Injection device and detector arrangement

Abstract

To provide an injection device for setting and injecting pre-set or user-selectable doses of a medicament.SOLUTION: An injection device comprises a detector arrangement 150 operable to detect a relative movement between a first element 100 and a second element 200, where the first element is subject to a first movement relative to the second element along a first longitudinal direction 3 for setting of a dose and where the first element is subject to a second movement relative to the second element along a second longitudinal direction 2 for dispensing of the dose. One of the first movement and the second movement is a helical movement and the other one of the first movement and the second movement is a sliding movement in the longitudinal direction. The second element includes at least one reference element 160 fixed to the second element, and the first element includes a tubular-shaped surface having a pattern 104 facing towards the reference element.SELECTED DRAWING: Figure 12

Description

[Technical field]

[0001] The present disclosure relates in one aspect to an injection device, such as a pen injector, for dispensing a preset or user-selectable dose of a medicament. In particular, the present disclosure relates to an injection device that includes a detector apparatus operable to detect or quantitatively measure the size of the dose actually set or dispensed by the injection device. [Background technology]

[0002] As such injection devices for setting and dispensing single or multiple doses of liquid medication are well known in the art. In general, such devices have substantially the same purpose as a conventional syringe.

[0003] Injection devices, especially pen-type injectors, must meet several requirements specific to the user. For example, due to the chronic diseases suffered by the patient, such as diabetes, the patient may be physically frail and may also have visual impairments. Therefore, a suitable injection device, especially intended for home medicines, must be robust in construction and easy to use. Furthermore, the operation and general handling of the device and its components must be straightforward and easily understandable. Moreover, the dose setting and dose dispensing procedures must be easy to operate and clear.

[0004] Typically, such devices include a housing with a specific cartridge holder adapted to receive a cartridge at least partially filled with a medicament to be dispensed. Such devices further include a drive or ejection mechanism, usually having a displaceable piston rod configured to operatively engage with a piston of the cartridge. The drive mechanism and its piston rod are operable to displace the piston of the cartridge in a distal or dispensing direction, thus ejecting a predetermined amount of medicament through a piercing assembly that is to be releasably coupled to the distal end of the housing of the injection device.

[0005] The medicament to be dispensed by the injection device is usually provided and contained in a multi-dose cartridge. Such cartridges usually include a vitreous body sealed distally by a pierceable seal and further sealed proximally by a piston. In a reusable injection device, the empty cartridge can be replaced with a new one. In contrast, a disposable injection device is discarded when the medicament in the cartridge has been dispensed or used up.

[0006] Some injection devices are mechanically and / or manually implemented. Here the user must set the dose by manually activating a dose dial, for example by rotating or sliding the dose dial relative to the housing of the injection device. To dispense or expel the dose, the user must displace the dial and / or the trigger in the opposite direction. There are pen-type injection devices, disclosed for example in US Pat. No. 5,399,433, US Pat. No. 5,499,446, US Pat. No. 5,523,663, and US Pat. No. 5,523,663, which have a dial extension that undergoes a combined rotational and longitudinal displacement in the proximal direction for setting the dose, and a sliding displacement in the opposite longitudinal direction, i.e., in the distal direction, for dispensing or expelling the dose of the medicament. In manually actuated injection devices, the user must apply a driving force to a trigger, for example embodied as a dose button or a trigger button. A driving mechanism usually converts the driving force applied by the user into a distally directed driving movement of a piston rod that is in operative engagement with a piston or stopper of a cartridge filled with the medicament. is operable to convert

[0007] The dial extension, which is an assembly of multiple components of, for example, an injection device, displaceable relative to the housing for at least the purposes of dose setting, typically includes a dose dial rotatable relative to the housing for setting the dose. The dial extension may further include a dose button or trigger button depressible in a distal longitudinal direction of the housing to initiate and / or control dispensing or expulsion of the dose.

[0008] For example, to monitor the use of an injection device for the purposes of investigating patient compliance with a prescribed medication schedule, such an injection device is equipped with a detector apparatus operable to detect at least one point in time when an injection is made and the size of the dose injected or expelled by the injection device. In order to determine or quantitatively measure the size of the dose, at least one of the rotational and longitudinal displacements of at least one component of the injection device relative to another component of the injection device must be detected and / or measured.

[0009] The implementation and embedding of electronic detector devices into manually operable and / or mechanically implemented injection devices is very difficult, especially when the electronic detector device must be retrofitted to an existing injection device. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] WO2004 / 078239A1 [Patent Document 2] WO2004 / 078240A1 [Patent Document 3] WO2004 / 078241A1 Summary of the Invention [Problem to be solved by the invention]

[0011] It is therefore desirable to provide an injection device with an improved detector arrangement that is easily available and can be embedded in a wide variety of different injection devices. The implementation of the detector arrangement should be fairly smooth and limited to minor modifications of only one or a few components of the injection device. Furthermore, the detector arrangement should be fairly cost-effective to implement and require only minimal additional mounting space. [Means for solving the problem]

[0012] In one aspect, the disclosure relates to an injection device for setting and injecting a preset or user-selectable dose of a medicament. The injection device includes an elongated housing defining a longitudinal direction. The elongated housing is configured to accommodate a cartridge. The cartridge includes a medicament. The injection device further includes a detector device operable to detect relative movement between a first element and a second element of the injection device. The first element makes a first movement along a first longitudinal direction relative to the second element for setting the dose. The first element makes a second movement along a second longitudinal direction relative to the second element for dispensing the dose. Wherein one of the first and second movements is a helical movement, i.e., the first element makes a combined longitudinal and rotational movement relative to the second element. The other of the first and second movements is a longitudinal sliding movement. The sliding movement is a longitudinal sliding movement, and the first element is non-rotatably fixed to the second element. Therefore, the sliding motion is not accompanied by rotation.

[0013] Typically, the first longitudinal direction is opposite to the second longitudinal direction. The hand component is opposite to the longitudinal component of the second motion.

[0014] The second element includes at least one reference element. The reference element may be a dedicated part of the second element. The reference element defines a position reference for the first element. The reference element is fixed to the second element. Hence, the reference element is immovable relative to the second element. The reference element is permanently fixed to the second element.

[0015] The first element of the injection device comprises a tubular surface with a pattern. The pattern is oriented towards at least one reference element. The pattern is provided on the tubular surface. The pattern is attached to or integrated into the tubular surface. The pattern is a spatial pattern. The pattern comprises a spatial code and may serve to code the first element.

[0016] The injection device further includes a detector device. The detector device includes at least one electric sensor. The electric sensor is operable to detect a position change of the pattern relative to the reference element. The electric sensor is further operable to generate at least one electric signal, typically a series of electric signals, in response to the position change of the pattern relative to the at least one reference element. Thus, the at least one electric sensor is operable to generate an electric signal in response to the movement during at least one of the first movement and the second movement of the first element relative to the second element.

[0017] At least one electric sensor is disposed on one of the first element and the second element. The at least one electric sensor is operable or configured to directly interact with at least one of the pattern and the reference element. In some examples, the at least one electric sensor is operable to detect and / or determine a direct interaction between the pattern and the reference element. In particular, the at least one electric sensor is operable to detect and / or determine a degree of rotation of the first element relative to the second element when the first element undergoes a helical movement relative to the second element. Furthermore, the at least one electric sensor is configured to detect a non-rotational, purely longitudinal sliding displacement of the first element relative to the second element.

[0018] In some examples, the at least one electrical sensor and the respective detector device may be configured or operable to detect and / or measure longitudinal and rotational displacement of the first element relative to the second element, In some examples, the detector device and the at least one electrical sensor may be operable to detect and / or quantitatively measure rotational and / or longitudinal displacement between the first element and the second element as the first element undergoes a helical movement relative to the second element.

[0019] The detector device and the at least one electrical sensor are configured to simultaneously measure the rotational and longitudinal displacements, thus increasing the detection and measurement accuracy and reducing the detection and / or measurement error rate.

[0020] In a further example, the at least one electric sensor is disposed on the first element or the second element. If the electric sensor is disposed on the second element, the second element can coincide with or constitute a reference element. If the electric sensor is disposed on the first element, the at least one electric sensor is typically electrically connected to the pattern of the first element. In this case, the pattern directly interacts with the reference element of the second element when the first and second elements undergo at least one of a first movement and a second movement in order to detect and / or measure a relative displacement of the first element with respect to the second element.

[0021] At least one electrical sensor, and eventually also the entire detection device, is located on the first element. This allows and supports a fairly easy straight forward and smooth embedding or integration of the reference element into or with a second element, where the reference element can be a passive electronic device or passive electronic structure such as a bridging contact.

[0022] In another example, the first movement of the first element relative to the second element is a helical movement and the second movement is a longitudinal sliding movement of the first element relative to the second element, during which the first element is non-rotatably locked to the second element.

[0023] In some examples of the injection device, the longitudinal displacement of the first element relative to the second element during the first movement is equal in size to the longitudinal displacement of the first element relative to the second element during the second movement.

[0024] Typically, the longitudinal component of the first motion is opposite to the longitudinal component of the second motion: if the first element moves in a proximal longitudinal direction during the first motion, the first element will move in the opposite longitudinal direction, i.e., distal direction, during the second motion.

[0025] Typically, the longitudinal position of the first element relative to the second element before setting a dose is the same as the longitudinal position of the first element relative to the second element after completion of the dose dispensing or dose expelling procedure.

[0026] The rotational position, and therefore the rotational state, of the first element relative to the second element prior to setting a dose may differ from the rotational state or orientation of the first element relative to the second element after completion of a dose dispensing or dose expelling procedure, particularly in situations where the helical motion of the first element relative to the second element involves only a portion of a rotation of the first element relative to the second element or involves a non-integer number of complete rotations.

[0027] In some examples, the detector device and the at least one electrical sensor are operable to detect and / or quantitatively measure at least one of the first and second movements regardless of an initial rotational state or rotational orientation of the first element relative to the second element, and the movement detection can begin and end at any possible, and therefore any, rotational position or rotational orientation of the first element relative to the second element.

[0028] In some examples, the first and second elements are both tubular in shape. The elements can be directly or indirectly mechanically engaged to follow a relative helical movement along the length of one and a relative non-rotational sliding displacement along the length of the other. The first and second elements are nested. One of the first and second elements can at least partially circumferentially or radially surround the other of the first and second elements.

[0029] In some examples, the first element undergoes a helical movement along a longitudinal proximal direction relative to the second element for dose setting. The first element then undergoes a non-rotational sliding displacement along a distal longitudinal direction relative to the second element during dose dispensing. In other examples, the first element is non-rotatably locked for dose setting but is normally axially displaceable along a longitudinal proximal direction relative to the second element. The second element can undergo a helical movement in a distal direction relative to the second element for dose dispensing or ejection.

[0030] In another example, the pattern includes at least a first pattern portion and a second pattern portion. The first and second pattern portions are spatially non-overlapping pattern portions. Thus, the second pattern portion does not overlap with the first pattern portion. The first pattern portion and the second pattern portion are positioned proximate or adjacent to one another on the bare tubular surface such that the first and second pattern portions form a spatial pattern that allows for characterization and / or quantification of at least one of rotational and longitudinal movement of the pattern relative to a reference.

[0031] The at least one electrical sensor is operable to distinguish between the first pattern portion and the second pattern portion, and each time one of the first and second pattern portions passes the at least one electrical sensor, the at least one electrical sensor is operable to generate a processable electrical signal thereby indicating that the pattern is currently moving relative to the reference element.

[0032] In another example, the first and second pattern portions exhibit a difference with respect to at least one of the following parameters: electrical conductivity, optical transmittance, optical reflectance, magnetic susceptibility, or electrical susceptibility. The first and second pattern portions may further exhibit a difference due to their radial position relative to the central axis of the tubular surface. For example, the first and second pattern portions are formed by protrusions or depressions, such as ridges and grooves, on the tubular surface of the first element.

[0033] The at least one electric sensor is implemented according to a characteristic parameter of the first pattern portion and the second pattern portion. If the first and second pattern portions show a difference by their electrical conductivity, the at least one electric sensor can typically measure the electrical conductivity of the pattern and of the respective first and second pattern portions. The at least one electric sensor may include at least one electrical contact tap configured and operable to make electrical contact with only one of the first and second pattern portions at a time. Similarly, if the first and second pattern portions show a difference in terms of light transmittance or light reflectance, the at least one electric sensor typically includes at least one of a light source and a light detector. Typically, the detector device and the at least one electric sensor include a combined light source and a light detector, such as a light emitting diode LED and a photodiode.

[0034] Accordingly, in the case where the first and second pattern portions exhibit a difference due to their magnetic susceptibility or electrical susceptibility, the at least one electric sensor comprises a respective magnetic or dielectric sensor device capable of distinguishing between a first pattern portion and a second pattern portion of the first element pattern, the first and second pattern portions being characterized by different magnetizations.

[0035] In the case where the first and second pattern portions exhibit different radial positions relative to the central axis of the tubular surface, the at least one electrical sensor is implemented as a mechanical or electromechanical switch located at a predetermined radial distance from the central axis, where the first and second pattern portions may exhibit a difference due to their radial height. For example, the first pattern portion may include a depression or groove in the tubular surface, and the second pattern portion may include at least one of a protrusion, a rib, or a ridge protruding radially from the tubular surface of the first element. When at least one of the protrusions or depressions passes by the at least one electrical sensor, the respective electromechanically implemented switch is brought into a conducting or non-conducting state, thereby generating a respective electrical signal that is processed for motion detection and / or for quantitative measurement of the size of at least one of the first and second motions between the first and second elements.

[0036] According to a further example, the longitudinal extension of the pattern is equal to or greater than the maximum longitudinal displacement of the first element relative to the second element. In this way, it is ensured that the first pattern is within and remains within a certain range of the reference element even if the first element undergoes a maximum longitudinal displacement relative to the second element. If the reference element comprises at least one electrical sensor, the pattern and the sensor may be coupled to each other to determine the maximum longitudinal displacement of the first element relative to the second element. The largest possible longitudinal displacement does not result in loss of contact or interaction, in this way at least one of the detector device, the at least one electric sensor and the reference element directly interacts and remains directly interacting with the pattern of the first element for every allowable longitudinal position of the first element relative to the second element.

[0037] According to another example, the pattern includes a first pattern section and a second pattern section. The first pattern section and the second pattern section are arranged on the tubular surface without overlapping. The second pattern section is longitudinally separated from the first pattern section. In other words, the first pattern section can include or form a first longitudinal portion of the pattern, and the second pattern section can include or form a second longitudinal pattern section that does not overlap with the first longitudinal pattern section.

[0038] At least one of the first and second pattern sections includes the first and second pattern portions described above. Both the first and second pattern sections can include at least the first and at least the second pattern portions, respectively.

[0039] For example, a first pattern section can include a first sub-pattern. A second pattern section can include a second sub-pattern. The first and second sub-patterns can be substantially similar. The first and second pattern sections can exhibit significant differences. The first and second pattern sections are typically separated longitudinally by a tubular surface of the first element.

[0040] The first and second pattern sections can serve separate detection purposes. The first pattern section can include a longitudinal extension that is greater than the longitudinal extension of the second pattern section. Furthermore, the second pattern section is provided or located at an axial end of the first pattern section. The second pattern section is surrounded or surrounded by the first pattern section. In some examples, the first pattern section is configured and operable to detect and / or measure rotational movement of the first element relative to the second element. The second pattern section is configured to detect and / or measure longitudinal, and therefore non-rotational, movement of the first element relative to the second element.

[0041] At least one electrical sensor is provided for interacting with at least one of the first pattern section and the second pattern section. At least two electrical sensors are provided, one configured and operable to interact exclusively with the first pattern section and another implemented and configured to interact exclusively with only the second pattern section.

[0042] Typically, the transition from the first pattern section along the longitudinal direction towards the second pattern section is detectable by at least one electrical sensor. In this manner, the interaction between the at least one electrical sensor and the first and second pattern sections may serve to detect a particular longitudinal position of the first element relative to the second element, for example when the first element returns to an initial or end-of-dose configuration relative to the second element upon completion of a dose dispensing or dose expelling procedure.

[0043] In another example, the first pattern section includes a stripe pattern including several parallel oriented longitudinal stripes. The longitudinal stripes extend parallel to the longitudinal direction. Thus, the stripes extend parallel to the central axis of the tubular surface of the first element. In another example, the longitudinal stripes extend parallel to the longitudinal direction. The axial extension extends at a predetermined non-zero angle relative to the axial extension.

[0044] In a stripe pattern comprising several parallel-oriented longitudinal stripes extending parallel to the longitudinal direction, the first pattern section is specifically dedicated and configured to determine and / or measure the rotational movement of the first element relative to the second element. If the longitudinal stripes extend at an angle to the longitudinal direction, in other words if the longitudinal stripes of the first pattern section are oblique or tilted to the central axis, not only the rotational displacement of the pattern and therefore the rotational displacement of the first element relative to the second element is detected and quantitatively measured by at least one electrical sensor, but also the non-rotational longitudinal sliding movement of the first element relative to the second element, e.g. detected and quantitatively measured using just one same electrical sensor.

[0045] The stripe pattern may include multiple stripes of equal or different geometries. The stripes are equiangularly spaced around the circumference of the tubular surface. Depending on the angle encoding, the stripes of the stripe pattern may also be non-uniformly distributed tangentially to the tubular surface. The stripes of the stripe pattern may also include discrete dimensions.

[0046] The position, size, shape and orientation of the stripes of the stripe pattern are highly dependent on the specific encoding scheme implemented. The stripes are determined by the number and location of at least one electrical sensor. In some examples, the number, size, geometry and orientation of the stripes are determined by the number, size and location or orientation of bridging contacts provided on the second element.

[0047] According to a further example, the detector device is operable to detect a longitudinal overlap of the reference element with the first and / or second pattern section, regardless of the rotational state of the first element relative to the second element. Longitudinal overlap means that the reference element and the first and / or second pattern section are at the same longitudinal position. Here, the reference element and the first and / or second pattern section may overlap radially with respect to the tubular shape of the pattern.

[0048] In particular, the detector device and / or the at least one electric sensor are operable to detect a transition from a first pattern section to a second pattern section and vice versa. In other words, the detector device is configured to detect when a first pattern section, which is initially radially overlapping with a reference element, undergoes a longitudinal displacement such that the second pattern section starts to radially overlap with the reference element. The separation or transition of the first and second pattern sections is detectable by the detector device. In this way, the longitudinal or axial end position of the first element relative to the second element is precisely detected, thereby indicating to the detector device, for example, that the dose ejection procedure is completed and that the injection device is in an initial state ready for the subsequent dose setting and dose injection procedures.

[0049] Typically, the detector device is operable and configured to detect a longitudinal sliding displacement of at least one of the first and second pattern sections relative to the reference element, regardless of the rotational state or orientation of the first element relative to the second element. In practice, at least a longitudinal displacement or movement of the first element relative to the second element is detected at any rotational position of the first element relative to the second element. To achieve such detection, the second pattern section may include a pattern or sub-pattern that differs in size and / or geometry from the pattern or sub-pattern of the first pattern section. For example, the second pattern section may be configured to detect a longitudinal sliding or screwing movement of the first element relative to the second element, and a longitudinal sliding or screwing movement of the first element relative to the second element, and a longitudinal sliding or screwing movement of the first element relative to the second element. The rotational orientation of the element may include an annular shape that allows for any possible rotational state or orientation of the element.

[0050] In a further example, the pattern includes at least a first pattern portion that is electrically conductive. The pattern includes at least a second pattern portion that is electrically insulating. Typically, the pattern includes a number of first pattern portions and a number of second pattern portions. For example, the pattern includes a series of conductive portions and a series of electrically insulating portions. The conductive pattern portions are electrically or galvanically separated from each other by the electrically insulating second pattern portion.

[0051] The first and second pattern portions, which are electrically conductive and electrically insulating, respectively, can correspond to and represent the first and second pattern portions of the above patterns which are arranged without overlapping each other and which exhibit differences in terms of their electrical conductivity.

[0052] The first and second pattern portions are alternately arranged along at least one of the first and second movements between the first and second elements. The first and second pattern portions are separated along the circumference or tangential direction of the tubular surface of the first element. The first and second pattern portions are also separated along the longitudinal direction of the tubular surface. The first and second pattern portions may include a stripe pattern in which the alternating stripes exhibit at least two different electrical conductivities. The pattern is not limited to a first pattern section and a second pattern section. A number of different pattern sections are provided, e.g. first, second, third and even more pattern sections, all exhibiting differences from each other in terms of their electrical conductivities. In this way, a higher information density or code density is provided on the tubular surface.

[0053] In some instances, the pattern is provided on an exterior surface of the first element. In other instances, the pattern is provided on an interior surface of the first element.

[0054] The pattern may comprise a binary pattern, with information content provided by at least two pattern portions, a first and a second pattern portion representing a digital 0 or a digital 1, respectively.

[0055] The pattern and at least one electrical sensor are implemented as an incremental or absolute quadrature encoder. The pattern and electrical sensor are implemented as a 2-bit Gray code. Depending on the number of electrical sensors or electrical contact taps and on the particular pattern implementation, other codes are also provided, including a 3-bit encoding, or an n-bit encoding, where n is an integer.

[0056] If the pattern includes a conductive structure, for example if the first pattern portion is conductive, the pattern may include one of a conductive varnish, a conductive lacquer, a conductive coating or a conductive etching. The conductive varnish or conductive lacquer may include conductive particles such as metal particles or carbon black particles. The conductive pattern may also include a metal inlay in or on the tubular surface of the first element. The first element may include a substantially electrically insulating thermoplastic material. In this way, only the conductive pattern portion has to be provided on the electrically insulating material of the first element. The conductive first pattern portion may also include a sheet metal attached to or embedded in the tubular surface of the first element and flush with the tubular surface. At least the first conductive pattern portion is attached to or combined with the tubular surface by insert molding or by two-component injection molding of the first element.

[0057] In a further example, the detector device is disposed on the second element and detects a first part of the pattern when the first element undergoes one of a first movement or a second movement relative to the second element. The at least one electrical contact tap is operable to alternately couple to the turn portion and the second pattern portion. The electrical contact tap is biased radially into frictional engagement with the pattern of the first element. When the pattern is disposed on the outer tubular surface of the first element, the at least one electrical contact tap is biased radially inward. The electrical contact tap is flexible or deformable radially outward by the pattern against an inherent restoring force.

[0058] When the tubular surface is an inner surface, the at least one electrical contact tap is biased radially outward and deformed or bent radially inward against a respective restoring force. The electrical contact tap can be a reference element. Thus, the reference element can include at least one electrical contact tap. The reference element can include multiple electrical contact taps arranged and distributed along the outer or inner circumference of the tubular surface.

[0059] In another example, the pattern includes at least one third pattern portion that is conductive, and the first and third pattern portions are electrically isolated from each other. Hence, the first and third pattern portions are galvanically isolated from each other. The first and third pattern portions are electrically isolated by the second pattern portion that is electrically insulating. Providing at least two different types of conductive pattern portions enables and supports the implementation of an n-bit rotary encoder, where n is an integer equal to or greater than 1. When the first and third pattern portions are electrically distinguishable, they can be individually and / or separately electrically connectable to the detector device during one of the first and second movements, which may enable, for example, a 3-bit rotary encoder.

[0060] In another example, the third pattern portion is permanently electrically connected to a voltage supply source of the detector device. Here, at least one electrical sensor is electrically connected to the first pattern portion. The rotary encoder is completed by a bridging contact provided on the second element. The bridging contact is configured and operable to selectively establish an electrical connection between the third pattern portion and the first pattern portion when the first element undergoes a spiral or rotational movement relative to the second element. In this example, the second element may be devoid of any active electronic components. The second element may include only passive conductive components, such as electrical contact taps or at least one bridging contact.

[0061] In another example, the detector device and the at least one electrical sensor are disposed on the first element. The at least one electrical sensor is electrically connected to the first pattern portion. The at least one reference element is disposed on the second element and includes an electrical bridging contact. The electrical bridging contact is configured to alternately establish and break electrical contact between the first pattern portion and the third pattern portion when the first element undergoes one of a first movement and a second movement relative to the second element.

[0062] Typically, the electrical bridging contact extends tangentially to the tubular shape of the first element. The bridging contact is implemented and operable to establish an electrical contact between the first and third pattern parts, for example, thereby bridging a second pattern part located between the first and third pattern parts and / or separating the first and third pattern parts. This electrical connection between the first and third pattern parts is typically provided when the first element is in a first rotational position or orientation relative to the second element. When the second element rotates further and reaches a second rotational state or orientation, at least one of the first and third pattern parts loses contact with the electrical bridging contact. In this way, the first and third pattern parts are electrically or galvanically separated.

[0063] At least one electrical sensor is electrically connected to the first pattern portion so that when the first element rotates relative to the second element, the electrical contact with the third pattern portion, which changes, is detected by the at least one electrical sensor. Here, the third pattern portion is also electrically connected to the at least one electrical sensor or to another electrical sensor of the detector device. Alternatively, the third pattern portion is permanently connected to a voltage source of the detector device. In a rotational position of the first and second elements in which the first pattern portion is electrically connected to the third pattern portion via at least one electrical bridging contact, a supply voltage is provided to the first element. In the other rotational state in which the first pattern portion is electrically isolated from the third pattern portion, the electrical sensor connected to the first pattern portion detects zero volts.

[0064] The use and implementation of at least one electrical bridge contact is beneficial since the second element is easily adapted for implementation and embedding in the detector device. Here, the geometry of the second element only needs to be slightly modified in order to receive or combine with the at least one electrical bridge contact. To that extent, the second element only needs a passive conductive structure without any active electrical or electronic components.

[0065] In another example, the electrical bridge contact includes a first electrical contact tap and a second electrical contact tap. The first electrical contact tap and the second electrical contact tap are electrically connected. The first electrical contact tap and the second electrical contact tap are spatially separated from each other along a first separation direction that is parallel to a distance between the first pattern portion and the third pattern portion. The magnitude of the spatial separation between the first electrical contact tap and the second electrical contact tap is typically greater than a size or width of at least one of the first pattern portion and the third pattern portion when viewed along the first separation direction.

[0066] Typically, the spatial separation between the first and second electrical contact taps is at least equal to or greater than the size or extension of the second pattern portion located between the first and third pattern portions when viewed along the first separation direction. In this way, it is ensured that at least in a rotational state or orientation of the first element relative to the second element, the first pattern portion is electrically connected to the third pattern portion via an electrical bridging contact, i.e. when the first electrical contact tap is in electrical communication with the first pattern portion and the second electrical contact tap is in electrical communication with the third pattern portion.

[0067] In another example, the first separation direction extends substantially parallel to an imaginary shortest connection between the first and third pattern portions, e.g., if the first and second pattern portions are portions of a striped pattern, the first separation direction extends substantially perpendicular to the longitudinal extension of the stripes of the pattern.

[0068] According to further examples, the electrical bridging contacts include a third electrical contact tap spatially separated from at least one of the first and second electrical contact taps along a second separation direction non-parallel to the first separation direction. In some examples, the second separation direction extends substantially perpendicular to the first separation direction. When the pattern on the first element includes a longitudinal stripe pattern, the first and second electrical contact taps are specifically configured to alternately engage or contact alternating stripes as the first element rotates or spirals relative to the second element.

[0069] Typically, the first and second electrical contact taps are displaceable only relative to the first element within the area of ​​the first pattern section. Further, the first pattern section may be entirely provided with a stripe pattern including at least one first, second, and at least one third pattern portion.

[0070] The third electrical contact tap of the electrical bridge contact is offset from at least one or both of the first and second electrical contact taps along the longitudinal direction. In this way, when the first element undergoes a longitudinal displacement relative to the second element, the third electrical contact tap can reach into or onto the second pattern section. The second pattern section is separated from the first pattern section along the longitudinal direction. The second pattern section can be out of reach of the first and second electrical contact taps of the electrical bridge contacts, but can only be engaged by the third electrical contact tap of the electrical bridge contact. In this way, the interaction of the third electrical bridge contact with the second pattern section can be an indicator of reaching a longitudinal end position, e.g. a zero dose or end dose configuration of the injection device.

[0071] Accordingly, in another example, the third bridging contact is configured to contact the second pattern section when the first and second elements return to their initial relative positions after completion of dose dispensing, such that mutual engagement or contact between the third bridging contact and the second pattern section provides a zero dose indicator, thereby indicating to the detector device that the end of the dose dispensing or expelling procedure has been reached.

[0072] In a further example, the injection device comprises two or more electrical bridge contacts distributed along the tubular circumference of the first element, the two or more electrical bridge contacts being located at the same longitudinal position on the second element, the electrical bridge contacts being equiangularly or equidistantly arranged along the circumference or tangential direction of the tubular surface of the first element.

[0073] Typically, the second element is also tubular in shape. The two or more electric bridge contacts are accordingly separated from one another along the circumference or tangential direction of the tubular second element. The two or more electric bridge contacts are implemented identically. Hence, the first electric bridge contact has the same shape and geometry compared to the second electric bridge contact. The two or more electric bridge contacts are also arranged asymmetrically along the circumference of the second element. Hence, the distance or angular distance between the first and second electric bridge contacts may differ from the distance or angular distance between the second and third electric bridge contacts. The geometric arrangement of the two or more electric bridge contacts is determined by the encoding of the pattern on the first element.

[0074] In another example, the two or more electrical bridging contacts and the first and third pattern portions are arranged such that at any resulting rotational position of the first element relative to the second element, at least one of the first pattern portions is electrically connected to at least one of the third pattern portions via at least one of the bridging contacts. In this way, if at least one third pattern portion is connected to a voltage supply source, at least one of the first pattern portions is at a supply voltage. In this way, a distinct electrical signal is provided for every resulting rotational position of the first element relative to the second element.

[0075] In another example, the electrical bridge contact comprises a body made of sheet metal and further comprising at least one flexible arm. At least one of the first and second electrical contact taps is arranged at or on the free end of the at least one flexible arm. The electrical bridge contact may comprise multiple flexible arms, such as the first flexible arm, the second flexible arm and possibly even a third flexible arm. Typically, the first electrical contact tap is placed at or on the free end of the first flexible arm of the electrical bridge contact. The second electrical contact tap is placed or on the free end of the second flexible arm of the electrical bridge contact. The same may be valid for the optional third electrical contact tap. The third electrical contact tap is also provided and arranged at or on the free end of the third flexible arm of the electrical bridge contact.

[0076] The electrical bridge contact is fixed to or embedded in the second element. For example, the electrical bridge contact is insert molded into or onto the second element, which may comprise an injection molded plastic component. Typically, at least one flexible arm of the electrical bridge contact is radially biased or pre-tensioned toward the tubular surface of the first element. This ensures uninterrupted mechanical contact between the at least one arm and / or between each electrical contact tap and the pattern on the tubular surface.

[0077] At least a first electrical contact tap can protrude from at least a first flexible arm of the electrical bridge contact. The electrical bridge contact can include an embossed dome-shaped or spherical structure integrally formed in the sheet metal and protruding from the flexible arm toward the tubular surface of the first element. The electrical bridge contact is manufactured by metal stamping. The electrical bridge contact can include stainless steel. The electrical contact tap can include a dome-shaped embossed pin of the flexible arm that exhibits a fairly low degree of static or dynamic friction against the pattern.

[0078] The at least one flexible arm may include or form a cantilever member that ensures good radial contact pressure between the pattern and the electrical bridge contact. The preload and / or radial deformation of the at least one flexible arm should be at least within the tolerances of manufacture and / or assembly of the injection device. In this way, possible manufacturing or assembly tolerances are easily compensated for.

[0079] In a further example, the injection device includes at least one cleaning pad disposed in or on the second element at a distance along at least one of the first and second movements from the at least one electrical contact tap. The cleaning pad is typically in frictional engagement with the tubular surface of the first element. The at least one cleaning pad is in mechanical frictional engagement with a portion of the pattern of the tubular surface that is in electrical contact with the at least one electrical contact tap when the first element makes one of the first and second movements relative to the second element.

[0080] In this way, the portion of the tubular surface that is in electrical contact with the at least one electrical contact tap is cleaned. In this way, a fairly long-lasting and reliable electrical contact is established and maintained between the conductive pattern and the at least one electrical contact tap. Furthermore, particles such as dust particles that may accumulate on the tubular surface are wiped off. Their potentially harmful effect on the electrical contact between the at least one electrical contact tap and the conductive pattern is thus reduced. Furthermore, by cleaning the tubular surface, the abrasion or wear induced by the at least one electrical contact tap sliding along the pattern is effectively reduced.

[0081] Typically, in another example, the cleaning pad comprises one of an elastomeric material and a woven material. The cleaning pad faces the pattern. The cleaning pad is configured to frictionally engage with the first element when the first element makes one of a first movement and a second movement relative to the second element. The elastomeric or woven material of the cleaning pad is beneficial for long-lasting and gentle cleaning effect of each cleaning pad. In a further example, the cleaning pad is elastically deformable or pivotable with respect to a longitudinal direction, such as a deformation axis or a pivot axis.

[0082] The cleaning pads, which correspond to the wiper blades of a windshield wiper, may include a tapered or pointed geometry towards the first element. The cleaning pads may further be pivotable or elastically deformable under the action of the first element rotating relative to the second element. For example, when the first element performs a helical movement along a first rotation direction, the cleaning pads automatically pivot to enlarge their contact surface with the tubular surface. When the helical movement stops, the at least one cleaning pad may return to its initial position. In this arrangement, the cleaning pad has only a relatively small contact area or surface with the tubular surface of the first element, thus reducing wear and abrasion of the tubular surface and the pattern provided thereon.

[0083] In another example, the length of the longitudinal movement of the first element relative to the second element during the first movement is the same as the length of the longitudinal movement of the first element relative to the second element during the second movement. At least one of the contact taps is in a first rotational position relative to the pattern before the first and second elements make the first movement. When the helical movement of the first element relative to the second element during one of the first and second movements includes a non-integer number of rotations of the first element relative to the second element, at least one of the contact taps is in a second rotational position after completion of the second movement. Here, the second rotational position and the first rotational position are different.

[0084] Thus, in the first rotational position, a first portion of the pattern is in contact with at least one contact tap. In the second rotational position, another, therefore different, portion of the pattern is in contact with at least one contact tap. This configuration is quite beneficial in reducing wear or abrasion of the pattern on the tubular surface of the first element. At least one, or a number of contact taps of the detector device and / or the reference element can be in permanent mechanical contact with the tubular surface of the first element. Since the first element only rotates during the first movement, and since dose settings involving integer or integer multiple rotations of the first element relative to the second element may be exceptional or rather rare cases, the tubular surface is fairly uniformly stressed with respect to friction with the at least one contact tap.

[0085] In another example, the detector device is disposed on the second element. Here, the at least one electrical sensor includes at least a first electrical contact tap disposed on the second element. The first electrical contact tap is configured to make alternating mechanical and electrical contact with the first pattern portion and the second pattern portion when the first element makes one of a first movement and a second movement relative to the second element. In such a configuration, a binary 2-bit Gray code rotary encoder is implemented. Typically, the electrical sensor includes at least one first electrical contact tap and one second electrical contact tap distributed or disposed along a first separation direction along the tubular circumference of the first element.

[0086] The distance between adjacent electrical contact taps and the distance between adjacent first and second pattern portions can be substantially equal. Furthermore, the periodicity of the arrangement of the multiple electrical contact taps and the periodicity of the pattern can be substantially equal. In such a configuration, at least two or all of the available sensor taps can generate or modify an electrical signal simultaneously. Here, the second sensor tab can provide a backup for the first sensor tab, and the detector device includes respective redundancy and failure safety devices.

[0087] In other examples, the spatial or angular distance between adjacent contact taps and adjacent first and second pattern portions are different from one another. In this manner, individual contact taps of the electrical sensor provide separate and / or alternating electrical signals upon at least one of the first and second movements of the first element relative to the second element, particularly as the first element rotates relative to the second element during the helical movement.

[0088] In another example, the distance between adjacent contact taps along the first separation direction is less than the spatial extension of at least one of the first and second pattern portions along the first separation direction. In this way, at least some rotational states of the first element relative to the second element are realized, where not only one but two contact taps are electrically connected to one and the same pattern portion. This can be useful for generating binary signals, such as implementing a 2-bit Gray code or incremental quadrature encoder.

[0089] In all examples described herein, the first and second elements are implemented as any components of an injection device, usually a pen-type injection device, that undergo a first movement relative to one another during setting a dose and a second movement relative to one another during dispensing or expelling a dose. The first and second elements are located inside a housing of the injection device. These elements may not be visible from the outside of the injection device. The first and second elements are implemented as components of a drive mechanism of the injection device. The first and second elements are mechanically engaged, usually indirectly, to allow a helical movement in one longitudinal direction and to allow a rotationally locked sliding displacement along an opposite longitudinal direction. The drive mechanism usually includes a clutch that is mechanically engaged with the first and second elements. The clutch includes at least two configurations. In one clutch configuration, the first element is displaceable along a helical direction relative to the second element. In the second clutch configuration, the first element is displaceable along a non-rotating longitudinal sliding motion relative to the second element.

[0090] Typically, the first element undergoes a helical, proximally directed movement relative to the second element during setting of a dose, and the first element undergoes a non-rotational sliding displacement relative to the second element during dispensing or expelling of a dose.

[0091] Typically, the longitudinal or axial position of the first element relative to the second element before setting a dose is the same as the axial or longitudinal position of the first element relative to the second element after dispensing or expelling the dose.

[0092] In another example, the second element is a tubular housing component of the injection device. The second element may include a proximal housing component configured to receive the dial extension and / or drive mechanism of the injection device. Here, the first element may belong to the dial extension of the injection device. The first element may include a tubular sleeve that holds and / or mechanically supports the dose dial. Alternatively, the first element is integrally formed with the dose dial. Typically, the first element protrudes proximally from the second element when making a first movement relative to the second element.

[0093] By way of example only, the injection device and detector arrangement described herein are suitable for implementation in the drug delivery device disclosed in WO2010 / 052275A2, where the cylindrical housing sleeve of the dosing assembly represents the second element according to the present disclosure and the dose selector represents the first element according to the present disclosure, where the dose selector has a proximally directed helical movement for setting the dose and a non-rotating distally directed movement relative to the housing sleeve for dispensing the dose.

[0094] The remaining components of the injection device necessary for setting and dispensing a dose of medicament from a cartridge are not shown in great detail here and are implemented identically or similarly as described in document WO2010 / 052275A2, the entirety of which is incorporated herein by reference.

[0095] In another aspect, the present disclosure relates to a detector apparatus operable to detect relative movement between a first element and a second element of an injection device. The detector apparatus includes at least one electric sensor and at least one reference element. One of the electric sensor and the reference element is disposed on the first element, and the other of the electric sensor and the reference element is disposed on the second element. The first element is movable relative to the second element for setting and dispensing or expelling a dose of a medicament contained in a cartridge disposed inside the injection device.

[0096] During and for setting a dose of the drug, the first element is compared to the second element by a first The first element performs a second movement relative to the second element for dispensing a dose. One of the first and second movements is a helical movement, and the other of the first and second movements is a non-rotating longitudinally sliding movement. Typically, the first and second elements are arranged coaxially. The first and / or second elements may comprise a tubular elongated body. Typically, the first and second elements are both of tubular geometry. These elements may be telescopically displaceable. Typically, the first movement is a helical movement, during which the first element is longitudinally rotatably displaceable relative to the second element in a longitudinal proximal direction. During the second movement, the first element is longitudinally non-rotatably displaceable relative to the second element in a distal direction.

[0097] The detector apparatus further includes a pattern provided or disposed on the tubular surface of the first element, the pattern undergoing longitudinal or helical movement relative to the reference element during at least one of the first and second movements of the first element relative to the second element, and the detector apparatus includes at least one electrical sensor operable to generate an electrical signal in response to a positional change of the pattern relative to the reference element.

[0098] The detector device is suitable for integration or embedding in various injection devices, usually handheld pen-type injection devices. Such injection devices are configured as reusable devices, in which the cartridge containing the medicament is replaceable. The detector device is also suitable for disposable injection devices, which are intended to be discarded altogether when the medicament provided in the cartridge has been used up or should no longer be used.

[0099] The detector arrangement, and in particular the electrical sensor and its pattern, may include any of the configurations described above with respect to the injection device.

[0100] 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 person or animal, and the term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest from the injection site of a person or animal.

[0101] The term "drug" or "medicament" as used herein means a pharmaceutical preparation containing at least one pharma- ceutical active compound; wherein in one embodiment the pharma- ceutical active compound has a molecular weight of up to 1500 Da and / or is a peptide, a protein, a polysaccharide, a vaccine, DNA, RNA, an enzyme, an antibody or a fragment thereof, a hormone, or an oligonucleotide, or a mixture of the abovementioned pharma-ceutical active compounds, wherein in a further embodiment the pharma- ceutically active compound is useful for the treatment and / or prophylaxis of diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis, Wherein in a further embodiment the pharma- ceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy, Wherein, in a further embodiment, the pharma- ceutical active compound comprises at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin-4 or an analog or derivative of exendin-3 or exendin-4.

[0102] Insulin analogs include, for example, Gly(A21), Arg(B31), Arg(B 32) Human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and 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.

[0103] Insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; 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-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0104] Exendin-4 means, for example, exendin-4(1-39), a peptide with the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0105] Exendin-4 derivatives include, for example, the compounds listed below: H-(Lys)4-desPro36,desPro37 Exendin-4(1-39)-NH2, H-(Lys)5-desPro36,desPro37 Exendin-4(1-39)-NH2, desPro36 exendin-4(1-39), desPro36[Asp28]exendin-4(1-39), desPro36[IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14,Asp28]Exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]Exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39); or desPro36[Asp28]exendin-4(1-39), desPro36[IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14,Asp28]Exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]Exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39), (wherein the group -Lys6-NH2 may be attached to the C-terminus of the exendin-4 derivative);

[0106] Or an exendin-4 derivative of the following sequence: desPro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010), H-(Lys)6-desPro36[Asp28]Exendin-4(1-39)-Lys6-NH2, desAsp28Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro38[Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2; H-(Lys)6-desPro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2, desMet(O)14 Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-desPro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2, desPro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2; or a pharma- ceutically acceptable salt or solvate of any one of the aforementioned exendin-4 derivatives. is selected from.

[0107] Hormones are, for example, the pituitary or hypothalamic hormones or regulatory active peptides listed in the Rote Liste, 2008 edition, chapter 50, and their antagonists, such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropines (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

[0108] The polysaccharides are, for example, glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or the above-mentioned polysaccharides in sulfated, e.g. polysulfated, form, and / or pharma- ceutically acceptable salts thereof. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

[0109] Antibodies are globular plasma proteins (approximately 150 kDa) also known as immunoglobulins that share a basic structure. They are glycoproteins because they have sugar chains attached to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only Ig units), and secretory antibodies can also be dimers with two Ig units, such as IgA, tetramers with four Ig units, such as IgM in bony fish, or pentamers with five Ig units, such as IgM in mammals.

[0110] An Ig monomer is a "Y" shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains joined by disulfide bonds between cysteine ​​residues. Each heavy chain is about 440 amino acids long, and each light chain is about 220 amino acids long. The heavy and light chains each contain intrachain disulfide bonds that stabilize their folded structure. Each chain is They are composed of structural domains called Ig domains. These domains contain 70-110 amino acids and are classified into different categories (e.g., variable or V, and constant or C) according to their size and function. They have the characteristic immunoglobulin fold, in which two beta sheets create a "sandwich" shape held together by interactions between conserved cysteines and other charged amino acids.

[0111] There are five types of mammalian Ig heavy chains, designated α, δ, ε, γ, and μ. The type of heavy chain present defines the antibody's isotype, and these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0112] The different heavy chains differ in size and composition, with α and γ containing approximately 450 amino acids, δ containing approximately 500 amino acids, and μ and ε containing approximately 550 amino acids. Each heavy chain is composed of two regions: the constant region (C H ) and variable region (V H ) in a species. The constant region is essentially identical in all antibodies of the same isotype, but different in antibodies of different isotypes. Heavy chains gamma, alpha, and delta have constant regions made up of three tandem Ig domains and a hinge region to add flexibility, while heavy chains mu and epsilon have constant regions made up of four immunoglobulin domains. The variable region of the heavy chains differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is about 110 amino acids long and is made up of a single Ig domain.

[0113] In mammals, there are two types of immunoglobulin light chains, designated λ and κ. Light chains have two consecutive domains, one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 211-217 amino acids. Each antibody contains two light chains that are always identical, and for each antibody in a mammal, there is only one type of light chain, κ or λ.

[0114] Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) region, as detailed above. More specifically, three variable loops for each light chain (VL) and three for each heavy chain (VH) are involved in binding to the antigen, i.e., its antigen specificity. These loops are called complementarity determining regions (CDRs). Since the CDRs from both the VH and VL domains contribute to the antigen binding site, it is the combination of the heavy and light chains that determines the final antigen specificity, not either one alone.

[0115] An "antibody fragment" contains at least one antigen-binding fragment as defined above and exhibits essentially the same function and specificity as the complete antibody from which it is derived. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing one complete L chain and approximately half of the H chain, are the antigen-binding fragments (Fab). The third fragment, which is comparable in size but contains the carboxyl termini at half of both heavy chains with interchain disulfide bonds, is the crystallizable fragment (Fc). Fc contains carbohydrate, complementary binding sites, and FcR sites. Limited pepsin digestion yields a single F(ab')2 fragment that contains both the Fab piece and the hinge region, including the HH interchain disulfide bond. F(ab')2 is bivalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. Additionally, the variable regions of the heavy and light chains can be fused to form single chain variable fragments (scFv).

[0116] Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. Acid addition salts are, for example, HCl or HBr salts. Base salts are, for example, alkali or alkaline salts. The salts are salts with cations selected from alkali earths, such as Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), where R1-R4 are each independently: hydrogen, an optionally substituted C1-C6 alkyl group, an optionally substituted C2-C6 alkenyl group, an optionally substituted C6-C10 aryl group, or an optionally substituted C6-C10 heteroaryl group. Further examples of pharma- ceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17th Edition, edited by Alfonso R. Gennaro, Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.

[0117] Pharmaceutically acceptable solvates are, for example, hydrates.

[0118] Furthermore, it will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope of the present invention. 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 invention.

[0119] In the following, a number of examples of drug delivery devices, drug delivery systems, and methods for adjusting at least one discharge or dosing parameter of a drug delivery device are described in detail with reference to the drawings. [Brief description of the drawings]

[0120] [Figure 1] FIG. 1 is a schematic diagram showing a pen-type injection device. [Diagram 2]FIG. 2 is a schematic diagram of the first and second elements of the injection device prior to the dose setting procedure. [Diagram 3] FIG. 2 is a schematic diagram of the first and second elements during or after dose setting. [Figure 4] FIG. 1 illustrates a diagram of first and second elements during dispensing or expelling a dose. [Diagram 5] FIG. 13 shows another example of the first and second elements during or after setting of the dose. [Figure 6] FIG. 6 shows the example of FIG. 5 during dosing of a dose. [Figure 7] FIG. 2 illustrates a first element in relation to a reference element. [Figure 8] FIG. 13 is a diagram showing another example of the first element. [Figure 9] FIG. 2 shows a further example of a first tubular element. [Figure 10] 2 is a cross-sectional view of a first and second element in a first rotational state or configuration of the first element. FIG. [Figure 11] 11 shows the arrangement of FIG. 10 with the first element in a different rotational state compared to the configuration of FIG. 10. FIG. [Figure 12] FIG. 2 is an exploded view of one example of an implementation of the injection device. [Figure 13] FIG. 13 is a perspective longitudinal cross-sectional view of the device of FIG. 12. [Figure 14] FIG. 13 is a side view of a further example of a first element. [Figure 15] FIG. 15 is a perspective view of the first element according to FIG. 14. [Figure 16] FIG. 16 shows the first element of FIGS. 14 and 15 with reference elements. [Figure 17] FIG. 17 shows a cross section of the assembly of FIG. 16 with three separate reference elements. [Figure 18] 18 is a schematic cross-sectional view of FIG. 17 showing the electrical circuitry of the pattern provided on the first element relative to the reference element. [Figure 19] FIG. 19 shows the geometrical structure of the pattern of the tubular surface of the first element according to FIGS. [Figure 20]FIG. 13 shows another example of a detector arrangement including only two reference elements in association with another example of the pattern of the tubular surface of the first element. [Figure 21] FIG. 21 shows the geometric structure of the pattern according to FIG. 20. [Figure 22] FIG. 2 is a schematic diagram showing first, second and third electrical contact taps of a reference element at a first longitudinal position of the first element relative to the reference element. [Diagram 23] FIG. 23 shows the configuration of FIG. 22 with the first element in a second longitudinal position relative to the second element. [Figure 24] FIG. 17 shows the example of FIG. 16, where the first element is near the zero dose longitudinal position. [Diagram 25] FIG. 25 shows the arrangement of FIG. 24, with the first element in a zero dose longitudinal position relative to the second element. [Figure 26] FIG. 16, 17, 24 and 25 in an isolated view of the reference elements. [Figure 27] FIG. 27 is a perspective view of the proximal end of the housing of the injection device with at least one reference element of FIG. 26. [Figure 28] FIG. 13 shows another example of a pattern provided on the tubular surface of the first element. [Figure 29] FIG. 13 shows another example of a detector device in which the reference element includes three electrical contact taps disposed on the second element. [Diagram 30] FIG. 30 is a diagram showing an electrical circuit of the electrical sensor of FIG. 29. [Diagram 31] FIG. 2 illustrates a first rotation state of a first element relative to a reference. [Diagram 32] FIG. 13 illustrates a second rotation state of the first element relative to the reference. [Diagram 33] FIG. 11 illustrates a third rotation state of the first element relative to the reference. [Diagram 34] FIG. 11 illustrates a fourth rotation state of the first element relative to the reference. [Diagram 35] FIG. 13 illustrates a further example of a detector apparatus with another example of an electrical sensor in an idle state. [Diagram 36]FIG. 36 shows the example of FIG. 35 with the electrical sensor in an activated state. [Figure 37] FIG. 13 illustrates another example of a detector arrangement. [Figure 38] FIG. 13 shows a further example of a detector arrangement. [Figure 39] FIG. 13 shows another example of a reference element including five contact taps arranged along the inner circumference of a tubular second element. [Diagram 40] FIG. 40 is a perspective view of another example of a first element operably configured to cooperate with the reference element shown in FIG. 39 . [Diagram 41] FIG. 41 shows the first element of FIG. 40 and the second element of FIG. 39 in an assembled configuration. [Diagram 42] FIG. 2 shows a schematic side view of a first and second element of the relative position of at least one cleaning pad with respect to at least one contact tap of an electrical sensor; [Diagram 43] FIG. 43 is a cross-sectional view of the arrangement of FIG. 42. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0121] An example of an injection device is shown diagrammatically in FIG. 1. The injection device 1 may include a pre-filled disposable injection device. The injection device 1 includes a housing 10 to which an injection needle 15 is attached. The injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 or protective cap 18 configured to surround and protect a distal portion of the housing 10 of the injection device 1. The housing 10 may include and form a main housing member configured to house a drive mechanism 8. The injection device 1 may further include a distal housing component shown as a cartridge holder 14. The cartridge holder 14 is permanently or releasably coupled to the main housing 10. The cartridge holder 14 is typically configured to house a cartridge 6 filled with a liquid medicament. The cartridge 6 includes a cylindrical or tubular barrel 25 sealed in a proximal direction 3 by a bung 7 located inside the barrel 25. The bung 7 is displaceable in a distal direction 2 relative to the barrel 25 of the cartridge 6 by a piston rod 20. The distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and pierceable by the tip of a proximally directed injection needle 15. The cartridge holder 1 4 includes a threaded socket 28 at its distal end for threaded engagement with a corresponding threaded portion 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.

[0122] When the injection device 1 is configured to administer, for example, human insulin, the dose set by the dial member 12 at the proximal end of the injection device 1 is displayed in so-called International Units (IU), where 1 IU is the biological equivalent of approximately 45.5 μg (1 / 22 mg) of pure crystalline insulin.

[0123] As further shown in FIG. 1, the housing 10 includes a dose window 13, which may be in the form of an aperture in the housing 10. The dose window 13 allows the user to view a limited portion of a number sleeve, which is configured to move when the dose member 12, e.g. in the form of a dial member, is turned to provide a visual indication of the currently set dose. The dose member may rotate on a helical path relative to the housing 10 when turned while setting and / or dispensing or expelling a dose. During and for setting a dose, the dose dial 12 normally rotates clockwise in a dose increase direction 4. If the actual set dose is too large, the dose dial 12 may also be rotated in the opposite direction, and therefore in a dose decrease direction 5.

[0124] Figures 2-4 show one example of a detector arrangement 50 operable to detect and quantitatively measure the relative movement between a first element 100 and a second element 200 of an injection device 1. Here, the first element 100 undergoes a first movement relative to the second element 200 as illustrated in Figure 3. This first movement is a helical movement and therefore a combined rotational and longitudinal movement of the first element 100 relative to the second element 200. During the first movement, the first element 100 may undergo a clockwise rotational movement relative to the second element 200. At the same time, the first element may undergo a longitudinal movement in the proximal direction 3. During the setting of the dose, the first element 100 undergoes a first movement relative to the second element 200 as illustrated in Figure 3.

[0125] The first element 100 also undergoes a second movement relative to the second element 200. Here, the second movement is a longitudinal movement of the first element 100 relative to the second element 200 along a second longitudinal direction, thus the distal direction 2. The second movement is a sliding movement of the first element 100 relative to the second element 200, the first element 100 being non-rotatably locked to the second element 200. Hence, during the second movement, the first element 100 cannot rotate relative to the second element 200. The second element 200 is provided with at least one reference element 60. The reference element 60 is fixed to the second element 200. The reference element is arranged at the proximal end of the second element 200.

[0126] The detector device 50 includes at least one electrical sensor 51 and a tubular surface 102. The tubular surface 102 is provided on the first element 100. Typically, the first element 100 is also tubular in shape. The first element 100 may include a sleeve, such as a dose dial sleeve or a dose sleeve, operatively coupled to or integrally formed with the dose dial 12, as shown in FIG. 1. The detector device 50 includes at least one electrical sensor 51 operable to generate an electrical signal corresponding to a positional change of the pattern 104 relative to the reference element 60 during at least one of a first movement and a second movement of the first element 100 relative to the second element 200. The reference element 60 is disposed on or incorporated into the second element 200. The at least one electrical sensor 51 may coincide with the reference element 60. In other examples, the at least one electrical sensor 51 is incorporated into or disposed on the first element 100. In that case, the reference element 60 is a passive electric or electronic element operable to interact with at least one electric sensor 51 mounted on the first element 100. It can be said that:

[0127] The pattern 104 is designed and configured to interact with the at least one electrical sensor 51 in such a way that movement of the pattern 104 due to at least one of the first and second movements is detectable and / or quantitatively measurable by the at least one electrical sensor. As movement of the pattern 104 relative to the reference element 60 changes the configuration of the pattern 104, the at least one electrical sensor 51 generates or modifies an electrical signal that can be processed by the detector arrangement 50 to detect and / or quantitatively measure at least one of the type of movement, the size of the movement, the position and the orientation of the first element relative to the second element.

[0128] The at least one electrical sensor 51 is particularly operable to directly detect and / or directly quantitatively measure a position change of the pattern 104 relative to the at least one reference element 60. The at least one electrical sensor 51 therefore interacts with the interface between the first element 100 and the second element 200.

[0129] The at least one electrical sensor 51 is operable to detect and / or quantitatively measure at least one of a spiral and a sliding movement of the first element 100 relative to the second element 200. The electrical sensor 51 is further configured to detect and / or quantitatively measure both a rotational movement and a longitudinal movement of the pattern 104 relative to the reference element 60.

[0130] In figures 2-4, the tubular surface 102 is the outer surface of the tubular first element 100. The second element 200 is implemented as another tubular element. Both the first element 100 and the second element 200 may comprise a tubular shape. These elements are arranged in a nested and therefore telescopic configuration. During dose setting, the overall longitudinal extension of the assembly of the first element 100 and the second element 200 is greater than at the end of the dose dispensing procedure illustrated in figure 2. The second element 200 is typically a hollow tubular sleeve. The at least one reference element 60 is typically arranged on the inner side wall of the sleeve of the second element 200. Similarly, the at least one electrical sensor 51 is also arranged on the radially inwardly facing part of the second element 200. The free inner diameter of the second element 200 is greater than the outer diameter of the first element 100. Hence, the first element 100 is longitudinally displaceable inside the second element 200 .

[0131] In the example of Fig. 5 and Fig. 6, the first element 100 still comprises a tubular surface 102 including a pattern 104. Here, however, the tubular surface 102 is the inner-facing surface of the hollow-shaped first element 100. The second element 200 is longitudinally displaceable in a non-rotating manner relative to the first element 100 during dose setting as illustrated in Fig. 5. Here, the second element 200 has a proximally directed longitudinal sliding movement relative to the first element 100 during and / or for dose setting. The reference element 60 and the at least one electric sensor 51 are located and arranged on the outer circumference of the second element 200. The second element 200 may include a tubular shape. The second element includes an outer diameter that is smaller than the free inner diameter of the first element 100.

[0132] For or during dose dispensing, the second element 200 undergoes a helical movement, with the components undergoing a longitudinal displacement in the longitudinal distal direction 2. Here, the reference element 60 and the at least one electrical sensor 51 undergo a combined rotational and longitudinal movement relative to the pattern 104 and thus relative to the first element 100. As illustrated in Figures 5 and 6, the first movement shown in Figure 5 is a sliding movement of the first element 100 relative to the second element 200 along the longitudinal proximal direction 3, the first element 100 and the second element 200 being non-rotatably locked.

[0133] 6 is a helical movement of the second element 200 relative to the first element 100, with a longitudinal displacement in the distal direction 2. It should be noted that the tubular pattern 104 may cover the entire inner circumference of the hollow first element 100. In this way, and with respect to any available rotational state of the second element 200 relative to the first element 100, there will be a defined relative and distinguishable position or orientation of the pattern 104 with respect to at least one reference element 60 or electrical sensor 51.

[0134] Another example of a detector device 50 is illustrated in Fig. 7. Here, the second element 200 comprises two reference elements 60 arranged on or in the second element 200 at a predetermined longitudinal distance from each other. In Fig. 7, the second element is only shown in dashed lines when the first element 100 is in a zero dose configuration, e.g. at the end of a dose dispensing procedure. Here, the first element 100 is in a most distal position with respect to the second element 200.

[0135] 7, the pattern 104 includes a longitudinal extension that substantially corresponds to the longitudinal distance between the first and second reference elements 60, each of which overlaps or coincides with the first and second electrical sensors 51. In the initial configuration shown in FIG. 7, one of the reference element 60 and the electrical sensor 51 is located at a proximal end of the pattern 104, and the other of the reference element 60 and the electrical sensor 51 is located near or adjacent to a distal end of the pattern 104.

[0136] As the first element 100 undergoes a first movement, and as the first element 100 is displaced in the proximal direction 3 relative to the second element 200, the pattern 104 begins to move away from the distally-located reference element 60 and from the distally-located electrical sensor 51. Accordingly, movement of the first element 100 relative to the second element 200 is detected and / or quantitatively measured only by the proximally-located reference element 60 and the respective proximally-located electrical sensor 51.

[0137] At the end of the dose dispensing procedure, when the first element 100 approaches the zero dose configuration as shown in FIG. 7, the pattern 104, typically a distal portion of the pattern 104, moves back into the coverage area of ​​the distally located reference element 60 and / or the distally located electrical sensor 51. Hence, the approach and / or reaching of the first element 100 to the zero dose configuration is separately detectable by the distally located electrical sensor 51, where the distally located electrical sensor 51 is limited to providing the function of a switch configured to indicate to the detector device 50 that the zero dose configuration has been reached. Thus, the other electrical sensor, hence the proximally located electrical sensor 51, may be configured and operable to detect and / or quantitatively measure the distance or angular distance moved by the first element 100 during at least one of the first and second movements relative to the second element 200.

[0138] 7, the pattern 104 may include a first pattern section 120 and a second pattern section 122. The first and second pattern sections 120, 122 are non-overlappingly disposed with respect to the tubular surface 102 of the first element 100. The second pattern section 122 is separated from the first pattern section 120 in at least a longitudinal direction.

[0139] Typically, the second pattern section 122 may include a ring shape. This second pattern section may be invariant with respect to the rotational state or orientation of the first element 100 relative to the second element 200. The second pattern section is specifically configured to detect a predetermined longitudinal position of the first element 100 relative to the second element 200. In contrast, the first pattern section 120 may assist in detecting and / or quantitatively measuring the degree of rotation or longitudinal displacement of the pattern 104 relative to the reference element 60. In some examples, the interaction of the first pattern section 120 with the reference element 60 and the at least one electrical sensor 51 is operable to definitively detect and / or quantitatively measure the degree of rotation of the first element 100 relative to the second element 200.

[0140] For this reason, the first pattern section 120 can be invariant in the longitudinal direction (z), so that longitudinal and non-rotational displacements of the first element 100 relative to the second element 200 do not generate an electrical signal by the at least one electrical sensor 51. This is particularly the case when the pattern 104, and in particular the first pattern section 120, comprises a stripe pattern 124 as illustrated in FIG. 8. The stripe pattern 124 may comprise a number of longitudinal stripes 126 that run parallel to the longitudinal direction or parallel to the extension of the tubular first element 100. In another example, illustrated in FIG. 9, the first pattern section 120 also comprises a stripe pattern 124. Here, however, the longitudinal stripes 126 run at an angle to the longitudinal direction (z).

[0141] The angle of the longitudinal stripes relative to the longitudinal direction may be different from the lead of the helical motion between the first element 100 and the second element 200. In this case, as the first element 100 undergoes helical motion relative to the second element 200, the at least one electrical sensor is operable to generate a varying electrical signal indicative of the degree of rotational displacement of the first element 100 relative to the second element 200. With the angled stripe pattern illustrated in FIG. 9, a varying electrical signal is also generated as the first element 100 undergoes a longitudinal non-rotational sliding motion relative to the second element 200.

[0142] As shown in Figures 8 and 9, the pattern 104 includes a first pattern section 120 that is specifically configured and dedicated to detecting and / or quantitatively measuring the degree of rotation of the first element 100 relative to the second element 200. In Figure 8, the second pattern section 122 is located next to the proximal end of the first pattern section 120. In Figure 9, the second pattern section 122 is located next to the distal end of the first pattern section 120. In the configuration of Figure 8, when the second pattern section 122 is close to or adjacent to the proximal end of the first pattern section 120, the respective electric sensors 51 that are specifically configured to detect and / or measure rotational and longitudinal movements are positioned close to each other. Furthermore, the separate electric sensors 51 can be combined in the form of a single electric sensor 51 and can be integrated into a single reference element 60 that is located near or at the proximal end of the second element 200.

[0143] There are generally no constraints regarding the physical or technical interaction between the pattern 104 and the at least one electrical sensor 51 .

[0144] Typically, the pattern 104 comprises at least a first pattern portion 110 and at least a second pattern portion 112. The first and second pattern portions 110, 112 are arranged without overlapping with the tubular surface 102 of the first element 100. The first pattern portion 110 and the second pattern portion 112 exhibit a difference with respect to at least one of the following parameters: electrical conductivity, light transmittance, light reflectance, magnetic susceptibility or electrical susceptibility. Furthermore, the first and second pattern portions 110, 112 may also exhibit a difference with respect to a radial position with respect to the central axis of the tubular surface 102 or with respect to the central axis of the tubular first element 100. For example, the first pattern portion 110 may comprise one or several radial protrusions and the second pattern portion 112 may comprise one or several radial recesses. The radial projections and recesses are provided on the outer tubular surface 102 of the first element 100 or on the inner tubular surface of the first element, depending on the particular implementation of the injection device 1 and the detector arrangement 50 .

[0145] The at least one electrical sensor 51 is configured to communicate or interact with the first and second pattern portions 110, 112. As such, the at least one electrical sensor 51 is configured to indicate a difference between the first pattern portion 110 and the second pattern portion 112 when the respective pattern portions 110, 112 are within a defined coverage area of ​​the at least one electrical sensor 51. When the first pattern portion 110 indicates a difference from the second pattern portion 112 by its electrical conductivity, the at least one electrical sensor 51 can include an electrical contact tap 52, which allows for generating a changing electrical signal when the first and second pattern portions 110, 112 pass by the at least one electrical sensor 51. If the first and second pattern portions 110, 112 include one of different light transmittances or light reflectances, or if the first and second pattern portions 110, 112 include different colors or exhibit differences in terms of brightness, the at least one electrical sensor 51 is implemented as an optical sensor, such as a photodiode, operable to indicate a difference between the pattern portions 110, 112 characterized by different light transmittances, different light reflectances, or different colors or different brightness.

[0146] If the first and second pattern portions 110, 112 exhibit different magnetic susceptibilities, the at least one electric sensor is implemented as a magnetic sensor. This magnetic sensor may include a Hall sensing element or a magnetically sensitive electronic structure. The same is valid for a combination of the at least one electric sensor and the pattern, the first and second pattern portions 110, 112 exhibiting different electrical susceptibilities.

[0147] When the first and second pattern portions 110, 112 include different radial positions or radial mechanical structures, the at least one electrical sensor 51 may be implemented as an electromechanical switch 56, 57, for example as shown in FIG. 38, that is normally radially biased and configured to mechanically engage with at least one radial protrusion or radial recess on the tubular surface 102 of the first element 100.

[0148] Pattern 104 is not limited to first pattern portion 110 and second pattern portion 112. Third, fourth and multiple further pattern portions that are distinct from one another are also provided, thereby making it possible to implement not only 2-bit patterns, but also 3-bit, 4-bit, 5-bit, 6-bit and even n-bit patterns, where n is an integer greater than 0, are supported.

[0149] The type of patterns, and therefore the type of the first and second pattern portions 110, 112 provided in the first pattern section 120 and in the second pattern section 122, may be substantially equal. However, the pattern portions of the first pattern section 120 and the pattern portions 110, 112 may exhibit differences from the respective pattern portions 110, 112 provided in the second pattern section 122, in particular with regard to their geometry, shape and orientation.

[0150] In other examples, the types of the first and second pattern portions 110, 112 of the first and second pattern sections may exhibit differences. For example, the first pattern section 120 may comprise first and second pattern portions 110, 112 exhibiting differences with respect to their electrical conductivity. The first and second pattern portions 110, 112 provided in the second pattern section 122 may exhibit differences with respect to their radial positions, for example. Here, the first and second pattern portions 110, 112 of the second pattern section 122 may include at least one of radial recesses or protrusions.

[0151] 10, a cross section of the first and second elements 100, 200 is shown in a first configuration, where the first element 100 includes a pattern 104 on its periphery. The pattern 104 is The electrical sensor 51 includes four first pattern portions 104, for example implemented as conductive stripes, and four second pattern portions 112 tangentially located between the first pattern portions 110. The second pattern portions 112 may be electrically insulating. The electrical sensor 51 includes a number of electrical contact taps 52, 53, 54 disposed on an inner surface of the second element 200.

[0152] As shown in FIG. 10, the circumferential or tangential distance between adjacent contact taps 52, 53, 54 is substantially equal to the circumferential or tangential distance between adjacent first pattern portions 110. In FIG. 10, at least two of the contact taps 52, 53 are in electrical contact with at least two of the first pattern portions 110. Furthermore, any and all of the contact taps 52, 53, 54 can be in electrical contact with their respective first pattern portions 110. In the examples of FIGS. 10 and 11, the first pattern portion 110 and the arrangement of the electrical sensor 51 with the multiple contact taps 52, 53, 54 include the same periodicity when viewed in the circumferential or tangential direction of the tubular surface 102. Thus, in the configuration of FIG. 10, all or at least some of the contact taps 52, 53, 54 are electrically connected with at least one of the conductive first pattern portions 110.

[0153] For example, during one of the first and second movements, as the first element 100 rotates relative to the second element 200, the first pattern portion 110 is displaced circumferentially or tangentially relative to the electrical contact taps 52, 53, 54. In practice, the electrical contact taps 52, 53, 54, and therefore the at least one electrical sensor 51, will not make contact with the conductive first pattern portion 110. This results in a change in the electrical signal obtainable from the at least one electrical sensor 51 or obtainable from at least one of the electrical contact taps 52, 53, 54.

[0154] In the example of Figures 10 and 11, the detector device 50 is implemented as an incremental rotation detector operable to generate at least one electrical signal when the first pattern portion 110 contacts or loses contact with the electrical contact taps 52, 53, 54. Here, multiple first pattern portions 110 simultaneously engage or disengage multiple contact taps 52, 53, 54, thereby providing redundancy of the detector device 50. For detection and / or measurement of the rotation of the first element 100 relative to the second element 200, it is usually sufficient when at least one of the first pattern portions 110 engages or disengages at least one of the electrical contact taps 52, 53, 54.

[0155] Of course, the number and arrangement of the first and second pattern portions 110, 112, as well as the number and arrangement of the multiple contact taps 52, 53, 54, may be different. To increase the detection or measurement range of the detector device 50, it may be advantageous for the pattern 104, including the first and second pattern portions 110, 112, to be irregular when viewed in the circumferential or tangential direction. In practice, the circumferential or tangential sizes of the first and second pattern portions may differ.

[0156] A number of first pattern portions 110 are provided, which have a tangential extension or size different from the tangential extension or size of the other first pattern portions 110. The same may be valid for the second pattern portions 112. In addition, the circumferential or tangential distance between adjacent first pattern portions and / or adjacent second pattern portions may be different or not identical along the circumference of the tubular surface 102. In this way, a high resolution of the angle detection is implemented with a minimum of components in the first element 100 and the second element 200 interacting with each other.

[0157] In Fig. 12 and Fig. 13 a possible implementation of the detector arrangement 150 of the pen injection device 1 is shown in more detail. The injection device 1 comprises a tubular housing 10 with a tubular body 201. The body 201 is open towards the proximal direction 3. The housing 10 represents a second element 200 according to the present disclosure. The first element 100 is tubular in shape. The first element 100 comprises a tubular sleeve that is telescopically arranged inside the second element 200. The first element 100 can be a dosing sleeve or a dose dial sleeve. The first element is rigidly and immovably connected to the dial 180. The housing 10, and therefore the second element 200, is closed in the proximal direction 3 by a retaining cap 202 attached to the proximal end of the side wall of the second element 200.

[0158] A number of reference elements 160 are provided, fixedly arranged on the inner surface of the side wall of the second element 200. By way of example, the reference elements 160 are implemented as electrical bridging contacts 162. The reference elements are held in place at or on the inner surface of the second element 200 by a retaining cap 202. The retaining cap includes a central through-hole through which the first element 100 can protrude longitudinally. The first element 100, in particular its tubular sleeve, is non-rotatably fixed to the dial 180. The tubular sleeve is also axially engaged with the dial 180. The tubular sleeve is rigidly connected to the dial 180 so as to transfer any rotational and / or longitudinal sliding movement of the dial 180 equally to the first element 100.

[0159] The dial 180 includes an annular and radially wide head section 184 that provides a hollow receptacle 185 for the detector device 150. The dial 180 further includes a longitudinally extending dial sleeve 182 that is rigidly connected to or integrally formed with the head section 184. The head section 184 forms the proximal end of the dial 180. The outer periphery of the annular head section 184 includes a diameter that may substantially match the outer diameter of the second element 200. The head section 184 is open in the proximal direction 3. The head section includes an annular or tubular side wall 187 to which a closure 196 in the form of a closure cap or lid is attached to close the receptacle 185.

[0160] Inside the receptacle 185 the electronic components of the detector device 150 are arranged. The detector device 150 comprises a printed circuit board 190 on which an integrated circuit 192 is arranged. Typically and as shown diagrammatically in Fig. 18, the integrated circuit 192 comprises at least a processor 191 and a storage device 193 for at least temporarily storing data retrieved or acquired by the detector device 150. Optionally, the integrated circuit 192 is further equipped with a communication unit 195, typically implemented as a wireless communication unit for establishing wireless signal transmission to another electronic device, e.g. a portable electronic device such as a smartphone, a tablet computer, etc.

[0161] The detector device 150 further includes a battery 188. The battery is mounted on one side of a printed circuit board 190, whereas an integrated circuit 192 is mounted on the opposite side of the printed circuit board 190. The integrated circuit 192 is further covered by a cover 194. As shown in FIG. 12, a number of electrical contacts 186 are provided, which are implemented as contact clamps, for example made of sheet metal, such as stainless steel. One end of the electrical contact clamps 186 is connected to a respective input terminal of the integrated circuit 192. The integrated circuit 192 may include a number of input terminals, which thus become input channels of a number of electrical sensors or of a number of contact taps of the electrical sensor 151. The opposite end of the electrical contacts may extend through the side wall or through the base of the dial 180 and may be in contact with a number of pattern portions 110, 112, 114 of the pattern 104 of the first element 100. The electrical contacts 186 are permanently connected to only one of the pattern portions 110, 112, 114. During dose setting and / or dose dispensing, the electrical contacts 186 may remain fixed relative to the multiple pattern portions 110, 112, 114, as described below.

[0162] Since any of the electrical contacts 186 are permanently connected with an input terminal of the integrated circuit 192 and further with one particular pattern portion of the patterns 110, 112, 114 of the first element 100, the detector device 150 does not have to be configured to read a code printed or provided on the tubular surface. Instead, the electrical state and / or electrical characteristics of at least one of the multiple pattern portions 110, 112 change when the first element 100 undergoes at least one of a first and a second movement relative to the second element 200. The electrical contacts 186 thus form or constitute an input of the detector device 150 and therefore of the integrated circuit 192, for example implemented as a microcontroller operable to detect and quantitatively measure or determine the degree of rotation and / or longitudinal movement of the pattern 104 relative to the reference 160.

[0163] An example of a two-bit rotary encoder is illustrated in Figures 18 and 19. Three separate reference elements 160 are provided on or about the inner tubular surface of the second element 200. Each of the reference elements 160 includes a bridging contact 162, 162', 162''. For example, the bridging contact 162 includes a first contact tap 164 and a second contact tap 166 that are radially oriented and preloaded in that direction for mechanical contact with pattern portions 110, 112, 114 provided on the pattern 104 of the tubular surface 102 of the first element 100.

[0164] The first and second contact taps 164, 166 are separated from each other along a first separation direction D1. As shown in Figs. 18 and 19, the first separation direction D1 extends along a circumferential or tangential direction with respect to the tubular shape of the first element 100. The first and second contact taps 164, 166 are placed apart by a predetermined angle, for example about 60°. The first and second pattern portions 110, 112 each include a longitudinal stripe. The first pattern portion 110 is a stripe with a width of 30°. The first pattern portion 110 is electrically conductive. The second pattern portion 112, which is electrically insulating, is placed tangentially adjacent to the first pattern portion 110. The first pattern portion 110 includes an angular or tangential width of about 15° to about 30°. A third pattern portion 114, also implemented as a conductive pattern portion, is further provided. The third pattern portion 114 also includes longitudinal stripes and includes a tangential or circumferential width of about 105° to about 120°.

[0165] When viewed along the first separation direction D1 or when viewed along a tangential direction, the first pattern portion 110 is followed by a second pattern portion 112. The second pattern portion 112 is followed by a third pattern portion 114. The third pattern portion 114 is followed by another second pattern portion 112. The other second pattern portion 112 is followed by another first pattern portion 110'. The other first pattern portion 110' is followed by another second pattern portion 112, and finally each second pattern portion 112 is followed by another third pattern portion 114. This third pattern portion 114 is again followed by the second pattern portion 112.

[0166] 19, the first pattern portions 110, 110' and the third pattern portion 114 are separated from each other by the second pattern portion 112. The first pattern portions 110, 110' are surrounded in both tangential directions by the second pattern portion 112. The third pattern portion 114 is also surrounded in a tangential direction by its respective second pattern portion 112.

[0167] The first pattern portions 110, 110' are permanently electrically connected to input terminals of the detector device 150, where the pattern portion 110' is connected to a first input 152 of the detector device 150. Another first pattern portion 110 is connected to a second input 153 of the detector device 150. 154. The third pattern portion 114 is electrically connected to a supply voltage 156. The third pattern portions are electrically interconnected to each other. The third pattern portions are provided with a predetermined DC voltage level as the first element 100 rotates relative to the second element 200.

[0168] As shown in FIG. 18, a number of bridging contacts 162 , 162 ′, 162 ″ are equally spaced around the circumference of the first element 100 .

[0169] When the first element 100 is rotated relative to the second element and the pattern 104 is rotated relative to the reference 160, a rotated 2-bit Gray code becomes detectable at the first and second input terminals of the detector arrangement.

[0170] In the rotated position shown in FIG. 18, only the first pattern portion 110′ is electrically connected to one of the third pattern portions 114 via the bridging contact 162. The other pattern portions 110 are disconnected from the pattern portions 114. Hence, a logic 1 is provided to the first input terminal 152. Now, when the first element 100 and the pattern 104 are rotated clockwise relative to the reference 160, the contact tap 164 loses electrical contact from the first pattern portion 110′. This provides a logic 0 to the first input terminal 152. In both configurations, the second input terminal 154, and therefore the other pattern portions 110 shown in the lower part of FIG. 18, loses electrical contact to the other bridging contacts 162′, 162″.

[0171] Accordingly, the second input terminal 154 remains at logic 0 until the first element 100 rotates further in the clockwise direction. The first contact tap 164 of the bridging contact 162'' then makes electrical contact with the first pattern portion 110, thereby generating a logic 1 at the second input terminal 154, while the first input terminal 152 remains at logic 0, because the other contact tap of the bridging contact 162'', and therefore the second contact tap 166, has made and remains in contact with the third pattern portion 114.

[0172] As the first element 100 rotates further in the clockwise direction, the first contact tap 164 of the bridging contact 162 will come into contact with the third pattern portion 114 and the second contact tap 166 of the bridging contact 162 will come into contact with the first pattern portion 110'. This also produces a logic 1 at the first input terminal 152. As the first element 100 then rotates further in the clockwise direction relative to the second element 200, and therefore relative to the reference element 160, the bridging contact 162'' will lose contact with the pattern portion 110, thereby producing a logic 0 at the second input terminal. In this manner, as the first element 100 rotates 60° clockwise relative to the second element 200, a 2-bit Gray code of 01, 00, 10, 11 is produced. In this manner, 24 distinct angular positions of the first element 100 relative to the second element 200 are electronically detected. With the implementation of the 2-bit Gray code, not only the magnitude of the relative rotation but also the direction of rotation is precisely determined. The 2-bit Gray code implementation requires that the detector device 150 counts signal transitions at the first and second input terminals 152,154.

[0173] In the just described implementation, the step size of the relative rotation between the first element 100 and the second element 200 is approximately 15°.

[0174] The angular width of the first, therefore electrically conductive, pattern portion 110, 110' is twice the step width. The angular width of the second, electrically insulating pattern portion 112 is substantially equal to the step size or substantially twice the step size. The angular position of the first pattern portion 110 and the other first pattern portion 110' is six times the step size. Thus, the angular offset in one direction between the first pattern portion 110 and the alternative first pattern portion 110' is 165°. The angular spacing between the first pattern portion 110 and the alternative first pattern portion 110' is 135° in one direction and 165° in the other direction.

[0175] Another example of the implementation of a 3-bit Gray code is shown in Fig. 20 and Fig. 21. Here, the pattern 104 comprises a stripe pattern 124 with a number of longitudinal stripes 126 including six equally spaced conductive pattern portions 110, 114, 110', 114, 110'', 114 and six insulating pattern portions 112 respectively located therebetween. As shown in Fig. 21, along a first separation direction D1, the first pattern portion 110 is followed by a second pattern portion 112. The second pattern portion 112 is followed by a third pattern portion 114. The third pattern portion is again followed by another second pattern portion 112. This other pattern portion is again followed by the first pattern portion 110', and so on. Each pattern portion 110, 112, 114 comprises a substantially identical extension along the first separation direction D1. Here, each pattern portion 110, 112, 114 includes an extension of approximately 30 degrees.

[0176] The reference element 160 includes two bridging contacts 162 as described above in relation to FIG. 18. Each of the bridging contacts 162 includes a first contact tap 164 and a second contact tap 166. The first and second contact taps 164, 166 are separated by an angular interval of about 50°. There is an angular offset of about 135° between the first bridging contact 162 and the second bridging contact 162'. Therefore, the shortest angular interval between the second contact tap 166 of the first bridging contact 162 and the first contact tap 164 of the second bridging contact 162' is about 85°. Therefore, the two bridging contacts 162, 162' are separated from each other by 2.25 times the width of the stripe 126.

[0177] Three pattern portions 114 are provided that are permanently connected to a voltage supply source. The three first pattern portions 110, 110', 110'' are permanently connected to a first input terminal, a second input terminal and a third input terminal of the detector device 150, respectively. In particular, the first pattern portion 110 is permanently electrically connected to the first input terminal. Another first pattern portion 110' is permanently electrically connected to the second input terminal and another first pattern portion 110'' is permanently electrically connected to the third input terminal.

[0178] With the stripe pattern 124 and reference element 160 configuration shown in Figures 20 and 21, the following 3-bit cyclic Gray code is implemented, with the individual doses including an angular offset of 15°:

[0179] [Table 1]

[0180] The cyclic Gray code shown above makes it possible to determine some units that have been dialed in, and to determine the direction of rotation of the first element 100 relative to the second element 200. In addition, some degree of error checking is also possible, since some states are not reachable.

[0181] The first element 100 only rotates relative to the second element 200 during one of the first and second movements. For example, the first element 100 only rotates relative to the second element 200 during and for setting a dose. There is no relative rotation between the first element 100 and the second element 200 during or for dispensing or expelling a dose of drug. During such non-rotating longitudinal sliding movements, the longitudinal stripe pattern 124 cannot generate an electrical signal.

[0182] To detect the completion of a dose dispensing procedure, the pattern 104 is divided into a first pattern section 120 and a second pattern section 122 that are separated from each other along the longitudinal direction of the first element 100. 22 and 23, such a longitudinal separation is generally along a second separation direction D2. Here, the first pattern section 120 may include a stripe pattern 124 as shown and described above in connection with FIGS. 18-21. The stripe pattern 125 includes multiple pattern portions 110, 112, 114 as described above. The reference element 160 may include a bridging contact 162 characterized by at least a first electrical contact tap 164 and a second contact tap 166.

[0183] As mentioned above, the third pattern portion 114 is permanently connected to the voltage supply source 156. In the configuration shown in FIG. 22, the first pattern portion 110, i.e., the conductive pattern portion, is electrically connected to the third pattern portion 114 through a bridging contact 162. Here, the bridging contact 162 includes a third contact tap 168 that is separated from at least one of the first contact tap 164 and the second contact tap 166 along a second separation direction D2. The second separation direction D2 extends non-parallel to the first separation direction D1. The second separation direction D2 extends at an angle to the first separation direction D1. Typically, during the non-rotating longitudinal sliding movement between the first element 100 and the second element 200, the pattern 104 has a sliding movement along the second separation direction relative to the reference element 160. In the configuration shown in FIG. 22, the third contact tap 168 is located on or in the first pattern section 120 .

[0184] The first pattern section 120 is disposed longitudinally adjacent to the second pattern section 122. The first pattern section 120 and the second pattern section 122 are separated from each other by a border line 121 implemented as a separation line. The border line 121 exhibits a difference with respect to the electrical conductivity and / or with respect to the electrical state of the first pattern section 120 and / or the second pattern section 122.

[0185] The second pattern section 122 includes a fourth pattern portion 116. The fourth pattern portion 116 is also a conductive pattern and is permanently connected to the detector device 150 via at least one electrical contact 186, as described in connection with Figures 12 and 13. In the configuration shown in Figure 22, the second pattern section 122, separated from the first pattern section 120 along the second separation direction D2, is not in contact with the third contact tap 168. When the first element 100, and therefore the pattern 104, makes a further sliding movement along the second separation direction D2, for example at the very end of a dose dispensing procedure, the third contact tap 168 crosses the boundary line 121 and makes electrical contact with the fourth pattern portion 116.

[0186] At the same time, the bridging contact 162 makes and remains in electrical contact with the third pattern portion 114. In this way, a conductive connection is formed between the third pattern portion 114 and the fourth pattern portion 116 when the first element 100 reaches a predetermined longitudinal position relative to the second element 200. For example, the fourth pattern portion 116 is provided with the respective supply voltage when the configuration shown in FIG. 23 is reached, typically at the end of a dose dispensing procedure and when the first element returns to its initial state relative to the second element 200.

[0187] The crossing of the boundary line 121 and the establishment of electrical contact between the fourth pattern portion 116 and the third pattern portion 114 are detected by the detector device 150. When electrical contact is established, the detector device 150 detects that the zero dose placement has been reached or that the end of the dose dispensing procedure has been reached. In this way, no separate detector or switch is required to detect a specific longitudinal position of the first element 100 relative to the second element 200. The longitudinal displacement and detection of at least one specific longitudinal position of the first element 100 relative to the second element 200 is easily implemented in the detector device 150 by simply providing another conductive pattern portion 116 on the pattern 104 and another contact tap 168 on the bridging contact 162, the other contact tap, and therefore the third contact tap 168, more or less parallel to the direction of the sliding movement between the first element 100 and the second element 200. It is separated from at least one of the other contact taps 164, 166 along a second possible separation direction D2.

[0188] In FIG. 28, a more detailed implementation of the pattern 104 is shown, which includes a first longitudinal pattern section 120 and a second longitudinal pattern section 122. In principle, the pattern 104 shown in FIG. 28 is very similar to the pattern 104 shown in FIG. 19. Two third pattern parts 114 are provided, which are permanently connected to a voltage supply source V0 via electrical contacts 186. At a longitudinal end of the first pattern part 120 facing away from the second pattern part 122, these two third pattern parts 114 are interconnected with each other. At a longitudinal distance from this longitudinal end, these two third pattern parts 114 are separated from each other by an angular distance of about 75°. At this angular section, one first pattern part 110′ is provided, which is electrically insulated from the third pattern part 114 by an insulating pattern part 112.

[0189] A small but well-defined longitudinal insulating gap is provided between the longitudinal end of the first pattern portion 110' and the interconnection between the two third pattern portions 114. The conductive first pattern portion 110' extends longitudinally almost along the entire first pattern section 120 and intersects with the second pattern section 122. The first pattern portion is electrically insulated from another pattern portion 116 provided in the second pattern section 122. The longitudinal end of the first pattern portion 110' located in the second pattern section 122 is electrically connected to a first input terminal 152 of the detector device 150. Another first pattern portion 110 includes elongated stripes 126 that are substantially identically shaped to the pattern portion 110'. This pattern portion 110 is connected to a second input terminal 154 via an electrical contact 186. Moreover, the further first pattern portion 110 extends across substantially the entire first pattern section 120 and the second pattern section 122 .

[0190] Only one of the third pattern portions 114 extends longitudinally through the entire second pattern section 122. Here, the longitudinal end of the third pattern portion 114 located in or on the second pattern section 122 is connected to an electrical contact 186 and therefore to a voltage supply source.

[0191] The shape, position and angular separation of the multiple pattern portions 110, 110', 112 and 114 of the first pattern section 120 are strongly similar to the pattern 104 illustrated in FIG. 9, resulting in a 2-bit orthogonal coding. In the second pattern section 122, the angular width of the third pattern portion 114 is reduced to 30°. The intermediate space of the second pattern section 122 between the first pattern portions 110, 110' and the third pattern portion 114 is substantially filled by the fourth pattern portions 116. These fourth pattern portions 116 are electrically interconnected. Each of the fourth pattern portions 116 is connected to an electrical contact 186. Each electrical contact is connected to a zero dose input terminal Z of the detector device 150.

[0192] The operating principle of this two-bit encoding with auxiliary zero dose position detection is illustrated in Figures 14-17 and with reference to Figures 24-26. The bridging contact 162 is fixedly connected to the tubular body 201 of the second element 200 as illustrated in Figure 27. The bridging contact is arranged on the inner tubular side wall of the housing of the injection device 1. As illustrated in more detail in Figure 26, the bridging contact 162 comprises three contact taps 164, 166, 168. The bridging contact 162 further comprises three flexible arms 163, 165, 167. The contact taps 164, 166, 168 are installed at the longitudinal ends, and therefore at the free ends, of the respective flexible arms 163, 165, 167. All arms 163, 165, 167 as well as the respective contact taps 164, 16 6, 168 are electrically interconnected. The bridging contact 162 may comprise a piece of sheet metal.

[0193] As shown generally and as described above, the first contact tap 164 and the second contact tap 166 are separated from each other along a first separation direction D1. The first separation direction D1 may coincide with a tangential or circumferential direction of the tubular pattern 104. The first and second contact taps 164, 166 are disposed at the same longitudinal position. The third contact tap 168 is located at a longitudinal distance from at least one of the first and second contact taps 164, 166. The third contact tap is typically longitudinally separated from both the first and second contact taps 164, 166 along a second separation direction D2.

[0194] The contact taps 164, 166, 168 are integrally formed with the flexible arms 163, 165, 167. The contact taps may each include an embossed portion projecting radially inward. The contact taps 164, 166, 168 may include a semi-dome shaped structure and therefore project radially inward from the substantially planar faces of the flexible arms 163, 165, 167. In this manner and due to the significant radial projections of the contact taps 164, 166, 168, good and reliable mechanical and therefore electrical contact is provided between the contact taps 164, 166, 168 and the conductive structure and therefore to the multiple pattern portions 110, 114, 116 of the pattern 104 of the first element 100. Typically, the flexible arms 163 , 165 , 167 and the radial projections of the respective contact taps 164 , 166 , 168 provide a type of radial preload as the first element 100 is disposed inside the hollow tubular second element 200 .

[0195] A comparison of Fig. 24 and Fig. 25 reveals the function of the third contact tap 168. In Fig. 24, the first element 100 has a non-rotational distal sliding movement relative to the second element 200 and therefore relative to the multiple bridging contacts 162, 162'. In the configuration of Fig. 24, the first element 100 is close to the zero-dose position but has not yet reached this zero-dose position. Here, the first pattern portion 110 is in electrical contact with the third pattern portion 114 via the bridging contacts 162. In this configuration, the third contact tap 168 is located in the first pattern section 120. Hence, the third contact tap is located distal to the boundary line 121.

[0196] Now, when the first element 100 approaches and reaches the zero dose position relative to the second element 200, and therefore relative to the reference element 160 shown in FIG. 25, the third contact tap 168 has crossed the boundary line 121 and is in electrical contact with the fourth pattern portion 116, while the first contact tap 164 remains in electrical contact with the third pattern portion 114. In this way, the supply voltage present in the third pattern portion 114 is also brought to the fourth pattern portion 116. As shown in FIG. 28, the input terminal Z of the detector device 150 is then coupled to the supply voltage and switches from logic 0 to logic 1, since the zero dose position shown in FIG. 26 has been reached. In this way, the zero dose position of the first element 100 relative to the second element 200 is accurately detected at the end of the dose dispensing procedure.

[0197] 29-37, another example of a detector device 50 is illustrated generally. Here again, the first element 100 includes a dial 180 or dial extension including a radially enlarged head section 184 with an annular outer gripping surface. The dial 180 further includes a longitudinally extending dial sleeve 182 rigidly connected to or integrally formed with the head section 184.

[0198] The first element 100 includes a high degree of similarity compared to the examples described above. The tubular first element 100 includes a tubular surface 102, which is actually an outer surface 106. On this outer surface, a pattern 10 4 is provided. The pattern 104 includes a first pattern section 120 and a second pattern section 122. The first pattern section 120 extends over almost the entire longitudinal extension of the dial sleeve 182. The second pattern section 122 is located at or near the distal end of the first element 100, and therefore at the distal end of the dial sleeve 182. The pattern 104 includes a number of pattern portions 110, 112. The pattern portion 110 is electrically conductive. The pattern portion 112 is electrically insulating. A fourth pattern portion 116 is further provided, which is located exclusively in the second pattern section 122. The pattern portions 110, 112 include elongated shapes. These pattern portions form a stripe pattern 124 including a number of elongated or rectangular stripes 126.

[0199] The detector device 50 comprises at least one electric sensor 51 arranged on a second element 200, which second element is not specifically illustrated in the series of Figures 29-37. The at least one electric sensor 51 comprises or forms at least one reference element 60. The at least one electric sensor 51 is fixedly attached and / or arranged on an inwardly facing surface of the second element 200.

[0200] As shown in FIG. 29, the at least one electrical sensor 51 includes three electrical contact taps 52, 53, 54. The contact taps 52, 53, 54 are located at the same longitudinal position. The contact taps are separated along a first separation direction D1, and thus along a tangential direction of the tubular shape of the surface 102. The multiple contact taps 52, 53, 54 are configured to be in electrical contact with the pattern portions 110, 112, or such that the pattern 104 rotates relative to the reference element 60, and thus the first element 100 rotates relative to the second element 200. The distance and / or separation between adjacent contact taps 52, 53, 54 along the first separation direction D1 is typically smaller than the width of the conductive pattern portion 110 in the respective separation direction D1.

[0201] It is also conceivable that the total separation distance of the two outer contact taps 52, 53 along the first separation direction D1 is smaller than the width of each of the first pattern portions 110.

[0202] An example of an electrical circuit is shown diagrammatically in Figure 30, showing three contact taps 52, 53, 54. The two outer contact taps 52, 54 are each permanently connected to respective input terminals A, B of the detector device 50. These two contact taps 52, 54 are connected to respective resistors R A and R B 31-34, which are diagrams illustrating a number of rotational states of the pattern 104 relative to the reference 60.

[0203] Here, the position of the contact tap 52 is designated A, the position of the contact tap 53 is designated G and the position of the contact tap 54 is designated B. In the configuration shown in FIG. 31, all three contact taps are electrically connected to each other via the conductive pattern portion 110. When the pattern 104 rotates, only one of the contact taps, namely the contact tap 54, is no longer in contact with the conductive pattern portion 110. As shown in FIG. 32, the contact tap 54, and therefore the contact B, is electrically connected to the insulating pattern portion 112. As a result, the contact tap 54 is no longer connected to the contact tap 53 and therefore to ground. As a result, the respective input terminal B of the detector device 50 is switched to logic 1, while the other input terminal A connected to the contact tap 52 remains at logic 0.

[0204] If the pattern 104 is rotated further in the same direction, both the contact tap 54 and the contact tap 53 are electrically isolated, since both are electrically connected to the insulating pattern portion 112. In this case, it is only important that the contact tap 53, and therefore the grounded contact tap 53, is electrically isolated from the other two contact taps. As shown in Fig. 33, both input terminals A and B become logic 1. As pattern 104 is further rotated, as shown in Fig. 34, both contact taps 53 and 54 are electrically connected via another conductive pattern portion 110'. In response, input terminal B switches to logic 0, while input terminal A is electrically connected to insulating pattern portion 112. In response, the respective input voltages are sensed at the input terminals of detector device 50.

[0205] The angular width or tangential extension of the conductive pattern portions 110, 110' may be equal to 45° or may be within a range of 45°. The extension or size of each of the insulating pattern portions 112 is significantly smaller than the extension or width of the first pattern portions 110, 110'. The extension or size of the first pattern portions 110, 110' may be three times as large as the width or size of each of the second pattern portions 110 along the first separation direction D1. The angular width of the second pattern portion 110 may be approximately 15°. In this way, a binary incremental quadrature encoder is implemented. The stripe pattern 124 extends in the longitudinal direction and is therefore invariant with respect to the longitudinal displacement of the first element 100 with respect to the second element 200.

[0206] In Fig. 35 and Fig. 36, another detector device 50 is illustrated diagrammatically. Here, the at least one electrical sensor 51 includes a switch 55 operable to mechanically engage at least one of a radial recess, a depression or a radial protrusion of the first element 100. Here, as also illustrated in Fig. 35 and Fig. 36, the first element 100 includes a radial stepped portion 181 longitudinally adjacent to the dial sleeve 182. The stepped portion 181 forms a neck of a radially wider head section 184. The switch 55 protrudes axially from the body 201 of the second element 200. The switch extends in the proximal direction 3 and is configured to engage the stepped portion 181 when the first element 100, and thus the dial 180, returns to the zero dose or end dose configuration illustrated in Fig. 36.

[0207] The radial position of the switch 55 overlaps with the radial position of the stepped portion 181. When the dial 180 and therefore the first element 100 return to the initial state shown in Fig. 36, the switch 55 is depressed in the distal direction 2. When the electromechanical switch 55 is depressed at the end of the dose dispensing procedure, a respective electrical signal is generated that can be processed by the detector device 50 located or embedded in the second element 200.

[0208] As an alternative, or in addition to the electromechanically implemented switch 55, a second pattern section 122 is provided at the longitudinal or distal end of the first element 100, as shown in Figure 37, where the fourth conductive pattern section 116 includes an annular shape and is longitudinally separated from the stripe pattern 124 confined to the first pattern section 120.

[0209] The electrical sensor 51, therefore the reference element 60 mounted and arranged on the second element 200, comprises two contact taps 52, 54, which are arranged at the same longitudinal position with a given separation distance in the tangential direction. When the first element 100 approaches and reaches the end-of-dose or zero-dose configuration shown in FIG. 36, the contact taps 52, 53 overlap the fourth conductive pattern portion 116. In effect, the two contact taps 52, 53 are electrically connected via the fourth pattern portion 116. As a result, an electrical circuit including the two contact taps 52, 53 is closed by the pattern portion 116 and a respective electrical signal is generated.

[0210] Another example of a pattern 104 is shown in Figure 38. Here, the pattern 104 includes a longitudinally extending stripe pattern with first and second pattern portions 110, 112 alternatingly arranged along the circumference or tangential direction of the tubular first element 100. Here, the first pattern portion 110 is radially elevated and therefore protruding radially outward. , longitudinally extending ribs or ridges 130. The second pattern portion 112 includes respective radial depressions or grooves 132.

[0211] To implement the binary encoding, at least two electromechanically implemented switches 56, 57 are provided which are radially preloaded. The switches 56, 57 are electrically connected to at least one electrical sensor 51. The switches 56, 57 become conducting and / or non-conducting upon tangential or circumferential rotation of the raised ridges 130 and / or grooves 132.

[0212] Also shown is an axially or longitudinally actuated switch 55 which is depressed by a stepped portion 181 at the distal end of head section 184 of dial 180, as described above in connection with Figures 35 and 36.

[0213] 39-41, another example of an arrangement of five contact taps forming a reference element 60 is illustrated diagrammatically, where a five-bit absolute code is provided to uniquely define each of the 24 rotational positions of the first element 100 relative to the second element 200.

[0214] 40 and 41 is again a longitudinal stripe pattern 124 that includes a number of first pattern portions 110 that are electrically conductive and a number of electrically insulating pattern portions 112. In contrast to the above examples, all conductive pattern portions 110 are electrically connected at the proximal or distal end of the pattern 104 via annular pattern connecting portions 111.

[0215] The multiple contact taps 52, 53, 54 and two further contact taps shown in Fig. 39 are located at 0°, 60°, 135°, 225° and 300° of the inner circumference of the second element 200. The pattern 104 is characterized as a binary pattern, with a zero indicating a 12° extension of the electrically insulating second pattern portion 112 and a logical one indicating a 15° tangential extension of the conductive first pattern portion 110. To that extent, for a given arrangement and distribution of the five contact taps 52, 53, 54 shown in Fig. 39, the code, and therefore the pattern 104, may include the following configuration: 000001110000111011100011. Thus, an initial non-conductive pattern portion 112 extends tangentially over 75°, followed by a 45° wide conductive pattern portion 110, followed by a 60° insulating pattern portion 112, followed by a 45° wide conductive pattern portion 110, followed by an insulating pattern portion 112 with a width of 15°, followed by another conductive pattern portion 110 with a width of 45°, followed by the insulating pattern portion 112 with a width of 45°, and finally followed by a conductive pattern portion with a width of 30°.

[0216] This code in conjunction with the arrangement of the five contact taps 52, 53, 54 of the electrical sensor 51 provides an absolute code for 24 unique positions. If it is assumed that the first element is rotated a little more than three times during dialing to give 80 possible rotational positions, each rotational position is inferred from the order in which the codes appear, giving a pseudo-absolute coding solution for every dialing dose. Furthermore, the unique code for each achievable rotational position of the first element 100 relative to the second element makes it possible to apply error checking algorithms when decoding the signals from the multiple contact taps 52, 53, 54. For example, if a "23 units" code was observed when dialing between 2 and 3 units, it would be obvious that this code was an artifact of the transmission and would not be counted, since it is not possible to move directly from the 2 unit position to the 23 unit position.

[0217] At the zero element position, and therefore at the end of the dose dispensing procedure, and when the first element 100 reaches its most distal position relative to the second element 200 at the end of the dose dispensing procedure, all five contact taps 52, 53, 54 are connected to the pattern connection portion 1 at the proximal end of the first element 100. 39-41 provides an increased level of robustness compared to incremental dose counting systems.

[0218] In all of the above examples, the use of electrical contact taps or switches allows the detector apparatus 50, 150 to be low power consuming and the device can remain powered on during its lifecycle, eliminating the need to separately detect mode shifts when the device is dispensed. This low power consumption, combined with the use of short range wireless communication technology, for example, for the communication unit 195, allows for small batteries and simple microcontroller implementations, making the examples suitable for embedding in disposable pen injection devices.

[0219] The detector device 50, 150 described herein can be implemented and embedded in the disposable injection device 1. The detector device 50, 150 can remain powered on for the duration of its life cycle. The detector device can remain dormant by default. The integrated circuit, and therefore the microcontroller of the detector device 50, 150, can be woken up by the first change in the electrical sensor 51, 151 observed the first time the first element 100 makes a movement relative to the second element 200.

[0220] The conductive pattern 104, particularly the conductive pattern portions 110, 114, 116, is realized by creating the pattern 104 on the tubular surface 102 using a carbon-based conductive ink. Such carbon-based inks are available at low cost and, when combined with a suitable thinning agent, are suitable for application by rotary tampon printing, which is a mass production process. Moreover, to reduce the electrical resistance of the conductive ink, it is possible to mix a miscible silver-based ink with the carbon-based ink. In addition, to improve the wear resistance, a hardener is added to the ink, which is specifically designed to improve the mechanical properties of the ink under sliding contact.

[0221] Optimized combinations of the above examples with carbon inks, diluents to reduce viscosity, conductive additives such as silver to reduce electrical resistance, and hardeners to improve mechanical wear are possible to achieve all of the required attributes.

[0222] Because the first element 100 only rotates or spirals relative to the second element 200 during one of the first and second movements, e.g., only during dose setting, the angular position of the first element relative to the second element at the end of a successive dose dispensing procedure changes with each non-integer number of revolutions of the dose dial 180 relative to the second element 200. This results in a regular change in the position of the electrical contact taps 52, 53, 54, 164, 166, 168 relative to the pattern 104, which essentially reduces mechanical wear and abrasion as the pattern 104 moves relative to the contact taps 52, 53, 54, 164, 166, 168.

[0223] In order to reduce the wear and / or abrasion of the conductive pattern 104, the second element 200 may comprise at least one cleaning pad 210, which is located at a distance along at least one of the first and second directions of movement from the at least one electrical contact tap 52, 53, 54, 164, 166, 168. Such an example is illustrated in FIG. 42. A contact tap 164 arranged on the second element 200 is assigned at least one cleaning pad 210, 211, 212, 213. The cleaning pads 210, 211 are longitudinally separated with respect to the contact tap 164. The cleaning pads 210, 211 are arranged in the same tangential position as the contact tap 164. When the first element 100, for example, undergoes a non-rotational longitudinal sliding displacement distally relative to the second element 200, the cleaning pad 211 cleans the pattern 104, which is located at a distance from the contact tap 164. 64. As the first element 100 undergoes a proximal sliding non-rotational movement, a cleaning pad 210 located proximally from the electrical contact taps 164 provides cleaning of each of the conductive patterns 104.

[0224] The same is valid for further cleaning pads 212, 213 arranged along a helical trajectory that corresponds to the helical movement of the first element 100 relative to the second element, for example during dose setting. Here the contact tap 213 is offset proximally, tangentially and longitudinally from the contact tap 164. The other contact tap 212 is arranged at a distal longitudinal offset and at a given tangential offset depending on the lead of the helical movement between the first element 100 and the second element 200.

[0225] As further shown in the cross section shown in Fig. 43, the cleaning pads 212, 213 can be elastically deformable and / or pivotable with respect to the longitudinal direction as a deformation or pivot axis. The cleaning pads 212, 213 can be elastically deformable like a windscreen wiper. When the first element 100 rotates, for example clockwise relative to the second element 200, the contact surface between the cleaning pads 212, 213 can be increased by elastic deformation of the radially protruding tips of the cleaning pads 212, 213 or by a respective rotational or tilting movement of the respective contact taps 212, 213. [Explanation of symbols]

[0226] 1. Injection device 2 Distal direction 3 Proximal direction 4. Dose escalation 5 Direction of dose reduction 6 Cartridges 7 Stopper 8 Driving mechanism 10. Housing 11 Trigger 12 Dial 13 Dosage window 14 Cartridge holder 15 Syringe needle 16 Inner needle cap 17 Outer needle cap 18 Protective Cap 20 Piston rod 25 barrels 26 Encapsulating materials 28 Sockets 50 Detector device 51 Electrical Sensors 52 Contact Tap 53 Contact Tap 54 Contact Tap 55 Switch 56 Switch 57 Switch 60 Reference Elements 100 First Element 102 Tubular Surface 104 Patterns 106 Exterior 110 Pattern part 111 Pattern connection part 112 Pattern part 114 Pattern part 116 Pattern part 120 Pattern Section 121 Border 122 Pattern Section 124 Stripe Pattern 126 Stripes 130 uplift 132 Groove 150 Detector Equipment 151 Electrical Sensor 152 Input terminal 154 Input terminal 156 Supply Voltage 160 Reference Elements 161 Main unit 162 Bridging Contacts 163 Arm 164 Contact Tap 165 Arm 166 Contact Tap 167 Arm 168 Contact Tap 180 Dial 181 Stepped section 182 Dial Sleeve 184 Head Section 185 Receptacle 186 Electrical Contacts 187 Side wall 188 Batteries 190 Printed Circuit Board 191 processors 192 Integrated Circuits 193 Storage device 194 Cover 195 Communication Unit 196 Closing part 200 Second Element 201 Tubular body 202 Retaining Cap 210 Cleaning Pad 211 Cleaning Pad 212 Cleaning Pad 213 Cleaning Pad

Claims

1. 1. An injection device for setting and injecting a preset or user-selectable dose of a medication, comprising: an elongate housing (10) defining a longitudinal direction (z) and configured to receive a cartridge (20) containing a medicament; a detector device (50) operable to detect relative movement between the first element (100) and the second element (200), wherein the first element (100) undergoes a first movement relative to the second element (200) along a first longitudinal direction (3) for setting a dose, and wherein the first element (100) undergoes a second movement relative to the second element (200) along a second longitudinal direction (2) for dispensing a dose, one of the first and second movements being a helical movement and the other of the first and second movements being a sliding movement in a longitudinal direction (z); The second element (200) comprises at least one reference element (60; 160) fixed to said second element (200), The first element (100) comprises a tubular surface (102) with a pattern (104) facing towards the reference element (60; 160), The injection device includes at least one electrical sensor (51; 151) that is arranged on one of the first element (100) and the second element (200) and is operable to detect a position change of the pattern (104) relative to the at least one reference element (60; 160) and to generate at least one electrical signal in response to a position change of the pattern (104) during at least one of a first movement and a second movement of the first element (100) relative to the second element (200).

2. 2. The injection device of claim 1, wherein the pattern (104) comprises at least a first pattern portion (110) and a second pattern portion (112) that does not overlap with the first pattern portion (110), and the first pattern portion (110) and the second pattern portion (112) exhibit differences with respect to at least one of the following parameters: electrical conductivity, light transmittance, light reflectance, magnetic susceptibility, electrical susceptibility, and radial position relative to a central axis of the tubular surface (102).

3. An injection device according to any one of claims 1 to 2, wherein the longitudinal extension of the pattern (104) is equal to or greater than the maximum longitudinal displacement of the first element (100) relative to the second element (200).

4. 4. The injection device according to claim 1, wherein the pattern (104) comprises a first pattern section (120) and a second pattern section (122), the first pattern section (120) and the second pattern section (122) being arranged without overlapping on the tubular surface (102), and the second pattern section (122) being separated from the first pattern section (120) in the longitudinal direction (z).

5. 5. The injection device of claim 4, wherein the first pattern section (120) comprises a stripe pattern (124) including several parallel oriented longitudinal stripes (126), the longitudinal stripes (126) extending parallel to the longitudinal direction (z) or the longitudinal stripes (126) extending at a predetermined angle to the longitudinal direction (z).

6. An injection device as claimed in claim 4 or 5, wherein the detector arrangement (50; 150) is operable to detect longitudinal overlap of the reference element (60; 160) with at least one of the first pattern section (120) and the second pattern section (122), regardless of the rotational state of the first element (100) relative to the second element (200).

7. An injection device according to any one of claims 1 to 6, wherein the pattern (104) comprises at least a first pattern portion (110) that is electrically conductive and at least a second pattern portion (112) that is electrically insulating.

8. 8. The injection device according to claim 7, wherein the detector arrangement (50; 150) comprises at least one electrical contact tap (52, 53, 54; 164, 166, 168) arranged on the second element (200) and operable to alternately couple to the first pattern portion (110) and the second pattern portion (112) of the pattern (104) when the first element (100) undergoes one of a first movement and a second movement relative to the second element (200).

9. An injection device as described in claim 7 or 8, wherein the pattern (104) comprises at least a third pattern portion (114) that is electrically conductive, and the first pattern portion (110) and the third pattern portion (114) are electrically isolated.

10. 10. The injection device according to claim 9, wherein the detector device (150) and the at least one electrical sensor (151) are arranged on the first element (100), the at least one electrical sensor (151) is electrically connected to the first pattern portion (110), the at least one reference element (160) is arranged on the second element (200), and the injection device comprises an electrical bridging contact (162) configured to alternately establish and interrupt electrical contact between the first pattern portion (110) and the third pattern portion (114) when the first element (100) makes one of a first movement and a second movement relative to the second element (200).

11. 11. The injection device of claim 10, wherein the electrical bridging contact (162) includes a first electrical contact tap (164) and a second electrical contact tap (166), the first electrical contact tap (164) and the second electrical contact tap (166) being electrically connected, and the first electrical contact tap (164) and the second electrical contact tap (166) being spatially separated from each other along a first separation direction (D1) parallel to a distance between the first pattern portion (110) and the third pattern portion (114).

12. 12. The injection device of claim 11, wherein the electrical bridging contact (162) includes a third electrical contact tap (168) spatially separated from at least one of the first electrical contact tap (164) and the second electrical contact tap (166) along a second separation direction (D2) non-parallel to the first separation direction (D1).

13. An injection device according to any one of claims 10 to 12, wherein the electrical bridging contact (162) comprises a body (161) made of sheet metal and comprising at least one flexible arm (163, 165, 167), and at least one of the first electrical contact tap (164) and the second electrical contact tap (166) is arranged at a free end of the at least one flexible arm (163, 165, 167).

14. 14. The injection device according to any one of claims 8 to 13, further comprising at least one cleaning pad (210, 211, 212, 213) arranged on or in the second element (200) at a distance along at least one of the first movement and the second movement from the at least one electrical contact tap (52, 53, 54; 164, 166, 168).

15. A length of longitudinal movement of the first element (100) relative to the second element (200) during the first movement is the same as a length of longitudinal movement of the first element (100) relative to the second element (200) during the second movement, and at least one of the contact taps (164, 166, 168) is in a position that is substantially parallel to the first element (100) before the first element (100) and the second element (200) make the first movement.

14. The injection device according to claim 10, wherein when the first element (100) is in a first rotational position relative to the pattern (104) during one of the first and second movements, and the helical movement of the first element (100) relative to the second element (200) during one of the first and second movements comprises a non-integer number of rotations of the first element (100) relative to the second element (200), at least one of the contact taps (164, 166, 168) is in a second rotational position after completion of the second movement, the second rotational position being different from the first rotational position.

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