Electronic Encoder Module for Drug Delivery Device and Drug Delivery Device - Patent application

Abstract

The present invention refers to charging an electronic module (2) of a drug delivery device (1) and a respective charging system. The electronic encoder module (2) may include at least one sensor unit, a PCBA (6) with a processor configured to control the operation of the at least one sensor unit and to process and / or store signals from the at least one sensor unit, a rechargeable battery (5) connected to the PCBA (6), and a cap-shaped outer shell (4) that at least partially houses the at least one sensor unit, the PCBA (6) and the battery (5). The outer shell (4) includes a side surface (11) and a top surface (10) arranged on the proximal side, and at least two electrical contacts (8, 9) connected to the battery (5) and / or the PCBA (6) are provided on the side surface (11) and / or on the top surface (10) arranged on the proximal side.

Description

[Technical field]

[0001] The present invention is generally directed to an electronic encoder module and to a drug delivery device having such a module. Additionally, a method of charging an electronic module of a drug delivery device and a charging system for charging an electronic module of a drug delivery device are disclosed. [Background technology]

[0002] Pen-type drug delivery devices have applications where regular injections occur by people without formal medical training. This is increasingly common for patients suffering from diabetes, where self-medication allows such patients to effectively manage their disease. In practice, such drug delivery devices allow the user to individually select and administer multiple user-variable doses of a medication. However, setting the correct dose can be difficult or burdensome for, for example, visually impaired and / or dexterous patients.

[0003] There are essentially two types of drug delivery devices: resettable (i.e., reusable) and non-resettable (i.e., disposable). For example, disposable pen delivery devices are supplied as self-contained devices. Such self-contained devices do not have a removable pre-filled cartridge. Rather, the pre-filled cartridge may not be removable and replaceable from these devices without destroying the device itself. Thus, such disposable devices do not need to include a resettable dose setting mechanism. The present invention is applicable to disposable and reusable devices.

[0004] For such devices, the ability to record the dose dialed and delivered from the pen may be valuable to users of a wide variety of devices as a memory aid or to support detailed recording of dose history. Thus, electronic drug delivery devices are becoming increasingly popular not only in the pharmaceutical industry, but also with users or patients. For example, a dose recording system is known from WO 2021 / 116387 A1, which includes a drug delivery device and an electronic module removably mechanically coupled to the drug delivery device. The electronic module of this known device comprises a rechargeable battery (accumulator). Furthermore, WO 2021 / 233799 A1 discloses a dial grip for an injection device, which includes internal electronics with a power source. Electrical contacts are provided on the handling part and on the top of the grip. WO 2019 / 101962 A1 and WO 2018 / 0134419 A1 disclose encoder modules for drug delivery devices. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present disclosure to further improve the ease of charging electronic modules used in or with pen-type drug delivery devices. [Means for solving the problem]

[0006] This object is solved, for example, by the subject matter defined in the independent claims. Advantageous embodiments and improvements are the subject of the dependent claims. It should be noted, however, that the present disclosure is not limited to the subject matter defined in the appended claims. Rather, the present disclosure may include improvements in addition to or instead of the independent claims, as will become apparent from the following description.

[0007] One aspect of the disclosure relates to an electronic encoder module for use with a drug delivery device, the electronic encoder module comprising at least one sensor unit, a PCBA having a processor configured to control the operation of the at least one sensor unit and to process and / or store signals from the at least one sensor unit, a rechargeable battery (accumulator) connected to the PCBA, and a cap-like outer shell at least partially housing the at least one sensor unit, the PCBA and the battery. The sensor unit may be part of the PCBA or may be connected, e.g. soldered, to the PCBA. The outer shell may include a side surface, e.g. a substantially cylindrical side surface, and a closely arranged top surface, e.g. a flat or dome-shaped top surface. Charging of the battery may be performed by at least two electrical contacts connected to the battery and / or the PCBA, the contacts being provided on the side surface and / or on the closely arranged top surface. The electrical contacts are preferably configured to abut, e.g. spring-loaded or elastic contacts, of a charging system, e.g. in a charging station, a cable connector or a housing. Such external, e.g. visible, contacts have the advantage that they offer a simple, reliable, compact and waterproof possibility for charging the battery of the electronic module.

[0008] The electrical contacts are made from a conductive material, such as a metal. The electrical contacts may include at least one ring, at least one ring segment, and / or at least one contact area made from a conductive material and surrounded by a non-conductive material of the shell. For example, when formed by a segmented ring or two rings, the contacts may be arranged axially symmetrically about a longitudinal axis of the electronic encoder module. In one example, both electrical contacts are located on a side of the shell. In another example, both electrical contacts are located on a top surface of the shell.

[0009] The supply contacts, including spring contacts or charging cables, can be attached to the module by magnets. Furthermore, the contacts can be used as sensing elements for activating the module, for example by detecting a finger by impedance measurement. Additionally or alternatively, the contacts can be used as sensing elements for detecting when the finger is released from the button again, for example to monitor the retention time after injection or to perform a plausibility check related to activation.

[0010] The electrical contacts may be attached to the shell by adhesive, press-fit, and / or overmolding. Additionally, the electronic encoder module may include a covered state and an uncovered state, in which a cap is attached to the electronic encoder module, the cap covering at least the electrical contacts of the electronic encoder module provided for charging.

[0011] The electronic encoder module may have a battery capable of supplying energy for several days, e.g. at least one week, to be used in or with a drug delivery device. The rechargeable battery may be a coin cell, e.g. a NiMH battery, with a charge capacity of e.g. more than 5 mAh and / or up to 50 mAh, e.g. between 6 mAh and 25 mAh. This is suitable for a battery life of about 6 weeks. The battery may have a height between 1.5 mm and 4.5 mm to avoid the module being bulky. Furthermore, the module may include a boost (power) supply unit, i.e. a boost converter unit, configured to supply a constant equal voltage, e.g. 3.3 V. The boost (power) supply unit may include at least one capacitor that can be used as a DC source with an output voltage greater than the DC voltage supplying the circuit, e.g. using a battery supplying only 1.2 V.

[0012] In the electronic encoder module, the at least one sensor unit may include at least one, e.g., two light sources, e.g., IR-LEDs, and at least two optical sensors, e.g., photodetectors. The sensor unit may be configured to detect a movement of, e.g., a rotatable encoder element, of the drug delivery device when the module is attached to the drug delivery device, which movement indicates a dose being dialed in and / or delivered from the drug delivery device.

[0013] More specifically, the first light source and the first optical sensor may be disposed adjacent to each other toward a sensor end of the first light pipe, and the second light source and the second optical sensor may be disposed adjacent to each other toward a sensor end of the second light pipe. Furthermore, each of the light pipes may have an opposite encoder end that, when blocked by a light reflective material, for example an encoder disk or an encoder ring of the drug delivery device, results in a light beam emitted from the respective first or second light source being reflected by the encoder element and then detected by the respective first or second optical sensor.

[0014] The electronic module may be permanently or releasably attached to or integrated with a drug delivery device for setting and administering variable doses of a liquid medicament. For example, the drug delivery device comprises a cartridge containing a liquid medicament and a dose setting and driving mechanism configured to perform a dose dialing operation for selecting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose. The electronic module may include at least one sensor unit configured to detect an operation of the dose setting and driving mechanism, and a processor configured to control an operation of the at least one sensor and to process and / or store signals from the at least one sensor. For example, the at least one sensor unit may include an optical sensor for detecting a dose delivery operation of the dose setting and driving mechanism.

[0015] The electronic module may further include a communication unit for wireless communication with other devices, e.g. a charger station and / or a communication unit for wireless communication with a mobile phone. The communication unit may include a wireless communication interface for communication with another device via a wireless network, such as Wi-Fi or Bluetooth, or an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), USB-C, mini-USB, or micro-USB connector. Preferably, the electronic module includes an RF, WiFi, and / or Bluetooth unit as a communication unit. The communication unit may be provided as a communication interface between the electronic module and the outside, e.g. another electronic device, e.g. a mobile phone, a personal computer, a laptop, etc. For example, the dosage data may be transmitted by the communication unit to the external device. The dosage data may be used for a dosage log or dosage history established in the external device. Additionally or alternatively, the communication unit may receive data from the external device, e.g. data regarding the health status of the user and / or dosage data regarding the amount of drug delivered by the drug delivery device.

[0016] According to an independent aspect of the present disclosure, a charging station for charging an electronic encoder module for a drug delivery device is provided. The charging station may comprise a socket, a battery unit, and electrical contacts, the socket being configured to receive the electronic encoder module with or without the drug delivery device. The electrical contacts of the charging station are arranged inside the socket and allow electrical connection with the electrical contacts of the electronic encoder module when the electronic encoder module is to be charged. The battery unit is configured to provide the power required for charging. For example, when the electronic encoder module is electrically connected to the charging station to charge the battery of the electronic encoder module, the charging station and the electronic encoder module include means such as ribs on the inside of the socket that engage with respective recesses of the electronic encoder module, allowing only connection in a predetermined orientation where charging is guaranteed.

[0017] A battery-powered docking station or charging pen may include a battery, e.g. a rechargeable battery (accumulator) or a non-rechargeable life-type battery, and spring contacts for contacting electrical contacts of the electronic encoder module during charging of the electronic encoder module. Such a battery-powered docking station or charging pen may further include means for indicating the status of the station and / or the module, e.g. at least one LED for indicating the charging status. Such a station has the advantage that it does not require cables or interfaces and is relatively cheap.

[0018] According to a further independent aspect of the present disclosure, a method for charging an electronic encoder module using a charging station is provided. The method may include the following steps: connecting the charging station to a power source to charge a battery unit of the charging station; inserting a drug delivery device including an electronic encoder module into the charging station or removing the electronic encoder module from the drug delivery device and inserting the electronic encoder module into the charging station to electrically connect the electrical contacts of the electronic encoder module to the electrical contacts of the charging station; removing the drug delivery device or the electronic encoder unit from the charging station. If the charging station is equipped with a life-type battery that does not require charging, the first step of charging the battery unit of the charging station can be omitted.

[0019] According to a further aspect of the present disclosure, a drug delivery device is provided that may include or be coupled to an electronic module, the electronic module configured such that its rechargeable battery may be charged by electrical contacts.

[0020] The drug delivery device may be a reusable device that allows replacement of an empty cartridge, for example the cartridge may be received in a releasably attached cartridge holder.

[0021] In one embodiment, the drug delivery device comprises a dial sleeve, e.g. a number sleeve, rotatable relative to the housing, e.g. along a helical path, at least in a dose setting operation. Further, a manually operable injection trigger, e.g. a dose and / or injection button, or a member axially and / or rotationally locked thereto, may be axially displaceable relative to the dial sleeve and rotationally constrained relative to the housing, at least in a dose delivery operation.

[0022] In one example, a drug delivery device may comprise an electronic encoder module, a housing, and a dose setting and drive mechanism configured to perform a dose dialing operation for selecting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose. The electronic encoder module may be removably coupled to said drug delivery device. Detection of the dose dialing operation and / or the dose delivery operation may be achieved by a drug delivery device further comprising an encoder disk or ring having a ring of teeth, the electronic encoder module being coupled to the drug delivery device such that movement of the encoder disk or ring relative to the at least one sensor unit is detectable by the at least one sensor unit. More specifically, the encoder disk or ring may comprise, for example, twelve light-reflecting teeth spaced 30° apart from one another, the at least one sensor unit being positioned such that, depending on the rotational position of the encoder, light emitted by one of the light sources is reflected by one of the teeth and detected by the respective optical sensor, while light emitted by the other of the light sources is not reflected by one of the teeth and thus not detected by the respective optical sensor. In one example, the encoder and the optical sensor unit are in an anti-phase arrangement, i.e., when both light sources emit light simultaneously, only one optical sensor receives the light and the other optical sensor does not receive the emitted light. When the encoder and the sensor unit move relative to each other, the optical sensor that previously received the light now does not receive the emitted light and the other optical sensor receives the light. This can be achieved by the encoder disk or the encoder ring selectively reflecting the light. Alternatively, the encoder disk or the encoder ring can selectively block the light. In another example, the encoder disk or the encoder ring and the optical sensor unit are not in an anti-phase arrangement or are arranged with a 90° phase difference, so that when both light sources emit light simultaneously, depending on the relative position of the encoder, none of the optical sensors detects the light, or only one optical sensor or all optical sensors detect the light.

[0023] The electronic system can be configured as a reusable clip-on module for the injection device or can be permanently attached to the drug delivery device. To this end, the electronic encoder module may further include a retention feature for permanently or releasably attaching the module to the drug delivery device, for example to a dial grip or button of the drug delivery device. Alternatively, the electronic system may be a unit or module integrated into the injection device. The terms electronic system and (electronic) module are used synonymously for both alternatives below. The ability to record doses may be valuable to a wide variety of device users as a memory aid or to support detailed recording of dose history. It is envisaged that the electronic system, e.g. the electronic module, may be configured to be connectable to a mobile phone or the like to allow the dose history to be downloaded periodically from the system.

[0024] The present disclosure further relates to a drug delivery device equipped with an electronic module, such as a dose recording module as disclosed in WO 2021 / 116387 A1, for use with a charging system as described above, the drug delivery device including a cartridge containing a medicament.

[0025] As used herein, the terms "drug" or "medicament" are used interchangeably to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof and, optionally, a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or to otherwise enhance physical or mental comfort. Drugs or agents may be used for a limited period of time, or periodically for chronic conditions.

[0026] As described below, a drug or agent may include at least one API, or a combination thereof, in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with 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 DNA 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.

[0027] The drug or agent may be contained within a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, a syringe, a reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some embodiments, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some examples, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing between two or more components prior to and / or during ejection into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with one another (e.g., by a conduit between the two chambers), allowing the two components to be mixed if desired by a user prior to ejection. Alternatively or additionally, the two chambers may be configured to allow mixing upon ejection of the components into the human or animal body.

[0028] The drugs or agents contained in the drug delivery devices described herein may be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, for example, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0029] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or substituted amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0030] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val, or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0031] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0032] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, These include ZP-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899) exenatide-XTEN and glucagon-Xten.

[0033] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0034] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0035] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0036] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharma- ceutically acceptable salts thereof.An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0037] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector functions and can fix complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).

[0038] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0039] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody 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.

[0040] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0041] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or pharmaceutical preparation in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0042] It will be understood by those skilled in the art that modifications (addition and / or deletions) may be made to the various components of the APIs, formulations, devices, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0043] Exemplary drug delivery devices may include 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 may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or an integrated non-exchangeable container.

[0044] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device integrated with a non-exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0045] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device having an interchangeable container. In one example of such a system, each container holds a single dose, such that the entire deliverable volume is discharged (fully discharged). In a further example, each container holds a single dose, such that a portion of the deliverable volume is discharged (partially discharged). As also described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device in which the non-interchangeable container is integrated. In one example of such a system, each container holds a single dose, such that the entire deliverable volume is discharged (fully discharged). In a further example, each container holds a single dose, such that a portion of the deliverable volume is discharged (partially discharged).

[0046] As used herein, the terms "axial", "radial", or "circumferential" may be used with respect to the major longitudinal axis of a device, cartridge, housing, or cartridge holder, e.g., an axis extending through the proximal and distal ends of a cartridge, cartridge holder, or drug delivery device.

[0047] Reference is now made to the accompanying drawings, in which non-limiting exemplary embodiments of the present disclosure are described.

Brief Description of the Drawings

[0048] [Figure 1a-b] An embodiment of a charging system according to the present invention is shown in a perspective view. [Figure 2a-d] An embodiment of an electronic module according to the present invention is shown in a perspective view. [Diagram 3] Shown is a partially exploded view of the module of FIG. 2a.

Mode for Carrying Out the Invention

[0049] In the figures, the same reference numerals may be used for the same elements, elements having the same function, or elements of the same kind.

[0050] In the following, some embodiments are described with reference to an insulin infusion device, however, the present disclosure is not limited to such application and can be equally deployed with infusion devices configured to expel other medicaments, or with drug delivery devices in general, preferably pen devices and / or infusion devices.

[0051] 1a and 1b show a pen-type drug delivery device 1 with an electronic module 2 which can be attached to or integrated into the drug delivery device 1. In the exemplary embodiment shown, the electronic module 2 is arranged at the proximal end of the drug delivery device 1, i.e. the end facing away from the injection needle. The electronic module 2 can be fully integrated, for example in a button or knob of the drug delivery device 1, or it can be permanently or releasably attached to the drug delivery device 1, for example as a cap connectable with a button or knob of the drug delivery device 1.

[0052] Further depicted is a charger station 3 connected to the module 2, with FIG. 1a diagrammatically showing a charger station suitable for holding and partially receiving the module 2 and / or the drug delivery device 1, while FIG. 1b diagrammatically showing a cap-like charger station which can be attached to the module 2 for charging.

[0053] 2a-3, the electronic encoder module 2 includes a shell 4 that at least partially houses or encloses a rechargeable battery (accumulator) 5 and a PCBA (printed circuit board assembly) 6 connected to the battery 5. The battery 5 and PCBA 6 may be carried in a chassis 7 that is carried by the shell 4 (FIG. 3).

[0054] The module 2 may further include at least one sensor unit (not shown) consisting of, for example, at least two light sources, e.g. IR-LEDs, and at least two optical sensors, e.g. photodetectors. The sensor unit is configured to detect a movement of a rotatable encoder element, e.g. a disk or a ring, of the drug delivery device when the module 2 is attached to the drug delivery device 1. Typically, this detectable movement indicates the dose dialed and / or delivered from the drug delivery device 1. Furthermore, the module 2 may include a communication unit (not shown) for wireless communication with another device, e.g. a smartphone, a network or a PC. The PCBA 6 may include a processor configured to control the operation of the at least one sensor unit and to process and / or store signals from the at least one sensor unit.

[0055] The battery 5 may be a lithium ion battery, for example having a capacity of about 25 mAh at 3.7 V with a peak current of about 50 mA. Such a battery may have a life span of about 15 to about 20 weeks without recharging and may be suitable for use in the module 2. Alternatively, the battery 5 may be a NiMH battery, for example having a capacity of about 6 mAh at 1.2 V with a peak current of about 18 mA. NiMH batteries have the advantage of being relatively small, less than 2.5 mm in height, for example about 2.3 mm. Such a battery may have a life span of about 2 weeks without recharging and may be suitable for use in the module 2.

[0056] To allow easy and reliable charging of the battery 5, the module 2 is provided with two electrical contacts 8, 9 connected to the battery 5 directly or indirectly via the PCBA 6. As shown in FIG. 2a, the contacts can be provided on the upper surface 10 arranged on the proximal side of the outer shell 4 as a central contact area 8, for example surrounded concentrically by a ring-shaped contact 9. In FIG. 2b, the electrical contacts 8, 9 are provided as two rings arranged on the side surface 11 of the outer shell 4. A further alternative is shown in FIG. 2c, where the contacts 8, 9 are provided as ring segments on the side surface 11 of the outer shell 4. Furthermore, FIG. 2d shows the contacts as two contact areas on the side surface 11 of the outer shell 4.

[0057] Each electrical contact 8, 9 is made from a conductive material and is surrounded by the non-conductive material of the shell 4. The electrical contacts 8, 9 can be attached to the shell 4 by, for example, gluing, press-fitting and / or overmolding. Charging of the battery 5 is performed by contact of the electrical contacts 8, 9 with spring contacts 12 of the charger station 3. Such spring contacts are a good and robust solution. However, other configurations are also suitable, for example elastic contacts made from spring-loaded sheet metal.

[0058] 3 an optional boost supply unit 13 is shown diagrammatically which may be carried by the chassis 7. The boost supply unit 13 may be located on or may be part of the PCBA 6. The boost supply unit 13 is configured to provide a constant equal voltage, for example 3.3V, from a battery having a lower voltage, for example 1.2V.

[0059] The drug delivery device 1 may be based on the same general operating principle as the disposable injection pen disclosed in EP 2 890 434 B1, where reference is made to the main functions and modes of operation. Non-limiting examples of modules 2 are disclosed in WO 2021 / 116387 A1 and PCT / EP2021 / 060631, where reference is made to the main functions and modes of operation of the electronic button module. [Explanation of symbols]

[0060] 1. Drug Delivery Devices 2 Electronic Module 3. Charging Station 4. Outer shell 5 batteries 6 PCBA 7 Chassis 8 Electrical Contacts 9 Electrical Contacts 10 Top side 11 Side 12 Spring contact 13 Boost supply unit

Claims

1. 1. An electronic encoder module for use with a drug delivery device (1), the electronic encoder module (2) comprising: At least one sensor unit; a PCBA (6) having a processor configured to control the operation of the at least one sensor unit and to process and / or store signals from the at least one sensor unit; A rechargeable battery (5) connected to the PCBA (6); 1. An electronic encoder module comprising a cap-shaped outer shell (4) that at least partially houses the at least one sensor unit, the PCBA (6) and the battery (5), the outer shell (4) comprising a side surface (11) and a top surface (10) arranged on a proximal side, and at least two electrical contacts (8, 9) connected to the battery (5) and / or the PCBA (6) are provided on the side surface (11) and / or on the top surface (10) arranged on the proximal side.

2. 2. The electronic encoder module of claim 1, wherein the electrical contacts (8, 9) comprise at least one ring, at least one ring segment, and / or at least one contact area made from a conductive material and surrounded by a non-conductive material of the outer shell (4).

3. 3. The electronic encoder module of claim 2, wherein the electrical contacts (8, 9) are both arranged on the side (11) of the shell (4).

4. The electronic encoder module of claim 2 , wherein the electrical contacts (8, 9) are both located on the top surface (10) of the shell (4).

5. The electronic encoder module according to any one of the preceding claims, wherein the electrical contacts (8, 9) are attached to the outer shell (4) by gluing, press-fitting and / or overmolding.

6. The electronic encoder module according to any one of claims 1 to 5, further comprising a boost supply unit (13) configured to provide a constant equal voltage, for example 3.3V.

7. The electronic encoder module according to any one of claims 1 to 6, wherein the rechargeable battery (5) is a coin cell battery with a charge capacity of 6mAh to 25mAh and / or a height of 1.5mm to 4.5mm.

8. The electronic encoder module of any one of claims 1 to 7, further comprising a communication unit for wirelessly communicating with other devices.

9. The electronic encoder module of any one of claims 1 to 8, wherein the at least one sensor unit comprises at least two light sources, e.g. IR-LEDs, and at least two optical sensors, e.g. photodetectors, and the sensor unit is configured to detect a movement of an encoder of the drug delivery device when the module (2) is attached to the drug delivery device, the movement indicating a dose being dialed in and / or delivered from the drug delivery device (1).

10. The electronic encoder module of any one of claims 1 to 9, further comprising a retention feature for permanently or releasably attaching the module (2) to a drug delivery device (1), such as to a dial grip or button of the drug delivery device.

11. A drug delivery device comprising an electronic encoder module according to any one of claims 1 to 10, comprising at least a housing and a dose setting and drive mechanism configured to perform a dose dialing operation for selecting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose.

12. The drug delivery device of claim 11, wherein the electronic encoder module (2) is removably coupled to the drug delivery device (1).

13. The drug delivery device of claim 11 or 12, further comprising an encoder having a ring of teeth, the electronic encoder module (2) being coupled to the drug delivery device (1) such that movement of the encoder relative to the at least one sensor unit is detectable by the at least one sensor unit.

14. 14. The drug delivery device of claim 9, wherein the encoder comprises 12 light-reflecting teeth spaced 30° from each other, and the at least one sensor unit is positioned such that, depending on the rotational position of the encoder, light emitted by one of the light sources is reflected by one of the teeth and detected by a respective optical sensor, while light emitted by the other light source is not reflected by one of the teeth.

15. The drug delivery device of any one of claims 11 to 14, further comprising a cartridge containing the medicament.

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