Modular system for drug delivery device with electronics and corresponding modules and methods

Abstract

A modular system (98) for a drug delivery device with electronic devices is disclosed, the modular system comprising: a mechanical module (100), the mechanical module comprising: a distal end (D) and a proximal end (P), and a mechanism (106), the mechanism configured to set a dose of a drug and / or deliver it away from the distal end (D) of the mechanical module (100); an electronic module (120, 220), the electronic module comprising: a detector unit (254, 264, 266), and an electronic unit (240), the electronic unit operably connected to the detector unit (254, 264, 266), wherein the electronic module (120, 220) is removably mechanically connected or connectable to the mechanical module (100) in the proximal region of the mechanical module (100).

Description

[0001] The present disclosure relates to a modular system of a drug delivery device with electronic devices and to corresponding modules. The drug delivery device can be an automatic injector or a manually operated or semi-automatically operated device. The energy storage element can be used in an automatic injector and in a semi-automatically operated device to transmit a driving force for an injection operation. The energy storage element can be biased in a factory or biased by a user before use. Medicines can include insulin or GLP-1 (glucagon-like peptide). However, other medicines can also be injected. In addition, other medical devices (e.g., syringes, spray devices, or inhalation devices) can also benefit from the present disclosure.

[0002] Typically, a drug delivery device may include many mechanical components. However, it may be desirable to use electronic components together with the mechanical components. A modular system would allow multiple uses of the electronic components. However, attaching the electronic module, for example laterally, to the drug delivery device may be cumbersome.

[0003] The purpose of the present disclosure is to provide a modular system for drug delivery devices. The modular system should preferably be easy and / or comfortable to use. The modular system should preferably be smaller in size and / or should allow the use of known drug delivery devices without modification or only slight modification. Preferably, the electronic and electromechanical components of the modular system should be protected in a simple and easy manner to avoid intrusion by the environment (e.g., dust, moisture, mechanical tampering, etc.). In addition, corresponding modules should be provided. Corresponding methods of use and manufacturing methods should also be provided.

[0004] This object is solved by a modular system according to claim 1. Further embodiments are given in the dependent claims. This object is also solved by the subject matter of the independent claims. Summary of the invention:

[0005] The proposed modular system for a drug delivery device with electronics may include:

[0006] - a mechanical module, said mechanical module comprising:

[0007] - distal and proximal ends; and

[0008] - a mechanism which may be configured to set a dose of a drug and / or deliver it away from the distal end of the mechanical module; and

[0009] - an electronic module, said electronic module comprising:

[0010] - a detector unit; and

[0011] - an electronics unit which may be operatively, eg electrically (eg by wires or via RF (radio frequency)) coupled to the detector unit.

[0012] Implementation plan:

[0013] The proposed modular system for a drug delivery device with electronics may include:

[0014] - a mechanical module, said mechanical module comprising:

[0015] - distal and proximal ends; and

[0016] - a mechanism which may be configured to set a dose of a drug and / or deliver it away from the distal end of the mechanical module; and

[0017] - an electronic module, said electronic module comprising:

[0018] - a detector unit; and

[0019] - an electronics unit which may be operatively, eg electrically (eg by wires or via RF (radio frequency)) coupled to the detector unit.

[0020] In the proximal region of the mechanical module, the electronic module may be mechanically coupled to or may be coupleable to the mechanical module. The mechanical module and the electronic module may be removably coupled / connected or may be coupleable / connectable to each other.

[0021] The technical effect of the proximal coupling of the electronic module to the mechanical module is that the length of the drug delivery device is only slightly extended, whereby the width or diameter of the drug delivery device is not changed. Thus, a comfortable pen shape is retained, allowing high user comfort and easy maneuverability. However, the electronic module can be used with several drug delivery devices, as the modular system is only a temporary assembly.

[0022] A clip connector or another connector may be used to connect the mechanical module and the electronic module. No electronic connector may be required between the mechanical module and the electronic module, thereby simplifying the interface connection, that is, only a mechanical interface connector may be required without an electronic interface connector.

[0023] The mechanical connection can be released without using additional tools. Alternatively, special tools can be used to simplify the separation and / or connection of the two modules, especially for elderly people and / or for people with reduced dexterity. Independently of whether tools are used, both modules can be removable / releasable without destroying the parts and / or using only one, two, three or four hand movements, e.g. disassembly of the two modules in 30 seconds is possible.

[0024] During dose setting, the detection unit may detect the amount of drug to be delivered.Alternatively or additionally, during drug injection, the detection unit may detect the amount of drug delivered.

[0025] The detection may be based on the detection of a rotation or relative rotation between mechanical parts of the mechanism or between such parts and the detection unit. Alternatively or additionally, a translation or relative translation between parts of the mechanism or between such parts and the detection unit may be detected.

[0026] The detection unit may include at least one sensor. The at least one sensor may operate on one or several of a wide range of physical principles. For example, an optical sensor, an electromechanical sensor, a magnetic sensor (Hall sensor), a capacitive sensor, an inductive sensor, an ultrasonic sensor and / or a pressure sensor may be used in the detection unit.

[0027] The mechanical module may include many components of a drug delivery device:

[0028] - a plunger rod element which can be pressed against a plunger within a syringe or cartridge of a drug delivery device in order to expel the drug; and / or

[0029] - optionally a drive mechanism comprising an energy storage element, such as a mechanical spring; and / or

[0030] - optionally a syringe or cartridge, preferably a replaceable syringe or cartridge, or a pre-filled container, which is part of the mechanical module; and / or

[0031] - Optionally a number sleeve with numbers indicating the amount of drug to be delivered. The number sleeve may be rotatable and / or axially movable along a central axis of the number sleeve by rotating a dial sleeve or dial element.

[0032] The electronic module may include:

[0033] - a battery or rechargeable battery holder; and / or

[0034] - optionally batteries or rechargeable batteries; and / or

[0035] - optionally only one or at least one circuit board; and / or

[0036] - electronic parts, such as resistors and / or at least one integrated circuit, which may form an electronic circuit or a circuit system;

[0037] - the electronic part may comprise at least one sensor element, such as an optical sensor; and / or

[0038] - a microprocessor or microcontroller or other control unit; and / or

[0039] - optionally a receiving and / or transmitting (sending) unit, for example based on the Bluetooth protocol (which may be a registered trademark), the WiFi protocol (which may be a registered trademark) or based on the USB protocol (Universal Serial Bus - which may be a registered trademark), for example for communication with a smartphone or other computer device; and / or

[0040] - an extension for the sensor (eg a light guide), the light guide being attached, for example, to a circuit board; and / or

[0041] - At least one switch, for example for power management.

[0042] The distal end of the mechanical module and the proximal end of the mechanical module may be arranged on the longitudinal axis of the mechanical module. The second module may be arranged on the extended longitudinal axis of the mechanical module. Thus, a serial connection along the longitudinal axis may be achieved.

[0043] The detector unit may include an extension feature or may be arranged on an extension feature that extends distally from the electronic module beyond the proximal end of the mechanical module. Alternatively, the detector unit may have the following detection range: extending distally from the electronic module beyond the proximal end of the mechanical module. The extension feature may extend at least 3 mm (millimeters), at least 4 mm or at least 5 mm beyond the proximal end of the mechanical module. The distance may be, for example, less than 20 mm. The extension feature may be a light guide or an optical guide. The extension feature may be embedded with the proximal section of the mechanical module. The extension feature may allow the use of a mechanical module with a movable and / or rotatable portion that is used to detect a selected or delivered drug deeper within the mechanical module. This may provide a degree of freedom for the design of the mechanical module. In addition, a purely mechanical drug delivery device may be used with the electronic module without further modification.

[0044] The mechanical module may include a proximal portion having at least one orifice. The extension feature may extend into or through the orifice, or it may extend to a position near at least one orifice, for example to a position within a range of 0.1 mm (millimeter) to 3 mm from the orifice. The orifice may be arranged within the housing of the mechanical module. The orifice may be as small as necessary for the detection unit to perform detection, so as to allow a high protective effect of the housing of the mechanical module even if the electrical module is not mounted on the mechanical module.

[0045] The proximal portion can be the housing or grip button or extension / dial sleeve of the mechanical module. If the amount of the dose is dialed, the extension / dial sleeve can extend out of the housing of the drug delivery device. During injection, the extension sleeve can be manually moved back into the interior of the housing of the mechanical module. Alternatively, the user can bias the energy storage element during the dialing of the amount of the dose. The energy of the energy storage element can be used to inject the selected dose of the drug. The following technical effect can exist: if the extension feature extending axially extends into the proximal portion of the drug delivery device or extends through the proximal portion of the drug delivery device to the rotation feature, the extension feature can reach the moving part (e.g., indicator element) of the mechanical module in an easy and simple manner.

[0046] The detector unit may comprise at least one optical sensor unit and at least one light source unit. The detector unit may preferably comprise an optical guide unit which is part of or forms the extended feature. The optical sensor may allow detection without mechanical contact, e.g. without disturbing the movement of the rotating and / or linear moving part. Furthermore, the optical sensor may cause only a small radiation impact on the environment and may operate using little energy, thereby enabling, for example, long operating times of batteries or accumulators.

[0047] The extension feature used as an optical guide may have a mechanically stable conical or frustum-conical shape, e.g., a smaller diameter at its free end compared to the diameter of its base. Additionally or alternatively, the conical shape may facilitate insertion of the extension feature into the mechanical module. Alternatively, a cylindrical optical guide may be used.

[0048] The extended feature can be arranged laterally to the longitudinal middle axis of the mechanical module, thereby allowing easy detection of a rotating part that can rotate around the middle axis, for example, detection of a rotating part comprising radially protruding features (teeth, corrugated features, etc.). It is possible to use only one optical guide for each detection unit, i.e. for the forward guidance and backward guidance of the electromagnetic radiation. Alternatively, two optical (light) guides can be used, for example in order to reduce noise and / or in order to increase the responsiveness of the detection unit. (Multiple) optical guides can include solid guides and / or hollow tubes.

[0049] The optical guide may include a boundary surface that can guide the electromagnetic radiation by total reflection. Thereby, the radiation can be reflected without energy loss, thereby allowing the responsiveness of the detection unit to be improved. The optical guide may be configured to guide the electromagnetic radiation radiated from the light source unit through the optical guide. The optical guide or another optical guide may be configured to guide at least a portion of the electromagnetic radiation back to the optical sensor unit. The electromagnetic radiation guided back to the optical sensor unit may be reflected radiation or transmitted radiation, such as reflected light or transmitted light, for example having a wavelength in the range of 400nm to 700nm or to 780nm (visible light) or in the range of 780nm to 1mm (infrared light). The reflected radiation can be more easily sensed than the transmitted radiation (e.g., light). The transmitted radiation can be brighter than the reflected radiation using the same radiation source.

[0050] The optical guide may be different from a lens forming the housing of the light source unit, such as an LED (light emitting diode) having a transparent housing made of, for example, synthetic resin or plastic. An air gap may exist between the housing of the LED and the optical guide.

[0051] The at least one optical guide may be coated laterally (e.g. along its entire circumference) with a coating material that is different from the material of the at least one optical guide or from its core material. The coating material may include:

[0052] - metal, for example for hardening the structure of the light / optical guide / tube, and / or

[0053] - a soft coating material that is softer than the material of the optical guide. The soft coating may be configured to absorb shock loads, thereby causing less mechanical stress to the light pipe or optical guide, and / or

[0054] - A reinforcing coating, which is reinforced, for example, by carbon fibers or a polymer / plastic reinforced by carbon fibers.

[0055] All three coating materials can prevent external loads, impacts, dirt, fluids (e.g., liquids and / or gases) from adversely affecting the optical guide, in particular the boundary surface for total reflection. A combination of two or all three coating options is possible, for example using two or three different coatings.

[0056] Carbon fiber reinforced polymers / plastics / thermoplastics (CFRP, CRP, CFRTP) containing carbon fibers may be used. A bonding polymer may be used, for example a thermosetting resin such as an epoxy resin. Other thermosetting or thermoplastic polymers may also be used, for example polyester, vinyl ester or nylon. In addition to carbon fibers, the composite material may include or contain aramid (Kevlar (may be a trademark) or Twaron (may be a trademark)).

[0057] The coating material may be blended so that the boundary surface for total reflection is not compromised by the coating itself. The coating may protect the sidewalls of the extended feature along the entire length or along at least 80% of the length. Based on the extended feature, protection may be provided by a cup-like structure surrounding the extended feature (e.g., a light pipe or optical guide).

[0058] The electronic module may include a substrate that carries part or at least some parts of the electronic unit. Only one or both sides of the substrate may be at least partially covered by a potting compound or by a conformal coating or covered at all positions not covered by the electronic part. Conformal coating or deposition methods may be used to produce the conformal coating. Conformal may mean that the topography (three-dimensional profile) of the surface is preserved in the coating, such as edges (elongated edges) and corners. In contrast, non-conformal may mean that the topography is not maintained, such as if a very viscous potting compound or potting material is used.

[0059] A chassis carrying and / or comprising at least a portion of the detector unit may be configured to separate a potting compound from an electrical sensor and / or from a radiation source of the detector unit and / or from the extended feature of the detector unit. Silicone, polyurethane, etc. may be used as potting material or as potting compound. Potting materials / compounds may protect the electronics from environmental influences, such as dust or moisture. Potting materials / compounds may mechanically stabilize the electronic module and / or may enhance or establish connections between different parts of the electronic module.

[0060] Several protection measures may be combined, such as potting and / or coating of extension features and / or barrier / keying features as mentioned below.

[0061] The substrate may comprise one or more metal sheets laminated to an insulator or non-conducting substrate, for example laminated to an FR4 (refractory) material which may comprise epoxy resin and glass fibre or fibres of another material. The substrate may be a single-sided substrate or a double-sided substrate, the double-sided substrate may reduce the overall size of the substrate. Thus, the substrate may be a printed circuit board.

[0062] The electronic module may include a protruding element. The protruding element may be configured to block unwanted and deliberate touching of the (multiple) extension features and / or other internal parts of the electronic module by a user. Additionally or alternatively, the protruding element may be configured as a keying element that engages with a keying element of the reverse shape of the mechanical module. The keying element may be an annular ring and annular recess or a cross-protruding feature and a cross-groove. However, other suitable shapes, such as prisms, may also be used. There may be two separate protruding elements, such as one for blocking and the other for keying.

[0063] The protruding keying / blocking feature(s) may extend to the same length as the extended feature measured, for example, relative to the circuit carrier / board or the substrate within the electronic module, or within a range of plus 10% or 20% relative to the length or distance of the distal end of the extended feature from the substrate of the electronic unit. Thus, the blocking / keying feature may mechanically protect the extended feature.

[0064] Different keying portions for different drug delivery devices may be used. Electronic modules with different keying features may operate differently if compared to each other. Depending on the type of electronic unit and the type of corresponding (e.g., fitted) drug delivery device, the amount of selected and / or injected drug may be calculated in different ways.

[0065] The mechanical module may include a movable and / or rotatable indicator element coupled to the mechanism. At least a portion of the detector unit may be arranged at the indicator element. The detector unit may be configured to detect movement (translation and / or rotation) of the movable and / or rotatable indicator element during a dose delivery operation to determine the size of a dose of the drug to be delivered by the mechanism (e.g., detecting the size or amount of a dose during dose setting) or the size of a dose of the drug delivered (e.g., detecting the size or amount of a dose during dose delivery). The indicator element may include a corrugated or castellated surface and / or an area having different absorption or reflectivity to light radiation. Using a protruding feature (e.g., a tooth of a coupling sprocket or a coupling sprocket sleeve), it is much simpler to detect the rotation and / or translation of the indicator element / indicator surface.

[0066] The mechanical module may include a proximal button, preferably a button including an outer knurled circumferential surface or a button including at least one groove or at least 10 grooves on its outer circumferential surface, the at least one groove or the at least 10 grooves extending into a plane or multiple planes including the longitudinal axis of the mechanical module. There may be less than 100 grooves. The electronic module may include an adapter element, the adapter element may include an inner circumferential surface, the inner circumferential surface is shaped to be opposite to the outer surface of the button, for example, with a protrusion corresponding to the groove. The adapter element may be configured to form fit and / or for press-fitting the button. The adapter element may be a separate part separated from the housing of the electronic module, so that, for example, molding is simpler. Alternatively, the adapter element may be a part of the housing of the electronic module, for example with fewer parts, simple mathematical logic, etc. Form fit and press fit are simple connection methods. However, other removable connections may also be used, such as threaded connections, for example using internal threads on the electronic module and external threads on the mechanical module to thread the electrical module to the mechanical module, or vice versa.

[0067] The electronic module may comprise a chassis. The chassis may comprise an annular wall which may form a compartment for the electronic unit. The chassis may carry the electronic unit. The chassis may be accommodated by a housing portion of the electronic unit. The chassis may be a separate component or element separate from the housing portion and may be assembled with the housing portion as described below. Alternatively, the chassis may be integral with the housing portion, for example formed as a molded part. Using a separate chassis may make the assembly of the electronic module easier than an assembly without a separate chassis. The chassis may be made of a plastic material, preferably produced by injection molding. The material may be transmissive for radiation of an applied wavelength so as to allow the detection unit to use transmission of optical radiation (e.g. for infrared radiation). However, there may be two different materials for the chassis, wherein the material for the optical guide is more transmissive for the relevant wavelength of light or electromagnetic radiation than the other material.

[0068] At least one adapter element may be used, which is preferably connected to the housing part by at least one snap-fit ​​connection. The adapter element may be used to adapt the electronic module to the mechanical module, for example as mentioned above, such as a knurled surface and / or grooves. Alternatively, the adapter element may be formed integrally with the housing part. A cover may be used, which is configured to be released from the chassis and / or from the housing part. The cover and / or the adapter part may be detachable from the electronic module, for example to facilitate replacement of batteries and / or accumulators.

[0069] A further aspect of the present disclosure relates to a mechanical module, preferably a mechanical module of a modular system according to any one of the previously mentioned embodiments, comprising:

[0070] - distal and proximal ends; and

[0071] - a mechanism configured to set a dose of a drug and / or deliver it away from the distal end of the mechanical module,

[0072] Wherein, the mechanical module is configured to be removably mechanically coupled to the electrical module in a proximal region of the mechanical module.

[0073] Thus, the features, advantages and technical effects valid for the modular system and its implementation scheme are also valid for the mechanical module.

[0074] A next aspect of the present disclosure relates to an electronic module, preferably an electronic module of a modular system according to any of the previously mentioned embodiments, comprising:

[0075] - a detector unit; and

[0076] - an electronics unit operatively coupled to the detector unit,

[0077] Wherein, the electronic module is configured to be removably mechanically connected to the mechanical module in a proximal region of the mechanical module.

[0078] Thus, the features, advantages and technical effects valid for the modular system and its embodiments are also valid for the electronic module.

[0079] Aspects of the present disclosure relate to using an electronic module, preferably an electronic module according to any one of one or more of the embodiments mentioned above, together with a first mechanical module for drug delivery, preferably a mechanical module according to any one of the (multiple) embodiments mentioned above, in a first modular system, and thereafter using the electronic module in a second modular system together with a second mechanical module, the second mechanical module being of the same type as the first mechanical module.

[0080] After the first mechanical module has reached the end of its life (e.g., the first mechanical module has completed all mechanical drug delivery operations for which it is designed), the electronic module can be connected to the second mechanical module. A signal indicating the end of the life of the first mechanical module can be generated by the electronic module, which can record or track the number of drug delivery operations and can compare the tracked number with the maximum number that can be stored in the memory of the electronic module. The electronic module can be used for more than two, three, four or for more than four mechanical modules or drug delivery devices. The number of drug delivery devices that the electronic module can be used for can be less than or equal to 1000 or 10000, particularly if used with a single dose / when using an automatic injector.

[0081] The extension feature and / or the light guide may be integrally formed with a chassis portion of the electronic module, preferably as one part comprising the same material and comprising a homogeneous material density. There may be no boundary surfaces between the chassis and the extension feature and / or the light guide, preferably no boundary surfaces having normal vectors pointing towards each other. Thus, only a single chassis / optical guide portion needs to be produced for each electronic module.

[0082] The keying / blocking feature can be a separate component separated from the housing of the electronic module and / or from the chassis of the electronic module. The keying / blocking feature can be fastened to the electronic module and / or fastened to the chassis of the electronic module. The keying and / or blocking feature can include at least one waterproof sealing element. Water or moisture can be prevented from intruding into the PCB (printed circuit board) or PCB assembly (PCBA). Press fit, form fit, tight fit, press fit or other connection methods can be used to connect the keying and / or blocking feature to the housing and / or to the chassis.

[0083] The chassis of the electronic module may include at least one wall element between the light pipe and the compartment for the above-mentioned electronic unit. The wall may block the potting material or potting compound from the extended feature (e.g. from the optical guide). There may be a gap between the bottom of the wall and the substrate of the electronic device (e.g. a PCB (printed circuit board)) that may be arranged in the compartment. The gap may be filled with potting material or potting compound and may fix the chassis and the PCB or the substrate to each other.

[0084] Some electronic components of the electronic unit may be only partially surrounded by the potting compound. For electronic components including their own housing or enclosure, it may not be necessary to be completely covered. Less molding compound may be used. The molding compound / material may harden faster, etc.

[0085] The indicator element may be part of a coupling element of the mechanical module, e.g. a drug delivery device. There may be a drug delivery device where such a coupling element is the nearest moving element in the drug delivery device, the nearest moving element being particularly suitable for detecting the size of the selected and / or delivered dose.

[0086] The next aspect relates to a method of using the modular system for a drug delivery device, preferably using the modular system according to any one of the previous embodiments or claims, the method comprising:

[0087] - assembling a first mechanical module and an electronic module, thereby providing a first modular system, wherein the first mechanical module includes a drug;

[0088] - using said first modular system for drug delivery;

[0089] - after drug delivery, separating (e.g., disassembling) the first mechanical module and the electronic module;

[0090] - assembling the electronic module with a second mechanical module of the same type as the first mechanical module, thereby providing a second modular system;

[0091] - Using said second modular system to perform drug delivery of a drug contained in said second mechanical module.

[0092] Preferably, in the proximal region of the mechanical module, the electronic module may be mechanically coupled to or may be coupleable to the mechanical module. The mechanical module and the electronic module may be removably coupled / connected to each other or may be coupleable / connectable to each other.

[0093] The electronic module may be an electronic module according to a further aspect of the present invention, which is manufactured using a special filling method as described below. Thus, the same technical effects as mentioned below (e.g. excellent protection of electromechanical or optoelectronic parts / components and electronic parts / components) also apply to the electronic module.

[0094] The first mechanical module may be structurally and / or functionally identical or similar to the second mechanical module.Thus, the features, advantages and technical effects valid for the modular system and its embodiments are also valid for the method of using the modular system.

[0095] Part 2 Summary of the invention:

[0097] Further, an electronic module for a drug delivery device is provided, preferably an electronic module according to the above-mentioned embodiment, the electronic module comprising:

[0098] - a circuit carrier comprising at least one component surface;

[0099] - a first electrically operable component of the circuit system, said first electrically operable component being arranged on said at least one component surface;

[0100] - a module part comprising at least one side wall,

[0101] wherein the side wall is arranged adjacent to the circuit carrier,

[0102] wherein the side wall and the circuit carrier cooperate to define a receiving space for a filling layer, and

[0103] The filling layer contacts at least one, at least two or all of the side wall, the first electrically operable component or the component surface.

[0104] Implementation plan:

[0105] The proposed electronic module for a drug delivery device may include:

[0106] - a circuit carrier comprising at least one component surface;

[0107] - a first electrically operable component of the circuit system, said first electrically operable component being arranged on said at least one component surface;

[0108] - a module part comprising at least one side wall,

[0109] wherein the side wall is arranged adjacent to the circuit carrier,

[0110] wherein the side wall and the circuit carrier cooperate to define a receiving space for a filling layer, and

[0111] The filling layer contacts at least one, at least two or all of the side wall, the first electrically operable component or the component surface, for example, at least one area / region of the component surface.

[0112] The filling layer may extend from the side wall to the first electrically operable component and / or from the side wall to the circuit carrier. The filling layer may preferably extend continuously and / or uninterruptedly from the side wall to the first electrically operable component and / or from the side wall to the circuit carrier. Thus, the filling layer may provide excellent protection for the first electrically operable component and / or for other electrically operable components carried by the circuit carrier.

[0113] The fill layer may be a non-conforming layer that does not preserve the topography of the underlying layer or adjacent surface. The thickness of the fill layer may be greater than the thickness of the conforming layer that preserves the topography. The fill layer may prevent access to electrically operable components and / or may provide protection from environmental intrusion (e.g., dust, moisture, etc.).

[0114] The mechanical contact surface of the filling layer may conform to the contour of the circuit carrier and / or the first electrically operable component. The filling layer may be an electrically insulating layer. The following conformal features may be present:

[0115] - the side surface of the filling layer may have the same profile as the surface of the side wall being contacted, for example both are arc-shaped; and / or

[0116] - the side surface of the filling layer may have the same contour as the side surface of the electrically operable component, for example around the entire or at least part of the circumference of the electrically operable component, for example at the edges of a rectangle there may be a concave edge in the filling layer and a convex edge on the electrically operable component; and / or

[0117] A surface area (region) of the filling layer adjacent to the circuit carrier may have the same shape / form as the component surface of the circuit carrier, eg both may be planar surface areas.

[0118] The module part can be a mechanical module part, for example a module part without conductive parts. The module part can be an outer shell part or an inner shell part (module chassis). The module part can also be a carrier, for example the module part can carry mechanical connection elements and / or light pipes, etc., see for example the description of the figures mentioned below.

[0119] The module part and the circuit carrier can be two parts that are manufactured separately from each other. If compared with each other, the module part and the circuit carrier can include different materials. The two parts can be assembled during the assembly process. The filling layer can fasten the two parts to each other. Thus, the filling material can adhere to the circuit carrier and / or to the module part and / or to the first electrically operable component.

[0120] The side walls of the module part may include side walls inclined to the circuit carrier and / or radially inwardly facing side walls. Thus, the two parts can form a recessed hole suitable for being at least partially filled with a liquid filling material, and the liquid filling material forms a solid filling layer after solidification. The circuit carrier can form the bottom of the recessed hole. If the circuit carrier is arranged so that the component side faces upward, the recessed hole may include a bottom (circuit carrier) and the side walls of the module part. The use of the filling layer can allow the electronic module to be used several times on several drug delivery devices. Thereby, the environmental impact and cost of the electronic part in the electronic module can be significantly reduced.

[0121] "Electrically operable" may involve operating using current and / or voltage. The electrically operable component may be an active electronic component (e.g., a transistor), or a passive electronic component (e.g., a capacitor, a resistor, an inductor), or a switch (e.g., a micro switch that is also electrically operable (e.g., electromechanically operable), for example, which may use current and / or voltage to detect the state of the switch (open or closed)).

[0122] The relationship between the boundary element and the circuit carrier can be rotationally fixed and / or secured against axial translational movements by the filling layer and / or by additional mechanical support parts.

[0123] The circuit carrier may include a plurality of conductive paths of an electronic circuit system on a surface of the circuit carrier pointing away from the side of the component and / or on a surface adjacent to the side of the component. Alternatively or additionally, the conductive paths may be arranged between two main surfaces of the circuit carrier. A main surface may be a surface with a largest surface area compared to, for example, a side surface of the circuit carrier. The main surfaces may be arranged parallel to each other or substantially parallel to each other. Flexible or rigid circuit carriers may be used.

[0124] The circuit carrier may comprise or consist of FR4 (fire resistant) (e.g., fiberglass and epoxy material). Single or multi-layer circuit boards may be used. The circuit board may be named a printed circuit board. Conductive traces, pads and other features may be etched from one or more layers of metal (e.g., copper laminated to and / or between non-conducting substrate layers). This may look printed. Alternatively, a printed circuit board may be produced using printing technology. In the first part of the description, the circuit carrier is named a substrate.

[0125] SMD (surface mount device) may be used to solder the electronic components to the circuit board. Alternatively, other connection techniques may be used.

[0126] The side wall may be circumferentially closed and / or may be adjacent to the filling layer, for example along the entire circumference of the side wall or along at least half of the circumference.The circumference may be an inner circumference.

[0127] The electronic module may include a second electrically operable component of the circuit system, and / or at least one further electrically operable component of the circuit system. The following functions may be implemented:

[0128] - wherein the first component has a first construction height measured from a surface of the component;

[0129] - wherein the second component has a second construction height measured from a surface of the component;

[0130] - wherein the second construction height is greater than the first construction height;

[0131] - wherein the first electrically operable component is embedded in the filling layer up to the first construction height; and

[0132] wherein the second electrically operable component is embedded in the filling layer at least up to the second construction height or up to a third height, the third height being greater than the first construction height but less than the second construction height.

[0133] The component surface may be a planar surface. Different build heights may result in a specific topography or a three-dimensional profile of the component top surface. This topography may differ from a plane. Therefore, it may be impossible to produce the filling layer using conventional casting or potting techniques. For example, it may be necessary to prevent the filling layer from reaching mechanically movable parts and / or optical parts, the build height of which is lower than other parts that must be covered by the filling layer or embedded in the filling layer up to a certain height, which is higher than the height of the mechanically movable part.

[0134] The second height and / or the third height may be at least 10%, at least 20%, at least 30%, at least 50%, at least 75% or at least 100% higher than the first height. However, the second height may be less than 1000% of the first height to give just one example.

[0135] Thus, the first component (the shallower component) may not be covered by the filling material of the filling layer. The second component (the higher component) may be covered by the filling material of the filling layer.

[0136] If the component is mounted without a distance to the component surface of the circuit carrier, the construction height may be the same as or correspond to the height given in the catalog. If there is a space between the lower surface of the component and the component surface, for example if longer contact wires are used, for example to facilitate assembly, there may be deviations from the height given in the catalog.

[0137] The filling layer may include a first profile in a first section perpendicular to the component surface. In the first section, the thickness of the filling layer in two peripheral regions may be smaller than in the central region. The first electrically operable component may be arranged in one of the peripheral regions. The filling layer may include a second profile in a second section, the second section being perpendicular to the component surface and perpendicular to the first section. In the second section, the thickness of the filling layer in two peripheral regions may be smaller than in the central region. The second electrically operable component may be arranged in the central region. The first profile of the filling layer may be the result of using a high viscosity filling material and / or using a filling material that is hardened or cured before it flows from the central region to the peripheral region. Thus, an easy-to-implement potting method is provided, for example, the potting method enables a lower filling height to be achieved in the peripheral region compared to the central region or compared to another peripheral region that is first filled with a filling material. The shape of the free surface of the filling layer, for example, the surface facing away from the component surface, may be the result of using a high viscosity filling layer and / or curing the filling layer before the filling layer reaches the first height on the first component. In an embodiment, each peripheral region of the packing layer may have a lower packing layer height than or compared to the central region.

[0138] Alternatively, the filling layer may include a first profile in a first cross section perpendicular to the component surface. In the first cross section, the thickness of the filling layer may increase from a first thickness in a first peripheral region in the peripheral regions to a second thickness in a central region to a third thickness in a second peripheral region in the peripheral regions. The first electrically operable component may be arranged in the first peripheral region in the peripheral regions, for example in a region with a low filling height or thickness of the filling layer. Preferably, the filling layer may include a second profile in a second cross section, the second cross section being perpendicular to the component surface and perpendicular to the first cross section. In the second cross section, the thickness of the filling layer may be constant or may deviate from a maximum filling height / thickness of the filling layer (e.g., measured from the component surface) by only up to two percent or up to five percent.

[0139] Thus, the filling layer may comprise a surface facing away from the component surface. The angle of inclination between the surface of the filling layer facing away from the component surface and the component surface may be at least 5 degrees, at least 10 degrees or at least 15 degrees. The angle of inclination may be less than 40 degrees, to name just one example. The angle of inclination and / or the first profile may be the result of casting the filling material onto the circuit carrier using an angle of inclination of the circuit carrier with respect to a horizontal plane. This may be a simple measure in order to have different thicknesses of the filling layer and in order to ensure that relatively shallow components (e.g. components with mechanically movable parts) are not covered by the filling layer.

[0140] The inclined surface can be essentially planar and / or can extend laterally via at least two electrically operable components and / or can extend laterally via a planar surface of the second electrically operable component, which planar surface can be parallel or (within manufacturing tolerances) essentially parallel to the circuit carrier or parallel to the component surface.

[0141] In an alternative embodiment, the electronic module may again include a second electrically operable component of the circuit system. The first electrically operable component may again have a first construction height measured from the component surface. The second electrically operable component may again have a second construction height measured from the component surface. The second construction height may be greater than the first construction height. The first electrically operable component and / or the second electrically operable component may be embedded in the filling layer up to the first construction height. The second electrically operable component may be sealed by a combination of the filling layer and at least one additional sealing element, the at least one additional sealing element being different from the filling layer, preferably different with respect to the material of the filling layer and / or the thickness of the filling layer and / or being another component compared to the filling layer (e.g., another type of protective feature). The combination of two sealing features may allow for advanced sealing techniques that allow for a thin thickness of the filling layer.

[0142] The second height may be higher than the first height by at least 10%, 20%, 30%, 50%, 75% or 100% of the first height. The second height may be higher than the first height by up to 1000%, to give just one example. If the component is mounted at no distance from the component surface, the construction height may be the same as or correspond to the construction height given in the catalogue for the electrically operable component. If there is a space between the lower surface of the component and the component surface, for example due to the use of longer contact wires, the construction height given in the catalogue may deviate.

[0143] The additional sealing element may be a coating. The second electrically operable component may include a coating on the surface furthest from the circuit carrier and at least partially also on its side surfaces. The coating may extend to the filling layer and / or may be in contact with the filling layer. The top surface of the component may be the surface opposite to the base surface, the base surface pointing to the surface of the circuit carrier or to an adjacent surface carrier. The coating may not cover the bottom surface of the second component.

[0144] Optionally, the coating may extend to the component surface and / or may be in contact with the component surface. This may be true if the coating is applied to the second electrically operable component in a state in which the second electrically operable component is already mounted on the circuit carrier, for example on the component surface.

[0145] The coating may be applied before or after mounting the second electrically operable component on the circuit carrier. The coating may only partially (e.g., not completely) or completely cover the sidewalls of the component. If the coating is applied after mounting the second component on the circuit carrier, important features of the second component may be protected by the coating, and areas near the surface of the component may be protected by the filling layer, in particular areas within slots or narrow spaces between adjacent components.

[0146] Conformal coating methods may be suitable for producing the coating. Conformal may mean that the topography (three-dimensional contour) of the surface is preserved in the coating, such as edges (elongated edges) and corners. The use of a coating in combination with the filling layer may enable advanced sealing or protection schemes and / or allow a reduction in the amount of filling material used to produce the filling layer. Furthermore, the use of an additional coating may allow the use of a filling layer with a smaller thickness, for example so as not to cover shallow components containing mechanical and / or optical elements, and also allow sealing of at least one component with a considerable build height.

[0147] The coating may include or consist of a coating material, preferably only one coating material, so that manufacturing can be simple. The coating material may include or consist of silicone. Silicone is waterproof and / or inhibits mechanical influences. Spraying can be used to produce the coating, such as MasterBond (which may be a trademark), such as UV (curable ultraviolet) 10-MED that may be suitable for use in medical devices and / or drug delivery devices.

[0148] Alternatively, the further sealing element may be a one-piece housing for a second electrically operable component which is integral with the module part. The second component may be sealed by the one-piece housing and by the filling layer in which the one-piece housing is at least partially and / or completely embedded.

[0149] However, the one-piece housing may allow easy assembly if the module parts are arranged only on one side of the circuit carrier and / or if the circuit carrier is inserted into the boundary element from a side opposite to the side comprising the one-piece housing.

[0150] In other embodiments, the housing of the second component is not an integral part of the module part, but is retained before the filling material is applied around the second component by other measures. After the filling material is applied, the housing can be retained or fixed by the filling material. In all cases, there is a lateral and / or axial space between the housing and the second component on at least one side or on all sides.

[0151] The combination of the outer shell and the filling layer may allow components having significantly different build heights to be easily sealed.

[0152] The one-piece housing may comprise at least one flat surface. The flat surface may comprise a marking and / or carry a label, such as a paper label and / or a plastic label or a plastic-coated label. The flat surface may be arranged parallel to a main surface of the circuit carrier, such as parallel to the component surface. The marking may be a laser marking, such as a marking melted into the material of the housing using a laser. The marking may be printed, such as a marking applied using a pad printing process. The surface carrying the marking and / or the label may be an outer surface of the housing. The marking may identify the type and / or quality grade and / or serial number of the module.

[0153] In embodiments using a further sealing element different from the filling layer, the filling material may form a free planar surface which may be parallel or substantially parallel to the circuit carrier. Thus, there may be no need to tilt the module and / or use fast curing during casting of the filling material of the filling layer. Substantially parallel may mean that the angle of inclination between the free surface and the component surface is in the range of zero to 3 degrees or zero to 1.5 degrees.

[0154] The free surface and / or the planar surface may point away from the circuit carrier.The free surface may be different from the lower boundary surface of the filling material, which forms the boundary between the circuit carrier and the filling material and is adjacent to the component surface of the circuit carrier.

[0155] The module part may include or carry at least one optical guiding structure, which may be configured to guide light generated by at least one light emitting component on the circuit carrier. Thus, a light guide or light pipe may be used to implement a sensor that detects a dose set by a user and / or a dose injected by a drug delivery device on which the electronic module is mounted or is part of. There may be only narrow holes or slits that allow detection of movement of a movable part of a drug delivery device comprising a tightly packed part.

[0156] The first component may be an electromechanical component including at least one movable part, the at least one movable part being movable with respect to a housing of the electromechanical component or with respect to another part of the electromechanical component. The first component may be or may include, for example, a switch, a mechanical switch, a micro switch, etc. Alternatively, the first electrically operable component may be an electro-optical component. The electro-optical component may be or may include a light emitting diode (LED), an infrared diode (IR), a photoelectric sensor, etc.

[0157] The second electrically operable component may alternatively be an electronic component, e.g. a component without movable parts and / or optical parts. Thus, the second component may preferably be a purely electronic component, e.g. a resistor, a capacitor, an inductor, a transistor, an integrated circuit. Alternatively, the second component may be or may include an integrated circuit according to another transmission protocol, e.g. a Bluetooth (may be a trademark) or ZigBee (may be a trademark) transmitter and / or receiver and / or sending unit.

[0158] The first component can be arranged at the periphery of the circuit carrier or closer to the periphery than the position of the second component. If the second component can be arranged more centrally than the position of the first component. Thus, during filling, the filling material can be poured or dripped centrally, preferably for a variant using a viscous filling material or for a variant using an inclination. Two variants are mentioned above. The technical effect can be that, for example, movable parts of the first component are not blocked by the filling material. However, the filling layer can provide a suitable seal for other components.

[0159] The electronic module may include at least one, at least two or all three of the following:

[0160] - an electric power source, which is carried by the module part or by a mechanical carrier; and / or

[0161] a delivery button comprising a delivery surface configured to be pressed in order to initiate delivery of a drug from a drug delivery device carried by the module part or by the mechanical carrier, and / or

[0162] wherein the delivery surface is preferably arranged substantially parallel to or is arranged parallel to the circuit carrier; and / or

[0163] - a lateral setting surface, which is configured to be used to set a dose of drug (Dr) for delivery, wherein, preferably, the setting surface faces radially away from the axis of the electronic module.

[0164] The delivery surface may be an axially (proximal) facing surface. If the electronic module is arranged on a drug delivery device, the main axis of the electronic module may be arranged on a linear extension of the longitudinal axis of the drug delivery device. Therefore, the main axis of the electronic module may also be named as a longitudinal axis. However, the longitudinal length of the electronic module may be quite short, for example shorter, for example compared to its diameter.

[0165] The power source may comprise or may be a battery (non-rechargeable) or an accumulator (rechargeable). The delivery surface may be arranged, for example, parallel to the circuit carrier and / or parallel to a main surface of the battery / accumulator. Thus, the components of the electronic module may be packed tightly with only small distances between adjacent components. In this way the overall assembly space may be kept small.

[0166] The setting surface may be, for example, inclined with respect to the delivery surface, for example with an angle in the range of 80 to 100 degrees. Thus, a dose of a medicament or drug may be set by rotating the setting surface (e.g. around the main axis of the electronic module), the main axis may correspond to the main axis of a drug delivery device comprising the electronic module or on which the electronic module is mounted.

[0167] A further aspect of the invention relates to a method of manufacturing an electronic module for a drug delivery device, the method comprising:

[0168] - providing a circuit carrier, said circuit carrier comprising at least one component surface,

[0169] wherein the circuit carrier carries a first electrically operable component of a circuit system on the at least one component surface;

[0170] - providing a module section, said module section comprising at least one side wall;

[0171] - forming a recess by arranging the side wall adjacent to the circuit carrier; and

[0172] - Casting, pouring or filling a filling material of a filling layer into the recessed hole between the first component and the side wall.

[0173] To form the filling layer, a liquid or viscous filling material may be used.The electronic module may be assembled after providing the filling layer or before providing the filling layer.

[0174] The module part may be an outer shell / casing or a chassis, such as an inner shell, an inner support structure or an inner casing surrounded by an outer casing of the electronic module.

[0175] The same technical effects described above for the electronic module may also be applicable to the method if corresponding features are implemented.

[0176] The circuit carrier can also carry the second electrically operable component of the circuit system.

[0177] The method may further comprise:

[0178] - ensuring that (a) the first electrically operable component is embedded in the filling layer up to the first build height, and that the second electrically operable component is embedded in the filling layer up to at least the second build height or up to at least a third height, the third height being greater than the first build height but preferably less than the second build height; or

[0179] It is ensured that (b) the second electrically operable component is sealed by a combination of the filling layer and at least one further sealing element different from the filling layer.

[0180] The method can be used to produce an electronic module according to one of the above-described embodiments.

[0181] The method may include at least one, at least two, at least three of all four of the following:

[0182] (a1) using a high viscosity filling layer and / or using energy radiation curing to ensure that the filling layer solidifies and / or hardens before rising to the level of the first component;

[0183] (a2) tilting the recess and / or the module and / or the circuit carrier during casting of the filling layer;

[0184] (b1) applying a coating to the second electrically operable component;

[0185] (b2) Using an integral cover on the module portion to seal the second electrically operable component.

[0186] Combinations of, for example, a1) and a2) may be used. Other combinations of variants a1, a2, b1 and / or b2 are also possible.

[0187] The manufacture and use of the currently preferred embodiments are discussed in detail below. However, it should be understood that the present disclosure provides many applicable concepts that can be implemented in a variety of specific contexts. The specific embodiments discussed are merely illustrations of specific ways to manufacture and use the disclosed concepts and do not limit the scope of the claims.

[0188] In addition, if not otherwise specified, the same reference numerals represent the same technical features. With regard to the "may" used in this application, this means the possibility of doing so and the actual technical implementation. The present concept of the present disclosure will be described in a more specific context (i.e., a drug delivery device, especially a drug delivery device for humans or animals) about the following preferred embodiments. However, the disclosed concept can also be applied to other situations and / or arrangements.

[0189] The foregoing has outlined quite extensively the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure (e.g., the subject matter of the dependent claims) will be described below. It will be appreciated by those skilled in the art that the disclosed concepts and specific embodiments can be readily used as a basis for modifying or designing other structures or processes for implementing concepts having the same or similar purposes as the concepts specifically discussed herein. It will also be appreciated by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the present disclosure, such as defined in the appended claims.

[0190] For a more complete understanding of the concepts disclosed herein and their advantages, reference is now made to the following description in conjunction with the accompanying drawings. The accompanying drawings are not drawn to scale. In the accompanying drawings, the following are shown:

[0191] Fig. 1 is a modular system according to a first embodiment;

[0192] Fig. 2 is a modular system of a second embodiment;

[0193] Fig. 3 is a modular system of a third embodiment;

[0194] Fig. 4 is a modular system of a fourth embodiment;

[0195] Figure 5 electronic circuit;

[0196] FIG6 shows method steps in a process of manufacturing an electronic module of a modular system using a high viscosity filling material according to a first filling embodiment;

[0197] 7 method steps in a process of manufacturing an electronic module of a modular system using a conformable coating applied prior to filling according to a second filling embodiment;

[0198] 8 method steps in the process of manufacturing an electronic module of a modular system using an additional housing, preferably a housing integral with the chassis, according to a third filling embodiment; and

[0199] 9 shows method steps in a process for manufacturing electronic modules of a modular system by tilting the electronic modules during the filling process according to a fourth filling embodiment.

[0200] FIG1 illustrates a modular system 98 according to a first embodiment. The modular system 98 may include a drug delivery device 100, which may include a container holding member 101 and a main housing portion 102. The container holding member 101 may include a drug Dr. The main housing portion 102 may fully or partially contain or surround the container holding member 101 and may include further portions of the drug delivery device 100. Alternatively, the main housing portion 102 may be connected to the container holding member 101, but may not surround it and may not even surround a portion of the container holding member 101, see dashed lines in FIG1 .

[0201] The following components may be arranged within the main housing portion 102:

[0202] - a piston rod 104 adapted to move a piston arranged in the container holding member 101;

[0203] - a drive mechanism 106 for the piston rod 104. The drive mechanism 106 may include an energy storage element, such as a spring that is manually loaded before each use. Alternatively, the energy storage element may be loaded, for example, during assembly of the drug delivery device 100. Alternatively, a manually driven drive mechanism may be used, for example without an energy storage element for driving the piston rod 104.

[0204] - an actuating element 108, for example at the proximal end P, for initiating the movement of the piston rod 104 into the container holding member 101, thereby using the drive mechanism 106. Alternatively, an automatic injector device actuated by axial movement of a movable needle guard housing (not shown) may be used. In some embodiments, an actuating element or dosing element may be used to dial the size or amount of a dose of the drug Dr.

[0205] A cap 112 which may be attached to the main housing part 102 or another part of the drug delivery device 100. The cap 112 may be an outer cap which may include a smaller inner cap directly protecting the needle 110.

[0206] If the drug delivery device 100 is not an autoinjector, the dial sleeve may be unscrewed from the main housing 102 and may be depressed by a user in order to move the plunger 104 distally and in order to inject the drug Dr.

[0207] The drug delivery device 100 may be a single use or a multiple use device.

[0208] The drug Dr may be dispensed from the container through the needle 110 or through a nozzle that may be connected and / or coupled to the distal end D of the drug delivery device 100. The needle 110 may be replaced before each use and may be used multiple times.

[0209] The modular system 98 may include an electronics module 120 that is mechanically connected to a proximal region P of the drug delivery device 100, such as to a proximal region P of the actuation element 108. The modular system 98 is described in more detail below, see Fig. 2 and the corresponding description.

[0210] The electronic module 120 can be applied not only to the drug delivery device 100, but also to other drug delivery devices that are similar or identical to the drug delivery device 100. Thus, the electronic module 120 can be used multiple times with different drug delivery devices in different modular systems 98, etc. In addition, the electronic module 120 does not increase the diameter of the drug delivery device 100, thereby facilitating excellent maneuverability of the modular system 98, and in particular the drug delivery device 100.

[0211] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0212] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may 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 may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0213] The drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of the pharmaceutical preparation to be applied separately, one of which is stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components if desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0214] The medicine or medicament contained in the drug delivery device as described herein can be used to treat and / or prevent many different types of medical disorders. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0215] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other natural residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0216] 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 is replaced by Asp, Lys, Leu, Val or Ala and in which 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.

[0217] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0218] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924 , NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA- 3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0219] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

[0220] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0221] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0222] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 It is a sodium hyaluronate.

[0223] 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, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0224] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide), which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., double-chain antibodies, three-chain antibodies, four-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, three antibodies or double antibodies, intracellular antibodies, nano antibodies, small modular immunopharmaceuticals (SMIP), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0225] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0226] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0227] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.Pharmacologically acceptable salts are, for example, acid addition salts and basic salts.

[0228] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components of the API, formulations, apparatus, methods, systems and embodiments described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0229] An example drug delivery device may involve a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (with partial or full discharge) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0230] As further described in ISO 11608--1:2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (preset by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (preset by the user).

[0231] As further described in ISO 11608--1:2014(E), a single-dose container system may relate to a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO 11608--1:2014(E), a single-dose container system may relate to a needle-based injection device with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (complete discharge). In another example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0232] FIG2 illustrates a modular system 200 of a second embodiment that may be the same as the first embodiment. However, more details are shown in FIG2. The modular system 200 may include, for example, a housing portion 102c that may correspond to the housing portion 102 described above. The actuating element 108c may correspond to the actuating element 108 described above.

[0233] The proximal portion P of the modular system 200 may include:

[0234] - a coupling element 202 or other rotatable or movable element which may include radially protruding features 204, such as teeth of a sprocket or of a sprocket bushing;

[0235] a substantially annular adapter element 210 which can surround the side wall of the actuating element 108 ;

[0236] - An electronic module 220, which may correspond to the electronic module 120 and may include an electronic unit 240. The electronic unit 240 is described in more detail below.

[0237] - an annular housing or casing 221 of the electronic module 220,

[0238] - Chassis 222 within the electronic module 220. The chassis 222 may comprise an annular wall 249 surrounding a compartment for the electronic unit 240 and / or for several other parts.

[0239] - and a cover 224 of the electronic module 220 .

[0240] Hooks (see, for example, hook 226) may be used to connect housing 221 and adapter element 210, such as a snap-fit ​​connection. Alternatively, other connecting means may be used, or housing 221 and adapter element 210 may be integrally formed as a single part.

[0241] The following electronic components may be included within the electronic module 220:

[0242] - batteries 230 or rechargeable batteries, and

[0243] - An electronic unit 240 which may form a PCBA (Printed Circuit Board Assembly).

[0244] The electronics unit 240 may include:

[0245] - a printed circuit board 242 (PCB), which may be named as a substrate in the claims;

[0246] at least one light source 264 (for example an IR (infrared) light source) or two light sources;

[0247] - at least one optical sensor 266 or at least two optical sensors;

[0248] a transmitter unit 270 , for example a transmitter unit 270 operating according to the Bluetooth (which may be a registered trademark) protocol, for example for communicating with a smartphone or other computer device;

[0249] a receiver unit 272, such as a receiver unit 270 operating according to the Bluetooth (which may be a registered trademark) protocol, for example for communicating with a smartphone or other computer device; and

[0250] - An optional switch 274, such as a micro switch.

[0251] 2 shows the longitudinal axis A of the modular system 200. The electronic module 220 can be arranged proximally of the actuating element 108c of the corresponding drug delivery device. The electronic module 220 and the actuating element 108c are arranged symmetrically with respect to the axis A, whereby the electronic module 220 and the actuating element 108c are in physical contact with each other mainly via the adapter element 210. The adapter element 210 can be mechanically plugged onto the actuating element 108c.

[0252] The chassis 222 may include:

[0253] - three annular wall portions 244 , 246 and 248 of annular wall 249 ;

[0254] - a distal end 250 of the chassis 222 and at the same time of the annular wall portion 248;

[0255] - a wall 252 of the chassis 222; and

[0256] At least one optical guide 254 or at least two optical guides, which may have the same shape and / or coating as the optical guide 254 .

[0257] The optical guide 254 may be coated with a coating 256, see for example the first part of the description, such as a metal coating and / or a carbon fiber coating and / or a soft coating.

[0258] The cup-like structure can be formed by the wall 252 and by a portion of the annular wall portion 248 around the proximal portion or base portion of the optical guide 254. The cup-like structure can include a thinner portion 259 extending laterally, which can be considered as the bottom of the cup-like structure. The thinner portion 259 can be close to the light source 264 (e.g., IR) and the optical sensor 266 but arranged distally. The rib 260 can be arranged on the thinner portion 259 and can extend proximally 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. There can be a gap 262 between the printed circuit board 242 and the proximal or bottom of the thinner portion 259 and / or the wall 252. The gap 262 can be filled with a potting compound / material 282. If the potting compound / material 282 is in its molten state, the ribs 260 can protect the light source 264 (e.g., IR) and / or the optical sensor 266 from the potting compound / material. The contact surface between the potting compound / material 282 and the chassis 224 can be increased by the gap 262, thereby promoting the mechanical connection between the chassis 224 and the potting compound 282 or potting material.

[0259] In this order from the proximal end P to the distal end of the annular wall 249, there may be a series of annular wall portions 244, 246, and 248. The annular wall portion 244 may have a first diameter corresponding to the diameter of the cover 224. The annular wall portion 246 may have a second diameter that is smaller than the first diameter. The second diameter may correspond to the diameter of the printed circuit board 242 (PCB). In addition, the annular wall portion 248 may have a third diameter that is smaller than the second diameter.

[0260] The filling height 280 measured from the PCB 242 can be in the range of 2 mm to 7 mm. The filling height 280 of the potting compound 282 or material can be appropriately selected, for example, to cover only a portion of some electronic parts of the electronic unit 240. The inner side of the distal end 250 of the annular wall portion 248 may not be covered by the potting compound 282 or by other potting materials. However, the more proximal area of ​​the inner side of the annular wall portion 248 may be in contact with the potting compound 282 or with another potting material. During potting, the printed surface board 242 is located below the potting compound 282, and the annular wall portion 248 forms a lateral boundary for the molten or ductile potting compound. After the potting compound 282 hardens, the chassis 222 can be arranged again in all directions, for example, in the direction or position shown in Figure 2. The potting compound 282 or potting material can be an electrical insulator. The wall 252 may protect the base portion of the optical guide 254 from the potting compound / material 282 during potting.

[0261] The chassis 222 may include keying / blocking features similar to those described in Figures 3 and 4. Alternatively, the chassis 222 may not include such keying / blocking features.

[0262] FIG3 illustrates a third embodiment of a modular system 300, which may be similar to the first modular system 98 or similar to the second modular system 200. The modular system 300 may include:

[0263] - Chassis 222a of the electronic module. Chassis 222a may be similar or identical to chassis 222 (see FIG. 2 ).

[0264] - A keying and / or blocking feature K1a, such as an annular ring, extending distally from the chassis 222a.

[0265] There may be a reverse shaped keying feature K1b on the actuation / adjustment element 108a, which may be similar or identical to the actuation / adjustment element 108 or 108c. In addition, the drug delivery device carrying the actuation / adjustment element 108a may be similar or identical to the drug delivery device 100. The reverse shaped keying feature K1b may be an annular groove having an inner diameter substantially the same as or slightly smaller than the annular ring K1a, and having an outer diameter substantially the same as or slightly larger than the annular ring K1a.

[0266] The outer annular groove 310 for the optical guides 254a, 258a can be separated from the annular groove of the keying feature K1b by an annular ring 311. If the chassis 222a and / or the corresponding electronic module is mounted or assembled to the drug delivery device carrying the actuation / adjustment element 108a (for example, mounted or assembled to the actuation / adjustment element 108a), the optical guides 254a, 258a can extend into the annular groove 310. The optical guides 254a, 258a can extend the same length as the length of the keying / blocking feature K1a, for example, measured from a circuit board within the chassis 222a. Alternatively, the optical guides 254a, 258a can be slightly shorter than the keying / blocking feature. Alternatively, only one optical guide 254a or 258a can be used.

[0267] An optional central cylindrical portion 312 may be arranged at the longitudinal axis A of the drug delivery device including the actuation / adjustment element 108a. The central cylindrical portion 312 may prevent dust, moisture, and / or humidity from intruding into the drug delivery device.

[0268] Hooks 320 to 324 and / or rotation blocking elements can be used on chassis 222a. Hooks 320 to 324 and / or other rotation blocking elements can cooperate with grooves 330 at the outer circumferential surface of actuating / adjusting element 108a. Alternatively, an adapter element corresponding to adapter element 210 (see FIG. 2 ) can be used. In an embodiment, three hooks 320 to 324 and / or rotation blocking elements having the same circumferential distance or angular distance are used. However, more than three or less than three hooks 320 to 324 and / or rotation blocking elements can be used.

[0269] Optional further clip connections 326a and 326b or other connection element(s) may be used to connect the chassis 222a to the actuation / adjustment element 108a. The clip connections 326a may be opened by a user in order to release the chassis 222a from the actuation / adjustment element 108a.

[0270] In an alternative embodiment, the keying feature K1a may be disposed on the actuation / adjustment element 108a (see, eg, annular ring 311 ), and the chassis 222a may include a corresponding annular groove.

[0271] FIG4 illustrates a modular system 400 of a fourth embodiment. The following components may correspond to the components of the modular system 300 of the third embodiment:

[0272] - the chassis 222b of the electronic module may correspond to the chassis 222a;

[0273] - the actuating / adjusting element 108b may correspond to the actuating / adjusting element 108a;

[0274] - the optical guide(s) 254b, 258b may correspond to the optical guide(s) 254a, 258a;

[0275] - the outer annular groove 410 may correspond to the outer annular groove 310;

[0276] - the central cylindrical portion 412 may correspond to the central cylindrical portion 312 except for the modifications mentioned below;

[0277] - the optional hooks 420 to 424 and / or the rotation blocking elements may correspond to the hooks 320 to 324 and / or the rotation blocking elements of the chassis 222a; and

[0278] - The optional further clip connections 426a and 426b may correspond to the optional further clip connections 326a and 326b.

[0279] The chassis 222b may include a protruding keying feature K2a, which may include two plate-like elements arranged crosswise. The reverse-shaped keying feature K2b on the actuating / adjusting element 108b may include two corresponding slits 411a, 411b, which allow the keying / blocking feature K2a to be inserted into the reverse-shaped keying / blocking feature K2b. The angle between the slits 410 and 411 may have a value of 90 degrees. However, other angles may also be used.

[0280] The keying / blocking feature K2a and the reverse-shaped keying / blocking K2b may satisfy the anti-rotation function of the chassis 226. Therefore, the hooks 420 to 424 and / or the rotation blocking element may be optional.

[0281] In an alternative embodiment, the keying feature K2a may be disposed on the actuation / adjustment element 108b, and the chassis 222b may include a corresponding slot.

[0282] Therefore, the chassis 222a is only adapted to the drug delivery device including the keying and / or blocking feature K1b (i.e., the annular groove), but not to the drug delivery device including the keying and / or blocking feature K2b (i.e., including two cross-shaped slits 410, 411). In the same way, the chassis 222b is only adapted to the drug delivery device including the keying and / or blocking feature K2b, but not to the drug delivery device including the keying and / or blocking feature K2a.

[0283] FIG5 schematically illustrates an electronic unit 500, such as the electronic unit 240. The electronic unit 500 may include:

[0284] - at least one processor Pr or another control unit;

[0285] - a memory Mem, for example a volatile and / or non-volatile storage memory;

[0286] - a battery Bat or a rechargeable accumulator or any other power source;

[0287] an output device Out, such as a sending unit, for example for communicating with a smartphone or other computer device;

[0288] - an optional input device In, for example for communicating with a smartphone or other computer device;

[0289] - a switch Sw; and

[0290] - At least one sensor S or at least two sensors, preferably optical sensor(s).

[0291] The electronics unit 500 may comprise further parts which are not shown, such as a radiation source, in particular a light source.

[0292] The processor Pr may be a microcontroller or microprocessor that executes instructions of a program stored in the memory M. Alternatively, an FPGA (field programmable gate array), an ASIC (application specific integrated circuit), a PLA (programmable logic array), a PLD (programmable logic device), or other suitable circuitry may be used to implement a finite state machine that does not execute instructions of a program.

[0293] The electronics unit 500 may implement a quadrature encoder between the two sensor signals (eg, anti-phase sensor signals), such as an encoder using amplitude modulation of the two sensors with a 180 degree phase shift. Alternatively, other sensing methods may be used.

[0294] According to various embodiments, there may be two optional sensing operating modes. According to a first alternative, a first sensor and a second sensor, such as an optical sensor, may be provided with an angular offset, the angular offset being, for example, half the period of the encoding area of ​​the encoder ring on the coupling element 202. In an embodiment according to the first alternative, the sensors may be operated to sample synchronously, i.e., at the same time (t1, t2, t3, ...). This may simplify signal detection and / or signal processing.

[0295] According to a second alternative, a first sensor and a second sensor, for example an optical sensor, may be provided with an angular offset that differs from half the characteristic period of the encoding region of the encoder ring. Thus, sensors I and II may be operated in an interleaved mode with a time offset (Δt) between sampling. This may be used to achieve a more balanced overall system power consumption than is possible in synchronous operation.

[0296] One of the following sensing modes can be used:

[0297] -1) Static threshold,

[0298] -2) Dynamic threshold,

[0299] -3) No threshold is used to detect the low-high transition of the sensor signal. However, a threshold of the voltage difference of the two sensor signals can be used. In addition, a scaling factor of the mean and the amplitude can be used. The scaling factor can be set during manufacturing (e.g. during a calibration method).

[0300] - 4) Same as 3), but with the difference that the scaling factor can be calculated after each dose delivery.

[0301] 5) A peak detection method that preferably does not use thresholding to detect low-high transitions of the sensor signal(s), and preferably does not use signal scaling to match mean and amplitude.

[0302] 6-9 relate to methods of manufacturing electronic modules 600 , 700 , 800 , and 900 , such as the electronic modules 120 , 300 described above or other electronic modules including components having different build heights.

[0303] The electronic modules 120, 220, 600, 700, 800 and 900 may include:

[0304] a circuit carrier 242 (eg a PCB), which comprises at least one component surface SF1;

[0305] a first electrically operable component of the circuit system (for example a switch 274 ), which is arranged on the at least one component surface SF1 ;

[0306] - a module portion comprising at least one side wall 248, 248a;

[0307] - and a filling layer 620, 720, 820, 920, such as a potting compound 282,

[0308] The side walls 248, 248a are arranged adjacent to the circuit carrier 242.

[0309] The side walls 248, 248a and the circuit carrier cooperate to define a receiving space for the filling layers 282, 620, 720, 820, 920, and

[0310] The filling layer 282 , 620 , 720 , 820 , 920 contacts at least one, at least two, or all of the sidewall 248 , 248 a , the first electrically operable component, or at least one region / area of ​​the component surface SF1 .

[0311] 2 , the module part is a chassis 222 carrying a printed circuit board 242 (circuit carrier), a battery 230 and a cover 224, which may also be designated as a delivery cover comprising a delivery surface DSF. The recesses 330, 430 may be part of a setting surface SF0 used for setting a dose.

[0312] In the example according to FIGS. 6 to 8 , the module part is a chassis comprising a tubular wall portion 248 a, which is arranged only on one side of the circuit carrier 242. More specifically, a proximal end 248 b of the wall portion 248 a is adjacent to the circuit carrier 242. A further chassis part is arranged on the opposite side of the circuit carrier 242. The further chassis comprises a separate tubular wall portion 246 a carrying the battery / accumulator 230.

[0313] 2 includes a separate cover 224 that is separate from the housing 221 of the electronic module 220. In contrast, in FIGS. 6 to 9 , a housing 221 with an integrated delivery surface DSF is used, e.g. without a separate cover 224. The housing 221 may also include or integrally include an adapter element similar to the adapter 210 described above, e.g. an adapter element that allows fastening to a setting knob of the drug delivery device 100.

[0314] However, the same method, in particular with regard to the sealing of electronic components, can also be applied to the examples shown in Figures 1 to 5. However, these design details are independent of the potting (filling) method used to provide the potting compound 282 or the filling layer 620, 720, 820, 920.

[0315] FIG. 6 illustrates method steps in a process of manufacturing an electronic module 600 of the modular system 98 using a high viscosity filling material of a filling layer 620 according to a first filling embodiment.

[0316] The following parts are shown in all four figures of Figures 6 to 9:

[0317] - Component 270 may be a transmitter (transmitter) such as a Bluetooth transmitter, or a receiver 272 such as a Bluetooth receiver. In the claims, components 270, 271, 272 are named as second electrically operable components.

[0318] - As an alternative or in addition to the component 270, a component 271 may be used, for example a capacitor 271. In the claims, the component 271 is also named as a second electrically operable component.

[0319] - a switch 274 which is named in the claims as a first electrically operable component and which may comprise a movable component MC;

[0320] - A battery 230, such as a button cell or coin cell. The diameter of the battery 230 may be less than 2 cm (centimeter) or less than 1.5 cm. Alternatively, a rechargeable battery or other energy source may be used.

[0321] - a first contact 231a (positive pole, positive potential, positive terminal) of the battery 230 / accumulator;

[0322] - a second contact 231 b of the battery 230 / storage battery (negative pole, negative terminal, negative potential, ground);

[0323] - an optical guide 254 or a corresponding optical guide 254a, 258a, 254b, 258b;

[0324] - wall 252; and

[0325] - annular wall 248 .

[0326] However, in the examples shown in FIGS. 6 to 9 , further parts may be provided:

[0327] - optional keying features K1a, K2a; K2a, K2b; and / or

[0328] - optional hook members 320, 322, 324, 420, 422, 424; and / or

[0329] -Optional clip connectors 326a, 326b, 426a, 426b, etc.

[0330] The setting surface SF0 is oriented radially outward and may extend circumferentially around the housing 221 of the electronic modules 600 , 700 , 800 and 900 .

[0331] The electronic module 600 may include a second electrically operable component of the circuit system, such as at least one of the components 270, 271 and / or 272. The first component (e.g., switch 274) may have a first construction height H6c measured from the component surface SF1. The first construction height H6c may be different from the maximum construction height of the first component. Thus, the maximum construction height may extend from the bottom of the housing of the switch 274 upward to the free end of the button of the switch 274, see movable component MC. The first construction height H6c may correspond to the height of the housing of the switch 274. If the first component is an electro-optical component (e.g., an LED (light emitting diode) or a multi-color LED IC (integrated circuit)), the first height H6c may extend to a reference point on the housing of the LED or to the top edge of the housing of the LED integrated circuit. The maximum construction height of the LED or the LED IC may be greater than the first construction height and may include, for example, an optical lens of the LED or the LED IC.

[0332] The second components 270, 271 and / or 272 may have a second construction height H6d measured from the component surface SF1. The second construction height H6d may correspond to the maximum construction height of the second components 270, 271 and / or 272 or may be less than the maximum construction height of the second components 270, 271 and / or 272.

[0333] The first construction height H6c is also valid for the first component 274 (e.g., a switch) in the electronic modules 700, 800, and 900, see FIGS. 7 to 9 explained in more detail below. Similarly, the second construction height H6d is also valid for the second component 270 and / or 271 and / or 272 (e.g., a transmitter or a capacitor) in the electronic modules 700, 800, and 900, see FIGS. 7 to 9.

[0334] The second construction height H6d can be greater than the first construction height H6c, for example, by an amount mentioned in the first part of the description above. The first electrically operable component 274 can be embedded in the filling layer 620 up to the first construction height H6c. The second electrically operable component 270 and / or 271 and / or 272 can be embedded in the filling layer 620 at least up to the second construction height H6d or up to a third height, the third height being greater than the first construction height H6c but less than the second construction height H6d. Thus, the second electrically operable component 270 and / or 271 and / or 272 can also be covered by the filling layer 620, for example, the material of the filling layer 620 can also extend above the top surface of the second electrically operable component 270 and / or 271 and / or 272.

[0335] The filling layer 620 may include a first profile in a first cross section, the first cross section being perpendicular to the component surface SF1 and may correspond to the plane shown in FIG6 . In the first cross section, the thickness of the filling layer 620 in two peripheral regions or in at least one peripheral region (see, for example, thickness H6b) may be smaller than the thickness H6a in the central region. The first electrically operable component (e.g., switch 274) may be arranged in one peripheral region, see the left side in FIG6 . Further, preferably, the filling layer 620 may include a second profile in a second cross section, the second cross section being perpendicular to the component surface and perpendicular to the first cross section. In the second cross section, the thickness of the filling layer 620 in two peripheral regions or in at least one peripheral region may also be smaller than the thickness of the filling layer 620 in the central region (see, for example, thickness H6a).

[0336] Thus, the recessed hole W is formed by the wall portion 248a and the circuit carrier 242. The recessed hole W is used to accommodate the liquid or viscous filling material of the filling layer 620, which can be poured into the recessed hole W in the central area (see arrow 610) or in another suitable area. The rapid hardening of the filling material may lead to the profile of the filling layer 620 mentioned above, for example, there may be a first ramp G1 of the free surface of the filling layer 620 from the right side to the central area, and a second ramp G2 of the free surface of the filling layer 620 from the left side to the central area. The ramps G1 and G2 may be the same or may be different from each other. The ramp G1 may include an angle A6b with a surface SF1. The ramp G2 may include an angle A6a with a surface SF1. The range of angles A6b and / or A6a may be in the range of 5 degrees to 30 degrees to give only one example.

[0337] Materials with high viscosity (e.g., having a viscosity of more than 10 mPa*s (milliPascal seconds) (cP centipoise), more than 100 mPa*s, or more than 1000 mPa*s, or more than 10000 mPa*s) can be used. The viscosity can be less than 10^10 mPa*s (Cp) or less than 10^12 mPa*s (Cp) to give just some examples. These values ​​are valid at a temperature of 20°C (degrees Celsius). If the temperature is higher, the viscosity is lower.

[0338] An automatic filling machine may be used to fill the filling material of the filling layer 620 into the recessed hole W. Alternatively, a syringe may be used to manually fill the filling material into the recessed hole W. An assembled module 600 or a partially assembled module 600 (e.g., without the battery 230, the housing 221, and / or the wall portion 246a) may be filled with the filling material of the filling layer 620.

[0339] 7 illustrates method steps in a process of manufacturing an electronic module 700 of a modular system 98 using a conformal coating 710 applied, for example, by a conformal coating prior to filling according to a second filling embodiment.

[0340] In addition to the filling layer 720, a further sealing element may be used, such as a coating 710. The second electrically operable component 270 and / or 271 and / or 272 may include a coating 710 on the surface furthest from the circuit carrier 242 and also at least partially on its side surfaces (see FIG. 7 , left and right surfaces). The coating 710 may extend to the filling layer 720 and / or may be in contact with the filling layer 620.

[0341] Coating 710 may include or may be composed of a coating material. The coating material may include silicone or may be composed of it. Before components 270 and / or 271 and / or 272 are mounted to circuit carrier 242 or after installation, spraying or liquid may be used to apply coating 710 on second component 270 and / or 271 and / or 272. If coating 710 is applied after second component 270 / 271 is mounted to circuit carrier 242, movable part MC may be covered by a protective structure to prevent the coating material of coating 710 from reaching movable part and blocking its motion. MasterBond (may be a trademark) UV 10-MED is an example of spray that can be used. Other sprays or liquids may also be used, especially materials that meet ISO (International Organization for Standardization) 10993.

[0342] After assembling the circuit carrier 242 and the wall portion 248a, for example, after forming the recessed hole W, the filling material of the filling layer 720 can be filled into the recessed hole W. The resulting filling layer 720 can have a constant thickness H7 throughout the circuit carrier 242. The thickness H7 can be equal to or less than the first height H6c of the first component 274. The assembled module 700 or the partially assembled module 700 (for example, without the battery 230, the housing 221 and / or the wall portion 246a) can be filled with the material of the filling layer 720. The second component 270 / 271 is sealed by the coating 710 and by the material of the filling layer 720. The second component 270 / 271 can be embedded in the material of the filling layer 720 only to a height equal to or less than the first height H6c.

[0343] Again, an automatic filling machine may be used to fill the filling material of the filling layer 720 into the recessed hole W. Alternatively, a syringe may be used to manually fill the filling material into the recessed hole W. Compared to the embodiment of FIG. 6 , the viscosity of the filling material of the filling layer 720 may be lower, for example, less than 10 mPa*s (milliPascal seconds) at 20° C. (degrees Celsius).

[0344] Figure 8 shows method steps in a process of manufacturing an electronic module 800 of a modular system 98 according to a third filling embodiment using an additional housing 810, preferably an integral cover 810 of a chassis 222 (module part in the claim), wherein the chassis also includes wall portions 248 and / or 248a and / or 252.

[0345] An integral cover 810 or a cover separated from the chassis 222 (module part in the claims) and / or from the wall 248 and / or the wall 248a can be used as an additional sealing element for the second component 270 and / or 271 and / or 272. The second component 270 and / or 271 and / or 272 can be sealed by the integral cover 810 and by the filling layer 820, in which the integral cover 810 can be at least partially embedded. The second component 270 / 271 can be embedded in the material of the filling layer 720 only to a height equal to or less than the first height H6c.

[0346] The one-piece cover 810 may include at least one flat surface SF8 on the top cover wall. The flat surface SF8 may include markings and / or carry labels. Laser markings may be used, which are imprinted and / or melted into the material on the surface SF8, for example into a plastic material.

[0347] The cover 810 can have three side walls surrounding the second components 270, 271 and / or 272. One of the three side walls is shown on the right side of the component 270 / 271 in FIG. 8. The fourth side wall can be formed by the wall portion 248. Alternatively, the fourth side wall can be connected to the wall portion 248, for example via a support structure. The height of the side wall of the cover 810 can be less than the height of the side wall of the component 270 / 271 / 272, for example, so as to use less material for the cover 810. Alternatively, the height of the side wall of the cover 810 can be equal to or greater than the height of the side wall of the component 270 / 271. The lower end of the side wall of the cover 810 is embedded in the filling layer 820 and / or can be in contact with the filling layer 820, for example on its outer surface.

[0348] After assembling the circuit carrier 242 and the wall portion 248a, for example, after forming the recessed hole W, the filling material of the filling layer 820 can be filled into the recessed hole W. The resulting filling layer 820 can have a constant thickness H8 throughout the circuit carrier 242. The thickness H8 can be equal to or less than the first height H6c of the first component 274. The assembled module 800 or the partially assembled module 800 (for example, without the battery 230, the housing 221 and / or the wall portion 246a) can be filled with the filling material of the filling layer 820.

[0349] An automatic filling machine may be used to fill the filling material of the filling layer 820 into the recessed hole W. Alternatively, a syringe may be used to manually fill the filling material into the recessed hole W. Compared to the embodiment of FIG6 , the viscosity of the filling material of the filling layer 820 may be lower, for example, less than 10 mPa*s (milliPascal seconds) at 20° C. (degrees Celsius).

[0350] 9 illustrates method steps in a process of manufacturing an electronic module 900 of a modular system 98 by utilizing a tilting of the electronic module 900 during filling of a material of a filling layer 920 into a recess W according to a fourth filling embodiment.

[0351] The filling layer 920 may include a first profile in a first cross section that is perpendicular to the component surface SF1 and may correspond to the plane shown in FIG. 9 . In the first cross section, the thickness of the filling layer 920 may increase (preferably continuously) from a first thickness H9c of a first peripheral region in the peripheral region to a second thickness H9b of the central region and further to a third thickness H9a of a second peripheral region in the peripheral region. The first electrically operable component 274 may be arranged in the first peripheral region in the peripheral region. The first thickness H9c of the filling layer 920 may be equal to or less than the first height H6c of the first component 274. Therefore, the movable component MC of the first component 274 is not covered by the filling layer 920.

[0352] The filling layer 920 may include or may be in a second profile in a second cross section that is perpendicular to the component surface SF1 and perpendicular to the first cross section. In the second cross section, the thickness of the filling layer 920 may be constant or may deviate only by at most two percent from the maximum filling height or thickness H9a of the filling layer 920. The second cross section may also extend through the peripheral portion and through the central region.

[0353] The filling layer 920 may include a free surface, which is the result of casting or pouring the filling material 920 using an inclination angle A9a, A9b of the circuit carrier 242 and / or the recess W and / or the module 920 with respect to the horizontal plane. The inclination angle A9a, A9b may be at least 5 degrees, at least 10 degrees, or at least 15 degrees.

[0354] The assembled module 900 or partially assembled module 900 (e.g. without the battery 230, the housing 221 and / or the wall 246a) is tilted as shown in Fig. 9. Thus, for example, in the center portion (see arrow 910), the liquid filling material is filled into the recess W, or into another appropriate portion.

[0355] There may be only one continuous ramp G9 between the free surface (eg, the surface not covered or adjacent to other parts) of the filling layer 920 and the component surface SF1. The ramp G9 corresponds to the tilt angles A9a, A9b used during filling the recess W with the filling material of the filling layer 920.

[0356] In all the above mentioned examples (FIG. 2, FIG. 6, FIG. 7, FIG. 8 and FIG. 9), the following method steps may be included:

[0357] - Assembling the circuit carrier 242 and the wall portion 248 a, for example forming a recess W;

[0358] - tilting assembly or pre-assembly (only in the example of FIG. 9 );

[0359] - The filling material of the filling layers 282, 620, 720, 820, 920 may be filled into the recessed holes W;

[0360] - optionally using a tempering step to harden the filling material of the filling layer 282 , 620 , 720 , 820 , 920 , as opposed to just waiting until the filling layer solidifies;

[0361] - optionally performing further assembly steps of the module 120 , 220 , 620 , 720 , 820 or 920 .

[0362] An automatic filling machine may be used to fill the filling material of the filling layer 920 into the recessed hole W. Alternatively, a syringe may be used to manually fill the filling material into the recessed hole W. Compared to the embodiment of FIG. 6 , the viscosity of the filling material of the filling layer may be lower, for example, less than 10 mPa*s (milliPascal seconds) at 20° C. (degrees Celsius).

[0363] In all four embodiments, the module 620, 720, 820, 920 may be connected to the medical drug delivery device 100 in order to monitor the setting of a dose and / or deliver a set dose of a medicament or drug Dr to a patient.

[0364] In other words, part of the disclosure relates to light pipe / light guide 254 or optical tube protection, preferably load resistance. The optical tube can be an optical fiber, a tube or other optical guide device. An additional coating 256 on the outer surface of the light pipe can be used to protect the light pipe from damage from loads from the outside. One option is a metal coating or a similar strong material coating to harden the structure of the light pipe. A second option is a soft coating to absorb impact loads, thereby reducing the stress of the light pipe. Another option is a reinforced coating, such as a material filled with carbon fiber reinforced polymer (German: CFK). Combinations of two or three of these options are also possible.

[0365] The second part of the disclosure relates to features used for the purpose of protecting the reusable clip-on electronic modules (electronic modules 120, 220, 600 to 900) from damage, dirt and water intrusion, and other environmental influences. The second part of the disclosure describes features used for the purpose of protecting the reusable clip-on electronic modules 120, 220 from damage, dirt and water intrusion, etc. The embodiments in this document are shown with an optical add-on module 120, 220, 600 to 900 for a disposable injection device, but are applicable to any module 120, 220, 600 to 900 attached to an injection device. This document does not include a complete description of the disposable device mechanism itself, nor does it include a complete description of the optical add-on module.

[0366] The described approach is intended to be applicable in the context (eg, size, cost, availability, etc.) of additional modules 120 , 220 , 600 - 900 .

[0367] The second part of the disclosure relates to the features of an additional module, which can be attached to a suitably configured pen injector for the purpose of recording the dose delivered from the pen. Electronic modules 120, 220, 600 to 900 can be used as memory aids and for accurate dose history records. It is conceivable that electronic modules 120, 220, 600 to 900 can be configured to be connected to a mobile device or similar device so that dose history can be downloaded from the module regularly. This information may be used by end users, healthcare providers or for more extensive research. In addition, if the number of dose delivery operations exceeds or reaches the number of times that the drug delivery device is designed for, electronic modules 120, 220, 600 to 900 can be used to remind users to replace the drug delivery device connected to the electronic modules 120, 220, 600 to 900.

[0368] Reusable electronic modules 120, 220, 600 to 900, such as the proposed optical encoder, can operate across multiple disposable devices and can resist physical damage and intrusion of dirt and water when not attached to a drug delivery device. The features described in the second part of the present disclosure attempt to variously minimize the risk of damage to the encoder in such circumstances.

[0369] Method 1 – Physically blocking features

[0370] Blocking features of parts molded as "light pipe chassis" can be utilized, see 222 in FIG. 2, as shown in FIG. 3 and FIG. 4. FIG. 3 and FIG. 4 show blocking ribs K1a, K2a and corresponding orifices K1b, K2b in buttons 108a, 108b. In this way, once the electronic modules 120, 220 of the modular system 300, 400 are assembled, when assembled with the grip ring (e.g., 210 in FIG. 2) and the end cap (e.g., the housing or shell 221 shown in FIG. 2) components, the user will not be able to contact the light pipe 254a, 258a, 254b, 258b or the electronic device PCBA. As shown in FIG. 3 and FIG. 4, corresponding orifices in the button top surface of the buttons 108a, 108b may be required.

[0371] This approach may have the advantage of not requiring any additional components by using the light pipe chassis molded to form the blocking features K1a, K2a (see 222 in FIG. 2). The blocking features K1a, K2a may also act as mechanical "dedicated" or keying features.

[0372] Alternatively, the blocking features K1a, K2a may be formed on a separate component that is clamped to the underside of the light pipe chassis, see 222 in Figure 2. This may allow for a more robust blocking feature K1a, K2a and the possibility of forming a waterproof seal to prevent water intrusion into the PCBA.

[0373] Method 2 – Elastomeric Potting Compound

[0374] To specifically prevent water and dust intrusion, an elastomeric "potting" compound 282 or filler layer 620 to 920 (such as silicone or polyurethane) may be applied to the underside of the light pipe chassis 222 after the electronic module 120, 220, 600 to 900 is assembled, see FIG2. The potting compound 282 may be applied to the underside of the reusable clip-on electronic module 120, 220, 600 to 900. The potting compound 282, 620 to 920 may be applied between the fill height 280 and the substrate 242.

[0375] The potting compound 282 of preferably low hardness (e.g., lower than the hardness of the chassis 222 or lower than the Shore hardness of A80 or A75 and / or Dymax MD1072-M (Shore hardness A70)) can be directly applied to the PCBA and thus can have good stress relief properties for the fragile component parts (e.g., resistors, capacitors, inductors and / or microprocessors or microcontrollers) on the board. However, the potting compound 282 can be sufficiently viscous in its molten state to prevent leakage through gaps.

[0376] Applying the potting compound 282 or the filler layers 620 to 920 in this manner will prevent the intrusion of dust and water into the conductive areas of the PCBA.

[0377] If the potting compound 282 is filled to a level 280 as shown in FIG2 , the micro switch 274 will be assisted by the compound and can be operated by the switch arm or pin. In addition, since the PCBA can be axially offset to the light pipe chassis 222, the optical sensor(s) can be kept isolated from the potting area to form a barrier to the potting compound 282 reaching the optically sensitive areas of the optical sensor(s) 266 and / or the optical radiation (light) source(s) 264. Filling to this level 280 prevents the potting compound 282 from contacting the optical sensor(s) 266 and / or the optical radiation (light) source(s) 264 through the features 252 (walls), 260 (ribs), etc.

[0378] It is also possible to combine method 1 and method 2.

[0379] Elastic potting variants

[0380] The elastomeric potting material can be applied to the electronic module 120, 220, 600 to 900 in a variety of ways, attempting to cover all electronic components except, for example, the exposed switch 274 or micro switch. The micro switch 274 can be lower in height than the other components, but does not need to be covered with the potting compound 282 and / or the filling layer 620 to 920, as this would prevent the reliable function of the micro switch 274.

[0381] Variant 2a – Apply potting compound or encapsulant to the highest component (Figure 6)

[0382] In this variation, the height of the micro switch 274 is lower than the height of other nearby electronic components (e.g., capacitor(s)). The elastomeric potting material is selected to be highly viscous or sufficiently viscous and is applied, for example, directly above the highest component. In such an arrangement, the potting compound 282 can be cured (e.g., using UV (ultraviolet) radiation) to ensure that the potting compound 282 / filling material 620, 720, 820, 920 solidifies before rising to the level of the micro switch 274.

[0383] This concept allows the micro switch 274 or another mechanical, electromechanical or optoelectronic component to remain exposed while covering the surrounding electronic components completely or to a greater extent than, for example, the micro switch 274. The elastomeric potting compound can be applied directly over the uppermost component, see arrow 610 in FIG6 , which shows the potting compound being applied over the uppermost component. A potting compound can be used instead of a potting compound to achieve the same effect.

[0384] Variant 2b – Conformal coating applied before potting (Figure 7)

[0385] In this variation, the height of the micro switch 274 or another relatively shallow component is again lower than the height of other nearby electronic components (e.g., capacitor(s), Bluetooth (can be a trademark) module). A conformable coating (e.g., a silicone spray such as Master Bond UV10-MED) or a non-conformal coating can be applied to the highest component on the board and cured before applying the elastomeric potting or filling material 720. The potting material can be filled up to a certain height that is lower than the critical height of the micro switch. Thus, isolation of tall electronic components from water and dust intrusion is ensured by a conformable or non-conformal coating. FIG7 illustrates applying a conformable coating to the highest component prior to the potting.

[0386] Variant 2c – Using a one-piece “cover” for the highest component (Figure 8)

[0387] In this variation, the height of the microswitch 274 or another component is again lower than the height of other nearby electronic components (e.g., (multiple) capacitors). A "cover" feature 810 can be formed on the light pipe chassis component 222. This component or feature 810 can prevent physical contact with the highest component from the bottom side. An elastomeric potting compound 282 or other filling material 820 can be applied around this cover feature 810 to form a seal. This method allows the potting compound 282 or filling layer 820 to be applied to a lower level, meaning that the microswitch 284 or other component can remain exposed while protecting the highest component from water and dust intrusion. If desired, this integrated cover 810 can also provide a flat surface SF8 for laser marking or labeling. Figure 8 shows a cover component / feature 810 for preventing contact with the highest component. A capacitor cover that is integral to the light pipe chassis 221 can be used.

[0388] Variant 2d – Tilt the module to control potting height (Figure 9)

[0389] In this variation, the height of the microswitch 274 or other component is again lower than the height of other nearby electronic components (e.g., capacitors). Thus, the module 120, 220, 900 is held at an inclined angle relative to the horizontal plane so that the level at which the elastomeric potting material 282 or other filling material 920 is applied is at a non-zero angle A9a, A9b relative to the PCB 242. This method allows for covering taller components while leaving the microswitch 274 or other component exposed. FIG. 9 illustrates holding the module 120, 220 at an angle A9a, A9b to the horizontal plane during potting application, for example applying the potting material while the module is held at the angle A9a, A9b, see arrow 910.

[0390] The concepts described in the second part of this disclosure are considered to be used as blocking and / or intrusion prevention features applied to a reusable clip-on encoder or electronic module 120, 220. This document has shown particularly useful implementations of the second part of this disclosure. In the broadest general terms, this second part of this disclosure and all other parts of this disclosure can be applied to any syringe device 100 in which a reusable electronic module 120, 220, 600 to 900 is to be attached and removed.

[0391] The third part of the present disclosure relates to recording of delivered doses in an injection device 100 using, for example, an optical additional electronic module 120, 220, 600 to 900. The third part of the present disclosure describes recording the dose delivered from the injection device 100. It may be applicable to the following drug delivery devices: in the drug delivery device, the number sleeve and / or the dial sleeve can rotate relative to the dose button 108, 108a, 108b during injection but may not rotate relative to the component during dialing. Alternatively, the recording of the dose can be performed during dialing, for example, the rotation of the number sleeve and / or the dial sleeve can be determined. The embodiments in this document are shown with a specific disposable injection device 100, but are also applicable to other drug delivery devices, for example, any device with an indicated component movement. This document does not include a complete description of the (disposable) drug delivery device mechanism itself. In addition to the retention features for the electronic module additional device, the injection device 100 may need to be adapted to provide axial passage for a preferably flexible switch element and / or one or more "light pipes" through the dose button or another button 108. The electronic module 120, 220, 600 to 900 additional components may include a "light pipe chassis" 222, which may be a single optically transparent plastic molding, including one or more light pipes or optical guides 254 to facilitate optical sensing of, for example, a castellated top surface of a number sleeve component and / or a dial sleeve component or a coupling element, into which the coupling element is inserted. During dialing with a larger set dose, the dial sleeve component or element may extend increasingly out of the chassis, depending on the dose selected. Additionally, this "light pipe chassis" 222 may include a flexible or rigid element to trigger a micro switch 274 or another appropriate switch element to indicate an axial mode shift when a dose button or another button is pressed (released) to deliver a dose. The electronics may be mounted within the "light pipe chassis" 222, which may then be covered by an "upper cap" 221, 210.

[0392] The relative rotation between the dose button and the number sleeve and / or the dial sleeve and / or the coupling within the dial sleeve may be optically encoded using, for example, an incremental encoder (e.g. a quadrature encoder) axially viewing castellations on the top surface of the number sleeve and / or the dial sleeve and / or the coupling within the dial sleeve, the incremental encoder having, for example, two reflective sensors 254 (e.g. IR (infrared) sensors).

[0393] A quadrature encoder can be an incremental encoder with two out-of-phase output channels where the direction of motion needs to be sensed. Each channel can provide a specific number of equally spaced pulses per revolution (PPR), and the direction of motion can be detected by the phase relationship of one channel leading or lagging the other.

[0394] The third part of the present disclosure also relates to the features of additional electronic modules 120, 220, 600 to 900, which can be attached to a suitably configured pen injector for recording the dose delivered from the pen. This function may be valuable to many device users as a memory aid or to support detailed recording of dose history. It is conceivable that electronic modules 120, 220, 600 to 900 can be configured to be connected to a mobile device (e.g., a smart phone) or similar device so that dose history can be downloaded from the module regularly. In addition, if the number of dose delivery operations exceeds or reaches the number of times that the drug delivery device 100 is designed for, the electronic modules 120, 220, 600 to 900 can be used to remind the user to replace the drug delivery device connected to the electronic modules 120, 220, 600 to 900.

[0395] Electronic modules 120, 220, 600 to 900 add-ons are disclosed that can be attached to a suitably configured disposable pen injector. The add-ons can allow recording of dose history information without the need to dispose of high value electronics each time a new pen is needed, and with minimal changes to the existing core mechanism of the disposable or non-disposable injector.

[0396] The (disposable) button may be embodied with an axial retaining tab feature on the outer surface to facilitate retaining the additional electronic module 120, 220, 600 to 900. Additionally, there may be an annular groove in the top surface, e.g. with only one aperture or with more than one aperture (e.g. four apertures), to allow access through a dose button or other button (e.g. a release button of an autoinjector) to a number sleeve and / or to a dial sleeve and / or to a coupling element within said dial sleeve.

[0397] The number sleeve and / or the dial sleeve and / or the coupling element within the dial sleeve may be embodied with, for example, 24 coupling teeth that may engage with a dose button or another portion at the proximal end of the drug delivery device. These coupling teeth or other indicator features may be castellated features that may be disposed at the distal end of the light pipe or optical guide 254, 254a, 258a, etc. and whose rotation may be encoded to record the dose size of the drug Dr delivered.

[0398] The dose button and / or release button may be designed to bottom out on the number sleeve and / or the dial sleeve and / or a coupling element within the dial sleeve to ensure a small and repeatable axial distance between the optical tube or optical guide and the coupling teeth when the dose button or another button is pressed.

[0399] The additional electronic modules 120, 220, 600 to 900 may include the following components:

[0400] a chassis 222 which can be axially and rotationally fixedly coupled to the dose button or to another button or simply to the housing of the autoinjector;

[0401] -PCB, electronic components and button batteries (housed in the chassis);

[0402] An “upper cap” or housing 221 , optionally in two pieces including the adapter element 210 .

[0403] The "top cap" may be used to hold and / or contain electronics and / or to provide visual and tactile features to a user on its outer side surface.

[0404] The embodiment of the "light pipe chassis" 222 shown in FIG. 2 may include two light pipes or optical guides 254, 254a, 254b, 258a, 258b, see also FIG. 3 and FIG. 4, above which a reflective or transmissive optical sensor 266, such as the IR sensor shown in FIG. 2, may be mounted. These light pipes or optical guides 254, 254a, 254b, 258a, 258b may allow (multiple) optical sensors 266 (e.g., mounted axially within the "light pipe chassis" or chassis 222 at the proximal end P of the light pipes) to detect the presence of castellated features at the distal end D of the light pipes or optical guides 254, 254a, 254b, 258a, 258b when a dose button or another button is pressed. Alternatively, an auto-injector may be used that does not include a release button but includes a needle guard housing that releases the mechanism 106 if the drug delivery device 100 is pressed against the injection site.

[0405] When the dose button 108 or the dose surface DSF is pressed and / or when the amount of the selected or delivered drug Dr has to be determined, the distal end of the light pipe can be kept at a small and well-controlled axial distance from the castellated feature or other appropriate feature. In addition, the embodiment can optionally include a single flexible or rigid element, which will contact the top surface of the number sleeve and / or the dial sleeve or another part of the drug delivery device when the dose button 108 or another button is pressed. Alternatively, the needle guard housing can be used as a trigger element. The flexible or rigid element can be deflected or moved to contact the micro switch 274 or another switch axially mounted on the PCB in the "light pipe chassis", and can be used as an axial mode shift trigger to wake up the electronic module 120, 220, 600 to 900, especially the power supply unit of the electronic module 120, 220. The flexible or rigid element can contact the micro switch 274 after a small axial stroke, but can be able to adapt to a significant overtravel exceeding the trigger point.

[0406] Embodiments of the third part of the present disclosure may include a clip feature that is intended to act as an axial retention feature when the additional electronic module 120, 220, 600 to 900 is assembled to the dose button 108, to another button of the pen injector, or directly to the pen injector. The additional electronic module 120, 220, 600 to 900 can be designed to be assembled to the dose button 108 in a unique rotational orientation. In addition, the outer diameter of the "light pipe chassis" or chassis 222 or another chassis or module portion can have the following features: the "upper cap" can be fixedly coupled to the feature in the rotation so that these components move together. It is conceivable that the "light pipe chassis" component can be molded with polycarbonate or a similar polymer that transmits infrared radiation or other optical radiation in the wavelength range of the optical sensor.

[0407] Two of the three parts of the present disclosure or all three parts of the present disclosure may be combined.

[0408] Although the embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and modifications may be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. In addition, the scope of the present application is not intended to be limited to the specific embodiments of the systems, processes, manufactures, methods or steps described in the present disclosure. As will be readily understood by those skilled in the art from the disclosure of the present disclosure, systems, processes, manufactures, methods or steps that currently exist or are later developed to perform functions substantially the same as the corresponding embodiments described herein or to achieve substantially the same results may be utilized according to the present disclosure. Thus, the appended claims are intended to include such systems, processes, methods or steps within their scope. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments described in the accompanying drawings may also be combined with each other. Further, the embodiments mentioned in the first part of the description may be combined with examples of the second part of the description involving Figures 1 to 9.

Claims

1. A modular system (98) for a drug delivery device having electronics, the modular system comprising: - a mechanical module (100), comprising: - Distal (D) and Proximal (P), and - a mechanism (106) configured to set a dose of a drug and / or deliver it away from the distal end (D) of the mechanical module (100); - an electronic module, said electronic module comprising: - a detector unit (254, 264, 266) for detecting the amount of drug to be delivered or delivered; - an electronics unit (240) operatively coupled to the detector unit (254, 264, 266), and - a chassis (222) comprising an annular wall (248, 249) surrounding a compartment for the electronic unit (240), wherein the detector unit (254, 264, 266) comprises an electrical sensor and a radiation source, wherein the electronic unit (240) comprises at least two electronic parts (274, 270, 271, 272), wherein the electronic module is removably mechanically coupled or connectable to the mechanical module (100) in a proximal region of the mechanical module (100); Wherein, the electronic module comprises a substrate (242), the substrate carrying at least some electronic parts of the electronic unit (240); wherein one side of the substrate (242) is at least partially covered by a potting compound (282) in a region between at least two electronic parts of the electronic unit (240); wherein the detector unit (254, 264, 266) is arranged on a side of the substrate (242) on which at least two electronic parts (274, 270, 271, 272) are arranged; And wherein the chassis (222) separates the potting compound (282) from the electrical sensor of the detector unit (254, 264, 266) or from the radiation source of the detector unit (254, 264, 266).

2. The modular system (98) of claim 1, wherein: The detector unit (254, 264, 266) includes or is arranged on an extension feature that extends distally from the electronic module beyond the proximal end (P) of the mechanical module (100).

3. The modular system (98) of claim 2, wherein: The extension feature extends distally from the electronic module at least 3 mm beyond the proximal end (P) of the mechanical module (100).

4. The modular system (98) of claim 2, wherein: The extension feature extends distally from the electronic module at least 4 mm beyond the proximal end (P) of the mechanical module (100).

5. The modular system (98) of claim 2, wherein: The extension feature extends distally from the electronic module at least 5 mm beyond the proximal end (P) of the mechanical module (100).

6. The modular system (98) of claim 2, wherein: The mechanical module (100) comprises a proximal portion having at least one orifice, Wherein the extension feature extends into or through the aperture or extends to a position near the at least one aperture.

7. The modular system (98) of claim 6, wherein: The extension feature extends to a position within a range of 0.1 mm to 3 mm from the orifice.

8. The modular system (98) of claim 6, wherein: The proximal portion is the housing (102) or the grip button (108) or the extension sleeve of the mechanical module (100).

9. The modular system (98) of claim 2, wherein: The chassis (222) is configured to separate the potting compound (282) from the extended features of the detector unit (254, 264, 266).

10. The modular system (98) according to any one of claims 1 to 9, wherein: The mechanical module (100) comprises a movable and / or rotatable indicator element (204) coupled to the mechanism (106), wherein at least a portion of the detector unit (254, 264, 266) is arranged at the indicator element (204), and The detector unit (254, 264, 266) is configured to detect movement and / or rotation of the indicator element (204) during a dose delivery operation to determine a dose size of the drug (Dr) to be delivered or delivered by the mechanism (106).

11. The modular system (98) of claim 10, wherein: The detector unit (254, 264, 266) is configured to detect movement and / or rotation of the indicator element (204) during a dose delivery operation to determine a dose size of the drug (Dr) to be delivered by the mechanism (106) during dose setting or delivered during dose delivery.

12. The modular system (98) according to any one of claims 1 to 9, wherein: The electronic module comprises: a housing portion (221) accommodating the base frame (222), The base frame (222) is a separate component with respect to the shell part (221), or the base frame (222) and the shell part (221) are integral.

13. The modular system (98) of claim 12, wherein: The electronic module comprises: At least one adapter element (210) connected to the housing portion (221) via at least one snap-fit ​​connection (226).

14. An electronic module comprising: - a detector unit (254, 264, 266) for detecting the amount of drug to be delivered or delivered; as well as - an electronics unit (240) operatively coupled to the detector unit (254, 264, 266), - a chassis (222) comprising an annular wall (248, 249) surrounding a compartment for the electronic unit (240), wherein the detector unit (254, 264, 266) comprises a radiation source and an electrical sensor, wherein the electronic unit (240) comprises at least two electronic parts (274, 270, 271, 272), wherein the electronic module is configured to be removably mechanically coupled to the mechanical module (100) at a proximal region of the mechanical module (100), Wherein, the electronic module comprises a substrate (242), the substrate carrying at least some electronic parts of the electronic unit (240); wherein one side of the substrate (242) is at least partially covered by a potting compound (282); And wherein the chassis (222) separates the potting compound (282) from the electrical sensor of the detector unit (254, 264, 266) or from the radiation source of the detector unit (254, 264, 266).

15. The electronic module according to claim 14, comprising: at least one component surface (SF1) on a circuit carrier, the circuit carrier being formed by the substrate (242); a first electrically operable component of an electrical circuit system, said electrical circuit system being arranged on said at least one component surface (SF1); At least one side wall of the base frame (222), wherein the side wall is arranged adjacent to the circuit carrier; wherein the side wall and the circuit carrier cooperate to define a receiving space for a filling layer (620, 720, 820, 920) formed by the potting compound (282), and The filling layer (620, 720, 820, 920) contacts at least one, at least two or all of the side wall, the first electrically operable component or the component surface (SF1).

16. An electronic module according to claim 15, comprising a second electrically operable part of the circuit system, wherein: The first electrically operable component has a first construction height (H6c) measured from the component surface (SF1), wherein the second electrically operable component has a second construction height (H6d) measured from the component surface (SF1), wherein the second construction height (H6d) is greater than the first construction height (H6c), wherein the first electrically operable component is embedded in the filling layer up to the first construction height (H6c), and The second electrically operable component is embedded in the filling layer at least up to the second construction height (H6d) or up to a third height, wherein the third height is greater than the first construction height (H6c) but less than the second construction height (H6d).

17. The electronic module according to claim 15 or 16, in, The filling layer comprises a first profile in a first cross section perpendicular to the component surface (SF1), wherein in the first cross section the thickness of the filling layer in two peripheral regions is smaller than in a central region, and Therein, the first electrically operable component is arranged in one of the peripheral areas.

18. The electronic module according to claim 17, wherein: The fill layer comprises a second profile in a second cross section, the second cross section being perpendicular to the component surface and perpendicular to the first cross section, and In the second cross section, the thickness of the filling layer in the two peripheral regions is smaller than that in the central region.

19. The electronic module according to claim 16, wherein: The filling layer comprises a first profile in a first section perpendicular to the component surface (SF1), wherein, in the first cross section, the thickness of the filling layer increases from a first thickness in a first peripheral region via a second thickness in a central region to a third thickness in a second peripheral region, and Wherein, the first electrically operable component is arranged in the first peripheral area of ​​the peripheral areas.

20. The electronic module according to claim 19, wherein: the filling layer comprises a second profile in a second cross section, the second cross section being perpendicular to the component surface and perpendicular to the first cross section, Therein, in the second cross section, the thickness of the filling layer is constant or deviates only by at most two percent from the maximum filling height of the filling layer.

21. The electronic module of claim 16, comprising a second electrically operable component of the circuit system, wherein: The first electrically operable component has a first construction height (H6c) measured from the component surface, wherein the second electrically operable component has a second construction height (H6d) measured from the component surface, wherein the second construction height (H6d) is greater than the first construction height (H6c), wherein the first electrically operable component and / or the second electrically operable component is embedded in the filling layer up to the first construction height (H6c), and Therein, the second electrically operable component is sealed by a combination of the filling layer and at least one additional sealing element different from the filling layer.

22. The electronic module according to claim 21, wherein: The additional sealing element is a coating (710), wherein the second electrically operable component comprises the coating (710) on the surface furthest from the circuit carrier and at least partially also on its side surfaces, Wherein, the coating (710) extends to the filling layer and / or contacts the filling layer.

23. The electronic module according to claim 21, wherein: The further sealing element is an integral cover (810) for the second electrically operable component integral with the module part, And wherein the second electrically operable component is sealed by the integral cover (810) and the filling layer in which the integral cover (810) is at least partially embedded.

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