Wireless electronics assembly for an injection device

Abstract

To provide electronics assemblies with wireless capabilities for use in a drug delivery device.SOLUTION: An electronics assembly for use in a drug delivery device includes: a processor; a sensor arranged to measure a fill level of a drug container and output a measurement to the processor; a wireless module with which an external device can be paired; a power module arranged to supply power to the assembly; and memory storing instructions that the processor performs. The instructions include: activating the sensor at first time intervals and receiving measurement signals; each time the sensor is activated at the first time internal, determining, based on the received measurement signal, a change in the fill level of the drug container; and, when the change in the fill level is detected, activating the wireless module for a first duration to enable the external device to pair with the wireless module.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present specification relates to an electronics assembly having wireless capabilities for use in a drug delivery device. [Background technology]

[0002] There are various diseases that require treatment by injection of medication. Such injections can be performed using a drug delivery device that can be applied by a medical professional or the patient themselves. As an example, type 1 and type 2 diabetes can be treated by the patient themselves, for example, by injecting one or several drug doses per day. For example, a pre-filled, disposable drug pen or auto-injector can be used as the drug delivery device. Alternatively, a reusable pen or auto-injector can be used. In a reusable pen or auto-injector, the empty drug cartridge can be replaced with a new drug cartridge. Both types of pens or auto-injectors come with a set of one-way needles, which are replaced before each use. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure relates to a drug delivery device having electronics capable of detecting certain characteristics related to the drug delivery device, such as the fill level of a medication in a cartridge of the drug delivery device, and wirelessly transmitting those detected characteristics to an external device, such as a mobile phone, tablet, or computer, for viewing by a user. In certain cases, the electronics are housed within a bung or stopper of the cartridge.

[0004] In a typical overview, the electronics assembly is inserted into the cartridge bung. The electronics assembly detects the cartridge's fill level (e.g., by detecting the bung position) and, in some examples, the temperature of the cartridge or the medication within the cartridge. The fill level within the cartridge fluctuates as the patient uses the device, and the electronics assembly senses this change at short time intervals (e.g., 5 minutes). This level change activates the Bluetooth transmitter at the moment of detection. The patient can then pair or link an external device to the electronics assembly to activate transmission of measurement data (e.g., delivered dose). If, after a short time (e.g., 10 minutes), no further change in the fill level within the cartridge is measured and the external device is not paired, the Bluetooth transmitter can be automatically set back into sleep mode, and the electronics assembly resumes sensing at regular intervals for the next drug delivery operation. Each time an injection is detected, a new communication between the device and the external device is possible. As an additional feature, when paired, printed variable data (i.e., batch or expiration date) or label material code can be used. These can be read by a camera or manually entered by the patient to verify that the data received from the electronics assembly matches the drug delivery device.

[0005] Typically, the electronics assembly is disposed within the cartridge or located elsewhere within the drug delivery device such that a sensor in the electronics assembly is effective to detect changes in the cartridge or in a drive mechanism of the drug delivery device used to change the fill level of the cartridge (e.g., filling and drug delivery operations). When the electronics assembly determines a change in fill level, it is configured to initiate data exchange via a Bluetooth wireless module or similar wireless protocol. In a first state, the processor instructs the sensor to take measurements very infrequently, for example once every few days, and the wireless module is deactivated. This state is valid before assembly or before filling of the cartridge. After the bung containing the electronics is assembled into the cartridge, a response can be measured, such as an indication that the drug has been introduced into the cartridge or that the cartridge has been assembled into a drug delivery device. Detection of such a reliable response triggers a processor to switch the sensor activation to a more frequent measurement, for example, once every few minutes. In this example, the wireless module is activated at this point, enabling it to pair with the external device and deliver the current measurement for a short period of time. Alternatively, the wireless module can be activated whenever a change in the measurement result is determined by the processor, thereby further reducing power consumption as the wireless module is only activated for "new" measurements rather than for each measurement. An advantage of this arrangement is that the electronics assembly does not need to be externally activated after production and prior to introduction into a cartridge or drug delivery device, enabling the electronics assembly to be a self-contained (e.g., sealed) assembly.

[0006] Example electronics assemblies can be used in both single-use (e.g., disposable) and multiple-use (e.g., reusable) drug delivery devices. In an exemplary disposable embodiment, the electronics assembly is assembled and inserted into a cartridge, at which point the electronics assembly senses the cartridge in a low-frequency sensing mode while awaiting detection of introduction of a drug, indicating complete assembly of the disposable drug delivery device. Upon detecting the drug, the disposable drug delivery device can be ready for use, and the electronics assembly then enters a high-frequency sensing mode and awaits detection of a drug delivery operation, at which point the electronics assembly activates the wireless module to enable pairing with an external device for a short period of time. In an alternative embodiment, the electronics assembly does not have an initial low-frequency sensing mode, but instead includes an activation mechanism or sensor configured to detect assembly of the disposable drug delivery device and activate the high-frequency sensing mode. The activation mechanism can be a switch located on the electronics assembly to be triggered by contact with the drug delivery device during assembly.

[0007] In the example of a reusable drug delivery device, the electronics assembly is constructed and assembled into a pre-filled cartridge, at which point the electronics assembly can be placed in a low frequency sensing state, for example by a sensor configured to detect the assembly of the pre-filled cartridge into the drug delivery device, or the electronics assembly can be placed in a high frequency sensing mode when a medication is commanded into the cartridge but before commanding the cartridge into the drug delivery device. In both the above example of a single-use drug delivery device and the example of a multi-use drug delivery device, when the drug delivery device is in a ready-to-use state, the electronics assembly enters a high frequency sensing mode using a sensor or activation mechanism, thereby enabling faster detection of the next drug delivery operation and faster activation of the wireless module for a given duration after detection of the drug delivery operation.

[0008] Certain aspects of the present disclosure provide several benefits beyond adding wireless connectivity to a drug delivery device. For example, sealed electronics assemblies with internal power sources have a limited shelf life due to a limited amount of internal power. By limiting sensor activation before the drug delivery device is in a ready-to-use configuration, the shelf life of the manufactured electronics assembly can be extended prior to incorporation into a drug delivery device or cartridge. Similarly, by limiting activation of the wireless module after a drug delivery operation, the shelf life of the electronics assembly after final manufacture (i.e., ready-to-use state) of the drug delivery device can be extended. The extended shelf life of the electronics assembly allows it to be manufactured separately and independently from the manufacture of the cartridge or drug delivery device, thereby reducing or eliminating the impact on existing production lines.

[0009] Another advantage is that the electronics assembly can provide additional information to the user via wireless transmission to an external device. For example, an expiration date can be provided on the drug delivery device or cartridge, which can be transmitted to and stored in the external device to help the user verify the printed information and better manage their drug delivery. Additional information, such as a batch number or unique serial number of the drug delivery device or cartridge, can be transmitted to the external device to assist the user. This data can also be tracked centrally by the manufacturer to assist with recalls, track and analyze patient behavior, and monitor product use. Additionally, in some embodiments, the electronics assembly includes a temperature sensor, which can provide temperature data to an external device to, for example, alert the user when a temperature limit is reached. This also allows the manufacturer to track patient and carrier compliance with medication temperature handling policies.

[0010] An exemplary embodiment of the present disclosure is an electronics assembly for use in a drug delivery device. The electronics assembly includes a processor, a sensor arranged to measure the fill level of a drug container of the drug delivery device and output a measurement signal to the processor; a wireless module capable of pairing with an external device; a power module arranged to provide power to the sensor, the processor, and the wireless transmitter; and at least one non-transitory computer-readable medium storing instructions operable to cause the processor to perform operations including activating the sensor at a first time interval and receiving a measurement signal each time the sensor is activated at the first time interval, determining a change in the fill level of the drug container based on the received measurement signal, and activating the wireless module for a first duration when a change in the fill level is detected to enable the external device to pair with the wireless module.

[0011] In some examples, the stored instructions include transmitting changes in the fill level of the medication container to the external device when the wireless module is paired and disabling the wireless module.

[0012] In some examples, the electronics assembly includes a switch positioned to be activated by assembly of the electronics assembly into the drug delivery device, the switch activating the electronics assembly.

[0013] In some examples, the instructions include activating the sensor for a second time interval longer than the first time interval and receiving a measurement signal before activating the sensor for the first time interval, determining whether the drug container is empty or filled based on the received measurement signal, and stopping activating the sensor for the second time interval and starting activating the sensor for the first time interval when it is determined that the drug container is filled.

[0014] In some examples, the first time interval is less than 1 hour, in some examples, the second time interval is greater than 12 hours, and in some examples, the first duration is less than 30 minutes.

[0015] In some examples, the instructions include determining a remaining power level of the power module and adjusting the first duration based on the remaining power level. In some examples, the instructions include storing each change in the fill level of the medication container in a memory and transmitting each stored change in the fill level of the medication container to an external device when the wireless module is paired, and transmitting the wireless module This includes putting the module into a stopped state.

[0016] In some examples, the sensor is positioned to be disposed inside the bung, and the bung is configured to be inserted into the medication container. In some examples, the electronics assembly is configured to be inserted into the bung. In some examples, the electronics assembly and / or the sensor are integrally formed with the bung.

[0017] In some examples, the sensor is configured to measure the fill level of the medication container by measuring the position of the bung within the medication container. In some examples, the instructions include calculating the fill level of the medication container based on the sensed position of the bung. In some examples, the sensor includes an ultrasonic transmitter and a corresponding detector, the ultrasonic transmitter configured to emit an ultrasonic signal into the medication container and the corresponding detector configured to receive a reflection of the ultrasonic signal from the medication container and output a measurement signal to the processor. In some examples, the external electronics device is selected from a smartphone, a smartwatch, a tablet, and a personal computer.

[0018] In some examples, the drug delivery device or drug container includes printed identification or expiration date information, and the instructions include transmitting confirmatory identification information corresponding to the printed identification or expiration date information when the wireless module is paired.

[0019] Another example of the present disclosure is a method for activating a wireless module of an electronics assembly configured to be inserted into a drug container of a drug delivery device, the method including activating a sensor of the electronics assembly at a first time interval and receiving a measurement signal from the sensor arranged to measure a fill level of the drug container each time the sensor is activated at the first time interval, determining a change in the fill level of the drug container based on the received measurement signal, and activating the wireless module of the electronics assembly for a first duration to enable an external device to pair with the wireless module when a change in the fill level is detected.

[0020] In some examples, the method includes transmitting a change in the fill level of the medication container to the external device when the wireless module is paired and disabling the wireless module.

[0021] In some examples, the method includes activating the sensor for a second time interval longer than the first time interval before activating the sensor for the first time interval and receiving a measurement signal; determining whether the drug container is empty or filled based on the received measurement signal; and when it is determined that the drug container is filled, stopping activating the sensor for the second time interval and starting activating the sensor for the first time interval.

[0022] In some instances, the first time interval is less than 1 hour. In some instances, the second time interval is greater than 12 hours.

[0023] In some examples, the method includes storing each change in the fill level of the medication container in a memory, and when the wireless module is paired, transmitting each stored change in the fill level of the medication container to the external device and disabling the wireless module.

[0024] In some examples, the method includes determining a remaining power level of a power module of the electronics assembly and adjusting the first duration based on the remaining power level.

[0025] Yet another example of the present disclosure is a system including a drug delivery device, the drug delivery device comprising a housing and a drug delivery device configured to be contained within the housing of the drug delivery device. The drug delivery device includes a container and a bung disposed within a cavity of the drug container and configured to be driven into the drug container by a drive mechanism of the drug delivery device. The bung or drug container includes an electronics assembly including a processor, a sensor arranged to measure the fill level of the drug container and output a measurement signal to the processor, a wireless module capable of pairing with an external device, a power module arranged to provide power to the sensor, the processor, and the wireless transmitter, and a non-transitory computer-readable medium storing instructions operable to cause the processor to perform operations including activating the sensor at a first time interval and receiving a measurement signal each time the sensor is activated at the first time interval, determining a change in the fill level of the drug container based on the received measurement signal, and activating the wireless module for a first duration when a change in the fill level is detected to enable the external device to pair with the wireless module. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 is an exploded view of a drug delivery device. [Figure 2A] 2 is a cross-sectional view of the stopper of FIG. 1 housing an electronics assembly. [Figure 2B] FIG. 2B is a top view of the stopper of FIG. 2A. [Figure 2C] 2B is a cross-sectional view of the stopper of FIG. 2A disposed within the cartridge of the drug delivery device of FIG. 1. [Figure 3] FIG. 2D is a cross-sectional schematic view of the internal components of the electronics assembly within the stopper of FIGS. 2A-2C. [Figure 4A] 2A-2C disposed within the drug delivery device of FIG. 1.

[0023] FIG. [Figure 4B] 4B is a cross-sectional view of the electronics assembly and stopper of FIG. 4A disposed within the drug delivery device of FIG. 1 in a ready-to-use configuration. [Figure 4C] FIG. 4C is a cross-sectional view of the electronics assembly, stopper, and drug delivery device of FIG. 4B after a drug delivery operation. [Figure 5A] 1 is a flow chart illustrating a method for controlling activation of a wireless module of an electronics assembly. [Figure 5B] 10 is a flow chart illustrating a method for controlling a sensing duration mode of an electronics assembly. DETAILED DESCRIPTION OF THE INVENTION

[0027] Some cartridge-based injection and medical syringe systems include integrated electronics that support wireless connectivity. In some examples, a cartridge stopper (also called a bung) can include a self-contained electronics assembly that includes a sensor, a wireless module, a power module, and a processor with memory. For example, the stopper can accept an insertable electronics assembly that is separate from the stopper. For example, the stopper can be assembled into the stopper or cartridge after sterilization. The electronics assembly can be a self-contained unit, constructed before assembly of the drug delivery device and embedded within the stopper during final assembly of the drug delivery device. In some examples, the self-contained electronics assembly enables detection of the cartridge fill level and reporting the measured fill level by pairing with an external device (e.g., via Bluetooth or a similar wireless protocol). For example, a drug delivery device with a wireless module enables a smartphone or tablet to pair with the drug delivery device to confirm that an injection has occurred or to receive measurements from an internal sensor that provides confirmation or measurement of the expelled dose.

[0028] Regardless of the information provided, challenges exist when balancing the power requirements of the internal wireless module with the size and shelf-life limitations of typical built-in power sources. Two specific examples of challenges, discussed in more detail below, involve (1) how to extend the shelf-life of the integrated electronics assembly before assembly of the drug delivery device or filling of the cartridge, and (2) how to further extend the operational life of the integrated electronics assembly after assembly or filling, when use of the wireless module is required. In some examples of the present disclosure, a solution to the first challenge involves using a sensor to detect that medication has been loaded into the cartridge and then changing to a response detection mode to respond to the next injection, as described in more detail below. Additionally, in some examples, a solution to the second challenge involves limiting the operation of the wireless module, and therefore power consumption, to a short interval after detection of the injection, as described in more detail below.

[0029] As used herein, the term "drug" or "medicine" is used herein to describe one or more pharmaceutically active compounds. As described below, a drug or agent can include at least one small molecule or large molecule, or a combination thereof, in various types of formulations for treating one or more diseases. Exemplary pharmaceutically active compounds can include small molecules; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.

[0030] The term "drug delivery device" is intended to encompass any type of device or system configured to administer a volume of a drug into the human or animal body. The volume can typically range from about 0.5 ml to about 10 ml. Drug delivery devices can include, but are not limited to, syringes, needle-safe systems, pen injectors, auto-injectors, large volume devices (LVDs), pumps, perfusion systems, or other devices configured for subcutaneous, intramuscular, or intravascular delivery of drugs. Such devices often include a needle, which can include a small-gauge needle (e.g., greater than about 24 gauge, including 27, 29, or 31 gauge).

[0031] In combination with a particular drug, the devices described herein can also be customized to operate within desired parameters, such as within a certain time period (e.g., about 3 to about 20 seconds for a syringe, about 5 to about 60 minutes for an LVD), with low or minimal levels of discomfort, or within certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, drug viscosities ranging from about 3 cP to about 50 cP.

[0032] The drug or agent can be contained within a primary package, cartridge, or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other container configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharmaceutically active compounds. For example, in some embodiments, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some embodiments, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some embodiments, the drug container can store two or more of the drug formulations. The cartridge may be or include a dual-chamber cartridge configured to separately store two or more components (e.g., a drug and a diluent, or two different types of drugs), one in each chamber. In such embodiments, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components of the drug or medication before and / or during administration into the human or animal body. For example, the two chambers may be configured to be in fluid communication with each other (e.g., by a conduit between the two chambers) to allow mixing of the two components by a user prior to administration, if desired. Alternatively, or in addition, the two chambers may be configured to allow mixing of the components as they are being administered into the human or animal body.

[0033] The drug delivery devices and drugs described herein can be used to treat and / or prevent many different types of disorders. Exemplary disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0034] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes 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 pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to thereby have a similar function or activity (e.g., therapeutic efficacy).

[0035] Exemplary insulin analogs are Gly(A21),Arg(B31),Arg(B32) human insulin (insulin glargine); Lys(B3),Glu(B29) human insulin; Lys(B28),Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and in which Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0036] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysProHuman insulin; B28-N-palmitoyl-LysProHuman insulin; B30-N-myristoyl-ThrLy sB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin. Exemplary GLP-1, GLP-1 analogs, and GLP-1 receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-4 / Byetta / Bydureon. dureon / ITCA650 / AC-2993 (a 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide / Victoza, semaglutide, taspoglutide, Syncria / albiglutide, dulaglutide, exendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-112 60C, CM-3, GLP-1 Erigen, ORMD-0901, 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, TT-114, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0037] An exemplary oligonucleotide is, for example: mipomersen / Kynamro, a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0038] Exemplary DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0039] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropins, menotropins), somatropins (somatropins), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0040] Exemplary polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the aforementioned polysaccharides, e.g., polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 / Synvisc, sodium hyaluronate.

[0041] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immunized, or humanized, fully human, non-human (e.g., murine), or single-chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, antibodies have reduced ability to bind or are unable to bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or variants that do not support binding to Fc receptors, e.g., they have mutated or deleted Fc receptor binding regions.

[0042] The term "fragment" or "antibody fragment" refers to an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include a full-length antibody polypeptide, but still contains at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments refer to polypeptides derived from a full-length antibody polypeptide. Antibody fragments can include cleaved portions of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, monospecific or multispecific antibody fragments such as Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, bispecific, trispecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0043] The term "complementarity-determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the correct positioning of the CDR sequences to enable antigen binding. Although framework regions themselves are generally not directly involved in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0044] Exemplary antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0045] The compounds described herein can be used in pharmaceutical preparations comprising (a) the compound or its pharmaceutically acceptable salt, and (b) a pharmaceutically acceptable carrier.The compounds can also be used in pharmaceutical preparations that contain one or more other active pharmaceutical ingredients, or in pharmaceutical preparations in which the compound or its pharmaceutically acceptable salt is the only active ingredient present.Therefore, the pharmaceutical preparations of the present disclosure encompass any preparation that is made by mixing the compounds described herein and a pharmaceutically acceptable carrier.

[0046] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, salts having a cation selected from alkali or alkaline earth metals, such as Na, K, or Ca, or ammonium ions N(R)(R)(R)(R), where R to R are independently hydrogen, an optionally substituted C-C alkyl group, an optionally substituted C-C alkenyl group, an optionally substituted C-C aryl group, or an optionally substituted C-C heteroaryl group. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0047] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0048] 1 is an exploded view of a drug delivery device 100, which may be a disposable drug delivery device or a reusable drug delivery device. The drug delivery device 100 includes a cartridge 114 and a cartridge holder in which the cartridge 114 is disposed. The drug delivery device 100 includes a housing 110 that houses a cartridge housing 104. A bung or stopper 200 is disposed within the body 104 of the cartridge 114, and during use, the bung or stopper 200 can be advanced within the body 104 to expel the medicament from the cartridge 114. A needle assembly 115 can be attached to the cartridge housing 104. Prior to use, the needle 109 of the needle assembly 115 is protected by an inner needle cap 116 and an outer needle cap 117, which can be covered by a cap 118. The dose of medicament or drug to be expelled from the drug delivery device 100 is selected by turning a dose knob 112, and the selected dose is displayed via a dose window or display 113.

[0049] As described further below, the drug delivery device 100 may include one or more electronic components 122, 124, some of which may be included within the stopper 200 of the cartridge 114, for example as a self-contained electronics assembly. In some examples, the electronic components 122, 124 are located within other members of the drug delivery device, enabling sensors in the electronic components 122, 124 to determine or measure the fill level of the cartridge 114.

[0050] Continuing with the operation of the drug delivery device 100, turning the dose knob 112 produces a mechanical click, providing audio feedback to the user. The numbers displayed in the dose display 113 are printed on a sleeve housed within the housing 110, which mechanically interacts with a plunger configured to interact with the cartridge 114. When the needle 109 is inserted into a patient and the injection button 111 is then pressed, the drug dose displayed in the display 113 is expelled from the drug delivery device 100. During injection, the drive mechanism 106, shown as the outline of a plunger arm, drives the stopper 200 into the cartridge 114 to expel the drug. The stopper 200 acts as a barrier to prevent fluids and gases from leaking into and out of the cartridge 114 and can prevent evaporation of HO and other fluids. In some embodiments, the sealing function is provided by a resilient sealing element that contacts the container wall, but still allows the stopper 200 to slide. After the injection button 111 is pressed, the majority of the dose is actually injected into the patient's body when the needle 109 of the drug delivery device 100 remains in the patient's skin for a certain period of time. It will be understood by those skilled in the art that in some examples, the drug delivery device 100 is a single-use or disposable device, and the electronic components 122, 124 used in the drug delivery device 100 may similarly be present with similar functionality in a single-use or disposable drug delivery device.

[0051] 2A is a cross-sectional view of one embodiment of a stopper 200 of the drug delivery device 100. The stopper 200 includes a shell 202 and a core 204 that house the electronic devices 122, 124; in some embodiments, the electronic devices 122, 124 are embedded within the material of the core 204. In some examples, the core 204 is configured to be inserted into the shell 202 of the stopper 200 after manufacture. For example, the core 204 can be inserted into the shell 202 after the shell is disposed within the cartridge 114 of the drug delivery device 100. In other examples, the shell 202 is assembled with the core 204 having the electronic devices 122, 124 and then inserted into the cartridge 114. In some examples, the shell 202 includes a sealing element 208 (e.g., an O-ring) arranged to provide a sealing interface with the inner surface of the cartridge 114 when the shell 202 is inserted into the cartridge 114. In some examples, the shell 202 and core 204, with or without the electronic devices 122, 124, are manufactured as a single component.

[0052] In some examples, the materials of the shell 202 and the core 204 are selected for their ability to allow a sensor signal to pass through the shell 202 and the core 204. For example, polymers or Non-metallic materials such as ceramics or very thin metals (e.g., less than 0.1 mm thick) can be used. The electronic devices 122, 124 can include, for example, sensors, energy sources, microcontrollers, and / or wireless transceivers. The electronic devices 122, 124 are merely representative. Any number of electronic devices can be present. The sensor can be a sensor / transceiver device, such as a piezoelectric device, an acoustic sensor, or an electromagnetic sensor. The sensor / transceiver can send a signal, such as an ultrasonic, acoustic, optical, or other signal, through the stopper 200 and measure a response, which in some embodiments can be used to determine the position of the stopper 200 within the cartridge 114 or whether an injection has occurred. In some embodiments, the sensor includes an ultrasonic sensor having an ultrasonic emitter and an acoustic sensor, the sensor positioned to emit an ultrasonic signal into the cartridge 114 using the ultrasonic emitter and the acoustic sensor positioned to receive a reflection of the ultrasonic signal from the cartridge 114 caused by the fill level of the drug in the cartridge 114 or the presence of the drug in the cartridge 114. The position of the stopper 200 before and after injection corresponds to a change in the volume of medication remaining in the cartridge 114, which may indicate the volume or dose of medication expelled from the cartridge 114. In some embodiments, the response received by the sensor is provided to a controller (e.g., a processor located in the stopper 200 or elsewhere in the drug delivery device 100), which can receive the response and calculate the status of the cartridge 114. The status of the cartridge 114 may correspond to the fill level of medication in the cartridge 114, the position of the stopper 200, or the dose volume.

[0053] In some embodiments, the energy source is a battery or an energy storage device. The wireless module can communicate with an external electronic device as well as the sensor and the energy source. The external electronic device can be a controller, smartphone, tablet, or computer and can communicate data received from the sensor to an external database. Communication with the external device can be one-way or two-way. Data communicated from the sensor device to the external database can include information related to device identification (e.g., unique number), calibration data, production lot information, device material information, data related to storage time and production time, and information related to sensor measurements (e.g., measurement time, sensor measurements such as temperature, distance, optical signal, acoustic signal, etc.). The wireless module can communicate using any known wireless communication technique, including, for example, Bluetooth, NFC, or radio frequency.

[0054] In some embodiments, the outer shell 202 of the stopper 200 is constructed from a material such as metal, polymer (e.g., COC, PA, PP, PE, POM, PS, ABS, COP, etc.), glass, or ceramic. In some embodiments, the electronic device (or electronic assembly) 122, 124 includes one or more of a sensor, a power source (e.g., a battery), a controller or processor, a wireless communication module (e.g., Bluetooth, NFC, Bluetooth LE, any RF, IrDA), memory, an on-off switch, a temperature-sensitive element, a pressure sensor, etc. In some embodiments, the electronic device 122, 124 includes an on-off mechanism configured to trigger the electronic device 122, 124 during assembly of the drug delivery device 100, for example, upon contact of a component of the drug delivery device 100 with the stopper 200 (e.g., force from the drive mechanism 106).

[0055] 2B is a top view of stopper 200. Shell 202 surrounds core 204 and interfaces with sealing element 208, which forms a sealing interface with cartridge 114 when stopper 200 is introduced into cartridge 114. The sealing interface forms at least a portion of a sterility barrier within cartridge 114 to prevent drug delivery. The delivery device 100 allows for the sterility of the drug to be delivered to be maintained.

[0056] 2C is a cross-sectional view of the stopper 200 disposed within the cartridge 114. Various features of the illustrated stopper 200 are described above with respect to FIGS. 2A and 2B. The cartridge 114 includes a housing 602 that cooperates with the sealing element 208 of the stopper 200 to seal the open end of the cartridge 114. In some embodiments, a medication is disposed within the space between the cap 604 of the cartridge 114 and the outer shell 202 of the stopper 200.

[0057] In some embodiments, different measurement methods are used to measure the position of the stopper 200. A specific signal is generated that changes with the movement of the stopper 200 relative to a fixed position within the system or cartridge 114. This fixed position can be inside the cartridge 114. In some cases, for example, the fixed position is on a septum area of ​​the cartridge 114 or another rigid wall of the cartridge 114. Alternatively, an element can be introduced into the cartridge to provide a fixed reference. In other embodiments, the fixed reference can be located outside the cartridge, such as on the housing of the drug delivery device 100. In some embodiments, the sensor measures changes in an optical signal by sending light from a light source (e.g., an LED) to a fixed area and receiving the attenuated light with a photodetector. The intensity of the attenuation can be correlated to distance. Another possibility is to measure the change in the time required for a signal (e.g., an acoustic signal) to travel from a transmitter to a fixed position and return to a receiver position proximate the transmitter. In another embodiment, a signal (optical, acoustic, capacitive, etc.) can be sent from a fixed location to a receiver within the movable stopper 200, changes in the signal can be measured as the stopper moves, and the changes in the signal can be correlated to the stopper position within the cartridge 114.

[0058] In one example, a transmitter (e.g., one of electronic devices 122, 124) transmits a sound wave at a first time t1. The first time t1 (e.g., the time of transmission of the sound wave) can be provided to an external device. The sound wave propagates from the transmitter in stopper 200 toward the distal end of cartridge 114 (i.e., the end having cap 604) and is reflected (e.g., bounces off) a surface of cartridge 114 or a reflector disposed within the distal end of cartridge 114. A reflection of the sound wave (e.g., a reflected wave) propagates from the distal end of cartridge 114 toward a sensor within stopper 200. The reflected wave is received at a second time t2. The speed of the sound wave is the known speed of sound S in the drug within cartridge 114. The elapsed time between transmission and reception of the sound wave is t2-t1. This elapsed time is multiplied by the speed of sound to determine the distance the wave traveled from the transmitter to the distal end of cartridge 114 and back to the sensor. The travel distance is divided by two to determine the distance D between the stopper 200 and the distal end of the cartridge 114. The volume V of the medication within the cartridge 114 (e.g., the volume of medication sealed within the cartridge 114 between the stopper 200 and the distal end) is determined by multiplying the determined distance by the cross-sectional area A of the cartridge 114. Thus, V=A*(t2-t1)*S / 2. The detected difference between the determined volumes of medication within the cartridge 114 before and after the drug delivery operation corresponds to the dose administered to the patient.

[0059] 3 is a cross-sectional schematic view of the internal components of an electronics assembly 340, which may be, for example, electronic components 122, 124 shown in FIG. 1. The electronics assembly 340 is shown disposed within the stopper 200, which itself is located within the open end of the cartridge 114. The electronics assembly 340 includes a sensor 341, a transmitter 342, a processor 343, a memory 344, a wireless module 345, and a power module 346. The sensor 341 and transmitter 342 transmit sensing signals into the interior volume 303 of the cartridge 114 when the electronics assembly 340 is disposed within the stopper 200. The electronics assembly 340 is disposed within the electronics assembly such that it can emit a signal and the sensor 341 can detect a return or reflected signal from the interior volume 303. A processor 343 is operatively coupled to all of the elements of the electronics assembly 340 and controls the activation of the sensor 341, the transmitter 342, and the wireless module 345. As described above and discussed in more detail with respect to the following figures, the memory 344 stores instructions for use by the processor 343 in operating the components of the electronics assembly 340.

[0060] In operation, wireless module 345 is configured to communicate with an external electronic device to communicate information from electronics assembly 340. Power module 346 is configured to provide power to all of the components of electronics assembly 340. In some embodiments, electronics assembly 340 includes a capacitive device including a capacitive circuit configured to wirelessly receive power and provide energy to module 346, for example, from a smartphone via Near Field Communication Protocol (NFC) signals or by a typical wireless charging device with other inductive loading means.

[0061] Figure 4A is a cross-sectional view of the electronics assembly 340 within a stopper 200 configured to be disposed within the drug delivery device 100. The stopper 200 includes a shell 202 that holds the electronics assembly 340 and a cap 410 configured to seal the electronics assembly 340 within the stopper 200. Figure 4A shows the cap 410 in place 497 during assembly of the cartridge 114, prior to loading of the internal volume 303 of the cartridge with a drug. Thus, Figure 4A illustrates the assembly process in which the electronics assembly 340 operates in a low frequency sensing mode and uses a sensing signal 470 to detect when the internal volume 303 has been loaded with a drug.

[0062] 4A, the wireless module of the electronics assembly 340 is disabled and the electronics assembly 340 is in a very low power usage state to extend the shelf life of the electronics assembly 340 until the electronics assembly 340 detects that the cartridge 114 is ready for use. In some embodiments, in addition to or as an alternative to the low frequency sensing mode, the electronics assembly 340 includes an activation mechanism configured to trigger the electronics assembly 340 by being located within the stopper 200 or within the drug delivery device 100, as shown in FIG.

[0063] 4B is a cross-sectional view of the electronics assembly 340 and stopper 200 disposed within the drug delivery device 100 in a ready-to-use configuration. FIG. 4B shows the cartridge 114 and stopper 200 containing the electronics assembly 340, with the cartridge 114 installed within the drug delivery device 100 and the plunger 106 positioned to drive the stopper 200 and electronics assembly 340 into the cartridge 114. A cap 410 seals the electronics assembly 340 within the interior region of the stopper 200. The inner volume 303 of the cartridge 114 is filled with a medicament 40, and the electronics assembly 340 senses (via a sensing signal 470) the presence of the medicament 40 within the inner volume 303. When the electronics assembly detects the medicament 40 within the cartridge 114, the electronics assembly 340 is triggered to change from a low-frequency sensing mode to a high-frequency sensing mode and detect the next drug delivery operation within a reasonable timescale (i.e., so that the user does not wait too long for the wireless module to activate). 4B, the plunger 106 is driven by an actuator or drive mechanism of the drug delivery device 100, which houses the cartridge 114. In operation, the plunger 106 is driven against the stopper 200 (indicated by arrow 498), applying a force to move the stopper 200 into the cartridge 114 and expel a portion of the medicament 40 from the cartridge 114. vinegar.

[0064] 4C is a cross-sectional view of the electronics assembly 340, stopper 200, and drug delivery device 100 after a drug delivery operation. FIG. 4C shows the plunger 106 of the drug delivery device 100 contacting the stopper 200 and driving the stopper 200 into the cartridge 114 (indicated by arrow 499) to perform a drug delivery operation (e.g., an injection through the needle 109). During operation, after detecting the presence of the medicament 40, the electronics assembly 340 is in a high-frequency mode and emits a sensing signal 470, which in some embodiments is responsive to the position of the stopper 200 within the cartridge 114. The sensing signal 470 is processed by the electronics assembly 340, which detects the movement of the stopper 200 or the fill level of the cartridge 114 after the drug delivery operation shown. In response to detecting the injection, the wireless module of the electronics assembly 340 is activated for a short duration to enable pairing with the external device 480.

[0065] FIG. 4C shows the external device 480 initiating wireless communication 481 with the electronics assembly 340 and the wireless module of the electronics assembly 340 responding with a return wireless communication 482. In some examples, the return wireless communication 482 to the external device 480 includes a detected change in the fill level of the cartridge 114. In some examples, the return wireless communication 482 includes a history of detected changes in the fill level of the cartridge 114, enabling the external device 480 to receive all or a portion of the previous drug delivery history of the cartridge 114 or the drug delivery device 100. The history of detected changes may include, for example, previous changes, multiple previous changes (e.g., a certain number or period of time), or a complete history of detected changes. In some examples, the return wireless communication 482 includes temperature information or a temperature history sensed by the electronics assembly 340. In some examples, the return wireless communication 482 includes batch or expiration date information for the medication, cartridge, or drug delivery device. The return wireless communication 482 may also include any other parameters or changes sensed, detected, or determined by any or all components of the electronics assembly 340. In some embodiments, the return wireless communication 482 includes the status of the electronics assembly or particular components of the electronics assembly, such as remaining power, etc. In some examples, the plunger 106 is a syringe plunger and the cartridge 114 is a syringe housing (e.g., a single-use drug delivery device).

[0066] FIG. 5A is a flow diagram illustrating a method for controlling activation of the wireless module 345 of the electronics assembly 340. In some examples, the logic of FIGS. 5A and 5B is stored in the memory 344 of the electronics assembly 340 and executed by the processor 343. When the electronics assembly 340 is in a ready-to-use state (501), upon previous detection of a drug in the cartridge 114 or triggering of an activation mechanism, as described above, the processor 343 activates (502) the sensors (i.e., the sensor 341 and the transmitter 342) and interrogates the status of the cartridge 114. The processor receives (503) a signal from the sensor 341 and determines (504) whether a change in the fill level of the cartridge 114 has been sensed. In some examples, the change in the fill level of the cartridge 114 can be sensed as a change in the position of the stopper 200 within the cartridge 114. If no change is determined, the processor 343 waits 511 for a period of time (hereafter referred to as Time A), which may be, for example, 5 minutes, 10 minutes, 15 minutes, or 1 minute to 1 hour, or any time in between. Generally, Time A is selected to balance the average detection time and power usage of the electronics assembly 340. In some examples, the power usage of the sensing operation is minimal compared to the wireless module 345, and therefore the duration of Time A (high frequency mode) is approximately 10 minutes. Time A can be as short as requiring the user to wait at most a few minutes after injection so that the external device 480 can pair with the external device 480. In some examples, time A can be dynamically selected. For example, if the medication is administered only once a day, time A can be set to 12 hours after detection of the injection, and then subsequently reduced to 5 minutes to expedite drug delivery operations the next day.

[0067] Subsequently, if a change in the fill level of the cartridge 114 is determined, the processor 343 activates the wireless module 345 for a short duration (hereinafter referred to as time B), which may be, for example, 5 minutes, 10 minutes, 15 minutes, or 1 minute to 1 hour, or any time in between. Generally, time B is selected to balance the high power usage of the wireless module 345 with the flexibility of giving the user a larger time window to initiate pairing of wireless devices. In some embodiments, if the initial detection occurs during a drug delivery operation rather than immediately after the operation is completed, after a change in the fill level is determined, the processor 343 commands rapid further sensing operations until no further change is detected. Additionally, in some embodiments, the processor 343 stores the detected change in the fill level in memory 344 (506). While the wireless module 345 is activated, the external device 480 can pair with the electronics assembly 340. While the wireless module 345 is activated, the processor verifies whether pairing is detected (507). If pairing is not detected, the processor checks whether time B has expired (508). If pairing is not detected at the end of time B, the wireless module 345 is deactivated (510) and the electronics assembly returns to the high-frequency sensing mode (i.e., ready-to-use state 501). When pairing is detected, the wireless module 345 transmits the detected change to the external device 480 (509) and deactivates the wireless module 345 (510). As described above, after deactivating, the processor 343 can return to the high-frequency mode to detect the next drug delivery operation, or it can wait a time A* (which may be the same as time A or a different time specifically selected to occur only after a detected drug delivery operation) before returning to the high-frequency detection mode (511).

[0068] FIG. 5B is a flow chart illustrating a method for controlling the sensing duration mode of the electronics assembly 340. As discussed in more detail above, in some examples, the electronics assembly 340 enters the ready-to-use state 501 using an activation mechanism prior to final assembly of the drug delivery device, and in some examples, the electronics assembly 340 detects the ready-to-use state 501 using an infrequent sensing mode, as shown in FIG. 5B. In the infrequent sensing mode, the electronics assembly 340 is in an assembly state, which may include an activation step during final assembly of the components of the electronics assembly 340 or assembly of the electronics assembly into the cartridge 114 or drug delivery device prior to filling the cartridge with a drug (i.e., final assembly of the drug delivery device to make it ready for use) (520). In this assembly state, the processor 343 activates (521) the sensors (i.e., the sensor 341 and the transmitter 342) to interrogate the status of the cartridge 114. The processor receives (522) a signal from the sensor 341 and determines (523) whether a drug is detected in the cartridge 114. In some examples, loading of the drug in the cartridge 114 can be sensed as a change in the position of the stopper 200 within the cartridge 114. If loading is not determined (523), the processor 343 waits (524) a period of time (hereinafter referred to as time C), which can be, for example, 12 hours, 24 hours, 48 ​​hours, 1 hour to 1 day, or any time in between. In some examples, time C is selected to balance the power usage of the electronics assembly 340 to enable a long shelf life of the electronics assembly after construction and the expected time between loading of the drug delivery device with a drug and its expected use by a patient. Time C is the time required for the electronics assembly 340 to load before the drug delivery device is delivered to the patient for use. The electronics assembly may be selected to ensure it is in a ready-to-use state 501. When a drug is detected in the cartridge 114, the processor stores (526) the initially sensed value in memory 344 for later use in determining whether the fill level has changed to indicate a drug delivery operation has occurred.

[0069] Described above are devices and methods for providing energy to electronic circuitry within a cartridge system (e.g., those disclosed herein) using power modules (PMs), which may include, for example, batteries or other power storage devices, using technologies such as lithium ion, nickel metal hydride, nickel-cadmium, zinc air, and the like.

[0070] Aspects of the system disclosed above enable medical injectors to utilize "smart" technology with the addition of included electronic components (e.g., RFID, sensors) to impart certain functionality to the cartridge of a drug delivery device (e.g., a pen injector). When electronics are integrated into the stopper of the cartridge, one or more components (e.g., a sensor for measuring certain characteristics of the injector or cartridge) can be activated, which requires an energy source, typically a battery. One alternative is to use an energy harvesting means as a power source substitute in place of a battery. In some examples, a light source, such as an LED or laser light source, is included in the drug delivery device, and the electronics assembly includes a receptacle (e.g., a photovoltaic unit or light sensor) configured to receive light from the light source. In some examples, the receptacle is configured to switch the electronics assembly on or off upon receiving or terminating light incident on the receptacle, or in some examples, the receptacle provides power to the electronics assembly by converting received light into electrical energy.

[0071]

[0013] Embodiments of the present disclosure can also be applied to pre-filled single- and dual-chamber syringes that do not utilize cartridges. The examples described above with respect to electronic assemblies within the stopper of a cartridge can also be used with other drug containers, such as disposable pre-filled syringes or reusable / refillable cartridges. In some examples, the electronics assembly is housed within the cartridge or drug delivery device such that it is effective to sense changes in the fill level of the cartridge or syringe after injection. In some examples, components of the electronics assembly are located outside the stopper or within a different member of the cartridge or drug delivery device.

[0072] Some of the functions described above can be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. An apparatus can be implemented in a computer program product tangibly embodied in an information carrier, for example a machine-readable storage device, for execution by a programmable processor; method steps can be implemented by the programmable processor executing a program of instructions to perform the functions of the described embodiments by operating on input data and generating output. The described functions can advantageously be embodied in one or more computer programs executable on a programmable system including at least one programmable processor, at least one input device, and at least one output device coupled to receive data and instructions from a data storage system and transmit data and instructions to the data storage system. A computer program is a set of instructions that can be used directly or indirectly in a computer to perform a certain activity or achieve a certain result. A computer program can be written in any type of programming language, including compiled or interpreted languages, and can be implemented in any form, including a stand-alone program, or can be integrated into a computing environment. It may be implemented as a module, component, subroutine, or other unit suitable for use within a facility.

[0073] Those skilled in the art will understand that modifications (e.g., adjustments, additions, or deletions) may be made to the materials, compositions, apparatus, methods, systems, devices, and various components of the embodiments described herein without departing from the full scope and spirit of the inventive concepts, and that the present invention encompasses such modifications and all equivalents thereof.

[0074] Although several embodiments of the present disclosure have been described, it will be understood that various modifications can be made without departing from the spirit and scope of the disclosure. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. An electronics assembly (340) for a drug delivery device (100), the electronics assembly (340) comprising: a sensor (341) configured to detect relative movement between the sensor (341) and a housing (110) of the drug delivery device (100); a processor (343), activating the electronics assembly (340) based on the detected relative movement between the sensor (341) and the housing (110) of the drug delivery device (100); and the processor (343) configured to determine a dose volume based on the detected relative movement detected by the sensor (341) after activation of the electronics assembly (340); a wireless module (345) configured to transmit (482) data representing the determined volume of the dose to an external electronic device (480); and The electronics assembly (340) includes a power module (346), the power module (346) configured to supply electrical energy to the sensor (341), the processor (343), and the wireless module (345).

2. 2. The electronics assembly (340) of claim 1, wherein the processor (343) is configured to wake up the electronics assembly (340) by changing the electronics assembly (340) from a low power usage state to a ready-to-use state (501).

3. The electronics assembly (340) of claim 2, wherein the electronics assembly (340) has a longer shelf life in a low power usage state compared to a ready-to-use state (501).

4. 10. The method of claim 1, wherein the wireless module is configured to transmit data representing a drug delivery history of the drug delivery device to an external electronic device. An electronics assembly (340) according to any one of claims 1 to 3.

5. The electronics assembly (340) of any one of claims 1 to 4, wherein the processor (343) is configured to determine whether an injection has occurred from the drug delivery device (100) based on the relative movement detected by the sensor (341).

6. The electronics assembly (340) of any one of claims 1 to 5, wherein the external electronic device (480) comprises a smartphone (480).

7. The electronics assembly (340) of claim 6, wherein the wireless module (345) is configured to pair to a smartphone (480) using Bluetooth.

8. 8. The electronics assembly (340) of claim 7, wherein the wireless module (345) is configured to transmit (482) the determined volume of the dose to a smartphone (480) while paired to the smartphone (480).

9. The electronics assembly (340) of any one of claims 1 to 8, comprising a memory (344) configured to store the determined volume of the dose.

10. The electronics assembly (340) of any one of claims 1 to 9, wherein the processor (343) is located external to the stopper of the drug delivery device (100).

11. The electronics assembly (340) of any one of claims 1 to 10, wherein the sensor (341) comprises an electromagnetic sensor (341).

12. An electronics assembly (340) for a drug delivery device (100), the electronics assembly (340) comprising: a sensor (341) configured to detect a first relative movement between the sensor (341) and a housing (110) of the drug delivery device (100) and a second relative movement between the sensor (341) and the housing (110) of the drug delivery device (100); a processor (343), activating an electronics assembly (340) based on the detected first relative movement detected by the sensor (341); and the processor (343) configured to determine whether an injection has occurred from the drug delivery device (100) based on the detected second relative movement detected by the sensor (341) after activation of the electronics assembly (340); a wireless module (345) configured to transmit (482) data representative of the drug delivery history of the drug delivery device (100) to an external electronic device (480); and The electronics assembly (340) includes a power module (346), the power module (346) configured to supply electrical energy to the sensor (341), the processor (343), and the wireless module (345).

13. 13. The electronics of claim 12, wherein the processor (343) is configured to wake up the electronics assembly (340) by changing the electronics assembly (340) from a low power usage state to a ready-to-use state (501). Assembly (340).

14. The electronics assembly (340) of claim 13, wherein the electronics assembly (340) has a longer shelf life in a low power usage state compared to a ready-to-use state (501).

15. The electronics assembly (340) of any one of claims 12 to 14, comprising a memory (344) configured to store a drug administration history.

16. The electronics assembly (340) of any one of claims 12 to 15, wherein the external electronic device (480) comprises a smartphone (480).

17. The electronics assembly (340) of claim 16, wherein the wireless module (345) is configured to transmit (482) data representing the drug delivery history of the drug delivery device (100) to an external electronic device (480) while paired to the smartphone (480) using Bluetooth.

18. The electronics assembly (340) of any one of claims 12 to 17, wherein the sensor (341) comprises an electromagnetic sensor (341).

19. The electronics assembly (340) of any one of claims 12 to 18, wherein the processor (343) is located external to the stopper of the drug delivery device (100).

20. The electronics assembly (340) of any one of claims 12 to 19, wherein the power module (346) includes a battery (346).

21. 1. A method comprising: a sensor (341) of the electronics assembly (340) detecting relative movement between said electronics assembly (340) and the housing (110) of the drug delivery device (100); a processor (343) of the electronics assembly (340) operating the electronics assembly (340) based on the relative movement detected by the sensor (341); After activation of the electronics assembly (340), the processor (343) determines a dose volume based on the detected relative movement detected by the sensor (341); and a wireless module (345) of the electronics assembly (340) transmitting (482) the determined volume of the dose to an external electronic device (480); The method, wherein a power module (346) of the electronics assembly (340) is configured to supply electrical energy to the sensor (341), the processor (343), and the wireless module (345).

22. 22. The method of claim 21, wherein changing the electronics assembly (340) from a low power usage state to a ready-to-use state (501) is configured to wake up the electronics assembly (340).

23. 23. The method of claim 22, wherein the electronics assembly (340) has a longer shelf life in a low power usage state compared to a ready-to-use state (501).

24. 24. The method of any one of claims 21 to 23, comprising storing a drug administration history in a memory of the electronics assembly (340).

25. 25. The method of claim 24, comprising storing the drug administration history in a memory of the electronics assembly (340) before transmitting the drug administration history to the external electronic device (480).

26. The method of any one of claims 21 to 25, wherein the external electronic device (480) comprises a smartphone (480).

27. 27. The method of claim 26, wherein the determined volume of the dose is transmitted to a smartphone (480) while the smartphone (480) is paired to the wireless module (345) using Bluetooth.

28. 1. A method comprising: a sensor (341) of the electronics assembly (340) detecting a first relative movement between the electronics assembly (340) and the housing (110) of the drug delivery device (100) and a second relative movement between the electronics assembly (340) and the housing (110) of the drug delivery device (100); a processor (343) of the electronics assembly (340) operating the electronics assembly (340) based on the detected first relative movement detected by the sensor (341); After activation of the electronics assembly (340), the processor (343) determines whether an injection has occurred from the drug delivery device (100) based on the detected second relative movement detected by the sensor (341); and a wireless module (345) of the electronics assembly (340) transmitting (482) data representing the drug delivery history to an external electronic device (480); The method, wherein a power module (346) of the electronics assembly (340) is configured to supply electrical energy to the sensor (341), the processor (343), and the wireless module (345).

29. 30. The method of claim 28, wherein changing the electronics assembly (340) from a low power usage state to a ready-to-use state (501) is configured to wake up the electronics assembly (340).

30. 30. The method of claim 29, wherein the electronics assembly (340) has a longer shelf life in a low power usage state compared to a ready-to-use state (501).

31. 31. The method of any one of claims 28 to 30, wherein the external electronic device (480) includes a smartphone (480), and the data representing drug delivery history is transmitted to the smartphone (480) while the smartphone (480) is paired to the wireless module (345) using Bluetooth.

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