Electronic add-on module comprising a conductive element providing a switch

Abstract

The present disclosure generally relates to an electronic system, such as an electronic add-on module (100), configured to be releasably attached to a drug delivery device (1). The module comprises a first part (101) configured to be releasably attached to a dose dial grip (12) of a drug delivery device and a second part (102) coupled to the first part allowing relative axial movement with respect to the first part, wherein the second part is configured to exert pressure on a dose button (11) of said drug delivery device when moved axially along a first longitudinal axis, and an electrical power source arranged inside said electronic add-on module and electrically connected to a circuit board assembly. The circuit board assembly is arranged inside said electronic add-on module (100). Further, the electronic add-on module comprises at least two first electrically conductive elements (115), wherein the relative axial movement of said second part with respect to said first part provides an electrical connection between said at least two first electrically conductive elements, and wherein the circuit board assembly or an electronic component (111; 112) connected to said circuit board assembly is activated due to said electrical connection.

Description

[0001] This disclosure generally relates to an electronic system, such as an electronic add-on module, configured to be releasably attached to a drug delivery device.

[0002] Electronic add-on modules for releasable attachment to drug delivery devices are generally known and are often used to measure relevant data regarding dose setting and / or dose distribution.

[0003] WO 2016 / 198516 A1 illustrates an exemplary data collection device for attachment to an injection device. Further injection monitoring modules are known from WO 2020 / 217094 A1, WO 2021 / 140352 A1, WO 2021 / 214275 A1, US 2021 / 008287 A1, and US 2020 / 061299 A1. These modules typically comprise two parts, one of which is attached and rotatably constrained to the dose dial grip of the injection device to measure, for example, relative rotational movement between the module and / or components of the injection device.

[0004] For example, WO 2016 / 198516 A1 discloses the use of a sensing arrangement within a data collection device, comprising optical, magnetic, capacitive, or mechanical sensors configured to detect rotational movement between a first and a second portion of the data collection device. The first portion is configured to attach to a dosing knob of an injection device, and the second portion is coupled to the first portion and is axially movable relative to the first portion. For example, during drug dosing, the first portion rotates with the dosing knob of the injection device, wherein the angle of rotation measured by the sensing arrangement allows determination of the amount of drug dispensed.

[0005] WO 2021 / 214 275 A1 discloses an electronic module having a power source, a sensor arrangement, and a processor. To limit power consumption, the module may further include a switch configured to be operated by means of a deflectable switching arm. The switch can activate or deactivate the power-consuming components; that is, the switch can be configured to activate the module's processor from a power-free sleep mode.

[0006] Similarly, WO 2021 / 140 352 A1 discloses an injection monitoring module with an injection detection switch configured to be activated by translational movement between a proximal activation button and a hollow body. When activated, the switch can send a signal to the integrated data processing and control unit of the injection monitoring module to initiate injection.

[0007] However, known switches used in electronic add-on modules have the following drawbacks: typically, even the slightest axial movement can cause undesirable energization of the switch, and thus undesirable power supply to electronic components. Additionally, switches typically comprise mechanical switching elements, which are subject to unpredictable wear during use, thereby compromising the reliable energization of the switch.

[0008] Therefore, the purpose of this disclosure is to provide an electronic add-on module that allows for improved excitation of a switch configured to power electronic components of the electronic add-on module.

[0009] This objective is achieved by the electronic add-on module according to claim 1. Further, this objective is achieved by the component according to claim 14.

[0010] An electronic add-on module for releasable attachment to a drug delivery device includes a first part, a second part, a power source, and a circuit board assembly. Further, the electronic add-on module includes conductive elements configured to activate the circuit board assembly or electronic components connected to the circuit board assembly when electrically connected between the conductive elements.

[0011] Drug delivery devices for attaching electronic add-on modules may include at least a dose button, a dose selector grip, a drive sleeve, and a plunger. Although not required in the context of this disclosure, the drug delivery device may optionally include additional components that interact with the dose button, dose selector grip, drive sleeve, plunger, and / or housing, such as a digital sleeve, clutch, cap, needle, spring, lead screw, etc., as disclosed, for example, in WO 2004 / 078239 A1. However, this disclosure is not limited to the drug delivery device of WO 2004 / 078239 A1. Other suitable drug delivery devices for use are described, for example, in EP 1 570 876 B1, EP 2 814 547 B1, EP 2 890 434 B1, WO 2005 / 018721 A1, WO2009 / 132777 A1, WO 2014 / 033195 A1, US 5,693,027 A, US 6,663,602 B2, US 7,241,278 B2 or US 9,937,294 B2.

[0012] If the drug delivery device operates on a similar principle to the example in WO 2004 / 078239 A1, the components of the drug delivery device can perform the following movements during dosage setting: The housing can be stationary and can serve as a reference system for further movement of other components. The plunger can be stationary and can be guided in the housing threads. The drive sleeve can perform helical movement, i.e., a combination of axial and rotational movement, and can engage with the plunger threads. The dosage selector grip can perform rotational movement, such as helical movement. The dosage button can rotate freely but is axially constrained to the drive sleeve. For example, the dosage button can be axially held to the drive sleeve by a clutch. An optional clutch can perform helical movement and can connect a digital sleeve to the drive sleeve. An optional clutch spring can perform axial movement and can be guided in the housing splines and can click onto the clutch teeth. An optional digital sleeve can be permanently fixed to the selector grip, can perform helical movement, and can be guided in the housing threads. The optional final dose nut can perform helical movement on the drive sleeve track of the drive sleeve and can be rotatably constrained to the housing. Therefore, the final dose nut can perform axial movement relative to the housing and helical movement relative to the drive sleeve.

[0013] During dosing, the components of the drug delivery device can perform the following movements: The housing can remain stationary, serving as a reference system for further movement of other components. The plunger can perform helical movement and can be guided in the housing threads. The drive sleeve can perform purely axial movement and can engage with the plunger threads. The dose selector grip can perform rotational movement, such as helical movement, and can be permanently fixed to the digital sleeve. When coupled to the drive sleeve and / or clutch, the dose button can perform axial movement. An optional clutch can perform purely axial movement and can disconnect the digital sleeve from the drive sleeve. An optional clutch spring can perform purely axial movement and can be rotationally constrained to the clutch due to pressure applied to the dose button. An optional digital sleeve can perform helical movement and can be guided in the housing threads. An optional final dose nut can maintain its axial position on the drive sleeve track and can be rotationally constrained to the housing.

[0014] The first part of the electronic add-on module may define an auxiliary dose selection grip. Further, the first part is configured to be releasably attached to the dose selection grip of the drug delivery device such that, when attached to the drug delivery device, the first part follows the axial and rotational movement, such as helical movement, of the dose selection grip. Therefore, when the auxiliary dose selection grip is attached to the dose selection grip and rotates, for example, during dose setting, the dose selection grip of the drug delivery device rotates and can be driven.

[0015] Furthermore, the first portion has a first longitudinal axis. Along the first longitudinal axis, the electronic attachment module or the first portion extends from the proximal region to the distal region. When the electronic attachment module is attached to the drug delivery device, the proximal region is generally closer to the second portion, and the distal region is closer to the drug delivery device. The drug delivery device may also include a second longitudinal axis. The drug delivery device can extend from the distal region, where, for example, a needle is provided, to the proximal region, where, for example, a dosage button is provided. When the electronic attachment module is releasably attached to the drug delivery device, the first longitudinal axis and the second longitudinal axis may be collinear.

[0016] The second portion of the electronic add-on module is coupled to the first portion, thereby allowing relative axial movement parallel to the first longitudinal axis relative to the first portion. Axial movement parallel to the first longitudinal axis may include parallel movement along the first longitudinal axis. Furthermore, allowing relative axial movement between the first and second portions does not preclude any other relative movement between the portions. In one aspect, for example, the second portion may be coupled to the first portion, thereby allowing helical movement relative to the first portion, such as axial movement along the first longitudinal axis and rotational movement about the first longitudinal axis.

[0017] The second part can be held within the first part, for example, by a clip engaging in a groove. Additionally, the second part can be configured to apply pressure to the dosage button of the drug delivery device when moving axially along the first longitudinal axis. Therefore, the second part can define an auxiliary dosage button configured to abut against the dosage button of the drug delivery device when attached to and moving axially. In other words, the auxiliary dosage button may initially not be abutted against the dosage button of the drug delivery device, but can move to abutment when the user applies pressure to the auxiliary dosage button. Thus, when the user applies pressure to the auxiliary dosage button, pressure is transmitted to the dosage button of the drug delivery device. Therefore, the second part is configured to apply pressure to the dosage button of the drug delivery device in the axial direction upon attachment.

[0018] Furthermore, the electronic add-on module includes a power source, such as a battery, disposed within the electronic add-on module. In one aspect, the power source is disposed within a second portion of the electronic add-on module. The power source is electrically connected to a circuit board assembly of the electronic add-on module. The circuit board assembly may be disposed within the second portion of the electronic add-on module and may be powered by the power source. Therefore, the power source may be configured to power electrical components electrically connected to the circuit board assembly. The electronic components may be chips, processors, conductors, wireless modules, etc. The circuit board assembly may include a printed circuit board assembly. The circuit board assembly may include a substrate equipped with the electronic components. The electronic components may be electrically connected to the circuit board assembly and therefore may also be powered by the power source.

[0019] Further, the electronic add-on module includes at least two first conductive elements. One of the first conductive elements may be electrically connected, for example, to a power source, while the other first conductive element may be electrically connected to a circuit board assembly. The circuit board assembly may also be electrically connected to the power source. According to one aspect, the power source may also be electrically connected to the circuit board assembly, wherein each of the first conductive elements forms a pole of an electronic component of the circuit board assembly. Other possible arrangements for powering the circuit board assembly or the electronic component are also possible. As described above, the relative axial movement of the second portion relative to the first portion along a first longitudinal axis provides an electrical connection between the at least two first conductive elements. In other words, the relative axial movement of the second portion relative to the first portion along a first longitudinal axis creates an electrical continuity between the at least two first conductive elements. The electrical connection actuates (e.g., activates) the circuit board assembly or the electronic component connected to the circuit board assembly. In other words, the electrical connection provided when the second portion moves axially relative to the first portion allows power to be supplied to the circuit board assembly or the electronic component of the electronic add-on module.

[0020] According to one aspect, the second part may be arranged at least partially around the first part. For example, the second part may also be arranged at least partially inside the first part. However, the second part may also be arranged entirely within the first part, for example, when the second part is moved to its furthest position. The electronic add-on module may also include additional parts, for example, a third part coupled to the second part. The third part may be freely rotatable relative to the first and second parts about a first longitudinal axis, wherein the second part may be rotatably constrained to the first part. Further, the second part may be held within the first part. According to another additional or alternative aspect, the circuit board assembly may be arranged at least partially perpendicular to the direction of relative axial movement of the first and second parts, i.e., perpendicular to the first longitudinal axis. In one example, the entire circuit board assembly may be arranged perpendicular to the first longitudinal axis.

[0021] Therefore, regardless of the arrangement of, for example, the first and second parts, the provision of the electrical connection and thereby activation of the circuit board assembly or its electronic components can be considered as a switch that can be activated without mechanically stimulating the switching elements.

[0022] According to one aspect, the electronic add-on module may include a second conductive element. The second conductive element may be at least partially axially constrained to the first portion. In other words, at least a portion of the second conductive element may be axially stationary relative to the first portion. However, some regions of the second conductive element may be flexible and therefore axially movable relative to the first portion. Further, the second conductive element may allow at least two first conductive elements to be electrically connected. In other words, the electrical connection between the at least two first conductive elements may include bringing the second conductive element into contact with the first conductive element. Thus, instead of direct contact with each other, at least two first conductive elements may both contact another element (such as the second conductive element) to provide an electrical connection between the at least two first conductive elements. Providing a partially stationary other element to electrically connect the first conductive elements ensures a more reliable electrical connection between the conductive elements.

[0023] According to one aspect, the first conductive element can be at least partially axially constrained to the second portion. In other words, the first conductive element can be at least partially axially stationary relative to the second portion. For example, the conductive element can be fixed to the second portion and can be elastically deformable. Therefore, the first conductive element can move axially together with the second portion. Axially constraining the first conductive element to the second portion further ensures a more reliable electrical connection between the conductive elements.

[0024] On one hand, when the second part is in an unloaded state, without pressure applied to it to allow axial movement relative to the first part, a gap can be provided between at least two first conductive elements and the second conductive element. This gap can be an axial gap that closes due to relative axial movement between the second and first parts. Therefore, before the second part moves axially, either of the at least two first conductive elements may not be in contact, for example, not in contact with the second conductive element. Thus, the gap prevents undesirable electrical connections caused by minor accidental loads on the second part.

[0025] In one aspect, the first conductive element and / or the second conductive element can be elastically deformable. In other words, when a load is applied to the second portion to provide an electrical connection, at least one of the first or second conductive elements can elastically deform. Therefore, when the second portion is not under stress, the first and / or second conductive elements can deform back to their initial state, i.e., the state before the stress was applied. This allows, for example, an electrical connection between at least two conductive elements to be provided after the gap has closed due to axial movement of the second portion relative to the first portion, where further travel is still possible, and the conductive elements can be deformed without interrupting the electrical connection. Furthermore, once an electrical connection is established between the conductive elements, the deformation of the conductive elements can help maintain the electrical connection.

[0026] In one aspect, the second conductive element can push the first and second portions apart axially along the first longitudinal axis. The second conductive element can provide a spring force, which can push the first and second portions apart. Therefore, as long as the second portion is not subjected to force, the second conductive element can maintain the first and second portions spaced apart with a constant axial gap. Thus, applying force to the second portion and thereby causing axial movement of the second portion relative to the first portion can elastically deform the second conductive element, wherein the first conductive element can approach the second conductive element when the second conductive element deforms.

[0027] According to one aspect, the first conductive element may be provided by a pin, a spring-loaded pin (e.g., a spring needle), or a spring element. The pin may include a circular contact surface. The pin may be rigid or may have a spring element (e.g., an internal spring element), and therefore may be spring-loaded. The elastic deformation of the aforementioned first conductive element can be achieved by the internal spring element. For example, the pin may be a spring needle. A spring-loaded pin can allow controlled, purely axial deformation under load, and simultaneously ensures reliable electrical connection because the deformation can have a constant contact surface. However, the first conductive element may also be formed by a spring element. For example, the first conductive element may be formed by a spring clip. The spring element may, for example, have two spring legs spaced apart from each other, wherein the spring legs can contact each other when they move toward each other under load.

[0028] In one aspect, the second conductive element can be provided by a spring washer or a rigid element (e.g., a rigid ring element). The spring washer can elastically deform when subjected to force due to axial movement of the second portion relative to the first portion. The spring washer can elastically deform due to the load applied by the first conductive element. The spring washer can provide at least two axial gaps between the first and second conductive elements. The spring washer can have a waveform, for example, similar to that of DIN 137 Form B. In other words, the waveform can be close to this shape but still different. For example, when subjected to force due to axial movement of the second portion, the spring washer can include at least three peaks in the waveform, i.e., at least three contact points. This can improve the stability of the spring washer and can prevent the second portion from tilting. Furthermore, the spring washer can have two free ends. In other words, the spring washer can be split. Therefore, the spring washer may not, for example, form a complete ring. However, the free ends can also be adjacent. Providing a spring washer with two free ends allows for easy formation of the spring washer in terms of spring force and flexibility. The spring washer can also have a flat shape, or it can present a wave-like shape when inserted into the electronic add-on module. The spring washer can be a disc spring. The rigid element can be a plate-shaped element. The rigid element can have a ring shape. The rigid element can also be a ring segment. The first conductive element and the second conductive element can include the same or different materials.

[0029] In one aspect, the electronic add-on module may include more than two first conductive elements. For example, the electronic add-on module may include four first conductive elements, each offset by 90°. Providing more than two first conductive elements allows for reliable electrical connection during off-axis forces on the second part. In other words, even if the second part is not centered under force, allowing it to tilt slightly, the multiple first conductive elements still ensure electrical connection of at least two of the conductive elements.

[0030] According to one aspect, when the second part is in an unstressed state and the second conductive element is provided by the spring washer, the spring washer can partially abut against the first and second parts without providing an electrical connection between the first and second conductive elements. The spring washer can be disposed inside the first part. The spring washer can be secured to the second part by a clamping element. Therefore, the spring washer can have two functions: firstly, the spring washer can allow the formation of an electrical connection between the first conductive elements, and secondly, when the second part is in an unstressed state, the spring washer can push the first and second parts apart. Thus, the spring washer can ensure that the electronic attachment module returns to its unstressed initial state after the stress has ceased (i.e., when the user does not apply any further pressure to the second part). The spring washer can therefore reduce the number of required components by fulfilling two functions.

[0031] In one aspect, the first portion may include a protrusion disposed on an inner surface of the first portion. The protrusion may be circumferential. A second conductive element may be abutted on the protrusion. For example, when the second conductive element may be a rigid ring, the rigid ring may rest on the protrusion. A second conductive element in the form of a spring washer may be abutted on the protrusion to space the first portion and the second portion apart. Compared to the plate inside the first portion, the protrusion may allow components of the second portion to be not separated from the dosage button of the drug delivery device.

[0032] According to one aspect, the electronic components connected to the circuit board assembly and energized during electrical connection can be a sensor arrangement. This ensures that sensor detection (e.g., detection of an encoder pattern) is activated when the second part moves axially, particularly when the axial movement of the second part causes dose distribution. However, other components (such as displays) can also be energized. Several electronic components can also be energized. The sensor arrangement can be an optical sensor arrangement. However, the sensor arrangement can also be a magnetic sensor arrangement, a capacitive sensor arrangement, or a mechanical sensor arrangement.

[0033] In one aspect, the second part can move axially relative to the first part by a distance greater than the gap. This axial movement greater than the gap distance can be termed overtravel. In other words, the relative axial movement of the second part relative to the first part can be greater than the axial gap in the unloaded state. Therefore, overtravel may exist after the gap is closed. Thus, after providing electrical connection between at least two first conductive elements, the second part can move further axially relative to the first part. Therefore, after activating the circuit board assembly or the electronic components connected to the circuit board assembly, the second part can move further axially. This further axial movement of the second part can induce dose distribution. Therefore, overtravel can ensure that the activation or stimulation of the circuit board assembly or electronic components occurs before dose distribution can begin.

[0034] According to one aspect, this objective can also be achieved by a component comprising a drug delivery device and an electronic add-on module according to the foregoing aspect. The electronic add-on module is configured for releasable attachment to the drug delivery device. Further, the drug delivery device includes at least a housing having a container configured to receive a drug or a cartridge filled with a drug. Further, the drug delivery device includes a dosage setting unit and a dosage delivery unit.

[0035] The dose setting unit includes a dose selection grip and a dose button. The dose selection grip is at least rotatably (e.g., helically) movable relative to the housing during dose setting, and the dose button is at least axially movable relative to the housing to induce dose dispensing. The dose button may have a T-shape, having a proximal surface that acts as a pressure surface and a central axis extending distally. The dose delivery unit includes a plunger that is at least axially (e.g., helically) movable relative to the housing during dose dispensing.

[0036] Furthermore, the electrical connection between the at least two first conductive elements is provided prior to the start of dose dispensing. Therefore, and as already mentioned above regarding the electronic add-on module, for example, the sensor arrangement can be activated before dose dispensing begins.

[0037] In one aspect, when the second part applies pressure to the dose button of the drug delivery device in the axial direction to move the dose button axially relative to the housing, both the first and second conductive elements may not be in contact with the dose button. Therefore, in other words, it is not the conductive elements that apply pressure to the dose button. However, and as stated above, the second part may overtravel and thus apply pressure to the dose button after the electrical connection is established.

[0038] Therefore, the electronic add-on module and the electronic add-on module with the drug delivery component allow for improved switching that causes excitation of the circuit board assembly or the electronic components electrically connected thereto.

[0039] The electronic add-in module can be an electronic dosing recording system for determining, storing, and / or transmitting data that at least indicates the status of a drug delivery device or its use. For example, the system can detect whether the drug delivery device is switching between a dose setting mode and a dose dispensing mode, and vice versa. Alternatively, the system can detect whether a dose has been set and / or dispensed. Further, the system can detect the amount of the selected dose and / or the amount of the dispensed dose. Preferably, the electronic add-in module is configured to switch from a first state with lower energy consumption to a second state with higher energy consumption. This can be achieved by operating the electronic add-in module, particularly by providing electrical connections between conductive elements. The first state can be a sleep mode, and the second mode can be a detection and / or communication mode. Alternatively, the electronic control unit can issue commands, such as signals, to another unit of the electronic dosing recording system, causing that unit to be turned on or become operable.

[0040] The electronic add-on module may further include a communication unit for communicating with another device, such as a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. Preferably, the electronic add-on module includes an RF, Wi-Fi, and / or Bluetooth unit as the communication unit. The communication unit can be configured as a communication interface between the electronic add-on module and external devices (e.g., other electronic devices, such as mobile phones, personal computers, laptops, etc.). For example, dose data can be transmitted from the communication unit to the external device. The dose data can be used for dose recording or dose history established in the external device.

[0041] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. 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 pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0042] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of 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 considered.

[0043] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing of the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during the dispensing of the components into a human or animal body.

[0044] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical barriers. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index 15.

[0045] Examples of APIs used to treat and / or prevent 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-1 (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 of the above. As used herein, the terms “analyte” and “derivative” refer 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) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, 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 a naturally occurring peptide may have been missing and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0046] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0047] Examples of insulin derivatives include, for instance, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human 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; and B30-N-myristoyl-ThrB29. LysB30 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 (Degludec insulin, Tresiba®); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0048] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilamide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, tasglutide, abiglutide (Syncria®), duraglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, and GLP-1. Eligen, 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, Telboride (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0049] Examples of oligonucleotides include, for example, mirtamicin sodium (Kynamro®), a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia, or RG012 used to treat Alport syndrome.

[0050] Examples of DPP4 inhibitors are liraliptin, vedagliptin, sitagliptin, degliptin, saxagliptin, and berberine.

[0051] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0052] Examples of polysaccharides include glucosamine, 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-mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), a sodium hyaluronate.

[0053] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. 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).

[0054] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may contain a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this 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, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and immunoglobulin single variable domains. Further examples of antigen-binding antibody fragments are known in the art.

[0055] The term "immunoglobulin single variable domain" (ISV) is used interchangeably with "single variable domain" and defines an immunoglobulin molecule in which an antigen-binding site is located on and formed by a single immunoglobulin domain. Therefore, an immunoglobulin single variable domain can specifically bind to an antigenic epitope without pairing with another immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Therefore, the antigen-binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0056] Immunoglobulin single variable domains (ISVs) can be heavy chain ISVs, such as VH (derived from conventional four-chain antibodies) or VHH (derived from heavy chain antibodies), including camel-derived VHH or humanized VHH. For example, an immunoglobulin single variable domain can be a (single) domain antibody, "dAb" or dAb or Nanobody® ISV (such as VHH, including humanized VHH or camel-derived VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx NV; other single variable domains, or any suitable fragment thereof.]

[0057] The “VHH domain,” also known as VHH, VHH antibody fragment, and VHH antibody, was initially described as a variable domain of a “heavy chain antibody” (i.e., “antibodies devoid of light chains”; Hamers-Casterman et al., 1993, Nature, 363: 446-448). The term “VHH domain” was chosen to distinguish these variable domains from the heavy chain variable domains (referred to herein as “VH domains”) present in conventional 4-chain antibodies and the light chain variable domains (referred herein as “VL domains”) present in conventional 4-chain antibodies. For a further description of VHH, see Muyldermans’ 2001 review article (Reviews in Molecular Biotechnology, 74: 277-302).

[0058] For the terms “dAb” and “domain antibody”, see, for example, Ward et al. 1989 (Nature 341:544), Holt et al. 2003 (Trends Biotechnol. 21:484); and WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of this invention because they are not of mammalian origin, single variable domains can be derived from certain shark species (e.g., the so-called “IgNAR domain,” see, for example, WO 2005 / 18629).

[0059] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0060] Examples of antibodies are anti-PCSK-9 mAb (e.g., aliximumab), anti-IL-6 mAb (e.g., thalidomumab), and anti-IL-4 mAb (e.g., dupilumab).

[0061] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0062] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope of the invention, and the invention covers such modifications and any.

[0063] Example drug delivery devices may involve needle-based injection systems, 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 categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0064] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0065] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

[0066] As used herein, the terms “axial,” “radial,” or “circumferential” may be used relative to a first longitudinal axis (e.g., an axis extending through the proximal and distal ends of the cartridge) of the electronic add-on module, the first part, the second part, the drug delivery device, the cartridge, the housing, the cartridge holder, or the drug delivery device and the electronic add-on module assembly.

[0067] The term "distal" herein is used to specify a direction, end, or surface that is arranged or is to be arranged facing or toward the dispensing end of the electronic add-in module or drug delivery device or its components and / or away from, or to be arranged away from, or away from the proximal end. Conversely, the term "proximal" is used to specify a direction, end, or surface that is arranged or is to be arranged away from or away from the dispensing end and / or distal end of the electronic add-in module or drug delivery device or its components. The distal end can be the end closest to the dispensing end and / or furthest from the proximal end, and the proximal end can be the end furthest from the dispensing end. The proximal surface can be away from the distal end and / or face the proximal end. The distal surface can face the distal end and / or be away from the proximal end. For example, the dispensing end can be the tip of a needle at which a needle unit is mounted or to be mounted onto the device. Similarly, distal elements are positioned closer to the dispensing end than to the proximal end compared to proximal elements. Furthermore, when considering the electronic add-on module in isolation, the term "distal" can be used with respect to the more distal end of the electronic add-on module, which, when attached to a drug delivery device, is located closer to the dispensing end of the drug delivery device, and the term "proximal" can be used with respect to the proximal end of the electronic add-on module, which, when attached to a drug delivery device, is located further away from the dispensing end of the drug delivery device.

[0068] In the following description, non-limiting examples of the electronic add-on module, the drug delivery device, and components thereof are described in more detail with reference to the accompanying drawings, in which:

[0069] Figure 1 A drug delivery device is shown;

[0070] Figure 2 A cross-sectional view of a first example of an electronic add-on module in an unstressed state is shown;

[0071] Figure 3 A cross-sectional view is shown of the electronic add-on module according to the first example in a state where the first conductive element provides an electrical connection;

[0072] Figure 4 A cross-sectional view of the electronic add-on module according to the first example in an overtravel state is shown;

[0073] Figure 5 A perspective bottom view of the electronic add-on module according to the first example is shown;

[0074] Figure 6 An exploded view of the electronic add-on module according to the first example is shown;

[0075] Figure 7 An exploded view of the electronic add-on module according to the second example is shown;

[0076] Figure 8A cross-sectional view is shown of the electronic add-on module according to the second example in a state where the first conductive element provides an electrical connection; and

[0077] Figure 9 A cross-sectional view of the electronic add-on module according to the second example in overtravel state is shown.

[0078] In the accompanying drawings, identical elements and components, as well as identical elements and components in different examples or embodiments (i.e., elements and components that function exactly the same or are provided for the same purpose but belong to different examples), are given the same reference numerals.

[0079] Figure 1 An exploded view of an exemplary drug delivery device 1 is shown. The drug delivery device 1 is a pen-type syringe comprising a housing 10 in which a drive mechanism for dose setting and dispensing is disposed. The drug delivery device 1 extends along a second longitudinal axis Y from a distal point in a proximal direction P or from a proximal point in a distal direction D. To set the dose for delivery, a user can rotate or select a dose selection grip 12 relative to the housing 10, wherein the dose selection grip 12 is disposed at the distal end of the housing 10. During dose setting, the dose selection grip 12 can perform helical movement, i.e., a combination of axial and rotational movement, or it can perform purely rotational movement.

[0080] The drive mechanism of the drug delivery device 1 may include a plunger movable during dose setting and / or dose dispensing, a drive sleeve 13, a clutch, a clutch spring, a digital sleeve, a final dose nut, etc. Although not all of these components are shown in detail, the drive mechanisms disclosed, for example, in EP 1 570 876, EP 2 814 547, US 9,937,294 B2, or WO 2004 / 078239 A1 represent suitable drive mechanisms for this disclosure.

[0081] Once the dosage has been set using the dose selector grip 12, the user can press the dose button 11, located proximally at the drug delivery device 1 in the distal direction D, to dispense the dose. When the dose button 11 is pressed, the user applies a force directed towards the proximal end of the drug delivery device 1, which causes the dose button 11 to move in the distal direction of the pen and parallel to the second longitudinal axis Y. This axial movement of the dose button 11 is achieved, for example, by disengaging the drive mechanism from the digital sleeve, wherein the dose selector grip 12 is engaged with the corresponding component of the drug delivery device 1 to perform rotational movement during dose delivery, regardless of which component of the drug delivery device 1 performs rotational movement during dose delivery.

[0082] This rotational movement of the dose selection grip 12 during dose delivery can be used to determine, for example, the actual dose delivered by means of the electronic add-on module 100, as shown in various examples in the accompanying drawings and described below.

[0083] In addition to the dose selection grip 12 and the dose button 11 Figure 1 The exemplary drug delivery device 1 shown also includes an optional dosing window 14, a container 15, and a needle 16. The set dose can be displayed via the dosing window 14. The container 15 can be directly filled with a drug, such as insulin, or can be configured to receive a cartridge and thus act as a cartridge holder. The needle 16 can be attached to the container or housing. During dosing, the drug is dispensed through the needle 16. The needle 16 can be protected by an inner needle cap 17. Alternatively, the needle 16 can be protected by an outer needle cap 18 or another cap 19.

[0084] In order to functionally attach the electronic add-on module 100 to the drug delivery device 1, i.e., attach and make it usable, the drug delivery device 1 may be adapted to the electronic add-on module 100, or conversely, the electronic add-on module 100 may be adapted to the drug delivery device 1. Nevertheless, the drug delivery device 1 and the electronic add-on module 100 may have different examples, wherein further description of the drug delivery device 1 essentially relates to a dose button 11, a dose selector grip 12, and a drive sleeve 13.

[0085] Figure 2 A corresponding first example of the electronic add-on module 100 is shown. The electronic add-on module 100 includes a first portion 101, a second portion 102, and a third portion 103 arranged along a first longitudinal axis X. The electronic add-on module 100 includes a coupling element 104 for releasable attachment to a drug delivery device 1. When the electronic add-on module 100 is coupled to the drug delivery device 1, the first longitudinal axis X and the second longitudinal axis Y may be collinear. The coupling element 104 of the electronic add-on module 100 may be adapted to a component of the drug delivery device for attachment, such as an adaptation to the dose selection grip 12 of the drug delivery device 1. Conversely, the drug delivery device 1 may also be adapted to the electronic add-on module 100, thereby allowing releasable attachment of the electronic add-on module 100.

[0086] When the electronic add-on module 100 is attached to the drug delivery device 1, the user can rotate the first portion 101 to set the dose for delivery. The first portion 101 may provide an auxiliary dose-selection grip that allows controlled rotational movement of the first portion 101. Further, pressure may be applied, for example, by the user's thumb to the proximal surface 105 to move the second portion 102 relative to the first portion 101 along a first longitudinal axis X. Here, the proximal surface 105 is part of a third portion 103 of the electronic add-on module 100, wherein the third portion 103 is coupled to the second portion 102 via a plug 106, and wherein the third portion 103 is freely rotatable about the plug 106. However, for example, if the electronic add-on module 100 comprises only two portions, the proximal surface 105 may also be part of the second portion 102.

[0087] If the proximal surface 105 is not centered under force, the third portion 103 can be tilted relative to the first longitudinal axis X, such that the third portion protrusion 107 contacts the spare friction surface 108. Preferably, the material pairing of the third portion protrusion 107 and the spare friction surface 108 is selected such that only low friction occurs between the two parts. In other words, when the second portion 102 moves axially due to the load applied to the proximal surface 105, the friction between the third portion protrusion 107 and the spare friction surface 108 can still allow relative rotation between the third portion 103 and the second portion 102.

[0088] A power source (here, battery 109) is arranged in the second part 102. Additionally, the second part 102 includes a circuit board assembly having a substrate 110. The power source is electrically connected to the circuit board assembly. Various electronic components 111 (such as sensor arrangement 112) are arranged on the substrate 110. The sensor arrangement 112 may be, for example, an optical sensor arrangement electrically connected to the circuit board assembly.

[0089] The components of the second part 102 are arranged inside the housing of the second part 102, wherein the housing is formed in particular by an abutment surface 113 configured to apply pressure to the dosage button 11 of the drug delivery device 1 to cause axial movement of the dosage button 11 to induce dose dispensing. The abutment surface 113 includes a protrusion 114 that provides a thrust bearing when the protrusion 114 contacts the dosage button 11 (e.g., a recess of the dosage button 11). The abutment surface 113 may be at least partially transparent, such that the sensor arrangement 112 can, for example, detect movement of the dosage button of the drug delivery device. The sensor arrangement 112 can detect relative rotational movement of the second part 102 and, for example, an encoder pattern arranged on the dosage button 11 of the drug delivery device 1.

[0090] Furthermore, the electronic add-on module 100 includes a first conductive element 115. Here, the first conductive element 115 is an elastically deformable spring-loaded pin, as in... Figure 4 As can be seen, among them, Figure 4 In this configuration, the pin is compressed, and the spring element (not shown) inside the pin elastically deforms. Additionally, the electronic add-on module 100 includes a second conductive element 116. Here, the second conductive element 116 is a spring washer with a wave pattern.

[0091] The second conductive element 116 abuts against a protrusion 117 disposed on the inner lateral surface 118 of the first portion 101 in the distal direction D, and abuts against an adjacent surface 113 in the proximal direction P, thereby pushing the first portion 101 and the second portion 102 apart in the axial direction along the first longitudinal axis X. An axial gap 119 is formed by the axial separation of the first portion 101 and the second portion 102. Here, the gap 119 is formed between the farthest end of the first conductive element 115 and a corresponding segment of the second conductive element 116, which is to be contacted by the first conductive element when the first conductive element 115 moves axially in the distal direction D.

[0092] When the second portion 102 moves axially in the distal direction D relative to the first portion 101, the spline 120 of the second portion 102 can slide within the groove 121 arranged on the inner surface 118 of the first portion 101. Figures 2 to 6 In the example shown, the connection between spline 120 and groove 121 between the second part 102 and the first part 101 allows only limited relative axial movement. However, other connections between the first part 101 and the second part 102 may be possible.

[0093] Furthermore, such as Figures 2 to 6 As shown, the spline 120 and groove 121 connection limits the maximum axial movement between the first part 101 and the second part. However, the maximum axial travel can also be limited by other means.

[0094] and Figure 2 Compared to the initial state shown, Figure 3 and Figure 4 The diagram shows two different states in which the second part 102 has moved axially relative to the first part 101 along the first longitudinal axis X. Figure 3 The diagram shows the state in which the first conductive element 115 of the electronic add-on module 100 contacts the second conductive element 116. Therefore, with... Figure 2 compared to, Figure 3 The second part 102 moves axially relative to the first part 101 by a distance corresponding to the gap 119. Further and with... Figure 3 compared to, Figure 4This illustrates a state where the second portion 102 has undergone further axial movement relative to the first portion 101. In other words, the relative axial movement between the second portion 102 and the first portion 101 is greater than the axial clearance 119. Therefore, Figure 4 The overtravel after gap 119 is closed is shown. Therefore, with Figure 2 and Figure 3 Compared to the state shown, the first conductive element 115 is compressed and therefore shorter. Figure 3 and Figure 4 In the comparison, the adjacent surface 113 moves further along the distal direction D, such that after providing an electrical connection between the first conductive elements 115, the second portion 102 moves further distally, and thus pressure can be applied to the dosage button of the drug delivery device after the circuit board assembly or the electronic component 111 or sensor arrangement 112 electrically connected to the circuit board assembly is energized.

[0095] exist Figure 5 In the image below, an electronic add-on module 100 is shown, in which two first conductive elements 115, which can contact the second conductive element 116 when the second portion 102 moves axially relative to the first portion 101, are visible as part of the electronic add-on module 100. Figure 5 The spring washer is secured to the second part 102 by clamping element 122. Clamping element 122 is provided by rods, and the spring washer is pushed under these rods to secure the second conductive element 116 to the second part 102.

[0096] Figure 6 As shown in Figures 2 to 5 An exploded view of the electronic add-on module 100 is shown. The spring washer is shown here with two free ends 123, which can deform relative to each other and allow the spring washer to be secured to the clamping element 122. However, as mentioned above, the spring washer does not necessarily have two free ends 123.

[0097] Figures 7 to 9 Another example of the additional electronic module 100 is shown, which is associated with... Figures 2 to 6 The difference in the example shown is the use of additional conductive elements 115 and 116.

[0098] Figure 7 An exploded view of the electronic add-on module 100, including corresponding first part 101, second part 102, and third part 103, is depicted. Since essentially only conductive elements 115 and 116 are connected to... Figures 2 to 6 Unlike the previous example shown, only these conductive elements 115 and 116 will be discussed below.

[0099] The electronic add-on module 100 includes three first conductive elements 115, each offset by 120°. The first conductive elements 115 are provided by spring clips. When these spring clips deform as the second portion 102 moves axially relative to the first portion 101, the first spring leg 124 and the second spring leg 125 of the spring clips are driven into contact.

[0100] Therefore, when the second spring leg 125 comes into contact, for example, with the second conductive element 116 shown herein as a rigid ring, the second spring leg 125 can begin to deform toward the first spring leg 124. Figure 8 The diagram shows a contact point between a first conductive element 115 and a second conductive element 116 that provides an electrical connection between the first conductive element 115 and the second conductive element 116.

[0101] like Figure 9 As shown, further axial movement of the second portion 102 relative to the first portion 101 causes the second spring leg 125 to abut against the first spring leg 124. This abutment prevents further deformation of the spring clip, thus preventing the first conductive element 115 from deforming beyond its elastic limit. Additionally, this abutment limits the amount of overtravel.

[0102] Furthermore, a ring element, serving as the second conductive element 116, is arranged on the protrusion 117 of the first portion 101, such as... Figure 8 and Figure 9 As shown. Therefore, the ring element will not move or deform relative to the first portion 101. However, when the second portion 102 moves axially in the distal direction D relative to the first portion 101, the first conductive element 115 contacts the second elastic conductive element 116.

[0103] In summary, the electronic add-on module 100 allows for the activation and thus switching of electronic components based solely on the relative axial movement of the first portion 101 and the second portion 102, through the provision of an electrical connection between conductive elements. Once the electronic add-on module is attached to the drug delivery device, the user can apply force to the proximal surface 105, thereby causing the second portion 102 to move axially relative to the first portion 101 and activating, for example, a sensor arrangement. The activation of the sensor arrangement can then allow the detection of the amount of drug dispensed when the dosage button moves axially, for example, due to pressure applied to the proximal surface of the electronic add-on module.

[0104] Figure Labels

[0105] 1. Drug delivery device

[0106] 10 housing

[0107] 11 Dosage Buttons

[0108] 12-dosage selection grip

[0109] 13 drive sleeve

[0110] 14 Display Windows

[0111] 15 containers

[0112] 16 stitches

[0113] 17 Inner Pin Cap

[0114] 18 outer pin cap

[0115] 19 hats

[0116] 100 Electronic Add-on Module

[0117] 101 Part 1

[0118] Part 2 of 102

[0119] Part 3 of 103

[0120] 104 Connecting Components

[0121] 105 proximal surface

[0122] 106 plugs

[0123] 107 Part 3 Extended Section

[0124] 108 spare friction surfaces

[0125] 109 battery

[0126] 110 (PCB assembly) substrate

[0127] 111 Electronic Components

[0128] 112 sensor layout

[0129] 113 Adjacent Surfaces

[0130] 114 protrusions

[0131] 115 First conductive element (spring loading pin)

[0132] 116 Second conductive element (spring washer)

[0133] 117 Extending part

[0134] 118 inner side surface

[0135] 119 gap

[0136] 120 splines

[0137] 121 groove

[0138] 122 clamping elements

[0139] 123 Free end (spring washer)

[0140] 124 First Spring Leg

[0141] 125 Second Spring Leg

[0142] D distal direction

[0143] P proximal direction

[0144] X (first part) first longitudinal axis

[0145] Y (the second longitudinal axis of the drug delivery device).

Claims

1. An electronic add-on module (100) for releasably attaching to a drug delivery device (1). The electronic add-on module includes: • A first part (101) is configured to be releasably attached to a dose selector grip (12) of the drug delivery device, such that when attached to the drug delivery device, the first part follows the axial and rotational movement of the dose selector grip, wherein the first part has a first longitudinal axis (X). • A second part (102), which is coupled to the first part, thereby allowing relative axial movement parallel to the first longitudinal axis relative to the first part, wherein the second part is configured to apply pressure to the dosage button (11) of the drug delivery device when moving axially along the first longitudinal axis. • An electrical power source, which is located inside the electronic add-on module and electrically connected to the circuit board assembly. • The circuit board assembly is located inside the electronic add-on module. The electronic add-on module is characterized in that it further includes at least two first conductive elements (115), wherein the relative axial movement of the second portion relative to the first portion along the first longitudinal axis provides an electrical connection between the at least two first conductive elements, and wherein the circuit board assembly or electronic components (111; 112) connected to the circuit board assembly are energized due to the electrical connection.

2. The electronic add-on module (100) according to claim 1, wherein, The electronic add-on module includes a second conductive element (116) which is at least partially axially constrained to the first portion (101), and wherein the second conductive element allows electrical connection between the at least two first conductive elements (115).

3. The electronic add-on module (100) according to claim 1 or 2, wherein, These first conductive elements (115) are at least partially axially constrained to the second portion (102).

4. The electronic add-on module (100) according to claim 2 or 3, wherein, When the second part (102) is in an unstressed state where no pressure is applied to the second part to allow the second part to move axially relative to the first part, a gap (119) is provided between the at least two first conductive elements (115) and the second conductive element (116).

5. The electronic add-on module (100) according to any one of claims 1 to 4, wherein, These first conductive elements (115) and / or the second conductive element (116) are elastically deformable.

6. The electronic add-on module (100) according to any one of claims 5, wherein, The second conductive element (116) pushes the first part (101) and the second part (102) apart in the axial direction along the first longitudinal axis (X).

7. The electronic add-on module (100) according to any one of claims 1 to 6, wherein, These first conductive elements (115) are provided by pins, by spring-loaded pins, such as spring needles or by spring elements.

8. The electronic add-on module (100) according to any one of claims 2 to 7, wherein, The second conductive element (116) is provided by a spring washer or by a rigid element, such as a rigid ring element.

9. The electronic add-on module (100) according to any one of claims 1 to 8, wherein, The electronic add-on module includes more than two first conductive elements (115).

10. The electronic add-on module (100) according to any one of claims 8 or 9, wherein, When the second part is in the unstressed state and the second conductive element (116) is provided by the spring washer, the spring washer partially abuts against the first part (101) and the second part (102) without providing an electrical connection between the first conductive elements (115) and the second conductive element.

11. The electronic add-on module (100) according to any one of claims 2 to 10, wherein, The first part (101) includes a protrusion (117) disposed on the inner side surface (118) of the first part, wherein the second conductive element (116) is adjacent to the protrusion.

12. The electronic add-on module (100) according to any one of claims 1 to 11, wherein, The electronic component that is energized when electrically connected and connected to the circuit board assembly is the sensor arrangement (112).

13. The electronic add-on module (100) according to any one of claims 4 to 12, wherein, The second part (102) is capable of moving axially relative to the first part (101) by a distance greater than the gap (119).

14. A component comprising a drug delivery device (1) and an electronic attachment module (100) according to any one of the preceding claims, the electronic attachment module being configured for releasable attachment to the drug delivery device, wherein, The drug delivery device includes: • A housing (10) having a container configured to receive a drug or a cartridge filled with a drug. • A dose setting unit, comprising a dose selection grip (12) and a dose button (11), the dose selection grip being rotatably movable relative to the housing during dose setting, and the dose button being axially movable relative to the housing to induce dose dispensing. • A dose delivery unit comprising a plunger capable of moving at least axially relative to the housing during dose dispensing. The feature is that the electrical connection between the at least two first conductive elements (115) is provided before the dose dispensing begins.

15. The component of claim 14, wherein, When the second part (102) applies pressure to the dose button (12) in the axial direction to move the dose button axially relative to the housing, neither the first conductive element (115) nor the second conductive element (116) comes into contact with the dose button.

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