Actuation units for drug delivery devices and related articles

Abstract

Disclosed is an actuation unit (301) for a drug delivery device (100), comprising: - a support structure (300) extending along a longitudinal axis (A) between a distal (D) portion of the support structure (300) and a proximal (P) portion of the support structure (300); - an interface unit (IF1, IF2) arranged in the support structure (300) and including a coupling portion (340) and an actuation portion (332); Including, The coupling portion (340) is configured to interact with a rotating member, the rotating member including a plurality of teeth (404a) and rotating about a rotation axis (A) parallel or coaxial with the longitudinal axis (A); The actuating portion (332) is configured to interact with the electrical component (Sw); the interface units (IF1, IF2) are configured to interact with the plurality of teeth (404a) of the rotating member and convert a rotational movement (R) of the rotating member into an axial displacement (Arr7Bp) in a first direction, e.g., from a first axial position to a second axial position, of the coupling portion (340) relative to the longitudinal axis (A) and into a radial displacement of at least a portion of the coupling portion (340) relative to the longitudinal axis; Axial and / or radial displacement of the coupling portion (340) displaces the actuation portion (332). An actuation unit (301) for a drug delivery device (100).

Description

[Technical field]

[0001] The present disclosure relates to an actuation unit for or of a drug delivery device. Further, the present disclosure relates to a rotating member interacting with the actuation unit, and to a drug delivery device comprising the actuation unit and / or the rotating member. [Background technology]

[0002] The drug delivery device may be a manually or semi-automatically operated device such as an autoinjector or a user-actuated pen injector with or without a dial extension. In autoinjectors and semi-automatically operated (spring-driven) devices, an energy storage element may be used to deliver the driving force for the injection operation. The energy storage element may be activated at the factory or by the user prior to use. The drug may include insulin or GLP-1 (glucagon-like peptide). However, other drugs may be injected. Additionally, other medical devices (e.g., injectors, nebulizers, or inhalation devices) may also benefit from the present disclosure.

[0003] Typically, drug delivery devices may include many mechanical components. However, there may be a desire to use electronic components along with the mechanical components. For long-term use of batteries or accumulators for storing electrical energy, power management of electronic circuits may be important. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present disclosure to provide an actuation unit for a drug delivery device. The actuation unit should preferably be easy and / or comfortable to use and / or include as few parts as possible. Furthermore, it should preferably allow easy assembly of the actuation unit itself and / or easy assembly of the actuation unit to the drug delivery device. Furthermore, it should preferably be compact and / or allow the use of known drug delivery devices without or only with minor modifications. Furthermore, corresponding rotating members, drug delivery devices and methods should be provided. [Means for solving the problem]

[0005] This object is solved by an actuation unit according to claim 1. Further embodiments are given in the dependent claims. The subject matter of the other independent claims also solves this object.

[0006] According to one embodiment, there is provided an actuation unit for a drug delivery device, comprising: - a support structure extending along a longitudinal axis between a distal portion of the support structure and a proximal portion of the support structure; and / or an interface unit disposed within the support structure, the interface unit including a coupling portion and an actuation portion; An actuation unit for a drug delivery device is provided, comprising:

[0007] According to one embodiment, the coupling part may be configured to interact with a rotating member, the rotating member including a plurality of teeth and rotating about a rotation axis parallel or coaxial to the longitudinal axis. The rotating member may be a dial sleeve and / or a number sleeve or may be part of the dial sleeve and / or a number sleeve. However, the rotating member may be another rotating part or may be coupled to another rotating part of the drug delivery device.

[0008] According to one embodiment, the actuator may be configured to interact with an electrical component, for example an electrical switch and / or an electrical or electronic sensor unit.

[0009] According to one embodiment, the interface unit may be configured to interact with a plurality of teeth of the rotating member and may be configured to convert a rotational movement of the rotating member into an axial displacement, e.g., in a first axis direction, of the coupling portion relative to the longitudinal axis, e.g., from a first axial position to a second axial position, and a radial displacement, e.g., from a first radial position to a second radial position, of at least a portion of the coupling portion relative to the longitudinal axis.

[0010] According to one embodiment, the axial and / or radial displacement of the coupling part may also displace the actuation part. Thus, a switch may be switched on or off. Alternatively, a sensor unit may detect the displacement of the actuation part and generate a signal that is used to switch on or off other electronic units of the drug delivery device. Thus, the device may be switched from a low energy state to a high energy state, where the drug delivery device uses more electrical energy compared to the low energy state. This means that the electronic units of the drug delivery device may be activated.

[0011] According to one embodiment, the direction and / or amount of radial displacement may be suitable to retain the coupling part, for example by a retaining structure arranged on the rotating member, thereby preventing re-engagement of the coupling part with the teeth of the rotating member during the expulsion of the dose. However, there may be concepts that do not require this "retaining structure" part of the device to function and have the technical effects mentioned in this application or other technical effects.

[0012] According to further embodiments, the retaining structure may be arranged on the teeth of the rotating member. Alternatively, the retaining structure may be arranged inside or outside the teeth, for example with a gap between the retaining structure and the teeth. The retaining structure may be arranged on the rotating member or on a part adjacent to the rotating member, for example a housing part.

[0013] The technical effect of the embodiment may be that after the first axial and / or radial displacement, the rotating member may rotate without further interference from teeth, and only some rotational energy is used, for example to slide on the retaining structure. Thus, it is possible to make losses due to friction low. Thus, the driving force for the injection of the dose of drug, i.e. the force of the drive spring and / or the force generated by the user during injection, may be mainly used for the injection. Thus, it may be possible to activate the electronic circuit of the drug delivery device as soon as possible after the start of rotation of the rotating member. Thus, the energy for the further sensor unit, which detects the rotation of the rotating member or a rotating part connected thereto, may be used efficiently.

[0014] The support structure may be cylindrical or may be cylindrical. The diameter of the support structure may be in the range of 1 cm (centimeter) to 2 cm. The length of the support structure may also be in the range of 1 cm to 2 cm. The amount of radial displacement may be in the range of 0.25 mm (millimeter) to 0.8 mm, or may be at least 0.25 mm. The amount of axial displacement may be in the range of 0.25 mm to 0.8 mm, or may be at least 0.25 mm or at least 0.3 mm or at least 0.5 mm, allowing mass production of parts by cost-effective injection molding and / or allowing high yields and / or allowing the use of larger tolerances sufficient to ensure safe functioning of the actuation unit, especially during interaction with the rotating member.

[0015] The ratio between the amount of axial displacement and the amount of radial displacement may be in the range of 3 to 1, or in the range of 1.5 to 1.

[0016] The axial displacement may be in a proximal direction, for example away from a needle or nozzle of a drug delivery device.

[0017] The radial displacement can be from a first radial location to a second radial location that is radially outward of the first radial location relative to the longitudinal axis or relative to the axis of rotation, however, in other examples, the second radial location can be radially inward relative to the first radial location.

[0018] The radially outward displacement may be achieved using retaining elements at the joint extending transversely to the longitudinal axis and / or using radially extending protrusions on the support structure or on the mechanical actuation element.

[0019] The coupling portion and the actuation portion may be located on the same element, e.g., on a coupling feature, or the coupling portion and the actuation portion may be located on different elements that are mechanically coupled together in any suitable manner.

[0020] According to one embodiment, the interface unit may include a retaining element that retains the coupling part on the retaining part of the retaining element. The retaining element may be attached to the support structure by an attachment part of the retaining element. The retaining element may be elastic (elastically deformable) and / or may be pivotally or pivotally attached to the support structure, thereby allowing distal and radial displacement of the coupling part. An elongated retaining element (arm) or a ring or other structure may be used. A ring or a curved arm may allow another part to be placed in the central opening of the rotatable member.

[0021] There may be no pivot point of the retaining element at the intermediate portion or at the portion attached to the intermediate portion of the retaining element. Thus, only one attachment point or several attachment points at the periphery may be used. This may increase the length of the pivot part measured from the pivot point. The longer the length, the greater the axial and / or radial displacement of the joint may be.

[0022] According to one embodiment, the coupling portion may be configured to interact with an interaction portion on each of the teeth of the rotating member of the drug delivery device such that the rotating member exerts a force, e.g., a circumferential or angular force, on the coupling portion. The rotating member or another part may include at least one retention structure disposed radially outward or radially inward of the interaction portion of the rotating member. The retention structure may include at least one proximally directed surface, the at least one proximally directed surface configured to allow sliding of the distal end of the coupling portion over the at least one proximally directed surface during further rotation of the rotating member.

[0023] Thus, for example, radial outward displacement of the distal end of the mechanical actuation element may be or is used to prevent the coupling from axially returning, for example, to a second pocket, for example, an inner pocket between two teeth of the rotating member. Ramp features may be used on the coupling and / or support structure to facilitate axial movement due to circumferential forces.

[0024] According to one embodiment, the actuation unit may include a coupling feature. The coupling may be included in the coupling feature or may be part of the coupling feature. The coupling feature may include at least one curved surface configured to interact with a guide feature arranged on the support structure when a circumferential force is applied to the coupling by the rotating member, thereby displacing the coupling feature and / or the coupling axially. Thus, conversion of rotational movement into axial movement may be easier. An angled guide feature may be used, see the angled features mentioned in the figure description. Alternatively, as described in more detail below, the curved surface may be used only for the guide feature and not for the coupling feature.

[0025] According to one embodiment, the guiding feature may include at least one curved surface opposing a curved surface of the mating feature, the curved surfaces being, for example, formed complementary to one another at least within each portion, thereby facilitating axial displacement of the mating feature.

[0026] Both curved surfaces may be fully engaged at the start of rotation of the rotatable member. Thus, at least one concave edge of one curved portion may be adjacent to a convex edge of the other curved portion, and / or vice versa. Furthermore, a concave portion of one curved portion may be adjacent to a convex portion of the other curved portion. The radii of curvature of the opposing portions of both curved portions may be the same.

[0027] According to one embodiment, the coupling portion may include at least two distal portions and a recessed portion disposed between the at least two distal portions, for example, the coupling portion may be comb-like with at least two protrusions or claws, e.g., prongs. The recessed portion may be recessed proximally relative to the at least two distal portions. Thus, with this design, the number of positions of the rotating member after dose dial setting may be twice the number of teeth of the rotating member. Thus, a less precise structure may be used for the rotating member and / or the coupling member, compared to the same number of both. This may reduce costs and / or improve the yield of production of the actuating member and / or the rotating member, for example, using injection molding. This may also improve the robustness and / or performance of the rotating member or the components to which it connects.

[0028] According to one embodiment, a first of the at least two distal portions may include a first side of the recessed portion, and a second of the at least two distal portions may include a second side of the recessed portion. The second side may be longer than the first side. This may be by using a sloping surface on the proximal side of the recessed portion. The first side may be at least 10 percent shorter, or at least 20 percent shorter, relative to the length of the second side.

[0029] A third surface of the recess can be disposed between a proximal end of the first surface and a proximal end of the second surface, and thus the recess can be asymmetric with respect to an axis located midway between and / or parallel to the two surfaces.

[0030] The technical effect may be that there is better engagement between the coupling features and the teeth of the rotating member, which may allow for the production of parts with larger tolerances.

[0031] According to a further aspect, a rotating member is disclosed that includes a ring member. According to one embodiment, a plurality of teeth can be circumferentially disposed on the ring member about a rotation axis of the ring member.

[0032] According to one embodiment, each tooth may include an inner portion and an outer portion disposed radially outward of the respective inner portion.

[0033] According to one embodiment, the inner portion may include a first tooth including at least one inclined surface facing proximally relative to the axis of rotation and circumferentially of the ring member. Such a tooth may be known as a crown tooth.

[0034] According to one embodiment, the outer portion may include second teeth of different orientation and / or type compared to the first teeth. Thus, the rotating member may include at least two or at least three different types of sub-teeth arranged on each tooth, for example a first type of teeth at the most radially inner position, a second type of teeth at an intermediate position but radially outside the first type of teeth, and / or a third type of teeth at a radially outer position relative to the intermediate position. Thus, a multifunctional use of the teeth may be possible.

[0035] According to further embodiments, the second teeth may include flat surfaces arranged in a plane perpendicular (e.g., in the range of 85-95 degrees) to the axis of rotation of the rotating member or the ring member. The second teeth may have an angular width greater than the angular width of the first teeth. The second teeth may thus form the above-mentioned retention structure, for example preventing the joints from "falling back" into pockets or spaces between the teeth, for example teeth of the first type. This kind of retention structure may be simplified to manufacture, for example compared to a continuous ring part instead of a separate retention part. However, such a ring structure may have other advantages. Furthermore, such a ring structure may be provided separately from the teeth of the rotating member, for example arranged on another suitable part of the rotating member or the actuation unit or on the drug delivery device.

[0036] According to further embodiments, the proximal-most part of the first tooth or the ramp starting from this proximal-most part of the first tooth may extend to a plane and / or have the same axial position as the adjacent flat surface of the second tooth, which may facilitate e.g. a radial movement / displacement at the end of the axial displacement, since no step or only a small step has to be overcome.

[0037] Alternatively, radially oriented ramp features on the teeth and / or joints may be used to allow for different axial positions of the proximal-most / upper surfaces (proximally facing surfaces) of the first and second teeth to be used.

[0038] According to a further embodiment, each first tooth may have at least one face facing in the same direction as a face, e.g. a rear face, of a second tooth, which may therefore be easier to produce, e.g. injection moulding.

[0039] According to a further embodiment, the teeth may have a constant distance to adjacent teeth, i.e. a constant pitch.

[0040] The outer portion may be adjacent to the inner portion, i.e., with no other portion disposed therebetween, or alternatively, another portion may be disposed between both portions.

[0041] According to one embodiment, the outer portions may each include an inner sub-portion and an outer sub-portion arranged radially outward of the inner sub-portion. The inner sub-portions may be used as retention structures to prevent re-engagement during dose ejection. The inner sub-portions may have an angular width greater than that of the outer sub-portion. It may be possible to connect the inner sub-portions circumferentially to further reduce friction between the coupling and the rotating member.

[0042] The outer sub-part may have further coupling functions and / or may be used as a rotational coding element to measure the expelled and / or dialed dose. Thus, the proximal or radially facing surface or other suitable surface of the outer sub-part may be used as a reflective surface to reflect electromagnetic radiation, e.g. light or infrared, to a sensor used for rotational sensing.

[0043] The inner and outer sub-portions may each have at least one face, or at least two faces, or at least three faces that face in the same direction, e.g., a "top" or proximal face and a rear face and / or a bottom face, when compared to the direction of rotation of the ring member, which may simplify design and / or production.

[0044] Each outer sub-portion may be adjacent to each inner sub-portion, i.e., no other portion may be disposed between them, or another portion may be disposed between both portions.

[0045] According to further embodiments, the rotating member may be made of plastic, for example using injection molding. Thus, the teeth of the rotating member may be integrally formed with the ring member. Cost-effective production may be possible by producing tens or hundreds of parts in one injection into one mold tool.

[0046] According to further embodiments, the rotating member may be part of the number sleeve of the drug delivery device or may be a part connected to the number sleeve, e.g. the drive sleeve. This connection may be a snap connection. Other types of connections may also be used, such as using an adhesive.

[0047] A further aspect is a housing extending along a longitudinal axis, preferably an elongated housing, and / or - a dose setting unit and / or a drug delivery unit arranged in the housing; and / or - an actuation unit as described above, and / or - the rotating member mentioned above The present invention relates to a drug delivery device comprising:

[0048] Therefore, the same technical effects as described above may also be applicable to drug delivery devices.

[0049] According to one embodiment, the actuation unit may be arranged on or in the proximal part of the housing. The actuation unit may include an actuation part of the actuation unit, for example an electrical component that can be actuated by an electrical switch (such as a microswitch) or a sensor, for example a magnetic sensor.

[0050] According to further embodiments, the rotating member may be part of the dose setting unit and / or the dose delivery unit or may be mechanically coupled to the dose setting unit and / or the dose delivery unit. The rotating member may preferably be arranged to interact with the actuation unit.

[0051] The dose setting unit may include, for example, a number or dial sleeve indicating the amount of the selected or dialed dose, and / or a drive sleeve which may be used, for example, to set the dose.

[0052] The drug delivery unit may include a plunger rod and / or a drive sleeve. The drive sleeve may interact with the plunger rod during drug delivery. Alternatively or additionally, a drive spring, such as a torsion spring or a compression spring or a tension spring, may be used. Advanced embodiments may use an electric motor for drug delivery, such as drug injection.

[0053] According to further embodiments, the drug delivery device may be an autoinjector including, for example, a drive spring and / or a distal needle shroud for initiating automatic injection when pressed against the patient's skin. Alternatively, a manually driven device may be used. Additionally, advanced drug delivery devices that may be used may include an electric motor that is used for dose delivery.

[0054] The actuation unit may form a module, preferably an electronic module / actuation unit. The module may be configured for use with at least two drug delivery devices or at least three drug delivery devices. Thus, multiple use of a valuable electronic module may be possible. Alternatively, however, the actuation unit / electronic unit may be an integral part of the drug delivery device, e.g. exchange between two drug delivery devices may not be possible without destroying the actuation unit and / or the first drug delivery device. This may prevent manipulation of the electronic unit and / or the drug delivery device.

[0055] According to a further embodiment, the electronic unit / module comprises a further electronic unit, e.g. connected to the electrical component, i.e. - a processing unit, and / or - a memory unit, and / or - Electronic power management unit, and / or - a communication unit, e.g. short-range communication, Bluetooth, ZigBee, etc.; and / or - at least one sensor unit configured to detect or measure the amount of the delivered and / or set dose, and / or - a detection or measurement unit, which for example comprises at least one sensor unit may include.

[0056] The sensor unit may include at least one optical sensor. However, other sensor principles, preferably contactless sensors, such as magnetic, capacitive, inductive, etc., may also be used. However, sensors making mechanical contact may also be used.

[0057] According to one embodiment, the dose setting unit and / or the dose delivery unit may be configured to position the rotating element in one of several positions. The number of teeth, e.g. inner teeth, of the rotating element may be equal to half the number of positions. This may have the technical effect that accurate positioning of the coupling may still be possible for a larger number of positions, e.g. by using a protruding or comb-like coupling. By reducing the number of teeth for a given diameter of the rotating element, larger teeth may be used. Thus, production yields may be improved and / or larger tolerances may be selected.

[0058] According to one embodiment, at least one, at least two, at least three, or all of the following formulas may be valid: - W1a>W2a, (1), Wherein W1a can be the angular width of the recess or the recess of the joint; and where W2a may be the angular width of the internal teeth or the internal teeth of the rotating member. Preferably, W1a may be at most 1 percent or 5 percent longer than W2a; and / or - D2b>W1b, (2), where D2b is the angular distance between the rear face of the first one of the inner teeth and the front face of the adjacent inner tooth; where W1b is the angular width of the bond, e.g., the distal width. Preferably, D2b may be at most 1 percent or 5 percent longer than W1b; and / or - W3a>W1a, (3), where W3a is the angular width of the inner sub-portion of the outer portion; and In the formula, W1a is the angular width of the recessed portion or the recessed portion of the joint. Preferably, W3a may be at least 10 percent longer than W1a. The upper limit may be appropriately selected, for example at most 30 percent or at most 50 percent longer; and / or - W1b>D3b, (4), In the formula, W1b is the angular width of the bond. Preferably, W1b may be at least 5 percent or at least 10 percent longer than D3b. The upper limit may be appropriately selected, for example at most 30 percent or at most 50 percent longer. where D3b is the angular distance between the rear face of the inner sub-portion of the outer portion and the front face or leading edge of the adjacent inner sub-portion of the adjacent outer portion.

[0059] Equations (1) and (2) can ensure that the coupling portion engages with the teeth of the rotating member even if there are more relative positions of the rotating member after dialing and / or delivery of a dose compared to the number of teeth of the rotating member, e.g., the internal teeth. Thus, the number of positions may be, for example, twice the number of internal teeth, e.g., there may be, for example, 24 positions and only 12 teeth at the same radial position.

[0060] Equations (3) and (4) can ensure that the coupling does not re-engage with the inner teeth when the coupling, or at least a portion of the coupling, is in a radially deflected position, e.g., the coupling may slide on the inner sub-portion of the outer portion described above. The outer sub-portion of the outer portion may be optional.

[0061] According to one embodiment, the coupling portion may be configured to interact with an interaction portion, e.g., an inner tooth, on each of the teeth of the rotating member of the drug delivery device such that the rotating member can exert a force on the coupling portion. The rotating member may include at least one retaining structure disposed radially outward of the interacting portion of the rotating member. The retaining structure may include at least one proximally directed surface, the at least one proximally directed surface configured to allow sliding of a distal end of the coupling portion over the at least one proximally directed surface during further rotation of the rotating member.

[0062] According to a further embodiment, the actuation unit may include a coupling feature, the coupling feature may be included within the coupling feature, the coupling feature may include at least one curved surface configured to interact with a guiding feature disposed on the support structure upon application of a circumferential force to the coupling feature, thereby displacing the coupling feature axially.

[0063] According to a further embodiment, the coupling feature may include two distal portions and a recessed portion disposed between the two distal portions.

[0064] According to one embodiment, it may be of the following formula: - W3a>W3b, (5), where W3a may be the angular width of the inner sub-portion of the outer portion; and W3b may be the angular width of the outer sub-portion of the outer portion.

[0065] W3a may be at least 10 percent longer than the length W3b. The upper limit of W3a may be appropriately selected, for example at most 30 percent or at most 50 percent longer than W3b. The outer sub-part may have at least one further function, such as a coupling function to at least one further mechanical element of the drug delivery device. The outer sub-part may be used as a rotary coding element to measure the expelled and / or dialed dose. Alternatively, a rotary coding element, such as a coding ring, may be engaged with the outer sub-part. Thus, the proximal or radially facing surface or other suitable surface of the outer sub-part or the additional encoder ring may be used as a reflective surface to reflect electromagnetic radiation, such as light or infrared light, to a sensor used for rotation detection.

[0066] One aspect is a method of operating a drug delivery device, comprising the steps of: - pushing the actuation unit distally, thereby engaging the coupling portion with the teeth of the rotating member, whereby preferably the actuation portion of the actuation unit does not actuate the electrical component; and - thereafter rotating the rotating member, thereby disengaging the coupling part from the pocket formed between adjacent teeth, whereby the actuation part or the actuation part of the actuation unit acts on the electrical component; - thereafter preventing the coupling part from re-engaging in the pocket between the teeth, for example by using a retaining structure arranged radially outwardly or radially inwardly with respect to the teeth, so that preferably the actuating part of the actuating unit can further act on the electrical component; The present invention relates to a method comprising the steps of:

[0067] The technical effect of this may be that after the first and only axial displacement of one working cycle, the rotating member may rotate without further interference from the teeth, i.e. only some rotational energy may be used for the first axial and / or radial displacement and the subsequent sliding of the coupling on the retaining structure. Low friction losses may occur.

[0068] According to further embodiments there may be at least one further method step. - Stop pressing the actuation unit, - preferably thereafter disengaging the coupling from the retaining structure, e.g. to establish an original configuration, e.g. a released configuration.

[0069] According to further embodiments, the main electronic unit of the electronic unit / module of the drug delivery device can be woken up by activating the electrical components. Thus, a second energy state, which is more energy consuming than the first energy state, e.g. a sleep state, can be used, thereby extending the life of the battery or accumulator and / or the time between two charging events of the accumulator of the drug delivery device and / or the electronic unit.

[0070] According to further embodiments, the method may use the above-mentioned actuation unit and its embodiments. Thus, the same technical effects as those described above may also apply to the method. Vice versa, the method may be used to operate the above-mentioned actuation unit. Thus, the technical effects of the method may be valid for the actuation unit. With regard to the application of the method, the same is also valid for the rotating member and / or the drug delivery device and vice versa.

[0071] According to further embodiments of the method, a guide feature, for example on the support structure (chassis) of the actuation unit, may be used to initiate the proximal displacement of the coupling. A tooth ramp may then be used to further displace the coupling. The following technical effects may be achieved: large engagement between the coupling and the rotatable member and / or a relatively low rotational force required to initiate and execute the proximal movement / displacement of the coupling. Moderate steepness of the angled or ramped surfaces of the coupling / coupling feature and / or of the guide feature.

[0072] According to a further embodiment, at the end of the proximal displacement, a radial displacement of the coupling part can be performed. The radial displacement can be radially outward or radially inward. The radial displacement can be used, for example, to move a distal face of the coupling part onto a retention structure, for example a retention structure arranged on the rotating member, in particular on the teeth of the rotating member.

[0073] According to further embodiments, instead of the retaining structures arranged on the teeth, an annular retaining ring (sleeve) can be used, e.g. a circular sleeve, which can rotate with the rotating member and / or surround the teeth of the rotating member.

[0074] The next aspect relates to a system. According to an embodiment, the system may include a drug delivery device and / or an electronic module. According to an embodiment, the drug delivery device may include a rotating member including a plurality of teeth. According to an embodiment, the electronic module may include an electric component and / or an electric energy source and / or an energy management unit electrically connected to at least one electric component. According to an embodiment, the energy management unit may be configured to switch from a low energy state to a high energy state consuming more electric energy from the electric energy source compared to the low energy state in response to an electric signal generated by the electric component. According to an embodiment, the electronic module may include an interface unit. According to an embodiment, the interface unit may include a coupling portion and an actuation portion configured to interact with the electric component. According to an embodiment, the interface unit may be configured to interact with the plurality of teeth of the rotating member by the coupling portion and to convert a rotational movement of the rotating member into an axial displacement in a first axial direction of the coupling portion relative to a longitudinal axis of the drug delivery device and a radial displacement of at least a part of the coupling portion relative to the longitudinal axis. According to an embodiment, the interface unit may be configured to transmit an axial and / or radial displacement to the actuation part, thereby initiating a switch to a high energy state by the energy management unit. According to an embodiment, the direction and amount of the radial displacement may be suitable to retain the coupling part by the retention structure, thereby preventing re-engagement of the coupling part with the teeth of the rotating member during ejection of the dose.

[0075] According to a further embodiment, the interface unit may be part of an actuation unit, preferably an actuation unit as mentioned above.

[0076] During dose delivery, the rotating member, e.g. the number sleeve and / or the dial sleeve, can rotate and the tilt feature of the rotating member can engage the coupling. This in turn allows the flexible coupling and / or the flexibly arranged coupling to be rotatably supported relative to a support structure, e.g. the chassis, of the electronic module and to be deflected axially, e.g. upwards, relative to the electronic module. Thereby, the interface unit can axially actuate a switch, e.g. a microswitch. Instead of a switch, a sensor unit may be used. The switch or sensor unit can activate a processor, e.g. a microcontroller, and / or can initialize a rotation sensor, e.g. an LED (light emitting diode) or an IR (infrared) LED, of the dose capture system.

[0077] According to one embodiment, the interface unit may be configured to prevent interaction between the actuating part and the electrical component when the coupling part moves in a second axial direction opposite to the first axial direction. Thus, a recess on the coupling part may be used. Alternatively or additionally, the coupling part may have a geometric dimension that allows engagement of the coupling part between two adjacent teeth of the rotating member. Furthermore, other features may be used, such as alignment features that align the rotatable member with respect to the coupling part.

[0078] According to further embodiments, the drug delivery device used in the system may be a drug delivery device according to any one of the above aspects and embodiments. According to further embodiments, the electronic module may include an actuation unit according to any one of the above aspects and embodiments. According to further embodiments, the rotating member may be a rotating member according to any one of the above aspects and embodiments. Thus, the above-mentioned technical effects may be advantageous for the system.

[0079] According to further embodiments, the actuation portion may be located laterally on the interface unit, or on the coupling portion, and / or in a proximal or another suitable location on these or other suitable components.

[0080] According to further embodiments, which may be valid for all aspects, the electronic module may be removable from the drug delivery device. Thus, the electronic module may be removed and / or installed without damaging the electronic module and / or without damaging the drug delivery device. Installation and / or removal of the electronic module may be possible without the use of separate tools. Thus, reuse of valuable parts may be possible.

[0081] Alternatively, the electronic module may be an integral part of the system, and therefore can only be removed by damaging the electronic module and / or damaging the drug delivery device, which approach may interfere with the operation of the electronic module and / or the drug delivery device.

[0082] The making and use of this preferred embodiment is discussed in detail below. It should be understood, however, that this disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.

[0083] Furthermore, the same reference numbers refer to the same technical features unless otherwise stated. When the word "may" is used in this application, it means not only the actual technical implementation but also the possibility of doing so. This concept of the present disclosure will be described in a more specific context, namely, a drug delivery device, particularly a drug delivery device for humans or animals, with reference to the following preferred embodiments. However, the disclosed concept may be applied to other situations and / or configurations as well.

[0084] The above has outlined rather broadly the features and technical advantages of the embodiments of the present disclosure. Additional features and advantages of the embodiments of the present disclosure are described below, e.g., in the subject matter of the dependent claims. It will be appreciated by those skilled in the art that the disclosed concepts and specific embodiments may be readily utilized as a basis for modifying or designing other structures or processes for achieving concepts having the same or similar purposes as those specifically discussed herein. It will also be appreciated by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the present disclosure, as defined in the appended claims.

[0085] For a more complete understanding of the concepts disclosed herein and the advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings, which are not drawn to scale, in which: [Brief description of the drawings]

[0086] [Figure 1] Drug delivery devices. [Diagram 2] Electronic unit. [Diagram 3] FIG. 13 is a cross-sectional view of the inside (e.g., chassis) of the button showing the binding features on the flexible arms or rings. [Figure 4] Number sleeve tooth slope feature. [Figure 5A-5B] The binding feature when the button has moved distally and spans one tooth. [Figure 6A-6B] The binding feature when the button is moved distally and is between the two teeth on the number sleeve. [Figure 7A] A first configuration of ring members, coupling features, and slope features. [Figure 7B-7E] The second configuration to the fifth configuration of the ring member, the coupling feature, and the angled feature. [Figure 8] The coupling features in a biased state, for example biased upwards and radially outward. [Figure 9A-9B] A mating feature configured to fill a gap between the teeth of the number sleeve. [Figure 10] The location of the mating feature that is again located above the inner pocket between the inner portions and is no longer on the top surface of the outer portion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0087] A cylindrical coordinate system may be referenced, i.e., each position may be defined by three coordinates: an axial value (height, distance to the zero plane), a radial distance to the axis, and an angle between the current radial position and a plane defined to have an angle of zero. As used herein, the term "at an axial position" may mean having an axial coordinate.

[0088] The distal end D may be the end closer to the needle than the proximal end P.

[0089] Certain embodiments herein are shown in relation to an injection device in which an injection button and a grip (dose setting member or dose setting part) are combined. In this regard, reference is made to WO 2014 / 033195 A1 or WO 2014 / 033197 A1, which are incorporated by reference for all legal purposes. The injection button may provide at least one user interface member for initiating and / or executing a dose delivery operation of the drug delivery device. The (dial) grip or knob may provide a user interface member for initiating and / or executing a dose setting operation using a dose setting surface, for example a circumferential surface of the (dial) grip or knob. The delivery surface may be used to initiate dose delivery. The delivery surface may be a proximal P surface of the (dial) grip or knob.

[0090] The device may be of the dial extension type, i.e. its length increases during dose setting or dose dial setting. Other injection devices having the same kinematic features of dial extension and button during dose setting and dose ejection operating modes are known, for example, the Kwikpen® and Savvio® devices marketed by Eli Lilly (see, for example, WO 2005 / 018721), and the FlexPen® (see, for example, U.S. Pat. No. 6,004,297), FlexTouch® (see, for example, U.S. Pat. No. 9,108,002) and Novopen® 4 (see, for example, U.S. Pat. No. 5,693,027) devices marketed by Novo Nordisk, or devices of other manufacturers. Therefore, the application of the general principles to these devices is believed to be easy, and will not be described further. Alternatively, the proposed concept may be used in devices that are not of the dial extension type, but are, for example, equipped with a torsion spring that is biased by the rotation of a dial knob. Additionally, fully electromechanical drug delivery devices may be used, including, for example, electric motors.

[0091] However, the general principles of the present disclosure are not limited to its kinematic properties. Certain other embodiments may be envisaged for application to other injection devices, for example from Sanofi, or other manufacturers' devices, for example, where there is a separate injection button and grip component / dose setting member. Thus, there may be two separate user interface members, one for the dose setting action and one for the dose delivery action.

[0092] Fig. 1 shows an electromechanical system 98 according to a first embodiment. The electromechanical system 98 may include a drug delivery device 100 which may include a container holding member 101 for holding a drug container (e.g., a syringe or a cartridge) and a main housing part 102. The container may contain a drug Dr. The main housing part 102 may fully or partially house or surround the container holding member 101 and / or the container and may include further parts of the drug delivery device 100. Alternatively, the main housing part 102 may be connected to the container holding member 101 but may not surround the container holding member 101 or even a part of the container holding member 101 (see dashed lines in Fig. 1).

[0093] The longitudinal axis A of the drug delivery device 100 is indicated by a dashed line in FIG.

[0094] Within the main housing part 102 are the following components: a piston rod 104 adapted to move a piston which may be arranged in the container holding member 101; - a drive mechanism 106 for the piston rod 104 may be disposed. The drive mechanism 106 may include an energy storage element, e.g., a spring, that is manually loaded before each use. Alternatively, the energy storage element may be loaded, e.g., during assembly of the drug delivery device 100. Alternatively, a manually driven drive mechanism may be used without an energy storage element, e.g., used to drive the piston rod 104. - For example, at the proximal end P there is an actuation element 108 that is used to initiate the movement of the piston rod 104 into the container retaining member 101, thereby using the drive mechanism 106. Alternatively, an autoinjector device may be used that is actuated by axial movement of a moveable needle shroud (not shown). In some embodiments, the actuation element 108 may be used to dial in the size of a dose of the drug Dr. A cap 112, which may be attached to the main housing part 102 or to another part of the drug delivery device 100. The cap 112 may be an outer cap which may include a smaller inner cap that directly protects the needle 110.

[0095] If the drug delivery device 100 is not an autoinjector, the dial sleeve can be screwed out of the main housing 102 and pressed by a user to move the plunger 104 distally to inject the drug Dr. The drug delivery device 100 can be a single use or a multi-use device.

[0096] The drug Dr can be expelled from the container through the needle 110 or through a nozzle connectable and / or connected to the distal end D of the drug delivery device 100. The needle 110 can be replaced before each use or can be used several times.

[0097] The system 98 may include an electronic unit 120 mechanically connected to a proximal end region P of the drug delivery device 100, such as the proximal end region P of the actuation element 108. The electronic unit 120 may have a longitudinal axis A that is the same axis as the longitudinal axis A of the drug delivery device 100.

[0098] The electronic unit 120 can be used not only in the drug delivery device 100, but also in other drug delivery devices similar or identical to the drug delivery device 100. Thus, the electronic unit 120 can be a module that is used multiple times, such as in different drug delivery devices 100, such as in different systems 98. Furthermore, the diameter of the drug delivery device 100 is not increased by the electronic unit 120, facilitating good handling of the modular system 98, and in particular the drug delivery device 100.

[0099] Alternatively, the electronic unit 120 may be an integral part of the drug delivery device 100 and in this case may be identical to the electromechanical system 98. That is, the electronic unit 120 may be used with only one drug delivery device 100, which may be a reusable or single-use only device.

[0100] The electronic unit 120 may include an interface unit IF1 suitable for converting a rotation of a rotating member of the drug delivery device 100 into an axial and / or radial displacement of a coupling. The interface unit IF1 may be similar to the interface unit IF2 described in more detail below. Alternatively, the interface unit IF1 may have a different structure, for example taking into account the modifications already mentioned in the beginning of this specification or mentioned below.

[0101] As used herein, the terms "drug" or "medicament" are used interchangeably to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof and, optionally, a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease or otherwise enhance physical or mental comfort. Drugs or agents may be used for a limited period of time or periodically for chronic conditions.

[0102] As described below, a drug or agent may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0103] The drug or agent may be contained in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, a syringe, a reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some examples, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some examples, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some examples, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs), one in each chamber. In such examples, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during ejection into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with one another (e.g., via a conduit between the two chambers) to allow mixing of the two components when desired by a user prior to ejection. Alternatively, or in addition, the two chambers may be configured to allow mixing of the components as they are ejected into the human or animal body.

[0104] The drugs or agents contained in the drug delivery devices described herein may be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications related to diabetes, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, for example, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index 15th Edition.

[0105] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analog or a GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue occurring in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or substituted amino acid residues can be either the coded amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more of the amino acids occurring in the naturally occurring peptide may be deleted and / or replaced with other amino acids, including non-coded amino acids, or amino acids, including non-coded amino acids, may be added to the naturally occurring peptide.

[0106] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0107] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0108] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are e.g. lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, Z P-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0109] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0110] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0111] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0112] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as polysulfated forms of the above polysaccharides and / or pharmaceutically acceptable salts thereof.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0113] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector functions and can fix complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).

[0114] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include a full-length antibody polypeptide but comprises at least a portion of a full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0115] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0116] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0117] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0118] It will be understood by those skilled in the art that modifications (addition and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0119] An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or may be an integrated non-replaceable container.

[0120] As further described in ISO11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Other multi-dose container systems may include a needle-based injection device integrated with a non-replaceable container. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0121] As further described in ISO11608-1:2014(E), the single dose container system may include a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion). As also described in ISO11608-1:2014(E), the single dose container system may include a needle-based injection device with an integrated replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion).

[0122] 2 shows a schematic diagram of an electronic unit 200, such as the electronic unit 120. The electronic unit 200 may include: - at least one processor Pr or another control unit, - a memory Mem, for example a volatile and / or non-volatile storage memory, - a battery Bat or a rechargeable accumulator or any other power source, An output device Out, e.g. a transmission (sending) unit for communication with, e.g. a smartphone or other computing device. Alternatively or additionally, the output device Out may include a display unit, e.g. an LCD (Liquid Crystal Display) unit or another suitable unit. any input device In for communication with, for example, a smartphone or other computing device, which may receive confirmation commands and / or data, in particular user data. a switch Sw that can be used to activate the electronic unit 200 from a first energy state with reduced energy consumption to a second energy state with a higher energy consumption compared to the first energy state, and - at least one sensor S or at least two sensors, preferably optical sensors, that may be placed in the vicinity of the rotating encoder part and configured to sense the rotation of the rotating encoder part, the rotation of which may be proportional to the drug Dr dialed or delivered by the drug delivery device 100.

[0123] Further components not shown, such as a radiation source, in particular a light source or another radiation source, for example IR (infrared), may be included in the electronic unit 200. A data transmission bus 210 may connect the processor Pr, the memory Mem.

[0124] The processor Pr may be a microcontroller or microprocessor that executes instructions of a program stored in the memory M. Alternatively, a FPGA (Field Programmable Gate Array), an ASIC (Application Specific Integrated Circuit), a PLA (Programmable Logic Array), a PLD (Programmable Logic Device), or another suitable circuit may be used to implement a finite state machine that does not execute instructions of a program.

[0125] FIG. 3 shows a cross-sectional view of a button interior 300 (eg, chassis) showing an interface unit IF2 including coupling features 341 (eg, comb features) on a flexible arm or ring 330.

[0126] For example, an activation switch embodiment is described for a clip-on electronically coded unit / module 120, 200. The present disclosure relates to features of an electronic unit / module 120, 200 that may be embodied as a reusable clip-on module with a suitably configured pen injector for the purpose of recording doses delivered from a pen or other drug delivery device 100. This functionality may be valuable to a wide variety of device users as a memory aid or to support detailed recording of dose history data. It is envisioned that the electronic unit / module 120, 200 may be configured to be connectable to a mobile device, such as a smartphone, to allow for periodic downloading of dose history data from the unit / module 120, 200.

[0127] In one embodiment, the activation switch Sw may be actuated by rotation of a dose delivery mechanism within the injection device 100. In devices such as those described in WO 2014 / 033195 A1 or WO 2014 / 033197 A1, this rotation may be seen in a number sleeve 400 which may be configured to rotate relative to the dose button during expulsion but not during e.g. dose setting (dialing). The dose button may include a button interior 300. Both documents, WO 2014 / 033197 A1, are incorporated herein by reference for all legal purposes.

[0128] The button interior 300 may form a chassis, for example a light pipe chassis or another chassis. The button interior 300 may include flexible switching arm features 330, 334l, 334r. The switching arm features 330, 334l, 334r may include a two-pronged coupling 340, for example a "comb" shape, configured to prevent axial contact with the number sleeve 400 during axial movement of the dose button, for example the button interior 300 (see FIG. 3), from closing the switch Sw, for example a microswitch. FIG. 3 shows the coupling 340 having a two-prong shape, for example a front coupling 352 and a rear coupling 354, and a rotation bearing surface 345 adapted to abut against an inclined feature 702 (see FIGS. 7A-7D) of the button interior 300, for example forming a chassis. FIG. 3 is a cross-sectional view of the button interior 300, for example a light pipe chassis or another chassis, showing the coupling 340 on the flexible arm, for example a retaining ring 330. The optional light pipe is not shown in FIG.

[0129] The button interior 300 may be part of the actuation unit 301 mentioned in the beginning of this specification. The actuation unit 301 may include an interface unit IF2. The interface unit IF2 may be similar to the interface unit IF1 or may have a different internal structure.

[0130] The button interior 300 may include: - an upper chamber 302 (compartment) for electronic components 303a, 303b and 303c, for example of an electronic circuit, which may be mounted and connected by a circuit carrier, not shown, for example a printed circuit board (PCB); the electronic components 303a, 303b and 303c may be capacitors, inductors and / or communication modules and / or other parts of the electronic unit 120, 200, and / or - a proximal opening 304, e.g. for a drug delivery button or a proximal P-cap, and / or - an inner peripheral shelf 306, for example for supporting a PCB or other electrical circuit carrier; and / or a cavity 308 for a switch Sw, e.g. a microswitch (not shown), and / or a lower chamber 312 (compartment), for example for the interface unit IF2, and / or a distal opening 314 for inserting, for example, a rotating member (ring member 402) of the drug delivery device 100; and / or - elastic hooks 320, 322 (e.g. extending from the peripheral shelf 306), for example for clipping the actuation unit 301 to the drug delivery device 100; and / or the retaining ring 330, e.g. the circumferential direction of the retaining ring 330 may correspond to the circumferential direction of the button interior 300; and / or - an actuating portion 332, e.g. a protruding region protruding from the retaining ring 330, e.g. from a proximal part of the coupling feature 341 into the cavity 308; and / or - the fastening area of ​​the ring is not shown and may be located on the opposite side of the working portion 332 on the retaining ring 330; and / or a left part 334l of the retaining ring 330. The left part 334l may have the function of a retaining element. Alternatively, a straight retaining element may be used, for example extending along the diameter of the retaining ring 330. However, curved arms may make it possible to place other components in the center of the retaining ring 330 and / or - optional right portion 334r of retaining ring 330;

[0131] The button interior 300 may include a mating portion 340. The mating portion 340 may be included in a mating feature 341. The mating feature 341 may be retained by a retaining ring 330.

[0132] Coupling feature 341 may include proximal portion 341a and / or intermediate portion 341b and / or distal portion 341c. Distal portion 341c may be essentially identical to coupling portion 340. Coupling feature 341 may include, for example, a rearward facing or rearward oriented rear surface 342 (vertical) with respect to the rotational direction R of ring member 402 (see FIG. 4). Coupling feature 341 may include a front surface 343 with respect to the rotational direction R of ring member 402.

[0133] The front surface 343 of the coupling feature 340 may include: a vertical portion 344, e.g. facing or oriented forward, and - the curved portion 345 of the front surface 343;

[0134] The curved portion 345 of the front surface 343 may include: - a distal curved portion 346, and - Proximal curved portion 348.

[0135] Point P1a may be located between curved portion 346 and curved portion 348. Point P1a may be located on a concave edge of coupling feature 341. Additionally, distally facing portion 349 may be present on second curved portion 348.

[0136] The coupling portion 340 may include: a recess 350, also called a recess, and / or - front joint 352 (projection, claw), and / or the rear surface 353 of the front joint 352 (the front surface of the recess 350 facing rearwards), and / or - rear joint 354 (projection, claw), and / or - a front surface 355 of the rear coupling portion 354 (the rear surface of the recess 350 facing forward).

[0137] Distal surface 360 ​​may form a distal end of front bond portion 352. Distal surface 362 may form a distal end of rear bond portion 354. There may be an edge E1 formed between distal surface 362 of rear bond portion 354 and vertical rear surface 342 of bond portion 340. Edge E1 is used to urge the bond feature proximally, as described in more detail below with reference to, for example, Figures 7A-7E.

[0138] FIG. 4 shows the angled features 412d of the teeth 404a-404l of the ring member 402 at the proximal end of the number sleeve 400. For example, the number sleeve 400 of the pen device or another drug delivery device 100 described in WO 2014 / 033197 A1 may be configured with angled features, e.g., 412d, on each of the teeth, e.g., 404d, e.g., clutch teeth. For example, there may be 12 teeth 404a-404e (see FIG. 4). Additionally, there may be flat surfaces or flat faces 426d on each of the teeth 404a-404e (see, e.g., tooth 404d) to prevent, for example, the coupling portion 340 (comb feature) from sliding back into the inner pockets 427i, 427j between the teeth 404i and 404k. Illustratively, in FIG. 4 of WO 2014 / 033195 A1, clutch 90 has teeth facing outward. The inner teeth at the proximal end of dial sleeve 62 face inward. In contrast, in the present application, teeth 404a-404l of number / dial sleeve 400 face radially outward. Thus, the "clutch" of this embodiment, i.e., ring member 402, is distinct from a clutch.

[0139] Illustratively, in International Publication WO 2014 / 033195 A1, the teeth of the number sleeve / dial sleeve face radially inward, while the teeth of the mating button component (or "clutch") face outward. In the concept described herein, the orientation of the teeth is swapped between the two components, so that the teeth face outward on the number sleeve and inward on the button. However, the clutch mechanism functions similarly to the devices described in WO 2014 / 033195 A1, WO 2014 / 033197 A1, with the clutch system still rotatably coupling the button and number sleeve (via the radial teeth) when the button moves to a particular relative axial position, and rotatably separating them in other relative axial positions. However, other clutch coupling mechanisms may also be used. Alternatively, no clutch mechanism may be involved.

[0140] The clutch mechanism is therefore based on the same design concept as in the international publication, but in a slightly different embodiment.

[0141] During dose delivery, the number sleeve 400 and / or dial sleeve 400 can rotate and the ramp feature, e.g. 412d, of the number sleeve 400 and / or dial sleeve 400 can engage with one of the two protrusions (front and rear joints 352 and 354) of the joint 340 of the button interior 300 of the light pipe chassis or chassis of another sensor unit. This in turn causes the flexible joint 340 to rotatably bear against the ramp feature 702 of the button holder (button interior 300) in the chassis or of the chassis itself, and deflect upwards relative to the dose button and the rest of the electronic module / unit 120, 200, thereby axially actuating, e.g., a switch Sw, e.g., a microswitch. The switch Sw may activate a microcontroller or another processor Pr, e.g., to initialize an IR-LED (infrared light emitting diode) of the dose capture system. The switch Sw or sensor preferably has a very light operating force so that the load to operate it does not impose a large freewheeling torque on the number / dial sleeve 400 during dispensing which may manifest as a high dispensing force to the user.

[0142] The coupling portion 340 may also be biased radially outward as it is biased upward by the rotation of the number / dial sleeve 400. This may allow the coupling portion 340 to fill in between adjacent teeth 404a-404l of the number / dial sleeve 400 with a radius that may be larger than the radius at which the ramp features, e.g., 412d, are formed. This may function to allow the coupling portion 340 to ride over flat sections, e.g., 426d, of the number / dial sleeve 400 during dose delivery, thereby applying a lower level of idle torque.

[0143] At the end of exhalation, the user can release the dose button, e.g., button interior 300, and the dose button, e.g., button interior 300, can pop axially outward, e.g., in a proximal direction, from the pen. This can allow the button interior 300 and / or the couplings 340 on the chassis flexible arms 334l, 334r to be deflected radially inward and downward again, allowing the switch Sw or another sensor to open or complete another switching operation.

[0144] Dose synchronization and / or Bluetooth (e.g., Bluetooth LE (low energy)) or other short-range wireless pairing may be accomplished by an additional switch located elsewhere on the electronic module, such as an axial switch on the top surface of the module. If the additional switch remains closed for a specified time, such as 3-5 seconds, it may cause a dose synchronization. Dose synchronization may include updating the list of doses injected and / or the time and date of injection. If the additional switch remains closed for longer, such as 5 seconds or more, Bluetooth pairing or another pairing protocol may be initiated. Pairing may refer to the initial joining of two devices to establish a communication connection between the two devices.

[0145] Number sleeve 400 may include a circular central opening 401 and a coupling ring member 402 at its proximal end. Coupling ring member 402 may include teeth 404a-4001, for example twelve teeth, disposed about circular opening 401 and supported by a central ring of ring member 402.

[0146] Teeth 404a-400l, such as tooth 404d, may include: - inner parts 406a-406l, e.g. 406k, which may form sub-tooths of the teeth 404a-404l and may have a specific function, e.g. that of a crown tooth suitable for axial engagement, and / or - outer portions 408a-408l, e.g. 408k, which may form at least one further sub-tooth or at least two further sub-tooths having a function different from that of the first sub-tooth, e.g. a retaining function and / or a spur tooth function as described below.

[0147] The inner portion of a tooth, for example tooth 404d, may have the following surfaces: - a vertical front surface, e.g. 410d, and / or - a front inclined surface, e.g. 412d, and / or - any rear bevel, e.g. 414d, and / or - Vertical rear face, e.g. 416d, and / or - Bottom area, e.g. 418d.

[0148] The outer portion, for example the outer portion of tooth 404d, may have the following surfaces: a front surface 420d arranged, for example, parallel to the longitudinal axis A of the drug delivery device 100, for example the axis of rotation A of the number sleeve 400, and / or - for example a side surface 422d parallel to the longitudinal axis A, and / or a rear surface 424d, for example parallel to the longitudinal axis A, and / or an upper surface 426d, for example arranged transversely to the longitudinal axis A; and / or - for example a bottom surface 428d intersecting the longitudinal axis A;

[0149] Additionally, there may be inner pockets, e.g., 427d, 427e, 427f, between two adjacent inner portions (see 406k). Outer pockets 429d, 429e, 429f may be disposed between two outer portions (see 408k).

[0150] The vertical rear surface 416d of the inner portion of each tooth, e.g., 404d, and the rear surface 424d of the outer portion may be disposed in the same plane, e.g., both rear surfaces, e.g., 416d and 424d, may be coplanar with each other, however, other arrangements may be used.

[0151] At least one intermediate portion 430e, e.g., right intermediate portion 430e1 and left intermediate portion 430e2, can be disposed at the bottom of an inner pocket between two adjacent inner portions, e.g., 406k. A proximal surface, e.g., 432, of at least one intermediate portion, e.g., 430e, can face the proximal P. Thus, there can be a proximal surface 432e1 of the right intermediate portion 430e1 and a proximal surface 432e2 of the left intermediate portion 430e2.

[0152] An inner sub-portion, e.g. 440f, of an outer portion, e.g. 408f, may have the function of a retention structure that prevents re-engagement of the coupling 340 with the inner teeth 406a-406l under certain conditions that will be explained in more detail below. An outer sub-portion, e.g. 442f, of an outer portion, e.g. 408f, may have a different function compared to the function of the inner sub-portion, e.g. 440f. Thus, an outer sub-portion, e.g. 442f, may have the function of a clutch tooth of a clutch for transmitting a rotational movement between different parts or for disabling the transmission of a rotational movement between these different parts of the clutch.

[0153] The proximal (top) surface of the inner sub-portion, e.g., 440f, and the proximal (top) surface of the outer sub-portion, e.g., 442f, may be disposed in the same plane, i.e., may be coplanar with one another (see, e.g., surface 426d), however, other arrangements of these two proximal surfaces may also be used.

[0154] Each of the front faces, e.g., 420g, of the outer portions, e.g., 408k, may have a leading edge, e.g., 444g. The leading edge, e.g., 444g, may be convex. Furthermore, at the interface between the inner sub-portion, e.g., 440g, and the outer sub-portion, e.g., 442g, on the front face, e.g., 420d, of the outer portions, e.g., 408d, 408k, there may be a concave edge, e.g., 446g, of the front face, e.g., 420g. The concave edge, e.g., 446g, may form an interface between the inner part of the front face, e.g., 420g, and the outer part of the front face, e.g., 420g. The front surface or the front face, e.g., the inner part of the front face, e.g., 420g, may be curved. The axis of curvature may be arranged parallel to the longitudinal axis A. The outer part of the front surface, e.g., 420g, may be flat. Figure 4 shows the rotational direction R with respect to which the terms "front" and "rear" are used.

[0155] As shown in more detail in Figure 9B, the rear surface, e.g., 460e, of an inner sub-portion, e.g., 440e, and the rear surface, e.g., 462e, of an outer sub-portion, e.g., 442e, of the same tooth, e.g., 404e, may be disposed in the same plane, although other arrangements of these surfaces are possible.

[0156] An upper surface, e.g., 470e (see FIG. 9B), of an inner sub-portion, e.g., 440, may be disposed in the same plane as an upper surface, e.g., 472e, of an outer sub-portion, e.g., 442e, of the same tooth, e.g., 404e. However, other arrangements of these surfaces are possible. A front surface, e.g., 480e, of an outer sub-portion, 408e, which will be described in more detail below, is also shown in FIG. 9B.

[0157] 5A and 5B show the coupling feature 340 as the button interior 300 moves axially, e.g., distally, and spans one tooth 404f, e.g., the seventh tooth of the ring member 402. Because there may be fewer teeth, e.g., 12 teeth, than there are distinct positions to terminate a dosing (dose delivery) operation, but there may be twice as many, e.g., 24 distinct positions, the coupling feature 340 may need to have at least two protrusions 352, 354 to be able to drop and engage with the teeth 404a-404l of the number / dial sleeve 400 in both conditions, i.e., spans one tooth, e.g., 404f (see FIGS. 5A and 5B) or is between the teeth (see FIGS. 6A and 6B).

[0158] 5A illustrates a configuration 500 including a first axial position and a first angular position of the button interior 300 and the coupling portion 340 relative to the ring member 402 and the number sleeve 400. There can be a first axial distance D0a between the distal surface 360 ​​of the front coupling portion 352 and the proximal surface 432 of the middle portion 430e. The distance D0a can be equal to the axial length of the inner portion, e.g., 406f.

[0159] The circumferential or angular width W1a of the recess 350 may be slightly larger than the circumferential or angular width W2a of each inner portion, e.g., 406f. Thus, the recess 350, and therefore also the coupling portion 340, may engage with the inner teeth, e.g., 406f (see FIG. 5A). Optional portions 504, 506 may be present. The front angled surface, e.g., 412f, may serve as a distal stop function for the recess 350, e.g., the coupling portion 340. Furthermore, the proximal surfaces, e.g., 432e, 432f, of the intermediate portions, e.g., 430e, 430f, may also be used as distal stop surfaces for the distal movement of the button interior 300, e.g., the coupling portion 340.

[0160] 5B shows a second configuration 510 including a second axial position and a first angular position of the button interior 300 (button interior) and the coupling portion 340 relative to the ring member 402 and the number sleeve 400. The button interior 300 has been moved distally by the user (see arrow Arr5Bd), so that the axial distance D0b between the distal surface 360 ​​of the front coupling portion 352 and the proximal surface 432 of the middle portion 430e is smaller than the axial distance D0a. The distance D0b may be greater than zero millimeters or may be zero millimeters. However, due to the engagement of the recess 350 with the inner teeth of the teeth 404f, the axial movement of the coupling member 340 is permitted and no blocking or deflection of the coupling portion 340 occurs, e.g., the actuation portion 332 does not act on the switch Sw.

[0161] 6A and 6B show the button 300 moving axially (distally) between two teeth 404e and 404f of the ring member 402 of the number sleeve 400, thereby not spanning the mating feature 340. Configuration 600 shows a first axial and third angular position of the button interior 300 and mating feature 340 relative to the number sleeve 400.

[0162] The bond portion 340 is disposed above the inner pocket 427e between the teeth 404e and 404f. A first axial distance D0a can exist between the distal surface 360 ​​of the front bond portion 352 and the proximal surface 432 of the middle portion 430e. The distance D0a can be equal to the axial length of the inner portion, for example, 406f.

[0163] Further configuration 610 illustrates a second axial and third angular position of button interior 300 (button interior) and coupling portion 340 relative to number sleeve 400. Arrow Arr6Bd illustrates distal movement of button interior 300 relative to number sleeve 400.

[0164] The binding portion 340 is now engaged in the inner pocket 427e. The axial distance D0b between the distal surface 360 ​​of the front binding portion 352 and the proximal surface 432 of the middle portion 430e is less than the axial distance D0a. The distance D0b may be greater than zero millimeters or may be zero millimeters. In the variation shown in Figures 6A and 6B, the proximal surface, e.g., 432e, of the middle portion, e.g., 430e, may be used as a distal stop surface for the distal movement of the button interior 300.

[0165] However, in the variation shown in Figures 6A and 6B, engagement of coupling portion 340 between teeth 404e and 404f allows axial movement of coupling member 340 and does not result in blocking or deflection of coupling portion 340, e.g., actuation portion 332 does not act on switch Sw.

[0166] 7A shows a first configuration 700 of ring member 402, mating feature 340, and angled feature 702. Configuration 700 shows the axial and angular positions of these components 402, 340, and 702 relative to one another. FIG 7A shows a cross-sectional view of mating feature 340 (comb) illustrating engagement of mating feature 340 with ring member 402 of number sleeve 400 within inner pocket 427e located between inner portion 406e and inner portion 406f forming teeth 406e and 406f, for example.

[0167] Taking a cross section through comb feature 340 in FIG. 7A, it can be seen that coupling feature 341 contacts both number sleeve tooth 406f on one side (left) and any angled feature 702 of button interior 300 (chassis) on the other side (right), such as front surface 343 of coupling feature 341, more specifically curved portion 345 of front surface 343.

[0168] FIG. 7A shows the following geometric dimensions: the circumferential or angular width W1a of the recess 350, the circumferential or angular width W1b of the distal portion 340c, in particular its distal end; - the circumferential distance D2b between the facing faces of two adjacent inner portions 406e, 406f, and - circumferential or angular width W2a of the inner portion, e.g. 406f

[0169] The following formula may be valid: W1a>W2a, (1), In the formula, W1a is the angular width of the recessed portion 350 of the coupling portion 340, and where W2a is the angular width of the internal teeth, e.g., 406e, 406f, of the rotating member 402. Thus, the recess 350 can engage with the internal tooth 406f.

[0170] Additionally, the following formula may be valid: D2b>W1b, (2), where D2b is the angular distance between the rear face, e.g., 416e, of a first one of the inner teeth, e.g., 404e, and the front face, e.g., 410f, of an adjacent inner tooth, e.g., 404f; and where W1b is the angular width of coupling portion 340. Thus, coupling portion 340 can engage with an inner portion, such as an inner pocket between 406e and 406f, such as 427e, that can form inner teeth, such as 406e and 406f.

[0171] Even when the recess 350 and the inner portion 406f (inner teeth) engage and the rotational force of the ring member 402 acts on the rear surface 353 of the front coupling portion 352, similar operations to those described below with respect to movement of the coupling portion 340 (coupling feature 341) and the angled feature 702 are still valid.

[0172] A circumferential or angular force F1 may be generated at the trailing edge E1 of the coupling member 340 by rotation of the ring member 402 by the internal teeth 406. As described in more detail below, the angular force F1 translates into proximal movement of the coupling feature 341 (see, e.g., arrow Arr7Bp in FIG. 7B).

[0173] 7A, arrow 701a indicates the contact between curved portion 345 of coupling feature 341 and angled feature 702. Arrow 701b indicates the contact between coupling portion 340 and inner tooth 406f.

[0174] The guiding feature or ramp feature 702 of the button interior 300 may include at least one ramp, such as a straight ramp or a curved ramp, as described in more detail below. The ramp feature 702 may be fixedly positioned relative to the button interior 300 (chassis), e.g., the ramp feature 702 is rotatably fixed to the button interior 300, which cannot rotate, but which similarly does not rotate but may move axially.

[0175] Other possibilities for using curved features, which may be referred to as guiding features, on the joining feature 341 and / or on the angled feature 702 are, for example, as follows. - the curved surface is only on the coupling feature 341 and not on the guiding feature 702, for example the guiding feature may be a round pin. The round pin may interact with the curved surface 345 of the coupling feature 741. - the curved surface is only on the guiding feature 702 and not on the coupling feature 341, for example only the round pin of the coupling feature 741 may be used. The round pin of the coupling feature 741 may interact with the curved surface 710 of the guiding feature 702.

[0176] The angled feature 702 may have the following surfaces: See also FIG. - a proximal (top) surface 704, and / or - a distal (bottom) surface 706, and / or - the front surface 708 (e.g., for rotation of the ring member 402), and / or - a curved rear surface 710, and / or - the outer surface 718, and / or - The inner side area between the sloped feature 702 and the button interior 300.

[0177] There may be the following portions of the curved posterior surface 710: See also FIG. a rearward facing distal portion 712, and / or a proximally facing intermediate portion 714, and / or - a posterior facing proximal portion 716;

[0178] Edge E2 may be formed by the interface between distal portion 712 and intermediate portion 714. Edge E2 may be a convex edge. Edge E3 may be formed by the interface between intermediate portion 714 and proximal portion 716. Edge E3 may be a concave edge.

[0179] In the first configuration 700, the curved surface 345 and the curved surface 710 can be complementarily engaged, e.g. the distal part of the distal curved portion 346 may be in opposing and / or (direct) mechanical contact with the distal part 712; - Convex edge E2 may contact the concave edge between curved portion 346 and curved portion 348. See point P1a. - the intermediate portion 714 may directly contact the distally facing portion 349; - The proximal portion 716 may be disposed opposite a more proximal portion of the curved portion 348 compared to the distally facing portion 349. There may be direct mechanical contact between these two portions, or there may be a small distance.

[0180] Point P2a is located on the vertical front surface 410f of the inner portion / tooth 406f. Point P2a may be in direct mechanical contact with edge E1 of coupling portion 354. Thus, a force F1 applied to point P2a may be transferred to point P1a via coupling feature 341 and then to angled feature 702. The angled feature 702 may generate a proximally directed force F2 due to its complementary contact with curved portion 345. The resilience of coupling feature 341 and / or the resilient retention of coupling feature 341 on arms (ring portions) 334l and 334r may facilitate the conversion of force F1 to force F2.

[0181] A distance D10a between the middle portion 714 of the curved surface 710 on the ramp feature 702 and the distally facing segment 349 of the curved portion 348 essentially corresponds to the axial distance between the edge E2 and the point P1a. In the configuration C1, 700, the distance D10a may be zero millimeters.

[0182] The distance D0b between the distal surface 360 ​​of the front bond portion 352 and the proximal surface 432e of the middle portion 430e may have the above-mentioned value of greater than or equal to zero millimeters, for example as shown in FIG. 7A.

[0183] 7A-B show a second configuration 720 of the ring member 402, the mating feature 340, and the angled feature 702. FIG. 7B shows a cross-sectional view of the mating feature 340 (comb) showing the mating feature 340 riding up the button interior 330, e.g., riding up the angled feature 702 of the button interior 330.

[0184] As the number sleeve 400 rotates, e.g., moving from left to right in Figs. 7A-7E, the coupling 340 is deflected to the right and the coupling 340 may push up onto the angled / curved surface 710 of the angled feature 702 of the button interior 300 (chassis), opening up the gap D10b shown in Fig. 7B. The angle of this surface 710 may start out steep and become less steep as the coupling 340 pushes up onto this surface. This may be because the force required to elastically deflect the coupling feature 340 may increase as the coupling 340 rises axially. This may be due in part to the actuation force required to actuate the switch Sw. Thus, as this angle becomes more gradual, the overall torque required by the number / dial sleeve 400 to drive this movement may decrease and may remain approximately constant during the movement. The torque to drive the number / dial sleeve 400 can be generated by a user applying an axial force to the number / dial sleeve 400, which can be reacted by the helical threaded connection of the number / dial sleeve 400. Thus, reducing this torque can reduce the additional force required by the user to initiate dispensing.

[0185] Here, a distance D10b between the middle portion 714 of the curved surface 710 of the ramp feature 702 and the distally-facing segment 349 of the curved portion 348 can be greater than distance D10a. Here, a distance D0c between the distal surface 360 ​​and the proximal surface 432e of the middle portion 430e can be greater than distance D0b.

[0186] Edge E2 reaches and / or directly mechanically contacts a point P1b that is located distally on the distal curved portion 346 compared to point P1a. Edge E1 reaches and / or directly mechanically contacts a point P2b that is proximal to point P2a on the front surface 410f of the inner tooth 406f.

[0187] Arrow Arr7Bp indicates proximal displacement of coupling feature 341, which includes coupling portion 340. Arrow Arr7Ba indicates angular movement of ring member 402.

[0188] 7C illustrates a third relative configuration 730 of the ring member 402, the mating feature 340, and the angled feature 702. FIG 7C illustrates a cross-sectional view of the mating feature 340 (comb) showing the mating feature 340 beginning to ride up onto a bevel of a tooth of the number sleeve 400, such as the bevel of tooth 406f or angled surface 412f.

[0189] After approximately 50% of the total axial deflection of the coupling feature 341 (e.g., coupling portion 340) has occurred, the coupling feature 341 moves onto a beveled surface, e.g., 412f, of a tooth, e.g., 406f, of the number / dial sleeve 400, as shown in FIG. 7C.

[0190] Here, a distance D10c between the middle portion 714 of the curved surface 710 of the ramp feature 702 and the distally-facing segment 349 of the curved portion 348 can be greater than distance D10b. Here, a distance D0c2 between the distal surface 360 ​​and the proximal surface 432e of the middle portion 430e can be greater than distance D0c.

[0191] Edge E2 may reach and / or directly mechanically contact point P1c, which is located distally relative to point P1b on distal curved portion 346. Edge E1 may reach and / or directly mechanically contact point P2c, which is more proximal than point P2b. Point P2c may be located on front angled surface 412f.

[0192] The minimum distance D11c between the edge E2 of the ramp feature 702 and the distal curved portion 346 of the joint 340 may still be zero millimeters due to direct mechanical contact of the curved portion 345 and the ramp feature 702.

[0193] Arrow Arr7Cp indicates proximal displacement of coupling feature 341, which includes coupling portion 340. Arrow Arr7Ca indicates angular movement of ring member 402.

[0194] Figure 7D shows a fourth configuration 740 of ring member 402, mating feature 340, and angled feature 702. Figure 7D shows a cross-sectional view of mating feature 340 going back "to the left" and showing mating feature 340 riding up beveled surface 412f of tooth 404f, and more specifically, inner portion 406f of tooth 404f.

[0195] At this point, the spring force generated by the tangential (i.e., rightward or angled) deflection of the mating feature 341 and mating portion 340 may allow mating feature 341 to return to the left, whereupon mating feature 341 may climb the more gently sloping surface 412f of the teeth 404f of the number / dial sleeve 400. At the same time, mating feature 341 may lose contact with the angled feature 702 of the button interior 300 (chassis). This is shown in FIG. 7D.

[0196] Here, a distance D10d between the middle portion 714 of the curved surface 710 of the ramp feature 702 and the distally-facing segment 349 of the curved portion 348 can be greater than distance D10c. Here, a distance D0d between the distal surface 360 ​​and the proximal surface 432e of the middle portion 430e can be greater than distance D0c2.

[0197] Edge E2 may no longer be in direct mechanical contact with curved portion 345 of front surface 343. Edge E1 may reach and / or be in direct mechanical contact with point P2d, which is more proximal than point P2c on front angled surface 412f.

[0198] The minimum distance D11d between the edge E2 of the slope feature 702 and the distal curved portion 346 of the joint 340 may be greater than the distance D11c, for example greater than zero millimeters, because there is no longer mechanical contact between the curved portion 345 and the slope feature 702.

[0199] Arrow Arr7Dp indicates proximal displacement of coupling feature 341, which includes coupling portion 340. Arrow Arr7Da indicates angular movement of ring member 402.

[0200] 7E illustrates a fifth relative configuration 750 of the ring member 402, the mating feature 340, and the angled feature 702. FIG. 7E illustrates a cross-sectional view of the mating feature 340, showing the mating feature 340 running along the top edge (see point P2e) or top surface of the inner portion 406f of the tooth 404f of the number sleeve 400.

[0201] The available "width" of the teeth of the number / dial sleeve 400, e.g., the inner teeth, e.g., 406f, may be limited, e.g., by a small lateral or radial dimension of the ring member 402. This means that to achieve the total required axial movement of the coupling 340 to activate a switch Sw, e.g., a microswitch or another sensor, based solely on the slope of the inner teeth, the required slope of the inner teeth may be too steep, requiring excessive torque for the coupling 340 to move up this slope.

[0202] By allowing the coupling portion 340 to be deflected tangentially (i.e., from left to right in FIGS. 7A-7E) and adding a slope 710 to the sloped feature 702 of the button interior 300 / chassis, the effective length of this drive slope can be shared between the teeth of the number / dial sleeve 400, e.g., 406f, and the sloped feature 702 of the button interior 300 (chassis), thereby reducing the length / slope of each individually.

[0203] Furthermore, the final action of the coupling 340 may be to suddenly release the energy stored by the elastic deformation, causing the coupling 340 to climb back up onto the shallow surface 412f of the tooth 406f of the number / dial sleeve 400, thereby minimizing the rotation required to axially displace the coupling 340 the distance required to activate a switch Sw, e.g., a microswitch, which may turn on the e-unit / module (electronic unit / module) 120, 200.

[0204] The act of axially displacing the coupling 340 may require additional user force to be applied to the button interior 300 (chassis), but this may only occur at the beginning of ejection, before fluid pressure within the cartridge builds up, and therefore when the user force to expel fluid is very low. This increase in ejection force at the start of administration is likely still below the typical force plateau during dose delivery (e.g., 150 International Units (IU) per second), and therefore is not expected to manifest as a noticeable increase in ejection force to the user.

[0205] Here, a distance D10e between the intermediate portion 714 of the curved surface 710 of the angled feature 702 and the distally-facing segment 349 of the curved portion 348 can be greater than distance D10d. Here, a distance D0e between the distal surface 360 ​​and the proximal surface 432e of the intermediate portion 430e can be greater than distance D0d.

[0206] Edge E2 may not be in direct mechanical contact with curved portion 345 of front surface 343. Edge E1 or distal surface 362 of rear bond 354 may reach and / or be in direct mechanical contact with point P2e, which is more proximal than point P2c on front angled surface 412f.

[0207] The minimum distance D11e between the edge E2 of the ramp feature 702 and the distal curved portion 346 of the coupling portion 340 may be greater than the distance D11d. Thus, the coupling portion 340 leaves the inner pocket 427e. As the button interior 300 is still pressed, there is a radial deflection of the coupling portion 340, resulting in a radial displacement of the coupling portion 340 from the inner portion 406f to the adjacent inner sub-portion 440f of the outer portion 408f of the same tooth 404f. This radial displacement is described in more detail below, for example in connection with FIG. 8.

[0208] Arrow Arr7Ep indicates proximal displacement of coupling feature 341, which includes coupling portion 340. Arrow Arr7Ea indicates angular movement of ring member 402.

[0209] The same is valid when the coupling feature 340 straddles an inner tooth, e.g. 406f. In this case, a rotational force is exerted on the front coupling part 352 of the coupling part 340. In this case too, the angled feature 702 slides along the curved surface 345, thereby moving the coupling feature 341 and therefore also the coupling part 340 proximally. As soon as the angled surface, e.g. 412f, of the tooth, e.g. 406f, engages with the face 360, e.g. the edge formed between the distal face 360 ​​and the rear face 353, the proximal displacement of the coupling feature 340 can be caused entirely or mainly by the angled surface, e.g. 412f, e.g. the support feature 702 may no longer contact the coupling feature 340.

[0210] 8 shows the coupling feature 340 in a biased state, for example, biased upward and radially outward. In order for the driving force to remain low during the drug ejection event, it may be important that the coupling portion 340 (comb portion) continues to ride over one or more flat upper surfaces 426d, 426e, 426f, 426g, etc. of the teeth 404d, 404e, 404f, and 404g of the number / dial sleeve 400 and does not fall back into the outer pockets 429d, 429e, and 429f between the teeth 404e, 404f, and 404g of the number / dial sleeve 400. The teeth 404e, 404f, and 404g may be part of the clutch of the drug delivery device 100.

[0211] This can be achieved by taking advantage of the fact that as the coupling portion 340 (comb) deflects axially upward, it can also deflect radially outward, particularly the distal tip, as shown by arrow 810 in FIG. 8. In the illustrated design, finite element analysis can predict that for an axial deflection of 0.6 mm (millimeters), the tip can deflect radially outward 0.42 mm. This radially outward displacement can occur as the coupling portion 340 (comb) exits the inner pocket 327e at the end of the beveled surface 412d, 412e, 412f, etc. of one of the inner teeth (inner portions) 406d, 406e, 406f, etc., and can allow the coupling portion 340 to ride along the flat surfaces 426d, 426f, 426g, etc. of the tops of the teeth 404d, 404f, 404g, etc. of the number / dial sleeve 400, particularly the flat surfaces of the inner sub-portions 442f, 442g, etc.

[0212] Configuration 800 shows coupling portion 340 on teeth 404f and 404g. There may be an angle A1 between the left portion 334l of ring 330, specifically its underside in its most axially (proximally) deflected position, and a reference plane parallel to the plane in which coupling ring 402 is located. The reference plane may correspond to a plane in which the underside of left portion 334l of ring 330 is located in its released position, e.g., in a position where no axial deflection of left portion 334l occurs. Angle A1 may be in the range of 1-5 degrees or in the range of 2-4 degrees or another suitable range.

[0213] Angle A2 may be formed between the outside of coupling portion 340 or coupling feature 341 as a whole and an axis parallel to longitudinal axis A. Angle A2 may have the same value as angle A1. Alternatively, angle A2 may be smaller, for example if coupling portion 340 tilts slightly inward in its released state. According to a further alternative, angle A2 may be larger than angle A1.

[0214] The left portion 334l of the retaining ring 330 and / or the right portion of the retaining ring 330 may be straight or may have a different configuration, such as crank-shaped.

[0215] 9A and 9B show how the coupling feature 340 is configured to fill the outer pocket 429e (gap) between the inner sub-portion 440f and the teeth of the number sleeve 400, such as teeth 404e and 404f, in order to continue to ride over flat surfaces 426d, 426f, 426g, etc. The configuration 900 is shown in Figure 9A. The following equations may be valid: W3a>W1a, (3), where W3a is the angular width of an inner sub-portion, e.g., 440f, of an outer portion, e.g., 408f; and In the formula, W1a is the angular width of the recessed portion 350 of the coupling portion 340.

[0216] The angular width W3a may be measured from the leading edge 444f or the inner sub-portion 440f of each tooth 404f to the rear surface of the same each tooth 404f, e.g., the rear surface 460f of the inner sub-portion 440f of each tooth 404f (see FIG. 9), the corresponding rear surface 460e of the tooth 404e. The angular width W1a of the recess 350 may be measured from the rear surface of the front joint 352 to the front surface 355 of the rear joint 354. Thus, the distal portion 340c of the joint 340 is supported by the inner sub-portion, e.g., 440f, if it is one of the above teeth, e.g., 404f, etc. Furthermore, the recess 350 may not engage the inner portion 406f at a radially outer position of the joint 340.

[0217] The configuration 910 is shown in Figure 9B. The following equations may be valid: W1b>D3b, (4), where W1b is the angular width of the joint 340, and where D3b is the angular distance between a rear face, e.g., 460e, of an inner sub-portion, e.g., 440e, of an outer portion, e.g., 408e, and a front face or leading edge, e.g., 444f, of an adjacent inner sub-portion, e.g., 444f, of an adjacent outer portion, e.g., 408f.

[0218] The angular width W1b may be measured between a vertical portion (eg, a distal end) of the front surface 344 and the vertical rear surface 342 of the coupling portion 340.

[0219] Thus, the distal portion 340c of the coupling feature 340 cannot fall back into the intermediate space or into the outer pocket 429e between two adjacent inner sub-portions 440e, 440f of the outer portion 408e because at least one of the front coupling portion 252 or the rear coupling portion 354 is supported by the inner sub-portions 440e, 440f, etc. The outer portion 408e and the outer portion 408f are shown in FIG.

[0220] Alternatively, instead of the inner sub-portions 440e, 440f etc., a closed circumferential ring may be used on the inner teeth 406a-406f, for example, there may be an intermediate portion connecting the inner sub-portions 440e, 440f etc. circumferentially or angularly.

[0221] According to another embodiment, instead of the inner sub-portions 440e, 440f, etc., an outer retaining ring of the number sleeve 400 may be used, thereby eliminating the outer sub-portions 442e, 442f, etc., e.g., the outer portion 408e and the outer portion 408f may not be used in this modification. The outer ring may not be directly attached to the inner teeth 406a-406f, e.g., there may be a radial gap between the inner teeth 406a-406f and the outer retaining ring. However, the outer retaining ring may also be disposed on the ring member 402, so that the outer retaining ring rotates together with the inner teeth 406a-406f. In this variant, the coupling 340 slides on the distal surface of the outer retaining ring.

[0222] 9B shows the rear surface 460e of the inner sub-portion 440e and the rear surface 462e of the outer sub-portion 442e of the outer portion 408e. As shown, the rear surface 460e and the rear surface 462e may be disposed in the same vertical plane in the illustrated embodiment. Alternatively, other arrangements of the two rear surfaces 260e and 262e may be used.

[0223] The following formula may be valid: W3a>W3b, (5), where W3a is the angular width of an inner sub-portion, e.g., 440e, of an outer portion, e.g., 408e; and W3b is the angular width of an outer sub-portion, e.g., 442e, of an outer portion, e.g., 408e.

[0224] The angular width W3a may be measured as described above with respect to formula (3). However, it is assumed that all teeth 404e, 404f have the same shape and certain dimensions, see tooth 404e. The angular width W3b of the outer sub-portion 442e may be measured from the front surface 480e of the outer sub-portion 442e to the rear surface 462e of the outer sub-portion 442e. Thus, the outer sub-portion 442e may be adapted to have an additional function when compared to the functions of the inner sub-portion 440e, etc. and / or when compared to the functions of the inner portion 406e, etc. Exemplarily, the outer sub-portion 442e may have an additional coupling function by forming a clutch tooth of a clutch of the drug delivery device 100.

[0225] FIG. 10 again shows the position of coupling feature 340 located above the inner pocket between the teeth, for example above inner pocket 427l between inner portion 406l and inner portion 406a, and no longer on upper surface 426a and upper surface 426l (see configuration 1000).

[0226] When the user releases the button at the end of the exhalation event, the button interior 300 can move axially away from the top surface of the number / dial sleeve 400, and as it does so, the flexible switching arms, e.g., the left portion 334l of ring 330 and the right portion 334r of ring 330, can relax to their original state in which the tips of the coupling portions 340 (comb portions) can either fall back into the inner portions, e.g., the inner pocket 427l between 406k and 406l, or are on a smaller radius that can engage with one of these inner portions, e.g., 406k and 406l, depending, for example, on the rotational end position of the coupling ring 402 after dose delivery.

[0227] In this state, if the user presses the button interior 300 again without the number / dial sleeve 400 being allowed to rotate (i.e. not during dose delivery), the coupling portion 340 (comb) may be radially positioned on the inclined inner pockets 427k, 427l, etc., rather than on the flat surfaces / flat faces 426l, 426a. Thus, the coupling portion 340 is not deflected axially and / or radially, and the switch Sw is not actuated during this depression of the button interior 300 (see FIG. 10). Arrow Arr10d indicates the proximal movement of the button interior 300 and the coupling portion 340 to release the coupling portion 340 from the flat faces 426l, 426a, etc.

[0228] The angle A1 described above becomes zero degrees again after release of the button, such as release of the button interior 300. Again, the left portion 334l of the ring 330 and / or the right portion of the ring 330 may be straight or may have a different configuration, such as crank-like.

[0229] One aspect of the disclosure described within this application may be a method of activating the clip-on electronics module / unit 120, 200 using the rotation of a mechanism designed for use with the injection device 100.

[0230] An advantage of activating the electronic module 120, 200 at or just before the start of dose delivery may be that the power consumption of the dose capture system can be limited by having the capture system operate for the shortest possible time.

[0231] This can be particularly useful in systems such as optical encoders where the power consumption of the IR-LED (infrared emitting diode) sensors constitutes a significant percentage of the total power consumption of the electronic module 120,200.

[0232] Thus, the actuation unit 301 for the drug delivery device 100 comprises: a support structure 300 extending along a longitudinal axis A between a distal portion D of the support structure 300 and a proximal portion P of the support structure 300; and / or - interface units IF1, IF2 arranged in the support structure 300 and including a coupling portion 340 and an actuation portion 332; It may include, The coupling portion 340 is configured to interact with a rotating member, the rotating member including a plurality of teeth 404a, rotating about a rotation axis A parallel or coaxial to the longitudinal axis A; The actuation portion 332 is configured to interact with the electrical component Sw, The interface units IF1, IF2 are configured to interact with the plurality of teeth 404a of the rotating member and convert a rotational movement R of the rotating member into an axial displacement Arr7Bp in a first direction, e.g., from a first axial position to a second axial position, of the coupling portion 340 relative to the longitudinal axis A, and a radial displacement of at least a portion of the coupling portion 340 relative to the longitudinal axis; Axial and / or radial displacement of the coupling portion 340 displaces the actuating portion 332, The direction and amount of radial displacement is appropriate to retain the coupling portion 340, for example using a retaining structure 440f disposed on the rotating member, thereby preventing the coupling portion 340 from re-engaging with the teeth 404a of the rotating member.

[0233] Furthermore, the rotating member is a ring member 330; a plurality of teeth 404a arranged circumferentially on the ring member 330 about the axis of rotation A of the ring member 330, Each tooth 404a may include an inner portion 406a and an outer portion 408a disposed radially outward of each inner portion 406a; It may include, The inner portion 406a includes a first tooth including at least one inclined surface 412a facing proximally relative to the axis of rotation A and circumferentially about the ring member 330; The outer portion 408a includes second teeth of a different orientation and / or type compared to the first teeth; The second tooth includes a flat surface 426d disposed in a plane perpendicular to the axis of rotation A, the second tooth having an angular width W3a, W3b greater than the angular width W2a of the first tooth; The proximal-most portion P2e of the first tooth extends to the plane.

[0234] A number sleeve 400 may be claimed that includes an actuation unit 301 and a rotating member.

[0235] A drug delivery device 100, such as a pen-type device, is disclosed that includes an actuation member 301 and / or a rotating member, such as a ring member 330.

[0236] Further, a method of operating the drug delivery device 100 includes: - pushing the actuation unit 301 distally, thereby engaging the coupling portion 340 with the teeth 404 of the rotating member; - thereafter rotating the rotating member R, thereby disengaging the coupling portion 340 from the pocket formed between adjacent teeth 404a, 404b, whereby the actuating portion 332 of the actuating unit 301 acts on the electrical component Sw; - thereafter preventing the coupling part 340 from re-engaging in the pocket between the teeth 404a, 404b, thereby preferably preventing the actuation part 332 of the actuation unit 301 from further acting on the electrical component Sw; may include.

[0237] 98. A system comprising: a drug delivery device 100; - an electronic module 120, 200; Including, The drug delivery device 100 includes a rotating member including a plurality of teeth 404a, The electronic module 120, 200 includes electrical components Sw, an electrical energy source Bat, and an energy management unit electrically connected to at least one electrical component Sw; the energy management unit is configured to switch from a low energy state to a high energy state consuming more electrical energy from the electrical energy source Bat compared to the low energy state in response to the electrical signal generated by the electrical component Sw; The electronic module includes interface units IF1, IF2, The interface units IF1, IF2 include a coupling portion 340 and an actuation portion 332 configured to interact with the electrical component Sw; The interface units IF1, IF2 are configured to interact with the plurality of teeth 404a of the rotating member by the coupling portion 340 and convert a rotational movement R of the rotating member into an axial displacement Arr7Bp in a first axial direction of the coupling portion 340 relative to the longitudinal axis A of the drug delivery device 100 and a radial displacement of at least a part of the coupling portion 340 relative to the longitudinal axis A; The interface units IF1, IF2 are configured to transmit the axial displacement Arr7Bp and / or the radial displacement 810 to the actuation portion 332, thereby initiating a switch to a high energy state by the energy management unit; the direction and amount of radial displacement is suitable to retain the coupling portion 340 by the retention structure 440f, thereby preventing re-engagement of the coupling portion 340 with the teeth 404a of the rotating member during expulsion of the dose; A system 98 is disclosed.

[0238] Although the embodiments of the present disclosure and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made in the present disclosure without departing from the spirit and scope of the present disclosure as defined in the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes, and methods described herein may be modified while remaining within the scope of the present disclosure. Furthermore, the scope of the present application is not intended to be limited to the specific embodiments of the systems, processes, manufactures, methods, or steps described in the present disclosure. As will be readily understood by those skilled in the art from the disclosure of the present disclosure, any currently existing or later developed system, process, manufacture, method, or step that performs substantially the same function or achieves substantially the same result as the corresponding embodiment described herein may be utilized in accordance with the present disclosure. Thus, the appended claims are intended to include within their scope such systems, processes, methods, or steps. Furthermore, the embodiments described in the first part of this specification may be combined with the examples in the second part of this specification related to Figures 1 to 10.

Claims

1. An actuation unit (301) for a drug delivery device (100), comprising: A support structure (300) extending along a longitudinal axis (A) between a distal (D) portion of said support structure (300) and a proximal (P) portion of said support structure (300); an interface unit (IF1, IF2) disposed within the support structure (300) and including a coupling portion (340) and an actuation portion (332); Including, the coupling portion (340) is configured to interact with a rotating member, the rotating member including a plurality of teeth (404a) and rotating about a rotation axis (A) parallel or coaxial to the longitudinal axis (A); The actuating portion (332) is configured to interact with an electrical component (Sw), the interface units (IF1, IF2) are configured to interact with the teeth (404a) of the rotating member and convert a rotational movement (R) of the rotating member into an axial displacement (Arr7Bp) of the coupling portion (340) relative to the longitudinal axis (A) and a radial displacement of at least a part of the coupling portion (340) relative to the longitudinal axis (A); the interface units (IF1, IF2) are configured to transmit the axial and / or radial displacements of the coupling portion (340) to displace the actuating portion (332) to interact with the electrical component (Sw); Actuation unit (301).

2. 2. The actuation unit (301) of claim 1, wherein the direction and amount of the radial displacement are suitable to retain the coupling portion (340) with a retaining structure (440f), thereby preventing the coupling portion (340) from re-engaging with the teeth (404a) of the rotating member during ejection of a dose.

3. The interface units (IF1, IF2) include at least one holding element (334l, 334r), the at least one holding element (334l, 334r) holding the coupling portion (340) on a holding portion of the holding element (334l, 334r), the retaining elements (334l, 334r) are attached to the support structure (300) by attachment portions of the retaining elements (334l, 334r); the retaining elements (334l, 334r) are resilient and / or pivotally attached to the support structure (300), thereby allowing distal and radial displacement of the coupling portion (340); An actuation unit (301) according to claim 1 or 2.

4. the coupling portion (340) is configured to interact with an interaction portion on each of the teeth (404a) of the rotating member such that the rotating member exerts a force (F1) on the coupling portion (340); the rotating member includes at least one retention structure (440f) disposed radially outward of the interacting portion of the rotating member; the retaining structure (440) includes at least one proximally directed surface (426d) configured to permit sliding of a distal end (360, 362) of the coupling portion (340) over the at least one proximally directed surface (426d) during further rotation of the rotating member. An actuation unit (301) according to any one of claims 1 to 3.

5. a coupling feature (341), said coupling portion (340) being contained within said coupling feature (341); the coupling feature (341) includes at least one curved surface (345) configured to interact with a guide feature (702) attached to the support structure (330) when a circumferential force (F1) is applied to the coupling portion (340) by the rotating member, thereby displacing the coupling feature (341) axially; Preferably, said guiding feature (702) includes at least one curved surface (710) that opposes said curved surface (345) of said mating feature (341); Preferably, both curved surfaces (710, 345) are complementary to each other, thereby facilitating said axial displacement of said coupling feature (341). An actuation unit (301) according to any one of the preceding claims.

6. The coupling portion (340) includes at least two distal portions (352, 354) and a recessed portion (350) disposed between the at least two distal portions (352, 354), The recessed portion (350) is recessed proximally relative to the at least two distal portions (352, 354). An actuation unit (301) according to any one of the preceding claims.

7. 7. The actuation unit (301) of claim 6, wherein a first distal portion (352) of the at least two distal portions (352, 354) includes a first side (353) of the recessed portion (350) and a second distal portion (354) of the at least two distal portions (352, 354) includes a second side (355) of the recessed portion (350), the second side (355) being longer than the first side (353).

8. A ring member (402); a plurality of teeth (404a) circumferentially arranged on the ring member (402) about a rotation axis (A) of the ring member (402), a plurality of teeth (404a), each tooth (404a) including an inner portion (406a, 406k) and an outer portion (408a, 408k) disposed radially outward of the respective inner portion (406a, 406k); Including, the inner portion (406a, 406k) includes a first tooth including at least one inclined surface (412a, 412d) facing proximally relative to the axis of rotation (A) and circumferentially about the ring member (402); the outer portion (408a, 408k) includes second teeth of a different orientation and / or type compared to the first teeth; the second tooth includes a flat surface (426d) disposed in a plane perpendicular to the axis of rotation (A), the second tooth having an angular width (W3a, W3b) greater than the angular width (W2a) of the first tooth; the inclined portion starting from the most proximal portion (P2e) of the first tooth or its proximal portion (P2e) extends to the plane, Rotating member.

9. Each of the outer portions (408a, 408k) includes an inner subportion (440f) and an outer subportion (442f) disposed radially outward of the inner subportion (440f), The inner sub-portion (440f) has an angular width (W3a) greater than the angular width (W3b) of the outer sub-portion (442f). A rotating member according to claim 8.

10. A housing (102) extending along a longitudinal axis (A); a dose setting unit and / or a drug delivery unit disposed within said housing (102); An actuation unit (301) according to any one of claims 1 to 7, comprising: an actuation unit (301) disposed on or within the housing (102), the actuation unit (301) including an electrical component (Sw) actuated by the actuation portion (332) of the actuation unit (301); The rotating member according to claim 8 or 9, the rotating member is part of or mechanically coupled to the dose setting unit and / or the dose delivery unit, a rotating member arranged such that the rotating member interacts with the actuation unit (301) or configured such that the rotating member interacts with the actuation unit (301); A drug delivery device (100) comprising:

11. the dose setting unit and / or the dose delivery unit are configured to place the rotatable member in one of several positions, the number of teeth (404a) of said rotating member is equal to one-half the number of said positions; The drug delivery device (100) of claim 10.

12. The following formula: W1a>W2a, (1), where W1a is the angular width of the recess (350) or the recess (350) of the coupling portion (340); W2a is the angular width of the internal teeth (406a) or the internal teeth (404a) of the rotating member; D2b>W1b, (2), where D2b is the angular distance between the rear face (416e) of a first one of the inner teeth (404e) and the front face (410f) of the adjacent inner tooth (404f); and W1b is the angular width of the joint (340); W3a>W1a, (3), where W3a is the angular width of the inner sub-portion (440f) of said outer portion (408f); and W1a is the angular width of the recess (350) or the recess (350) of the coupling portion (340); W1b>D3b, (4), where W1b is the angular width of the joint (340); and D3b is the angular distance between the rear face (460e) of the inner sub-portion (440e) of the outer portion (408e) and the front face or leading edge (444f) of the adjacent inner sub-portion (444f) of the adjacent outer portion (408f); The drug delivery device (100) of claim 10 or 11, wherein at least one, at least two, at least three, or all of the following are effective:

13. the coupling portion (340) is configured to interact with an interaction portion (406e) on each of the teeth (404a) of the rotating member such that the rotating member exerts a force (F1) on the coupling portion (340); the rotating member includes at least one retention structure (440e, 470e) disposed radially outward of the interacting portion (406e) of the rotating member; the retention structure (440e, 470e) includes at least one proximally directed surface (470e) configured to permit sliding of a distal end (360, 362) of the coupling portion (340) over the at least one proximally directed surface (470e) during further rotation of the rotating member. A drug delivery device (100) according to any one of claims 10 to 12.

14. The following formula: W3a>W3b, (5), where W3a is the angular width of the inner sub-portion (440f) of said outer portion (408f); and W3b is the angular width of the outer sub-portion (442e) of said outer portion (408e); The drug delivery device (100) according to any one of claims 10 to 13, wherein the following is effective:

15. A method of operating a drug delivery device (100), comprising: pushing the actuation unit (301) distally, thereby engaging the coupling portion (340) with the teeth (404) of the rotating member; thereafter, rotating (R) the rotating member, thereby disengaging the coupling portion (340) from the pocket formed between adjacent teeth (404a, 404b), thereby causing the actuating portion (332) of the actuating unit (301) to act on an electrical component (Sw); thereafter, preventing said coupling portion (340) from re-engaging in the pocket between said teeth (404a, 404b), thereby preferably allowing said actuation portion (332) of said actuation unit (301) to further act on said electrical component (Sw); A method comprising:

16. A drug delivery device (100); An electronic module (120, 200); Including, The drug delivery device (100) includes a rotating member including a plurality of teeth (404a); The electronic module (120, 200) comprises an electrical component (Sw), an electrical energy source (Bat) and an energy management unit electrically connected to the at least one electrical component (Sw), the energy management unit is configured to switch from a low energy state to a high energy state consuming more electrical energy from the electrical energy source (Bat) compared to the low energy state in response to an electrical signal generated by the electrical component (Sw), The electronic module includes an interface unit (IF1, IF2), The interface unit (IF1, IF2) includes a coupling portion (340) and an actuation portion (332) configured to interact with the electrical component (Sw), the interface units (IF1, IF2) are configured to interact with the plurality of teeth (404a) of the rotating member by means of the coupling portion (340) and to convert a rotational movement (R) of the rotating member into an axial displacement (Arr7Bp) of the coupling portion (340) in a first axial direction relative to a longitudinal axis (A) of the drug delivery device (100) and into a radial displacement of at least a part of the coupling portion (340) relative to the longitudinal axis (A); the interface units (IF1, IF2) are configured to transmit the axial displacement (Arr7Bp) and / or the radial displacement (810) to the actuation part (332), thereby initiating a switch to the high energy state by the energy management unit; the direction and amount of said radial displacement is suitable to retain said coupling portion (340) by a retention structure (440f), thereby preventing re-engagement of said coupling portion (340) with said teeth (404a) of said rotating member during expulsion of a dose; System (98).

17. 17. The system (98) of claim 16, wherein the interface units (IF1, IF2) are configured to prevent interaction between the actuating portion (332) and the electrical component (Sw) when the coupling portion (340) moves in a second axial direction opposite to the first axial direction.

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