housing, the dose size can be increased. By rotating the dial extension in the opposite direction, for example, counterclockwise, the dose size can be decreased. During dose dispensing, the dose dial can rotate in a dose decrement direction. In some examples, the dose dial can be stationary relative to the housing during dose dispensing.

[0075] The second component, when implemented as a dial extension, typically undergoes a proximal longitudinal displacement relative to the housing during dose setting, and then a distal longitudinal displacement relative to the housing during dose dispensing. When implemented as a dial extension, the trigger is typically supported on the dial extension and thus also undergoes a respective longitudinal displacement during dose setting and dose dispensing. However, to switch the drive mechanism from the default dose setting mode to the dose dispensing mode, the trigger or trigger button undergoes a specialized distal displacement or distal sliding movement relative to the second component, and thus relative to the dial extension.

[0076] According to another example, an injection device comprises a cartridge filled with a medicament. The cartridge typically comprises a tubular barrel sealed in a proximal direction by a bung. The bung is typically movable inside the barrel along the longitudinal direction of the barrel. The distal end of the barrel or cartridge is typically sealed by a pierceable seal, for example a septum pierceable by a double-ended needle.

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

[0078] In other examples, the injection device is a reusable injection device, where the cartridge is replaceably positionable inside the housing.

[0079] At least the first gasket and / or the at least the second gasket may include an annular structure. The annular structure may be provided as a type of O-ring. The first gasket or the second gasket may include a resilient material, such as a polymeric or elastomeric material. The gasket may include, for example, an epoxy resin or a silicone or a mixture thereof. The first or second gasket may 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 may be attached to the first component, the second component of the housing by a hot melt method, injection molding, or insert molding. The first and / or second gasket may include a foam material, such as a foamed plastic, a foamed rubber, a foamed thermoplastic material, etc. The first and / or second gasket may include a thermosetting material.

[0080] The first and / or second gaskets can be formed as a unit or can be provided as a single piece. In some examples, the first and / or second gaskets can each include a composite gasket featuring at least a first and a second section. The first and / or second gaskets can include a composite clamp or bracket to encapsulate a sidewall of the first or second component, respectively.

[0081] The first or second gasket can be extruded 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 effectively seals the void. The first and / or second gasket can be adhesively or cohesively 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 with 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 defeated by moving the first component relative to at least one of the housing and the second component.

[0083] Generally, the scope of the present disclosure is defined by the contents of the claims. The injection device is not limited to a particular embodiment or example, but includes any combination of elements of the various embodiments or examples. In that case only, the present disclosure encompasses any combination of the claims and any technically feasible combination of the features disclosed in relation to the various examples or embodiments.

[0084] In the present context, the term "distal" or "distal end" refers to the end of the injection device that faces the injection site of a human or animal, whereas the term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest away from the injection site of a human or animal.

[0085] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0086] As described below, drugs or agents may include at least one API or combinations thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0087] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0088] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0089] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue or another naturally occurring residue or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, e.g., the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[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 in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0091] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0092] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0093] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0094] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0095] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0096] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0097] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with crossover binding region orientation.

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

[0099] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0100] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0101] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0102] Those skilled in the art will appreciate that modifications (additions and / or omissions) can be made to the various components, formulations, devices, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0103] It is further apparent to those skilled in the art that various modifications and changes can be made to the present disclosure without departing from the scope of the present disclosure. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of the present disclosure.

[0104] In the following, a number of examples of the injection device and the method of pairing the data logging device with an external electronic device are described in further detail by reference to the drawings. [Brief description of the drawings]

[0105] [Figure 1] FIG. 1 illustrates a schematic diagram of an example of a drug delivery device implemented as an injection device. [Diagram 2] FIG. 2 shows a schematic diagram of a number of components of the drug delivery device of FIG. 1. [Diagram 3] FIG. 2 shows the pen injection device after dose setting. [Figure 4] FIG. 13 shows a further example of a pen injection device after dose setting. [Diagram 5] FIG. 13 shows another example of a pen injector after dose setting and before dose dispensing. [Figure 6] FIG. 2 shows an example of a proximal part of an injection device with the first and second components in an initial position. [Figure 7] FIG. 7 shows the example of FIG. 6 with the first component in a trigger position. [Figure 8] FIG. 13 illustrates another example of a first and second component, with the first component in an initial position. [Figure 9] FIG. 9 shows the example of FIG. 8 with the first component in a trigger position. [Figure 10] FIG. 2 shows another example of a first and second component of an injection device, where the gap between the first and second components is sealable by a first gasket and a second gasket. [Figure 11] FIG. 11 shows the example of FIG. 10 with the first component in a trigger position. [Figure 12] FIG. 13 illustrates another example of a first and second component, with the first component in an initial position. [Figure 13] FIG. 13 shows the example of FIG. 12 with the first component in a trigger position. [Figure 14] FIG. 13 is another example diagram of the first and second components, with the first component in an initial position. [Figure 15] FIG. 15 shows the example of FIG. 14 with the first component in a trigger position. [Figure 16] FIG. 13 illustrates another example of a first and second component, with the first component in an initial position. [Figure 17] FIG. 17 shows the example of FIG. 16 with the first component in a trigger position. [Figure 18] FIG. 13 illustrates another example of a first and second component, with the first component in an initial position. [Figure 19] FIG. 19 shows the example of FIG. 18 with the first component in a trigger position. [Figure 20] FIG. 13 shows another example of the first and second components relative to the housing of the injection device, with the first component in an initial position. [Figure 21] FIG. 21 shows the example of FIG. 20 with the first component in a trigger position. [Figure 22] FIG. 13 illustrates an example where an electron detector is at least partially encapsulated by a gasket or seal. [Figure 23] FIG. 1 illustrates another example of an at least partially encapsulated electron detector. [Figure 24] FIG. 1 illustrates another example of an at least partially encapsulated electron detector. [Diagram 25] FIG. 13 shows a further example of an at least partially encapsulated electron detector. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0106] An example of a drug delivery device 1 for administering a dose of a medication 27 is shown in Figures 1 and 2. The drug delivery device 1 is implemented as an injection device 30. The injection device 30 is a handheld pen-type injector. The injection device 30 can be implemented as a disposable injection device 30. The injection device 30 can include a pre-filled cartridge 6 disposed inside a cartridge holder 14. In the disposable injection device 30, the cartridge holder 14 can be permanently coupled to the body 10 of the housing 32 of the injection device 30.

[0107] In another example, the injection device 30 is a reusable injection device, and the cartridge holder 14 is removably coupled to the body 10 for replacing the empty cartridge 6. At or near the distal end of the housing 32, and thus the distal end of the cartridge holder 14, a socket 28 is provided configured to mount or engage the injection needle 15. The socket 28 may be implemented as a threaded socket, and the injection needle 15 may include a needle hub that is correspondingly threaded for threaded engagement with the socket 28.

[0108] Typically, the injection needle 15 is protected by an inner needle cap 16 and by an outer needle cap 17 and / or protective cap 18. The protective cap 18 is configured to surround and protect a distal section of a housing 32 of the injection device 30. The body 10 may include or form a main housing member configured to accommodate a drive mechanism 34 as shown in FIG. 2. The cartridge holder 14 may be considered a distal housing component of the injection device 30. The cartridge holder 14 may be permanently or releasably coupled to the body 10 or to the main housing member.

[0109] The cartridge 6 comprises a cylindrical or tubular barrel 25, which is sealed in the proximal direction 3 by a bung 7 located inside the barrel 25. The cartridge 6 can be filled with a liquid medicament 27. The bung 7 is displaceable in the distal direction 2 relative to the barrel 25 of the cartridge 6 by a piston rod 20 of a drive mechanism 34. The distal end of the cartridge 6 is sealed by a pierceable seal 26, which is configured as a septum and is pierceable by the proximally directed tip of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is pierced, thereby establishing fluid transfer access to the interior of the cartridge 6.

[0110] When the injection device 1 is configured to administer, for example, human insulin, the dosage set by a 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 bioequivalent to approximately 45.5 μg (1 / 22 mg) of pure crystalline insulin). The dose dial 12 can comprise a sleeve-shaped knob at the proximal end of the housing 32 of the injection device 30.

[0111] As further shown in Figures 1 and 2, the body 10 includes a dosage window 13, which may be in the form of an opening in the body 10. The dosage window 13 allows a user to view a limited portion of the number sleeve 80. The number sleeve 80 is configured to move when the dose dial 12 is turned. The number sleeve 80 and dosage window 13 provide a visual indication of the currently set dose. The dose dial 12 may rotate on a helical path relative to the body 10 when turned during dose setting and / or during dosing or expelling.

[0112] The injection device 30 can be configured to provide acoustic feedback to the user with a mechanical click sound when the dosage knob 12 is turned. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is inserted into the patient's skin area and the trigger 11 or injection button is pressed, the insulin dose displayed in the dosage window 13 is ejected from the injection device 1. When the needle 15 of the injection device 1 remains on the skin area for a period of time after the trigger 11 is pressed, a majority of the dose is actually injected into the patient's body. The ejection of the insulin dose can also generate a mechanical click sound. However, the sound is different from the sound produced when using the dose dial 12.

[0113] In the illustrated embodiment, during delivery of an insulin dose, the dose dial 12 returns to its initial position with axial movement, i.e., without rotation, and the number sleeve 80 rotates back to its initial position, e.g., to display a dose of zero units.

[0114] The injection device 30 can be used for multiple injection processes until the cartridge 6 is empty or the expiration date of the medication in the injection device 1 is reached (eg 28 days after first use).

[0115] At least some components of an example of the drive mechanism 34 are shown in more detail in FIG. 2. The drive mechanism 34 includes a number of mechanically interacting components. A flange-like support of the housing 32 includes a threaded axial through-bore that is threadedly engaged with the thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a bearing 21 on which a presser 23 is free to rotate about the longitudinal axis of the piston rod 20. The presser 23 is configured to axially abut a proximally facing thrust receiving surface of the bung 7 of the cartridge 6. During a dosing operation, the piston rod 20 rotates relative to the housing 32 and in so doing is moved forward in a distal direction relative to the housing 32 and thus relative to the barrel 25 of the cartridge 6. As a result, the bung 7 of the cartridge 6 is displaced in the distal direction 2 by a well-defined distance due to the threaded engagement of the piston rod 20 with the housing 32.

[0116] Further, a dose dial sleeve, also indicated as number sleeve 80, is provided. The number sleeve 80 is located radially inside the housing 32. An outer surface of the number sleeve 80 is provided with a helical groove 81. The body 10 is provided with a dosage window 13 through which a portion of the outer surface of the number sleeve 80 is visible. The body 10 further includes a helical rib on an inner sidewall portion, which is to be seated in the helical groove 81 of the number sleeve 80. The helical rib is fixed to the body 10. The rib may be integrally formed with the body 10. The body 10 may be provided with first and second stops to limit a dose setting procedure during which the number sleeve 80 moves in a helical rotation relative to the housing 32.

[0117] A dose dial 12 in the form of a dose dial grip is disposed on the exterior 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 to the number sleeve 80 to prevent relative movement therebetween. The dose dial 12 includes a central opening.

[0118] The trigger 11, also indicated as a dose button, is substantially T-shaped. The trigger 11 is provided at the proximal end of the injection device 10. The stem 64 of the trigger 11 extends through an opening in the dose dial 12. The stem 64, and therefore the trigger 11, is held in a restricted axial movement relative to the number sleeve 80. The head of the trigger 11 is generally circular. A side wall or skirt of the trigger extends from the periphery of the head and is further adapted to be seated in a proximally accessible annular recess of the dose dial 12. Typically, the trigger 11 is axially or longitudinally engaged with a clutch 90 by which the drive mechanism can be switched 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.

[0119] To dial in a dose, the user rotates the dose dial 12 along the dose increment direction 4, e.g., clockwise. Dialing in a dose may be accompanied by a clicking sound. In this manner, audible and / or tactile feedback of dialing in a dose is provided. Dialing in a dose may also be accompanied by rotation of the number sleeve 80, which begins to extend from the body 10 in the proximal direction 3 when dialing in the dose increment direction 4, e.g., clockwise.

[0120] The number sleeve 80, dose dial 12 and trigger may form part of the dial extension 70, and thus an assembly of components of the drive mechanism 34, that begins to extend or displace from the proximal end of the body 10 as the dose is dialed. During dose dispensing, thus when a user depresses the trigger 11 in the distal direction 2, the dial extension 70 undergoes movement distally relative to the body 10, and thus along the distal direction 2. During such a dispensing action, the number sleeve 80 undergoes a rotation, e.g., counterclockwise, along the dose decrement direction 5.

[0121] The ejection mechanism or drive mechanism 34 as described above is merely illustrative of one of a number of different configurations of drive mechanisms that may be implemented in a generally disposable or reusable pen injector. Drive mechanisms as described above are described in more detail, for example, in WO2004 / 078239A1, WO2004 / 078240A1 or WO2004 / 078241A1, which are incorporated herein by reference.

[0122] The pen injection device 30, as shown in FIG. 3, includes a housing 32, characterized by a proximal housing component, designated as the body 10, and a distal housing component, designated as the cartridge holder 14. The drive mechanism 34, the details of which are not shown in further detail here, includes a dial extension 70. The dial extension 70 undergoes a proximal displacement relative to the body 10 during the course of dose setting. The dial extension 70 undergoes a distal displacement during dose dispensing. The dial extension 70 includes a dose dial 12 that is rotatable relative to the body 10 for dose setting. The dose size typically appears in a dosage window 13. A number sleeve 80 may partially constitute or form a part of the dial extension 70. Numbers provided on the outer surface of the number sleeve 80 are visible on the portion of the dial extension 70 that proximally projects from the proximal end of the body 10 when a dose of a particular size has been set.

[0123] To dispense a dose, the user must depress the injection button 11 located at the proximal end of the dial extension 70 .

[0124] Another example of injection device 30, as shown in Figure 4, is very similar to, and therefore equivalent to, the example shown in Figure 3. Here, dial extension 70 includes a sleeve 71 that begins to protrude proximally from body 10 as a dose is set by dial setting of dose dial 12. Again, dial extension 70 undergoes movement in proximal direction 3 as the dose size being set increases. During dispensing of a dose, initiated by depressing trigger 11 in distal direction 2, dial extension 70 is biased back into body 10.

[0125] In the example of Figures 3 and 4, the driving force leading to the distal forward movement of the piston rod 20 relative to the body 10 and relative to the cartridge 6 is provided by a user urging the dial extension 70 from the dose setting position shown in Figures 3 and 4 to an initial configuration, for example as will be apparent from Figure 1.

[0126] In a further example of an injection device 30 as shown in Fig. 5, the driving force for moving the piston rod 20 in the distal direction 2 can be provided by a mechanical energy store provided inside the body 10. The mechanical energy store can include a torsion spring. An example of such a driving mechanism is shown in WO2014 / 033195A1, which document is incorporated herein by reference.

[0127] Dialing or dose setting is performed by rotating the dose dial 12 relative to the body 10. As shown in FIG. 5, a dose of a particular size is set and a number indicating the respective dose size appears in the dose window 13. The dose window 13 can be a fixed window provided in the body 10 or a movable window that is longitudinally displaceable in the opening 8. The movable dose window 13 can be provided by a gauge element that is non-rotatably locked relative to the body 10 and longitudinally displaceable. In the examples of FIGS. 3 and 4, the number sleeve 80 is threadedly engaged with the body 10, while the number sleeve 80 in the example of FIG. 5 can be longitudinally or axially locked to the body 10.

[0128] In the example of multiple injection device 30 as shown in Figs. 3-5, the dose dial 12 serves as a second component 200 rotatable relative to the housing 32 and relative to the body 10 for dose setting and / or dose dispensing. The trigger 11 or trigger button is movable relative to the housing 32 or body 10 or relative to the second component 200 to switch the injection device 30 from a dose setting mode to a dose dispensing mode. Typically, the first component 100 or trigger 11 is displaceable from a proximal initial position to a distal trigger position, as is evident from a comparison of Figs. 6 and 7. To that end, the first component 100 is biased towards the proximal direction 3 by a return element, for example in the form of a spring 160.

[0129] In some examples of the injection device 30, the second component 200 undergoes rotation relative to the first component 100 during dose setting and / or dose dispensing. To detect and quantitatively measure 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 or both of the first component 100 and the second component 200.

[0130] The electronic detector 300 includes 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 to the other of the first component 100 and the second component 200. In the example as shown in Figures 6 to 15, the electronic detector 300 with at least one electronic sensor 308, 310 is attached and / or fixed to the first component 100. The code 330, for example implemented as a rotary coding 332, is provided or fixed to the second component 200.

[0131] 6, a first component 100 is slidably engaged along a longitudinal direction with a second component 200. A spring 160 is provided that acts between the first component 100 and the second component 200.

[0132] One end of the spring 160, typically implemented as a longitudinally extending compression spring, abuts longitudinally with a distally facing abutment or abutment surface 122 of the first component 100. The opposite end of the spring 160 abuts with a proximally facing mating abutment 220 of the second component 200. The mating abutment 220 may be provided at the bottom of a cup-shaped receptacle 210 provided or formed by the second component 200.

[0133] 6, the bottom 211 of the second component 200 comprises a code 330, for example implemented as an annular rotary coding 332. The rotary coding 332 faces in the proximal direction 3. The first component 100 comprises a receptacle 110 having a side wall 112 open towards the distal direction 2, and the second component 200 comprises a cup-shaped receptacle 210 open towards the proximal direction. The receptacle 210 is delimited by a tubular side wall 212, which can be slidably engaged with a complementary tubular side wall 112 of the first component 100.

[0134] 6, the first component includes a cup-shaped receptacle 110 that is bounded in a proximal direction 3 by a proximal end face 106 and by a tubular side wall 112. Towards a distal direction 2, the receptacle 110 includes at least two distally facing openings 118, 120 that are aligned with respective first and second electronic sensors 308, 310 of the electronic detector 300.

[0135] As shown in Fig. 6, the electronic detector 300 is disposed inside the cup-shaped receptacle 110. The electronic detector 300 is fixed to the first component 100. The sensors 308, 310 are longitudinally aligned with the openings 118, 120 of the first component 100. They face the rotary coding 332. When the first component 100 undergoes a rotation relative to the longitudinal axis of the injection device 30 as the rotation axis, the electronic detector 300 rotates relative to the code 330 and relative to the rotary coding 332, respectively.

[0136] Since the rotary coding 332 is coded in the circumferential direction, each sensor 308, 310 is operable to detect and quantitatively measure the degree of rotation of the first component 100 relative to the second component 200. The relative rotation between the first component 100 and the second component 200 is typically performed when the first component 100 is pushed down in the distal direction 2 relative to the second component 200 as shown in FIG. 7. Here, the spring 160 is compressed and the first component 100, which is in axial or longitudinal contact with the clutch 90 via the extension 92, acts to displace or move the clutch 90 relative to the housing 32 or body 10 of the injection device 30, thereby switching the drive mechanism 34 to a dose dispensing mode.

[0137] As shown in Figures 6 and 7, the abutment portion 122 or the bottom of the first component 100 abuts longitudinally with the longitudinal extension 92 of the clutch 90. By moving the first component 100 from an initial position as shown in Figure 6 to a trigger position as shown in Figure 7, the clutch 90 is correspondingly moved distally relative to the second component 200 and / or relative to the body 10 or housing 32 of the injection device 30. The movement of the clutch 90 switches the drive mechanism from a default dose setting mode to a dose dispensing mode.

[0138] At the same time, longitudinal displacement of the first component 100 relative to the second component 200 or relative to the housing 32 can activate the electronic detector 300. Additionally, a switch or some other type of activation mechanism can be provided for the electronic detector 300 to set the electronic detector in an activated mode. The electronic detector 300 typically comprises a printed circuit board 304 on which at least a processor 306 and electronic sensors 308, 310 are located. The electronic detector 300 further comprises a battery 302.

[0139] Of course, the electronic detector 300 may further comprise an electronic storage device 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 may further comprise a clock oscillator for providing time information for storing the injection-related data in the electronic storage device. The electronic detector may further comprise a communication module, typically implemented as a wireless communication module. The communication module is typically configured and operable to establish a communication link with an external electronic device, such as a smartphone, a tablet computer, a smart watch or any other type of electronic mobile or fixed device. In the communication module, the data captured by the electronic detector 300 may be shared with other electronic devices for data analysis.

[0140] As shown in Figures 6 and 7, the arrangement of the first component 100 and the second component provides and forms a cavity 150 in which the electronic detector 300 and corresponding code 330 are located and disposed. Since the first component 100 must be movable relative to the second component 200, the ingress of impurities cannot be completely avoided due to the requirement that the first component 100 and the second component 200 must move smoothly relative to each other during dose setting or dose dispensing.

[0141] Therefore, to allow smooth or relative displacement between the first component 100 and the second component 200, a gap of a predetermined size is always provided between the side wall 212 of the second component and the side wall 112 of the first component 100.

[0142] In the example shown in Figures 8 and 9, at least a first gasket 400 is provided at the interface between the first component 100 and the second component 200. In the configuration of Figure 8, where the first component 100 is in an initial position relative to the second component 200, the first component 100, specifically the side wall 112 of the first component 100, is in sealing engagement with the first gasket 400, where 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.

[0143] As is further apparent from Figures 8 and 9, sidewall 112 of first component 100 includes a radially outwardly extending raised section 117 near its distal end. In an initial position as shown in Figure 8, outwardly extending raised section 117 is in mechanical engagement with at least first gasket 400. In this manner, cavity 150 formed or provided by first component 100 and second component 200 is effectively sealed against the ingress of external impurities.

[0144] When the first component 100 is moved or depressed relative to the second component 200 in the distal direction 2 against the action of the return spring 160 as shown in Figure 9, the outwardly ridged portion 117 is displaced distally from at least the first gasket 400. In this manner, the ridged portion 117 of the sidewall 112 of the first component 100 is decoupled from the first gasket 400. The mechanical decoupling between the sidewall 112 and the gasket 400 enables and assists in smooth and low-friction or even frictionless rotation of the second component 200 relative to the first component 100 during the course of dose dispensing.

[0145] It should be noted that even though the seal between first component 100 and second component 200 is temporarily defeated upon disengagement of sidewall 112 from gasket 400, such defeat of the seal in cavity 150 occurs only for a relatively limited period of time, i.e., exclusively during dose dispensing. At the end of the dose dispensing procedure, typically when there is no longer any distal thrust exerted on first component 100 by the user, spring 160 acts to move first component 100 back to its initial position as shown in FIG. 8 where the seal between sidewall 112 and sidewall 212 is re-established.

[0146] In the example of Fig. 10 and Fig. 11, a second gasket 420 is provided at the interface between the first component 100 and the second component 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 portion of the longitudinal direction of the side wall 112 is generally surrounded by the second side wall 212, the second gasket 420 protruding radially outward on the side wall 112 can abut or engage longitudinally or axially with the first gasket 400 provided on the side wall 212 of the second component 200. As shown in Fig. 10 and Fig. 11, the first gasket 400 is provided on the radially inward portion of the side wall 212, and the second gasket 420 is provided on the radially outward portion of the side wall 112. In the initial position of the first component 100 relative to the second component 200, the first and second gaskets 400, 420 abut axially or longitudinally, thereby effectively sealing the cavity 150 provided or defined by the cup-shaped receptacles 110, 210 of the first and second components 100, 200, respectively.

[0147] 10, when the first component 100 undergoes a distal displacement, e.g., a distal sliding displacement relative to the second component 200, the first gasket 400 and the second gasket 420 are longitudinally separated from each other. In this manner, the first gasket 400 and the second gasket 420 are disengaged. Such disengagement is sufficient to allow and support rotation of the second component 200 relative to the housing 32 and / or relative to the first component 100.

[0148] 12 and 13, the electronic detector 300, and specifically the printed circuit board PCB 304 of the electronic detector 300, protrudes at least slightly radially outward from the side wall 112. Here, the printed circuit board 304 can also serve as a sort of distal closure for the cup-shaped receptacle 110 of the first component 100. However, the associated electronic components of the PCB 304, i.e., the sensors 308, 310, are located on the distally facing surface of the PCB 304.

[0149] In some examples, the PCB 304 may only traverse the sidewall 112 and may project radially outward from the sidewall 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 a first gasket 400, which is provided on and secured to the sidewall 212 of the second component 200. When the first component 100 and the PCB 304 secured thereto undergo a distal displacement as shown in FIG. 13, the sealing engagement between the PCB 304 and the first gasket 400 is defeated, thereby allowing rotation of the second component 200 relative to the first component 100, at least during dose dispensing.

[0150] In a further example as shown in Figs. 14 and 15, a first gasket 400 is attached and secured to a first sidewall 112 of a first component 100, where the sidewall 212 of the second component 200 includes a tapered section 215. The tapered section 215 includes an inner diameter that gradually decreases in a proximal direction 3. In an initial position of the first component 100 relative to the second component 200 as shown in Fig. 14, the first gasket 400 is radially sandwiched between an outer surface of the first sidewall 112 and an inner surface of the second sidewall 212. As the first component 100 undergoes a distal displacement relative to the second component 200 in the distal direction 2 toward a trigger position as shown in Fig. 15, the first gasket 400 begins to slide along the radially expanding tapered section 215 of the second sidewall 212. 15, the first gasket 400 can disengage from the second sidewall 212. As a result, the second component 200 can freely rotate relative to the housing 32 and / or relative to the first component 100, for example, during dose dispensing.

[0151] In a further example, as shown in Figures 16 and 17, the first gasket 400 is again provided at or near the proximal end of the second sidewall 212 of the second component 200. Here, the sidewall 112 of the first component 100 includes a radially outwardly extending raised section 117 near the distal end of the first component 100. Proximally adjacent to the raised section 117 is a radially inwardly extending curved section 115, e.g., having a somewhat concave shape. The curved section 115 forms a sort of radial recess in the outer surface of the first sidewall 112.

[0152] In the initial position of the first component 100 as shown in FIG. 16, the raised section 117 abuts the first gasket 400 axially or longitudinally. The cavity 150 is now effectively sealed against the ingress of impurities. As shown in FIG. 17, when the first component 100 undergoes a distal displacement relative to the second component 200, the radially narrowed or recessed curved section 115 is moved in the distal direction 2 into alignment with the first gasket 400. Due to the smaller outer diameter of the curved section 115 compared to the raised section 117, the sealing engagement between the first gasket 400 and the sidewall 112 of the first component 100 is effectively nullified. Thus, smooth rotation of the second component 200 relative to the first component 100 and / or relative to the housing 32 is provided and supported.

[0153] In the examples of Figures 16 and 17, the positions of the electronic detector 300 and the code 330 have been swapped compared to a number of examples such as those described above in connection with Figures 6 to 15. Here, the electronic detector 300 is located on or inside the second component 200, and the code 330 with the rotary coding 332 is provided on the first component 100.

[0154] 18 and 19, another example of the first and second components 100, 200 is shown in schematic form. Here, the second component 200 includes a tubular sidewall 212 and further includes a serrated section 230 configured to engage a correspondingly shaped serrated section 130 of the clutch 90 of the first component 100. The clutch 90 can be permanently and immovably fixed to the first component 100. The clutch 90 and / or the first component 100 can be biased longitudinally by a spring 160. The spring 160 can bias the clutch 90 as well as the first component 100 in the proximal direction 3 such that the serrated section 130 of the clutch 90 engages the serrated section 230 of the second component 200.

[0155] In an initial configuration as shown in Fig. 18 where the serrated sections 130, 230 are engaged with each other, the first component 100 is non-rotatably locked to the second component 200. For dose setting, both the first component 100 and the second component 200 can undergo rotation relative to the housing 32 or body 10 of the injection device 30. During dose setting, the first component 100 and the second component 200 can be non-rotatably locked. They can also be longitudinally locked to each other.

[0156] As shown in Figures 18 and 19, the first component 100 includes a cup-shaped receptacle 110 formed by a tubular sidewall that at least partially surrounds a tubular or cylindrical sidewall 212 at or near the proximal end of the second component 200. The cup-shaped receptacle 110 opens towards a code 330, for example provided on the proximally facing end face 206 of the second component 200. The code 330, implemented for example as a rotary coding 332, faces towards the sensors 308, 310 of the electronic detector 300 attached to the first component 100.

[0157] Again, the cavity 150 configured to house both the electron detector 300 and the corresponding code 330 is sealed against ingress of impurities by a gasket 400 provided on the exterior surface of the second sidewall 212 of the second component 200. In the initial configuration shown in FIG. 18, the gasket 400 is provided in the overlapping section of the first sidewall 112 and the second sidewall 212. The distal end of the first sidewall 112 includes a radially inwardly extending, e.g., annular, protrusion, e.g., in the form of a radially inwardly extending raised section 117, that axially or longitudinally engages the first gasket 400. In this manner, the cavity 150 formed at the interface between the first component 100 and the second component 200 is effectively sealed against ingress of impurities.

[0158] When the first component is depressed or moved to a triggered position as shown in Fig. 19, and when the first component 100 undergoes a distal longitudinal displacement relative to the second component 200 as shown in Fig. 19, the protruding or inwardly bulging section 117 of the first sidewall 112 moves distally away from the gasket 400. At the same time, the serrated section 130 moves out of engagement with and decouples from the correspondingly shaped or complementary serrated section 230, thus defeating the rotational interlock between the first component 100 and the second component 200.

[0159] Here, the second component 200 is allowed to rotate freely relative to the first component for and during dispensing of a drug dose.

[0160] 18 and 19, where the first component 100 has a dual function, the first component 100 together with the second component 200 serves to set a dose by dialing or rotating the first component 100 relative to the housing 32. Additionally, the first component serves as a trigger 11, which can be depressed in the distal direction 2 relative to the second component 200 to initiate dispensing or expelling a dose.

[0161] A further example as shown in Figs. 20 and 21 shows a dial extension 70, where the first component 100 and the second component 200 constitute or form part of the dial extension 70. The dial extension 70, and thus the first component 100 and the second component 200, are longitudinally displaceable together with respect to the housing 32 or the body 10 of the injection device 30. In the initial position of the first component 100 with respect to the housing 32, the first gasket 400 effectively seals the cavity 150, which is provided and delimited by the first component 100, the second component 200 and the housing 32. Again, the first component 100 is axially abutted or permanently connected and fixed to the clutch 90.

[0162] The clutch 90 is biased longitudinally against the second component 200 by a return spring 160. As shown in FIG. 21, the cord 330 is provided on the proximal facing end face 206 of the second component 200, and the electronic detector 300 is located inside the cup-shaped receptacle 110 of the first component 100. The cup-shaped receptacle 100 can be closed by a distal facing end face 106, which is provided with at least one opening 118, 120 to allow uninterrupted interaction between at least one sensor 308, 310 of the electronic detector 300 and the cord 300 provided on the end face 206.

[0163] 20 and 21, the end face 106 is provided with a gasket 400. In an initial position as shown in Fig. 20, the gasket 400 is in axial sealing abutment with the end face 36 of the housing 32. Similarly, the end face 36 may be provided with a gasket 400, which may abut axially or longitudinally with the end face 106 of the first component.

[0164] As shown in FIG. 21, when the first component 100 is moved to the trigger position for dispensing a drug dose, the sealing engagement between the first component 100 and the housing 32 is nullified. Here, unlike the examples described above with respect to FIGS. 6-19, the trigger position of the first component is displaced 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 a user to initiate or trigger dispensing a drug dose. For dose dispensing, the first component 100 is depressed in the distal direction 2, such that the serrated sections 130, 230 of the clutch 90 and the second component 200 are disengaged, similar to that described above with respect to FIG. 19.

[0165] The second component 200 is then free to rotate relative to the first component 100 and relative to the housing 32. Upon release of the first component 100 during dose dispensing or at the end of the dose dispensing procedure, the spring-loaded clutch 90 displaces the first component 100 proximally against the second component 200, thereby re-engaging the correspondingly shaped serrated sections 130, 230 and re-establishing a seal in the cavity 150.

[0166] In many of the examples in Figures 22-25, the electronic detector 300 can be encapsulated by a gasket 440, where the gasket 440 may include a sealing compound or may include some type of potting compound. As shown in Figure 22, the proximal portion of the PCB 304 and the entire battery 302 can be encapsulated by the gasket 440. The sensors 308, 310 as well as the processor 306 can be provided on the distally facing surface of the PCB 304. They may be gasket-free or may protrude distally from the gasket 440.

[0167] 23, only the proximal and peripheral sections of the PCB 304 and the battery 302 are encapsulated in the gasket 440. The proximal contact surface 303 of the battery is free of the gasket 440.

[0168] 24, the gasket 440 surrounds and encloses only the PCB 304. Here, at least some of the electronic components of the electronic detector 300, such as the sensors 308, 310 and / or the processor 306, may be partially surrounded or at least partially encapsulated by the gasket 440. At least the sensing faces or sides 309 of the sensors 308, 310 facing away from the PCB 304 are not covered, remain uncovered, or protrude from the gasket 440.

[0169] 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 to allow unimpeded measurement and detection. [Explanation of symbols]

[0170] 1. Drug Delivery Devices 2 Distal direction 3. First Direction 4. Second Direction 5 Dose decrement direction 6 Cartridges 7 Stopper 8 Fixed Windows 10 Main unit 11 Trigger 12 Dose Dial 13 Dosage window 14 Cartridge holder 15 Syringe needle 16 Inner needle cap 17 Outer needle cap 18 Protective Cap 20 Piston rod 21 Bearing part 22 Threaded Section 23 Press 25 Cylinder 26 Sealing part 27 Drugs 28 Sockets 30 Injection Device 32 Housing 33 Label 34 Drive mechanism 36 End face 64 Stem 65 External Electronic Devices 66 Communication Links 70 Dial extension 71 Sleeve 80 Number Sleeve 81 Groove 90 Clutch 92 Extension 100 First Component 106 End face 110 Receptacle 112 Side wall 115 Curved Section 117 Raised Section 118 Aperture 120 aperture 122 Contact part 130 Serrated Section 150 Vacant Space 160 Spring 200 Second Component 206 End face 210 Receptacle 211 Bottom 212 Side wall 215 Tapered Section 220 Opponent contact part 230 Serrated Section 300 Electron Detector 302 Battery 303 Contact surface 304 PCB 306 Processor 308 Sensors 309 sides 310 Sensors 330 Code 332 Rotary Coding 400 Gasket 420 Gasket 440 Gasket

Claims

1. An injection device (30) for administering a dose of a medicament (27), comprising: a housing (32) extending along a longitudinal direction (2, 3) and configured to receive a cartridge (6) filled with a medicament (27); a drive mechanism (34) configured to operatively engage the cartridge (6) for dispensing a dose of the medicament (27); a first component (100) movable along the longitudinal direction (2, 3) relative to the housing (32) between an initial position and a trigger position for dispensing a dose of a medicament (27); a second component (200) rotatable relative to the housing (32) for at least one of dose setting and dose dispensing; a cavity (150) provided in or formed by at least one of the first component (100) and the second component (200) and sized to accommodate an electronic detector (300), one of the first component (100) and the second component (200) configured to receive the electronic detector (300), the electronic detector (300) configured to recognize 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 the ingress of impurities while at least the first component (100) is in an initial position; Including, The injection device, wherein when the first component (100) is in the trigger position, at least the first gasket (400) is disengaged from the other two of the housing (32), the first component (100) and the second component (200).

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

3. An injection device (30) according to claim 1 or 2, wherein the code (330) comprises a rotary coding (332).

4. An injection device (30) according to any one of claims 1 to 3, wherein the first component (100) is movable along the longitudinal direction (2, 3) relative to the second component (200) to a trigger position for dispensing a dose of a medicament (27).

5. An injection device (30) according to any one of claims 1 to 4, wherein at least the first gasket (400) is in sealing engagement with at least two of the housing (32), the first component (100) and the second component (200) when the first component is in an initial position.

6. 6. The injection device (30) according to any one of claims 1 to 5, further comprising at least a second gasket (420) fastened to the housing (32), the first component (100) and the second component (200) which does not include the first gasket (400), wherein when the first component (100) is in an initial position, the first gasket (400) and the second gasket (420) are engaged with each other, and when the first component (100) is in a trigger position, the first gasket (400) and the second gasket (420) are disengaged from each other.

7. An injection device (30) according to any one of claims 1 to 6, wherein at least a first gasket (400) is provided on one of the proximal end face (36) of the housing (32) and one of the longitudinal end faces (106; 206) of the first component (100) and the second component (200), and when the first component (100) is in an initial position, at least the first gasket (400) is in sealing engagement with the proximal end face (36) and the longitudinal end face (106; 206).

8. The injection device (30) according to any one of claims 1 to 7, wherein the first component (100) comprises a first side wall (112), the second component (200) comprises a second side wall (212) at least partially surrounding the first side wall (112), and at least a first gasket (400) is fastened to one of the first side wall (112) and the second side wall (212) and faces the other of the first side wall (112) and the second side wall (212).

9. 9. The injection device of claim 8, wherein at least the first gasket (400) is attached to one of the first side wall (112) and the second side wall (212) and protrudes toward the other of the first side wall (112) and the second side wall (212).

10. 10. The injection device (30) according to claim 8 or 9, 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 raised section (117) when viewed in the longitudinal direction.

11. An injection device (30) according to any one of claims 8 to 10, wherein when the first component (100) is in an initial position, at least the first gasket (400) is in sealing engagement with the first side wall (112) and the second side wall (212).

12. An injection device according to any one of claims 8 to 10, wherein at least the first gasket (400) is in sealing disengagement from at least one of the first side wall (112) and the second side wall (212) when the first component (100) is in the trigger position.

13. An injection device according to any one of claims 1 to 12, wherein the first component (100) comprises a trigger (11) provided at the proximal end of the injection device (30) and depressable longitudinally distally (2) for dose dispensing, and the second component (200) comprises one of a dose dial (12) and a dial extension (70) rotatable relative to the housing (32) for dose setting.

14. An injection device according to any one of the preceding claims, further comprising a cartridge (6) filled with a medicament (27) and disposed inside the housing (32).

Images