Method and system for charging electronic modules
By adopting resonance coupling technology in pen-type drug delivery equipment, efficient long-distance wireless charging is achieved, solving the problem of high alignment requirements in traditional technologies, and improving operational convenience and charging efficiency.
Patent Information
- Application Number
- JP2024541168
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-01-10
- Filing Date
- 2023-01-09
- Publication Date
- 2025-02-12
AI Technical Summary
The prior art is difficult to achieve efficient and long-distance wireless charging in pen-type drug delivery devices, and traditional short-range induction technology requires precise alignment of charging stations and equipment, which is inconvenient to operate.
Resonance coupling technology is adopted to establish resonance coupling between the charging station and the electronic module, wireless charging is performed using high-frequency resonance circuits, and frequency and phase are automatically adjusted to achieve high-efficiency energy transmission at long distances.
It realizes efficient wireless charging within the 15 cm range, reduces alignment requirements, improves operational convenience, and reduces interference to the electromagnetic environment.
Smart Images

Figure 2025504396000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates generally to a method for wireless charging of an electronic module of a drug delivery device.The present invention further relates to a charging system for wireless charging of an electronic module of a drug delivery device. [Background technology]
[0002] Pen-type drug delivery devices are used in applications where regular injections occur by people without formal medical training. This is becoming increasingly common among diabetics, who are able to effectively manage their disease through self-care. In practice, such drug delivery devices allow the user to individually select and expel multiple, user-modifiable drug doses. However, setting the correct dose can be difficult or burdensome, for example for patients with visual and / or physical disabilities.
[0003] There are essentially two types of drug delivery devices: resettable (i.e., reusable) and non-resettable (i.e., disposable) devices. 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, removing and replacing the pre-filled cartridge from these devices may require 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 set by the dial and delivered from the pen can be useful for various device users for memorization or to assist in detailed logging of the dose history. Therefore, drug delivery devices using electronic devices are becoming increasingly popular among users and patients as well as in the pharmaceutical industry. 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 connected to the drug delivery device. The electronic module of this known device is provided with a rechargeable battery (accumulator).
[0005] Wireless charging of electronic modules is generally known. Typically, short-range electromagnetic induction methods are applied for wireless charging of smartphones, e.g. the Qi standard. Devices operating according to the Qi standard rely on electromagnetic induction between planar coils. The Qi system consists of two types of devices: a base station, which is connected to a power source and provides inductive power, and a mobile device, which consumes the inductive power. The base station includes a power source, which includes a power source coil that generates an oscillating magnetic field. The mobile device includes a power receiver, which holds a power receiver coil. The magnetic field induces an alternating current in the power receiver coil (Faraday's law of electromagnetic induction). This power transfer is efficient if a short distance between the two coils and shielding of their surfaces are ensured. More specifically, shielding is required on the two "outer" faces of the coil, i.e. the face opposite the other coil.
[0006] In addition, power transmission by resonant circuits is known, for example from EP 3544196 A1. This technology is relatively new and requires coils with very low losses, i.e. very high Q resonant circuits, resulting in high voltages and currents in the resonant circuits. In addition, efficient power transmission requires tuning the resonant circuits to exactly the same frequency, and to achieve this, manufacturing tolerances must be compensated. Due to the limited space in electronic modules used in or with drug delivery devices, it is hardly possible to automatically tune or match the resonant circuit on the receiver side to a known frequency. The space required for tuning circuits used in or with drug delivery devices, among other constraints, means that the technology of loosely coupled resonant circuits cannot be used in the field of pen-type drug delivery devices if the receiver circuit has to be tuned. Summary of the Invention [Problem to be solved by the invention]
[0007] It is an object of the present disclosure to further improve the operability of wireless charging of electronic modules used in or with pen-type drug delivery devices. [Means for solving the problem]
[0008] This object is solved, for example, by the subject matter defined in the independent patent 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 in place of those defined in the independent claims, as will become apparent from the following description.
[0009] One aspect of the present disclosure relates to a method for wireless charging of an electronic module of a drug delivery device, comprising providing a charging station with an oscillator connectable to a power source, e.g., a source coil through which alternating current (AC) electricity flows to form an oscillating electromagnetic field, and a source resonant circuit inductively coupled to the oscillator, and an electronic module with a rectifier, e.g., a load coil connected to a rechargeable battery (accumulator), and a receiver resonant circuit inductively coupled to the rectifier, further comprising the steps of connecting a power source to the oscillator of the charging station, placing the electronic module at a distance of 15 cm or less from the charging station, and matching, adjusting or synchronizing the frequency of the source resonant circuit with the frequency of the receiver resonant circuit, thereby establishing a resonant coupling between the source resonant circuit and the receiver resonant circuit for transmitting (tunneling) power from the charging station to the electronic module.
[0010] The inductive coupling between the oscillator and / or rectifier and the respective resonant circuit may be realized by a respective coil, for example a single copper loop. The resonant circuit may be a coil, optionally connected to a capacitor. Preferably, the resistance in the resonant coil is significantly reduced, for example by using high frequency twisted wire of sufficient diameter. Furthermore, the optional capacitor is preferably capable of holding a high voltage, for example several thousand volts.
[0011] The application of the tunneling technique based on resonant coupling has the advantage over conventional short-range inductive coupling techniques (e.g., the QI standard for wireless charging of smartphones) that a much longer transmission range is possible. In other words, the electronic module does not need to be installed directly adjacent to or abutting the charging station. Rather, a distance of, for example, up to 15 cm is sufficient to charge the battery of the electronic module, thereby facilitating charging and improving operability. In addition, resonant coupling provides very high efficiency even for long-distance applications and does not radiate electromagnetic fields. The oscillating magnetic field generated by the resonant circuit is sinusoidal and almost distortion-free, which is a great advantage in terms of electromagnetic compatibility. Furthermore, the coil does not need to be rigorously oriented. Rather, the tunneling effect allows a wide range of misalignments to be compensated for.
[0012] According to the present disclosure, the frequency of the power supply side resonant circuit is matched or adjusted to the frequency of the power receiver side resonant circuit, thereby eliminating the need for bulky circuitry on the receiver side to automatically adjust and / or match the resonant circuit of the receiver to the known frequency of the power supply. In an optional embodiment, the frequency and phase can be matched, i.e., synchronized, so that the two existing signals overlap. This may be the case in options where the receiver circuit is already oscillating by itself and the power supply must match its signal to allow resonant coupling. There are several options for matching the frequency or synchronizing the power supply device signal with the receiver, which has a certain resonant frequency, which may be used alternatively or in combination.
[0013] For example, several power coils and resonant circuits can be provided with different orientations, which makes it possible to always select the best one, i.e. the one with the best power ratio.
[0014] According to a first option, the step of tuning or matching the frequency of the resonant circuit on the power source side to the frequency of the resonant circuit on the power receiver side includes the steps of generating a frequency sweep on the power source side and measuring the power delivered by the resonant circuit on the power source side, i.e. detecting the load. Depending on the Q of the resonant circuit, i.e. the losses of the coil and the initial coupling coefficient of both circuits, a long hold time may be required at the frequency to stimulate the receiver to a level that can be measured by the power source. Nevertheless, this first option provides a simple and reliable way to tune an adaptable power source to a receiver with a constant resonant frequency.
[0015] Furthermore, according to a second option, the step of tuning or matching the frequency of the power source resonant circuit to the frequency of the power receiver resonant circuit includes generating a frequency sweep on the power source side and wirelessly transmitting an answer from the electronic module, for example via Bluetooth, to the charging station when the power receiver resonant circuit receives a sufficient amount of energy. This approach speeds up the tuning or matching procedure.
[0016] Still further, according to a third option, the step of adjusting or matching the frequency of the resonant circuit on the power supply side to the frequency of the resonant circuit on the power receiver side includes the steps of frequently stimulating the coil of the resonant circuit on the power receiver side by the electronic module, receiving this signal by the charging station, for example by a wideband antenna, measuring its phase and frequency, and adjusting the resonant circuit on the power supply side to said phase and frequency of the resonant circuit on the power receiver side. In other words, the coil of the receiver can be frequently stimulated by the receiver itself, which can generate an oscillating magnetic field corresponding to the resonant frequency of the receiver. This can include frequency mismatches caused by foreign objects. The power supply unit can receive the signal by a wideband antenna, which can be a low-Q resonant circuit, and measure its phase and frequency. This information can be used to adjust the resonant circuit on the power supply device to the exact phase and frequency of the receiver. This method also has the additional advantage of achieving the fastest adjustment time and being very precise and efficient. Furthermore, this method allows the tunneling effect to be established from the start, which offers the advantage that the coil coplanarity misalignment can be compensated for over a relatively wide angle.
[0017] Generally, these options do not require the receiver to know its exact resonant frequency. Rather, the power source is responsible for identifying the proper frequency at which resonant coupling and power transfer can occur, and adjusting its resonant circuit accordingly. More specifically, according to one example of the present invention, the operating principle may include the following steps: Step 1: The receiver stimulates its load coil with a short signal impulse with a wide frequency content. An example of such a stimulation signal may include a chirp signal, i.e. a sine wave whose frequency increases starting from, for example, 0 Hz or higher. For stimulation purposes, the chirp signal does not have to start at 0 Hz. Instead, a frequency sweep limited to the expected range of possible resonant frequencies can be used. Step 2: The stimulation signal is inductively coupled from the load coil of the receiver to the receiver-side resonant circuit. Step 3: A "ringing" effect occurs in the receiver resonant circuit, i.e. frequencies away from the resonant frequency are quickly damped, and the circuit continues to oscillate at the resonant frequency for a short period of time (i.e. depending on its Q factor). The apparent resonant frequency includes the effect of any foreign objects in the vicinity of the coil. Optional Step 3a: The receiver estimates the resonant frequency of its resonator based on observing the impedance change in its load coil. It then repeats steps 1-3, but only using stimulation signals that are close to the observed resonant frequency, resulting in stronger and more efficient stimulation of the receiver resonator (assuming the same amount of energy is used). Step 4: A wideband antenna at the feeder side is used to detect this (weak) "ringing" signal (frequency and phase). Step 5: The power supply side matches its resonant frequency to the detected signal and begins stimulating the phase of its resonant circuit with the received signal. Step 6: Energy begins to be generated in the resonant circuit of the power source and is also transmitted to the power receiver, forming a resonant coupling.
[0018] The frequency sweep can be used to find the frequency at which power transfer is most efficient. It is not essential that this frequency be precisely known. The practical goal of this method is rather to find the frequency at which power transfer is most efficient. This frequency also depends on parasitic and detuning effects caused by nearby objects and materials, and on the load presented by the electronic module being charged. The frequency may also vary over time. Therefore, any reference to a resonant frequency, instead of the actual resonant frequency of the receiver, may be understood as a reference to a system resonant frequency that is useful for achieving the desired resonant coupling effect and efficient power transfer.
[0019] According to another aspect of the present disclosure, the electronic module is installed at a distance of 12 cm or less from the charging station, for example, at a distance of 3 to 6 cm or less from the charging station. This makes it much easier to handle compared to conventional short-distance inductive coupling technologies (e.g., QI standard for wireless charging of smartphones), because the electronic module or the drug delivery device including the electronic module must be installed near the charging station without aligning these units with each other or taking care to install these units side by side and in close proximity to each other. For example, the diameter of the receiver side coil may be 15 mm, and the electronic module may be installed at a distance of 10 times or less, preferably 4 to 8 times or less, of the coil diameter of the receiver side resonant circuit from the charging station.
[0020] According to an independent aspect of the present disclosure, a charging system for an electronic module of a drug delivery device may include a charging station with an oscillator connectable to a power source, and an electronic module with a rectifier connected to a rechargeable battery. The charging system may further include a resonant circuit pair with a high Q factor, a source-side resonant circuit inductively coupled to the oscillator in the charging station, and a receiver-side resonant circuit inductively coupled to the rectifier in the electronic module. The quality factor, or Q factor, is a dimensionless parameter that describes the damping or energy loss rate of an oscillator. A high Q factor corresponds to low losses. It may also be approximately defined as the ratio of the energy stored in the resonator to the energy lost in one radian of an oscillation cycle. The Q factor may alternatively be defined as the ratio of the center frequency of the resonator to its bandwidth when subjected to an oscillating driving force. Low losses are favorable for obtaining the required strong resonant oscillation, and a reduction in bandwidth is related to the tuning process. To transfer power from the charging station to the electronic module, the charging station and the electronic module are configured to establish a resonant coupling between the source-side resonant circuit and the receiver-side resonant circuit, for example according to the method described above.
[0021] The charging system may include at least one resonant circuit having a Q factor of at least 500, such as at least 800, and preferably at least 1000. In an embodiment, the Q factor may be in the range of 800 to 1200.
[0022] Additionally or alternatively, at least one resonant circuit may be formed by a single-phase solenoid in parallel with a capacitor, i.e., one loop coil. For example, the power source side resonant circuit and / or the power receiver side resonant circuit may be formed by a single-phase solenoid in parallel with a capacitor.
[0023] To transfer power from the charging station to the electronic module, the source-side resonant circuit in the charging station and the receiver-side resonant circuit in the electronic module may have substantially the same, or at least very close, resonant frequencies.
[0024] In the charging system, the electronic module may be permanently or releasably attached or incorporated into a drug delivery device for setting and expelling variable doses of a liquid drug. For example, the drug delivery device includes a cartridge containing a liquid drug and a dose setting and drive mechanism configured to perform a dose dial setting operation to select a dose to be delivered by the drug delivery device and a dose delivery operation to deliver the set dose. The electronic module may include at least one sensor configured to detect operation of the dose setting and drive mechanism, and a processor configured to control operation of the at least one sensor and process and / or store signals from the at least one sensor. For example, the at least one sensor may be an optical sensor for detecting dose delivery operation of the dose setting and drive mechanism.
[0025] The electronic module may further include a communication unit for wireless communication with other devices, e.g. for wireless communication with a charging station and / or a mobile phone. The communication unit may be a wireless communication interface for communicating with other devices via a Wi-Fi or Bluetooth wireless network, 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, 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 to be delivered by the drug delivery device.
[0026] According to yet another 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 can be charged by a loosely coupled resonant circuit.
[0027] The drug delivery device may be a reusable device allowing replacement of an emptied cartridge, for example the cartridge may be received in a releasably attached cartridge holder.
[0028] In one embodiment, the drug delivery device includes a dial sleeve, e.g. a numbered sleeve, which is rotatable relative to the housing, e.g. along a helical path, at least in a dose setting operation. Additionally, a manual injection trigger, e.g. a dose and / or injection button or a member axially and / or rotationally locked thereto, may be axially movable relative to the dial sleeve and rotationally constrained to the housing, at least in a dose delivery operation.
[0029] The present disclosure further relates to a drug delivery device comprising an electronic module, such as the dose recording module disclosed in WO 2021 / 116387 A1, for use in the aforementioned charging system, the drug delivery device including a cartridge containing a medicinal product.
[0030] The terms "drug" or "medication" are used synonymously herein to refer to a pharmaceutical formulation comprising 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 exerts a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental health. Drugs or medicines may be used for a limited duration or periodically for chronic conditions.
[0031] As described below, a drug or pharmaceutical product 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 molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
[0032] The drug or pharmaceutical product may be contained within a primary package or "drug container" adapted for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible container configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, 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 cases, 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 the two or more components prior to and / or during administration to the human or animal body. For example, the two chambers may be configured to be in fluid communication with one another (e.g., via a conduit between the two chambers) and 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 upon administration of the components to the human or animal body.
[0033] The drugs or pharmaceuticals contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, 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.
[0034] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, 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 occurring in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue or other naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the molecular structure of human insulin with one or more organic substituents (e.g., fatty acids) attached to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.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.
[0035] 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. These include, but are not limited to, B30-N-palmitoyl-ThrB29LysB30 human insulin, B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®), B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin, B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
[0036] Examples of GLP-1, GLP-1 analogues 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 Gila monster), 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, Z P-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.
[0037] 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.
[0038] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.
[0039] 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.
[0040] 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 pharmaceutically acceptable salts thereof.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.
[0041] 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 (TBTIs) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).
[0042] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include a full-length antibody polypeptide but comprises at least a portion of a full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can 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.
[0043] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the 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 the 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 participate directly 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] 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).
[0045] 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.
[0046] 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 all equivalents thereof.
[0047] 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 (partial or total discharge) container systems. The container may be a replaceable container or an integrated non-replaceable container.
[0048] As further described in ISO 11608-1:2014(E), multi-dose container systems may include injection devices using a needle with replaceable containers. In such systems, each container holds multiple doses whose volume may be fixed or variable (pre-set by the user). Other multi-dose container systems may include injection devices using a needle with integrated non-replaceable containers. In such systems, each container holds multiple doses whose volume may be fixed or variable (pre-set by the user).
[0049] As further described in ISO 11608-1:2014(E), single-dose container systems may include injection devices using needles with replaceable containers. In one example of such a system, each container holds a single dose, which allows the entire amount of the administrable amount to be expelled (full expelled). In a further example, each container holds a single dose, which allows a portion of the administrable amount to be expelled (partial expelled). As also described in ISO 11608-1:2014(E), single-dose container systems may include injection devices using needles with non-replaceable containers. In one example of such a system, each container holds a single dose, which allows the entire amount of the administrable amount to be expelled (full expelled). In a further example, each container holds a single dose, which allows a portion of the administrable amount to be expelled (partial expelled).
[0050] As used herein, the terms "axial," "radial," or "circumferential" may be used with respect to the main 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.
[0051] Non-limiting exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings, in which: [Brief description of the drawings]
[0052] [Figure 1] 1 shows a perspective view of a charging system according to the present invention; [Diagram 2] FIG. 2 is a schematic diagram of the operating principle of resonant inductive coupling of the charging system of FIG. 1; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0053] In the figures, identical elements, identically functioning elements, or elements of the same type may be labeled with the same reference numbers.
[0054] In the following, some embodiments are described with respect to an insulin infusion device, however, the present disclosure is not limited to such application and may equally be implemented in infusion devices configured to expel other medicinal drugs, or in drug delivery devices in general, preferably pen devices and / or infusion devices.
[0055] 1 shows a pen-type drug delivery device 1, which comprises an electronic module 2 that can be attached or integrated into the drug delivery device 1. In the illustrated exemplary embodiment, the electronic module 2 is located at the proximal end of the drug delivery device 1, i.e. the end opposite the injection needle. The electronic module 2 can be fully integrated, for example into 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 to a button or knob of the drug delivery device 1.
[0056] In addition, the charging station 3 is depicted a few centimetres away from the drug delivery device 1. The charging station 3 may be connected to a power source via a cable 4.
[0057] The operating principle of energy transmission from a charging station 3 to an electronic module 2 by resonant inductive coupling is shown in Fig. 2, where the energy transmitter, the charging station 3, is depicted diagrammatically on the left and the energy receiver, the electronic module 2, is depicted diagrammatically on the right. The charging station 3 comprises an oscillator 5 connectable to a power source 6. A source coil 7 of the oscillator 5 is inductively coupled to a power source-side resonant circuit 8.
[0058] Similarly, a load of the electronic module 2, for example a rechargeable battery 9, is connected to a load coil 10 via a rectifier 11, and the load coil 10 is inductively coupled to a receiver-side resonant circuit 12.
[0059] Although the source coil 7 and the load coil 10 are depicted in the example of FIG. 2 as including multiple loops, they may each be a single loop of copper.
[0060] The resonant circuit 8 on the power supply side and the resonant circuit 12 on the power receiver side each include a self-resonant coil. The coils of the resonant circuit 8 on the power supply side and the resonant circuit 12 on the power receiver side resonate at the same frequency. For example, the resonant circuits 8 and 12 are coils of copper wire that resonate at, for example, 10 MHz due to their internal capacitance (represented by the dashed capacitor in FIG. 2).
[0061] When connected to the power source 6, alternating current (AC) electricity flows through the source coil 7 in the charging station 3 to form an oscillating electromagnetic field, which causes the power supply side resonant circuit 8 to output a sine wave with a frequency of, for example, 10 MHz. The frequency is not limited to 10 MHz, but is adjusted to a frequency at which the power supply side resonant circuit 8 and the power receiver side resonant circuit 12 resonate. The power receiver side resonant circuit 12, which resonates at the same frequency as the power supply side resonant circuit 8, captures the energy of the electromagnetic field, and the rectifier supplies direct current (DC) to the battery 9.
[0062] Assuming that the electronic module 2 in the cap of the pen 1 contains a coil 12 with a diameter of 15 mm, a transmission distance of more than 3 cm, for example 6 cm to 12 cm, can be realized. With a larger diameter on the power supply side, this distance can be further extended, for example to 15 cm. It is not necessary that both coils have the same diameter.
[0063] In use, assuming a very high Q factor, i.e. low losses, the energy stored in the resonant circuit will grow over multiple cycles, resulting in a stronger magnetic field between both resonators 8, 12. The increased power in the resonant magnetic field leads to the possibility of power transmission over longer distances. Ultimately, the receiver coil 10 will only receive a portion of the energy, but will benefit from the high energy and the resulting tunneling effect of the resonant magnetic field.
[0064] Furthermore, the source oscillator and receiver circuits may cause mismatching of the resonant circuits 8, 12 depending on the load. Therefore, it may be desirable to match the impedance of the load to improve efficiency and keep the resonant frequency on both sides the same.
[0065] The aforementioned tunneling effect only exists when both circuits are oscillating substantially in phase. The critical moment is the start-up of the receiver coil 12, when the energy transferred must be sufficient to stimulate the resonant circuit and create a resonant current in the resonator. After start-up, when both circuits are resonant, the tunneling effect provides higher efficiency and lower losses.
[0066] The resistance in the coils should be reduced as much as possible, for example by using high frequency twisted wire of sufficient diameter for coils 7, 8, 10 and / or 12.
[0067] To synchronize, adjust and match the receiver-side resonant circuit 12, which has a fixed resonant frequency, with the power source-side resonant circuit 8, which is, for example, self-adjusting and adaptive, a frequency sweep on the power source side can be generated and the power provided by the power source can be measured. Additionally or alternatively, a frequency sweep can be generated by the power source coil and the powered device can reply, for example, by Bluetooth, when the powered circuit receives a small amount of energy. This requires a Bluetooth interface on the charger side, but allows the receiver to communicate its charging state or the current it needs. In this way, the adjustment or matching can be speeded up. Furthermore, the receiver coil can be frequently stimulated by the receiver itself, which can generate an oscillating magnetic field corresponding to the receiver's resonant frequency, including frequency mismatches caused by foreign objects. The power source unit receives this signal with a wideband antenna and measures its phase and frequency. This information can be used to adjust the resonant circuit on the power source device to the exact phase value and frequency of the receiver. This method provides faster adjustment or matching and is also more accurate and efficient. Furthermore, the tunneling effect may be present from the start, providing the advantage of compensating for coil coplanarity misalignment over relatively wide angles.
[0068] The active resonator on the receiver side can also be used to communicate information from the device to the power source, which can be done by frequency modulation of the resonant circuit. [Explanation of symbols]
[0069] 1. Drug Delivery Devices 2 Electronic Module 3. Charging Station 4 Cable 5. Oscillators 6 Power supply 7 Source Coil 8 Power feeder side resonant circuit 9 Rechargeable battery (accumulator) 10 Load coil 11 Rectifier 12 Power receiver side resonant circuit
Claims
1. A method for wireless charging of an electronic module (2) of a drug delivery device (1), comprising: - connecting a power source (6) to an oscillator (5) of a charging station (3), said charging station (3) including a power source-side resonant circuit (8) inductively coupled to said oscillator (5); - placing an electronic module (2) including a receiver-side resonant circuit (12) inductively coupled to a rectifier (11) connected to a rechargeable battery (9) at a distance of less than 15 cm from said charging station (3); - adjusting the frequency of the power source resonant circuit (8) to the frequency of the power receiver resonant circuit (12) to establish a resonant coupling between the power source resonant circuit (8) and the power receiver resonant circuit (12) for transmitting power from the charging station (3) to the electronic module (2); The method includes:
2. 2. The method of claim 1, wherein the step of adjusting the frequency of the power supply side resonant circuit (8) to the frequency of the power receiver side resonant circuit (12) includes the steps of generating a frequency sweep at the power supply side and measuring the power supplied by the power supply side resonant circuit (8).
3. 2. The method according to claim 1, wherein the step of adjusting the frequency of the power source side resonant circuit (8) to the frequency of the power receiver side resonant circuit (12) comprises the steps of generating a frequency sweep on the power source side and, after the power receiver side resonant circuit (12) has received a certain amount of energy, wirelessly transmitting a reply from the electronic module (2) to the charging station (3), for example via Bluetooth over a coupling transformer.
4. 2. The method according to claim 1, wherein the step of adjusting the frequency of the power supply side resonant circuit (8) to the frequency of the power receiver side resonant circuit (12) comprises the steps of: frequently stimulating a coil of the power receiver side resonant circuit (12) by the electronic module (2); receiving this signal by the charging station (3), for example by a wideband antenna, measuring its phase and frequency; and adjusting the power supply side resonant circuit to the phase and frequency of the power receiver side resonant circuit (12).
5. The method according to any one of claims 1 to 4, wherein the electronic module (2) is placed at a distance of less than 12 cm from the charging station (3).
6. 6. The method according to claim 5, wherein the electronic module (2) is placed at a distance of 6 cm or less from the charging station (3).
7. The method according to any one of claims 1 to 6, wherein the electronic module (2) is installed at a distance from the charging station (3) that is less than 10 times, preferably less than 4 to 8 times, the diameter of the coil of the receiver-side resonant circuit (12).
8. A charging system for an electronic module (2) of a drug delivery device (1), comprising: a charging station (3) including an oscillator (5) connectable to a power source (6), an electronic module (2) including a rectifier (11) connected to a rechargeable battery (9); Including, The charging station further includes a high-Q resonant circuit pair (8, 12) including a power supply side resonant circuit (8) inductively coupled to the oscillator (5) in the charging station (3) and a power receiver side resonant circuit (12) inductively coupled to the rectifier (11) in the electronic module (2); A charging system, wherein the charging station (3) and the electronic module (2) are configured to establish a resonant coupling between the power supply side resonant circuit (8) and the power receiver side resonant circuit (12) to transmit power from the charging station (3) to the electronic module (2).
9. Charging system according to claim 8, characterized in that the Q factor of the resonant circuit (8, 12) is at least 800, preferably at least 1,000.
10. Charging system according to claim 8 or 9, characterized in that the supply-side resonant circuit (8) is formed by a single-phase solenoid in parallel with a capacitor.
11. The charging system according to any one of claims 8 to 10, wherein the receiver-side resonant circuit (12) is formed by a single-phase solenoid in parallel with a capacitor.
12. The charging system according to any one of claims 8 to 11, wherein the power supply side resonant circuit (8) in the charging station (3) and the power receiver side resonant circuit (12) in the electronic module (2) have the same resonant frequency.
13. 13. The charging system according to any one of claims 8 to 12, wherein the electronic module (2) is permanently or releasably attached or integrated into a drug delivery device (1) for setting and expelling variable doses of a liquid drug, the drug delivery device (1) comprising a cartridge containing a liquid drug, and a dose setting and driving mechanism configured to perform a dose dial setting 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 (2) comprising at least one sensor configured to detect operation of the dose setting and driving mechanism, and a processor configured to control operation of the at least one sensor and to process and / or store signals from the at least one sensor.
14. Charging system according to any one of claims 8 to 13, wherein the at least one sensor is an optical sensor for detecting dose delivery operation of the dose setting and drive mechanism.
15. Charging system according to any one of claims 8 to 14, wherein the electronic module (2) further comprises a communication unit for wireless communication with other devices, e.g. for wireless communication with the charging station (3).