Electronic Module and Module System for Drug Delivery Devices

Abstract

The present disclosure relates to an electronic module (320; 420; 520; 620) configured to be attached in a predetermined fastening configuration to a proximal end (P) of a drug delivery device (100), the drug delivery device (100) comprising an elongate housing extending longitudinally and comprising a distal end (D) and a proximal end (P), the electronic module (320; 420; 520; 620) comprising: - a mechanical coding portion (350; 450; 550; 650) comprising mechanical coding features (351; 451; 551; 651) that engage with mechanical counter-coding features (371; 471; 571; 671) of a mechanical counter-coding portion (370; 470; 570; 670) provided on the proximal end (P) of the drug delivery device (100); wherein one of the mechanical coding features (351; 451; 551; 651) and the mechanical counter-coding features (371; 471; 571; 671) comprises a longitudinally extending protrusion (352; 452; 552; 652) and the other of the mechanical coding features (351; 451; 551; 651) and the mechanical counter-coding features (371; 471; 571; 671) comprises a recess (372; 472; 572; 672), - the geometric shape of the protrusion (352; 452; 552; 652) does not match the geometric shape of the recess (372; 472; 572; 672), or - The mechanical coding portions (350; 450; 550; 650) and the mechanical counter-coding portions (370; 470; 570; 670) are operable to prevent fastening of the electronic module (320; 420; 520; 620) to the proximal end (P) of the drug delivery device (100) in a predetermined fastening configuration if the position of the protrusions (352; 452; 552; 652) in a plane transverse to the longitudinal direction does not match the position of the recesses (372; 472; 572; 672) in that transverse plane, or if the longitudinal length of the protrusions (352; 452; 552; 652) exceeds the longitudinal length of the recesses (372; 472; 572; 672).

Description

Technical Field

[0001] The present disclosure relates to an electronic module configured to be attached to a drug delivery device. The drug delivery device may be an auto-injector or a manually or semi-automatically operated device. The drug delivery device may be an injection device such as a pen-type syringe. The present disclosure further relates to a mechanical interface between the electronic module and the drug delivery device. In particular, the present disclosure relates to a mechanical coding portion of the electronic module for engaging with a mechanical mating coding portion of the drug delivery device. Additionally, the present disclosure further relates to a module system including the electronic module and further including the drug delivery device.

Background Art

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

[0003] Drug delivery devices such as pen-type syringes must meet several user-specific requirements. For example, in the case of patients with chronic diseases such as diabetes, the patient may be physically frail and may also have reduced vision. Therefore, an appropriate drug delivery device, especially for home drug therapy, must have a robust structure and must be easy to use. Further, the operation of the device and its components, as well as general handling, must be understandable and easily comprehensible. Such an injection device must provide for the setting of variable-sized doses of the medicament and subsequent dispensing. Further, the dose setting as well as the dose dispensing procedure must be easy to operate and must be clear.

[0004] Not only mechanically actuated drug delivery devices, but also electronically actuated drug delivery devices, such as injection devices equipped with an electric drive, it is desirable to enable precise and reliable semi-automatic monitoring and / or collection of drug delivery-related data during use of the injection device. Mechanically operating drug delivery devices and / or injection devices are equipped with an electronically implemented electronic module that functions as an additional device or data collection device and is configured to monitor the operation of the injection device induced by the user. Such an electronic module must be fairly compact with respect to its geometric size. Generally, such an electronic module is used for memory assistance and also for accurate dosage history logging.

[0005] Drug delivery devices, such as pen-type syringes, are configured to deliver various drugs at various dosing rates (i.e., the number of insulin units per click). By providing a dedicated electronic module or additional device for data capture and data logging to a specific drug delivery device, there can be a substantial risk of inadvertently pairing the electronic module with the wrong drug delivery device. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] Accordingly, an object of the present disclosure is to provide an electronic module, a drug delivery device, and a module system with a reduced risk of inappropriately pairing the electronic module with the drug delivery device. Thus, the goal is to provide an electronic module dedicated to a specific drug delivery device and to ensure that the electronic module is mechanically connected or attached only to, i.e., exclusively to, the dedicated drug delivery device and vice versa. MEANS FOR SOLVING THE PROBLEMS

[0007] In a first aspect, the present disclosure relates to an electronic module configured to be attached to a proximal end of a drug delivery device in a predetermined fastening configuration. The electronic module is configured to be attached to a drug delivery device including an elongated housing extending in a longitudinal direction. The housing includes a distal end and a proximal end. Typically, the drug delivery device is configured to deliver a dose of drug from the distal end.

[0008] The electronic module includes a mechanical coding portion. The mechanical coding portion includes a mechanical coding function for engaging with a mechanical counter-coding function of a mechanical counter-coding portion provided at the proximal end of the drug delivery device. The mechanical counter-coding portion is provided at the proximal end of the drug delivery device and includes a mechanical counter-coding function configured to mechanically engage with the mechanical coding function of the mechanical coding portion of the electronic module. The mutual engagement between the mechanical coding portion and the mechanical counter-coding portion is achieved when the mechanical coding portion matches the mechanical counter-coding portion and when the electronic module is attached to the proximal end of the drug delivery device in a predetermined fastening configuration.

[0009] The electronic module is configured to be removably fixed to, and / or removably fastened to, the proximal end of the drug delivery device. In that sense, the electronic module can be mechanically connected to, or connectable to, the drug delivery device in the proximal end region of the drug delivery device.

[0010] The technical effect of attaching the electronic module proximally to the drug delivery device is that the overall extension or overall length of the drug delivery device is extended only slightly by attaching the electronic module, whereby the outer diameter of the drug delivery device does not substantially change. When the drug delivery device is implemented as a pen-type syringe, a comfortable pen shape is maintained, thereby enabling the user to easily handle the drug delivery device comfortably.

[0011] Generally, an electronic module is used together with several drug delivery devices of the same or identical type. Therefore, assembling or fastening the electronic module to the drug delivery device is merely a temporary assembly.

[0012] One of the mechanical coding function and the mechanical counter - coding function includes a protrusion. This protrusion extends in the longitudinal direction. The other of the mechanical coding function and the mechanical counter - coding function includes a recess. Usually, the protrusion and the recess are complementary shaped such that at least a part or the whole of the protrusion can enter or penetrate into the recess.

[0013] If the geometry of the protrusion does not match the geometry of the recess, or the position of the protrusion in a plane transverse to the longitudinal direction does not match the position of the recess within its cross - section, or further, if the longitudinal length of the protrusion exceeds the longitudinal length of the recess, the mechanical coding part and the mechanical counter - coding part are operable to prevent fastening the electronic module to the proximal end of the drug delivery device in a predetermined fastening configuration.

[0014] To mutually fasten the electronic module and the drug delivery device, a distal movement of the electronic module from a pre - assembly configuration to a final assembly configuration is required, and this final assembly configuration coincides with a predetermined fastening configuration. If the mechanical coding part of the electronic module does not match the mechanical counter - coding part of the drug delivery device at least with respect to any one of the above - mentioned criteria, geometry, position within the cross - section or longitudinal length, the protrusion is prevented from entering the recess, engaging with the recess, or reaching the final assembly position inside the recess, thereby preventing and / or obstructing the final distal movement of the electronic module with respect to the drug delivery device towards or into the final assembly configuration or the predetermined fastening configuration from the pre - assembly configuration.

[0015] To successfully pair and fasten the electronic module to the drug delivery device, it is necessary for the mechanical coding function to match the mechanical counter-coding function. The mechanical coding part is longitudinally aligned with the mechanical counter-coding part towards or so as to a predetermined fastening configuration, thus, the distal displacement of the electronic module relative to the drug delivery device from the pre-assembly configuration is only possible when the geometry of the protrusion matches the geometry of the recess and / or when the lateral or transverse position of the protrusion matches the lateral or transverse position of the recess. The transverse or lateral direction extends perpendicular to the extension of the housing of the drug delivery device.

[0016] In some examples, the mechanical coding function is a keying function for engaging with the corresponding shaped keying function of the mechanical counter-coding part. In a configuration where the mechanical coding part does not match the mechanical counter-coding part, the mechanical coding function and / or the mechanical counter-coding function act and operate as a blocking function configured to prevent the mutual attachment of the drug delivery device and the electronic module.

[0017] Generally, a kit of a number of electronic modules distinguished by the mechanical coding part is provided. The first mechanical coding part of the first electronic module is distinguished from the second mechanical coding part of the second electronic module. The first mechanical coding part includes the first mechanical coding function. The second mechanical coding part includes the second mechanical coding function. Accordingly, the first mechanical coding function includes at least one of the first protrusion and the first recess. The second mechanical coding function includes at least one of the second protrusion and the second recess. The geometry of the first protrusion can be distinguished from the geometry of the second protrusion. Additionally, or alternatively, the position of the first protrusion in a plane transverse to the longitudinal direction is distinguished from the position of the second protrusion in the cross-section. The same also applies to the first and second recesses of the first and second electronic modules.

[0018] Accordingly, the present disclosure also relates to a set of drug delivery devices distinguished by mechanical mating coding portions. At least a first drug delivery device is provided with a first mechanical mating coding portion, and a second drug delivery device is provided with a second mechanical mating coding portion. The first mechanical mating coding portion matches the first mechanical coding portion but does not match the second mechanical coding portion. Similarly, the second mechanical mating coding portion only matches the second mechanical coding portion and does not match the first mechanical coding portion. The first and second mechanical mating coding portions of the first and second drug delivery devices are distinguished by at least one of the geometry and the transverse position of the respective mating coding functions, and thus by the shape and / or the transverse position of the protrusions or recesses of the mating coding functions.

[0019] In this way, a dedicated electronic module with a specific mechanical coding portion is guaranteed to mechanically engage or be mechanically paired only with a drug delivery device having a matching mechanical mating coding portion. The mechanical coding portion of the electronic module and the mechanically mating coding portion of complementary shape of the drug delivery device can prevent the electronic module from being assembled with an unintended drug delivery device or injection device other than the dedicated drug delivery device or injection device.

[0020] Here, a fairly robust and fail-safe modular system can be provided that prevents mismatches between an electronic module and a drug delivery device that does not require or rely on complex or costly electronically implemented pairing inspections. For existing modular systems that include an electronic module and a drug delivery device, realizing a mechanical coding portion and a mechanical countercoding portion respectively requires modifying only a limited number of plastic injection molded components of the electronic module and / or the drug delivery device. Realizing the coding portion and the countercoding portion results in relatively low costs, but high strength and reliability.

[0021] According to a further example, the electronic module includes a fastening element configured to mechanically engage with a complementary shaped counterfastening element of the drug delivery device in a predetermined fastening configuration. The fastening element and the counterfastening element can define a predetermined fastening configuration in which the electronic module is attachable, connectable or connectable to the drug delivery device. The position and / or geometry of the fastening element of the electronic module typically matches the position and / or geometry of the counterfastening element of the drug delivery device. For mutual assembly, and thus for placing the electronic module on the drug delivery device in a predetermined fastening configuration, the fastening element needs to mechanically engage with the complementary shaped counterfastening element. When the fastening element and the complementary shaped counterfastening element are mechanically engaged, the electronic module is in a predetermined orientation and in a predetermined position relative to the drug delivery device.

[0022] In some examples, the mechanical coding portion can be part of the fastening element, and each countercoding portion can be part of the counterfastening element. In some examples, the fastening element can provide or be the mechanical coding portion, and the counterfastening element can provide or be the mechanical countercoding portion.

[0023] In some examples, the fastening element is separate from the mechanical coding part, and the opposing fastening element is separate from the mechanical opposing coding part. In some examples, also, when a relatively diverse set of electronic modules and drug delivery devices are provided, a set of electronic modules includes a number of electronic modules, each including a separate mechanical coding part, but each including the same fastening element. The same applies to the diverse available drug delivery devices, and thus to a set of drug delivery devices. In a set of drug delivery devices, the individual drug delivery devices can be distinguished with respect to their mechanical opposing coding parts, but can include the same opposing fastening element shaped complementary to each of the fastening elements of the electronic modules.

[0024] In some examples, a set of electronic modules including a first electronic module and a second electronic module is provided. The first electronic module includes a first mechanical coding part. The second electronic module includes a second mechanical coding part. The first and second mechanical coding parts are distinguishable, for example, with respect to their geometry and / or with respect to the transverse position of at least one of the protrusions and recesses of their respective mechanical coding functions.

[0025] The first and second electronic modules include the same fastening element. Thus, the fastening element of the first electronic module and the fastening element of the second electronic module are substantially identical both with respect to their geometry and with respect to the transverse position of these fastening elements with respect to the shape or housing of the electronic modules.

[0026] The same can apply to a set of drug delivery devices including a first drug delivery device and a second drug delivery device, where the first drug delivery device includes a first mechanical mating coding part and the second drug delivery device includes a second mechanical mating coding part. The first and second mechanical mating coding parts are distinguishable, for example, with respect to their geometry and / or with respect to the transverse position of at least one of the protrusions and recesses of the respective first and second mechanical mating coding functions. The first and second drug delivery devices each include mating fastening elements. The mating fastening elements of the first and second drug delivery devices can be substantially identical. They can have the same geometry and be arranged at the same position within the cross-section.

[0027] Providing an electronic module with fastening elements configured to engage with mating fastening elements of complementary shapes is effective in obtaining a fastening configuration appropriately defined for a variety of electronic modules intended to be mechanically coupled to a variety of drug delivery devices in general. By spatially separating the mechanical coding part from the fastening element, the fastening element does not need to make geometric modifications to provide the desired mechanical coding part. Thus, the existing fastening mechanism for fastening the electronic module to the drug delivery device can remain unchanged. By providing the mechanical coding part in a configuration that does not overlap with the fastening element, a fairly cost-effective and simple approach for mechanically encoding the electronic module is provided.

[0028] The fastening element can include a clip function and can form a clip connection with a corresponding or complementary-shaped mating fastening element. Thus, the mating fastening element of the drug delivery device can also include a clip function and can contribute to a click connection between the electronic module and the drug delivery device. In other examples, the fastening element is configured to establish a friction fit or a press fit with a complementary-shaped mating fastening element of the drug delivery device.

[0029] According to another example of an electronic module, the mechanical coding part is defined by at least one of the position, orientation, and longitudinal length of the mechanical coding function with respect to the fastening element. In some examples, the fastening element provides a symmetry-breaking function of the electronic module. The electronic module can have a tubular or disc-like shape. The electronic module can include a circular cross-section and can thus be rotationally symmetric with respect to the longitudinal direction as the axis of symmetry or axis of rotation.

[0030] When a set of a number of electronic modules is provided, for example a first electronic module and a second electronic module, the respective first and second mechanical coding parts are distinguished by at least one of the position, orientation, and longitudinal length of the respective first and second mechanical coding functions with respect to the fastening element. In other words, the mechanical coding function of the first mechanical coding part of the first electronic module is distinguished with respect to at least one of its position, orientation, and longitudinal length with respect to the fastening element as compared to the respective position and / or orientation of the second mechanical coding function of the second mechanical coding part with respect to the fastening element.

[0031] The same or similar applies to the mechanical mating coding portion of each drug delivery device. Also, the mechanical mating coding portion is defined by at least one of the position, orientation, and longitudinal length of its mechanical mating coding function relative to the mating fastening element of the drug delivery device. By defining the mechanical coding portion for the mechanical coding function, each electronic module of a set of electronic modules can be characterized without the need to compare the electronic modules to each other. Generally, the mechanical code is defined, for example, by the distance between the mechanical coding function and the fastening element of the electronic module. This distance can be at least one of the radial distance, circumferential distance, and longitudinal distance between the mechanical coding function and the fastening element. Usually, a set of electronic modules including a first and a second electronic module is provided, and at least one of the axial distance, radial distance, and circumferential distance of the first mechanical coding function of the first electronic module relative to the fastening element of the first electronic module is distinguished from and different from at least one of the radial distance, circumferential distance, and axial distance between the second mechanical coding function and the respective fastening element of the second electronic module.

[0032] Thus, arranging the electronic modules in a predetermined fastening configuration and attaching the electronic modules to the drug delivery device is only possible when the mechanical coding portion matches the mechanical mating coding portion.

[0033] According to a further example, the electronic module includes at least one longitudinally extending extension that extends distally from the distal end of the electronic module. The at least one longitudinally extending extension is configured to extend into or through an aperture at or near the proximal end of the drug delivery device. The extension can be an extension of a sensor disposed in the electronic module. The extension can be, for example, an optical guide attached to a circuit board. In other examples, the extension is implemented as, for example, a switch for power management of the electronic module. When in a predetermined fastening configuration, the longitudinally extending extension of the electronic module can extend distally beyond or across the proximal end of the drug delivery device. In a predetermined fastening configuration, the extension can engage with the proximal end or proximal end section of the drug delivery device. The extension can enable the use of a drug delivery device having a movable and / or rotatable part used to detect the dose of the selected or delivered drug.

[0034] The longitudinally extending extension that reaches the proximal end of the drug delivery device is configured to cooperate with an encoder provided on the movable and / or rotatable part of the drug delivery device.

[0035] According to a further example, the mechanical coding part is defined by at least one of the position, orientation, and longitudinal length of the mechanical coding function with respect to the longitudinally extending extension. Here, the longitudinally extending extension can provide a symmetry-breaking function of the electronic module. Additionally or alternatively, when the longitudinally extending extension engages with, extends into, or through an aperture at the proximal end of the drug delivery device, the longitudinally extending extension can define a predetermined fastening configuration of the electronic module and the drug delivery device. The predetermined fastening configuration in which the electronic module can be attached or coupled to the drug delivery device is defined by the position of the fastening element and the opposing fastening element, or by the longitudinally extending extension and a complementary-shaped aperture of the drug delivery device.

[0036] In some examples, the electronic module includes both a fastening element having a shape complementary to the opposing fastening element and a longitudinal extension extending into or through the aperture of the drug delivery device.

[0037] According to further examples, the electronic module includes not only one but a plurality of fastening elements configured to mechanically engage with the opposing fastening elements of the respective number of complementary shapes and complementary arrangements of the drug delivery device in a predetermined fastening configuration. In some examples, the electronic module includes two fastening elements disposed at geometrically opposing positions on or near the outer periphery of the housing of the electronic module.

[0038] In some examples, the electronic module includes three, four, or even more fastening elements, each of which has a shape complementary to the respective number of opposing fastening elements of the drug delivery device. When a plurality of fastening elements are provided, the fastening elements are arranged equidistantly along the periphery of the housing of the electronic module. In this way, a fairly robust and fail-safe mechanical attachment of the electronic module to the drug delivery device is provided.

[0039] According to further examples, the mechanical coding function includes a protrusion protruding in the longitudinal distal direction from the surface facing distally of the electronic module. Providing a protrusion on the electronic module is advantageous in that the mating mechanical counter-coding function of the drug delivery device comprises a recess of complementary shape at the proximal end of the drug delivery device. Thus, the drug delivery device has no longitudinally extending protrusion at its proximal end, which can be advantageous for using the drug delivery device when the electronic module is not provided or attached at its proximal end. The protrusion of the mechanical coding function is typically configured to engage with the recess of complementary shape of the mechanical counter-coding function. The mechanical counter-coding function, and thus the recess, is typically provided on or adjacent to the surface facing proximally of the drug delivery device.

[0040] According to a further example, when the distally facing surface of the electronic module is in a predetermined fastening configuration, it is in longitudinal or axial contact with the proximally facing surface of the complementary shape of the drug delivery device. In some examples, the protrusion of the electronic module and the recess of the drug delivery device are shaped such that when the predetermined fastening configuration is reached, the distally facing surface of the electronic module contacts the proximally facing surface of the drug delivery device. In this way, a fairly stable and strong mutual contact configuration between the electronic module and the drug delivery device can be achieved. The mutual contact of the distally facing surface with the proximally facing surface results in a non-tilted mechanical attachment of the electronic module to the proximal end of the drug delivery device.

[0041] In some examples, a mechanical mating coding function, for example, each recess, is provided on the inner surface of the side wall of the drug delivery device or on the outer surface of the side wall of the drug delivery device. The recess may include a longitudinal slot having a radial depth that matches the geometry of the protrusion of the mechanical coding function of the electronic module.

[0042] In a predetermined fastening configuration, the protrusion of the mechanical coding function may include a radially inward engaging section configured to engage a recess or slot provided on the outer surface of the side wall of the drug delivery device. Similarly, the longitudinal protrusion of the mechanical coding function may include a radially outward engaging section or engaging portion configured to engage a recess or slot provided on the inside facing the inner surface of the side wall of the drug delivery device. Each slot provided on the inner or outer surface of the side wall of the drug delivery device may extend towards the proximal end of the respective side wall. At the proximal end, the side wall may include a flange extending radially outward or radially inward that functions as a longitudinal end stop for each recess or slot.

[0043] Thus, when the slot is formed as a longitudinal groove on the outer surface of the sidewall of the drug delivery device, the slot may terminate in a flange that extends radially outward at the proximal end of the drug delivery device. Here, a flange or flange portion that terminates the slot or recess in the longitudinal proximal direction may form or constitute a snap function or clip function for engaging with a corresponding shaped snap function of the longitudinal protrusion of the coding function in a predetermined fastening configuration.

[0044] In this way, the coding function and the opposing coding function of the corresponding shape may provide or support fixing the electronic module longitudinally to the drug delivery device and / or mechanically attaching it.

[0045] According to another example, the mechanical coding portion of the electronic module includes a coding section. The coding section includes a number n of individual coding function positions that do not spatially overlap and a number k of mechanical coding functions. Each of the coding functions is arranged at one of the coding function positions. The size of the coding function matches the size of the coding function position. The coding function positions are arranged adjacent to each other immediately, and can be adjacent, for example, in the circumferential direction or the radial direction, or along a combination thereof.

[0046] The coding function positions are arranged along a line or a curve. Thus, the first coding function position is arranged next to the second coding function position. The second coding function position is arranged next to the third coding function position. The second coding function position is arranged between the first coding function position and the third coding function position. The third coding function position is arranged adjacent to or next to the fourth coding function position. The third coding function position is arranged between the second coding function position and the fourth coding function position.

[0047] Typically, n and k are integers. Further, n ≤ k or n < k. In some examples, n = k / 2.

[0048] Generally, if the total number of distinct coding function positions that do not spatially overlap is n, there are 2 n n possible configurations and arrangements. However, not all of these arrangements can guarantee a unique and dedicated pairing between the electronic device and the drug delivery device. The condition that all but one of the electronic modules 620 are guaranteed to be prevented from engaging with one drug delivery device is that all mechanical coding portions 650 contain the same number of mechanical coding functions 651, 653. The number of non - overlapping permutations of k coding functions in n coding function positions is equal to the binomial coefficient given by the following formula:

Number

[0049] A coding section with several mechanical coding functions arranged at one of the many available coding function positions provides a kind of binary code. If a coding function is not at a coding function position, this represents the digit 0. If a coding function is provided at a coding function position, this represents the digit 1. Generally, if there are two coding function positions in the coding section, up to 4 different mechanical coding portions can be provided. If there are three coding function positions, up to 8 different mechanical coding portions can be provided, and if there are four coding function positions in the coding section, up to 16 different mechanical coding portions can be provided. Generally, the number of available mechanical coding portions is 2 2 n.

[0050] Naturally, the mechanical opposing coding portion includes the reverse arrangement of the mechanical opposing coding function in the mechanical opposing coding section.

[0051] According to a further example, the mechanical coding function of the coding section of the mechanical coding part of the electronic module is configured to engage with the respective mechanical counter-coding parts of the drug delivery device, and this mechanical counter-coding part includes a counter-coding section. The counter-coding part includes a number M of individual counter-coding function positions that do not spatially overlap and a number L of mechanical counter-coding functions. Each of the mechanical counter-coding functions is arranged at one of the counter-coding function positions. Here, M and L are integers, and L≦M or L<M. In some examples, L = M / 2.

[0052] According to another example of the electronic module, the number n of coding function positions of the coding section is equal to the number M of counter-coding function positions of the mechanical counter-coding part, and / or the number k of mechanical coding functions provided in the coding section is equal to the number L of mechanical counter-coding functions provided in the mechanical counter-coding section.

[0053] In another aspect, the present disclosure relates to a drug delivery device. The drug delivery device includes a housing. The housing includes a distal end and a proximal end. The proximal end is configured to attach the above-described electronic module in a predetermined fastening configuration. The drug delivery device further includes a drive mechanism. The drive mechanism is configured to set a dose of the drug and / or deliver it from the distal end. Usually, the proximal end of the drug delivery device is provided at one longitudinal end of the housing, and the distal end of the drug delivery device is provided at the longitudinal end located on the opposite side of the housing.

[0054] The drug delivery device includes a mechanical counter-coding part provided at the proximal end. The mechanical counter-coding part includes a mechanical counter-coding function for engaging with the mechanical coding function of the mechanical coding part of the above-described electronic module when attached to the proximal end of the drug delivery device in a predetermined fastening configuration.

[0055] Generally, a drug delivery device is configured and designed to engage with an electronic module as described above with respect to its mating coding portion. To that extent, any functions, advantages, and effects as described above in relation to the electronic module equally apply to the drug delivery device; and vice versa.

[0056] The mating coding function can include longitudinally extending protrusions, or can include recesses for engaging and receiving each protrusion of the coding function. The protrusions or each recess has a complementary shape or is in a complementary position to each recess or protrusion of the coding function of the electronic module. When the mechanical mating coding function includes longitudinally extending protrusions, the coding function of the electronic module includes recesses. When the mechanical mating coding portion includes recesses, the mechanical coding portion includes longitudinally extending protrusions of complementary shape.

[0057] In a matching pair of the mechanical coding portion and the mechanical mating coding portion, the geometry of the protrusion matches the geometry of the recess, and the position of the protrusion in a plane transverse to the longitudinal direction matches the respective position of the recess within its cross-section. Otherwise, when the electronic module is in a pre-assembly configuration where the fastening element of the electronic module and the drug delivery device and the mating fastening element are at least longitudinally aligned, if at least one of the geometries of the protrusion and the recess, or at least one of the transverse positions of the protrusion and the recess do not match or align with each other, the mechanical pairing of the electronic module and the drug delivery device is effectively impeded and prevented. At this time, the protrusion can abut against the boundary region of the recess, and / or the protrusion of its geometry cannot enter the recess longitudinally.

[0058] According to a further example, the drug delivery device includes opposing fastening elements configured to mechanically engage with complementary-shaped fastening elements of the electronic module in a predetermined fastening configuration. Again, the opposing fastening elements may define a predetermined fastening configuration. The fastening configuration of the electronic module and the drug delivery device is defined when the fastening elements engage with the opposing fastening elements of complementary shape.

[0059] In some examples, the drug delivery device and the electronic module each include a plurality of fastening elements, for example, two fastening elements respectively arranged along the periphery of the housing of the electronic module and along the periphery of the housing of the drug delivery device. When two or more fastening elements are provided, these are arranged at diametrically opposite positions on the electronic module and / or on the drug delivery device. In this way, not only a single unique predetermined fastening configuration, but also, for example, two or more predetermined fastening configurations are provided.

[0060] The predetermined fastening configuration is characterized by the orientation of the electronic module with respect to the drug delivery device, in particular with respect to the proximal end of the drug delivery device, with respect to a rotational axis that coincides with or extends parallel to the longitudinal direction of the housing of the electronic module and / or the housing of the drug delivery device.

[0061] In the case of two fastening configurations, it is particularly advantageous when the electronic module includes two mechanical coding parts and the drug delivery device includes two complementary-shaped mechanical opposing coding parts. It is also conceivable that the electronic module includes three or four fastening elements arranged equidistantly along the periphery of the housing of the electronic module. In this case, the drug delivery device may accordingly include the respective three or four opposing fastening elements at its proximal end.

[0062] As the number of fastening elements increases, a respective increasing number of mechanical coding parts and / or mechanical opposing coding parts are also provided on the electronic module and on the drug delivery device respectively.

[0063] When the fastening element and the opposing fastening element are arranged equidistantly along the periphery of each of the electronic module and the drug delivery device, a number of predetermined fastening configurations are provided.

[0064] In a predetermined fastening configuration with a number C, an integer number of mechanical coding portions are provided on the electronic module. To prevent the electronic module from being inappropriately paired with a drug delivery device, a matching drug delivery device may include only one or more mechanical opposing coding portions and it may be sufficient to engage with only one of the mechanical coding portions of the electronic module.

[0065] In another example, the matching drug delivery device may be a drug delivery device including a number C of mechanical opposing coding portions. At this time, if the electronic module includes one or more mechanical codings, it may be sufficient to engage with any one of the mechanical opposing coding portions of the drug delivery device.

[0066] According to another example, the mechanical opposing coding portion is defined by at least one of the position, orientation, and longitudinal length of the mechanical opposing coding function with respect to the opposing fastening element.

[0067] According to a further example, the drug delivery device includes an aperture for receiving at least one longitudinal extension of the electronic module. In the case of a predetermined fastening configuration, the aperture at the proximal end of the drug delivery device is configured to receive or align with the longitudinal extension of the electronic module. Here, according to a further example, the mechanical opposing coding portion is defined by at least one of the position, orientation, and longitudinal length of the mechanical opposing coding function with respect to the aperture at the proximal end of the drug delivery device.

[0068] At least one of the opposing fastening element and the aperture at the proximal end of the drug delivery device can define one or several predetermined fastening configurations of the electronic module and the drug delivery device. Thus, at least one of the opposing fastening element and the aperture at the proximal end of the drug delivery device can function as a reference for defining different opposing coding portions of the drug delivery device. The different opposing coding portions are distinguished from each other by varying the position, orientation or longitudinal length of their respective opposing coding functions with respect to at least one of the opposing fastening element and the aperture at the proximal end of the drug delivery device.

[0069] According to another example, the mechanical opposing coding function includes a recess configured to receive or engage with a complementary-shaped protrusion extending distally that forms the coding function of the mechanical coding portion of the electronic module in a predetermined fastening configuration. In this way, there may be no protrusion at the proximal end of the drug delivery device. Thus, the proximal end of the drug delivery device is configured to receive a protrusion of the electronic module that functions as a mechanical coding function, extending longitudinally, usually in the distal direction. Avoiding implementing a longitudinally extending protrusion at the proximal end of the drug delivery device is somewhat advantageous for the general handling of the device and the associated user comfort, especially when the drug delivery device is to be used without an electronic module.

[0070] In another example, the recess providing the mechanical opposing coding function is located and provided on at least one of the surface facing proximally of the drug delivery device, the outer surface of the side wall of the drug delivery device, and the inner surface of the side wall of the drug delivery device. When the recess is located on the side wall of the drug delivery device (for example, the side wall of the dose dial or the side wall of a drive element movably arranged at the proximal end of the drug delivery device), the recess is implemented as a longitudinal slot or groove that receives and / or engages with the longitudinally extending coding function of the mechanical coding portion of the electronic module.

[0071] For example, recesses on the inner or outer surface of a tubular or sleeve-like component of a drug delivery device can be fairly easily realized and implemented in an injection-molded plastic component. The recesses are provided as longitudinal grooves or slots on the inner or outer surface of a component of the drug delivery device. The same or a similar function is provided in an electronic module. That is, when the mechanical coding function of the electronic module includes respective recesses, the mechanical counter-coding function of the drug delivery device includes protrusions extending in the longitudinal direction.

[0072] Generally, there are many different configurations for the protrusions and recesses. In some examples, the protrusion includes a somewhat linear and elongated pin. This protrusion can include a rectangular slab or tab. The protrusion can include a specific geometric structure. Thus, the protrusion can include a tubular sleeve-like, for example, circular or oval hollow structure. In other examples, the protrusion includes a rectangular or triangular cross-section. In a further example, the protrusion can include an intersection structure within the cross-section formed by two slab-like or planar elements intersecting each other.

[0073] Correspondingly, the recess can include a single blind hole on the surface of a drug delivery device facing distally or proximally to one of the electronic modules. In other examples, the recess includes a longitudinally extending groove or slot extending along the side wall facing the inside or outside of the housing, or the drive element, or the adjustment element. Usually, the mechanical coding function is a keying function having a shape complementary to or corresponding to each counter-keying function provided by the mechanical counter-coding function, or forms the same.

[0074] According to another example, the drug delivery device includes a drug container filled with a drug. The drug is provided in liquid form inside the drug container. The drug container may include at least one of a syringe, a cartridge, or a cartridge. The drug container typically includes a barrel sealed in the distal direction and sealed in the proximal direction. The drug container or barrel is sealed toward the proximal direction by a movable stopper. The movable stopper can be made movable relative to the side wall of the barrel by the piston rod and drive mechanism of the drug delivery device. The distal end of the barrel or the distal end of the drug container is permanently or temporarily connected to a dispenser such as a syringe needle or an infusion line. In some examples, when the drug delivery device is implemented as a pen-type injection device, the distal end of the housing of the drug delivery device is configured to receive a double-ended syringe needle configured to pierce or penetrate the distal seal of the drug container when attached to the housing of the drug delivery device.

[0075] The drug delivery device is implemented as a reusable device, and the drug container is configured to be replaced. In other examples, the drug delivery device is implemented as a disposable device. Here, the drug container is not intended to be replaced. Rather, when the contents of the drug container have been used up, the drug delivery device is intended to be discarded in its entirety. Before discarding the drug delivery device, the electronic module is removed from the proximal end of the drug delivery device and connected or attached to another drug delivery device. In a disposable drug delivery device, the drug container filled with the drug is easily assembled inside the drug delivery device when delivered to the end consumer or patient.

[0076] According to another aspect, the present disclosure relates to a module system. The module system includes an electronic module as described above. The module system further includes a drug delivery device as described above. Here, the mechanical coding portion of the electronic module matches the mechanical coding portion of the drug delivery device. Further, the mechanical coding portion mechanically engages with the mechanical opposing coding portion when the electronic module and the drug delivery device are in a predetermined fastening configuration.

[0077] The modular system can include several differently configured electronic modules, as well as several differently configured drug delivery devices. A number of electronic modules can be distinguished by their machine code part or coding part. A number of drug delivery devices can be distinguished by their machine counter code part or coding part. When an electronic module with a first machine coding part has to be assembled in accordance with an assembly procedure together with a drug delivery device with a second machine counter code part that is not suitable for pairing or engaging with the first machine coding part, the first machine coding part and the second machine counter code part, and thus the machine coding part that does not match the machine counter code part, effectively prevent establishing a predetermined fastening configuration of the electronic module in the drug delivery device.

[0078] Generally, an electronic module can include at least one of the following: - A battery or rechargeable accumulator holder, and / or - Optionally, a battery or rechargeable accumulator, and / or - Optionally, only one or at least one circuit board, and / or - Electronic components (such as resistors and / or at least one integrated circuit) can form an electronic circuit, - The electronic components can include at least one sensor element (such as an optical sensor), and / or - A microprocessor or microcontroller or another control unit, and / or - Optionally, a receiving and / or transmitting (sending) unit for communicating with, for example, a smartphone or other computer device, for example, based on the Bluetooth protocol (which may be a registered trademark), the WiFi protocol (which may be a registered trademark), or the USB protocol (Universal Serial Bus, which may be a registered trademark), and / or - An extension of the sensor, for example, an optical guide attached to a circuit board, and / or - At least one switch, for example, for power management.

[0079] The distal end of the electronic module and the proximal end of the drug delivery device are arranged on the longitudinal axis of the drug delivery device. The second module is arranged on the extended longitudinal axis of the drug delivery device. Thus, a series connection along the longitudinal axis is realized.

[0080] Generally, the scope of the present disclosure is defined by the content of the claims. The injection device is not limited to a specific embodiment or example, and includes any combination of elements of various embodiments or examples. To that extent, the present disclosure encompasses any combination of the claims and any technically feasible combination of the functions disclosed in various examples or embodiments.

[0081] In this context, the term "distal" or "distal end" is associated with the end of the injection device facing the injection site of a human or animal. The term "proximal" or "proximal end" is associated with the end of the injection device on the opposite side, farthest from the injection site of a human or animal.

[0082] The terms "drug" or "agent" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, optionally together with a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in the broadest sense, a chemical structure having a biological effect on a human or animal. In pharmacology, a drug or medicine is used for the treatment, cure, prevention, or diagnosis of a disease, or otherwise for improving physical or mental well-being. A drug or agent can be used for a limited duration or, in the case of a chronic disorder, periodically.

[0083] As described below, a drug or agent can contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0084] A drug or medicament can be contained in a primary package or “drug container” adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for containing one or more drugs (e.g., short-term or long-term containment). For example, in some cases, the chamber can be designed to contain a drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to contain a drug for about one month to about two years. The containment can be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately contain in each chamber two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing upon dosing of the components into a human or animal body.

[0085] The drugs or agents included in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic agents) or 86 (oncological agents)) or the Merck Index, 15th edition.

[0086] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, and their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms "analog" and "derivative" refer to polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the molecular structure of human insulin in which one or more organic substituents (such as fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids including non-codable amino acids, or amino acids are added including those non-codable for the naturally occurring peptide.

[0087] Examples of insulin analogs 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 at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28 - B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0088] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, Levemir®); B29 - N - palmitoyl - des(B30) human insulin; B29 - N - myristoyl human insulin; B29 - N - palmitoyl human insulin; B28 - N - myristoyl LysB28ProB29 human insulin; B28 - N - palmitoyl - LysB28ProB29 human insulin; B30 - N - myristoyl - ThrB29LysB30 human insulin; B30 - N - palmitoyl - ThrB29LysB30 human insulin; B29 - N - (N - palmitoyl - gamma - glutamyl) - des(B30) human insulin, B29 - N - omega - carboxypentadecanoyl - gamma - L - glutamyl - des(B30) human insulin (insulin degludec, Tresiba®); B29 - N - (N - lithocholyl - gamma - glutamyl) - des(B30) human insulin; B29 - N - (ω - carboxyheptadecanoyl) - des(B30) human insulin and B29 - N - (ω - carboxyheptadecanoyl) human insulin.

[0089] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligens, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0090] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0091] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0092] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0093] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in poly-sulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hyaluronan G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0094] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has a reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to an Fc receptor, e.g., having a mutation or deletion in the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODVs) having a crossover binding region orientation.

[0095] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may include a cleaved portion of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, e.g., bispecific, trispecific, tetra-specific, and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or polyvalent antibody fragments, e.g., divalent, trivalent, tetravalent, and polyvalent antibodies, minibodies, chelated 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.

[0096] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of CDR sequences to enable antigen binding. The framework region itself typically does not directly participate in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody may directly participate in antigen binding or may affect the ability of one or more amino acids within a CDR to interact with an antigen.

[0097] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0098] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use in the drug or agent in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0099] Those skilled in the art will understand that various modifications (additions and / or removals) of the components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be made without departing from the scope and spirit of the invention, which includes such modifications and any equivalents thereof.

[0100] Furthermore, it will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from its scope. It should be noted that any reference numbers used in the appended claims should not be construed as limiting the scope of the present disclosure.

[0101] In the following, numerous examples of injection devices and methods of pairing a data logging device with an external electronic device will be described in more detail with reference to the drawings.

Brief Description of the Drawings

[0102]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

DETAILED DESCRIPTION OF THE INVENTION

[0103] Figure 1 shows a module system 98 according to a first example. The module system 98 can include a drug delivery device 100 that can include a container holding member 101 and a main housing member 102. The container holding member 101 can accommodate a drug container 103. The drug container 103 can include a cartridge sealed in the proximal direction by a movable stopper 105, and the drug container 103 can contain a drug Dr. The main housing member 102 can completely or partially accommodate or surround the container holding member 101, and can also include further parts of the drug delivery device 100. Alternatively, the main housing member 102 is connected to the container holding member 101, but cannot surround it, and cannot even surround a part of the container holding member 101 (see the dashed line in Figure 1).

[0104] Inside the main housing member 102, the following components are arranged: - A piston rod 104 applied to move a piston arranged inside the container holding member 101, - A drive mechanism 106 for the piston rod 104. The drive mechanism 106 can include an energy storage element (for example, a spring manually loaded before each use). Alternatively, the energy storage element is loaded, for example, during the assembly of the drug delivery device 100. Alternatively, a manually driven drive mechanism without an energy storage element used to drive the piston rod 104, for example, is used.

[0105] In some examples, for example, at the proximal end P, a drive element 108 used to initiate the movement of the piston rod 104 into the container holding member 101 is arranged, whereby the drive mechanism 106 is used. Alternatively, an auto-injector device driven by the axial movement of a movable needle shroud (not shown) is used. The drive element is used, in some embodiments, to dial-set the size of the dose of the drug Dr.

[0106] In addition, the cap 112 is attached to the main housing member 102 or to another member of the drug delivery device 100. The cap 112 can be an outer cap that may include an inner cap smaller than that directly protecting the needle 110.

[0107] If the drug delivery device 100 is not an auto-injector, the dial sleeve is rotated out of the main housing 102 and pushed by the user to move the plunger 104 distally to inject the drug Dr.

[0108] The drug delivery device 100 may be a single-use device or a multi-use device.

[0109] The drug Dr is dispensed from the container through the needle 110 or through a nozzle connectable to and / or connected to the distal end D of the drug delivery device 100. The needle 110 is replaced before each use or used several times.

[0110] The module system 98 may include an electronic module 120 that is mechanically connected to the proximal end region P of the drug delivery device 100 (for example, the proximal end region P of the drive element 108). The module system 98 will be described in more detail below (see FIG. 2 and the corresponding description).

[0111] The electronic module 120 is used not only for the drug delivery device 100 but also for other drug delivery devices that are similar or identical to the drug delivery device 100. Therefore, the electronic module 120 is used multiple times with different drug delivery devices such as different module systems 98. Furthermore, the diameter of the drug delivery device 100 is not increased by the electronic module 120 that promotes excellent operability of the module system 98, particularly of the drug delivery device 100.

[0112] FIG. 2 shows a module system 200 which may be the same as the first embodiment, although more details are shown in FIG. 2. The module system 200 may include, for example, a housing member 102c which may correspond to the housing member 102 described above. The drive element 108c may correspond to the drive element 108 described above.

[0113] The module system 200 may include the following: - A clutch element 202 or other rotatable or movable element that may include a radially protruding feature 204, such as teeth of a sprocket or sprocket sleeve (e.g., providing a rotary encoder). - An essentially annular adapter element 210 that can encompass the sidewall of the drive element 108. - An electronic module 220 that can correspond to the electronic module 120 and may include an electronic unit 240, which will be described in more detail below. - An annular casing or housing 221 of the electronic module 220. - A chassis 222 inside the electronic module 220. The chassis 222 may include an annular wall 249 that surrounds a compartment of the electronic unit 240 and / or compartments of several other members. - And a lid 224 of the electronic module 220.

[0114] A fastening element 226 is used to connect the housing 221 and the adapter element 210. Alternatively, other connecting means may be used, or the housing 221 and the adapter element 210 may be integrally formed as a single member.

[0115] The following electronic components are included inside the electronic module 220: - A battery 230 or rechargeable accumulator, and - An electronic unit 240 that can form a printed circuit board assembly (PCBA).

[0116] The electronic unit 240: - A printed circuit board 242 (PCB) referred to as a substrate in the claims, - At least one light source 264 (e.g., an infrared (IR) light source), or two light sources, - At least one optical sensor 266, or at least two optical sensors, - A transmitter unit 270, such as a transmitter unit 270 that operates according to a Bluetooth (which may be a registered trademark) protocol for communicating with, for example, a smartphone or other computer device, - A receiver unit 272, such as a receiver unit 272 that operates according to a Bluetooth (which may be a registered trademark) protocol for communicating with, for example, a smartphone or other computer device, - An optional switch 274, such as a microswitch may be included.

[0117] Figure 2 shows the longitudinal axis A of the module system 200. The electronic module 220 is disposed proximate to the drive element 108c of the corresponding drug delivery device. The electronic module 220 and the drive element 108c are symmetrically disposed with respect to the axis A, whereby the electronic module 220 and the drive element 108c are in physical contact with each other mainly through the adapter element 210. The adapter element 210 is mechanically plugged into the drive element 108c.

[0118] The chassis 222 includes: - Three annular wall portions 244, 246, and 248 of the annular wall 249, - The distal end 250 of the chassis 222 and, simultaneously, of the annular wall portion 248, - The wall 252 of the chassis 222, - At least one optical guide 254, or at least two optical guides 254, 258 may be included.

[0119] The cup-shaped structure is formed by the wall 252 and a part of the annular wall portion 248 around the proximal member or the base member of the optical guide 254. The cup-shaped structure may include a laterally extending thin portion 259 regarded as the bottom of the cup-shaped structure. The thin portion 259 is near but distally disposed from the light source 264 (e.g., IR) and the optical sensor 266. The rib 260 is disposed on the thin portion 259 and may extend proximally P to the printed circuit board 242. The rib 260 can be adjacent to the light source 264 (e.g., IR) and / or the optical sensor 266. A gap 262 may exist between the printed circuit board 242 and the proximal portion or the bottom of the thin portion 259 and / or the wall 252. The gap 262 is filled with a potting compound / material 282. The rib 260 can protect the light source 264 (e.g., IR) and / or the optical sensor 266 from the potting compound / material 282, even when it is in a dissolved state.

[0120] A series of annular wall portions 244, 246, and 248 may exist in this order from the proximal P end to the distal end of the annular wall 249. The annular wall portion 244 may have a first diameter corresponding to the diameter of the lid 224. The annular wall portion 246 may have a second diameter smaller than the first diameter. The second diameter may correspond to the diameter of the printed circuit board 242. Further, the annular wall portion 248 may have a third diameter smaller than the second diameter.

[0121] The filling height 280 measured from the printed circuit board 242 can be in the range of 2 mm to 7 mm. The filling height 280 of the potting compound 282 or the potting material is appropriately selected, for example, to cover only a part of the electrical components of the electronic unit 240. The inside of the distal end 250 of the annular wall portion 248 may not be covered with the potting compound 282 or another potting material. The potting compound 282 or the potting material can be an electrical insulator. The wall 252 can protect the base of the optical guide 254 from the potting compound / material 282 during potting.

[0122] Figure 5 schematically shows an electronic unit 500 (for example, the electronic unit 240). The electronic unit 500 includes: - at least one processor Pr or another control unit, and - a memory Mem (for example, a volatile and / or non-volatile storage memory), and - a battery Bat or a rechargeable accumulator or any other power source, and - an output device Out (for example, a transmission unit) for communicating with, for example, a smartphone or another computer device, and - an optional input device In for communicating with, for example, a smartphone or another computer device, and - a switch Sw, and - at least one sensor S or at least two sensors, preferably an optical sensor and may include.

[0123] The electronic unit 500 includes further members (for example, a radiation source, in particular a light source) not shown in the figure.

[0124] The processor Pr can be a microcontroller or a microprocessor that executes program instructions stored in the memory M. Alternatively, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a programmable logic array (PLA), a programmable logic device (PLD) or another suitable circuit can be used to implement a finite state machine that does not execute program instructions.

[0125] The electronic unit 500 can implement an orthogonal encoder, which is, for example, an encoder that uses amplitude modulation 180 of two sensors having a 180-degree phase shift between two sensor signals (for example, inverse-phase sensor signals). Alternatively, other detection methods are used.

[0126] According to various embodiments, there may be two alternative modes of the detection operation method. According to the first alternative form, the first sensor and the second sensor (e.g., an optical sensor) are provided with an angular offset that is, for example, half of the period of the encoding region of the encoder encoding on the clutch element 202. In an embodiment according to the first alternative form, the sensors are operated to sample synchronously, i.e., at the same times (t1; t2, t3,...). By doing so, signal detection and / or signal processing can be facilitated.

[0127] According to the second alternative form, the first sensor and the second sensor (e.g., an optical sensor) are provided with an angular offset different from half of the constituent period of the encoding region of the encoder encoding. Therefore, sensors I and II can operate in a staggered mode with a time offset (Δt) between samplings. Using this mode, a more balanced total system power consumption than that available with the synchronous operation method can be achieved.

[0128] One of the following detection modes is used: - 1) Static threshold processing, - 2) Dynamic threshold processing, - 3) Detect the low-to-high transition of the sensor signal without using a threshold. However, a threshold of the voltage difference between the two sensor signals is used. Further, a conversion coefficient of the average value and the amplitude is used. The conversion coefficient is set during manufacturing, for example, during a calibration method. - 4) It is the same as 3), but different in that the conversion coefficient is calculated after each dose delivery. 5) A peak detection method that preferably does not use a threshold setting to detect the low-to-high transition of the sensor signal, and preferably does not use signal scaling to match the average value and the amplitude.

[0129] In other words, part of the present disclosure relates to preferably protecting the optical pipe / guide 254 or the optical pipe from a load. The optical pipe can be an optical fiber, a tube, or other optical guiding means. An additional coating 256 on the outer surface of the optical pipe is used to prevent damage caused by loads coming from the outside to the optical pipe. The first option is a metal coating or a similar robust material coating for hardening the structure of the optical pipe. The second option is a soft coating for absorbing impact loads and reducing the stress of the optical pipe. Another option is a reinforcing coating, for example, a carbon fiber reinforced polymer (in German: CFK) filling material. Combinations of two or three of these options are also possible.

[0130] FIG. 3 shows another example of a module system 300. Generally, the module system 300 is similar or almost identical to the module systems 98 or 200 as described above in relation to FIGS. 1 and 2. The module system 300 includes an electronic module 320. The electronic module 320 includes a housing 321. The housing 321 can form or include a chassis 322. The chassis 322 is somewhat identical or equivalent to the chassis 222 as described above in relation to FIG. 2.

[0131] The electronic module 320 includes a distal end 301 and a proximal end 302. At or near the distal end 301, the electronic module 320 includes a surface 360 facing distally. A mechanical coding portion 350 is further provided on the distal surface 360 and / or the distal end 301. The mechanical coding portion 350 includes longitudinally extending protrusions 352 that form or constitute a mechanical coding function 351. In this example, the mechanical coding function 351 includes an annular or tubular hollow sleeve.

[0132] Along the periphery of the housing 321, a number of fastening elements 323, 324 and 325, 326 are provided. The fastening elements 323, 324, 325 are arranged at equal distances along the periphery of the housing 321. Further, two separate optical guides are also provided, for example, in the form of optical guides or light pipes 254, 258 that project distally from a surface 360 facing distally at the distal end 301. Figure 3 further shows the proximal end P of the drug delivery device 100. The proximal end P may include a drive element 108. Thus, the movable (e.g., rotatable) drive element 108 can constitute or form the proximal end P of the drug delivery device 100.

[0133] A mechanical mating coding portion 370 is provided at the proximal end P. The mechanical mating coding portion 370 includes a mechanical mating coding function 371. Here, the mechanical mating coding function 371 includes an annular recess 372 configured to engage with and / or receive the protrusions 352 of the electronic module 320, and thus the mechanical coding function 351. The recess 372 is arranged radially between a central cylindrical portion 312 and a surrounding side wall portion having a proximally facing surface 380. The proximally facing surface of the cylindrical portion 312, the surface 380, and the proximal end of the drive element 108 can be at the same height and arranged in a common transverse plane.

[0134] The surface 380 is provided on an inner annular side wall 381 or an annular ring 311. An annular groove 310 is provided between the inner side wall 381 and the outer side wall 382 of the drive element 108. An outer annular groove 310 is provided radially between the inner side wall 381 and the outer side wall 382 for receiving the optical guides 254, 258. The outer annular groove 310 is separated from the annular recess 372 by the annular ring 311, and thus by the inner side wall 381.

[0135] Optical guides 254, 258 extend into annular groove 310 when electronic module 320, and thus its chassis 322, is attached to or assembled with drug delivery device 100 in at least one of two available predetermined fastening configurations. Optical guides 254, 258 can extend the same length as keying function 316 or coding function 351 measured from a circuit board within chassis 322, for example. Alternatively, optical guides 254, 258 may be slightly shorter than mechanical coding function 351. In some examples, only one of optical guides 254 or 258 is used.

[0136] The recess 372 forming or configuring keying function 318, and thus the annular groove, has a shape complementary to keying function 316. In fact, only drug delivery device 100 equipped with mechanical opposing coding function 371 is coupled with electronic module 320 provided with coding function 351 of complementary shape as illustrated herein. To that extent, keying function 318, and thus mechanical opposing coding function 371, has an inverse shape compared to keying function 316 or mechanical coding function 351. Opposing coding function 371 is dimensioned to receive the outer dimension of mechanical coding function 351 and includes an inner diameter configured as such.

[0137] The longitudinal length of mechanical opposing coding function 371 exceeds or is equal to the longitudinal length of coding function 351 of complementary shape. This enables coding function 351 (e.g., protrusion 352) to be fully inserted into (e.g., into recess 372) and supported within opposing coding function 371 of complementary shape.

[0138] In other, non-matching examples, the longitudinal length of the coding feature 351 may exceed the corresponding longitudinal length of the opposing coding feature 371. In this way, when the coding feature 351 enters or engages with the opposing coding feature 371, the entire coding feature 351 is not received by the opposing coding feature 371, thereby preventing the fastening element 326 from interengaging with the opposing fastening element 327 of complementary shape. Here, the movement of inserting the coding feature 351 into the opposing coding feature 371 is effectively blocked, for example, by a blocking feature or an end wall of the opposing coding feature 371. Thus, when such a blocking configuration is reached, the fastening element 326 will be located longitudinally offset from the opposing fastening element 327. Here, the effective fastening of the electronic module 320 to the drug delivery device 100 is prevented.

[0139] The same applies when the geometry of the protrusion 352 of the coding feature 351 does not match the geometry of the recess 372 of the opposing coding feature 371, or when the position of the protrusion 352 in a plane transverse to the longitudinal direction does not match the respective position of the recess 372 within its cross-section.

[0140] The outer sidewall 382 of the drive or adjustment element 108 includes a number of opposing fastening elements 327 on its inner side facing the sidewall portion and thus towards the annular groove 310. The opposing fastening elements 327 are configured to engage with the corresponding shaped fastening elements 326 of the electronic module 320. The fastening element 326 protrudes distally from the distal face 360 of the housing 321. The fastening element 326 and / or the opposing fastening element 327 are configured as snap or clip elements and thus are configured to form a snap fit or clip connection between the electronic module 320 and the drug delivery device 100.

[0141] Additional fastening elements 323, 324, 325 can include or form hooks, each of which is configured to engage a longitudinal groove 330 on the outer surface of the drive / adjustment element 108.

[0142] The hooks or fastening elements 323, 324, 325 serve to prevent relative rotation between the electronic module 320 and the drive / adjustment element 108. The hooks or fastening elements 323, 324, 325 cooperate with the groove 330. Alternatively, an adapter element corresponding to the adapter element 210 shown in FIG. 2 is used. The hooks or fastening elements 323, 324, 325 can provide or effect axial fixation of the electronic module 322 to the drug delivery device 100, for example by clamping or friction fitting to the drive / adjustment element 108.

[0143] Although not shown, in an alternative example, the mechanical coding function 351, and thus the keying function 316, is disposed on the drive / adjustment element 108, while the annular ring 311 is disposed on the chassis 322 or housing 321 of the electronic module 320.

[0144] The fastening element 326 and the opposing fastening element 327 can form or constitute a clip connection and can provide a fastening portion for the electronic module 322 removable from the drug delivery device 100.

[0145] A further example of the module system 400 shown in FIG. 4 includes a similar structure but is distinguished from the electronic module 320 shown in FIG. 3 by a particular embodiment of the mechanical coding portion 450 and the mechanical coding function 451. Thus, the mechanical opposing coding portion 470 and the respective mechanical opposing coding function 471 of the drug delivery device 100 are also distinguished from the example of FIG. 3.

[0146] As already explained in connection with FIG. 3, the electronic module 420 includes two fastening elements 426 arranged diametrically opposite to engage corresponding shaped opposing fastening elements 427 inside the outer sidewall 482 of the drive / adjustment element 108. The housing 421 and / or chassis 422 of the electronic module 420 further includes several auxiliary fastening elements 423, 424, 425. These fastening elements 423, 424, 425 are implemented as hooks that engage longitudinal grooves 430 on the outer surface of the drive / adjustment element 180 when the electronic module 420 is assembled and / or attached to the proximal end P of the drug delivery device 100 in a predetermined fastening configuration.

[0147] The housing 421 or chassis 422 includes a distally facing surface 460. The optical guides 254, 258, as well as a number of fastening elements 423, 424, 425, 426 can project distally from this distally facing surface 460. A mechanical coding portion 450 is provided at the distal end 401 of the chassis 422. The mechanical coding portion 450 includes a mechanical coding function 451. The mechanical coding function 451 includes a geometric structure with a cross-shaped cross-section that projects distally from the distally facing surface 460. This structure can provide a keying function 416. The proximal end P of the drug delivery device 100, and thus the proximal surface 480 of the drive / adjustment member element 108, includes a complementary shaped opposing coding function 471. The opposing coding function 471 forms a mechanical opposing coding portion 470 that mates with the mechanical coding portion 450 when the electronic module 420 is assembled and attached to the drug delivery device 100 in a predetermined fastening configuration.

[0148] The counter coding function 471 includes a recess 472. The recess has a cross-shaped configuration. The recess 472 is provided in the central cylindrical portion 412 of the drive / adjustment element 108. The recess 472 includes two elongated and intersecting slits 411, 413. Here, the slit 411 is shaped to receive a slab or plate-like element 438 of the coding function 451. The slit 413 is shaped and arranged to engage with and / or receive a further slab or plate-like element 436 of the mechanical coding function 451.

[0149] An annular groove 410 is also provided between the central cylindrical portion 412 and the outer or outer side wall 482 for receiving the light guides 254, 258.

[0150] It should be noted that the light guides 254, 258 are an example of the longitudinal extensions 255 provided as a symmetry-breaking function for the chassis 322, 422 of the electronic modules 320, 420.

[0151] Generally, the coding portions 350, 450 are defined by the shape of the mechanical coding functions 351, 451 and by the position of the mechanical coding functions 351, 451 with respect to at least one of the extensions 255 and / or with respect to at least one of the fastening elements 326, 426.

[0152] When the electronic modules 320, 420 are in a predetermined fastening configuration on the drug delivery device 100, the distally facing surfaces 360, 460 of the electronic modules 320, 420 can abut against the proximally facing surfaces 380, 480 provided at the proximal end P of the drug delivery device 100. In this way, a mechanically stable fastening of the electronic modules 320, 420 to the drug delivery device 100, which is substantially non-tilted, is achieved.

[0153] The cross-shaped and non-rotationally symmetric structure of the coding function 451 and each opposing coding function 471 is further beneficial for providing a torque-resistant engagement between the electronic module 420 and the drive / adjustment element 108. The adjustment element 108 can be made rotatable, for example, to adjust or set the dosage of a drug. Here, the user can use the electronic module 420 as a kind of dial extension. The user can use or grip the chassis 422 or housing 421 of the electronic module 420 to induce the respective torque to the drive / adjustment element 108.

[0154] Another example of an electronic module 520 suitable for attachment to the proximal end P of the drug delivery device 100 is shown in a series of FIGS. 6 to 10. Again, the electronic module 520 is configured to be attached to the drive / adjustment element 108 as shown in FIG. 2. The electronic module 520 includes a housing 521 with a chassis 522. The housing 521 includes a distal end 501 and a proximal end 502. The housing 521 or the chassis 522 may include a somewhat tubular structure. Here, the distally facing surface 560 is provided on the peripheral rim of the housing that faces distally and is disposed at or near the distal end 501 of the housing 521.

[0155] As previously described in connection with FIGS. 3 and 4, in the examples of FIGS. 6 to 10 as well, a number of fastening elements 523, 524, 525, 526 are provided around the outer periphery of the housing 521. The fastening elements 523, 524, 525, 526 can project from the distal end 501 of the housing 521. They can at least project from the distally facing surface 560. As is apparent from FIGS. 8 and 9, at least two of the fastening elements, namely the fastening elements 524 and 526, serve to provide the mechanical coding portion 550.

[0156] The mechanical coding section 550 includes at least one coding function 551, 552. Here, the coding function 551 coincides with the fastening element 526. In other words, the mechanical coding function 552 is formed by the fastening element 526. The other coding function 551 is provided and / or formed by the fastening element 524.

[0157] At least one auxiliary fastening element 526 is further provided on or near the distal end 501 of the housing 521. The fastening element 526 is configured to engage with a corresponding or complementary shaped opposing fastening element 527 provided on the inner surface of the side wall 534 of the drive / adjustment element 108.

[0158] A number of slots or grooves 530 are provided on the outer surface 532 of the side wall 534 of the drive / adjustment element 108. In this example, at least one coding groove 536, 538 is provided, which has a radial depth exceeding the radial depth of the other grooves 530 provided on the outer surface 532. The coding grooves 536, 538 are configured to engage exclusively with the mechanical coding functions 551, 552 of the mechanical coding section 550 of the electronic module 520. The radial depth, as well as the circumferential or tangential size of the coding grooves 536, 538, matches the respective geometry of the protrusions 552 to form the mechanical coding function. The protrusions 552 may include engagement structures extending radially inward that are complementary in shape to the geometry and size of the coding grooves 536, 538.

[0159] As can be further seen from FIG. 8, the drive / adjustment element 108 further includes two apertures 542, 544 that are diametrically opposed to each other adjacent to the inner side 533 of the side wall 534. The apertures 542, 544 are shaped and configured to receive the optical guides 254, 258, and thus the longitudinal extensions 255 that protrude from the distal end 501 of the electronic module 520. The position of the mechanical coding function 551 relative to the longitudinal extension 255 defines the mechanical coding section 550 of the electronic module 520.

[0160] Thus, as is apparent from the comparison of FIGS. 9 and 10, the positions of the coding grooves 536, 538 relative to the apertures 542, 544 and / or the position relative to the opposing fastening function 527 define the respective opposing coding portions 570. The mutual assembly of the electronic module 520 and the drug delivery device 100 is only possible when the longitudinal extension 255 is aligned with one of the apertures 542, 544. Further, the mutual assembly is only possible when the fastening element 526 is longitudinally aligned with the opposing fastening element 527. Therefore, the mutual orientation and alignment of the fastening element 526 with the opposing fastening element 527 and / or the alignment of the longitudinal extension 255 with the apertures 542, 544 define two specific predetermined fastening configurations that are distinguishable from each other by a 180° relative rotation.

[0161] FIG. 9 shows a virtual line L1 extending through the centers of the opposing fastening elements 527 arranged opposite each other. Further, another virtual line L2 is shown extending through the mechanical opposing coding function 571 arranged diametrically opposite.

[0162] The example of FIG. 10 shows a mechanical opposing coding portion 570 that is distinguishable from the mechanical opposing coding portion 570 shown in FIG. 9. In the example of FIG. 10, the angle between each L1 and L2 is distinguishable from the respective angles in the example of FIG. 9. In the example of FIG. 9, the angular position or tangential direction or circumferential position of the opposing coding function 571 relative to the opposing fastening element 527 and / or relative to the apertures 542, 544 has changed compared to the configuration of FIG. 9. Therefore, the proximal end of the drug delivery device 100 shown in FIG. 10 includes a mechanical opposing coding portion that is distinguishable from the mechanical opposing coding portion of the proximal end of the drug delivery device 100 shown in FIG. 9.

[0163] The coding grooves 536, 538 are here arranged in the radially recessed portion 572 of the outer surface 532 of the side wall 534 of the drive / adjustment element 108. By varying the angular position of the mechanical counter-coding function 571 relative to the fixed position of the counter-fastening element 527 and / or relative to the position of the apertures 542, 544, a number of different mechanical counter-coding portions 570 are provided for generally equivalent or similar types of drug delivery devices 110. Similarly, the position of the coding function 551, in particular the position of the fastening elements 524, 526, can also be varied to provide different mechanical coding portions for a number of electronic modules 520.

[0164] If the electronic module 520 including the mechanical coding portion 550 does not match the mechanical counter-coding portion 570 of the drug delivery device 100, the coding function 551 is positioned offset circumferentially and thus located outside the coding grooves 536, 538. In a given fastening configuration where the fastening element 526 is engaged with the counter-fastening element 527 of corresponding shape, there may be no suitable channel for insertion in the coding function 551 and thus the protrusion 552. Thus, these can prevent and impede proper placement and assembly of the electronic module 522 and the drug delivery device 100.

[0165] As can be seen in FIGS. 9 and 10, the coding groove 536 can terminate in the form of a radially outwardly extending flange provided at the very proximal end P of the drive / adjustment element 108. In this way, the coding grooves 536, 538 and thus the respective counter-coding functions 571 can effect a snap-fit engagement of the respective coding functions 551 of the mechanical coding portion 550 of the electronic module 520 with the protrusions 552 of corresponding shape.

[0166] Each mechanical coding function 551 may include an elastically deformable snap function to form a snap-fit connection with a corresponding-shaped opposing coding function 571 provided at the proximal end P of the drug delivery device 100. The snap-fit engagement may further result in longitudinal fastening and / or fixation between the electronic module 320 and the drug delivery device 100.

[0167] The proximal end P of the drug delivery device 100 may also include a proximally facing surface 580, as shown in FIG. 7. In the predetermined fastening configuration shown in FIG. 7, the distally facing surface 560 of the electronic module 520 abuts the proximally facing surface 580 of the drive / adjustment element 108. In this way, a non-tilting mutual fastening between the electronic module 520 and the drug delivery device 100 is achieved.

[0168] In a further example shown in FIGS. 11 to 18, the electronic module 620 includes a housing 621 with a chassis 622. The electronic module 620 includes a distal end 601 and a proximal end 602 located on the opposite side. The electronic module 620 can be made to be somewhat equivalent, and even identical, to the electronic modules 220, 320, 420, or 520 described above in relation to FIGS. 2, 3, 4, or 6 respectively. The electronic module 620 is distinguished from another example by a specific type of mechanical coding portion 650. The housing 621 includes a number of wall portions 644, 646, 648 that are somewhat equivalent or identical to the wall portions 244, 246, 248 as described above.

[0169] The distal end of the wall portion 648 comprises a distally facing surface 660. A mechanical coding section 659 is provided on this surface 660. Separately, the housing 621 includes a fastening element 626 implemented as a snap function or as a clip function for engaging a corresponding shaped opposing fastening element 627 provided at the proximal end P of the drug delivery device 100. The proximal end P of the drug delivery device 100 comprises a proximally facing surface 680. When the electronic module 620 is in a predetermined fastening configuration, the proximally facing surface 680 can abut against the distally facing surface 660.

[0170] In the examples of FIGS. 11 - 18, the mechanical opposing coding portion 670 is provided on a part of the drive / adjustment element 108. This mechanical opposing coding portion is provided on the radially inner portion of the drive / adjustment element 108. Thus, the drive / adjustment element 108 can include such an inner portion and an outer (e.g., sleeve - like) portion surrounding the inner portion. The outer portion can include, for example, the outer wall 534 shown in the example of FIG. 7.

[0171] In this example, the coding section 659 includes four individual coding function positions 655, 656, 657, 658 that do not spatially overlap, as shown in more detail in FIG. 12. Coding functions 651, 653 are individually provided at the coding function positions 655, 656, 657, 658. In the example shown here, two individual coding functions 651, 653 are provided. The coding function 651 is provided at the first coding function position 655. The second coding function 653 is provided at the fourth coding function position 658. There are no coding functions at the coding function positions 656, 657. The coding functions 651, 653 each include protrusions 652, 654 that protrude distally from the distally facing surface 660. The protrusions 652, 654 of the coding functions 651, 653 include a tab-like geometry. The coding functions 651, 653 are of a shape complementary to and / or are complementarily positioned with respect to opposing coding functions 671, 673 provided at the proximal end P of the drug delivery device 100, as shown for example in FIG. 15.

[0172] Here, the opposing coding portion 670 includes an opposing coding section 679 of complementary shape. The opposing coding section 679 includes several individual opposing coding function positions 675, 676, 677, 678 that do not spatially overlap. In the example of FIG. 14, an opposing coding function 671 in the form of a recess 672 is provided at the first opposing coding function position 675, and another coding function 673 in the form of another recess 674 is provided at the third opposing coding function position 677.

[0173] As is apparent in all of the examples of FIGS. 13 and 18, the mechanical coding portion 650 is of a shape complementary to the respective mechanical opposing coding portion 670. The mechanical opposing coding portion 670 is of an opposite shape compared to the respective mechanical coding portion 650.

[0174] In this example, the coding section 659 includes four separate coding function positions that do not spatially overlap for two mechanical coding functions, each of which is located at one of the coding function positions. Similarly, the mechanical countercoding section 679 includes four separate countercoding function positions 675, 676, 677, 678 that do not spatially overlap, and two mechanical countercoding functions 671, 673, each of which is located at one of the countercoding function positions.

[0175] In the example shown in FIGS. 13 to 18, the number of coding function positions in the coding section 659 is equal to the number of countercoding function positions in the countercoding section 679. Further, the number of coding functions is equal to the number of countercoding functions. Thus, in this illustrated example with four coding function positions and two mechanical coding functions, six different mechanical code portions or coding portions 650 and their respective mechanical countercode portions or coding portions 670 are provided. Generally, if the total number of separate coding function positions that do not spatially overlap is n, there are n two possible configurations and arrangements. However, not all of these arrangements can guarantee unique and dedicated pairing. The condition for ensuring that all but one of the electronic modules 620 are prevented from engaging with one drug delivery device is that all the mechanical coding portions 650 include the same number of mechanical coding functions 651, 653. The number of non-repeating permutations of k coding functions among n coding function positions is equal to the binomial coefficient given by the following formula:

Number

Claims

Claim 1 An electronic module (320; 420; 520; 620) configured to be attached in a predetermined fastening configuration to a proximal end (P) of a drug delivery device (100), the drug delivery device (100) including an elongated housing (102) extending longitudinally and including a distal end (D) and a proximal end (P), the electronic module (320; 420; 520; 620) comprising: A mechanical coding portion (350; 450; 550; 650) including a mechanical coding function (351; 451; 551; 651) that engages a mechanical counter-coding function (371; 471; 571; 671) of a mechanical counter-coding portion (370; 470; 570; 670) provided at the proximal end (P) of the drug delivery device (100); wherein one of the mechanical coding function (351; 451; 551; 651) and the mechanical counter-coding function (371; 471; 571; 671) includes a protrusion (352; 452; 552; 652) extending longitudinally and protruding, and the other of the mechanical coding function (351; 451; 551; 651) and the mechanical counter-coding function (371; 471; 571; 671) includes a recess (372; 472; 572; 672); when the geometry of the protrusion (352; 452; 552; 652) does not match the geometry of the recess (372; 472; 572; 672), or when the position of the protrusion (352; 452; 552; 652) in a plane transverse to the longitudinal direction does not match the position of the recess (372; 472; 572; 672) within its cross-section, or when the longitudinal length of the protrusion (352; 452; 552; 652) exceeds the longitudinal length of the recess (372; 472; 572; 672), the mechanical coding portion (350; 450; 550; 650) and the mechanical counter-coding portion (370; 470; 570; 670) are operable to prevent fastening the electronic module (320; 420; 520; 620) to the proximal end (P) of the drug delivery device (100) in the predetermined fastening configuration. The electronic module. Claim 2 The electronic module (320; 420; 520; 620) according to claim 1, further comprising fastening elements (326; 426; 524, 526; 626) configured to mechanically engage with complementary-shaped opposing fastening elements (327; 427; 527; 627) of the drug delivery device in a defined fastening configuration.

3. The electronic module (320; 420; 520; 620) according to claim 2, wherein the mechanical coding part (350; 450; 550; 650) is defined by at least one of the position, orientation and longitudinal length of the mechanical coding function (351; 451; 551; 651) with respect to the fastening element (326; 426; 524, 526; 626).

4. The electronic module (320; 420; 520; 620) according to any one of claims 1 to 3, further comprising at least one longitudinal extension (255) configured to extend distally from the distal end (301; 401; 501; 601) of the electronic module into or through an aperture (242, 244) at the proximal end (P) of the drug delivery device (100).

5. The electronic module (320; 420; 520; 620) according to claim 4, wherein the mechanical coding part (350; 450; 550; 650) is defined by at least one of the position, orientation and longitudinal length of the mechanical coding function (351; 451; 551; 651) with respect to the longitudinal extension (255).

6. The electronic module (320; 420; 520; 620) according to any one of claims 1 to 5, wherein the mechanical coding function (351; 451; 551; 651) includes a protrusion (352; 452; 552; 652) that projects in the longitudinal distal direction from a distally-facing surface (360; 460; 560; 660) of the electronic module and is configured to engage with a complementary-shaped recess (372; 472; 572; 672) of the mechanical opposing coding function (371; 471; 571; 671).

7. The distal-facing surface (360; 460; 560; 660) of the electronic module (320; 420; 520; 620) is in longitudinal abutment with the proximal-facing surface (380; 480; 580; 680) of complementary shape of the drug delivery device (100) in a predetermined fastening configuration, the electronic module (320; 420; 520; 620) according to claim 6.

8. The mechanical coding section (659) includes a number n of individual coding function positions (655, 656, 657, 658) that do not spatially overlap, and a number k of mechanical coding functions (651, 653) each located at one of these coding function positions (655, 656, 657, 658), where n and k are integers and k ≤ n or k < n, the electronic module (320; 420; 520.620) according to any one of claims 1 to 7.

9. A drug delivery device (100) comprising: A housing (102) including a distal end (D) and a proximal end (P), the proximal end (P) being configured to attach the electronic module (320; 420; 520; 620) according to any one of claims 1 to 8 in a predetermined fastening configuration, A drive mechanism (106) configured to set and / or deliver a dose of drug (Dr) from the distal end (D), A mechanical counter-coding section (370; 470; 570; 670) provided at the proximal end (P) and including a mechanical counter-coding function (371; 471; 571; 671) that engages with the mechanical coding function (351; 451; 551; 651) of the mechanical coding section (350; 450; 550; 650) of the electronic module (320; 420; 520; 620) The drug delivery device comprising.

10. The drug delivery device (100) according to claim 9, further comprising a counter-fastening element (327; 427; 527; 627) configured to mechanically engage with the complementary-shaped fastening element (326 ; 426; 524, 526; 626) of the electronic module (320; 420; 520; 620) in a predetermined fastening configuration.

11. The mechanical opposing coding part (370; 470; 570; 670) defines the drug delivery device (100) according to claim 10 by at least one of the position, orientation, and longitudinal length of the mechanical opposing coding function (371; 471; 571; 671) with respect to the opposing fastening element (327; 427; 527; 627).

12. The mechanical opposing coding function (371; 471; 571; 671) includes a recess (372; 472; 572; 672) configured to receive or engage with a protrusion (352; 452; 552; 652) extending distally in a complementary shape to the coding function (351; 451; 551; 651) of the mechanical coding part (350; 450; 550; 650) when in a predetermined fastening configuration, for the drug delivery device (100) according to any one of claims 9 to 11.

13. The recess (372; 472; 572; 672) is provided on at least one of the surface (380; 480; 580; 680) facing proximally of the drug delivery device (100), the outer surface (532) of the side wall (534) of the drug delivery device (100), and the inner surface (533) of the side wall (534) of the drug delivery device (100), for the drug delivery device (100) according to claim 12.

14. The drug delivery device (100) according to any one of claims 9 to 13 further includes a drug container (103) filled with a drug (Dr).

15. A module system comprising: an electronic module (320; 420; 520; 620) according to any one of claims 1 to 8, and a drug delivery device (100) according to any one of claims 9 to 14, wherein the mechanical coding part (350; 450; 550; 650) of the electronic module (320; 420; 520; 620) matches the mechanical opposing coding part (370; 470; 570; 670) of the drug delivery device (100), and the mechanical coding part (350; 450; 550; 650) mechanically engages with the mechanical opposing coding part (370; 470; 570; 670) when the electronic module (320; 420; 520; 620) and the drug delivery device (100) are in a predetermined fastening configuration, said module system.

Images